Hyseq-gute Zahlen - 500 Beiträge pro Seite

[Bombenleger]

wer hat meinungen zu Hyseq.finde die zahlen nicht schlecht und auch die Aussichten sehr gut.

[Bombenleger]

Hyseq Pharmaceuticals Announces Third Quarter 2002
Financial Results
Thursday October 24, 6:31 am ET

SUNNYVALE, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Hyseq Pharmaceuticals, Inc. (Nasdaq: HYSQ -
News), today announced results for the quarter ended September 30, 2002.

For the three months ended September 30, 2002, Hyseq reported a net loss of $1.4 million or $0.06 per
share compared to a net loss of $10.0 million or $0.59 per share for the same period in 2001. For the nine
months ended September 30, 2002, Hyseq reported a net loss of $28.5 million or $1.34 per share,
compared to a net loss of $25.1 million or $1.64 per share for the same period in 2001.

Revenues for the third quarter of 2002 were approximately $11.0 million, compared to revenues of $5.9
million for the same period in 2001. Revenues for the nine-month period ended September 30, 2002 were
$22.9 million compared to revenues of $17.5 million for the same period in 2001. The increase was primarily
due to the accelerated completion of Hyseq`s agreement with BASF Plant Sciences GmbH, scheduled to
end approximately January 31, 2003.

Net loss for the nine months ended September 30, 2002 included a one-time non-cash expense of $10.0
million for the issuance of warrants to collaboration partner, Amgen, as part of Hyseq and Amgen`s
agreement to develop and market the novel thrombolytic drug, alfimeprase, for the treatment of peripheral
arterial occlusion (PAO) and other cardiovascular indications. Excluding the one-time non-cash charge,
Hyseq reported a pro forma net loss of $18.5 million or $0.87 per share for the first nine months of 2002,
compared to a net loss of $25.1 million or $1.64 for the same period in 2001.

As of September 30, 2002, Hyseq had approximately $4.3 million in unrestricted cash compared to
approximately $12.3 million at December 31, 2001. In addition, as of September 30, 2002, Hyseq had $16.0
million available through a line of credit from George Rathmann, Ph.D., chairman of Hyseq`s board of
directors. Hyseq also expects to receive approximately $7.3 million in cash payments over the next four
months from BASF.

"As we move into the fourth quarter, we continue to push forward with clinical programs, collaborations and
financial strategies," said Dr. Ted W. Love, president and chief executive officer of Hyseq Pharmaceuticals.
"Development of our lead product candidate, alfimeprase, is on schedule, expected to begin Phase II trials in
the first half of 2003, and we continue to pursue revenue generating business development opportunities as
well as a variety of financial strategies to bring additional funding into the company."

Company Highlights

-- Granted our fifteenth gene-related patent from our proprietary
collection of rarely expressed full-length human gene sequences.
-- Callida Genomics, Inc., a majority-owned subsidiary of Hyseq, signed an
agreement with SurroMed and the National Institute of Standards and
Technology to develop a genome-wide SNP scoring system.
-- Signed license agreement with UCSF and Celera Diagnostics granting
Celera Diagnostics non-exclusive access to a large-scale cardiovascular
patient DNA sample collection for use in diagnostics.
-- Initiated Phase I trial for our lead product candidate, alfimeprase,
for the treatment of peripheral arterial occlusion.


As noted in our first quarter conference call, we have readjusted our conference call schedule, conducting
calls periodically around major news events and milestones, and holding one call at the end of the fiscal
year instead of on a quarterly basis. We will be updating the investing public regularly on our progress
through press releases and in conjunction with presentations at investor meetings and conferences in
compliance with Regulation FD.

About Hyseq

Hyseq Pharmaceuticals, Inc. is engaged in research and development of novel biopharmaceutical products
from its collection of proprietary genes discovered using its high-throughput screening-by-hybridization
platform. This platform provided a significant advantage in discovering novel, rarely-expressed genes, and
assembly of one of the most important proprietary databases of full-length human gene sequences. Hyseq
intends to further elucidate the physiological roles of its proprietary novel genes. Hyseq`s database includes
genes which encode a number of therapeutically important classes of molecules including chemokines,
growth factors, stem cell factors, interferons, integrins, proteases, hormones, receptors, and other potential
protein therapeutics or drug targets.

Information about Hyseq Pharmaceuticals is available at www.hyseq.com or by phoning 408-524-8100.

Statements contained in this press release which are not historical in nature, are intended to be, and are
hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private
Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as
"believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such
statements are based on our management`s current expectations and involve risks and uncertainties. Actual
results and performance could differ materially from those projected in the forward-looking statements as a
result of many factors, including, without limitation, uncertainties relating to unanticipated difficulties and
delays relating to gene identification, drug discovery and clinical development processes; changes in
relationships with strategic partners and dependence upon strategic partners for the performance of critical
activities under collaborative agreements; the impact of competitive products and technological changes;
uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to
obtain substantial additional funds required for progress in drug discovery and development. These and other
factors are identified and described in more detail in our periodic reports filed from time to time with the
SEC, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2001.
We disclaim any intent or obligation to update these forward-looking statements.

HYSEQ PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended Nine months ended
September 30 September 30
2002 2001 2002 2001

Contract revenues $11,022 $5,872 $22,915 $17,522
Operating expense:
Research and development 9,131 11,350 40,885 31,532
General and administrative 2,879 3,602 9,102 9,805
Restructuring -- 825 610 825
Total operating expenses 12,010 15,777 50,597 42,162
Loss from operations (988) (9,905) (27,682) (26,640)
Gain/(loss) on sale of fixed
assets (47) -- (34) --
Interest expense, net (409) (103) (864) (475)
Net loss before minority
interest (1,444) (10,008) (28,580) (25,115)
Loss attributable to minority
interest -- -- 112 --
Net loss $(1,444) $(10,008) $(28,468) $(25,115)

Basic and diluted net loss
per share $(0.06) $(0.59) $(1.34) $(1.64)
Weighted average shares used
in computing basic and diluted
net loss per share 22,767 16,911 21,197 15,351
Note (A)

(A) Pro forma net loss for the first nine months of 2002 was $(18,468) or
$(0.87) per share, excluding a one-time non-cash expense of
$10.0 million on the issuance of warrants to collaboration partner
Amgen, as part of Hyseq and Amgen`s agreement to develop and market
the novel acting thrombolytic drug alfimeprase for the treatment of
peripheral arterial occlusion (PAO) and other cardiovascular
indications.


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)

September 30, December 31,
2002 2001*
(unaudited)

Cash $4,272 $12,329
Working capital (3,151) (1,717)
Cash on deposit 1,106 1,606
Total assets 32,143 39,904
Deferred revenue 1,204 3,702
Noncurrent portion of capital lease
and loan obligations 1,289 2,228
Note Payable 4,000 4,000
Accumulated deficit (136,862) (108,394)
Total stockholders` equity 11,690 15,421

* The condensed consolidated balance sheet data at December 31, 2001 has
been derived from the audited financial statements as of that date.

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Source: Hyseq Pharmaceuticals, Inc.

[Aeppler]

On January 20, 2003, the Variagenics board of directors determined that the proposal (from acacia research) was not in the best interests of Variagenics or its stockholders and determined to reaffirm its recommendation that stockholders of Variagenics vote to approve the merger with Hyseq.


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[Bombenleger]

Hyseq To Mull Reverse Stock Split For Nasdaq
Compliance
Wednesday January 29, 5:58 pm ET

WASHINGTON (Dow Jones)--Hyseq Inc. said it will consider numerous alternatives, including a
possible reverse stock split, to ensure compliance with the Nasdaq Stock Market`s $1
minimum share price rule.

Variagenics Inc. (NasdaqNM:VGNX -
News) , which is merging with Hyseq,
provided the information about Hyseq`s
discussion on reverse split in a Form
8-K filed Wednesday with the
Securities and Exchange Commission.

The filing said Hyseq management
discussed the possibility of the reverse
stock split during a recent
stockholders` meeting.

The filing said Hyseq hasn`t yet
received a noncompliance notification
from Nasdaq about its share price.

Hyseq shares closed Wednesday at
81 cents each, down 1 cent.

Hyseq and Variagenics holders approved the merger of their companies at separate meetings
Tuesday. The combined company will be named Nuvelo Inc. and is scheduled to begin trading
under the Nasdaq symbol NUVO from Monday.

Sunnyvale, Calif.-based Hyseq develops products and tests using DNA array technology.

Variagenics, Cambridge, Mass., develops technologies for the discovery and commercialization
of drugs and diagnostics based on the genetic differences among individuals.

-By Christopher Scinta, Dow Jones Newswires; 202-628-7699; [e-mail]

[Bombenleger]

Hyseq and VARIAGENICS Merge to Form New
Company, Nuvelo
Monday February 3, 6:30 am ET

Combined Company Begins Trading on Nasdaq Under New Name And Ticker
Symbol, (Nasdaq: NUVO)

SUNNYVALE, Calif. and CAMBRIDGE, Mass., Feb. 3 /PRNewswire-FirstCall/ -- Hyseq
Pharmaceuticals, Inc. (Nasdaq: HYSQ - News) and VARIAGENICS, Inc. (Nasdaq: VGNX -
News) today announced that they have completed the merger of the two companies. The
combined company will be named Nuvelo, Inc. and will begin trading on Nasdaq under the
ticker symbol, NUVO, at the open of market today.

As previously announced, Dr. Ted W.
Love will serve as president, CEO and
board member of Nuvelo and Dr.
George Rathmann will assume the
chairmanship of the new board. The
remainder of the Nuvelo board of
directors will include Richard Brewer
and Mary Pendergast from the Hyseq
board and Dr. Philippe Chambon, Dr.
Jean-Francois Formela and Martin
Vogelbaum from the VARIAGENICS
board.

"With the combination of our emerging
product portfolios and strong corporate
relationships, we are confident that
Nuvelo will create substantial value for
its shareholders," commented Dr. Ted
W. Love, president and chief executive officer of Nuvelo. "We are excited to leverage the
strength of the new company to continue development of our lead product candidate,
alfimeprase, as well as our other biotherapeutic and diagnostic products."

2002 Year End Results and Conference Call Information

Nuvelo will announce its fourth quarter and 2002 results on February 24, 2003 and will hold a
conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the year end
results as well as the strategy and focus of the company.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is
engaged in the discovery and development of biopharmaceutical and molecular diagnostic
products. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is
currently in Phase I clinical trials. Additional programs include cancer diagnostics and drug
discovery focused on cancer immunotherapeutics and secreted proteins.

Information about Nuvelo is available at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to
be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements
may be identified by words such as "believe," "expect," "anticipate," "should," "may,"
"estimate," "goals," and "potential," among others. Such statements are based on our
management`s current expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the forward-looking statements as a
result of many factors, including, without limitation, the risk that we may not successfully
integrate the VARIAGENICS business following our recent merger, uncertainties relating to
drug discovery, clinical development processes and the development and commercialization of
our molecular diagnostics technology; changes in relationships with strategic partners and
dependence upon strategic partners for the performance of critical activities under collaborative
agreements; the impact of competitive products and technological changes; uncertainties
relating to patent protection and regulatory approval; and uncertainties relating to our ability to
obtain substantial additional funds required for progress in drug discovery and development.
These and other factors are identified and described in more detail in Hyseq filings, and those
of VARIAGENICS, with the SEC, including without limitation our respective Annual Reports on
Form 10-K for the year ended December 31, 2001, our most recent quarterly report on Form
10-Q, and the joint proxy statement/prospectus filed in connection with the merger. We
disclaim any intent or obligation to update these forward-looking statements.



Source: Hyseq Pharmaceuticals, Inc.

[Bombenleger]

Total Revenue
$11,022,000
$6,661,000
$5,232,000
$7,068,000
Cost Of Revenue
N/A
N/A
N/A
N/A
Gross Profit
$11,022,000
$6,661,000
$5,232,000
$7,068,000
Operating Expenses
Research And Development
$9,131,000
$10,740,000
$21,014,000
$14,974,000
Selling General And Administrative Expenses
$2,879,000
$3,165,000
$3,058,000
$3,647,000
Non Recurring
N/A
$610,000
N/A
$825,000
Other Operating Expenses
N/A
N/A
N/A
N/A
Operating Income
($988,000)
($7,854,000)
($18,840,000)
($12,378,000)
Total Other Income And Expenses Net
($34,000)
$40,000
$30,000
$927,000
Earnings Before Interest And Taxes
($1,022,000)
($7,814,000)
($18,698,000)
($11,451,000)
Interest Expense
$422,000
$253,000
$259,000
$199,000
Income Before Tax
($1,444,000)
($8,067,000)
($18,957,000)
($11,650,000)
Income Tax Expense
N/A
N/A
N/A
N/A
Equity Earnings Or Loss Unconsolidated Subsidiary
N/A
N/A
N/A
N/A
Minority Interest
N/A
N/A
$112,000
$293,000
Net Income From Continuing Operations
($1,444,000)
($8,067,000)
($18,957,000)
($11,357,000)
Nonrecurring Events
Discontinued Operations
N/A
N/A
N/A
N/A
Extraordinary Items
N/A
N/A
N/A
N/A
Effect Of Accounting Changes
N/A
N/A
N/A
N/A
Other Items
N/A
N/A
N/A
N/A
Net Income
($1,444,000)
($8,067,000)
($18,957,000)
($11,357,000)
Preferred Stock And Other Adjustments
N/A
N/A
N/A
N/A
Net Income Applicable To Common Shares
($1,444,000)
($8,067,000)
($18,957,000)
($11,357,000)

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[Bombenleger]

Nuvelo Announces Strategic Focus and Reports Fourth
Quarter and Year End 2002 Results
Monday February 24, 9:30 am ET

- Company to Focus on Biopharmaceutical Discovery and Development
-

- Company Announces IND Filing for Second Indication with
Alfimeprase -

SUNNYVALE, Calif., Feb. 24 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News),
formerly Hyseq Pharmaceuticals, today announced fourth quarter and year end 2002 financial
results and a continued strategic focus dedicated to the discovery and development of novel
biotherapeutics. The strategy resulted from a careful review of all assets and programs at both
Hyseq and VARIAGENICS following the close of the merger between the two companies on January
31, 2003.

As part of this plan, the Company will dedicate its resources to advancing its most promising
biopharmaceutical discovery and development programs, including alfimeprase, Nuvelo`s novel
acting thrombolytic currently in Phase I trials for peripheral arterial occlusion (PAO).

Nuvelo will leverage its proprietary gene collection and opportunistic in-licensing strategy to build
upon its pipeline of attractive therapeutic candidates. The Company also intends to out-license or
partner its immunotherapeutics portfolio and monetize non-core assets including its microarray
business, pharmacogenomic technology and molecular diagnostic programs, to further support its
biopharmaceutical development programs.

"Our focus is dedicated to building a successful biopharmaceutical business," stated Dr. Ted W.
Love, president and chief executive officer of Nuvelo. "This strategic initiative reflects our
commitment to creating a valuable product-focused company that leverages our drug discovery
and development expertise. To execute on this strategy, we will align the company`s assets and
resources and efficiently manage our finances to provide our key development programs with the
greatest chance of success."

Alfimeprase, Nuvelo`s lead development program, is projected to complete its Phase I trial by the
end of the first quarter 2003. In addition the Company recently filed an investigational new drug
(IND) application for a second indication in catheter occlusion. Nuvelo plans to initiate two Phase II
programs with alfimeprase in the first half of this year in both PAO and catheter occlusion and
anticipates to complete at least one Phase II "proof-of-concept" program by the end of 2003.

As previously announced, Nuvelo will take steps to help ensure that cash resulting from the merger
will fund its operations through 2004. As of the merger date, January 31, 2003, Nuvelo had
approximately $53.2 million cash available for the future operations.

The combined company changed its name to Nuvelo, Inc. and began trading under its new name
and Nasdaq symbol, NUVO, on February 3, 2003.

Fourth Quarter and Year End 2002 Financial Results

For the three months ended December 31, 2002, Nuvelo reported a net loss of $16.5 million or
$0.72 per share compared to a net loss of $11.4 million or $0.61 per share for the same period in
2001. For the twelve months ended December 31, 2002, Nuvelo reported a net loss of $45.0
million or $2.08 per share, compared to a net loss of $36.5 million or $2.26 per share for the same
period in 2001.

Revenues for the fourth quarter of 2002 were approximately $3.5 million, compared to revenues of
$7.1 million for the same period in 2001. Revenues for the twelve-month period ended December
31, 2002 were $26.4 million compared to revenues of $24.6 million for the same period in 2001.

Net loss for the year ended December 31, 2002 included a one-time non-cash expense of $10.0
million or $.47 per share for the issuance of warrants to collaboration partner, Amgen, as part of
Nuvelo and Amgen`s agreement to develop and market, alfimeprase.

As of December 31, 2002, Nuvelo had approximately $2.2 million in unrestricted cash compared to
approximately $12.3 million at December 31, 2001. In addition, as of December 31, 2002, Nuvelo
had $10.0 million available through a line of credit from George Rathmann, Ph.D., chairman of
Nuvelo`s board of directors.

2002 Company Highlights

-- Executed merger with VARIAGENICS.
-- Entered into a collaboration with Amgen to develop and commercialize
alfimeprase, a novel thrombolytic for the treatment of acute PAO and
other potential indications. Initiated Phase I trial for PAO in the
second half of 2002.
-- Signed a license agreement with UCSF and Celera Diagnostics granting
Celera Diagnostics non-exclusive access to a large-scale cardiovascular
patient DNA sample collection for use in diagnostics. This resulted in
an upfront payment, expense reductions and potential milestones and
royalties to Nuvelo.
-- Granted our nineteenth gene-related patent from our proprietary
collection of rarely expressed full-length human genes, demonstrating
the concept that Nuvelo can leverage its initial intellectual property
position on potentially important therapeutic products.
-- Accelerated completion of our agricultural gene discovery collaboration
with BASF Plant Science, resulting in a cost savings to both parties,
strengthening our biopharmaceutical focus and financial position.
-- Raised $15 million in a private placement involving new and existing
institutional investors.


Conference Call Information

Nuvelo will hold a conference call today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to
discuss this announcement. To participate in the conference call, please dial 800/915-4836. A
telephone replay of the conference call will be available through Monday, March 10, 2003. To
access the replay, please dial 800/428-6051 for domestic callers and 973/709-2089 for
international callers, and reference pass code 286609.

This call is also being webcast by CCBN and can be accessed at Nuvelo`s Web site at
www.nuvelo.com, CCBN`s individual investor center at www.companyboardroom.com or by visiting
any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access
the call via CCBN`s password-protected event management site, StreetEvents
(www.streetevents.com).

Upcoming Events

Dr. Ted W. Love, president and CEO, will be presenting at the BIO CEO & Investor Conference
2003 in New York on Thursday, February 27, 2003 at 10:00 a.m. ET.

Dr. Love will discuss the Company`s strategy and focus, including an update on clinical trials for
alfimeprase, Nuvelo`s lead product candidate to treat peripheral arterial occlusion.

A live audio and visual webcast of the presentation will be available online at
http://www.firstcallevents.com/service/ajwz374944458gf12.htm… or via Nuvelo`s Web site at
www.nuvelo.com.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is
engaged in the discovery and development of novel biopharmaceutical products. Nuvelo`s lead
product candidate, alfimeprase, is partnered with Amgen and is currently in Phase I clinical trials for
peripheral arterial occlusion. Additional programs include drug discovery focused on
immunotherapeutics and secreted proteins.

Information about Nuvelo is available at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be,
and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided
by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be
identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals,"
and "potential," among others. Such statements are based on our management`s current
expectations and involve risks and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements as a result of many factors,
including, without limitation, the risk that we may not successfully integrate the VARIAGENICS
business following our recent merger, uncertainties relating to drug discovery, clinical development
processes and the development and commercialization of our molecular diagnostics technology;
changes in relationships with strategic partners and dependence upon strategic partners for the
performance of critical activities under collaborative agreements; the impact of competitive
products and technological changes; uncertainties relating to patent protection and regulatory
approval; and uncertainties relating to our ability to obtain substantial additional funds required for
progress in drug discovery and development. These and other factors are identified and described
in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation
our respective Annual Reports on Form 10-K for the year ended December 31, 2001, Hyseq and
VARIAGENICS most recent quarterly reports on Form 10-Q, and the joint proxy
statement/prospectus filed in connection with the merger. We disclaim any intent or obligation to
update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)

Three months ended Twelve months ended
December 31 December 31
2002 2001 2002 2001
(unaudited) (unaudited)

Contract revenues $3,518 $7,069 $26,433 $24,590
Operating expense:
Research and development 9,268 14,975 50,157 46,506
General and administrative 9,005 3,647 18,108 13,452
Restructuring 1,462 -- 2,067 825
Total operating expenses 19,735 18,622 70,332 60,783
Loss from operations (16,217) (11,553) (43,899) (36,193)
Gain/(loss) on sale
of fixed assets (2) -- (36) --
Interest expense, net (291) (97) (1,155) (572)
Net loss before
minority interest (16,510) (11,650) (45,090) (36,765)
Loss attributable
to minority interest -- 293 112 293
Net loss $(16,510) $(11,357) $(44,978) $(36,472)

Basic and diluted
net loss per share $(0.72) $(0.61) $(2.08) $(2.26)
Weighted average shares
used in computing
basic and diluted
net loss per share 23,039 18,550 21,661 16,158


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)

December 31, December 31,
2002 2001*
(unaudited)

Cash $2,225 $12,329
Working capital (17,928) (1,717)
Restricted cash 1,106 1,606
Total assets 27,072 39,904
Deferred revenue 525 3,702
Noncurrent portion of
capital lease and loan obligations 1,027 2,228
Note Payable 4,000 4,000
Accumulated deficit (153,373) (108,394)
Total stockholders` equity (4,564) 15,421


The condensed consolidated balance sheet data at December 31, 2001 has been derived from
the audited financial statements as of that date.



Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Successful Results in Phase I
Clinical Trial
Thursday March 27, 11:32 am ET

The Company Plans to Initiate Phase II Trials in Both PAO and Catheter
Occlusion in the First Half of 2003

SUNNYVALE, Calif., March 27 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News),
formerly Hyseq Pharmaceuticals, today announced positive Phase I results with its lead
product candidate, alfimeprase, for the treatment of peripheral arterial occlusion (PAO).

Enrollment in the multi-center,
open-label, dose-escalation study to
evaluate the safety and
pharmacokinetics of alfimeprase, was
completed in twenty patients across
seven centers in the United States. The
results show that alfimeprase was safe
and well-tolerated. There were no drug
related adverse events.

Based on the positive results from this
Phase I trial, Nuvelo plans to rapidly
initiate a Phase II trial in acute PAO
patients. In addition, Nuvelo filed an
investigational new drug (IND)
application for a second indication,
catheter occlusion. This IND was
accepted by the Food and Drug
Administration (FDA) and Nuvelo plans to initiate a Phase II program in this indication as well.
Both trials are expected to begin enrollment in the first half of this year.

"The Phase I study is an important step in establishing the safety of alfimeprase," stated Dr.
Ted W. Love, president and chief executive officer of Nuvelo. "We are extremely pleased with
the results and are ready to initiate both of our Phase II programs. In these trials we should
begin to see clear patient benefit in the safe and rapid dissolution of clots in both PAO and
catheter occlusion and we expect to complete at least one of these Phase II `proof-of-concept`
programs by the end of 2003."

Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic and
principal investigator of the Phase I study, and Dr. Timothy Murphy, associate professor of
diagnostic imaging at Brown University Medical School, will both discuss alfimeprase at the
Society for Interventional Radiology (SIR) Annual Meeting March 27-April 1, 2003. Nuvelo
expects to present the clinical trial data in either a journal publication or at a medical
conference later this year.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a
catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical
studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition,
alfimeprase`s novel clearance mechanism dramatically limits the molecule`s half-life, reducing
the risk of bleeding complications, a common side-effect of current therapies.

Alfimeprase was identified through Amgen`s research program and partnered with Nuvelo in
January 2002 for development and commercialization. Under the terms of the collaboration,
Nuvelo will lead all clinical development activities and Amgen will be responsible for
manufacturing activities. Amgen will have the option to lead the commercialization efforts in
which both companies may participate.

About PAO

PAO is the blocking of arterial blood flow to a distant part of the body by a clot. PAO usually
occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which
chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAO is leg pain
or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to
pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated,
foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO, however treatment with
thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are
currently no products on the market widely used to treat PAO. With the limited treatment
options currently available, alfimeprase has received orphan drug designation for the PAO
indication.

About Catheter Occlusion

Catheter occlusion is a major complication affecting central venous catheters and can impair
the ability to infuse fluid through, or withdraw fluid from the catheter. When a catheter becomes
occluded, the ultimate goal is to restore patency in a timely and cost-effective manner with
minimal risk to the patient. In many cases, restoring flow is preferred over replacement of the
catheter for several reasons. These include: limited interruption of therapy, reduced risk of
trauma to the patient, reduced risk of complications and decreased cost. In the case of
thrombolytic occlusions, treatment with thrombolytic drugs represents a less-invasive and more
cost-effective alternative to replacement. Currently, urokinase and alteplase are approved for
restoring function to central venous access devices.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is
engaged in the discovery and development of novel therapeutics. Nuvelo`s lead product
candidate, alfimeprase, is partnered with Amgen and is scheduled to enter two Phase II trials in
the first half of 2003 in both peripheral arterial occlusion and catheter occlusion. Additional
programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new website at www.nuvelo.com or by phoning
408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to
be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements
may be identified by words such as "believe," "expect," "anticipate," "should," "may,"
"estimate," "goals," and "potential," among others. Such statements are based on our
management`s current expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the forward-looking statements as a
result of many factors, including, without limitation, the risk that we may not successfully
integrate the VARIAGENICS business following our recent merger, uncertainties relating to
drug discovery, clinical development processes and the development and commercialization of
our molecular diagnostics technology; changes in relationships with strategic partners and
dependence upon strategic partners for the performance of critical activities under collaborative
agreements; the impact of competitive products and technological changes; uncertainties
relating to patent protection and regulatory approval; and uncertainties relating to our ability to
obtain substantial additional funds required for progress in drug discovery and development.
These and other factors are identified and described in more detail in Nuvelo, Hyseq and
VARIAGENICS filings with the SEC, including without limitation our respective Annual Reports
on Form 10-K for the year ended December 31, 2001, Hyseq and VARIAGENICS most recent
quarterly reports on Form 10-Q, and the joint proxy statement/prospectus filed in connection
with the merger. We disclaim any intent or obligation to update these forward-looking
statements.



Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces First Quarter 2003 Financial Results and Accomplishments
Thursday May 1, 6:30 am ET

SUNNYVALE, Calif., May 1 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News), formerly Hyseq Pharmaceuticals, Inc., today announced results for the quarter ended March 31, 2003.

Revenues for the first quarter of 2003 were approximately $1.3 million, compared to revenues of $5.2 million for the same period in 2002. The decline in revenues was primarily due to the completion of the company`s agricultural gene discovery collaboration with BASF Plant Science LLC in January 2003. Net loss for the first quarter was $13.6 million or $0.27 per share compared to a net loss of $19.0 million or $1.01 per share for the same period in 2002. The net loss decrease of $5.4 million was primarily attributable to a one time warrant expense associated with our agreement with Amgen, Inc. to develop our lead product candidate, alfimeprase, signed in 2002, and partially offset by lower revenue in 2003. The loss per share for the quarter ended March 31, 2003 was also impacted and reduced from the same period in 2002 as a result of additional shares issued through the acquisition of VARIAGENICS, Inc. which was completed on January 31, 2003.

As of March 31, 2003, Nuvelo had approximately $41.3 million in unrestricted cash, cash equivalents and short term investments compared to approximately $2.2 million at December 31, 2002. In addition, as of March 31, 2003, Nuvelo had $9.0 million available through a line of credit from George Rathmann, Ph.D., chairman of Nuvelo`s board of directors.

"Our achievements in the first quarter highlight the tremendous progress we have made as a company," said Ted W. Love, president and chief executive officer of Nuvelo. "We completed our merger with VARIAGENICS, concluded our first human clinical trial as a company, are on target to begin two Phase II `proof-of-concept` trials with alfimeprase in the first half of this year and are targeting completion of at least one of these trials by year-end. We are also encouraged by our continued progress in our secreted protein and immunotherapeutic programs."

Nuvelo`s immunotherapeutic program has recently identified four antibody target genes as promising pre-clinical candidates, NUVO 17289, NUVO 2788, NUVO 18832 and NUVO 13759. These are the first validated cell surface proteins identified as part of a program to develop therapeutic antibodies that specifically target cancer-associated proteins.

Additional First Quarter Highlights

-- Shareholders approved the merger with VARIAGENICS, Inc.
-- The combined company changed its name to Nuvelo and began trading on
the Nasdaq with its new name and symbol, NUVO
-- An investigational new drug application was filed and approved for
alfimeprase in a second indication, catheter occlusion
-- Successfully completed enrollment for our Phase I clinical trial with
alfimeprase in chronic peripheral arterial occlusion


Upcoming Events

Nuvelo will hold its annual shareholder`s meeting on Thursday, June 19, 2003 at 11:00 a.m. (Pacific Standard Time) at 675 Almanor Avenue, Sunnyvale, CA 94085.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery and development of novel therapeutics. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is scheduled to enter two Phase II trials in the first half of 2003 in both peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended
March 31, 2003 March 31, 2002

Contract Revenue: 1,283 5,232

Operating expense:
Research and development 10,803 21,014
General and administrative 3,847 3,058
Loss on sale of fixed asset 44 --
Total operating expenses 14,694 24,072

Loss from operations (13,411) (18,840)


Realized gain on investment 40 --
Interest expense, net (212) (229)
Loss before minority interest (13,583) (19,069)

Loss attributable to minority interest -- 112

Net loss (13,583) (18,957)

Basic and diluted net loss per share (0.27) (1.01)

Weighted average shares used in computing
basic and diluted net loss per share 49,636 18,725


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)

March 31, December 31,
2003 2002*
(unaudited)

Cash, cash equivalents and short
term investments $41,266 $2,225
Restricted cash 1,856 1,106
Total assets 69,018 27,072
Deferred revenue 2 525
Noncurrent portion of capital leases 2,548 1,026
Notes payable - long term 4,000 4,000
Accumulated deficit (167,068) (153,372)
Total stockholders` equity (deficit) $30,581 $(4,564)


* The condensed consolidated balance sheet data at December 31, 2002 has
been derived from the Hyseq Pharmaceuticals, Inc. audited financial
statements as of that date.


Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Initiates Phase II Clinical Trial in Catheter Occlusion
Thursday June 5, 6:30 am ET
Dr. Ted W. Love, President and CEO, to Discuss the Trial As Part of Today`s Presentation and Webcast at the Second Annual JMP Securities Research Conference

SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the commencement of dosing in a Phase II trial with its lead product candidate, alfimeprase, for the treatment of catheter occlusion.

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The multi-center, randomized, double-blind study will evaluate the safety and efficacy of alfimeprase for restoring function to occluded central venous catheters. The study will compare three doses of alfimeprase against the approved dose of t-PA (alteplase). Dr. Steven Deitcher, head of hematology and coagulation medicine at the Cleveland Clinic, will serve as the principal investigator of the study that will be conducted in approximately 100 patients across twenty centers in the United States.

"This Phase II trial is very straightforward in its design," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We should be able to evaluate clearance of the clot within hours of dosing patients with either alfimeprase or t-PA. In addition, this trial is designed to provide `proof of concept` data and further safety information necessary to advance alfimeprase towards approval."

Nuvelo previously announced positive Phase I results with its lead product candidate, alfimeprase, for the treatment of peripheral arterial occlusion (PAO) and expects to initiate an additional Phase II trial with alfimeprase in this primary indication in the second quarter of 2003.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel mechanism of action dramatically limits the molecule`s systemic activity, reducing the risk of bleeding complications, a common side-effect of current therapies.

Alfimeprase was identified through Amgen`s research program and partnered with Nuvelo in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will have the first right to manufacture alfimeprase. Amgen will have the option to lead the commercialization efforts in which both companies may participate. Both Amgen and Nuvelo share worldwide commercial rights.

About Catheter Occlusion

Catheter occlusion is the obstruction of flow through a central venous catheter by a blood clot. This impairs the ability to infuse medications or other fluids through the catheter. It is estimated that about five million catheters are placed in patients each year in the U.S., of which approximately 20-25% become occluded. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter in a timely and cost-effective manner with minimal risk to the patient. In many cases, restoring flow is preferred over replacement of the catheter for several reasons including: limited interruption of therapy, reduced risk of trauma to the patient, reduced risk of complications and decreased cost. Treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Current treatment options include surgery to replace the catheter or treatment with Cathflo®Activase®, a recombinant form of a naturally-occurring enzyme, t-PA.

About PAO

PAO affects more than 100,000 people annually in the U.S. alone and occurs when arterial blood flow is blocked to an extremity of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAD is leg pain or fatigue during activity that subsides with rest. Acute PAO is due to an occlusive blood clot which results in the total blockage of flow. If blood flow is not restored, this can lead to ulcers, gangrene, tissue death and ultimately to foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no products on the market widely used to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.

Webcast Information

Ted W. Love, M.D. will be presenting at the Second Annual JMP Securities Research Conference in San Francisco, California, today, June 5, 2003 at 4:10 p.m. Pacific Time. A live audio webcast of the presentation will be available online at http://eventmanager.on24.com/eventRegistration/eventRegistra… d=2214&sessionid=75&key=CF1B6C29CBD2423F17AD1E156A9093C6 or via Nuvelo`s Web site at www.nuvelo.com.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is scheduled to enter a Phase II trial in peripheral arterial occlusion in the first half of 2003, in addition to the Phase II trial in catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology, changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements, the impact of competitive products and technological changes, uncertainties relating to patent protection and regulatory approval and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including and without limitation, Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002. We disclaim any intent or obligation to update these forward-looking statements.


Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Appoints Jan Johansson, MD, PhD, to Lead Clinical Affairs
Monday June 9, 9:30 am ET

SUNNYVALE, Calif., June 9 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News), today announced the appointment of Jan Johansson, M.D., Ph.D., as chief medical officer and vice president, clinical affairs. Dr. Johansson joins Nuvelo as a member of the senior management team and will be responsible for Nuvelo`s clinical affairs activities.

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"With our lead product candidate, alfimeprase, moving rapidly through the clinic and the promise of additional candidates emerging from our secreted protein and immunotherapeutic programs, we sought to strengthen our clinical development capabilities," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "Dr. Johansson provides this expertise, bringing both an excellent academic research background and relevant industry experience needed to strengthen both our current and future clinical development programs."

Dr. Johansson brings to Nuvelo over 16 years of experience as a practicing physician in internal medicine and cardiology and 14 years of experience in academic medicine including work in atherosclerosis studies, drug intervention trials, multi-center, multi-international trials and he has published more than 50 peer reviewed scientific articles.

Prior to joining Nuvelo, Dr. Johansson served the pharmaceutical industry in various vice president positions in both public and private biotechnology companies, conducting several clinical trials in all phases of development and preparing the corresponding regulatory documents. Most recently he served as vice president, clinical research and development for Lipid Sciences, Inc. and was co-founder, vice president, clinical affairs and senior clinical research fellow of Esperion Therapeutics, Inc. From 1995 to 1997, Dr. Johansson was a medical adviser with executive responsibilities at Pharmacia, working in clinical research and thrombosis.

Dr. Johansson earned his M.D. and Ph.D. at the Karolinska Institute in Sweden and subsequently became associate professor at the Karolinska Hospital before joining the pharmaceutical industry in 1995.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently conducting a Phase II trial in catheter occlusion. A second Phase II trial in peripheral arterial occlusion is scheduled to begin in the first half of 2003. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology, changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements, the impact of competitive products and technological changes, uncertainties relating to patent protection and regulatory approval and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including and without limitation, Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002. We disclaim any intent or obligation to update these forward-looking statements.


Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Initiates Phase II Clinical Trial in Acute Peripheral Arterial Occlusion
Tuesday June 24, 6:30 am ET

SUNNYVALE, Calif., June 24 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the commencement of dosing in a Phase II trial with its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion (PAO).

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The multi-center, open-label, dose-escalation study will evaluate the safety and efficacy of alfimeprase in patients suffering from acute PAO. Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic, and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center, will serve as the principal investigators of the study that will compare three different doses of alfimeprase in approximately 100 patients across twenty centers in the United States, Europe and South Africa.

"Current treatment options are limited for patients suffering from PAO," stated Dr. Ouriel. "One established treatment, bypass surgery, is associated with a significant risk to the patient`s life as PAO generally occurs in elderly or medically compromised individuals, poorly able to withstand a major operation. Thrombolytic therapy provides a less-invasive alternative, with the potential to re-open the blood vessel without the need for open surgery."

"Our clinical development program with alfimeprase is right on track," stated Dr. Ted W. Love, president and chief executive officer of Nuvelo. "The Phase II study design is intended to demonstrate clear patient benefit with the rapid dissolution of clots, in addition to enabling us to further establish the safety of alfimeprase. We will continue to support the advancement of this compound through the clinic and onto the market in addition to further advancing Nuvelo`s internal development programs in secreted proteins and immunotherapeutics."

Nuvelo is also currently conducting an additional Phase II trial to evaluate safety and efficacy of alfimeprase in catheter occlusion. This trial began earlier this month and the company expects to complete at least one of these Phase II trials by the end of 2003.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel mechanism of action dramatically limits the molecule`s systemic activity, reducing the risk of bleeding complications, a common side-effect of current therapies.

Alfimeprase was identified through Amgen`s research program and partnered with Nuvelo in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will have the first right to manufacture alfimeprase. Amgen will have the option to lead the commercialization efforts in which both companies may participate. Both Amgen and Nuvelo share worldwide commercial rights.

About PAO

PAO affects more than 100,000 people annually in the U.S. alone and occurs when arterial blood flow is blocked to an extremity of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAD is leg pain or fatigue during activity that subsides with rest. Acute PAO is due to an occlusive blood clot which results in the total blockage of flow. If blood flow is not restored, this can lead to ulcers, gangrene, tissue death and ultimately to foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no products on the market widely used to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.

About Catheter Occlusion

Catheter occlusion is the obstruction of flow through a central venous catheter by a blood clot. This impairs the ability to infuse medications or other fluids through the catheter. It is estimated that about five million catheters are placed in patients each year in the U.S., of which approximately 20-25% become occluded. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter in a timely and cost-effective manner with minimal risk to the patient. In many cases, restoring flow is preferred over replacement of the catheter for several reasons including: limited interruption of therapy, reduced risk of trauma to the patient, reduced risk of complications and decreased cost. Treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Current treatment options include surgery to replace the catheter or treatment with Cathflo®Activase®, a recombinant form of a naturally-occurring enzyme, t-PA.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and has entered two Phase II trials in both peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology, changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements, the impact of competitive products and technological changes, uncertainties relating to patent protection and regulatory approval and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including and without limitation, Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002. We disclaim any intent or obligation to update these forward-looking statements.


Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Added to Russell 3000(R) Index
Monday June 30, 9:01 am ET

SUNNYVALE, Calif., June 30 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced it has been added to the Russell 3000® Index.

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The broad-market index was recently reconstituted, according to a preliminary list of additions issued by Frank Russell Company. Index membership will go into effect July 1, 2003 and will remain in place for one year. Membership in the Russell 3000 means automatic inclusion in either the large-cap Russell 1000® Index or small-cap Russell 2000® Index. Nuvelo will be included in the small-cap Russell 2000® Index.

Membership in Russell`s 21 U.S. equity indexes is determined primarily by market capitalization rankings and style attributes. Russell indexes are widely used by managers for index funds and as benchmarks for both passive and active investment strategies. About $250 billion is invested in index funds based on Russell`s indexes and an additional $850 billion is benchmarked to them. Investment managers who oversee these funds purchase shares of member stocks according to that company`s weighting in the particular index.

Annual reconstitution of the Russell indexes captures the 3,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000. The largest 1,000 companies in the ranking comprise the Russell 1000 Index while the remaining 2,000 companies become the widely used Russell 2000 Index.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and has entered two Phase II trials in both peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Russell, global leaders in multi-manager investment services, provides investment products and services in more than 35 countries. Russell manages $67 billion in assets and advises clients worldwide representing US $1.6 trillion. Founded in 1936, Russell is a subsidiary of Northwestern Mutual and is headquartered in Tacoma, Wash., with additional offices in New York, Toronto, London, Paris, Singapore, Sydney, Auckland and Tokyo. For more information, go to www.russell.com.


Source: Nuvelo, Inc.

[Bombenleger]

UPDATE - Nuvelo files $50 million mixed shelf with SEC
Tuesday July 8, 3:38 pm ET

(Adds detail, share price)

WASHINGTON, July 8 (Reuters) - Pharmaceutical company Nuvelo Inc. (NasdaqNM:NUVO - News) filed on Tuesday with the U.S. Securities and Exchange Commission (News - Websites) to periodically sell up to $50 million in debt and stock.

Net proceeds from the sale will be used for general corporate purposes, including capital expenditures, the company said in a shelf registration statement.

Under such a filing, a company may sell securities in one or more offerings, with the terms and conditions determined at the time of sale.

Nuvelo shares traded 15 cents lower Tuesday afternoon at $2.00 on the Nasdaq Stock Exchange.

[Bombenleger]

Nuvelo Announces Second Quarter 2003 Financial Results and Accomplishments
Thursday July 31, 6:30 am ET


SUNNYVALE, Calif., July 31 /PRNewswire/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced results for the second quarter ended June 30, 2003.
For the three months ended June 30, 2003, Nuvelo reported a net loss of $16.3 million or $0.26 per share compared to a net loss of $8.1 million or $0.37 per share for the same period in 2002. The net loss increase of $8.2 million was primarily attributed to a one-time expense charge of $5.0 million related to the termination of a lease associated with one of our facilities, and reduced revenue related to the completion of the company`s agricultural gene discovery collaboration with BASF Plant Science LLC in January 2003. Revenues for the second quarter of 2003 were approximately $0.4 million, compared to revenues of $6.7 million for the same period in 2002. For the six months ended June 30, 2003 Nuvelo reported a net loss of $29.9 million or $0.53 per share, compared to a net loss of $27.0 million or $1.32 per share for the same period in 2002. Revenues for the six-month period ended June 30, 2003 were $1.7 million compared to revenues of $11.9 million for the same period in 2002. The loss per share for the three and six months ended June 30, 2003 was impacted and reduced from the same period in 2002 as a result of additional shares issued through the acquisition of VARIAGENICS, Inc., which was completed on January 31, 2003.

As of June 30, 2003, Nuvelo had approximately $29.2 million in cash, cash equivalents, short-term investments and restricted cash compared to approximately $3.3 million at December 31, 2002. In addition, as of June 30, 2003, Nuvelo had $9.0 million available through a line of credit from George Rathmann, Ph.D., chairman of Nuvelo`s board of directors.

"Over the past quarter we have made significant progress toward our goal of building a world-class biopharmaceutical company," said Ted W. Love, M.D., president and chief executive officer of Nuvelo. "We initiated two Phase II trials with our lead product candidate, alfimeprase, marking the achievement of a major clinical goal we had set earlier in the year. These trials are progressing as planned and we are on target to meet our year-end goal of completing at least one of these trials by the end of 2003. In addition, we are executing on our goal to monetize non-core assets acquired from our merger with VARIAGENICS and we have made important advances in both our immunotherapeutics and secreted proteins programs."

Additional Highlights

-- Sell-side analyst coverage initiated by JMP Securities
-- Added to the Russell 3000 Index(R)
-- Filed a universal shelf registration statement with the SEC
to offer up to $50 million worth of common or preferred stock,
or debt securities, to be used for general corporate purposes,
including capital expenditures and to meet working capital needs
-- Appointed Jan Johansson, MD, PhD, as chief medical officer
and VP of Clinical Affairs

Forward Outlook

-- Full publication of results from our Phase I trial with
alfimeprase in a medical journal later this year
-- Completion of at least one of our two Phase II "proof of concept"
trials with alfimeprase by the end of 2003
-- Near-term monetization of our non-core assets
-- Identification of additional clinical candidates from Nuvelo
research programs


About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended March 31, 2003. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended Six months ended
June 30, June 30, June 30, June 30,
2003 2002 2003 2002
Contract Revenue: 394 6,661 1,678 11,893
Operating expense:
Research and development 7,270 10,740 18,072 31,754
General and administrative 7,675 3,165 11,523 6,223
Restructuring -- 610 - 610
Total operating expenses 14,945 14,515 29,595 38,587

Loss from operations (14,551) (7,854) (27,917) (26,694)

Loss on sale of fixed assets (1,518) -- (1,562) --
Realized Gain on investment -- -- 40 --
Interest expense, net (239) (214) (451) (442)
Loss before minority interest (16,308) (8,068) (29,890) (27,136)

Loss attributable
to minority interest -- -- -- 112

Net loss (16,308) (8,068) (29,890) (27,024)

Basic and diluted net loss
per share (0.26) (0.37) (0.53) (1.32)

Weighted average shares used in
computing basic and diluted
net loss per share 63,149 22,055 56,430 20,399



CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)
(unaudited)

June 30, December 31,
2003 2002
Cash, cash equivalents and short
term investments $26,576 $2,225
Restricted cash 2,612 1,106
Total assets 49,035 27,072
Deferred revenue -- 525
Noncurrent portion of capital leases 2,013 1,026
Notes payable - long term 6,600 4,000
Accumulated deficit (183,262) (153,372)
Total stockholders` equity
(deficit) $15,260 $(4,564)




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Appoints Vice President of Regulatory Affairs and Quality Assurance
Tuesday August 5, 9:30 am ET


SUNNYVALE, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Hana B. Moran, PhD, as vice president of regulatory affairs and quality assurance.
ADVERTISEMENT


Dr. Moran brings over twenty years of development, regulatory affairs and quality assurance experience to Nuvelo. Most recently, Dr. Moran served as vice president, regulatory affairs and quality assurance for Lipid Sciences, Inc., and prior to that she held senior management positions at both BioMedicines, Inc. and SangStat Medical Corp. From 1983 to 1994, Dr. Moran served in various regulatory affairs and quality assurance roles at companies including Athena Neurosciences, Inc., Fujisawa Pharmaceutical Company, Boehringer-Ingelheim, Inc. and G.D. Searle & Co. She has received several awards including the National Institutes of Health Research Service Award and is involved in the American Association of Pharmaceutical Sciences, the Drug Information Association and the Regulatory Affairs Professional Society. Dr. Moran earned her master`s degree at the Slovak Technical University in Czechoslovakia and her PhD at the Weizmann Institute of Science in Israel.

"With clinical development efforts successfully moving forward, we have been strategically building our team," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "The addition of Dr. Moran will provide significant expertise in working with the FDA that is invaluable to the progress of our development programs."

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in both peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended March 31, 2003. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Assigns Patents to SEQUENOM
Wednesday September 17, 9:30 am ET


SUNNYVALE, Calif. and SAN DIEGO, Sept. 17 /PRNewswire/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) and SEQUENOM, Inc. (Nasdaq: SQNM - News) today announced a patent assignment and license agreement. Under terms of the agreement, Nuvelo assigned SEQUENOM the entire chemical cleavage patent estate acquired through its merger with VARIAGENICS, including 25 issued and pending patents, as well as an exclusive worldwide license to nine additional restriction enzyme patents. Nuvelo will receive a licensing payment and potential royalties for any eventual revenues from sublicensing of the restriction enzyme patents.
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"This agreement strengthens our proprietary position with respect to our MassARRAY(TM) products and expands our potential application offerings," said Toni Schuh, Ph.D., SEQUENOM`s President and Chief Executive Officer. "This leverages our ability to develop new applications, such as viral load determination, bacterial and viral typing, DNA methylation analysis and mutation detection. The acquisition of this patent estate strengthens our position as a leader in high-performance DNA analysis."

"We are pleased that we have been able to execute on the monetization of some of the VARIAGENICS assets and place them in the hands of a company that is focused on utilizing them to their fullest potential," said Ted W. Love, M.D., President and Chief Executive Officer of Nuvelo. "The agreement allows Nuvelo to stay focused on its core business, the discovery and development of life improving therapeutics."

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

About SEQUENOM

SEQUENOM is a leading genetics company organized into two distinct business units: SEQUENOM Genetic Systems and SEQUENOM Pharmaceuticals. The two business units combine to capitalize on the Company`s high performance DNA analysis platform, SNP assay portfolio, disease gene discovery programs and extensive DNA sample repository. SEQUENOM Genetic Systems is dedicated to the sales and support of the Company`s MassARRAY products and the continual expansion of platform applications. SEQUENOM Pharmaceuticals applies the power of human genetics to systematically identify disease-related genes that affect significant portions of the overall population. The Pharmaceuticals business unit focuses on disease gene discovery, target identification, functional validation and ultimately diagnostic and therapeutic product development. SEQUENOM® and MassARRAY(TM) are trademarks of SEQUENOM, Inc.

Nuvelo Safe Harbor

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended June 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.

SEQUENOM Safe Harbor

Except for the historical information contained herein, the matters set forth in this press release, including statements related to SEQUENOM`s potential payment of royalties from sublicensing, and SEQUENOM`s ability to develop and commercialize new applications, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties inherent in and associated with drug discovery, development and commercialization, new product and application introductions and SEQUENOM`s technologies and other risks detailed from time to time in SEQUENOM`s SEC reports, including SEQUENOM`s Annual Report on Form 10-K for the year ended December 31, 2002, and its most recently filed quarterly report. These forward-looking statements are based on current information that is likely to change and speak only as of the date hereof.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Present at the UBS Warburg Global Life Sciences Conference
Thursday September 18, 9:30 am ET


SUNNYVALE, Calif., Sept. 18 /PRNewswire-FirstCall/ -- Nuvelo today announced that Dr. Ted W. Love, president and CEO, will be presenting at the UBS Warburg Global Life Sciences Conference on Thursday, September 25, 2003 at 8:00 a.m. Eastern Time at The Plaza Hotel in New York City.
ADVERTISEMENT


Dr. Love will provide a brief corporate overview and discuss the company`s near-term milestones, including an update on the status of its two Phase II clinical trials with lead product candidate, alfimeprase.

A live audio webcast of the presentation will be available online on the UBS homepage at www.ibb.ubs.com. To access the webcast, click on the Conferences section and follow the link for the webcast under the Global Life Sciences Conference heading. You can also access the webcast via the Investor Relations portion of the Nuvelo Web site at www.nuvelo.com.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Erbse1]

Hallo Bombenleger, ich glaube es ist einfacher nur die BIO Unternehmen zu nennen, die nicht auf der UBS Warburg Global Life Sciences Conference präsentieren.
Danke für den Hinweis
Erbse1

[Bombenleger]

Nuvelo Reports Successful Completion of Interim Analysis in Phase II Trial With Alfimeprase
Thursday September 25, 6:30 am ET


SUNNYVALE, Calif., Sept. 25 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced successful completion of a planned interim analysis of its Phase II trial with lead product candidate, alfimeprase, for the potential treatment of acute peripheral arterial occlusion (PAO).
ADVERTISEMENT


The interim analysis was conducted on data from the first 36 patients enrolled in the trial. Following review of the patient data, the Data Safety and Monitoring Board (DSMB) and the Trial Steering Committee have recommended that the company continue to move forward with the trial in all three doses of alfimeprase, 0.1 mg/kg, 0.3 mg/kg and 0.6 mg/kg.

"I am encouraged by the decision of the DSMB," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "This preliminary data suggests that all three doses are worthy of further investigation."

Upcoming Clinical Events

Phase I data on alfimeprase will be featured in a scientific session presented at the upcoming AIM (Advanced Interventional Management) Symposium, November 18, 2003 in New York City. The presentation will be given by one of Nuvelo`s principal investigators, Dr. Jacob Cynamon, entitled, `Alfimeprase: A Novel New Thrombolytic Agent That May Reduce Complications And Improve Efficacy.`

Phase II Alfimeprase Programs

The multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic, and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. The study is comparing three different doses of alfimeprase, in over 100 patients across twenty centers in the United States, Europe and South Africa.

Nuvelo is also currently conducting a Phase II trial to evaluate the safety and efficacy of alfimeprase in a second indication, catheter occlusion. This multi-center, randomized, double-blind study began in June 2003 and is comparing three doses of alfimeprase against the approved dose of t-PA (alteplase). Dr. Steven Deitcher, head of hematology and coagulation medicine at the Cleveland Clinic, is the principal investigator of the study that is being conducted in approximately 100 patients across twenty centers in the United States.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

The last sentence in the third paragraph of this press release is a "forward-looking statement" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. This statement is based on our management`s current expectations and involves risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery and clinical development processes. These and other factors are identified and described in more detail in our filings with the SEC, including without limitation our annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and our quarterly report on Form 10-Q for the quarter ended June 30, 2003. We disclaim any intent or obligation to update this forward-looking statement.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Raises $24.5 Million
Thursday October 2, 9:01 am ET


SUNNYVALE, Calif., Oct. 2 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the sale of 10,000,000 shares of its common stock at a price of $2.45 per share, placed directly with unaffiliated institutional investors. All of the shares are being offered by Nuvelo under its currently effective shelf registration statement. Subject to customary closing conditions, Nuvelo will receive proceeds of approximately $24.5 million, net of fees and other expenses related to the transaction.
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"Nuvelo has made significant progress over the past year and we have been able to capitalize on this success by securing strong, respected institutional investors," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We recently announced the successful completion of an interim analysis of our Phase II study with alfimeprase for the potential treatment of peripheral arterial occlusion. We are encouraged by this analysis and continue to push aggressively forward with these trials. In addition, we continue to drive progress with our internal development activities in secreted proteins and antibody targets while pursuing potential clinical-stage in-licensing opportunities."

Nuvelo intends to use the net proceeds of the sale of the common stock primarily for general corporate purposes including current and future clinical trials of its lead product candidate, alfimeprase, as well as other research and product development activities.

JMP Securities LLC served as the sole underwriter of the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. Copies of the prospectus relating to the offering may be obtained from JMP Securities LLC at 1 Embarcadero Center, Suite 2100, San Francisco, CA 94111 or by calling 415-835-8900.

About Alfimeprase

Alfimeprase is a thrombolytic agent or clot dissolver. It is a modified fibrolase, a naturally occurring enzyme that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel mechanism of action dramatically limits the molecule`s systemic activity, reducing the risk of bleeding complications, a common side-effect of current therapies.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended June 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Mark Perry Joins Nuvelo Board of Directors
Tuesday October 14, 9:30 am ET


SUNNYVALE, Calif., Oct. 14 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Mark Perry to its board of directors. Mr. Perry will replace Jean-Francois Formela who stepped down as a member of the board of directors effective October 13, 2003.
ADVERTISEMENT


"I want to thank Jean-Francois personally for his contributions throughout the company`s post-merger transition," said Dr. George Rathmann, chairman of Nuvelo`s board of directors. "We wish him well in his future endeavors."

Mr. Perry currently serves as the executive vice president of operations for Gilead Sciences, Inc. (Nasdaq: GILD - News), a biopharmaceutical company located in Foster City, California. Mr. Perry joined Gilead in 1994 as vice president, general counsel and secretary; assumed the additional responsibilities of chief financial officer in 1996 and was promoted to his current position in 2000. At Gilead, Mr. Perry is responsible for worldwide commercial operations and the legal, intellectual property, manufacturing and facilities functions.

Prior to joining Gilead, Mr. Perry served as a partner at the law firm Cooley Godward LLP, based in San Francisco and Palo Alto, California. Mr. Perry also sits on the board of directors of IntraBiotics Pharmaceuticals, Inc. and DNA Sciences, Inc.

"We are pleased to welcome Mark to our board of directors," said Dr. Rathmann. "We will be able to leverage his financial, legal, operational and commercial background and expertise as we navigate Nuvelo through future business development deals, clinical trials and other corporate activities."

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase II trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended June 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Present at the Rodman & Renshaw Techvest Healthcare Conference
Friday October 17, 9:30 am ET


SUNNYVALE, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Dr. Ted W. Love, president and CEO, will be presenting at the Rodman & Renshaw Techvest Healthcare Conference on Tuesday, October 21, 2003 at 11:00 a.m. Eastern Time at The Boston Marriott Long Wharf Hotel.
ADVERTISEMENT


Dr. Love will provide a brief corporate overview and discuss the company`s near-term milestones, including an update on its two Phase 2 clinical trials with lead product candidate, alfimeprase.

A live audio webcast of the presentation will be available online at http://www.wallstreetwebcasting.com/webcast/rrshq/nuvo . You can also access the webcast via the Investor Relations portion of the Nuvelo Web site at www.nuvelo.com.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com, or by phoning 408-215-4000.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Third Quarter 2003 Financial Results and Accomplishments
Thursday October 30, 6:32 am ET


SUNNYVALE, Calif., Oct. 30 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced results for the third quarter ended September 30, 2003.
For the three months ended September 30, 2003, Nuvelo reported a net loss of $10.9 million or $0.17 per share compared to a net loss of $1.4 million or $0.06 per share for the same period in 2002. The net loss increase of $9.5 million was primarily attributed to reduced revenue related to the completion of the company`s agricultural gene discovery collaboration with BASF Plant Science LLC in January 2003. Revenues for the third quarter of 2003 were approximately $0.3 million, compared to revenues of $11.0 million for the same period in 2002. Total operating expenses were reduced to $10.9 million for the three months ended September 30, 2003 compared to $12.1 million for the same period in 2002. Nuvelo experienced significant reductions in expenses related to completion of the BASF agreement, eliminating non-core programs and its continued focus on developing biotherapeutics. These expense reductions were partially offset by additional clinical trial and alfimeprase manufacturing costs as Nuvelo continues to move toward completion of its Phase 2 trials.

For the nine months ended September 30, 2003, Nuvelo reported a net loss of $40.8 million or $0.69 per share, compared to a net loss of $28.5 million or $1.34 per share for the same period in 2002. Revenues for the nine month period ended September 30, 2003 were $1.9 million compared to revenues of $22.9 million for the same period in 2002. The loss per share for the three and nine months ended September 30, 2003 was impacted and reduced from the same period in 2002 as a result of additional shares issued through the acquisition of VARIAGENICS, Inc., which was completed on January 31, 2003.

As of September 30, 2003, Nuvelo had approximately $20.4 million in cash, cash equivalents, short-term investments and restricted cash compared to approximately $3.3 million at December 31, 2002. In addition, Nuvelo closed a financing on October 7, 2003, which resulted in proceeds of approximately $26.2 million, after deduction of fees and other expenses related to the transaction.

"In the third quarter, we have continued to make substantial progress in executing our strategy to monetize our non-core assets, advance our gene portfolio into potential product candidates and move forward with our Phase 2 alfimeprase trials," said Ted W. Love, MD, president and chief executive officer of Nuvelo. "We are focused on further advancement in all of these areas. We are in several discussions surrounding our non-core assets, in the first quarter of next year we expect to complete analysis of the 50 secreted protein genes currently partnered with Kirin and we are beginning preparations for our Phase 3 trials with alfimeprase, expected to begin in the first half of 2004."

Additional Highlights
-- Appointed Mark Perry, executive vice president of operations for Gilead
Sciences, Inc., to our board of directors, replacing Jean-Francois
Formela, MD
-- Reported successful completion of an interim analysis of our Phase 2
clinical trial with alfimeprase for the potential treatment of patients
with peripheral arterial occlusion
-- Signed an agreement with SEQUENOM assigning them the entire chemical
cleavage patent estate acquired through our merger with VARIAGENICS, as
well as an exclusive worldwide license to nine additional restriction
enzyme patents

Forward Outlook
-- Oral presentation of our Phase 1 alfimeprase data by Jacob Cynamon,
MD of the Montefiore Medical Center at the AIM Symposium, November 18,
2003 in New York, titled "Alfimeprase: A Novel New Thrombolytic Agent
That May Reduce Complications And Improve Efficacy"
-- Full publication of results from our Phase 1 alfimeprase trial in a
medical journal
-- Completion of our two Phase 2 "proof of concept" trials with
alfimeprase
-- Continued monetization of our non-core assets
-- Completion of analysis on the 50 secreted protein genes we have in
collaboration with the pharmaceutical division of Kirin Brewery Co.,
Ltd.
-- Identification of additional clinical candidates from Nuvelo`s research
programs


About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended June 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended Nine months ended
Sept 30, Sept 30, Sept 30, Sept 30,
2003 2002 2003 2002

Contract Revenue: 262 11,022 1,940 22,915

Operating expense:
Research and development 8,348 9,131 26,421 40,885
General and administrative 2,861 2,879 14,384 9,102
Restructuring -- -- -- 610
(Gain) Loss on sale
of assets (350) 47 1,212 34
Total operating expenses 10,859 12,057 42,017 50,631

Loss from operations (10,597) (1,035) (40,077) (27,716)

Realized gain on investment -- -- 40 --
Interest expense, net (310) (409) (760) (864)
Loss before
minority interest (10,907) (1,444) (40,797) (28,580)

Loss attributable
to minority interest -- -- -- 112

Net loss (10,907) (1,444) (40,797) (28,468)

Basic and diluted net loss
per share (0.17) (0.06) (0.69) (1.34)

Weighted average shares
used in computing
basic and diluted
net loss per share 63,961 22,767 58,968 21,197


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)

September 30, December 31,
2003 2002*
(unaudited)

Cash, cash equivalents and short term investments $18,368 $2,225
Restricted cash 2,010 1,106
Total assets 43,828 27,072
Deferred revenue -- 525
Noncurrent portion of capital leases 1,504 1,026
Notes payable - long term 6,600 4,000
Accumulated deficit (194,169) (153,372)
Total stockholders` equity (deficit) $4,885 $(4,564)


* The condensed consolidated balance sheet data at December 31, 2002 has
been derived from the audited financial statements as of that date




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Present at the CIBC World Markets Fourteenth Annual Healthcare Conference
Friday November 7, 9:30 am ET


SUNNYVALE, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Dr. Ted W. Love, president and CEO, will be presenting at the CIBC World Markets Fourteenth Annual Healthcare Conference on Tuesday, November 11, 2003 at 2:00 p.m. Eastern Time at The Plaza Hotel in New York City.
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Dr. Love will provide a brief corporate overview and discuss the company`s near-term milestones, including an update on its two Phase 2 clinical trials with lead product candidate, alfimeprase.

A live audio webcast of the presentation will be available online at http://www.veracast.com/webcasts/cibcwm/healthcare03/4910613… . You can also access the webcast via the Investor Relations portion of the Nuvelo Web site at www.nuvelo.com.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Phase 1 Alfimeprase Results Presented at the AIM Symposium
Tuesday November 18, 4:45 pm ET
Nuvelo to Webcast the Phase 1 Data at a Meeting for the Financial Community on November 19, 2003


SUNNYVALE, Calif., Nov. 18 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the formal presentation of clinical data from its Phase 1 alfimeprase trial in patients with chronic peripheral arterial occlusion (PAO), showing that alfimeprase was safe and well-tolerated with no drug related adverse events.
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The Phase 1 data was presented today at the Advanced Interventional Management (AIM) Symposium in New York City. The presentation entitled, "Alfimeprase: A Novel New Thrombolytic Agent That May Reduce Complications And Improve Efficacy," was given by Dr. Jacob Cynamon, professor of clinical radiology and director, division of vascular and interventional radiology at the Montefiore Medical Center and a principal investigator for Nuvelo`s Phase 2 alfimeprase trial for the potential treatment of PAO.

The presentation provided clinical data from Nuvelo`s multi-center, open- label, dose-escalation Phase 1 study evaluating the safety and pharmacokinetics of alfimeprase in patients with chronic PAO. Each of the study`s 20 patients was treated with one of five escalating weight-based doses of alfimeprase (0.025, 0.05, 0.1, 0.3, and 0.5 mg/kg), with four patients per dose group. Doses were delivered as manual, pulsed injections through a multi- sidehole infusion catheter. Angiograms were performed prior to treatment and one hour after administration of the drug.

There were no drug related serious adverse events observed. There were no immune responses observed, no signs of vascular wall damage noted and no aneurysmal changes were detected. In addition, plasminogen and fibrinogen levels remained unchanged, supporting the belief that alfimeprase acts directly, independent of the plasminogen-plasmin system and that the systemic inactivation of alfimeprase by alpha-2 macroglobulin appeared to be effective.

A dose-dependent consumption of alpha-2 macroglobulin was observed during administration of alfimeprase, consistent with the predicted binding of alfimeprase and subsequent clearance from the circulation.

Thrombolytic efficacy was not an objective of the study; however there were anecdotal observations of efficacy. One patient receiving 0.1 mg/kg experienced lysis of a clot approximately ten centimeters in length, approximately one hour after dosing. An additional four patients experienced partial thrombolysis.

"This early Phase 1 experience suggests that alfimeprase is well tolerated and has the potential to offer novel thrombolytic activity without some of the significant side-effects experienced today, such as major bleeding and intracerebral hemorrhage," said Dr. Cynamon. "Clinical trials are ongoing to confirm these findings."

Nuvelo previously announced the completion of this Phase 1 trial in March 2003 and rapidly initiated two Phase 2 alfimeprase trials in acute PAO and catheter occlusion in June 2003.

Upcoming Event

On November 19, 2003 from 11:30 a.m. to 1:30 p.m. ET, Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and a principal investigator for Nuvelo`s Phase 1 and 2 alfimeprase PAO trials, will present the Phase 1 data at a meeting for the financial community in New York City.

A simultaneous webcast of Dr. Ouriel`s presentation will be available live and via replay in the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com.

About PAO

PAO affects more than 100,000 people annually in the U.S. alone and occurs when arterial blood flow is blocked to an extremity of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAD is leg pain or fatigue during activity that subsides with rest. Acute PAO is due to an occlusive blood clot which results in the total blockage of flow. If blood flow is not restored, this can lead to ulcers, gangrene, tissue death and ultimately to foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost- effective alternative. There are currently no approved, widely used products on the market to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel clearance mechanism appears to dramatically limit the molecule`s half-life, reducing the risk of bleeding complications, a common side-effect of current therapies.

Alfimeprase was identified through Amgen`s research program and partnered with Nuvelo in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will be responsible for manufacturing activities. Amgen will have the option to lead the commercialization efforts in which both companies may participate.

Phase 2 Alfimeprase Programs

The multi-center, open-label, dose-escalation Phase 2 study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic, and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. The study is comparing three different doses of alfimeprase, in over 100 patients across twenty centers in the United States, Europe and South Africa.

Nuvelo is also currently conducting a Phase 2 trial to evaluate the safety and efficacy of alfimeprase in a second indication, catheter occlusion. This multi-center, randomized, double-blind study began in June 2003 and is comparing three doses of alfimeprase against the approved dose of t-PA (alteplase). Dr. Steven Deitcher, head of hematology and coagulation medicine at the Cleveland Clinic, is the principal investigator of the study that is being conducted in approximately 100 patients across twenty centers in the United States.

About AIM

The Advanced Interventional Management (AIM) Symposium is a continuing medical education event providing scientific sessions, workshops, panel discussions and live cases, presented by a nationally renowned faculty. The Symposium, targeting interventional radiologists, vascular surgeons, cardiologists and interventional nephrologists, will provide an overview of the most current issues and hands-on experience in the new techniques in percutaneous, endovascular and surgical treatment methods. Nuvelo will host a scientific booth at the Symposium.

About Nuvelo

Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Archemix and Nuvelo Announce Partnership on Thrombin Inhibitor
Monday January 12, 4:25 pm ET


CAMBRIDGE, Mass. and SUNNYVALE, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Archemix Corp. and Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that they have entered into a worldwide collaboration agreement to develop and commercialize Archemix`s thrombin inhibitor, ARC183, for potential use in coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI) and other acute anticoagulant applications.
Under the terms of the agreement, Archemix will initially lead development and be responsible for all clinical development activities. Nuvelo will have the option to lead commercialization efforts in which both companies may participate. As part of the transaction, Archemix and Nuvelo will equally share all costs associated with the development and marketing of ARC183 and will have 50/50 ownership of the compound. Archemix will receive an upfront payment and additional development and milestone payments over the first year of the partnership and upon initiation of the Phase 2 trial. Additional financial terms were not disclosed.

Archemix`s ARC183 is an anti-thrombin aptamer that is initially being developed as an anticoagulant/anti-thrombotic for use in CABG surgery. A Phase 1 clinical trial with ARC183 for use in this procedure is expected to begin in the second half of 2004.

According to the American Heart Association, currently more than 500,000 CABG procedures are performed annually in the U.S., and more than 700,000 are performed worldwide. Heparin is the anticoagulant currently used in the majority of CABG surgeries, however it has significant limitations such as bleeding, heparin-induced thrombocytopenia (HIT), is difficult to dose accurately and requires dose monitoring. In addition, heparin requires protamine to reverse its anticoagulant effects which carries the risk of significant side effects such as allergic reaction and hypotension.

Experiments in animal models suggest that the potent anticoagulant ARC183 has many desirable properties for CABG surgeries including rapid onset and predictable anticoagulant effects, reduced bleeding complications, no risk of HIT and most importantly, a very short half-life, negating the need for an antidote. In addition, as an aptamer, ARC183 has all the advantages normally attributed to aptamers, such as high specificity and affinity for its targets, chemical synthesis allowing for scaleable production and stable shelf life.

"This is an important collaboration for Archemix. Through this deal, we are able to generate substantial cash flow, while also retaining a significant ownership interest in the future development of ARC183," stated Dr. Errol De Souza, president and chief executive officer of Archemix. "Archemix is enthusiastic about having Nuvelo as a development and marketing partner for this program. In combination with the development group at Archemix, Nuvelo`s significant expertise in the areas of anticoagulation and thrombolysis will allow this new partnership to efficiently and rapidly realize the potential of this new therapeutic treatment."

"Nuvelo is excited about the prospect of collaborating with Archemix on ARC183. There is a compelling need for a short-acting anticoagulant to improve upon existing treatments in coronary and other interventional procedures, and preclinical studies show that ARC183 has the potential to fill this void," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "Additionally, this collaboration marks the achievement of another key goal Nuvelo had set for itself in 2003. It allows Nuvelo to strategically expand its pipeline by adding another promising cardiovascular product candidate to its expanding franchise."

About Aptamers

Aptamers are single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind target molecules in a manner conceptually similar to antibodies. Aptamers combine the optimal characteristics of small molecules and antibodies, including high specificity and affinity, chemical and biological stability, low toxicity and immunogenicity and the ability to target protein-protein interactions. Further, in contrast to monoclonal antibodies, aptamers are chemically synthesized rather than biologically expressed, offering a significant cost advantage. Because of their unique properties, aptamers promise to provide a superior alternative to conventional therapeutic approaches and can potentially be used in a wide range of disease areas, including many of those currently addressed by protein-based therapeutics.

About Archemix

Archemix Corp. is a privately held biopharmaceutical company based in Cambridge, Massachusetts. Founded in May 2001, the company`s mission is to develop aptamers as novel synthetic therapeutics that can be used in a wide range of disease areas. Further information on Archemix can be found at www.archemix.com, or calling Temin and Company at 212-588-8788; or email at [e-mail].

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on antibody targets and secreted proteins.

Further information about Nuvelo is available at www.nuvelo.com or by phoning 408-215-4000.

Nuvelo Safe Harbor

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Former Goldman Sachs Executive Joins Nuvelo Board of Directors
Wednesday February 4, 5:05 pm ET


SUNNYVALE, Calif., Feb. 4 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Barry L. Zubrow, a former senior executive of The Goldman Sachs Group, Inc., to its board of directors. Mr. Zubrow will replace Thomas McCarter who stepped down as a member of the board of directors effective February 3, 2004. Mr. Zubrow will also replace Mr. McCarter on the audit committee.
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"Thomas has served as a member of our board for several years, on two separate occasions, and I want to personally thank him for his contributions," said Dr. George Rathmann, chairman of Nuvelo`s board of directors. "We wish him well in his future endeavors."

Mr. Zubrow brings over 26 years of corporate finance experience to Nuvelo`s board of directors. From 1977 to 2003, Mr. Zubrow held a variety of positions at The Goldman Sachs Group (Goldman, Sachs & Co.) including chief administrative officer and head of the operations and the administration division. As the firm`s first chief administrative officer, he was responsible for overseeing a 4,500 plus person group of departments in charge of financial reporting, credit and risk functions, operations and trade processing, facilities, security and corporate services. Prior to that, Mr. Zubrow was elected the firm`s first chief credit officer, with responsibility for overseeing the entire firm`s global credit exposures.

Throughout his career Mr. Zubrow has provided corporate finance and strategic advice for a wide range of investment banking clients including major Fortune 100 companies. He received his J.D. and M.B.A. from the University of Chicago and is an active board member for a number of non-profit organizations.

"We are pleased to welcome Barry to our board of directors," said Dr. Rathmann. "His vast financial and strategic experience will be a great asset to Nuvelo."

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidate ARC183 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Licenses rNAPc2, a Novel Anticoagulant, From Dendreon
Wednesday February 4, 8:43 pm ET
Nuvelo Adds Phase 2 Product Candidate to Its Cardiovascular Pipeline


SUNNYVALE, Calif. and SEATTLE, Feb. 4 /PRNewswire/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced a worldwide licensing agreement with Dendreon Corporation (Nasdaq: DNDN - News) for Dendreon`s novel anticoagulant, recombinant nematode anticoagulant protein c2 (rNAPc2) and all other rNAPc proteins.
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Under the terms of the agreement, Nuvelo will pay to Dendreon in cash and common stock an upfront payment of $4 million. In addition to the upfront payment, the agreement provides for milestone payments for development and royalties upon the commercialization of rNAPc product candidates. Nuvelo will own worldwide rights to all indications for rNAPc products. No additional financial terms were disclosed.

"Given Dendreon`s focus on oncology product development, we are pleased to license the rNAPc2 program to Nuvelo while maintaining the downstream potential for this product candidate through a potential royalty stream," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We believe Nuvelo has the capabilities to effectively advance rNAPc2."

"rNAPc2 is a natural fit for Nuvelo," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "The addition of this molecule strengthens our cardiovascular portfolio of product candidates and our promising research pipeline."

The novel anticoagulant rNAPc2 is a naturally occurring protein that was originally isolated from hookworms and is currently manufactured as a recombinant protein for clinical use. The anticoagulant effect of rNAPc2 results from its apparent ability to block the Factor VIIa/Tissue Factor protease complex, which is responsible for the initiation of the process leading to blood clot formation. Unlike aspirin, heparin and antiplatelet agents, which exert their effects at later stages of the blood coagulation cascade, rNAPc2 blocks the first step in the clotting cascade, inhibiting coagulation before it starts.

Currently, a multi-center, Phase 2a study to investigate the safety and efficacy of rNAPc2 in patients with acute coronary syndromes (ACS) is being conducted with the TIMI Study Group led by Dr. Eugene Braunwald of Brigham and Women`s Hospital and Harvard Medical School. Nuvelo plans to complete the Phase 2a study and based on the data, further evaluate how to move clinical development forward.

ACS is a potentially life threatening heart condition that usually occurs when an atherosclerotic plaque ruptures in one or more arteries of the heart. This rupture triggers a series of biochemical events know as the blood coagulation cascade, which results in the formation of a blood clot. Blocking the flow of blood through the heart, the clot deprives heart tissues of oxygen, causing chest pain. The use of rNAPc2 may significantly reduce the risk of heart attack or death in patients suffering from ACS.

In both the United States and Europe, ACS accounts for more than 1 million hospitalizations annually. Despite current treatments, a significant proportion of patients still experience recurrent angina, myocardial infarction or death.

"Given the significant number of patients with acute coronary syndromes who continue to experience poor outcomes, there is a clear need for better anticoagulant therapy," said Dr. Love. "rNAPc2 has the potential to offer safer, more effective anticoagulation, reducing bleeding side-effects and the formation of unwanted blood clots."

To date, rNAPc2 has been shown to be well tolerated in over 500 patients and healthy volunteers in several Phase 1 and 2 studies. A Phase 2 study for the prevention of deep vein thrombosis (DVT) demonstrated that rNAPc2 appears to reduce the risk of developing DVT and related complications by over 50% compared to the current standard therapy for patients undergoing total knee replacement surgery without compromising safety. A second Phase 2a study demonstrated that rNAPc2 was well-tolerated when added to standard therapy with unfractionated heparin, aspirin and clopidogrel in patients undergoing elective percutaneous coronary intervention (PCI). This study also demonstrated that rNAPc2 suppresses the formation of thrombin for at least 36 hours following a single administration, compared to standard therapy alone, in which thrombin generation continued unabated.

Other potential indications under evaluation include orthopedic and vascular surgery, Ebola and cancer. A recent study published in The Lancet suggests rNAPc2 may be effective in the treatment of the Ebola virus infection. In addition, preclinical studies published in Cancer Research showed that blocking the protease complex Factor VIIa/Tissue Factor prevented the growth of primary and metastatic tumors in animal models.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular candidate ARC183, and drug discovery focused on antibody targets and secreted proteins.

Further information about Nuvelo is available at www.nuvelo.com or by phoning 408-215-4000.

About Dendreon

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The company`s lead investigational product candidate, Provenge®, is a cancer immunotherapy undergoing a pivotal Phase 3 clinical trial for the treatment of androgen independent prostate cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon`s product pipeline also includes monoclonal antibody, small molecule and pro-drug product candidates.

Nuvelo Safe Harbor

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.

Dendreon Safe Harbor

Except for historical information contained herein, this news release contains forward looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties relating to our dependence on the efforts of third parties, including Nuvelo, Inc., and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks related to Dendreon`s limited operating history, risks associated with development of product candidates through clinical research and development, risks associated with completing clinical trials, the risk that the safety and/or efficacy results of clinical trials will not support further development, the risks that the safety and/or efficacy results of a clinical trial will not support an application for a biologics license, the risk that the FDA will not approve a product for which a biologics license application has been applied, the failure by Dendreon to secure and maintain relationships with collaborators, and dependence on intellectual property. Further information on the factors and risks that could affect Dendreon`s business, financial condition and results of operations, are contained in Dendreon`s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Reports Fourth Quarter and Year End 2003 Results, Accomplishments and 2004 Forward Outlook
Thursday February 5, 6:30 am ET


SUNNYVALE, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced fourth quarter and year end 2003 financial results, accomplishments and 2004 forward outlook.
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For the three months ended December 31, 2003, Nuvelo reported a net loss of $9.4 million or $0.12 per share compared to a net loss of $16.5 million or $0.72 per share for the same period in 2002. The net loss decrease of $7.1 million was primarily attributed to decreased research and administrative costs in the fourth quarter as Nuvelo continued to streamline operations, focusing spending on the development of its lead drug candidate, alfimeprase. This was partially offset by a decrease in revenue from Nuvelo`s collaboration with BASF Plant Science LLC which was completed in January 2003. Revenues for the fourth quarter of 2003 were approximately $0.4 million, compared to revenues of $3.5 million for the same period in 2002. For the twelve months ended December 31, 2003 Nuvelo reported a net loss of $50.2 million or $0.79 per share, compared to a net loss of $45.0 million or $2.08 per share for the same period in 2002. The loss per share for the three months and year ended December 31, 2003 was impacted and reduced from the same period in 2002 as a result of additional shares issued through the acquisition of VARIAGENICS, Inc., which was completed on January 31, 2003.

As of December 31, 2003, Nuvelo had approximately $34.7 million in cash, cash equivalents, short-term investments and restricted cash compared to approximately $3.3 million at December 31, 2002.

"This time last year we committed to a singular strategic focus on therapeutic products and a promise to build a formidable biopharmaceutical business," stated Dr. Ted W. Love, president and chief executive officer of Nuvelo. "Throughout the past year, Nuvelo has continued to deliver on this promise. Through its recent partnerships, Nuvelo has created a robust cardiovascular franchise including alfimeprase, a novel thrombolytic currently in two Phase 2 trials, ARC183, an anticoagulant poised to begin a Phase 1 trial in the second half of 2004 and most recently, rNAPc2, a novel anticoagulant currently in Phase 2 trials."

Recent Highlights

Licensed novel anticoagulant, rNAPc2, from Dendreon, acquiring worldwide rights to all indications including acute coronary syndromes (ACS), orthopedic and vascular surgery, Ebola and cancer
Appointed former Goldman Sachs executive, Barry L. Zubrow, to Nuvelo`s board of directors
Filed a universal shelf registration statement with the SEC to offer up to $75 million worth of common or preferred stock, or debt securities, to be used for general corporate purposes, including capital expenditures and to meet working capital needs
Entered into a 50/50 partnership with Archemix to develop and commercialize ARC183, Archemix`s thrombin inhibitor for potential use in coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI) and other acute anticoagulant applications
Appointed current Gilead Sciences executive, Mark L. Perry, to Nuvelo`s board of directors
Completed a financing with net proceeds of approximately $26 million
Successfully completed the Phase 1 alfimeprase trial in peripheral arterial occlusion (PAO) and rapidly initiated two Phase 2 trials in both PAO and catheter occlusion. Subsequently reported successful completion of an interim analysis of our Phase 2 clinical trial for the potential treatment of patients with PAO
Entered into a patent assignment and license agreement with SEQUENOM assigning to them the entire chemical cleavage patent estate acquired through our merger with VARIAGENICS, as well as an exclusive worldwide license to nine restriction enzyme patents
Completed the merger with VARIAGENICS and changed our name to Nuvelo
2004 Outlook

Reinitiate enrollment of the Phase 2a rNAPc2 trial
Based on our current rate of enrollment, we anticipate completing enrollment of the Phase 2 alfimeprase trial in PAO in March or April of 2004
Based on our current rate of enrollment, we anticipate completing the interim analysis of the Phase 2 alfimeprase trial in catheter occlusion in March or April of 2004
Expect to initiate the Phase 3 alfimeprase trial in PAO in the second half of 2004
Expect to initiate the Phase 1 ARC183 trial in the second half of 2004
Expect to complete the analysis of the 50 secreted protein genes in our Kirin collaboration in the first half of 2004
Expect to advance at least one internal product candidate into IND-nabling studies in 2004
Actively seeking to secure strategic partners for our antibody target and/or secreted proteins programs
Continue to monetize assets outside of our therapeutic focus
Conference Call Information

Nuvelo will hold a conference call today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 800-915-4836 for domestic callers and 973-317-5300 for international callers. A telephone replay of the conference call will be available through Thursday, February 19, 2004. To access the replay, please dial 800-428-6051 for domestic callers and 973-709-2089 for international callers, and reference pass code 333575.

This call is also being webcast by CCBN and can be accessed at Nuvelo`s Web site at www.nuvelo.com, CCBN`s individual investor center at www.companyboardroom.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended Twelve months ended
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2003 2002 2003 2002

Contract Revenue: $350 $3,518 $2,290 $26,433

Operating expense:
Research and development 6,664 9,268 33,084 50,157
General and administrative 2,837 9,005 17,223 18,108
Restructuring -- 1,462 -- 2,067
Loss on sale of fixed assets 14 2 1,225 36
Total operating expenses 9,515 19,737 51,532 70,368

Loss from operations (9,165) (16,219) (49,242) (43,935)

Realized gain on investment -- -- 40 --
Interest expense, net (224) (291) (985) (1,155)
Loss before minority interest (9,389) (16,510) (50,187) (45,090)

Loss attributable to minority
interest -- -- -- 112

Net loss $(9,389) $(16,510) $(50,187) $(44,978)

Basic and diluted net loss per
share $(0.12) $(0.72) $(0.79) $(2.08)

Weighted average shares used in
computing basic and diluted net
loss per share 75,610 23,039 63,163 21,661


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)
(unaudited)

December 31, 2003 12/31/2002 *
Cash, cash equivalents and short
term investments $34,189 $2,225
Restricted cash 501 1,106
Total assets 57,809 27,072
Deferred revenue -- 525
Line of credit 10,542 10,000
Noncurrent portion of capital
leases 1,079 1,026
Notes payable - long term 6,600 4,000
Accumulated deficit (203,559) (153,372)
Total stockholders` equity
(deficit) $22,701 $(4,564)


* The condensed consolidated balance sheet data at December 31, 2002 has
been derived from the audited financial statements as of that date.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Proposed Public Offering of Common Stock
Thursday February 19, 6:54 am ET


SUNNYVALE, Calif., Feb. 19 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced plans to offer 4,000,000 shares of its common stock in an underwritten public offering. The offering will be made pursuant to the Company`s effective shelf registration statement previously filed with the Securities and Exchange Commission (SEC). The underwriters will have an option to purchase up to an additional 600,000 shares to cover over- allotments. The 4,000,000 shares of common stock is the amount of shares offered after giving effect to a 1-for-3 reverse stock split, which the Company anticipates will become effective on February 23, 2004, as announced in a separate press release today.
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UBS Securities LLC is acting as the sole book-running manager in this offering with CIBC World Markets Corp., Needham & Company, Inc. and JMP Securities LLC acting as co-managers.

A shelf registration statement relating to these shares was originally filed with the SEC on January 26, 2004 and has since been declared effective. The offering will be made pursuant to a prospectus supplement, which has been filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities nor shall there be any sale of these securities in any state in which such solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state. This offering of shares of common stock may be made only by means of a prospectus supplement and accompanying prospectus. Copies of the preliminary prospectus supplement and the accompanying prospectus can be obtained from UBS Securities LLC, ECMG Syndicate, 299 Park Avenue, New York, NY 10171.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "expect," "anticipate" and "plan" among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation, Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Declares 1-for-3 Reverse Stock Split
Thursday February 19, 11:55 am ET


SUNNYVALE, Calif. (Dow Jones)--Nuvelo Inc. (NasdaqNM:NUVO - News) will implement a 1-for-3 reverse stock split, expected to take effect on Feb. 23.
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In a news release, Nuvelo said the reverse split was approved by shareholders in June 2003 and is being implemented at this time to facilitate a public offering of 4 million common shares, also announced Thursday.

Without initiating the reverse split now, Nuvelo would have had an insufficient number of authorized shares for the expected size of the offering, it noted.

After giving effect to the reverse split, Nuvelo will have about 26 million shares outstanding, subject to rounding for fractional shares. The number of shares of common stock authorized for issuance under Nuvelo`s amended and restated Certificate of Incorporation will remain at 100 million shares.

Nuvelo expects the company`s common stock to begin trading on a split-adjusted basis when trading opens on Feb. 23, with the interim ticker symbol "NUVOD." After 20 days, it expects that the "D" designation (signifying the reverse split) will be removed, and its ticker symbol will revert to "NUVO."

Nuvelo discovers and develops therapeutics for the treatment of human disease.

Company Web Site: http://www.nuvelo.com

-Carolyn King, Dow Jones Newswires; 416-306-2100

[Bombenleger]

Nuvelo Announces Completion of Common Stock Offering
Monday March 8, 12:59 pm ET


SUNNYVALE, Calif., March 8 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO; NUVOD) today announced the completion of its public offering of 5,000,000 shares of common stock and the additional sale of 750,000 shares pursuant to the exercise of an over-allotment option granted to the underwriters. Including the sale of these additional shares, the offering was for 5,750,000 shares of common stock at $13.00 per share, resulting in total gross proceeds of approximately $74.8 million.
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UBS Securities LLC acted as the sole book-running manager in this offering. CIBC World Markets Corp., Needham & Company, Inc. and JMP Securities LLC acted as co-managers.

A shelf registration statement relating to these securities was originally filed with the Securities and Exchange Commission on January 26, 2004 and has since been declared effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any jurisdiction. This offering of shares of common stock was made only by means of a prospectus supplement and accompanying prospectus. Copies of the prospectus supplement and the accompanying prospectus can be obtained from UBS Securities LLC, ECMG Syndicate, 299 Park Avenue, New York, NY 10171.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Appoints Steven R. Deitcher, M.D. to Lead Clinical Affairs
Tuesday March 9, 9:01 am ET


SUNNYVALE, Calif., March 9 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO, interim ticker symbol: NUVOD) today announced the appointment of Steven Deitcher, M.D., as vice president, medical affairs. Dr. Deitcher joins Nuvelo as a member of the senior management team and will be responsible for all aspects of the Company`s clinical programs.
"We now have three promising cardiovascular candidates poised to enter, or currently in, human clinical trials," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "Dr. Deitcher`s extensive medical background and research experience will strengthen our clinical development efforts as we continue to make progress with our newly expanded pipeline."

Dr. Deitcher brings to Nuvelo over 15 years of experience as a practicing physician in hematology, medical oncology and vascular medicine. Prior to joining Nuvelo, he served as the head of hematology and coagulation medicine for The Cleveland Clinic Foundation and was the principal investigator for Nuvelo`s Phase 2 alfimeprase trial in catheter occlusion.

From 1998 to 2004, Dr. Deitcher held a variety of positions in both the department of vascular medicine and the department of hematology-oncology while at The Cleveland Clinic Foundation. Prior to that, he spent four years at The University of Tennessee in positions including associate chairman, department of medicine; director, combined pediatric and adult thrombosis clinic and director, special coagulation laboratory.

Dr. Deitcher earned his B.S. and M.D. at Northwestern University Medical School. He completed his residency in internal medicine at Barnes Hospital and completed his fellowship training in hematology and medical oncology at New England Medical Center and Tufts University School of Medicine. Dr. Deitcher is a member of several medical societies including The American Society of Hematology, the International Society on Thrombosis and Haemostasis and is a fellow for the Society for Vascular Medicine and Biology. He has published over 130 journal papers, abstracts, and book chapters and has made over 25 scientific conference presentations.

"The Nuvelo pipeline is a dream for anyone interested in cardiovascular drug development," said Dr. Deitcher. "The Nuvelo team is poised to usher in a new era of thrombolytic therapy and anticoagulation management."

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo and Hyseq filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K and the related Form 10-K/A for the year ended December 31, 2002 and Nuvelo`s quarterly report on Form 10-Q for the quarter ended September 30, 2003. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

12-Mar-2004

Annual Report


Item 7. Management`s Discussion and Analysis of Financial Condition and Results of Operations


We have included or incorporated by reference into this Management`s Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Annual Report on Form 10-K, and from time to time our management may make statements that constitute "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words including "anticipate," "believe," "intends," "estimates," "expect," "should," "may," "potential" and similar expressions. Such statements are based on our management`s current expectations and involve risks and uncertainties. Our actual results and performance could differ materially from those projected in the forward-




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looking statements as a result of many factors discussed in this Annual Report, including those set forth in this Item 7 as well as under "Item 1. Business," including "Risk Factors."



Critical Accounting Policies and Estimates



Our discussion and analysis of our operating results and financial condition is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires us to make estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent amounts. While we believe our estimates, judgments, and assumptions are reasonable, the inherent nature of estimates is that actual results will likely be different from the estimates made.



We believe the following critical accounting policies, among others, affect the more significant judgments and estimates used in the preparation of our consolidated financial statements.



Revenue Recognition



We recognize revenue when all of the following conditions have occurred:



• Persuasive evidence of an arrangement exists,




• Delivery has occurred or services have been rendered,




• The price is fixed and determinable, and




• Collectibility is reasonably assured.




We defer up-front refundable fees and recognize revenues upon the later of when they become nonrefundable or when performance obligations are completed. In situations where we have no continuing performance obligations, we recognize up-front nonrefundable fees as revenues when received. In situations where continuing performance obligations exist, we defer and amortize up-front nonrefundable fees over the performance period. The terms of such arrangements may cause our operating results to vary considerably from period to period.



Accounting for Goodwill



We adopted the provisions of Statement of Financial Accounting Standards No. 142, "Goodwill and Other Intangible Assets" ("SFAS 142") of the Financial Accounting Standards Board ("FASB") upon the completion of the merger with Variagenics in the current year. SFAS 142 requires that goodwill and intangible assets with indefinite useful lives no longer be amortized, but instead be tested for impairment at least annually in accordance with provisions of SFAS 142. SFAS 142 also requires that intangible assets with estimable useful lives be amortized over their respective estimated useful lives, and reviewed for impairment in accordance with SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets."



The SFAS 142 goodwill impairment model involves a two-step process. During the first step, we compare the fair value of the reporting unit with its carrying value. The estimated fair value is computed using the present value of expected cash flows, discounted at a risk-adjusted weighted average cost of capital. If the fair value of the reporting unit is determined to be more than its carrying value, no goodwill impairment is recognized. Additionally, we determined that our reporting units are the same as the operating segments as there is no discrete financial information available, and segment management does not review the operating results of components of any operating segment separately.



If the fair value of the reporting unit is determined to be less than its carrying value, goodwill impairment, if any, is computed using the second step. The second step requires the fair value of the reporting unit to be




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allocated to all the assets and liabilities of the reporting unit as if the reporting unit had been acquired in a business combination at the date of the impairment test. The excess of the fair value of assets over the fair value of liabilities is the implied value of goodwill, which is used to determine the impairment amount.



We have designated the beginning of the fourth quarter as the annual impairment testing date for our goodwill. Upon completion of the merger with Variagenics, we obtained an independent valuation for Variagenics` property, plant and equipment, and its intellectual property and internally determined the fair value of its other assets and liabilities.



Impairment of Long-Lived Assets



Periodically, we determine whether any property and equipment or any other assets have been impaired based on the criteria established in Statement of Financial Accounting Standards No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" ("SFAS No. 144").



SFAS No. 144 requires, among other things, that long-lived assets be measured at the lower of carrying amount or fair value, less cost to sell, whether reported in continuing operations or in discontinued operations. Intangibles with determinable lives and other long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Our judgments regarding the existence of impairment indicators are based on historical and projected future operating results, changes in the manner of our use of the acquired assets or our overall business strategy, and market and economic trends. In the future, events could cause the Company to conclude that impairment indicators exist and that certain intangibles with determinable lives and other long-lived assets are impaired which may result in an adverse impact on its financial condition and results of operations.



Income Taxes



Income taxes are accounted for under the asset and liability method pursuant to Statement of Financial Accounting Standards (SFAS) No. 109. Under SFAS 109, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.



We record a valuation allowance to reduce deferred income tax assets to an amount that is more likely than not to be realized. Assessment of the realization of deferred income tax assets requires that estimates and assumptions be made as to the taxable income of future periods. Our deferred tax assets are reduced to zero, as management believes that it is more likely than not that the deferred tax assets will not be realized. Projection of future period earnings is inherently difficult as it involves consideration of numerous factors such as our overall strategies and estimates of new product development and acceptance, product lifecycles, selling prices and volumes, responses by competitors, manufacturing costs and assumptions as to operating expenses and other industry specific and macro and micro economic factors. In addition, consideration is also given to ongoing and constantly evolving global tax laws and our own tax minimization strategies.



Capitalization of Software Developed for Internal Use



We account for software developed for internal use in accordance with Statement of Position ("SOP") 98-1, "Accounting for the Costs of Computer Software Developed or Obtained for Internal Use," which requires research and development costs associated with the application development stage to be capitalized for internal use software. Platform and software development costs incurred prior to the application development stage are




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charged to expense as incurred. Management is required to use professional judgment in determining whether development costs meet the criteria in SOP 98-1 for immediate expense or capitalization. Amortization of the capitalized costs begins when all substantial testing is completed and the software is ready for its intended use. Management periodically reviews the carrying value of the projects that have been capitalized to determine if impairment may exist. If it is determined that the carrying value of the asset has been impaired, the value would be reduced by a charge to operations in the amount of the impairment.



Overview



Our Company is strategically focused on the discovery and development of novel biotherapeutics. This strategy resulted from a careful review of all assets and programs at both Hyseq and Variagenics following the close of our merger between the two companies on January 31, 2003.



As part of this plan, we will dedicate our resources to advancing our most promising biopharmaceutical discovery and development programs, including alfimeprase, which entered two Phase 2 trials in the first half of 2003, rNAPc2, which is currently in a Phase 2a clinical trial, and ARC183, with an IND anticipated to be filed in mid-2004 .



We will leverage our proprietary gene collection and opportunistic in-licensing and partnering strategy to build upon our pipeline of attractive therapeutic candidates. We also intend to out-license or partner our immunotherapeutics portfolio and monetize non-core assets including our microarray business, pharmacogenomic technology and molecular diagnostic programs, to further support our biopharmaceutical development programs. Our focus is on building a successful biopharmaceutical business. This strategic initiative reflects our commitment to creating a valuable product-focused company that leverages our drug discovery and development expertise. To execute on this strategy, we will align our assets and resources and efficiently manage our finances to provide our key development programs with the greatest chance of success.



Alfimeprase, our lead development program, successfully completed its Phase 1 trial in the first quarter, 2003. This trial was a multi-center, open label, dose-escalation study to evaluate the safety and pharmacokinetics of alfimeprase, and was completed in twenty patients across seven centers in the United States. The results show that alfimephase was safe and well-tolerated. There were no drug related adverse events. In addition, we filed an IND application for a second indication in catheter occlusion. We initiated two Phase 2 programs with alfimeprase in the first half of 2003 in both PAO and catheter occlusion. On September 25, 2003, we announced successful completion of a planned interim analysis of our Phase 2 trial with alfimeprase for the potential treatment of PAO. This interim analysis was conducted on data from the first 36 patients enrolled in the trial. Following review of the patient data, the Data Safety and Monitoring Board (DSMB) and the Trial Steering Committee recommended that we continue to move forward with the trial in three doses. At an investigator meeting following the interim analysis, it was recommended that we concentrate on the two highest doses of alfimeprase. This change will result in 115 patients being treated. Based on the current rate of enrollment, we project completing enrollment of the Phase 2 PAO trial in March or April of 2004. If we successfully complete the Phase 2 trial and discussions with the FDA regarding the design of our planned Phase 3 trial, we expect to begin a Phase 3 PAO trial in the second half of 2004. Our second medical indication, catheter occlusion, is currently in a Phase 2 multi-center, double-blind, randomized study in patients with occluded catheters comparing three doses of alfimeprase against the approved dose of Cathflo Activase. We expect to treat approximately 100 patients in this trial. We have recently increased the number of sites participating in the trial and, as a result, we have seen increased enrollment over the past few months. We project completing an interim analysis on the first 48 patients in March or April of 2004.



On January 12, 2004, we entered into a worldwide collaboration agreement with Archemix to develop and commercialize ARC183 for potential use in CABG surgery, PCI and other acute anticoagulant applications. We paid Archemix an upfront payment of $3.0 million and we will also pay a milestone payment upon initiation of the Phase 2 trial and a reimbursement of $1.0 million upon the designation of any backup compound. Under the terms of the agreement, Archemix will initially lead development and be responsible for all clinical development




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activities. As part of the transaction, we and Archemix will equally share all revenues and costs associated with the development and commercialization of ARC183 after we fund the first $4.0 million in research and development costs. We will have the option to lead commercialization efforts in which both companies may participate.



We anticipate that an Investigational New Drug (IND) application for ARC183 will be filed in mid-2004. If an IND is accepted by the Food and Drug Administration (FDA), we expect that Phase 1 clinical trials will begin in the second half of 2004.



On February 4, 2004, we entered into a worldwide licensing agreement with Dendreon for our second drug candidate, rNAPc2, and all other rNAPc molecules owned by Dendreon. rNAPc2 is a recombinant version of a naturally occurring protein that has anticoagulant properties resulting from its ability to block the Factor VIIa/Tissue Factor protease complex, which is responsible for the initiation of the process leading to blood clot formation. Under the terms of the agreement, we paid Dendreon an upfront payment of $4.0 million ($500,000 in cash and $3.5 million worth of Nuvelo common stock). In addition, we will pay to Dendreon milestone payments prior to and upon any commercialization, as well as royalties if and when we reach commercialization. Our license from Dendreon grants us exclusive worldwide rights to all indications for rNAPc products. rNAPc2 is currently undergoing a Phase 2a double-blind, placebo controlled clinical trial for use in treating acute coronary syndromes (ACS), including unstable angina (UA) and non-ST segment elevation myocardial infarction
(NSTEMI).




We have raised approximately $70.3 million, net of the underwriters` fee of $4.5 million, from our recent sale of 5,750,000 shares of our common stock, including 750,000 shares related to the exercise of an over-allotment option granted to the underwriters, in a public offering at a price of $13.00 per share on March 8, 2004. We intend to use the net proceeds for general corporate purposes, including capital expenditures and to meet working capital needs. We expect from time to time to evaluate the acquisition of businesses, products and technologies for which a portion of the net proceeds may be used, although we currently are not planning or negotiating any such transactions.



Results of Operations



In October 2001, we created a majority-owned subsidiary, Callida Genomics, Inc. (Callida) to develop and commercialize our sequencing-by-hybridization (SBH) technology, including a high-speed DNA sequencing chip developed in collaboration with Affymetrix, Inc. Nuvelo`s core business is to develop and market therapeutic drugs for the treatment of human diseases. Therefore, we have chosen to organize and manage Callida as a separate segment to provide DNA analysis solutions useful to businesses engaged in the genomic sciences.



Contract Revenues



Comparison of Years Ended December 31, 2003 and 2002.



Our contract revenues were $2.3 million for 2003 compared to $26.4 million for 2002. The decrease was primarily due to completion of our collaboration with BASF in January of 2003 resulting in a decrease of $21.9 million, and completion of the recognition of deferred license revenues received from Affymetrix upon the creation of our subsidiary, Callida, in October 2001, resulting in a decrease of $2.2 million.



Revenues earned during 2003 by Nuvelo were $1.0 million compared with $25.6 million for 2002. Revenues earned during 2003 by Callida were $1.3 million compared with $0.9 million for 2002.



Revenues recognized under our gene screening services agreement with BASF were $40,000 for 2003 compared to $21.9 million for 2002. During the second quarter of 2002 we announced an agreement with BASF to accelerate the completion of our existing three-and-a-half year collaboration by six months to approximately




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January 31, 2003, resulting in significant cost savings for both parties, thereby strengthening our biopharmaceutical focus and financial position. By December 31, 2002 our performance under this $60.0 million gene discovery services agreement was substantially complete.



Revenues recognized in 2003 under our agreement with Affymetrix consist of $0.5 million related to recognition of deferred revenues from the $4.0 million license payment received from Affymetrix as part of the October 2001 settlement of all our outstanding litigation with Affymetrix and simultaneous creation of Callida, in which Affymetrix holds a minority ownership. During 2002, $2.7 million of this license payment was recognized as revenue.



Revenues recognized in 2003 also included $1.0 million for research funding received from the National Institute of Standards and Technology`s Advanced Technology Program compared to $0.4 million in 2002. The research grant awards Callida Genomics $3.2 million over three-and-a-half years, commencing September 2002. In addition, Callida received two new grants from the National Institute of Health in late 2003 resulting in revenue of $0.3 million. The combined funding of these 2 grants totals $3.0 million, which covers research operation through February 2006.



Our revenues typically vary from quarter to quarter and may result in significant fluctuations in our operating results from year to year. In the future, we may not be able to maintain existing collaborations, obtain additional collaboration partners or obtain revenue from other sources. The failure to maintain existing collaborations, the inability to enter into additional collaborative arrangements or obtain revenue from other sources could have a material adverse effect on our revenues and operating results.



Comparison of Years Ended December 31, 2002 and 2001.



Our contract revenues were $26.4 million for 2002 compared to $24.6 million for 2001. The increase was primarily due to recognition of deferred license revenues received from Affymetrix upon the creation of our subsidiary, Callida, in October 2001.



Revenues earned during 2002 by Nuvelo were $25.5 million compared with $24.6 million for 2001. Revenues earned during 2002 by Callida were $0.9 million, prior to which time Callida did not exist as a separate reportable business segment.



Revenues recognized under our gene screening services agreement with BASF were $21.9 million for 2002 compared to $22.4 million for 2001. During the second quarter of 2002 we announced an agreement with BASF to accelerate the completion of our existing three-and-a-half year collaboration by six months to approximately January 31, 2003, resulting in significant cost savings for both parties, thereby strengthening our biopharmaceutical focus and financial position. By December 31, 2002 our performance under this $60.0 million gene discovery services agreement was substantially complete.



Revenues recognized in 2002 under our agreement with Affymetrix consist of $2.7 million of deferred revenues recognized from the $4.0 million license payment received from Affymetrix as part of the October 2001 settlement of all our outstanding litigation with Affymetrix and simultaneous creation of Callida, in which Affymetrix holds a minority ownership. During 2001, $0.8 million of this license payment was recognized as revenue. As of December 31, 2002, $0.5 million of this funding remained as deferred revenue.



Revenues recognized in 2002 under our agreement with Chiron consist of the final $0.5 million amortization of $2.2 million in fees received in return for a two-year extension to our three year 1997 agreement. In May of 2002, Chiron elected not to add a second two-year extension to our agreement.



Revenues recognized in 2002 included $0.5 million received from Applera Corporation`s Celera Diagnostics business unit to license certain technologies achieved during our research collaboration with the




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University of California, San Francisco. We may receive additional licensing fees or royalties in future years if the University of California, San Francisco and Celera pursue additional research into the technologies or commercial sale of licensed products.



Revenues recognized in 2002 included $0.5 million which was received from Agilent Technologies, Inc. to license certain Callida patents and patent applications. We may receive product and services royalties in future years from Agilent, if Agilent utilizes these technologies in commercial products.



Revenues recognized in 2002 also included $0.4 million for research funding received from the National Institute of Standards and Technology`s Advanced Technology Program. The research grant awards Callida Genomics $3.2 million over three-and-a-half years, commencing September 2002.



Operating Expenses



Comparison of Years Ended December 31, 2003 and 2002.



Our total operating expenses, consisting of research and development expenses, general and administrative expenses, restructuring costs, and loss on sale of assets decreased by $18.9 million to $51.5 million for 2003 compared to $70.4 million for 2002.



For 2003, Nuvelo`s total research and development expenses decreased by $17.1 million to $33.1 million compared to $50.2 million for 2002. This decrease was primarily due to net savings of $15.0 million of research and personnel costs as a result of the early completion of our agricultural gene screening services agreement with BASF in January 2003, total rent savings of $3.5 million realized from our early lease termination of the Humboldt Court facility executed in November 2002, and a general decrease of $1.5 million in depreciation expense due to significantly lower capital expenditures in 2003 in conjunction with fixed assets becoming fully depreciated in 2003. Decrease in research and development expenses was partially offset by additional expense of $2.7 million from operation at Cambridge, Massachusetts, in connection with the Variagenics merger completed on January 31, 2003. We, subsequently, shut down Variagenics` research operation at the end of the third quarter.



Research and development costs were virtually flat for Callida with a slight increase of $0.1 million in 2003.



Our total general and administrative expenses decreased $0.9 million to $17.2 million in 2003 compared to $18.1 million in 2002. The decrease in general and administrative expenses during 2003 was primarily due to cost savings of $3.5 million by Nuvelo and Callida from a decrease in average headcount from 41 employees in 2002 to 32 employees in 2003 and decreased rent expense as a result of Humboldt`s lease termination, offset by an increase of $3.6 million from Variagenics` general and administrative costs before it was completely shut down toward the end of 2003.



Loss on sale of assets increased by $1.2 million in 2003 primarily due to writing off the Humboldt leasehold improvements in connection with our decision of not exercising our purchase option in April 2003 subsequent to Humboldt`s early lease termination executed in November 2002.



There was no restructuring cost in 2003, compared to restructuring cost of $2.1 million in 2002 for the severance costs related to headcount reduction in connection with the early completion of our BASF collaboration and Variagenics merger.



We expect operating expenses to increase during 2004 as we continue to dedicate our resources to advance ongoing alfimeprase clinical trials as well as increasing our pipeline with attractive therapeutic candidates that complement our ongoing development programs while prosecuting and enforcing our intellectual property rights. We also intend to out-license or partner our immunotherapeutics portfolio and monetize all non-core assets including Callida`s microarray to further support our biopharmaceutical development programs.




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Comparison of Years Ended December 31, 2002 and 2001.



Our total operating expenses, consisting of research and development expenses, general and administrative expenses and restructuring costs increased by $9.6 million to $70.4 million for 2002 compared to $60.8 million for 2001.



During the quarter ended December 31, 2002, we recorded a restructuring charge of $1.5 million for severance costs in connection with our anticipated merger with Variagenics. The restructuring plan includes a reduction of approximately 50 employees from research, operations and administration in our Sunnyvale California headquarters. As we focus our Company on building a successful biopharmaceutical business we may incur costs associated with additional employee reductions in research, operations and administration.



During the quarter ended June 30, 2002, we recorded a restructuring charge of $0.6 million for severance costs due to our agreement to accelerate completion of our agricultural gene discovery collaboration with BASF. The strategic restructuring plan includes a reduction of approximately 76 employees from research, operations and administration.



Operating expenses incurred during 2002 by Nuvelo were $63.9 million compared with $60.8 million for 2001. Operating expenses incurred during 2002 by Callida were $6.4 million, prior to which time Callida did not exist as a separate reportable business segment.



For 2002, our research and development expenses increased by $3.7 million to $50.2 million compared to $46.5 million for 2001. This increase was primarily due to a $10.0 million non-cash charge for the fair value of warrants issued to Amgen, Inc. in the first quarter as we began our collaboration to develop and commercialize alfimeprase. Excluding this $10.0 million charge, research and development expenses decreased $6.3 million, principally as a result of savings in cost of scientific personnel and lab supplies of $5.4 million from our agreement to accelerate completion of gene screening services for BASF by approximately six months. We also received cost recoveries of $1.0 million and $0.8 million for shared research with Kirin and Intel, respectively. Offsetting these cost recoveries, costs of outside services related to the alfimeprase Phase 1 clinical trials increased by $1.3 million. Due to the acquisition of additional facilities for research and development, rent expense increased $2.9 million. In 2002, we paid $0.9 million lower fees to the University of California, San Francisco under our research collaboration which was concluded in 2002. In addition, in 2001 we wrote off $1.1 million of capitalized software costs.



During 2002, research and development expenses under our collaboration with BASF were $7.2 million compared with $9.1 million for 2001, when gene screening services were performed at slightly higher than contractual levels. During the second quarter of 2002, we announced an agreement with BASF to accelerate the completion of the existing three and a half year collaboration by six months, to approximately January 31, 2003, resulting in significant cost savings for both parties.



Research and development expense during 2002 for our alfimeprase Phase 1 clinical studies was $3.7 million following in-licensing of alfimeprase from Amgen Inc. in the first quarter of the year, including $1.3 million for outside consultants and subcontracted clinical trial costs.



Our general and administrative expenses increased $4.6 million to $18.1 million in 2002 compared to $13.5 million in 2001. This increase was primarily due to $6.1 million in expenses incurred in connection with our early lease termination with an option to buy the underlying real properties as part of our ongoing strategy to manage our long-term costs. Termination of this lease resulted in a reduction of future rental commitments under operating leases of approximately $33.0 million, with an average reduction of $3.7 million per year. Excluding this early lease termination expense, general and administrative costs decreased $1.5 million from the previous year, due in part to lower legal expenses from bringing outside patent work in-house.




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Interest Income and Expense, Net



Comparison of Years Ended December 31, 2003 and 2002.



Our interest income and expense, net decreased by $0.2 million to $1 million for 2003 compared to $1.2 million for 2002. The net decrease is a result of the increase in interest income resulted from higher average cash and investment balances due to our merger with Variagenics and a public offering completed in October 2003, which is partially offset by increased interest expense from financing from the line of credit from our Chairman and increased amortization of premium/discount related to our investment balances and additional capital leases assumed from merger.



Comparison of Years Ended December 31, 2002 and 2001.



Our net interest expense increased by $0.6 million to $1.2 million for 2002 compared to $0.6 million for 2001. The increase in interest expense resulted from additional financing activities from the line of credit from our Chairman and loan from Affymetrix, and from lower interest income based on lower average cash and investment balances and interest rates.



Net Loss



Since our inception, we have incurred net losses, and as of December 31, 2003, we had an accumulated deficit of $203.6 million. During 2003, we incurred a net loss of $50.2 million as compared to a $45.0 million net loss in 2002 and a net loss of $36.5 million in 2001. We expect to continue to incur significant net losses, which may increase substantially as we pursue research and development of our drug candidates and other operations, and prosecute and enforce our intellectual property rights.



Net losses incurred during 2003 by Nuvelo Inc. were $46.2 million compared with $39.4 million for 2002. Net losses incurred during 2003 by Callida were $4.0 million compared with $5.6 million for 2002.



Liquidity and Capital Resources



Our primary source of liquidity is cash from financing and investing activities. We generated cash of $27.6 million and $22.8 million from financing activities in 2003 and 2002, respectively. We generated cash of $28.4 million in 2003 and used cash of $2.0 million in 2002 from investing activities.



Dr. Rathmann has been an important source of liquidity for us in the past. In March 2001 we completely drew down a $20.0 million line of credit he provided us and repaid it with shares of our common stock. In August 2001, Dr. Rathmann provided us with a second $20.0 million line of credit of which we have drawn down $11.0 million to date. In November 2003, we began repaying the outstanding balance over 48 months with equal principal payments of approximately $0.2 million. The accrued interest will be paid with the final payment in October 2007. The remaining $9.0 million under this line of credit has expired.



Dr. Rathmann guaranteed to a certain maximum amount and provided the collateral for our $4.0 million letter of credit under our 985 Almanor facility lease.



Collaboration receipts in 2003 by Nuvelo Inc. were $1.0 million compared with $22.2 million for 2002. Collaboration receipts by Callida Genomics were $1.3 million for both 2003 and 2002. Our collaboration receipts declined significantly in 2003 due to the termination of our BASF collaboration.



Our primary use of capital resources has been to fund operating activities and to acquire capital equipment and make leasehold improvements. We used cash of $45.1 million and $30.9 million for operating activities, and cash of $0.3 million and $2.1 million to acquire capital equipment and make leasehold improvements in 2003 and 2002, respectively. We expect operating expenses and capital expenditures to increase slightly during 2004 as compared to 2003 as we continue to see benefits from our 2003 cost cutting measures offset by increasing spending on our pipeline of clinical development drug candidates.




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Cash and Cash Equivalents, Cash on Deposit, and Short-Term Investments



Comparison of Years Ended December 31, 2003 and 2002. As of December 31, 2003, we had $34.2 million in cash, cash equivalents, and short-term investments. These amounts reflect a net increase of $32.0 million from the $2.2 million in cash and cash equivalents we had as of December 31, 2002. This increase resulted primarily from cash provided by our investing and financing activities in connection with our Variagenics merger and sale of common stock through an offering in October 2003.



Sources of Capital and Uses of Capital



All of our short-term investments in marketable securities have maturities of less than one year, and have been classified as available-for-sale securities, as defined by Statement of Financial Accounting Standards (SFAS) No. 115, "Accounting for Certain Investments in Debt and Equity Securities." These securities are recorded at their fair value and consist solely of corporate debt securities. We make our investments in accordance with our investment policy. The primary objectives of our investment policy are liquidity, safety of principal and diversity of investments. At December 31, 2003, we had $21.0 million in short-term investments. In addition to our recent financing activity where we raised total net proceeds of $70.3 million through a public offering completed on March 8, 2004, we plan to continue to raise funds through additional public and/or private offerings in the future to support our operations before we are ready to market our drug candidates.



We expect research and development costs for our alfimeprase clinical studies to increase, as Phase 2 clinical studies end in the first half of the year and we move into pivotal Phase 3 clinical studies in the second half of 2004. In addition, our clinical development costs will increase in 2004 as we move forward our newest drug candidates rNAPc2, licensed from Dendreon in February 2004, and our collaboration with Archemix signed in January 2004 to develop ARC183. It is not unusual for the clinical development of these types of products to take in excess of 5 years and to cost well in excess of $100 million. The time and cost of completing the clinical development of any product candidate will depend on a number of factors, including the disease or medical condition to be treated, clinical trial design and endpoints, availability of patients to participate in trials and the relative efficacy of the product versus treatments already approved. Due to these uncertainties, the Company is unable to estimate the length of time or the costs that will be required to complete the development of this product candidate.



On October 25, 2002, we terminated our eleven-year lease agreements of buildings at 225, 249 and 257 Humboldt Court, Sunnyvale, California (originally entered into June 23, 2000) and received a six-month option to purchase these properties for a purchase price of $15.3 million. These termination agreements provided for: the retroactive termination of the leases, effective as of October 1, 2002; payment of a $5.4 million termination fee (of which $3.1 million was already held by the landlord for prepaid rent and a security deposit); payment of $4.5 million ($1.7 million was cash, $2.6 million was in the form of a six-month interest free promissory note guaranteed by Company`s Chairman, Dr. George B. Rathmann (the "Option Note"), and approximately $200,000 was in the form of warrants issued to the landlord) for the option to purchase the buildings, which payment was creditable against the purchase price of the buildings if the option was ultimately exercised; and payment of $95,000 per month, commencing November 1, 2002 and ending upon the earlier of exercise of the purchase option or April 30, 2003, as additional consideration for the purchase option. We paid the entire lease termination and option fees on November 1, 2002. If we chose not to exercise the purchase option or failed to pay any installment of the additional option consideration, the $2.6 million Option Note would become due and payable immediately, the purchase option would terminate and we would recognize a lease termination expense for the $2.6 million Option Note. On May 9, 2003, we amended the lease termination agreement and terminated the option agreement. As part of this amendment to the termination agreements, we amended Dr. Rathmann`s promissory note such that the balance of $2.6 million guaranteed by Dr. Rathmann will be due and payable on May 1, 2005. Interest will accrue on the balance at an annual rate of 8.0%, and we will pay the accrued interest of approximately $17,000 on a monthly basis. In addition, under the amendment, we provided to the landlord a warrant to purchase 66,666 shares of our common stock.




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Termination of the original lease resulted in a reduction of future rental commitments under operating leases of approximately $33 million, with an average reduction of $3.7 million per year. Since we chose not to exercise this purchase option in May 2003, we immediately recognized additional lease termination expense of $3.5 million which consisted of the $2.6 million Option Note and the fair value, at the date of the grant, of the warrants issued to the landlord to purchase 66,666 shares of Nuvelo`s common stock.



In August 2002 we amended our lease on the property at 985 Almanor Ave. The amendment provides for a rent deferral of approximately $4.9 million over the next three years, retroactive to June 1, 2002. The deferred rent liability will be forgiven if we complete our planned building improvements, which are budgeted for at least $7.0 million, by September 30, 2005. Otherwise we will be required to repay the deferred rent liability, plus interest, over a four-year period beginning June 1, 2005 in equal monthly installments of $0.1 million. Other terms of the amendment include extending the term of our existing $4 million letter of credit until the end of the lease term, and early reinstatement of the original rental rates if we raise $75 million in cash as a result of a single public or private offering, with the amount of rent deferred up to that date coming due immediately. In addition, Dr. Rathmann agreed to continue his existing $1.5 million guarantee of our obligations under the lease for three years. On October 21, 2003, we entered into a second amendment with our landlord, The Irvine Company. The amendment provides for a rent deferral of approximately $2.9 million and rent savings of $200,000. In order to receive this rent deferral, we pre-paid approximately $2.7 million of its base rental payments on October 22, 2003 to cover the 9 month period beginning October 1, 2003 and ending June 30, 2004. The amendment provides that no base rent will be due for the period July 1, 2004 through March 30, 2005, resulting in a $2.9 million deferral and $200,000 savings. The deferral amount will be repaid on May 30, 2011. Other terms of the agreement include the ability to repay the $2.9 million deferred rent in 36 monthly installments of $79,975 commencing on June 1, 2011 if the lease term is extended for at least 36 months and early reinstatement of the original rental rates if we successfully raise $75 million in a single public or private equity offering, with the amount of rent deferred up to that date coming due immediately.



Until we complete the building improvements, we will record a deferred rent liability recalculated on a straight-line basis for the remainder of the lease term beginning on the amendment date of October 21, 2003, including the additional rent payments of $0.1 million in the calculation. If we complete the building improvements and receive the rental credits, we will again recalculate on a straight-line basis the rental payments over the remaining term of the lease, including the rental credits.



In August 2001, we received a commitment from our Chairman to provide a line of credit of up to $20.0 million in aggregate principal amount, available for draw down through August 5, 2003. Amounts outstanding under the line of credit bear interest at prime plus 1% and are payable in 48 equal monthly installments beginning upon the expiration date of August 5, 2003. A promissory note issued pursuant to the line of credit may be repaid by converting into shares of our common stock at any time upon the agreement of us and the Chairman at a price based upon the average price of our common stock over the 20-day period prior to the conversion or, if in connection with an equity financing, at the offering price. On August 5, 2003, with Dr. George Rathmann, we entered into a second amendment of the Amended and Restated Line of Credit Agreement to extend the expiration date set forth in the agreement to September 5, 2003. A subsequent waiver was granted to us by Dr. Rathmann to waive any and all rights to receive payment from the Company before November 5, 2003. On November 5, 2003, the parties agreed that the Company would begin repayment of the outstanding principal of $11.0 million in 48 equal monthly installments of $229,167 beginning November 6, 2003 and ending October 6, 2007. A final payment of accrued interest will be made on October 6, 2007. The remaining $9.0 million available under the $20.0 million line of credit has expired. All other terms of the line of credit agreement remain in effect. Our Chairman guaranteed to a certain maximum amount and provided the collateral for our $4.0 million letter of credit under a lease, and guaranteed our $2.6 million promissory note under it`s real estate terminated option agreement.



In October 2003, we completed a public offering of approximately 3.8 million newly issued shares of common stock at $7.35 per share for aggregate proceeds of approximately $26.3 million net of offering expenses. We may seek to raise funds through additional public offerings in the future but cannot guarantee that we will be successful.




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We have $0.5 million in restricted cash on deposit as security for a $0.5 million letter of credit in conjunction with the 675 Almanor lease. Provided that no event of default under the lease occurs, the letter of credit and the cash collateralizing it will be reduced by $0.4 million in July 2004. The cash on deposit at any time in conjunction with this letter of credit is restricted and cannot be withdrawn. We control the investment of the cash and receive the interest earned thereon.



Our liquidity and capital resources also improved as we received additional net cash and cash equivalents of $25.7 million as a result of our merger with Variagenics on January 31, 2003.



Commitments and Contingencies



Our major outstanding contractual obligations relate to our facilities` operating leases, line of credit, and notes payable. The following table summarizes our significant contractual obligations at December 31, 2003, and the effect such obligations are expected to have on our liquidity and cash flow in future periods (in thousands):




2009 and
2004 2005 2006 2007 2009 Thereafter Total
------- -------- -------- -------- ------- ------------ --------
Contractual obligations:
Line of credit (b) $ 2,750 $ 2,750 $ 2,750 $ 3,213 — — $ 11,463
Clinical trial manufacturing
costs — Amgen — 5,552 — — — — 5,552
Operating leases 3,437 5,693 7,260 7,479 7,707 18,909 50,485
Capital leases (a) 2,196 1,010 105 14 — — 3,325
Note payable — AMB (a) (c) 204 2,668 — — — — 2,872
Note payable — Affymetrix (d) — — 5,500 — — — 5,500
- ----- - ------ - ------ - ------ - ----- -- --------- - ------
Total contractual obligations $ 8,587 $ 17,673 $ 15,615 $ 10,706 $ 7,707 $ 18,909 $ 79,197
- ----- - ------ - ------ - ------ - ----- -- --------- - ------

(a) Includes interest payments.




(b) Interest is accrued at a variable rate based on current Prime

rate + 1%; all interest is due when the line of credit is
completely paid off on October 6, 2007; including accrued
interest of $921,000 accumulated through 12/31/03 in the last
monthly payment of 2007.



(c) Guaranteed by Nuvelo`s Chairman, Dr. Rathmann; including monthly interest payment of $17,000 (at fixed annual interest

rate of 8.0%)



(d) Fixed interest of 7.5% per annum is accrued and due upon complete paydown of the loan in October 2006; in lieu of cash repayment of this loan, Nuvelo has the right, at any time, to

exchange the note in whole or in part into such number of
shares of its common stock (based on a price per share equal
to 90% of the ten day trailing average price) equal to the
aggregate amount of principal and interest to be exchanged.




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[Bombenleger]

Nuvelo Changes State of Incorporation to Delaware
Thursday March 25, 5:47 pm ET


SUNNYVALE, Calif., March 25 /PRNewswire/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the completion of reincorporation from a Nevada to Delaware corporation. The reincorporation was approved by the shareholders of Nuvelo at its 2003 annual meeting, as disclosed in Nuvelo`s Form 10-Q filed on August 14, 2003. The reincorporation became effective March 25, 2004 in accordance with the time frame set out in Nuvelo`s proxy statement for its 2003 annual meeting.
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"Given that Delaware has been a leader in adopting comprehensive, modern, corporate laws that are periodically updated and revised to meet changing business needs, we believe that the reincorporation will allow our board of directors to more effectively perform its duties and benefit our stockholders," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "In addition, given the widespread acceptance of Delaware as a state of incorporation, investors may feel more comfortable investing in us."

The reincorporation was accomplished by the merger of Nuvelo into its wholly owned subsidiary, which is incorporated in the state of Delaware. As a result of the reincorporation, holders of common stock of Nuvelo now automatically own the same number of shares of common stock in Nuvelo as they did prior to the reincorporation. Stockholders do not need to exchange share certificates based upon the reincorporation. The reincorporation will not result in any change in Nuvelo`s ticker symbol, Nasdaq National Market listing, business, assets or liabilities, will not cause Nuvelo`s corporate headquarters to be moved and will not result in any relocation of management or other employees.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "anticipated" and "may" among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, future changes in Delaware law, and our inability to realize the anticipated benefits of the reincorporation.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Be Featured at the CIBC World Markets Annual Biotechnology & Specialty Pharmaceuticals Conference
Thursday April 22, 9:30 am ET


SUNNYVALE, Calif., April 22 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Ted W. Love, M.D., president and CEO, will be presenting at the CIBC World Markets Annual Biotechnology & Specialty Conference in New York City, on Tuesday, April 27, 2004 at 3:45 p.m. Eastern Time.
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Dr. Love will provide a brief corporate overview and discuss the company`s recently expanded pipeline and near-term milestones. A live audio webcast of the presentation will be available online via the Investor Relations portion of Nuvelo`s Web site at www.nuvelo.com or at http://www.veracast.com/webcasts/cibcwm/biotech04/74114139.c…

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins. Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces First Quarter 2004 Financial Results and Accomplishments
Thursday May 6, 4:01 pm ET


SUNNYVALE, Calif., May 6 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced results for the quarter ended March 31, 2004.
For the three months ended March 31, 2004, Nuvelo reported a net loss of $17.7 million or $0.65 per share compared to a net loss of $13.6 million or $0.82 per share for the same period in 2003. The net loss increase was primarily attributed to increased development expenses related to a license for our new drug candidate, rNAPc2, and an upfront collaboration expense and ongoing development costs for our additional new drug candidate, ARC183. The net loss was partially offset by decreased research and administrative costs as the Company continued to streamline operations since completing its merger with Variagenics, Inc. in January 2003. Revenues for the first quarter of 2004 were approximately $0.6 million, compared to revenues of $1.3 million for the same period in 2003.

As of March 31, 2004, Nuvelo had approximately $94.0 million in cash, cash equivalents and short-term investments compared to approximately $34.2 million at December 31, 2003. This increase in cash was a result of the $69.6 million in net proceeds raised from our recently completed public offering. The net cash burn rate for the quarter was $9.8 million.

"Over the past few months, we have expanded our pipeline from one promising clinical stage candidate to a pipeline of three synergistic, acute, hospital based cardiovascular candidates," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "In addition, Dr. Steven Deitcher, the former principal investigator for our Phase 2 alfimeprase trial in catheter occlusion, joined the Company to lead our clinical development efforts as our product candidates progress through clinical trials and we greatly improved our financial position through a public offering that gives us the ability to fund our product development programs."

Additional First Quarter Highlights
-- Nearing completion of our Phase 2 trial with alfimeprase in acute
peripheral arterial occlusion (PAO). To date, we have enrolled 104 of
the necessary 115 patients in this trial.
-- Nearing completion of the interim analysis of the first 48 patients in
our Phase 2 trial with alfimeprase in catheter occlusion. To date, we
have enrolled 39 patients in this trial.
-- Reinitiated our Phase 2a trial with rNAPc2 for patients with acute
coronary syndromes (ACS).
-- Changed our state of incorporation from Nevada to Delaware.
-- Completed a ~$74.8 million public offering and implemented a
one-for-three reverse stock split in order to facilitate the
transaction.
-- Licensed novel anticoagulant, rNAPc2, from Dendreon, acquiring
worldwide rights to all indications including acute coronary syndromes
(ACS), orthopedic and vascular surgery, Ebola and cancer.
-- Appointed former Goldman Sachs executive, Barry L. Zubrow, to Nuvelo`s
board of directors.
-- Entered into a 50/50 collaboration with Archemix to develop and
commercialize ARC183, Archemix`s thrombin inhibitor for potential use
in coronary artery bypass graft (CABG) surgery, percutaneous coronary
intervention (PCI) and other acute anticoagulant applications.


Conference Call Information

Nuvelo will hold its previously noticed annual shareholder`s meeting today, Thursday, May 6, 2004 at 4:00 p.m. Eastern Time (1:00 p.m. Pacific Time) at 675 Almanor Avenue, Sunnyvale, CA 94085. In conjunction with this meeting, the Company will hold a conference call and webcast to begin at approximately 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To participate in the conference call, please dial 800/915-4836 for domestic callers and 973/317-5319 for international callers. A telephone replay of the conference call will be available through Thursday, May 20, 2004. To access the replay, please dial 800/428-6051 for domestic callers and 973/709-2089 for international callers, and reference passcode 350862.

This call is being webcast by CCBN and can be accessed via the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com.

The webcast is also being distributed over CCBN`s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN`s individual investor center at www.fulldisclosure.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended
March 31, 2004 March 31, 2003

Contract Revenue: $642 $1,283

Operating expense:
Research and development 16,313 10,803
General and administrative 1,825 3,847
(Gain) loss on sale of fixed
assets (21) 44
Total operating expenses 18,117 14,694

Loss from operations (17,475) (13,411)

Realized gain on investment -- 40
Interest expense, net (203) (212)
Net loss $(17,678) $(13,583)

Basic and diluted net loss per share $(0.65) $(0.82)

Weighted average shares used in
computing basic and diluted net loss
per share 27,391 16,545


CONDENSED CONSOLIDATED BALANCE SHEET
AND OTHER DATA
(in thousands)
(unaudited)

March 31, 2004 December 31, 2003
Cash, cash equivalents and short
term investments $94,026 $34,189
Restricted cash 501 501
Total assets 119,725 57,809
Noncurrent portion of capital
leases 674 1,079
Notes payable - long term 6,600 6,600
Accumulated deficit (221,237) (203,559)
Total stockholders` equity
(deficit) 78,650 22,701




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Be Featured at the Rodman & Renshaw Techvest Global Healthcare Conference
Friday May 7, 9:30 am ET


SUNNYVALE, Calif., May 7 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Ted W. Love, M.D., president and CEO, will be presenting at the Rodman & Renshaw Techvest Global Healthcare Conference in London, on Wednesday, May 12, 2004 at 9:05 a.m. BST (British Summer Time).
ADVERTISEMENT


Dr. Love will provide a brief corporate overview and discuss the company`s recently expanded pipeline and near-term milestones. A live audio webcast of the presentation will be available online via the Investor Relations portion of Nuvelo`s Web site at www.nuvelo.com or at http://www.wallstreetwebcasting.com/webcast/rrshq2/nuvo/.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Form 10-Q for NUVELO INC


--------------------------------------------------------------------------------

10-May-2004

Quarterly Report


RESULTS OF OPERATIONS


Contract Revenues



Comparison of the Three Months Ended March 31, 2004 and 2003.



Revenues decreased by $0.7 million to $0.6 million for the three months ended March 31, 2004 from $1.3 million for the comparable period ended March 31, 2003 due to completion of the recognition of our license fee revenue from the Affymetrix collaboration for the development of a high speed universal DNA sequencing chip in 2003 and decreased grant revenue of $0.4 million from NIST in the first quarter of 2004, partially offset by increased new grant revenue of $0.4 million from NIH in the first quarter of 2004.



Revenues earned by our Nuvelo segment were $0.1 million for the three months ended March 31, 2004, compared to $0.8 million during the same period of 2003. Our Callida segment had revenues of $0.6 million for the three months ended March 31, 2004, compared to $0.5 million in the same period of 2003. We anticipate that revenues will remain small as we continue to focus on clinical development and work toward commercialization of our product candidates, alfimeprase, rNAPc2 and ARC183.



Our revenues typically vary from quarter to quarter and may result in significant fluctuations in our operating results from year to year. In the future, we may not be able to maintain existing collaborations, obtain additional collaboration partners or obtain revenue from other sources. The failure to maintain existing collaborations or the inability to enter into additional collaborative arrangements or obtain revenues from other sources could have a material adverse effect on our revenues, operating results, and cash flows.



Operating Expenses




THREE MONTHS ENDED
MARCH 31,
---------------------------------
2004 2003 % Change
-------- -------- --------
Research and development $ 16,313 $ 10,803 51 %
General and administrative 1,825 3,847 -53 %
(Gain) loss on sale of assets (21 ) 44 -148 %
- ------ - - ------ -------- -
Total operating expense $ 18,117 $ 14,694 23 %
- ------ - - ------ -------- -



Comparison of the Three Months Ended March 31, 2004 and 2003.



Research and development (R&D) expenses consist of personnel costs and other R&D related operating expenses predominantly covering clinical trial costs, supplies, outside services, licenses and royalties fees, depreciation and amortization, and facilities expenses. Total R&D expenses increased to $16.3 million for the three months ended March 31, 2004, compared to $10.8 million for the comparable period ended March 31, 2003. The increase was primarily due to total upfront fees of $7.0 million paid in connection with our collaboration agreement with Archemix and licensing agreement with Dendreon in addition to $1.8 million clinical trial expense reimbursement related to our Archemix collaboration; partially offset by $1.6 million in savings realized from completion of the shut-down of our Variagenics` operations in the third quarter of 2003, and a facility`s purchase option expense of $0.3 million incurred in the first quarter of 2003 relating to our lease termination of the Humboldt Court facility.



General and administrative expenses decreased to $1.8 million for the three months ended March 31, 2004, compared to $3.9 million for the comparable period ended March 31, 2003. The decrease was primarily due to $1.3 million in cost savings realized from our Variagenics` operation shut-down in the third quarter of 2003, and personnel related cost savings realized from various headcount reductions carried out in the first, third and fourth quarters of 2003.



Our Nuvelo segment had operating expenses of $17.0 million for the three months ended March 31, 2004, compared to $12.5 million for the comparable period ended March 31, 2003. Our Callida segment had operating expenses of $1.1 million for the three months ended March 31, 2004, compared to $2.2 million for the comparable period ended March 31, 2003.



Excluding our upfront payments made in conjunction with ARC 183 and rNAPc2 in the first quarter of 2004, we expect total operating expenses to increase for the remainder of 2004 for clinical development costs as we continue to advance our drug candidates, alfimeprase, rNAPc2, and ARC183 through clinical trials. In addition we have incurred liabilities of $10.9 million for clinical development and drug manufacturing costs as of March 31, 2004, of which $3.6 million has been expensed and $7.3 million is expected to be expensed within the next twelve months as we advance alfimeprase into Phase 3 clinical trials in the second half of 2004. We may also incur milestone expenses for our rNAPc2 and ARC183 drug candidates within the next twelve months.




Interest Income and Expense



Comparison of the Three Months Ended March 31, 2004 and 2003.



Our net interest income and expense remained flat at $0.2 million for the three months ended March 31, 2004 and for the comparable period ended March 31, 2003. The unchanged net result is related to increased interest income primarily due to higher average cash and investment balances from our financing activities in October 2003 and March 2004, which is offset by amortization of premium of corporate debt securities held to maturity in our short-term investment account.



Net Loss



Comparison of the Three Months Ended March 31, 2004 and 2003.



Since our inception, we have incurred operating losses, and as of March 31, 2004 we had an accumulated deficit of $221.2 million. We incurred a net loss for the three months ended March 31, 2004 of $17.7 million, compared to a net loss of $13.6 million in the comparable period ended March 31, 2003. Our Nuvelo segment had net losses of $17.2 million for the three months ended March 31, 2004, compared to net losses of $11.9 million in the comparable period ended March 31, 2003. Callida had net losses of $0.5 million for three months ended March 31, 2004, as compared to losses of $1.7 million in comparable period ended March 31, 2003.



The increased net loss in the first quarter of 2004 resulted primarily from increased license expenses incurred in connection with our worldwide license fees paid for our novel anticoagulant, rNAPc2 and our worldwide collaboration agreement fees and development expenses for our thrombin inhibitor, ARC183, and was partially offset by the decreased general and administrative and other research and development expenses in the three months ended March 31, 2004 as compared to three months ended March 31, 2003. We expect to continue to incur significant operating losses for the foreseeable future, which may increase substantially as we continue clinical development of our lead drug candidate, alfimeprase, continue clinical development of our two new drug candidates rNAPc2 and ARC183, further expand research and development of our potential biopharmaceutical product candidates, and continue to prosecute and enforce our intellectual property rights. These losses may be partially offset by our efforts to monetize non-core assets in the near future.




LIQUIDITY AND CAPITAL RESOURCES




First Quarter Highlights:



Completed financing resulting in net proceeds received in the first quarter of approximately $69.6 million



Entered into a worldwide license agreement for rNAPc2 with a license fee of $4.0 million

$0.5 million in cash paid and expensed in the first quarter

$3.5 million in common stock expensed in the first quarter



Entered into a worldwide collaboration with Archemix to develop ARC183

$3.0 million collaboration fee paid and expensed in the first quarter

$1.8 million expensed for drug development costs to be paid in the second quarter






(Dollars in Thousands)
--------------------------------------------
March 31, 2004 December 31, 2003
----------------- -------------------
Cash, Cash Equivalents & Short Term Investments $ 94,026 $ 34,189
Total Assets 119,725 57,809
Working Capital 76,087 25,772
Accrued Clinical Trial Liabilities 10,881 5,552
Capital Lease, Line of Credit and Notes Payable 19,002 20,212
Stockholders` Equity $ 78,650 $ 22,701



To date our primary source of liquidity has been cash from financing activities, collaboration receipts and our merger with Variagenics on January 31, 2003. We believe that currently, we have adequate cash reserve to fund our operations through 2005.






Cash and Cash Equivalents, Short-Term Investments, and Restricted Cash on Deposit



As of March 31, 2004, we had $94.0 million in cash, cash equivalents and short-term investments. This amount reflects a net increase of $59.8 million from $34.2 million as of December 31, 2003. This increase resulted from cash provided by sale of common stock through financing activities completed in October 2003 and in March 2004.



In addition, we have $0.5 million in total restricted cash on deposit. This restricted cash is security for a $0.5 million letter of credit in conjunction with a facility lease for our office at 675 Almanor Avenue in Sunnyvale, California. The cash on deposit in conjunction with these letters of credit is restricted and cannot be withdrawn. Provided that no default has occurred under the lease for the 675 Almanor facility, the letter of credit and the cash collateralizing it may be reduced to $0.1 million in the third quarter of 2004. We control the investment of the restricted cash and receive the interest earned thereon.



The primary objectives for our investment portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return to us, consistent with these two objectives. Our investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer.



Cash Used in Operating Activities



Net cash used in operating activities decreased $1.7 million to $8.8 million in the first three months of 2004 compared to $10.6 million during the same period in 2003. The decrease in cash used in operating activities was primarily due to expenses incurred by Variagenics in the first quarter of 2003 which were eliminated, and was partially offset by a decrease in collaboration revenue, primarily Affymetrix license revenue, in the first quarter of 2004.



We expect a net increase in operating expenses in the second quarter of 2004 as we continue to balance increased clinical development and manufacturing costs with cost cutting measures and potential licensing and collaboration receipts. We have incurred liabilities of $10.9 million for manufacturing of alfimeprase phase 2 and phase 3 drug product and other clinical development costs. We anticipate cash outflows of the accrued liability within the next twelve months as we advance our lead drug candidate, alfimeprase into and through phase 3 clinical trials. We also anticipate incurring significant additional drug manufacturing costs and clinical development costs related to our three drug candidates.



Our strategic plan includes monetization of our non-core assets that we expect will generate additional cash. Not achieving these goals could significantly harm our results of operations, which may require us to delay and scale back one or more of our research or development programs, or relinquish greater rights to products at an earlier stage of development on less favorable terms than we would otherwise seek to obtain, which could have a materially adverse affect on our long term business, our financial condition, and our operating results.



Cash Provided by Investing Activities



Net cash provided by investing activities was $7.5 million during the first three months of 2004, compared to $33.1 million during the comparable period ended March 31, 2003. The decrease in net cash provided by investing activities was primarily due to increased cash and short-term investments assumed from the acquisition of Variagenics during the first quarter of 2003. New capital equipment purchases remained flat at $0.2 million for the three months ended March 31, 2004, as we continue to minimize and control capital expenditures. Other than purchases and sales of short term investments, we expect net cash provided by investing activities to stay at a low level for the foreseeable future.



Cash Provided by Financing Activities



We generated cash of $68.8 million and $0.5 million from financing activities in the three months ended March 31, 2004 and 2003, respectively. Net cash generated in financing activities for Nuvelo in the three months ended March 31, 2004 resulted from proceeds from a public offering completed on March 8, 2004 and from exercise of stock options and from the employee stock purchase plan, partially offset by payments made on our lease and loan obligations. Net cash provided by financing activities in the three months ended March 31, 2003 was due to additional drawdown made from a line of credit, made available to us by the chairman of our board of directors, partially offset by payments made on our lease obligations. The remaining line of credit from our chairman has expired, and we have begun paying down this line of credit through a plan of 48 monthly installments that started in November of 2003. There was no cash generated by financing activities in the first three months of 2004 and 2003 by Callida.



As of March 31, 2004, 441,358 shares of our common stock were issuable upon repayment of a note held by Affymetrix. Affymetrix has the ability to declare all outstanding principal and interest under the note immediately due and payable in the event that our market capitalization is under $50 million and Affymetrix reasonably determines that the loan evidenced by the note is impaired, and we have an obligation to prepay amounts owing under the note to the extent that the amounts outstanding exceed 10% of our market capitalization. Moreover, we have registered for resale a portion of these shares on a registration statement that has been declared effective by the SEC.



Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth under "Risk Factors – We Must Be Able to Continue to Secure Additional Financing" below. We may not be able to secure additional financing to meet our funding requirements on acceptable terms, if at all. If we raise additional funds by issuing equity securities, substantial dilution to our existing stockholders may result. If we are unable to obtain additional funds, we may have to additionally curtail the scope of our operations.




Operating Leases



Through March 31, 2004, we were leasing three facilities under operating lease agreements, two of which expire in June 2005 and one that expires in May 2011. The rent is being recognized as expense on a straight-line basis.



Our minimum future rental commitments under non-cancelable operating leases at March 31, 2004 are as follows (in thousands):




Minimum Rental
Commitments
---------------
For the remaining nine months ended December 31,
2004 2,120
For the year ended December 31,
2005 5,693
2006 7,260
2007 7,479
2008 7,707
2009 and thereafter 18,909
-- ------------
$ 49,169
-- ------------



Critical Accounting Policies and Estimates



Our discussion and analysis of our operating results and financial condition is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires us to make estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent amounts. While we believe our estimates, judgments, and assumptions are reasonable, the inherent nature of estimates is such that actual results will likely be different from the estimates made.



We have not made changes to our critical accounting policies as presented in our Form 10-K filed on March 12, 2004.




NEW ACCOUNTING PRONOUNCEMENTS




In May 2003, the FASB issued SFAS No. 150, effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. The adoptionof SFAS No. 150 did not have a material impact on the results of operations or the financial position of the Company.



In November 2003, the Emerging Issues Task Force reached consensus on EITF Issue No. 03-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments," concerning the meaning of the term "other-than-temporary" as it applies to impairment losses on various types of investments. The EITF reached a consensus that an investor should estimate the fair value of a cost method investment when an impairment indicator is present. Impairment indicators are relevant only for cost method investments for which the investor is not otherwise required to estimate the fair value on an annual basis. The guidance for evaluating whether an investment is other-than-temporarily impaired should be applied in other-than-temporary impairment evaluations made in reporting periods beginning after June 15, 2004. We are currently assessing the impact of EITF 03-1 on our consolidated financial position and results of operations.




RISK FACTORS




We operate in a rapidly changing environment that involves a number of risks, some of which are beyond our control. The following discussion highlights some of these risks.



Future sales of our common stock may depress the market price of our common stock.



Sales in the public market of substantial amounts of our common stock could depress prevailing market prices of our common stock. As of March 31, 2004, we had 31,839,223 shares of our common stock outstanding. All of these shares are freely transferable without restriction or further registration under the Securities Act of 1933, as amended, or the Securities Act, except for shares held by our affiliates and unregistered shares held by non-affiliates. As of March 31, 2004, our affiliates held 6,546,649 shares of our common stock, which are transferable pursuant to Rule 144 or in some cases Rule 145, each as promulgated under the Securities Act, or pursuant to effective registration statements. Although we do not believe that our affiliates have any present intentions to dispose of any shares of common stock owned by them, there can be no assurance that such intentions will not change in the future.



As of March 31, 2004, warrants to purchase 1,757,633 shares of our common stock were outstanding. Options to exercise 2,471,120 shares of our common stock were outstanding under our 2002 Equity Incentive Plan, 1995 Stock Option Plan, Non-Employee Director Stock Option Plan, Scientific Advisory Board/ Consultants Stock Option Plan, the Variagenics, Inc. Amended 1997 Employee Director and Consultant Stock Option




Plan, and stock option agreements entered into outside of any of our stock option. In addition, we have 1,476,963 shares remaining for future option grants under our stock option plans. Under our Employee Stock Purchase Plan, we have approximately 82,396 shares of our common stock reserved for future issuance as of March 31, 2004. The existence of the currently outstanding warrants and options to purchase our common stock may negatively affect our ability to complete future equity financings at acceptable prices and on acceptable terms.



As of March 31, 2004, 441,358 shares of our common stock were issuable upon repayment of a note held by Affymetrix. Affymetrix has the ability to declare all outstanding principal and interest under the note immediately due and payable in the event that our market capitalization is under $50 million and Affymetrix reasonably determines that the loan evidenced by the note is impaired, and we have an obligation to prepay amounts owing under the note to the extent that the amounts outstanding exceed 10% of our market capitalization. Moreover, we have registered for resale a portion of these shares on a registration statement that has been declared effective by the SEC. If we decide to repay this note with our common stock, whether pursuant to acceleration of the note or otherwise, the resale of shares of our common stock received by Affymetrix may also result in significant downward pressure on the price of our common stock.



We have not achieved profitability, have recent and anticipated continuing losses and may never become profitable.



For the years ended December 31, 2001, 2002 and 2003, we had net losses of $36.5 million, $45.0 million and $50.2 million, respectively. As of March 31, 2004, we had an accumulated deficit of $221.2 million.



All of our product candidates are in various stages of product development, and some are still in research or in early development. None of them are approved for sale. The process of developing biotherapeutics and related products will require significant additional research and development, preclinical testing, clinical trials and regulatory approvals. These activities, together with general administrative and other expenses, are expected to result in operating losses for the foreseeable future. To date, we have not generated any revenues from product sales. We do not expect to achieve significant product sales or royalty revenue for several years, and we may never do so. We expect to incur additional operating losses in the future, and these losses may increase significantly as we continue preclinical research and clinical trials, apply for regulatory approvals, develop our drug candidates, expand our operations and develop systems that support commercialization of our potential products. These losses, among other things, have caused and may cause our stockholders` equity and working capital to decrease. We may not be successful in developing our drug candidates, obtaining regulatory approvals and commercializing our products, and our operations may not be profitable even if any of our drug candidates are commercialized. We may never generate profits and, as a result, the trading price of our common stock could decline. Moreover, utilization of our net operating loss carryforwards and credits may be subject to an annual limitation due to the "change in ownership" provisions of the Internal Revenue Code of 1986 and similar state law provisions. It is possible that certain transactions that we have entered into, including our merger with Variagenics that occurred in January 2003, when considered in connection with other transactions, may result in a "change in ownership" for purposes of these provisions.



Our relatively short operating history may affect our ability to execute our business strategy.



We have a short operating history. We commenced operations in the fourth quarter of 1994 with an initial business focused on gene discovery using our signature-by-hybridization platform and applications of our sequencing-by-hybridization technology, including the HyChip system. In 1998, we began to transition our business strategy from gene discovery to research and development of potential therapeutic protein candidates. As a company with a relatively short operating history, we face risks and uncertainties frequently encountered by companies in new and rapidly evolving markets, including:



• the implementation and successful execution of our business strategy

and our sales and marketing initiatives;



• retention of current customers and collaborators and attraction of new

customers and collaborators;



• our ability to respond effectively to competitive and technological

developments related to our technologies, products and services;



• our ability to attract, retain and motivate qualified personnel; and




• our ability to effectively manage our anticipated growth.




If we fail to address these risks and uncertainties successfully, our business, results of operations, financial condition and prospects will be materially adversely affected.



We may face fluctuations in operating results.



Our operating results may rise or fall significantly as a result of many factors, including:



• the amount of research and development we engage in;





• the number of product candidates we have and their progress in
research and preclinical studies;




• our ability to expand our facilities to support our operations;




• our ability to enter into new strategic relationships;




• the scope, duration and effectiveness of our collaborative arrangements;




• the costs involved in prosecuting, maintaining and enforcing patent claims;




• the possibility that others may have or obtain patent rights that

are superior to ours;



• changes in government regulation; and




• release of successful products into the market by our competitors.




Excluding our three clinical and development stage drug candidates, our potential products currently are in research or preclinical development, and revenues from the sales of any products resulting from these efforts may not occur for several years, if at all. A high percentage of our expenses are fixed costs such as lease obligations. As a result, we may experience fluctuations in our operating results from quarter to quarter and continue to generate losses. Quarterly comparisons of our financial results may not necessarily be meaningful, and investors should not rely upon such results as an indication of our future performance. In addition, investors may react adversely if our reported operating results are less favorable than in a prior period or are less favorable than those anticipated by investors or the financial community, which may result in a drop of our stock price.



We will need to raise additional capital, and such capital may be unavailable to us when we need it or not available on acceptable terms.



Even though we raised net $69.6 million during our recent public offering completed on March 8, 2004, we will need to continue to raise significant additional capital. Financing may be unavailable when we need it or may not be available on acceptable terms. The unavailability of financing may require us to delay, scale back or eliminate expenditures for our research, development and marketing activities necessary to commercialize our potential biopharmaceutical products. We may also be required to grant rights to third parties to develop and market drug candidates that we would prefer to develop and market on our own, potentially reducing the ultimate value that we could realize from these drug candidates.



If we are unable to obtain additional financing when we need it, the capital markets may perceive that we are not able to raise the amount of financing we desire, or on the terms that we desire. This perception, if it occurs, may negatively affect the trading price of our common stock. In addition, a new equity financings could result in significant dilution of current stockholders` equity interests. If sufficient capital is not available, we may be forced to delay, reduce the scope of, eliminate or divest one or more of our subsidiaries or our discovery, research or development programs. Any such action could significantly harm our business, financial condition and results of operations.



Our future capital requirements and the adequacy of our currently available funds will depend on many factors, including, among others, the following:




• continued scientific progress in our research and development
programs, including progress in our research and preclinical
studies;



• the cost involved in any facilities expansion to support research

and development of our product candidates;



• our ability to attract additional financing on favorable terms;




• the magnitude and scope of our research and development programs,

including development of product candidates;




• our ability to maintain, and the financial commitments involved in
our existing collaborative and licensing arrangements;



• our ability to establish new collaborative relationships with other companies to share costs and expertise of identifying and developing

drug candidates;




• the cost of prosecuting and enforcing our intellectual property rights;




• the cost of manufacturing our material for preclinical, clinical and

commercial purposes;



• progress in our clinical studies of alfimeprase and rNAPc2;




• the time and cost involved in obtaining regulatory approvals;




• our need to develop, acquire or license new technologies or products;




• competing technological and market developments;





• future funding commitments to our subsidiary, Callida, and our
ability to borrow funds from Affymetrix to fund our commitment,
under the terms of the Affymetrix settlement;



• our ability to use our common stock to repay the outstanding note to Affymetrix and our line of credit from our Chairman, Dr. George

B. Rathmann;



• legal and Nasdaq restrictions that impede our ability to raise funds

from private placements of our common stock;



• future funding commitments to our collaborators;




• general conditions in the financial markets and in the biotech sector;




• the uncertain condition of the capital markets and in the biotech sector; and




• other factors not within our control.




Development of our products will take years, and our products require regulatory approval before they can be sold.



Excluding our three clinical and development stage drug candidates, our potential products currently are in research or preclinical development and revenues from the sales of any products resulting from these efforts may not occur for several years, if at all. We cannot be certain that any of our products will be demonstrated to be safe and effective or that we will obtain regulatory approvals. In addition, any products that we develop may not be economical to manufacture on a commercial scale. Even if we develop a product that becomes available for commercial sale, we cannot be certain that consumers will accept the product. We cannot predict whether we will be able to develop and commercialize any of our drug candidates successfully. If we are unable to do so, our business, results of operations and financial condition will be affected in a materially adverse manner.



We do not yet have products in the commercial markets. We must demonstrate that our product candidates satisfy rigorous standards of safety and efficiency before the FDA and comparable agencies in foreign markets. We cannot apply for regulatory approval of our potential products until we have performed significant additional research and development and testing. We cannot be certain that we, or our strategic partners, will be permitted to undertake clinical testing of our potential products or continue clinical testing of alfimeprase or rNAPc2. If we are successful in initiating clinical trials, we may experience delays in conducting them. Our clinical trials may not demonstrate the safety and efficacy of our potential products, and we may encounter unacceptable side effects or other problems in the clinical trials. Should this occur, we may have to delay or discontinue development of the potential product that causes the problem. After a successful clinical trial, we cannot market products in the United States until we receive regulatory approval. Even if we are able to gain regulatory approval of our products after successful clinical trials and then commercialize and sell those products, we may be unable to manufacture enough products to maintain our business, which could have a negative impact on our financial condition.



We face heavy government regulation, and FDA regulatory approval of our products is uncertain.



The research, testing, manufacturing and marketing of drug products such as those proposed to be developed by us or our collaboration partners are subject to extensive regulation by federal, state and local governmental authorities, including the FDA, and comparable agencies in other countries. In order to obtain regulatory approval of a drug product, we or our collaboration partners must demonstrate to the satisfaction of the applicable regulatory agency, among other things, that such product is safe and effective for its intended uses. In addition, we must show that the




manufacturing facilities used to produce the products are in compliance with current Good Manufacturing Practices, or cGMP, requirements. The process of obtaining FDA and other required regulatory approvals and clearances typically takes several years and will require us to expend substantial capital and resources. Despite the time and expense exerted, regulatory approval is never guaranteed. The number of preclinical and clinical tests that will be required for FDA approval varies depending on the drug candidate, the disease or condition that the drug candidate is in development for, and the regulations applicable to that particular drug candidate. The FDA can delay, limit or deny approval of a drug candidate for many reasons, including:



• a drug candidate may not be safe or effective;





• FDA officials may interpret data from preclinical and clinical
testing in different ways than we and our collaboration partners
interpret it;



• the FDA may not approve our manufacturing processes or facilities or

the processes or facilities of our collaboration partners; or



• the FDA may change its approval polices or adopt new regulations.




Moreover, if and when our products do obtain such approval or clearances, the marketing, distribution and manufacture of such products would remain subject to extensive ongoing regulatory requirements. Failure to comply with applicable regulatory requirements could result in:



• warning letters;




• fines;




• civil penalties;




• injunctions;




• recall or seizure of products;




• total or partial suspension of production;




• refusal of the government to grant approvals; or




• withdrawal of approvals and criminal prosecution.




Any delay or failure by us or our collaboration partners to obtain regulatory approvals for our product candidates:



• would adversely affect our ability to generate product and royalty revenues;




• could impose significant additional costs on us or our collaboration

partners;



• could diminish competitive advantages that we may attain; and




• would adversely affect the marketing of our products.




Even if we do receive regulatory approval for our drug candidates, the FDA or international regulatory authorities may impose limitations on the indicated uses for which our products may be marketed, subsequently withdraw approval or take other actions against us or our products adverse to our business. The FDA and international regulatory authorities generally approve products for particular indications. If an approval is for a limited indication, this limitation reduces the size of the potential market for the product. Product approvals, once granted, may be withdrawn if problems occur after initial marketing.




We also are subject to numerous federal, state and local laws, regulations and recommendations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, the environment and the use and disposal of hazardous substances used in connection with our discovery, research and development work, including radioactive compounds and infectious disease agents. In addition, we cannot predict the extent of government regulations or the impact of new governmental regulations that might significantly harm the discovery, development, production and marketing of our products. We may be required to incur significant costs to comply with current or future laws or regulations, and we may be adversely affected by the cost of such compliance.



Our clinical trials may not yield results that will enable us to obtain regulatory approval for our products.



We will only receive regulatory approval for a drug candidate if we can demonstrate in carefully designed and conducted clinical trials that the drug candidate is safe and effective. We do not know whether our pending or any future clinical trials will demonstrate sufficient safety and efficacy to obtain the requisite regulatory approvals or will result in marketable products. Clinical trials are lengthy, complex, expensive and uncertain processes. It will take us several years to complete our testing, and failure can occur at any stage of testing. Results attained in preclinical testing and early clinical studies, or trials, may not be predictive of results that are obtained in later studies. We may suffer significant setbacks in advanced clinical trials, even after promising results in earlier studies. Based on results at any stage of clinical trials, we may decide to repeat or redesign a trial or discontinue development of one or more of our drug candidates. If we fail to adequately demonstrate the safety and efficacy of our products under development, we will not be able to obtain the required regulatory approvals to commercialize our drug candidates.



Clinical trials are subject to continuing oversight by governmental regulatory authorities and institutional review boards, or IRBs, and must meet the requirements of these authorities in the United States, including those for informed consent and good clinical practices. We may not be able to comply with these requirements and the FDA, an IRB or we may suspend or terminate clinical trials at any time.



Administering any drug candidates we develop to humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical trials of our drug candidates and could result in the FDA or other regulatory authorities denying approval of our drug candidates for any or all targeted indications.



We rely on third parties, including contract research organizations and outside consultants, to assist us in managing and monitoring clinical trials. Our reliance on these third parties may result in delays in completing, or in failing to complete, these trials if they fail to perform with the speed and competency we expect.



If clinical trials for a drug candidate are unsuccessful, we will be unable to commercialize the drug candidate. If one or more of our clinical trials are delayed, we will be unable to meet our anticipated development or commercialization timelines. Either circumstance could cause the price of our shares to decline.



If we encounter difficulties enrolling patients in our clinical trials, our trials could be delayed or otherwise adversely affected.



Clinical trials for our drug candidates require that we identify and enroll a large number of patients with the disorder under investigation. We may not be able to enroll a sufficient number of patients to complete our clinical trials in a timely manner. Patient enrollment is affected by factors including:



• design of the protocol;




• the size of the patient population;




• eligibility criteria for the study in question;




• perceived risks and benefits of the drug under study;




• availability of competing therapies;




• efforts to facilitate timely enrollment in clinical trials;




• patient referral practices of physicians; and




• availability of clinical trial sites.




If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay or terminate ongoing or planned clinical trials.




If we fail to maintain existing third-party arrangements and collaborative agreements or fail to develop new collaborative arrangements, our business will be harmed.



The success of our business is dependent, in significant part, upon our ability to enter into multiple collaboration agreements and to manage effectively the numerous issues that arise from such arrangements. Management of our relationships with these third parties has required and will require:



• our management team to devote a significant amount of time and effort

to the management of these relationships;



• effective allocation of our and third-party resources to multiple projects;




• agreement with third parties as to ownership of proprietary rights

and development plans, including clinical trials or regulatory
approval strategy; and



• an ability to obtain and retain management, scientific and other personnel.




Our collaboration with Amgen is a 50/50 cost/profit sharing arrangement with certain additional payment obligations by us prior to commercialization and upon regulatory approval. Both parties share worldwide rights to alfimeprase, and Amgen has the option to lead the commercialization in which both parties may participate. If Amgen decides not to pursue this option, we would be responsible for the commercialization and manufacturing activities in addition to clinical development activities, which may cause us to reduce or delay further development of some of our drug candidates and/or increase our capital expenditures.



In our collaboration with Archemix, we share equally all research and developments costs and revenues after we fund the first $4.0 million in research and development costs. We will make a milestone payment of $10.0 million upon commencement of a Phase 2 trial and will reimburse $1.8 million upon the designation of any backup compound selected by both Nuvelo and Archemix for IND-enabling studies. We are obligated to make the Phase 2 milestone payment to Archemix even if the collaboration is terminated by Archemix or Archemix does not meet its obligations under the agreement and we terminate the collaboration for default by Archemix. We have the option to lead commercialization in which both parties may participate if we establish commercialization capabilities, however, if we do not establish such commercialization capabilities, Archemix or a third party selected by the parties` joint steering committee will have the option to lead commercialization. We do not currently have established commercialization experience or an internal trained sales force and we may not successfully develop such capabilities without incurring additional expenses. If we cannot develop an internal sales force, we will not be able to lead commercialization activities on our own. If we do not lead the commercialization efforts, we are dependent on Archemix or a third party`s experience in commercialization and ability to perform and we may also incur additional expenses for a third party to undertake commercialization efforts.



We are subject to a number of additional risks associated with our collaboration with Archemix for ARC183, including the right of Archemix to terminate its collaboration with us on limited notice and for reasons outside our control and loss of significant rights if the collaboration is terminated because we fail to meet our obligations under it or we elect to terminate for our convenience. In particular, if we terminate the collaboration or if Archemix terminates for our breach, all of our rights to ARC183 and other collaboration products will become the property of Archemix, and we may not practice certain activities related to anti-thrombin compounds in the field of modifying blood-clotting times in therapeutic applications through the use of aptamers such as ARC183, including research and development, manufacture and commercialization activities.



In our licensing arrangement with Dendreon, we are obligated to make milestone payments prior to and upon commercialization, if any, including $2.0 million upon the first dosing of the first patient in a Phase 3 clinical trial for the first indication. There is no guarantee that we will reach commercialization or that our product will be accepted by the market. In addition, we may not generate any revenue from this licensing arrangement.



Our efforts, including the efforts of our direct and indirect subsidiaries, to manage simultaneously a number of collaboration arrangements may not be successful, and the failure to manage effectively such collaborations would significantly harm our business, financial condition and results of operations.



Due to these factors and other possible disagreements with Amgen, Archemix and Dendreon, we may be delayed or prevented from developing or commercializing alfimeprase, ARC183 and rNAPc2 or we may become involved in litigation or arbitration, which would be time-consuming or expensive and could have a material adverse effect on our stock price.



In addition to our existing collaborations, we will focus on effecting new collaborative arrangements where we would share costs of identifying, developing and marketing drug candidates. We cannot assure you that we will be able to negotiate new collaboration arrangements of this type on acceptable terms, or at all.



We are currently dependent on third parties for a variety of functions and may enter into future collaborations for the manufacture of our products. Our arrangements with these third parties may not provide us with the benefits we expect.



We currently rely upon third parties to perform functions related to the research, development, preclinical testing and clinical trials of our drug candidates. In addition, because we do not have the resources, facilities or experience to manufacture our drug candidates on our own, we currently rely, and will continue to rely, on third parties to manufacture our drug candidates for clinical trials, and, if our products are approved, in quantities




for commercial sales. We currently rely on a number of sole-source suppliers and do not have long-term supply agreements with our third-party manufacturers. Our reliance on these relationships poses a number of risks, including:




• disagreements with third parties that could delay or terminate the
research, development or manufacturing of drug candidates, or result
in litigation or arbitration;



• our inability to effectively control the resources devoted by our

partners to our programs or products;




• inadequate contractual protection or difficulty in enforcing the
contracts if one of our partners fails to perform;



• failure of these third parties to comply with regulatory requirements;





• conflicts of interest between their work for us and their work
for another entity, and the loss of their services;




• failure to locate acceptable manufacturers or other suppliers or
enter into favorable long-term agreements with them;




• inability of third parties to manufacture our drug candidates in a
cost-effective or timely manner or in quantities needed for clinical
trials or commercial sales;



• delays in, or failures to achieve, scale-up to commercial quantities, or changes to current raw material suppliers or product manufacturers

(whether the change is attributable to us or the supplier or
manufacturer), resulting in delayed clinical studies, regulatory
submissions and commercialization of our drug candidates; and




• lack of all necessary intellectual property rights to manufacture
our drug candidates.



Given these risks, our current and future collaborative efforts with third parties may not be successful. If these efforts fail, we would be required to devote additional internal resources to the activities currently performed, or to be performed, by third parties, to seek alternative third-party collaborators, or to delay our product development or commercialization.



We lack manufacturing experience and intend to rely initially on contract manufacturers.



We do not currently have significant manufacturing facilities for clinical or commercial production of our drug candidates and depend on contract research and manufacturing organizations. We may not be able to finalize contractual arrangements, transfer technology or maintain relationships with such organizations in order to file an IND, with the FDA, and proceed with clinical trials for any of our drug candidates. We currently rely on Amgen to manufacture our clinical drug product, alfimeprase. We also rely on other third parties to manufacture rNAPc2 and ARC183. The cost of manufacturing our drug product by Amgen is based upon a standard cost which has not been determined. This cost may be more than we are anticipating and may make it difficult or impossible to profitably market alfimeprase.



We are dependent on third-party contract research organizations to conduct certain research, including good laboratory practices toxicology studies, in order to gather the data necessary to file INDs with the FDA for ARC183 or any of our drug candidates. ARC183 and our other drug candidates have never been manufactured on a commercial scale. Third-party manufacturers may not be able to manufacture these drug candidates at a cost or in quantities necessary to make them commercially viable. In addition, if ARC183 or any of our other drug candidates enter the clinical trial phase, we will initially depend on third-party contract manufacturers to produce the volume of current good manufacturing practices materials needed to complete such trials. We will need to enter into contractual relationships with these or other organizations in order to (1) complete the Good Laboratory Practices, or GLP, toxicology and other studies necessary to file an IND with the FDA, and (2) produce a sufficient volume of current cGMP grade material in order to conduct clinical trials of ARC183 and our other drug candidates. We cannot be certain that we will be able to do so on a timely basis or that we will be able to obtain sufficient quantities of material on commercially reasonable terms. In addition, the failure of any of these relationships with third-party contract organizations may delay our filing for an IND or impede our progress through the clinical trial phase. Any significant delay or interruption would have a material adverse effect on our ability to file an IND with the FDA and/or proceed with the clinical trial phase for ARC183 or any of our drug candidates.



Moreover, contract manufacturers that we may use must continually adhere to current cGMP regulations enforced by the FDA through a facilities inspection program. If one of our contract manufacturers fails to maintain compliance, the production of our product candidates could be interrupted, resulting in delays, additional costs and potentially lost revenues. In addition, if the facilities of such manufacturers do not pass a pre-approval plant inspection, the FDA will not grant premarket approval of our products.




The commercial success of our products will be dependent upon our ability to protect the intellectual property rights associated with our products and drug candidates.





Our competitive success will depend in part on our ability to obtain and maintain patent protection for our inventions, technologies and discoveries, including intellectual property that we license. The patent positions of biotechnology companies involve complex legal and factual questions, and we cannot assure you that our patents and licenses will successfully preclude others from using our technology. We could incur substantial costs in seeking enforcement of our proprietary rights against infringement. In addition, to obtain a patent on a novel gene, we need to identify a utility for the novel gene or the encoded protein we seek to protect under patent law. Identifying a utility may require significant research and development with respect to which we may incur a substantial expense and invest a significant amount of time.



We currently have, or have in-licensed, issued patents and pending patent applications that cover portions of our in-licensed clinical products. ARC183 is covered both by a US patent specifically claiming ARC183 and by US patents covering aptamers generically. However, there are no equivalent international applications pending specifically claiming ARC183. International patent applications generically covering aptamers are pending but we cannot assure you that such patents will issue. We also currently have patents that cover some of our technological discoveries and patent applications that we expect to protect some of our gene, protein and technological discoveries. We have approximately 30 issued patents relating to our gene and protein discoveries. We also currently have or have rights to 44 issued patents which cover or describe, respectively, single nucleotide polymorpohisms and their application to pharmacogenetic studies, genotyping and haplotyping methods, and allele specific inhibitors. In addition, we have rights to 22 issued U.S. patents relating to the in-licensed clinical products. We will continue to apply for patents for our discoveries. We cannot assure you that any of our applications will issue as patents, or that any patent issued or licensed to us will not be challenged, invalidated, circumvented or held unenforceable by way of an interference proceeding or litigation.



The timing of the grant of a patent cannot be predicted. Patent applications describing and seeking patent protection of methods, compositions, or processes relating to proprietary inventions involving human therapeutics could require us to generate data, which may involve substantial costs. Our pending patent applications may lack priority over others` applications or may not result in the issuance of patents. Even if issued, our patents may not be sufficiently broad to provide protection against competitors with similar technologies and may be challenged, invalidated or circumvented.



In addition to patents, we rely on a combination of trade secrets, copyright and trademark laws, nondisclosure agreements, licenses and other contractual provisions and technical measures to maintain and develop our competitive position with respect to intellectual property. Nevertheless, these measures may not be adequate to safeguard the technology underlying our products. For example, employees, consultants and others who participate in the development of our products may breach their agreements with us regarding our intellectual property and we may not have adequate remedies for the breach. Our trade secrets could become known through other unforeseen means.



We also may not be able to effectively protect our intellectual property rights in some foreign countries, as many countries do not offer the same level of legal protection for intellectual property as the United States. Furthermore, certain of the patent applications describing our proprietary methods are filed only in the United States. Even where we have filed our patent applications internationally, for some cases and in certain countries, we have chosen not to maintain foreign patent protection by opting not to enter national phase or opting not to pay maintenance annuities.



Notwithstanding our efforts to protect our intellectual property, our competitors may independently develop similar or alternative technologies or products that are equal or superior to our technology. Our competitors may also develop similar products without infringing on any of our intellectual property rights or design around our proprietary technologies.



If our products infringe on the intellectual property rights of others, we could face costly litigation, which could cause us to pay substantial damages and limit our ability to sell some or all of our products.



Our market success depends in part on us neither infringing valid, enforceable patents or proprietary rights of third parties, nor breaching any licenses that may relate to our technologies and products. We are aware of third-party patents that may relate to our technology. We may be required to obtain licenses to patents or other proprietary rights of others in order to conduct research, development, or commercialization of some or all our programs. We plan to seek licenses, as we deem appropriate, but it is possible that we may unintentionally infringe upon these patents or proprietary rights of third parties. If we do not obtain these licenses, we may encounter delays in product market introductions, incur substantial costs while we attempt to design around existing patents or not be able to develop, manufacture or sell products. In response, third parties may assert infringement or other intellectual property claims against us. We may consequently be subjected to substantial damages for past infringement or be required to modify our products if it is ultimately determined that our products infringe a third party`s proprietary rights. Further, we may be prohibited from selling our products before we obtain a license, which, if available at all, may require us to pay substantial royalties, which could adversely impact our product costs and have an impact on our business. Further, if we do obtain these licenses, the agreed terms may necessitate reevaluation of the potential commercialization of any one of our programs. Failing to obtain a license could result in litigation. Even if these claims are without merit, defending a lawsuit takes significant time, may be expensive and may divert management attention from other business concerns. Any public announcements related to litigation or interference proceedings initiated or threatened against us could cause our stock price to decline.



We may be subject to litigation and infringement claims that may be costly, divert management`s attention, and materially harm our business.



Extensive litigation regarding patents and other intellectual property rights has been common in the genomics and biopharmaceutical industries. Litigation may be necessary to assert infringement claims, enforce patent rights, protect trade secrets or know-how and determine the enforceability, scope and validity of certain proprietary rights. The defense and prosecution of intellectual property lawsuits, United States Patent and Trademark Office interference proceedings, and related legal and administrative proceedings in the United States and internationally involve complex legal and factual questions. As a result, such proceedings are costly and time-consuming to pursue and their outcome is uncertain.




Regardless of merit or outcome, our involvement in any litigation, interference or other administrative proceedings could cause us to incur substantial expense and could significantly divert the efforts of our technical and management personnel. An adverse determination may subject us to the loss of our proprietary position or to significant liabilities, or require us to seek licenses that may include substantial cost and ongoing royalties. Licenses may not be available from third parties, or may not be obtainable on satisfactory terms. An adverse determination or a failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling our products, if any. These outcomes could materially harm our business, financial condition and results of operations.



We face intense competition.



The biopharmaceutical industry is intensely competitive and is accentuated by the rapid pace of technological development. We expect to face increased competition in the future as new companies enter our markets. Research and discoveries by others may result in breakthroughs that render our potential products obsolete even before they begin to generate any revenue. Our competitors include major pharmaceutical, biotechnology and diagnostic firms, not-for-profit entities and US and foreign government-financed programs, many of which have substantially greater research and product development capabilities and financial, scientific, marketing and human resources than we have. They may succeed in developing products or identifying genes and determining their functions earlier than we or our collaboration partners. They also may obtain patents and regulatory approvals for such products more rapidly than we or our collaboration partners, or develop products that are more effective than those developed by us or our collaboration partners. Any potential products based on genes we identify ultimately will face competition from other companies developing gene-based products as well as from companies developing other forms of treatment for diseases which may be caused by, or related to, the genes we identify. Similarly, our products will face competition from other companies developing similar products as well as from companies developing other forms of treatment for the same conditions.



In addition, our technologies have undergone and are expected to continue to undergo rapid and significant change. Our competitors may make rapid technological developments, which may result in products or technologies becoming obsolete, before we can recover the expenses incurred. The introduction of less expensive or more effective drug discovery and development technologies may also make our products and services obsolete. We may not be able to make the necessary enhancements to our technology to compete successfully with newly emerging technologies.



Many of the companies developing competing products have significantly greater financial resources than we have. Many such companies also have greater expertise than we or our collaboration partners have in discovery, research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing. Other smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Academic institutions, go

[Bombenleger]

Nuvelo Announces Reinitiation of Phase 2a Clinical Trial in Acute Coronary Syndromes
Thursday May 13, 9:01 am ET


SUNNYVALE, Calif., May 13 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced reinitiation and enrollment of the first patient in a Phase 2a trial with recombinant nematode anticoagulant protein c2 (rNAPc2), for the treatment of patients with acute coronary syndromes (ACS).
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After licensing the molecule from Dendreon Corporation in February 2004, Nuvelo took steps to reinitiate the study also referred to as ANTHEM (Anticoagulation with NAPc2 To Help Eliminate Mace)/TIMI 32. Prior to reinitiation, 77 patients had been enrolled in the trial. An additional 98 patients will be enrolled in this phase of the trial for a total of 175 patients in centers across the United States and Canada.

The multi-center, randomized, double-blind, placebo-controlled, ascending dose-ranging study to evaluate the safety and efficacy of Factor VIIa/Tissue Factor Inhibitor, rNAPc2, in patients with non-ST-elevation ACS is being conducted with the TIMI Study Group led by Dr. Eugene Braunwald of Brigham and Women`s Hospital and Harvard Medical School. The study will consist of a dose ranging phase and a dose confirmation phase. During the dose ranging phase, seven ascending doses of rNAPc2 (1.5, 2.0, 3.0, 4.0, 5.0, 7.5 and 10 micrograms/kg given intravenously every 48 hours) will be compared, one at a time, to matching placebo doses in a 4:1 randomization. The primary focus of dose ranging will be to identify the highest safe and effective dose measured by major or minor hemorrhage occurring in the period from randomization to 7 days after the last dose of study drug and the presence of ischemia measured by the Holter monitor. In the dose confirmation phase, the highest safe and effective dose will be compared to placebo in a 1:1 randomization. All patients will receive low molecular weight heparin or unfractionated heparin and aspirin. Use of clopidogrel will be strongly encouraged per the ACC/AHA Guidelines.

"rNAPc2 uniquely targets the beginning of the coagulation cascade and may be beneficial in select non-vascular as well as vascular diseases," stated Dr. Steven R. Deitcher, vice president medical affairs for Nuvelo. "Having dedicated my career to the study of thrombosis and anticoagulation, I am enthusiastic to get these trials up and running again. rNAPc2 has great potential and this trial will continue to build the case for the molecule`s safety and efficacy as an anticoagulant."

About rNAPc2

The novel anticoagulant rNAPc2 is a naturally occurring protein that was originally isolated from hookworms and is currently manufactured as a recombinant protein for clinical use. The anticoagulant effect of rNAPc2 results from its apparent ability to block the Factor VIIa/Tissue Factor protease complex, which is responsible for the initiation of the process leading to blood clot formation. Unlike aspirin, heparins and antiplatelet agents, which exert their effects at later stages of the blood coagulation cascade, rNAPc2 blocks the first step in the clotting cascade, inhibiting coagulation before it starts.

About ACS

ACS is a potentially life threatening heart condition that usually occurs when tissue factor-rich atherosclerotic plaque ruptures in one or more arteries of the heart. This rupture triggers a series of biochemical events known as the blood coagulation cascade, which results in the formation of a blood clot. Blocking the flow of blood through the heart, the clot deprives heart tissues of oxygen, causing chest pain. The use of rNAPc2 may significantly reduce the risk of heart attack or death in patients suffering from ACS.

In both the United States and Europe, ACS accounts for more than 1 million hospitalizations annually. Despite current treatments, a significant proportion of patients still experience recurrent angina, myocardial infarction or death.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Added to Nasdaq Biotechnology Index
Monday May 17, 9:01 am ET


SUNNYVALE, Calif., May 17 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced it has been selected to be included in the Nasdaq Biotechnology Index (Nasdaq: NBI - News).
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The Company`s inclusion in the Index will become effective on Monday, May 24, 2004. All securities in the Index are listed on the Nasdaq National Market and meet minimum requirements including market value, average daily share volume and seasoning as a public company.

Launched in 1993, the Nasdaq Biotech Index includes companies classified according to the FTSE(TM) Global Classification System as either biotechnology or pharmaceutical. The Index is ranked on a semi-annual basis in May and in November and serves as the basis for the iShares Nasdaq Biotechnology Index Fund(SM) (IBB). For more information about the Nasdaq Biotechnology Index, including eligibility criteria, visit www.nasdaq.com.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to be Featured at the 2004 UBS Global Specialty Pharmaceuticals Conference
Thursday May 20, 9:00 am ET


SUNNYVALE, Calif., May 20 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Ted W. Love, M.D., president and CEO, will be presenting at the 2004 UBS Global Specialty Pharmaceuticals Conference in New York City, on Monday, May 24, 2004 at 9:00 a.m. Eastern Time.
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Dr. Love will provide a brief corporate overview and discuss the company`s recently expanded pipeline and near-term milestones. A live audio webcast of the presentation will be available online via the Investor Relations portion of Nuvelo`s Web site at www.nuvelo.com or go to the UBS Investment Bank website at www.ibb.ubs.com and follow these instructions: find the Conferences icon in the middle of the page, click on Link and follow the link for Webcast under the Global Specialty Pharmaceuticals Conference heading.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Preliminary Phase 2 Alfimeprase Results in Acute Peripheral Arterial Occlusion Trial to be Presented at the Vascular 2004 Annual Meeting
Tuesday June 1, 9:01 am ET


SUNNYVALE, Calif., June 1 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that preliminary clinical data from the first 87 patients in its Phase 2 alfimeprase trial in acute peripheral arterial occlusion (PAO) will be presented in a late breaking session at the Society of Vascular Surgery`s Vascular 2004 Annual Meeting on June 5, 2004 in Anaheim, CA. The presentation is entitled "Safety and efficacy of alfimeprase for catheter-directed thrombolysis in patients with acute peripheral arterial occlusion: Interim Phase 2 report (NAPA 1)."
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Data included in this presentation will be released on Saturday, June 5, 2004 and the presentation and abstract will be posted on the Investor Relation`s portion of Nuvelo`s Web site at www.nuvelo.com.

About the Study

This multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. This international study is comparing three different doses of alfimeprase in 115 patients across 24 centers in the United States, Europe and South Africa.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Alfimeprase was identified through Amgen`s research program and a collaboration with Nuvelo was formed in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will be responsible for manufacturing activities. Amgen will have the option to lead the commercialization efforts in which both companies may participate.

About PAO

PAO is the blocking of arterial blood flow to a distant part of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAO is leg pain or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated, foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO, however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no approved, widely used products on the market to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.

About The Vascular 2004 Annual Meeting

The Vascular 2004 Annual Meeting held June 3 - 6, 2004 will be a historic event where four prominent vascular associations will come together for the first time to create the world`s premier event for specialists in vascular disease. The Society for Vascular Ultrasound (SVU), the Peripheral Vascular Surgery Society (PVSS), and the Society for Vascular Medicine and Biology (SVMB) will meet in conjunction with the Society for Vascular Surgery (SVS).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

NOTE: Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Reports Successful Completion of Interim Analysis in Phase 2 Trial With Alfimeprase in Catheter Occlusion
Tuesday June 8, 9:01 am ET


SUNNYVALE, Calif., June 8 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced successful completion of a planned interim analysis of its Phase 2 trial with lead product candidate, alfimeprase, for the potential treatment of venous catheter occlusions.
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The planned interim analysis was conducted on data from the first 48 patients enrolled in the trial. Following review of the patient data, the Data Safety and Monitoring Board (DSMB) and the Trial Operations Committee have recommended that the trial continue to enroll in the two highest dose groups, 1.0 mg and 3.0 mg, compared to the approved dose of Cathflo®Activase® (alteplase). In addition, the DSMB identified no safety concerns and no bleeding complications in any of the three Alfimeprase dose groups.

"Alfimeprase has the potential to be a safe, effective, and faster solution to clearing occluded catheters," said Dr. Steven R. Deitcher, vice president medical affairs for Nuvelo and former principal investigator for the Phase 2 alfimeprase trial in catheter occlusion. "The interim results are encouraging and this interim look enables us to begin to pinpoint an optimal dose in addition to reducing the number of patients that will be required to complete study enrollment."

Phase 2 Alfimeprase Programs

This multi-center, randomized, double-blind study began in June 2003 and is comparing three doses of alfimeprase, 0.3 mg, 1.0 mg and 3.0 mg, against the approved dose of Cathflo®Activase® (alteplase). The study is being conducted in approximately 90 patients across 32 centers in the United States.

Nuvelo is also currently conducting a Phase 2 trial to evaluate the safety and efficacy of alfimeprase in a second indication, peripheral arterial occlusion (PAO). This multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic, and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. The study is comparing three different doses of alfimeprase, in 115 patients across 24 centers in the United States, Europe and South Africa.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release may contain forward-looking statements regarding the development and commercialization of potential therapeutic products. Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward- looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our product candidates; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and Form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Be Featured at Needham and Company`s Third Annual Biotechnology Conference
Thursday June 10, 9:00 am ET


SUNNYVALE, Calif., June 10 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Ted W. Love, M.D., president and CEO, will be presenting at the Needham and Company Third Annual Biotechnology Conference in New York City, on Wednesday, June 16, 2004 at 2:30 p.m. Eastern Time.
Dr. Love will provide a brief corporate overview and discuss the company`s recently expanded pipeline, clinical updates and near-term milestones. A live audio webcast of the presentation will be available online via the Investor Relations portion of Nuvelo`s Web site at www.nuvelo.com or at http://www.wsw.com/webcast/needham8/nuvo .

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is partnered with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Press Release Source: Nuvelo, Inc.


Nuvelo Announces the Completion of Its Phase 2 Alfimeprase Trial in Acute Peripheral Arterial Occlusion
Monday June 28, 9:02 am ET
- Alfimeprase Rapidly Restores Blood Flow to Patients With Acute PAO -


SUNNYVALE, Calif., June 28 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced completion of enrollment of its Phase 2 trial with lead product candidate, alfimeprase, showing that alfimeprase restored blood flow in the limbs of patients with acute peripheral arterial occlusion (PAO) in four hours or less.
"Most thrombolytic agents require a prolonged infusion of 24 to 36 hours in patients with acute PAO," stated Dr. Steven R. Deitcher, vice president medical affairs for Nuvelo. "This trial showed that we can rapidly restore arterial blood flow to these patients with alfimeprase."

While the full data set is still being analyzed, the preliminary data suggest that there was a dose response, increasing the rate of restoration of blood flow as we moved from the 0.1 mg/kg dose to the 0.6 mg/kg dose. There were no incidences of intracerebral hemorrhage (ICH) and no major bleeding events were unequivocally attributed to alfimeprase. The most common adverse event observed was hypotension. All serious adverse events that were observed were reversible, did not result in any clinical sequelae and were compatible with outcomes observed in other thrombolytic trials.

"Alfimeprase has shown promise in its ability to dissolve blood clots in a rapid time frame, in a dose-dependent fashion and without any major bleeding events attributed to study drug," stated Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and principal investigator for Nuvelo`s Phase 1 and 2 alfimeprase trials in PAO. "These characteristics show the potential of alfimeprase to be a breakthrough therapy for patients suffering from acute PAO."

Based on the encouraging preliminary results from this Phase 2 trial, Nuvelo plans to meet with the Food and Drug Administration (FDA) to discuss the initiation of a pivotal Phase 3 trial in acute PAO patients to fully assess the safety and efficacy of alfimeprase.

In addition, Nuvelo expects to present the full clinical trial data at a major medical conference this year and to submit a trial manuscript to a peer-reviewed journal for publication.

About the Study

The multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients was led by Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. Patients were randomized to receive one of three doses of alfimeprase, 0.1 mg/kg, 0.3 mg/kg or 0.6 mg/kg. Doses were administered via a side-hole catheter in two separate, five to fifteen minute pulsed infusions, giving 2/3 of the dose up front, followed by the remaining 1/3 of the dose after two hours. Angiograms were taken at baseline (time zero), one hour and two hours with the final and conclusive angiogram taken at four hours after initial dosing.

Endpoints included: the evaluation of safety; the evaluation of efficacy as calculated by the percentage of patients with partial or complete restoration of flow at two and four hours after treatment; measurement of the amount of time it took to re-perfuse the limb; determination of the open, surgery-free survival rates at 30 days after treatment with alfimeprase; comparison of the severity of interventions and the severity of ischemia after treatment with alfimeprase; determination of levels of alpha-2 macroglobulin consumption and the assessment of whether antibodies form in response to alfimeprase.

This was an international study in 24 centers in the United States, Europe and South Africa.

Catheter Occlusion Study

Nuvelo is also currently conducting a Phase 2 trial to evaluate the safety and efficacy of alfimeprase in a second indication, catheter occlusion. This multi-center, randomized, double-blind study began in June 2003 and is comparing alfimeprase against the approved dose of Cathflo®Activase® (alteplase). The study is being conducted in approximately 90 patients across 35 centers in the United States.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical and clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel clearance mechanism dramatically limits the molecule`s half-life, reducing the risk of bleeding complications, a common side-effect of current therapies.

About PAO

PAO is the blocking of arterial blood flow to a distant part of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAO is leg pain or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated, foot or leg amputation.

Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no approved, widely used products on the market to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is currently in a Phase 2 trial in catheter occlusion and recently completed a Phase 2 trial in acute peripheral arterial occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release may contain forward-looking statements regarding the development and commercialization of potential therapeutic products. Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our product candidates; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and Form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Press Release Source: Nuvelo, Inc.


Archemix and Nuvelo Announce Submission of an IND for Thrombin Inhibitor, ARC183
Wednesday June 30, 9:01 am ET


CAMBRIDGE, Mass. and SUNNYVALE, Calif., June 30 /PRNewswire-FirstCall/ -- Archemix Corp. and Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that an Investigational New Drug (IND) application was submitted to the United States Food and Drug Administration (FDA) to begin a Phase 1 clinical trial with thrombin inhibitor, ARC183, for potential use in coronary artery bypass graft (CABG) surgery.
ARC183 is an anti-thrombin aptamer that is being developed as an anticoagulant/anti-thrombotic. The Phase 1 clinical trial with ARC183 for use in CABG surgery is expected to begin in the second half of 2004.

"The data we plan to generate from this trial should educate us on the safety and tolerability of ARC183," stated Dr. Claude Benedict, head of development at Archemix. "Furthermore, this study will also validate the anticoagulant activity of this novel compound."

"ARC183 has the potential to provide a rapid onset and offset of action not seen with current intravenous anticoagulants," stated Dr. Steven R. Deitcher, vice president medical affairs for Nuvelo. "The ability to provide anticoagulation on demand may benefit both medical and surgical patients alike."

"This is an important milestone for our collaboration and demonstrates our mutual commitment to the rapid development of this compound as a replacement for heparin-protamine in CABG surgeries," commented David Fontana, head of program management and regulatory affairs and ARC183 program leader for Archemix.

According to the American Heart Association, currently more than 500,000 CABG procedures are performed annually in the U.S., and more than 700,000 are performed worldwide. Heparin is the anticoagulant currently used in the majority of CABG surgeries; however it has significant limitations such as bleeding and heparin-induced thrombocytopenia (HIT). It is also difficult to dose accurately and requires dose monitoring. In addition, heparin requires protamine to reverse its anticoagulant effects.

Experiments in animal models suggest that the potent anticoagulant, ARC183, has many desirable properties for CABG surgeries including rapid onset and predictable anticoagulant effects, reduced bleeding complications, no risk of HIT and most importantly, a very short half-life, negating the need for an antidote. In addition, as an aptamer, ARC183 has all the advantages normally attributed to aptamers, such as high specificity and affinity for its targets, chemical synthesis allowing for scaleable production and stable shelf life.

About Aptamers

Aptamers are single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind target molecules in a manner conceptually similar to antibodies. Aptamers combine the optimal characteristics of small molecules and antibodies, including high specificity and affinity, chemical and biological stability, low toxicity and immunogenicity and the ability to target protein-protein interactions. Further, in contrast to monoclonal antibodies, aptamers are chemically synthesized rather than biologically expressed, offering a significant cost advantage. Because of their unique properties, aptamers may provide a superior alternative to conventional therapeutic approaches and could potentially be used in a wide range of disease areas, including many of those currently addressed by protein-based therapeutics.

About the Collaboration

ARC183 is the first product candidate in Archemix`s aptamer portfolio. In January 2004, a worldwide collaboration agreement was formed with Nuvelo for the development and commercialization of ARC183. Under the terms of the agreement, Archemix will initially lead development and be responsible for all clinical development activities. Nuvelo will have the option to lead commercialization efforts in which both companies may participate. As part of the transaction, Archemix and Nuvelo will equally share all costs associated with the development and marketing of ARC183 and will have 50/50 ownership of the compound.

About Archemix

Archemix Corp. is a privately held biopharmaceutical company based in Cambridge, Massachusetts. Founded in May 2001, the company`s mission is to develop aptamers as novel synthetic therapeutics that can be used in a wide range of disease areas. Further information on Archemix can be found at www.archemix.com, or calling Temin and Company at 212-588-8788; or email at [e-mail].

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, is currently in a Phase 2 trial in catheter occlusion and recently completed a Phase 2 trial in acute peripheral arterial occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release may contain forward-looking statements regarding the development and commercialization of potential therapeutic products. Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward- looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our product candidates; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and Form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Press Release Source: Nuvelo, Inc.


Nuvelo Announces Strategy to Accelerate Catheter Occlusion Program
Monday July 12, 9:01 am ET
Phase 2 Alfimeprase Trial in Catheter Occlusion Concluded with 56 Patients Dosed


SUNNYVALE, Calif., July 12 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that the Company has decided to close its Phase 2 alfimeprase trial in patients with occluded central venous catheters sooner than expected in order to accelerate the program. The Phase 2 trial concluded with 56 patients dosed.
"A Data Safety and Monitoring Board (DSMB) analysis suggests that there were no safety concerns in any of the alfimeprase dose groups and that two of the alfimeprase dose groups demonstrated efficacy that merits further study," stated Dr. Steven R. Deitcher, vice president of medical affairs for Nuvelo and former principal investigator for the Phase 2 alfimeprase trial in catheter occlusion. "We believe this data is more than sufficient to guide our continuing development efforts."

"Closure of this trial not only provides the opportunity to present proof of concept data earlier than expected, it also allows us to accelerate our timeline with this program," stated Luis Pena, vice president of product development for Nuvelo. "Based on the encouraging data from the DSMB analysis, we intend to work with the Food and Drug Administration (FDA) to design a trial focused on obtaining approval in this indication."

In addition, Nuvelo expects to present the clinical trial data at a major medical conference and to submit a trial manuscript to a peer-reviewed journal for publication.

About the Study

This multi-center, randomized, double-blind study began in June 2003 and compared three doses of alfimeprase, 0.3 mg, 1.0 mg and 3.0 mg, against the approved dose of Cathflo®Activase® (alteplase). The study was designed to treat up to 100 patients and was conducted in 32 centers in the United States.

About Alfimeprase

Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical and clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase`s novel clearance mechanism dramatically limits the molecule`s half-life, reducing the risk of bleeding complications, a common side-effect of current therapies.

About Catheter Occlusion

Catheter occlusion is a major complication affecting central venous catheters and can impair the ability to infuse fluid through, or withdraw fluid from the catheter. When a catheter becomes occluded, the ultimate goal is to restore patency in a timely and cost-effective manner with minimal risk to the patient. In many cases, restoring flow is preferred over replacement of the catheter for several reasons. These include: limited interruption of therapy, reduced risk of trauma to the patient, reduced risk of complications and decreased cost. In the case of thrombolytic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Currently, Cathflo®Activase® (alteplase) is approved for restoring function to central venous access devices.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release may contain forward-looking statements regarding the development and commercialization of alfimeprase as a potential therapeutic product. Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our product candidates; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and Form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Press Release Source: Nuvelo, Inc.


Nuvelo Appoints Lee Bendekgey as Senior Vice President and General Counsel
Tuesday July 13, 9:00 am ET


SUNNYVALE, Calif., July 13 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Lee Bendekgey as senior vice president and general counsel. Mr. Bendekgey joins Nuvelo as a member of the senior management team and will be responsible for managing all of the Company`s legal functions including licensing, corporate policies and intellectual property affairs.
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"Lee brings to Nuvelo a demonstrated track record and over 20 years of experience," said Ted W. Love, president and chief executive officer of Nuvelo. "We are excited to have someone with the extensive legal, financial and strategic expertise that Lee brings to the table."

Prior to joining Nuvelo, Mr. Bendekgey spent six years at Incyte Corporation where he held several executive positions, including executive vice president, general counsel, acting chief financial officer and acting general manager of information business. He had an essential role at Incyte, managing acquisitions, PIPE offerings, patents, licensing, as well as leading Incyte`s government relations strategy, acting as a company spokesperson and leading efforts to reposition and restructure the company.

From 1993 to 1997, Mr. Bendekgey worked for Silicon Graphics, Inc. where he held a variety of positions in their legal group including director of legal services, products and technology and director of strategic relations, helping the company to negotiate strategic relationships and providing legal support to all product divisions. Prior to his time at Silicon Graphics, he served as a partner at Graham & James (now Squire Sanders & Dempsey) where he specialized in intellectual property, corporate and commercial law and founded the firm`s Palo Alto office.

Mr. Bendekgey graduated magna cum laude with a bachelor of arts degree from Kalamazoo College and received his juris doctorate from Stanford University.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Press Release Source: Nuvelo, Inc.


Nuvelo Announces Appointment of Vice President, Corporate and Business Development and Expansion of Senior Management Team
Friday July 23, 9:00 am ET
Simon Allen Joins Nuvelo as Vice President of Corporate and Business Development
Gary Titus Promoted to Vice President of Finance and Chief Accounting Officer
Lee Bendekgey to Replace Peter Garcia as CFO


SUNNYVALE, Calif., July 23 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the strengthening of its senior management team appointing Simon Allen as vice president of business development, promoting Gary Titus to vice president of finance and chief accounting officer and appointing Lee Bendekgey as chief financial officer (CFO), upon the resignation of Peter Garcia, senior vice president and CFO.
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Under the new structure Mr. Allen will join Nuvelo as a member of the senior management team and will be responsible for overseeing all licensing and corporate initiatives. Mr. Titus will also join the senior management team upon his promotion from senior director of finance to vice president of finance and chief accounting officer. Finally, Mr. Bendekgey will become CFO, in addition to his current role as senior vice president and general counsel, replacing Mr. Garcia who is stepping down as CFO in order to pursue opportunities outside of the Company.

"We are pleased to welcome Simon and Gary to the senior management team," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "As Nuvelo moves closer to bringing a product to the market and as our research efforts continue to progress toward providing multiple clinical opportunities, we will be able to leverage Simon`s expertise in navigating through future business development deals. In addition, we have created a new position, chief accounting officer, to strengthen our finance and accounting functions. Gary has been a pivotal member of the finance team here at Nuvelo and we congratulate him on his expanding responsibilities. In addition, I want to thank Pete. He has been a valued member of the senior management team and has been vital to the substantial growth the Company has experienced over the past three years. We wish him well as he takes this next step in his career. Finally, we are fortunate to welcome Lee to his newest role at Nuvelo. Lee has over 20 years of experience and has served in both the CFO and general counsel roles at Incyte. We look forward to this next phase in Nuvelo`s development and are excited to welcome the new members of the team."

Mr. Allen has a strong pharmaceutical foundation with experience in the areas of scientific research, product development, equities analysis, capital markets and most recently, business development. Prior to joining Nuvelo, he served as vice president of business development for SkyePharma, where he was responsible for licensing and corporate development. Mr. Allen held similar responsibilities as director of business development for AGY Therapeutics and manager of business development for Corixa Corporation. Additionally, he has held positions as a biotechnology and healthcare consultant and a pharmaceutical analyst at Lexington Partners and Burdett, Buckeridge & Young, respectively. Mr. Allen also has an extensive background in biotechnology research, beginning his career as a viral research biologist for Gilead Sciences and a genetic research biologist for Burns Philp. Mr. Allen graduated from the University of Sydney with a BS in biochemistry and genetics and earned his MBA from the Australian Graduate School of Management with a major in finance and portfolio management.

Mr. Titus joined Nuvelo in January 2003 as a senior director of finance, bringing 15 years of financial management experience to Nuvelo. Prior to Nuvelo, he served as a senior director of finance at emerging life science companies including Metabolex, Inc. and IntraBiotics Pharmaceuticals, Inc. In addition, he held a variety of financial management positions at Johnson & Johnson. Mr. Titus is a CPA and has a bachelor`s degree in finance from the University of Florida and a bachelor`s degree in accounting from the University of South Florida.

Mr. Bendekgey recently joined Nuvelo from Incyte Corporation where he held several executive positions, including executive vice president, general counsel, acting chief financial officer and acting general manager of information business. Mr. Bendekgey had an essential role at Incyte, managing acquisitions, PIPE offerings, patents, licensing, as well as leading Incyte`s government relations strategy, acting as a company spokesperson and leading efforts to reposition and restructure the company. Additionally, he held a variety of positions in the legal group at Silicon Graphics, Inc. and served as a partner at Graham & James (now Squire Sanders & Dempsey). Mr. Bendekgey graduated magna cum laude with a bachelor of arts degree from Kalamazoo College and received his juris doctorate from Stanford University.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and form 10-Q for the quarter ended March 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Form 8-K for NUVELO INC


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29-Jul-2004

Other Events, Financial Statements and Exhibits



Item 5. Other Events and Regulation FD Disclosure.
On July 23, 2004, we issued a press release announcing, amongst other things,the appointment of Lee Bendekgey as Chief Financial Officer of Nuvelo, Inc. uponthe resignation of Peter S. Garcia as Senior Vice President and Chief FinancialOfficer. The press release, entitled "Nuvelo Announces Appointment of VicePresident, Corporate and Business Development and Expansion of Senior ManagementTeam," is attached hereto as Exhibit 99.1 and is incorporated herein byreference.





Item 7. Financial Statements and Exhibits.
(c) Exhibits.

The following exhibit is filed with this Form 8-K:

99.1 Press Release dated July 23, 2004, and entitled "Nuvelo AnnouncesAppointment of Vice President, Corporate and Business Development and Expansionof Senior Management Team."

[Bombenleger]

Nuvelo Announces Second Quarter 2004 Financial Results and Accomplishments Conference Call
Monday August 2, 9:00 am ET


SUNNYVALE, Calif.--(BUSINESS WIRE)--Aug. 2, 2004--Nuvelo, Inc. (Nasdaq:NUVO - News), today announced that it will hold a conference call to discuss the second quarter 2004 financial results and accomplishments on Monday, August 9, 2004 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
To participate in the conference call, please dial 800/562-8369 for domestic callers and 913/981-5581 for international callers. A telephone replay of the conference call will be available through Monday, August 23, 2004. To access the replay, please dial 888/203-1112 for domestic callers and 719/457-0820 for international callers, and reference passcode 669122.

In addition, this call is being webcast by CCBN and can be accessed via the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com.

The webcast is also being distributed over CCBN`s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN`s individual investor center at www.fulldisclosure.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.



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Contact:
Nuvelo, Inc.
Nicole Estrin, 408-215-4572
[e-mail]



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Source: Nuvelo, Inc.

[Bombenleger]

9-Aug-2004

Quarterly Report



ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Management`s Discussion and Analysis of Financial Condition and Results of Operations contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words including "will," "anticipate," "believe," "intends," "estimates," "expect," "should," "may," "potential" and similar expressions. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors discussed herein and elsewhere including, in particular, those factors described under the "Risk Factors" set forth below, and in our other periodic reports filed from time to time with the Securities and Exchange Commission, or SEC. Actual results and performance could also differ materially from time to time from those projected in our filings with the SEC.

Overview

We are strategically focused on the discovery, development and commercialization of life improving therapeutics for the treatment of acute cardiovascular indications and cancer. As part of this plan, we intend to dedicate our resources to advancing our most promising biopharmaceutical discovery and development programs, including our lead product candidate alfimeprase, which recently completed two Phase 2 trials in acute peripheral arterial occlusion, or PAO, and catheter occlusion, rNAPc2, an anticoagulant which is currently in a Phase 2a clinical trial in acute coronary syndromes, or ACS, and ARC183, a thrombin inhibitor that began a Phase 1 trial in August 2004.

In addition, we intend to leverage our robust proprietary gene sequence collection and expertise in secreted proteins and antibody targets to identify additional candidates for internal development or collaboration opportunities. We will also continue to employ an opportunistic in-licensing and collaboration strategy to build upon our pipeline of attractive therapeutic candidates. Finally, we intend to out-license or collaboratively partner our antibody target portfolio, co-develop biotherapeutic secreted proteins with our collaboration partner Kirin, and we intend to monetize non-core assets including our microarray business, pharmacogenomic technology and molecular diagnostic programs, to further support our biopharmaceutical development programs.

Alfimeprase, our lead product candidate, is a thrombolytic agent, or blood clot dissolver. Alfimeprase is currently under investigation in two indications, acute PAO and catheter occlusion. On June 5, 2004, preliminary clinical data from the first 87 patients in our Phase 2 trial in acute PAO patients were presented in a late breaking session at the Vascular 2004 Annual Meeting, showing that there was a clear dose response, increasing the rate of restoration of flow as the trial moved from the 0.1 mg/kg dose to the 0.6 mg/kg dose. Following this presentation on June 28, 2004, we announced the completion of enrollment of this trial. Dependent upon discussions with the FDA regarding the design of our planned Phase 3 trial and the potential of securing a special protocol assessment, or SPA, we expect to begin a Phase 3 PAO trial towards the end of 2004 or early 2005.

On June 8, 2004, we announced completion of a planned interim analysis of our Phase 2 trial in patients with occluded central venous catheters. The interim analysis was conducted on data from the first 48 patients enrolled in the trial. Following review of the patient data, the data safety and monitoring board, or DSMB, and the Trial Operations Committee recommended that the trial continue to enroll in the two highest dose groups, compared to the approved dose of Cathflo(R)Activase(R), also referred to as alteplase. In addition, the DSMB identified no safety concerns and no bleeding complications in any of the three alfimeprase dose groups. Based on the report of the DSMB, we subsequently decided to conclude this trial sooner than expected in order to accelerate the program. The Phase 2 trial concluded on July 12, 2004 with 56 patients dosed. Moving forward, we intend to work with the FDA to design a trial focused on obtaining approval in this indication.

On January 12, 2004, we entered into a worldwide collaboration agreement with Archemix Corporation to develop and commercialize ARC183, a thrombin inhibitor, that we intend to develop for potential use in coronary artery bypass graft, or CABG, surgery, percutaneous coronary intervention, or PCI, and other acute anticoagulant applications that require rapid resolution of anticoagulation or that require reversal of anticoagulation shortly after the procedure is completed. ARC183 is a DNA aptamer, which is a single-stranded DNA molecule consisting of 15 deoxynucleotides that forms a well-defined three-dimensional configuration, allowing it to bind to thrombin. Under the terms of the Agreement, we paid Archemix an upfront fee of $3.0 million. We have reimbursed Archemix $1.8 million of pre-clinical trial costs in the second quarter of 2004 and will reimburse Archemix $1.1 million in the third quarter of 2004. In addition, we are also required to make a milestone payment of $10.0 million upon initiation of the Phase 2 trial and $1.0 million upon the designation of any backup compound. Under the terms of the agreement, Archemix is initially responsible for leading development and for all clinical development activities. As part of the transaction, Nuvelo and Archemix equally share all costs associated with its development and commercialization and any revenues associated with commercialization of ARC183 after we fund the first $4.0 million in research and development costs. We will have the option to lead commercialization efforts in which both companies may participate. An IND application for ARC183 was filed in June 2004, and we subsequently initiated a Phase 1 clinical trial in August 2004.

On February 4, 2004, We entered into a worldwide licensing agreement with Dendreon Corporation for the drug candidate, rNAPc2, and all other rNAPc molecules owned by Dendreon. rNAPc2 is a recombinant version of a naturally occurring protein that has anticoagulant properties. To date, over 500 patients and healthy volunteers have received rNAPc2 in several Phase 1 and 2 studies. Under the terms of the agreement, we paid Dendreon an upfront fee of $4.0 million ($500,000 in cash and $3.5 million worth of Nuvelo common stock). We are required to pay Dendreon milestone payments (ranging from $2.0 million to $6.0 million each) for both rNAPc2`s first and second indications upon dosing of the first patient in a Phase 3 clinical trial, submission of a NDA, and first commercial sale. Total future payments, if all milestones are achieved, can reach as much as $21.0 million. We believe that achieving these milestones is uncertain, and most milestones will probably not take place in the next twelve months, if ever. In addition, we will pay Dendreon milestone payments of up to $2.5 million for net sales in excess of certain amounts for rNAPc molecules commercialized for the diagnosis, treatment or prevention of Ebola hemmorrhagic fever



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indication. Our license from Dendreon grants us exclusive worldwide rights to all indications for rNAPc products. We are currently investigating rNAPC2 in a Phase 2a double-blind, placebo controlled clinical trial for potential use in treating ACS, including unstable angina, or UA, and non-ST segment elevation myocardial infarction, or NSTEMI.

In a public offering completed on March 8, 2004, we raised approximately $69.5 million, net of total underwriters` fees and stock issuance costs of $5.3 million, from the sale of 5,750,000 shares of our common stock, including 750,000 shares related to the exercise of an over-allotment option granted to the underwriters, at a public offering price of $13.00 per share. We intend to use the net proceeds for general corporate purposes, including capital expenditures and to meet working capital needs. We expect from time to time to evaluate the acquisition of businesses, products and technologies for which a portion of the net proceeds may be used, although we currently are not planning or negotiating any such transactions.

RESULTS OF OPERATIONS

Contract Revenues

Comparison of the Three and Six Months Ended June 30, 2004 and 2003.

Revenues increased by $0.5 million to $0.9 million for the three months ended June 30, 2004, up from $0.4 million for the comparable period ended June 30, 2003 primarily due to increased new grant revenue of $0.6 million from National Institute of Health, or NIH, in the second quarter of 2004.

Revenues decreased by $0.1 million to $1.6 million for the six months ended June 30, 2004, down from $1.7 million for the comparable period ended June 30, 2003. This decrease is due to completion of recognition of license fee revenues of $0.5 million associated with our Affymetrix Inc. collaboration for the development of a high speed universal DNA sequencing chip which was completed in the first quarter of 2003, the completion of of $0.3 million in revenues from the Celera Diagnostics collaboration, and a decrease in National Institute of Standards and Technology, or NIST, grant revenue of $0.2 million, offset by new grant revenue of $1.0 million from the NIH.

Revenues earned by our Nuvelo segment were insignificant for the three months ended June 30, 2004 and $0.1 million for the six months ended June 30, 2004, compared to $0.2 million for the three months ended June 30, 2003 and to $1.0 million for the six months ended June 30, 2003. Our Callida segment had revenues of $0.9 million for the three months ended June 30, 2004 and of $1.5 million for the six months ended June 30, 2004, compared to $0.2 million for the three months ended June 30, 2003 and $0.7 million for the six months ended June 30, 2003. We anticipate that revenues will remain small as we continue to focus on clinical development and work toward the commercialization of our product candidates, alfimeprase, rNAPc2 and ARC183.

Our revenues typically vary from quarter to quarter and may result in significant fluctuations in our operating results from year to year. In the future, we may not be able to maintain existing collaborations, obtain additional collaboration partners or obtain revenue from other sources. The failure to maintain existing collaborations or the inability to enter into additional collaborative arrangements or obtain revenues from other sources could have a material adverse effect on our revenues, operating results, and cash flows.



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Operating Expenses



THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
-------------------------------------- --------------------------------------
2004 2003 % Change 2004 2003 % Change
-------- -------- -------- -------- -------- --------
Research and development $ 9,785 $ 7,270 35 % $ 26,097 $ 18,072 44 %
General and administrative 2,075 7,675 (73 )% 3,900 11,523 (66 )%
(Gain) loss on sale of assets (4 ) 1,518 (100 )% (24 ) 1,562 (102 )%
- ------ - - ------ -------- -- - ------ - - ------ -------- --
Total operating expense $ 11,856 $ 16,463 (28 )% $ 29,973 $ 31,157 (4 )%
- ------ - - ------ -------- -- - ------ - - ------ -------- --







Comparison of the Three Months and Six Months Ended June 30, 2004 and 2003.

Research and development, or R&D, expenses consist of personnel costs and other R&D related operating expenses predominantly covering clinical trial and drug manufacturing costs, supplies, outside services, licenses and royalty fees, depreciation and amortization, and facilities expenses. Total R&D expenses increased to $9.8 million for the three months ended June 30, 2004, compared to $7.3 million for the comparable period ended June 30, 2003. The increase was primarily due to additional clinical trial costs of $1.4 million for alfimeprase, and a $1.1 million pre-clinical trial expense reimbursement to Archemix, and $0.2 million Phase 2a clinical trial expense for rNAPc2, as partially offset by $0.5 million in savings realized during the the three months ended June 30, 2004 from completion of the shut-down of our Variagenics` operations in the third quarter of 2003.

Research and development expenses increased to $26.1 million for the six months ended June 30, 2004 from $18.1 million for the comparable period ended June 30, 2003. The increase was primarily due to total upfront license fees of $7.0 million paid in connection with our collaboration agreement with Archemix and a licensing agreement with Dendreon, and a $2.9 million pre-clinical trial expense related to our Archemix collaboration, partially offset by $2.0 million in savings realized during the the six months ended June 30, 2004 from completion of the shut-down of our Variagenics operations in the third quarter of 2003.

General and administrative expenses decreased to $2.1 million for the three months ended June 30, 2004, compared to $7.7 million for the comparable period ended June 30, 2003. The decrease was primarily due to a $3.6 million lease termination and related expense in connection with management`s decision not to exercise the Humboldt Court facility purchase option, incurred in the second quarter of 2003, Cost savings of $1.2 million was realized during the three months ended June 30, 2004 from shutting down our Variagenics` operation in the third quarter of 2003, and various personnel-related cost savings realized from headcount reductions carried out in the third and fourth quarters of 2003.

General and administrative expenses decreased to $3.9 million for the six months ended June 30, 2004 from $11.5 million for the comparable period ended June 30, 2003. The decrease in general and administrative expense was primarily due to $3.9 million in lease termination and related expenses in connection with management`s decision not to exercise the Humboldt Court facility purchase option and $2.4 million in savings realized during the the six months ended June 30, 2004 from completion of the shut-down of our Variagenics` operations, in addition to various personnel related cost savings realized from headcount reductions carried out in the third and forth quarter of 2003.

Our Nuvelo segment had operating expenses of $10.7 million for the three months ended June 30, 2004 and $27.7 million for the six months ended June 30, 2004, compared to $13.8 million for the three months ended June 30, 2003 and $26.2 million for the six months ended June 30, 2003. Our Callida segment had operating expenses of $1.2 million for the three months ended June 30, 2004 and of $2.3 million for the six months ended June 30, 2004, compared to $1.2 million for the three months ended June 30, 2003 and to $3.4 million for the six months ended June 30, 2003.

In addition to our upfront payments made in conjunction with ARC 183 and rNAPc2 in the first quarter of 2004, we expect total operating expenses to increase for the remainder of 2004 for clinical development costs as we continue to advance our drug candidates, alfimeprase, rNAPc2, and ARC183 through clinical trials. As of June 30, 2004, we have recorded current liabilities related to clinical development and drug manufacturing costs of $10.1 million with related prepaid balance of $10.1 million. Thus far, we have expensed cumulatively $1.9 million of drug manufacturing costs, of which $0.4 million was expensed in 2004. In addition, we have expensed $3.0 million of other clinical development costs related to ARC183 and rNAPc2 product candidates in 2004. We expect to expense $9.0 million of drug manufacturing costs within the next twelve months as we advance alfimeprase into Phase 3 clinical trials in the second half of 2004. We may also incur milestone expenses for our rNAPc2 and ARC183 drug candidates within the next twelve months.

Interest Income and Expense

Comparison of the Three Months and Six Months Ended June 30, 2004 and 2003.

Our net interest expense decreased to $14,000 during the three months ended June 30, 2004 and to $218,000 during the six months ended June 30, 2004, from $239,000 during the three months ended June 30, 2003 and from $451,000 during the six



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months ended June 30, 2003. The decrease in net interest expense is related to increased interest income primarily due to higher average cash and investment balances from financing activities in October 2003 and March 2004, which were offset by increased interest expense related to the amortization of premiums associated with corporate debt securities held to maturity in our short-term investment account.

Net Loss

Comparison of the Three Months and Six Months Ended June 30, 2004 and 2003.

Since our inception, we have incurred operating losses, and as of June 30, 2004, we had an accumulated deficit of $232.2 million. We incurred a net loss of $11.0 million for the three months ended June 30, 2004 and of $28.6 million for the six months ended June 30, 2004, compared to a net loss of $16.3 million for the three months ended June 30, 2003 and of $29.9 million for the six months ended June 30, 2003. Our Nuvelo segment had net losses of $10.7 million for the three months ended June 30, 2004 and of $27.8 million for the six months ended June 30, 2004, compared to net losses of $15.3 million for the three months ended June 30, 2003 and of $27.2 million for the six months ended June 30, 2003. Callida had net losses of $0.3 million for the three months ended June 30, 2004 and of $0.8 million for the six months ended June 30, 2004, as compared to losses of $1.0 million for the three months ended June 30, 2003 and of $2.7 million for the six months ended June 30, 2003.

The decreased net loss in the six months ended June 30, 2004 as compared to the six months ended June 30, 2003, resulted primarily from decreased general and administrative expenses, R&D employee costs and depreciation expenses, and the loss on sale of certain assets in 2003 as compared to the six months ended June 30, 2003, which were partially offset by increased license expenses incurred in connection with worldwide license fees and development expenses paid relating to our rNAPc2and ARC183 drug candidates. We expect to continue to incur significant operating losses for the foreseeable future, which may increase substantially as we continue clinical development of our lead drug candidate, alfimeprase, continue clinical development of our rNAPc2 and ARC183, further expand research and development of our potential biopharmaceutical product candidates, potentially in-license other drug candidates, and continue to prosecute and enforce our intellectual property rights.


LIQUIDITY AND CAPITAL RESOURCES



(Dollars in Millions)
------------------------------------------------
June 30, 2004 December 31, 2003
--------------- ---------------------
Cash, Cash Equivalents & Short Term Investments $ 80.0 $ 34.2
Total Assets 108.5 57.8
Working Capital 64.9 25.8
Accrued Clinical Trial and Drug Manufacturing Costs 10.1 5.6
Capital Lease, Line of Credit and Notes Payable 17.8 20.2
Stockholders` Equity 67.6 22.7








To date our primary source of liquidity has been cash from financing activities, collaboration receipts and our merger with Variagenics on January 31, 2003. We believe that, currently, we have adequate cash reserve to fund our operations through 2005.
Cash and Cash Equivalents, Short-Term Investments, and Restricted Cash on Deposit

As of June 30, 2004, we had $80.0 million in cash, cash equivalents and short-term investments. This amount reflects a net increase of $45.8 million from $34.2 million as of December 31, 2003. This increase resulted from cash provided by the sale of common stock through financing activities completed in March 2004, as partially offset by cash consumed by our operations during the year-to-date net cash expenses.

In addition, we have $0.5 million in total restricted cash on deposit. This restricted cash is security for a $0.5 million letter of credit in conjunction with a facility lease for our office at 675 Almanor Avenue in Sunnyvale, California. The cash on deposit in conjunction with this letter of credit is restricted and cannot be withdrawn. Provided that no default has occurred under the lease for the 675 Almanor facility, the letter of credit and the cash collateralizing it may be reduced to $0.1 million in the third quarter of 2004. We control the investment of the restricted cash and receive the interest earned thereon.



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The primary objectives for our investment portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return to us, consistent with these two objectives. Our investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer.

Cash Used in Operating Activities

Net cash used in operating activities decreased $3.1 million to $21.3 million in the first six months of 2004, compared to $24.4 million during the same period in 2003. The decrease in cash used in operating activities was primarily due to the reduction in 2004 of expenses incurred as part of our merger with Variagenics in the first six months of 2003 which were subsequently eliminated last year, and was partially offset by increased license fees of $3.5 million paid in connection with license agreements and increased manufacturing and development costs of $4.8 million paid to Archemix and Amgen for our ARC183 pre-clinical development costs reimbursementand drug manufacturing costs for our lead product candidate, alfimeprase.

We expect a net increase in operating expenses in the third quarter of 2004 as we continue to incur increased clinical development and manufacturing costs. We have incurred liabilities of $10.1 million for the manufacture of alfimeprase for use in Phase 2 and Phase 3 trials and other clinical development costs. We anticipate cash outflows of the accrued liability within the next twelve months as we advance alfimeprase into and through Phase 3 clinical trials. We also anticipate incurring significant additional drug manufacturing costs and clinical development costs related to our three drug candidates.

Cash Used in / Provided by Investing Activities

Net cash used in investing activities was $40.4 million during the first six months of 2004, compared to $43.1 million of net cash provided by investing activities during the comparable period ended June 30, 2003. The increased use of cash from the six months ended June 30, 2003, as compared to the six months ended June 30, 2004 was primarily due to increased purchases of short-term investments as a result of cash raised from the public offering completed in March 2004. New capital equipment purchases increased slightly at $0.4 million for the six months ended June 30, 2004, as we continued to attempt to minimize and control capital expenditures. Other than purchases and sales of short term investments, we expect net cash used by investing activities to stay at a low level for the foreseeable future.

Cash Used in / Provided by Financing Activities

We generated cash of $67.8 million from financing activities in the six months ended June 30, 2004 and used cash of $0.4 million from financing activities in the six months ended June 30, 2003. Net cash provided by financing activities for Nuvelo in the six months ended June 30, 2004 resulted from proceeds from a public offering completed on March 8, 2004, and from the exercise of stock options and the employee stock purchase plan, which was partially offset by payments made on our lease and loan obligations. Net cash used by financing activities in the six months ended June 30, 2003 was due to payments made on our lease obligations and increased cash restricted for letters of credit, partially offset by additional funds drawn from a line of credit, made available to us by the chairman of our board of directors. The remaining line of credit from our chairman has expired, and we have begun paying down this line of credit through a plan of 48 monthly installments that started in November of 2003. There was no cash generated by financing activities in the first six months of 2004 or 2003 by our Callida segment.

As of June 30, 2004, 540,522 shares of our common stock were issuable upon repayment of a note held by Affymetrix. Affymetrix has the ability to declare all outstanding principal and interest under the note immediately due and payable if our market capitalization is under $50 million and Affymetrix reasonably determines that the loan evidenced by the note is impaired, and we have an obligation to prepay amounts owing under the note to the extent that the amounts outstanding exceed 10% of our market capitalization. Moreover, we have registered for resale a portion of these shares on a registration statement that has been declared effective by the SEC.

Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth under "Risk Factors" below. We may not be able to secure additional financing to meet our funding requirements on acceptable terms, if at all. If we raise additional funds by issuing equity securities, substantial dilution to our existing stockholders may result. If we are unable to obtain additional funds, we may have to additionally curtail the scope of our operations.

Operating Leases

Through June 30, 2004, we are leasing three facilities under operating lease agreements, two of which expire in June 2005 and one that expires in May 2011. There is no change in any lease agreements since the filing of our Form 10-K on March 12, 2004. The rent is being recognized as expense on a straight-line basis.



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Our minimum future rental commitments under non-cancelable operating leases at June 30, 2004 are as follows (in thousands):

Minimum Rental Commitments
For the remaining six months ended December 31,

[Bombenleger]

Nuvelo Announces Extension and Expansion of Kirin Collaboration
Wednesday September 15, 9:01 am ET


SUNNYVALE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the extension and expansion of its research and development collaboration with the Pharmaceutical Division of Kirin Brewery Co., Ltd.
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The amended agreement extends the term of the current collaboration to December 31, 2005 and expands the scope of the collaboration to include additional secreted protein genes from Nuvelo`s full-length gene portfolio. The collaboration is expected to foster further development of therapeutic candidates using Kirin`s proprietary site-directed transgenic mouse technology to identify and develop secreted proteins and associated antibodies with therapeutic utility.

"We are pleased to continue what has been a very successful relationship with Nuvelo," said Toshifumi Mikayama, vice president of planning for Kirin. "Nuvelo`s novel gene sequences coupled with Kirin`s proprietary technologies have resulted in a discovery engine that has yielded promising results."

"Our initial collaborative efforts have generated a number of exciting development leads," said Dr. Walter Funk, vice president of research for Nuvelo. "We aim to advance at least one internal product candidate into IND-enabling studies this year as a result of this successful collaboration."

Upcoming Events

Full data from Nuvelo`s Phase 2 alfimeprase trial in patients with acute peripheral arterial occlusion (PAO) will be featured in the `Advances in the Management of Arterial, Venous and Aortic Disease` session at the upcoming TCT 2004 Scientific Symposium, September 30, 2004 in Washington, DC. The presentation will be given by one of Nuvelo`s principal investigators, Dr. Kenneth Ouriel, entitled, `Safety And Activity Of Alfimeprase For Catheter-Directed Thrombolysis In Patients With Lower Extremity, Acute Peripheral Arterial Occlusion: Report Of A Phase 2, Multi-Center, Multi-National, Open-Label, Dose-Escalation Study (NAPA-1).`

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

About Kirin

Kirin Brewery Co., Ltd, located in Tokyo, Japan, is the world`s foremost brewery. Its Pharmaceutical Division focuses on kidney diseases, cancers (including hematopoietic diseases), and immune-system/allergy-related diseases and has recently been focused on the areas of cell therapy and fully human antibodies. www.kirin.co.jp

This press release contains "forward-looking statements" regarding the development and commercialization of Nuvelo`s potential therapeutic products, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Dr. Burton Sobel Joins Nuvelo Board Of Directors
Wednesday September 15, 5:07 pm ET


SUNNYVALE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Burton Sobel, MD to its board of directors. Dr. Sobel will replace Philippe Chambon, MD, PhD who stepped down as a member of the board of directors effective September 13, 2004.
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"Dr. Sobel`s cardiovascular expertise and medical background fit perfectly with Nuvelo`s emerging, acute cardiovascular portfolio," said Dr. George Rathmann, chairman of Nuvelo`s board of directors. "He has a very distinguished academic reputation and we are pleased to welcome him to our board of directors."

Dr. Sobel is currently at the University of Vermont and Fletcher Allen Health Care where he serves as an E.L. Amidon professor and chair of the department of medicine, professor of biochemistry and director of the Cardiovascular Center.

Dr. Sobel has received numerous honors throughout the course of his career including: International Health Professional of the Year in 2004, Who`s Who in Medicine and Healthcare in 2002, a special recognition award from the American Heart Association (AHA) Council on Arteriosclerosis, Thrombosis and Vascular Biology in 1999, the James B. Herrick Award from the 1992 AHA National Meeting, the American College of Cardiology (ACC) Distinguished Scientist Award in 1987 and the AHA Scientific Councils Distinguished Achievement Award in 1984. He has served on many distinguished editorial boards including Circulation, Annals of Internal Medicine and American Journal of Cardiology. Dr. Sobel has also held multiple visiting professorships and lectureships and has published over 850 journal papers, abstracts and book chapters.

"Philippe had been a member of Nuvelo`s board since the merger with Variagenics," said Dr. Rathmann. "I want to thank him personally for his contributions and we wish him well in his future endeavors."

Upcoming Events

Full data from Nuvelo`s Phase 2 alfimeprase trial in patients with acute peripheral arterial occlusion (PAO) will be featured in the "Advances in the Management of Arterial, Venous and Aortic Disease" session at the upcoming Transcatheter Cardiovascular Therapeutics 2004 Scientific Symposium, September 30, 2004 in Washington, DC. The presentation will be given by one of Nuvelo`s principal investigators, Dr. Kenneth Ouriel, entitled, "Safety And Activity Of Alfimeprase For Catheter-Directed Thrombolysis In Patients With Lower Extremity, Acute Peripheral Arterial Occlusion: Report Of A Phase 2, Multi- Center, Multi-National, Open-Label, Dose-Escalation Study (NAPA-1)."

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the development and commercialization of Nuvelo`s potential therapeutic products, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward- looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Phase 2 Clinical Trial Results Show Potential of Alfimeprase to Treat Acute Peripheral Arterial Occlusion, Also Known as `Leg Attack`
Thursday September 30, 8:00 am ET
New thrombolytic shows potential to restore blood flow to patients within four hours of initiation of dosing


WASHINGTON, Sept. 30 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that Phase 2 trial results showed the potential of its lead product candidate, alfimeprase, to treat acute peripheral arterial occlusion (PAO), also known as "leg attack." The results were presented today at the Cardiovascular Research Foundation`s (CRF) Sixteenth Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium (TCT 2004), in Washington, D.C.
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Full analysis of the multi-center, multi-national, open-label, dose- escalation study, NAPA-1 (Novel Arterial Perfusion with alfimeprase-1), revealed that alfimeprase showed potential for thrombolysis (breaking up of a blood clot) with rates of up to 76% and restoration of arterial flow with rates of up to 60% based on intention to treat analysis. Furthermore, all thrombolytic activity and restoration of flow was recorded within four hours of initiation of dosing. Most plasminogen activator type thrombolytic agents may require a prolonged infusion of 24 to 36 hours in patients with leg attack.

"Based on these data, I believe alfimeprase presents an opportunity to shift the paradigm of treatment for this very sick patient population," stated Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and principal investigator for Nuvelo`s Phase 1 and 2 alfimeprase trials in PAO. "This is reflected in alfimeprase`s potential to offer significant advances in the rapid resolution of a clot while minimizing systemic side-effects such as intracerebral hemorrhage and other bleeding complications. I therefore believe alfimeprase warrants further study in acute PAO."

"The opportunity to restore arterial blood flow within four hours of initiation of dosing with alfimeprase is remarkable," said Steven R. Deitcher, M.D., vice president clinical and regulatory affairs for Nuvelo. "As in heart attack, rapid restoration of blood flow is critical to reducing morbidity and mortality in leg attack. There is a real unmet medical need to address leg attack. While avoidance of open-vascular surgery with the use of currently available thrombolytics can reduce the risk of peri-operative morbidity and mortality, use of these plasminogen activator-based therapies presents unavoidable risks of major bleeding and intracerebral hemorrhage. Unlike these thrombolytics, alfimeprase shows the potential to avoid a systemic lytic state as its suggested lytic activity is localized to the site of drug delivery."

Nuvelo is scheduled to meet with the Food and Drug Administration (FDA) to discuss the initiation of a Phase 3 trial that will be designed to further assess the efficacy and safety of alfimeprase in acute PAO patients.

About the Study

The 24-center, open-label, dose-escalation study conducted in the United States, Europe, Hungary, Russia and South Africa evaluated the safety and activity of alfimeprase in acute PAO patients. The study was led by Dr. Ouriel and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center.

Patients were randomized to receive one of three doses of alfimeprase, 0.1 mg/kg, 0.3 mg/kg or 0.6 mg/kg. Doses were administered via a side-hole catheter in two separate, five to fifteen minute pulsed infusions, giving 2/3 of the dose up front, followed by the remaining 1/3 of the dose after two hours. Angiograms were taken at baseline (time zero), one hour and two hours with the final and conclusive angiogram taken at four hours after initial dosing.

Primary endpoints included: adverse event (AE) rate, serious adverse event (SAE) rate and major bleeding, including intracerebral hemorrhage (ICH), up to 30 days after dosing. Secondary endpoints included determination of alfimeprase activity; open-surgery free survival at 14 and 30 days; patency, as defined by restoration of flow; increase in ankle-brachial index (ABI) by greater than or equal to 0.15; and reduction in severity of planned surgical interventions.

Full analysis of the 113 subjects revealed that there were no ICHs or deaths. Hypotension rates in the lower doses (0.1 mg/kg and 0.3 mg/kg) were approximately 3% or 2 patients, one of whom was categorized by the investigator as not related to alfimeprase. AE, SAE, major hemorrhage and hypotension rates were dose-related and hypotensive episodes were not associated with any clinical sequelae. Of the 16 SAE level bleeding events reported, seven were major bleeds and nine were minor bleeds. Of the seven major bleeds, six were unrelated to alfimeprase and only one was categorized by the investigator as possibly related (a groin hematoma). Of the nine minor bleeds, three were categorized as possibly related to alfimeprase and six were unrelated or unlikely to be related to alfimeprase as determined by investigators. From 52% to 69% of study patients were able to avoid surgical intervention.

Upcoming Event

Today, from 12:00 p.m. to 2:00 p.m. ET, Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and a principal investigator for Nuvelo`s Phase 1 and 2 alfimeprase PAO trials, will present this Phase 2 data at a meeting for the financial community in Washington, D.C.

A simultaneous webcast of Dr. Ouriel`s presentation will be available live, starting at approximately 12:15 p.m. ET, and via replay in the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com.

About Alfimeprase

Alfimeprase is an enzyme produced by recombinant DNA technology. It is a thrombolytic agent or blood clot dissolver that is intended to directly degrade fibrin when delivered through a catheter at the site of a blood clot. Thrombolytics currently on the market such as Abbokinase® or Activase® are plasminogen activators which rely on the plasminogen system to degrade fibrin. The activity of plasminogen activators is impacted by the amount of plasminogen found in the blood clot and may require prolonged infusions when dissolving very large clots such as those found in patients with acute PAO. Alfimeprase directly degrades fibrin, producing a rapid dissolution of blood clots. In preclinical and clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing. In addition, alfimeprase possesses a unique mechanism of action. Preliminary testing suggests that its lytic activity is localized to the site of delivery. Alfimeprase is inhibited within seconds of moving away from the clot and into the general circulation by alpha-2 macroglobulin, a naturally occurring protein in our blood. This clearance mechanism helps focus the thrombolytic activity to the site of delivery and in preclinical and clinical testing, appears to minimize bleeding side effects.

About Leg Attack

Acute PAO, also known as "leg attack," which affects more than 100,000 people in the United States per year, is the blocking of arterial blood flow to the lower limbs by a clot. Leg attack is the result of underlying peripheral arterial disease, in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of leg attack is leg pain or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated, foot or leg amputation.

Bypass surgery, angioplasty and off-label use of thrombolytics are established treatments for leg attack. There are currently no approved, widely used products on the market to treat leg attack. With the limited treatment options currently available, alfimeprase has received orphan drug designation for leg attack.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the potential clinical benefits of alfimeprase for the treatment of acute PAO and the development and commercialization of Nuvelo`s potential therapeutic products, such as alfimeprase, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward- looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery, clinical development processes; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. The Biologics License Application (BLA) for alfimeprase may never be filed, or, if filed, many never win FDA approval. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo to Gain Worldwide Rights to Alfimeprase Through Amgen Licensing Agreement
Monday November 1, 4:01 pm ET
- Company Finalizing Phase 3 Alfimeprase Trial Design with Food and Drug Administration (FDA) for the Treatment of Acute Peripheral Arterial Occlusion (PAO), also Known as `Leg Attack` -
- Company to Host a Conference Call and Webcast Today at 5:30 p.m. Eastern Time -


SUNNYVALE, Calif., Nov. 1 /PRNewswire-FirstCall/-- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that it will gain worldwide rights to develop and commercialize the novel acting thrombolytic agent, alfimeprase, from Amgen Inc. in exchange for payment of previously negotiated development milestones and royalties. No additional financial terms were disclosed.
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"The collaboration that we commenced with Amgen in 2002 for the development and commercialization of alfimeprase was the entrance for Nuvelo into becoming a clinical stage company," said Ted W. Love, M.D., president and CEO of Nuvelo. "I have very much enjoyed working with Amgen, particularly my extensive interaction with Dr. Roger Perlmutter, their executive vice president of research and development."

Alfimeprase was originally identified through Amgen`s internal research program. In January 2002, Amgen entered into a collaboration agreement with Nuvelo (then known as Hyseq Pharmaceuticals, Inc.) for the development and commercialization of alfimeprase. Under the terms of this agreement, Nuvelo was responsible for leading all clinical development activities for alfimeprase and Amgen was responsible for leading manufacturing activities. Amgen had the option to lead commercialization activities in which both companies could participate. Following completion of the Phase 2 alfimeprase trial in acute PAO, the agreement also allowed Amgen to transition the alfimeprase collaboration with Nuvelo into a licensing arrangement under which Amgen would grant Nuvelo worldwide rights to alfimeprase. Amgen has exercised its right under the agreement and will grant Nuvelo worldwide rights to develop and commercialize alfimeprase.

"After the positive outcome of our recent FDA meeting to discuss the Phase 3 trial design for alfimeprase for the treatment of patients with acute peripheral arterial occlusion (PAO), we are more convinced than ever that this product represents a major opportunity for Nuvelo and our shareholders," said Dr. Love. "We have the cardiovascular expertise, clinical development capability, managerial talent and financial resources to move forward with our planned Phase 3 program and to further develop our promising cardiovascular franchise."

Based on recent discussions with the FDA, Nuvelo is finalizing the design of and preparing to initiate a multi-center, multi-national, randomized, double-blind, placebo-controlled Phase 3 program to determine the efficacy and safety of alfimeprase for the treatment of patients with acute PAO. This Phase 3 program, also known as NAPA-2 (Novel Arterial Perfusion with Alfimprase-2), will be led by Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and Dr. Gunnar Tepe, department of diagnostic radiology at the University of Tubingen, Germany. Nuvelo anticipates this program will consist of two overlapping trials that will include a total of approximately 700 patients. These patients will be randomized to receive either 0.3 mg/kg of alfimeprase or placebo. The primary endpoint will be avoidance of open vascular surgery at 30 days. Secondary endpoints will include restoration of arterial blood flow and increase in ankle brachial index (ankle blood pressure). Nuvelo is focused on beginning this Phase 3 program in acute PAO in the first quarter of 2005. In addition, Nuvelo is preparing to meet with the FDA to discuss the initiation of an additional Phase 3 program for alfimeprase in a second potential indication, central venous catheter occlusion.

Phase 2 PAO Trial Results

Full analysis of the Phase 2 multi-national, open-label, dose-escalation study, NAPA-1, on 113 patients with acute PAO, indicated that alfimeprase was generally safe and well tolerated. In the trial, alfimeprase showed potential for thrombolysis (breaking up of a blood clot) at rates of up to 76% and restoration of arterial flow at rates of up to 60%, based on intention to treat analysis. Furthermore, all thrombolytic activity and restoration of flow was recorded within four hours of initiation of dosing. From 52% to 69% of study patients were able to avoid vascular surgical intervention. Among the 113 patients enrolled, there were no intracerebral hemorrhages or deaths at 30 days. There were seven major bleeding events reported. Of these, only one major bleed was categorized by the investigator as possibly related to alfimeprase (a groin hematoma). Hypotension rates in the lower doses (0.1 mg/kg and 0.3 mg/kg) were approximately 3% or 2 patients, one of whom was categorized by the investigator as not related to alfimeprase.

About Leg Attack

Acute PAO, also known as "leg attack," which affects more than 100,000 people in the United States per year, is the blocking of arterial blood flow to the lower limbs by a clot. Leg attack often develops at sites of underlying atherosclerotic peripheral arterial disease. The classic early symptom of leg attack is leg pain. Continued restriction of blood flow can lead to ulcers, gangrene, tissue death and if untreated, foot or leg amputation.

Vascular surgery, angioplasty and off-label use of thrombolytics are established initial treatments for leg attack. These plasminogen activator type thrombolytic agents may require a prolonged infusion of 24 to 36 hours in patients with leg attack. There are currently no approved, widely used products on the market to treat leg attack. With the limited treatment options currently available, alfimeprase has received orphan drug designation for leg attack.

About Alfimeprase

Alfimeprase is an enzyme produced by recombinant DNA technology. It is a thrombolytic agent or blood clot dissolver that is intended to directly degrade fibrin when delivered through a catheter at the site of a blood clot. Thrombolytics currently on the market such as Abbokinase® or Activase® are plasminogen activators which rely on the plasminogen system to degrade fibrin. The activity of plasminogen activators is impacted by the amount of plasminogen found in the blood clot and may require prolonged infusions when dissolving very large clots such as those found in patients with acute PAO. Alfimeprase directly degrades fibrin, producing a rapid dissolution of blood clots. In preclinical and clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing. In addition, alfimeprase possesses a unique mechanism of action. Preliminary testing suggests that its lytic activity is localized to the site of delivery. Alfimeprase is inhibited within seconds of moving away from the clot and into the general circulation by alpha-2 macroglobulin, a naturally occurring protein in our blood. This clearance mechanism helps focus the thrombolytic activity to the site of delivery and in preclinical and clinical testing, appears to minimize bleeding side effects.

Conference Call Details

Nuvelo will hold a conference call to discuss the conversion of its alfimeprase development and commercialization agreement with Amgen to a licensing agreement and to also discuss the results of its recent meeting with the FDA about the design of the Phase 3 alfimeprase program. The call will take place today, November 1, 2004 at 5:30 p.m. Eastern Time (2:30 p.m. Pacific Time).

To participate in the conference call, please dial 800-795-1259 for domestic callers and 785-832-0326 for international callers, and reference conference ID, 7Nuvelo. A telephone replay of the conference call will be available through Sunday, November 14, 2004 at 11:59 p.m. Eastern Time. To access the replay, please dial 800-839-5634 for domestic callers and 402-220-2560 for international callers.

In addition, this call is being webcast by CCBN and can be accessed via the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com. The webcast is also being distributed over CCBN`s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN`s individual investor center at www.fulldisclosure.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the potential clinical benefits of alfimeprase for the treatment of acute PAO and catheter occlusion and the development and commercialization of Nuvelo`s potential therapeutic products, such as alfimeprase. Such statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. The Biologics License Application (BLA) for alfimeprase may never be filed, or, if filed, many never win FDA approval. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s annual report on Form 10-K for the year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Appoints Dr. Michael Levy as Senior Vice President, Research and Development
Wednesday November 3, 9:01 am ET


SUNNYVALE, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the appointment of Michael Levy, M.D. as senior vice president, research and development (R&D). Dr. Levy joins Nuvelo as a member of the senior management team and will be responsible for providing strategic direction and leading the R&D organization.
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"Dr. Levy has had a distinguished career and a proven track record of success, within both the pharmaceutical and biotechnology industries," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We are excited to welcome him to the team as we prepare to begin Phase 3 trials with alfimeprase, continue to make progress with rNAPc2 and ARC183, and start to identify preclinical candidates from our internal research efforts."

Dr. Levy comes to Nuvelo from Tularik Inc. (recently acquired by Amgen Inc.) where he served as vice president of development and chief medical officer. While at Tularik, Dr. Levy created and built a new development organization and directed the clinical development of seven novel drugs across three therapeutic areas: oncology, metabolic disease and inflammation/immunology.

Prior to joining Tularik, Dr. Levy spent 12 years at Glaxo SmithKline Inc. (GSK) in Canada, where he held several positions including his final role as senior vice president of R&D and chief medical officer. While at GSK, he had dual responsibilities for supporting global drug development and the Canadian commercial business.

Dr. Levy earned his B.A., M.A. and M.D. at Cambridge University, U.K. He undertook his surgical residency at the Mayo Clinic and received the distinction of being elected a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Phase 2 Alfimeprase Trial Results in Patients With Central Venous Catheter Occlusion to Be Presented at the American Society of Hematology 46th Annual Meeting And Exposition
Thursday December 2, 9:00 am ET
Company to Host Webcast at 8:30 p.m. PT on Saturday, December 4, 2004


SAN DIEGO, Dec. 2 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that the clinical data from its Phase 2 alfimeprase trial in patients with occluded central venous access devices (CVADs) will be presented at the American Society of Hematology (ASH) 46th Annual Meeting and Exposition on December 4, 2004 in San Diego, California. The poster presentation entitled, "Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters: Interim Results of a Phase 2, Multi-center, Randomized, Double-blind Study (NuCath)," will be given by Dr. Steven Deitcher, vice president of medical affairs for Nuvelo and former principal investigator for the trial.
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Following the poster presentation at ASH, Dr. Deitcher will present this Phase 2 data at a meeting for the financial community in San Diego, CA at 8:30 p.m. Pacific Time. A simultaneous webcast of Dr. Deitcher`s presentation will be available live and via replay in the Investor Relations section of Nuvelo`s Web site at www.nuvelo.com.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our Web site at www.nuvelo.com or by phoning 408-215-4000.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Plans to Sell 7 Million Shares
Monday January 24, 5:10 pm ET
Nuvelo Plans to Sell 7 Million Shares in Public Offering Under Existing Shelf Registration


SUNNYVALE, Calif. (AP) -- Biotech company Nuvelo Inc. reported Monday that it plans to offer 7 million shares of stock to the public under an existing shelf registration.
UBS Securities is sole book-running manager, with Deutsche Bank Securities acting as a co-lead manager and CIBC World Markets and Needham & Co. acting as co-managers. Underwriters will have the option to buy just under 1.1 million additional shares to cover over-allotments.

Nuvelo has more than 32.2 million shares outstanding.

The company`s lead product in development, alfimeprase, is an enzyme that clears out blood clots that form in the catheters of central venous access devices.

Nuvelo shares fell 37 cents, or 4.1 percent, to close at $8.68 on the Nasdaq in regular trading, and fell another 6 cents in the aftermarket session.

[Bombenleger]

Nuvelo Reports Fourth Quarter and Year End 2004 Results, Accomplishments and 2005 Outlook
Tuesday February 15, 4:01 pm ET


SUNNYVALE, Calif., Feb. 15 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced fourth quarter and year end 2004 financial results, accomplishments and 2005 outlook.
For the three months ended December 31, 2004, Nuvelo reported a net loss of $13.0 million or $0.40 per share compared to a net loss of $9.4 million or $0.37 per share for the same period in 2003. The loss from continuing operations during the three month period was $10.8 million or $0.33 per share in 2004 compared to $8.9 million or $0.35 per share in 2003. Revenues from continuing operations for the fourth quarter of 2004 were $43,000, compared to revenues of $12,000 for the same period in 2003, after accounting for the sale of Callida Genomics, Inc. in December 2004.

For the twelve months ended December 31, 2004 Nuvelo reported a net loss of $52.5 million or $1.70 per share, compared to a net loss of $50.2 million or $2.37 per share in 2003. The loss from continuing operations was $48.9 million or $1.59 per share in 2004 compared to $46.2 million or $2.19 per share in 2003. Revenues from continuing operations for the twelve months ended December 31, 2004 were $0.2 million compared to revenues of $1.0 million for the same period in 2003.

The increase in net loss for the twelve months ended December 31, 2004 of $2.3 million was primarily attributable to an increase of $10.0 million in research and development expenses offset by a decrease of $6.4 million in general and administrative expenses. The increase in research and development expenses was primarily related to increased spending on our development stage drug candidates, including license and collaboration fees and the advancement of our preclinical research programs. The decrease in general and administrative expenses was primarily due to decreases from the costs incurred in 2003 related to the Humboldt Court lease termination and the merger with Variagenics.

As of December 31, 2004, Nuvelo had approximately $50.6 million in cash, cash equivalents and short-term investments compared to approximately $34.2 million at December 31, 2003. On February 9, 2005, Nuvelo completed a public offering of 9,775,000 shares of common stock with gross proceeds totaling $73.3 million. Net proceeds after underwriters` fees and estimated stock issuance costs are expected to be approximately $68.3 million. Nuvelo intends to use the net proceeds from this offering for general corporate purposes, including capital expenditures, working capital needs, current and future clinical trials of the lead drug candidate, alfimeprase, as well as other research and drug development activities.

"In 2004, we became a late-stage product company with multiple development opportunities focused on acute, hospital based cardiovascular care," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We made significant progress advancing this acute cardiovascular franchise. We acquired worldwide rights to our lead product candidate, alfimeprase, completed enrollment in and announced positive results for both of our Phase 2 alfimeprase trials for acute peripheral arterial occlusion (PAO) and catheter occlusion and look forward to initiating Phase 3 clinical programs in both indications this year. We also significantly strengthened our financial position and are beginning to seek collaborations for our development programs where we believe partnerships can accelerate or improve our efforts."

Recent Corporate Accomplishments

-- Gained worldwide rights from Amgen to develop and commercialize
alfimeprase in exchange for payment of previously negotiated
development milestones and royalties.
-- Presented positive, full Phase 2 clinical trial results at the
American Society of Hematology (ASH) 46th Annual Meeting and
Exposition showing that alfimeprase has the potential to restore
function in patients with occluded central venous access devices
(CVADs) in as early as 5 minutes.
-- Completed a financing with gross proceeds of approximately $73.3
million.
-- Advanced an internal research candidate, NU206, into IND-enabling
studies.
-- Entered into an interim agreement with Avecia Limited for the
manufacture of commercial supply of alfimeprase.
-- Appointed Dr. Michael Levy as senior vice president of research and
development.
-- Sold our subsidiary, Callida Genomics, Inc., to SBH Genomics, Inc.,
a privately held Delaware corporation, as part of our strategy to
focus our resources and management attention on our drug discovery
and development programs.

2005 Outlook
In 2005, Nuvelo anticipates accomplishing the following:

-- Enroll the first patient in the Phase 3 alfimeprase trial in acute
PAO in the first quarter of 2005.
-- Enroll the first patient in the Phase 3 alfimeprase trial in
patients with central venous catheter occlusion in the second half
of 2005.
-- Complete enrollment in the Phase 2a rNAPc2 trial in patients with
acute coronary syndromes (ACS) currently being conducted with the
TIMI Study Group led by Dr. Eugene Braunwald of Brigham and Women`s
Hospital and Harvard Medical School in the first half of 2005.
-- Complete enrollment in the Phase 1 ARC183 program for use in
coronary artery bypass graft (CABG) surgery, in the first half of
2005.
-- Announce a primary indication for our preclinical candidate, NU206
in the first half of 2005.


Conference Call Information

Nuvelo will hold a conference call today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 800-795-1259 for domestic callers and 785-832-2422 for international callers and reference conference ID, 7Nuvelo. A telephone replay of the conference call will be available through Tuesday, March 15, 2005. To access the replay, please dial 877-693-4281 for domestic callers and 402-220-1602 for international callers.

This call is also being webcast by Thomson/CCBN and can be accessed at Nuvelo`s Web site at www.nuvelo.com or by visiting Thomson/CCBN`s individual investor portal, powered by StreetEvents, at www.fulldisclosure.com. Institutional investors can access the call via Thomson`s password-protected event management site, StreetEvents (www.streetevents.com).

Upcoming Events

Dr. Ted W. Love, president and CEO will be presenting at the BIOCEO & Investor Conference in New York City, on Thursday, February 24, 2005 at 2:00 p.m. Eastern Time.

Dr. Love will provide a brief corporate overview, clinical updates and near-term milestones. A live audio webcast of the presentation will be available online via the Investor Relations portion of Nuvelo`s Web site at www.nuvelo.com or http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=NUV…

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s lead product candidate, alfimeprase, recently completed two Phase 2 trials in acute peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.

Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding our anticipated use of cash in the fiscal year 2005, our success in concluding collaboration agreements for our research and development programs and the timing of any such agreements, and the timing and progress of Nuvelo`s clinical stage and internal research programs, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent Form 8-K filing of January 24, 2005, annual report on Form 10-K for the year ended December 31, 2003 and subsequent quarterly reports on Form 10-Q. We disclaim any intent or obligation to update these forward-looking statements.

NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)

Three months ended Twelve months ended
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2004 2003 2004 2003

Contract revenues: $43 $12 $195 $1,024

Operating expenses:
Research and development 8,168 6,241 39,970 30,014
General and administrative 2,461 2,414 8,702 15,069
Loss on sale of assets 192 15 167 1,225
Total operating expenses 10,821 8,670 48,839 46,308

Operating loss (10,778) (8,658) (48,644) (45,284)

Interest and other income 602 333 2,889 747
Interest and other expense (661) (557) (3,187) (1,692)

Loss from continuing operations (10,837) (8,882) (48,942) (46,229)

Discontinued operations:
Loss from discontinued operations
(including loss on disposal of
$1,641 in 2004) (2,145) (507) (3,547) (3,958)

Net loss ($12,982) ($9,389) ($52,489) ($50,187)

Basic and diluted net loss per share:
Continuing operations ($0.33) ($0.35) ($1.59) ($2.19)
Discontinued operations ($0.07) ($0.02) ($0.11) ($0.18)
Total basic and diluted net loss
per share ($0.40) ($0.37) ($1.70) ($2.37)

Weighted average shares used in
computing basic and diluted net
loss per share 32,218 25,203 30,874 21,054


CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)

December 31, December 31,
2004 2003 *
Cash, cash equivalents and short
term investments $50,625 $34,189
Restricted cash 191 501
Total assets 79,264 57,809
Bank loan 2,600 --
Notes payable 4,000 6,600
Capital lease obligations 1,079 3,070
Line of credit 7,792 10,542
Accumulated deficit (254,739) (203,559)
Total stockholders` equity 45,589 22,701

* The consolidated balance sheet data at December 31, 2003 has been
derived from the audited financial statements as of that date.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Partners With Kirin to Develop NU206, a Lead Compound From Its Secreted Proteins Program
Monday April 4, 6:30 am ET


SUNNYVALE, Calif., April 4 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that it has entered a new development collaboration with the Pharmaceutical Division of Kirin Brewery Co., Ltd. to advance a potent growth factor, NU206, which entered IND-enabling studies late in 2004. Under the terms of the new agreement, Nuvelo will receive a $2 million upfront payment from Kirin for NU206 with Nuvelo leading worldwide development, manufacturing and commercialization. All expenses and operating profits will be shared in a 60(Nuvelo)/40(Kirin) ratio while Nuvelo and Kirin are both actively collaborating under the agreement.
ADVERTISEMENT


Scientists from Nuvelo and Kirin worked together to identify and characterize NU206 as part of a longstanding collaboration focused on the discovery of novel, secreted proteins. NU206 is the first compound to move into IND-enabling studies from this program. Research to date indicates that NU206 acts as a specific and potent stimulator of alimentary epithelial cells and therefore could have potential clinical utility in both inflammatory bowel disease and in chemotherapy or radiation therapy induced mucositis.

"The advancement of NU206 is an important milestone achievement that demonstrates Nuvelo`s proprietary research can produce novel candidates to supplement our promising late-stage clinical pipeline focused on acute cardiovascular disease," said Dr. Michael Levy, senior vice president of research and development for Nuvelo. "In animal disease models, this compound shows promise for treating chemotherapy and radiation therapy induced oral and gastrointestinal mucositis, as well as inflammatory bowel conditions, such as Crohn`s disease or ulcerative colitis. Our collaboration with Kirin has resulted in additional promising leads, and we look forward to progressing other potential candidates in a similar fashion."

"This new partnership further validates our successful relationship with Nuvelo to date," said Toshifumi Mikayama, vice president of planning for Kirin. "We are very pleased with the productive outcome of the collaboration with Nuvelo. Nuvelo`s novel gene sequences and target identification capabilities coupled with Kirin`s proprietary technologies have yielded a promising early-stage product candidate in NU206."

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits factor VIIa/tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

About Kirin

Kirin Brewery Co., Ltd., located in Tokyo, Japan, is the world`s foremost brewery. Its Pharmaceutical Division focuses on kidney diseases, cancers (including hematopoietic diseases), and immune-system/allergy-related diseases and has recently been focused on the areas of cell therapy and fully human antibodies. www.kirin.co.jp

This press release contains "forward-looking statements" regarding the timing and progress of Nuvelo`s clinical stage and internal research programs, the expenses, revenues and the potential for profits from sales of any drug products resulting from such programs, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

5-Apr-2005

Entry Material Agreement, Financial Obligation Matter, Financial Statements and Exhibi



Item 1.01. Entry into a Material Definitive Agreement.
Development Collaboration with Kirin Brewery Co. Ltd. On March 31, 2005, we entered into a Collaboration Agreement with Kirin Brewery Company, Ltd., or Kirin, for the development of the amino acid sequence referred to as NU206. With respect only to the development of NU206, this Collaboration Agreement supersedes and replaces our prior agreement with Kirin dated August 11, 2001, and as amended March 5, 2002, September 3, 2002 and August 10, 2004. The August 11, 2001 agreement, as amended, continues to govern the development of all product candidates other than NU206 that may arise from our collaboration with Kirin.

Under the terms of the NU206 Collaboration Agreement, we will receive a $2 million upfront payment from Kirin, and we will lead worldwide development, manufacturing and commercialization of the compound. So long as we and Kirin are collaborating under the NU206 Collaboration Agreement, we and Kirin will share all operating expenses and profits related to the development and commercialization of NU206, 60% Nuvelo and 40% Kirin. If the collaboration is terminated under certain circumstances, the relationship between us and Kirin with respect to NU206 will convert from an expense and profit sharing structure to a royalty based structure.

Our press release dated April 4, 2005, titled "Nuvelo Partners With Kirin to Develop NU206, a Lead Compound From Its Secreted Proteins Program" is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Neither the filing of any press release as an exhibit to this Current Report on Form 8-K nor the inclusion in that press release of a reference to our Internet address or Kirin`s Internet address shall, under any circumstances, be deemed to incorporate the information available at those Internet addresses into this Current Report on Form 8-K. The information available at those Internet addresses is not part of this Current Report on Form 8-K or any other report filed by us with the Securities and Exchange Commission.

Modification of Loan and Security Agreement with Silicon Valley Bank. On March 30, 2005 we entered into a letter agreement with Silicon Valley Bank, or SVB, modifying our August 31, 2004 Loan and Security Agreement with SVB. Under the letter agreement, we agreed to a second term loan in the amount of $1.5 million, under the terms of the original Loan and Security Agreement, except that the interest rate with respect only to this second term loan was reduced by up to 0.5%.

This second term loan from SVB will be used to retire approximately $0.6 million of our existing debt under capital leases, and for working capital and other general business requirements. Following the advance of this second term loan, our outstanding principal balance under our Loan and Security Agreement with SVB was $4.1 million. The proceeds of the first term loan advanced under this agreement, totaling $2.6 million, were used to repay amounts owing to AMB Property, LP.

A copy of our March 30, 2005 letter agreement with SVB is attached hereto as Exhibit 10.52, and is incorporated herein by reference.





Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information under Item 1.01 of this Current Report on Form 8-K, under the title "Modification of Loan and Security Agreement with Silicon Valley Bank" is incorporated by reference into this Item 2.03.



--------------------------------------------------------------------------------





Item 9.01. Financial Statements and Exhibits.
(c) Exhibits


Exhibit
Number Description
------- -----------------------------------------------------------------------
10.52 Letter Agreement, dated March 30, 2005, between Silicon Valley Bank and
Nuvelo, Inc.

99.1 Press Release titled "Nuvelo Partners With Kirin to Develop NU206, a
Lead Compound From Its Secreted Proteins Program" dated April 4, 2005.

[Bombenleger]

Nuvelo Begins Phase 3 Trial of Alfimeprase for Acute Peripheral Arterial Occlusion, or `Leg Attack` NAPA-2 trial to Evaluate Avoidance of Open Vascular Surgery Within 30 Days of Treatment
Monday April 18, 6:30 am ET


SUNNYVALE, Calif., April 18 /PRNewswire-FirstCall/ -- Nuvelo Inc., (Nasdaq: NUVO - News) today announced that it has begun patient enrollment in a Phase 3 trial of its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion (PAO), or "leg attack."
ADVERTISEMENT


This Phase 3 trial, also known as NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), is a randomized, double-blind study comparing 0.3 mg/kg of alfimeprase versus placebo in approximately 300 patients. The trial will be conducted in over 100 centers worldwide. The study`s primary endpoint is avoidance of open vascular surgery within 30 days of treatment. Open vascular surgery includes procedures such as surgical embolectomy and peripheral arterial bypass graft surgery as well as amputation, but does not include catheter-based procedures such as percutaneous angioplasty or stenting. A variety of secondary endpoints are also being evaluated, including safety endpoints such as the incidence of bleeding, as well as pharmacoeconomic endpoints, such as length of hospital and intensive care unit (ICU) stay.

"I`m excited to be part of the next step in evaluating this promising new therapy for a patient population that would very much benefit from a new and improved treatment option," said Dr. Sean Lyden, assistant professor at the Cleveland Clinic and the first physician to treat a patient in our Phase 3 program. "Current treatments can be time consuming and cause significant side effects, particularly bleeding. In clinical trials to date, alfimeprase has shown potential as an easily administered, rapid acting clot dissolver with a favorable safety profile and attractive dosing schedule."

Previously announced results from the NAPA-1 trial, a Phase 2 multi-center, multi-national, open-label, dose-escalation study, revealed that alfimeprase can restore arterial blood flow within four hours of initiation of dosing, demonstrated a favorable safety profile with minimal bleeding complications and resulted in a minority of patients requiring open vascular surgery within 30 days of treatment.

Because there are no FDA approved thrombolytic therapies available to treat acute PAO, off-label use of plasminogen activators are often used in this indication. As noted in published studies, plasminogen activators may require a prolonged infusion averaging 24 to 36 hours in patients with leg attack, and carry the risk of significant bleeding complications.

"Nuvelo is committed to delivering cardiovascular products that are safe, effective and easy to administer in order to advance the care of patients suffering from medical problems caused by a thrombus or blood clot," said Dr. Steven R. Deitcher, vice president of medical affairs for Nuvelo. "We are encouraged by alfimeprase`s potential to offer physicians treating PAO patients an important, new and improved therapeutic alternative."

"The initiation of this trial is a significant milestone for Nuvelo and is evidence of our progress in advancing our acute cardiovascular franchise," stated Dr. Ted W. Love, president and chief executive officer of Nuvelo. "It has been only three years since we acquired alfimeprase and began our first human clinical study. It is exciting to see this promising drug move into late-stage clinical trials."

About Leg Attack

Acute peripheral arterial occlusion (PAO), or "leg attack," is the blocking of arterial blood flow to the lower limbs by a clot. Affecting more than 100,000 people in the United States per year, it is the result of underlying peripheral arterial disease, in which chronic fatty plaque buildup restricts blood flow and is complicated by the formation of an acute clot. If blood flow is not restored quickly, leg attack can lead to permanent nerve and muscle damage, gangrene, and in the most severe cases, amputation and death.

About Alfimeprase

Alfimeprase is an enzyme produced by recombinant DNA technology. It is a thrombolytic agent that is intended to directly degrade fibrin when delivered through a catheter at the site of a blood clot. Thrombolytics currently on the market such as Abbokinase® or Activase® are plasminogen activators which rely on the plasminogen system to degrade fibrin. The activity of plasminogen activators is impacted by the amount of plasminogen found in the blood clot and according to published studies, may require prolonged infusions averaging 24 to 36 hours when dissolving very large clots such as those found in patients with acute PAO. In addition, studies have shown that plasminogen activators cause major bleeding in 5-16% of patients and intracerebral hemorrhage (ICH) in 1-2% of patients.

In contrast, alfimeprase possesses a unique mechanism of action. It directly degrades fibrin, producing a rapid dissolution of blood clots. In clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing. In addition, preliminary testing suggests that its lytic activity is localized to the site of delivery because within seconds of moving away from the clot and into the general circulation it is inhibited by alpha-2 macroglobulin, a naturally occurring protein in our blood. This clearance mechanism helps focus the thrombolytic activity to the site of delivery and in clinical testing, appears to minimize bleeding side effects.

Additional Clinical Trials

The NAPA-2 study is the first of two overlapping Phase 3 trials evaluating alfimeprase for the treatment of acute PAO. The Phase 3 acute PAO program is expected to include up to 700 patients between the two trials. The second Phase 3 trial is expected to begin in the second half of 2005.

Alfimeprase is also under evaluation for a second target indication, central venous catheter occlusion, which affects over one million patients each year in the U.S. alone. Catheter occlusion occurs when a clot forms within an in-dwelling catheter, hindering the inward or outward flow of solutions or blood. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter as soon as possible. A recently completed Phase 2 study demonstrated the ability of alfimeprase to lyse clots in occluded catheters in as early as five minutes. A Phase 3 program in catheter occlusion is expected to begin in the second half of 2005.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits factor VIIa/tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding potential use of alfimeprase as a treatment for PAO and catheter occlusion and timing and progress of Nuvelo`s clinical stage and internal research programs, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004. We disclaim any intent or obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Reports First Quarter 2005 Financial Results and Accomplishments
Monday May 2, 4:01 pm ET


SUNNYVALE, Calif., May 2 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced first quarter 2005 financial results and accomplishments.
ADVERTISEMENT


For the three months ended March 31, 2005, Nuvelo reported a net loss of $14.7 million or $0.39 per share compared to a net loss of $17.7 million or $0.65 per share for the same period in 2004. The loss from continuing operations during the three-month period was $14.7 million or $0.39 per share in 2005 compared to $17.2 million or $0.63 per share in 2004. The decrease in loss from continuing operations in the first quarter of 2005 was primarily due to $7.0 million in upfront fees expensed in the first quarter of 2004 related to license and collaboration agreements for our rNAPc2 and ARC183 clinical development candidates, partially offset by increased expenses associated with the start of our alfimeprase Phase 3 acute peripheral arterial occlusion (PAO) trial in the first quarter of 2005.

Revenues from continuing operations for the three months ended March 31, 2005 were approximately $42,000, compared to revenues of $78,000 for the same period in 2004. In March 2005, we entered into a new collaboration agreement with the Pharmaceutical Division of Kirin Brewery Co., Ltd. for the development and commercialization of NU206. In connection with the agreement, we received an up-front fee of $2.0 million in April 2005, which will be recognized as revenue ratably over the estimated performance period under the contract.

As of March 31, 2005, Nuvelo had $106.7 million in cash, cash equivalents and short-term investments compared to $50.6 million as of December 31, 2004. The increase of $56.1 million resulted primarily from net proceeds of $68.5 million from the public offering in February 2005, partially offset by cash used in our drug development, research and administrative activities.

"We recently accomplished two major milestones as a company," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We advanced our first internal research candidate into IND-enabling studies and we dosed our first patient in a Phase 3 trial. With these latest milestones, we have truly evolved into a late-stage biopharmaceutical company with multiple drug candidates focused on acute, hospital-based medicine."

Recent Corporate Accomplishments and Upcoming Milestones

-- Completed a financing in February 2005 with net proceeds of $68.5 million.

-- Expanded our partnership with the Pharmaceutical Division of Kirin Brewery Co., Ltd. to develop and commercialize NU206, which began IND-enabling studies in late 2004.

-- Began enrollment in the first Phase 3 alfimeprase trial in acute PAO and expect to begin the second Phase 3 trial in acute PAO in the second half of 2005.

-- Initiated discussions with the FDA to finalize the design of a Phase 3 alfimeprase trial in patients with central venous catheter occlusion, scheduled to begin in the second half of 2005.

-- Entered into an interim agreement with Avecia Limited to manufacture the commercial supply of alfimeprase.

-- Completed enrollment of the scheduled 175 patients in our Phase 2a rNAPc2 trial (TIMI 32) in patients with acute coronary syndromes (ACS), and have added an additional cohort of 25 patients at the highest dose level, 10ug/kg. With the additional cohort we are still on schedule to complete enrollment in this trial in the second quarter of 2005.

-- Expect to begin an additional Phase 2 trial with rNAPc2, a heparin replacement study called TIMI 32b, in the second half of 2005.

-- Expect to complete enrollment in the Phase 1 ARC183 program for potential use in coronary artery bypass graft (CABG) surgery in the second quarter of 2005.

Conference Call Information

Nuvelo will hold a conference call today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 800-540-0559 for domestic callers and 785-832- 1508 for international callers and reference conference ID, 7Nuvelo. A telephone replay of the conference call will be available through Monday, May 16, 2005. To access the replay, please dial 888-214-9522 for domestic callers and 402-220-4934 for international callers.

This call is also being webcast by Thomson/CCBN and can be accessed at Nuvelo`s website at www.nuvelo.com or by visiting Thomson/CCBN`s individual investor portal, powered by StreetEvents, at www.fulldisclosure.com. Institutional investors can access the call via Thomson`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding our anticipated use of cash in the fiscal year 2005, our success in concluding collaboration agreements for our research and development programs and the timing of any such agreements, the timing and progress of Nuvelo`s clinical stage and internal research programs, the expenses, revenues and the potential for profits from sales of any drug products resulting from such programs, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.



NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)

Three months ended
March 31, 2005 March 31, 2004
Contract revenue: $42 $78
-------------- --------------
Operating expenses:
Research and development 11,057 15,373
General and administrative 3,813 1,689
Loss (gain) on sale or disposal of assets 24 (21)
Total operating expenses 14,894 17,041

Operating loss (14,852) (16,963)

Interest income 508 478
Interest expense - related party (118) (126)
Interest expense - other (200) (555)

Loss from continuing operations (14,662) (17,166)
Loss from discontinued operations -- (512)

Net loss $(14,662) $(17,678)

Basic and diluted net loss per share:
Continuing operations $(0.39) $(0.63)
Discontinued operations -- (0.02)
Total basic and diluted net loss per
share $(0.39) $(0.65)

Weighted average shares used in computing
basic and diluted net loss per share 37,960 27,391


CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)

March 31, December 31,
2005 2004
Cash, cash equivalents and short-term
investments $106,692 $50,625
Total assets 134,116 79,264
Bank loans 4,100 2,600
Notes payable 4,000 4,000
Capital lease obligations 127 1,079
Related party line of credit 7,104 7,792
Accumulated deficit (270,710) (256,048)
Total stockholders` equity 99,857 45,589





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Source: Nuvelo, Inc.

[Bombenleger]

10-May-2005

Quarterly Report



ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Management`s Discussion and Analysis of Financial Condition and Results of Operations contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words including "will," "anticipate," "believe," "intends," "estimates," "expect," "should," "may," "potential" and similar expressions. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors discussed herein and elsewhere including, in particular, those factors described under the "Risk Factors" set forth below, and in our other periodic reports filed from time to time with the Securities and Exchange Commission, or SEC. Actual results and performance could also differ materially from time to time from those projected in our filings with the SEC.

Overview

We are engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. In April 2005, we began patient enrollment in a Phase 3 trial of our lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion (PAO), or "leg attack." Alfimeprase, a thrombolytic agent, has completed Phase 2 trials in two indications, acute PAO and catheter occlusion. A Phase 3 program in catheter occlusion is expected to begin in the second half of 2005. Adding to our cardiovascular portfolio, in the first quarter of 2004 we entered into a partnership with Archemix for the development and commercialization of ARC183, a novel thrombin inhibitor, and a license agreement with Dendreon for worldwide rights to rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor. ARC183 is currently in a Phase 1 program evaluating its potential use in coronary artery bypass graft (CABG) surgery, which we expect to conclude in the second quarter of 2005; rNAPc2 is currently in a Phase 2 program evaluating its potential use in treating acute coronary syndromes (ACS). Within this program, we are conducting a Phase 2a trial evaluating the safety and efficacy of rNAPc2 that is expected to conclude in the second quarter of 2005, and an additional Phase 2 trial evaluating heparin replacement is expected to commence in the second half of 2005.

In March 2005, we entered into a new collaboration agreement with the Pharmaceutical Division of Kirin Brewery Company, Ltd. (Kirin), for the development and commercialization of NU206, a potent gastrointestinal growth factor identified as a result of our proprietary research programs. In addition, we plan to leverage our proprietary gene collection and expertise in secreted proteins and antibody discovery to expand our pipeline and create partnering and licensing opportunities.

The alfimeprase Phase 3 acute PAO program will consist of two overlapping trials with an estimated total of approximately 700 patients between the two trials. The first trial in this program, NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), is a randomized, double-blind study comparing 0.3 mg/kg of alfimeprase versus placebo in 300 patients. The trial will be conducted in over 100 centers worldwide. The study`s primary endpoint is avoidance of open vascular surgery within 30 days of treatment. Open vascular surgery includes procedures such as surgical embolectomy and peripheral arterial bypass graft surgery as well as amputation, but does not include catheter-based procedures such as percutaneous angioplasty or stenting. A variety of secondary endpoints are also being evaluated, including safety endpoints such as the incidence of bleeding, as well as pharmacoeconomic endpoints, such as length of hospital and intensive care unit (ICU) stay. The second Phase 3 trial, NAPA-3, is expected to begin in the second half of 2005.

Alfimeprase is a thrombolytic agent, or blood clot dissolver, with a novel mechanism of action, and was identified through a research program at Amgen Inc. In January 2002 we entered into a 50/50 cost/profit sharing arrangement with Amgen for the development and commercialization of alfimeprase. In October 2004, Amgen exercised its rights pursuant to the terms of this collaboration agreement to terminate its collaboration with us and enter instead into an exclusive license whereby we are granted the worldwide rights to develop and commercialize alfimeprase in exchange for the payment to Amgen of previously negotiated milestone payments and royalties. Under the terms of our license agreement, Amgen will transfer the technology necessary for the manufacture of alfimeprase to us or our designated manufacturer. On January 21, 2005, we entered into an Interim Agreement with Avecia, our designated manufacturer, to manufacture alfimeprase, and we are currently in negotiations with Avecia for a definitive agreement to manufacture commercial quantities of alfimeprase. Amgen is required to continue to supply alfimeprase to us during the transition period. As a result of dosing the first patient in the first Phase 3 clinical trial for alfimeprase on April 15, 2005, we are required to pay Amgen $5.0 million within 30 days of this date. Additional future milestone payments under the license agreement could total as much as $35.0 million, although we currently cannot predict if and when any of these additional milestones will be achieved.

rNAPc2 is a recombinant version of a naturally occurring protein that has anticoagulant properties. We are currently investigating rNAPc2 in a Phase 2a double-blind, placebo-controlled clinical trial for potential use in treating acute coronary syndromes (ACS), including unstable angina (UA), and non-ST segment elevation myocardial infarction (NSTEMI). We plan to complete patient enrollment of this trial in the second quarter of 2005. We also plan to commence an additional Phase 2 trial with rNAPc2, a heparin-replacement study, in the second half of 2005. We have licensed worldwide rights to all indications of rNAPc2 and all other rNAPc molecules owned by Dendreon, as a result of a licensing agreement entered into with Dendreon Corporation in February 2004. Under the terms of the agreement, we paid Dendreon an upfront fee of $4.0 million ($0.5 million in cash and $3.5 million in Nuvelo common stock), and have expensed $5.6 million for this and related development costs in 2004 and $0.6 million for related development costs in the first three months of 2005. We are required to pay Dendreon milestone payments, ranging from $2.0 million to $6.0 million, for both of rNAPc2`s first and second indications upon dosing of the first patient in a Phase 3 clinical trial, upon submission of a New Drug Application (NDA), and upon first commercial sale. If all development and commercialization milestones are achieved, total milestone payments to Dendreon can reach as much as $23.5 million, although we currently cannot predict if and when any of these milestone will be achieved. If rNAPc2 is commercialized, we will also be responsible for paying future royalties to Dendreon depending on certain sales volume of rNAPc2.

We continue to pursue the development and commercialization of ARC183 under a collaboration agreement entered into with Archemix, a privately held biotechnology company located in Cambridge, Massachusetts, in January 2004. In August 2004, we jointly initiated a Phase 1 clinical program for ARC183, a novel thrombin inhibitor, for potential use in coronary artery bypass graft (CABG) surgery. These studies are evaluating the safety, tolerability, anticoagulation activity and titratability of ARC183. We expect to complete enrollment of the Phase 1 clinical program of ARC183 in the second quarter of 2005. Under the terms of the agreement, we paid Archemix an upfront fee of $3.0 million in cash, and equally share all costs associated with its development and commercialization since our initial funding of these costs reached $4.0 million in the third quarter of 2004. We expensed $7.7 million for the upfront fee and related development costs in 2004 and $0.7 million for related development costs in the first three months of 2005. Archemix is initially responsible for leading development and for all clinical development activities through the dosing of the first patient in a Phase 2 study. Thereafter, we and Archemix will agree on leadership of clinical development and commercialization activities. We are required to pay Archemix total development milestone payments of up to $11.0 million, including $10.0 million upon the first dosing of a patient in a Phase 2 trial and $1.0 million upon the designation of any backup compound selected by both Nuvelo and Archemix for IND-enabling studies. We estimate that the milestone payment of $10.0 million could occur in the first half of 2006. If ARC183 is commercialized, both companies are responsible for paying any related royalties to each other depending on product sales volume.



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On March 31, 2005, we entered into a new collaboration agreement with Kirin for the development and commercialization of NU206 (NU206 Agreement). In late 2004, NU206 became the first compound to enter IND-enabling studies from our existing collaboration with Kirin. Research to date indicates that NU206 acts as a specific and potent stimulator of gastrointestinal epithelial cells and therefore could have potential clinical utility in inflammatory bowel disease, short-bowel syndrome and in chemotherapy or radiation therapy induced mucositis. We plan to announce a primary indication in the second quarter of 2005. Our existing collaboration agreement with Kirin (Original Agreement), which was amended in the third quarter of 2004 to extend the term to December 31, 2005 and expand the scope to include additional secreted protein genes from our full-length gene portfolio, continues to govern all product candidates other than NU206. Under the NU206 Agreement, we received a $2.0 million upfront cash payment from Kirin in April 2005, and will lead worldwide development, manufacturing and commercialization of the compound. All operating expenses and profits related to the development and commercialization of NU206 will be shared in a 60 (Nuvelo) / 40 (Kirin) ratio. If the NU206 Agreement is terminated, or Nuvelo or Kirin elects under certain circumstances to no longer actively participate in the collaboration, the relationship with respect to NU206 will convert from an expense and profit sharing structure to a royalty based structure. Under the Original Agreement, we have completed the initial analysis of 50 secreted protein genes in mouse models and will be testing additional candidates genes in 2005. We will continue to jointly own discoveries resulting from the Original Agreement and jointly develop and market the resulting products, while sharing costs, efforts and revenues with Kirin.

In January 2005, we entered into a seven-year facility lease agreement with BMR-201 Industrial Road LLC for 61,826 square feet of industrial space at 201 Industrial Road in San Carlos, California at $2.35 per square foot per month, subject to annual adjustments. The lease will commence on or around September 1, 2005 and contains an option to cancel the lease after five years, two options to extend the lease for five additional years at 95% of the then-current fair market rental rate (but not less than the existing rental rate), and rights of first refusal over all vacant space in the building during the first two years of the lease. The lease contains a tenant improvement allowance of $8.7 million, or $140 per square foot.

In February 2005, we raised $68.5 million in a public offering, net of underwriters` fees and stock issuance costs of $4.8 million, from the sale of 9,775,000 shares of our common stock, including 1,275,000 shares related to the exercise of an over-allotment option granted to the underwriters, at a public offering price of $7.50 per share. We intend to use the net proceeds from this offering for general corporate purposes, including capital expenditures, working capital needs, current and future clinical trials of alfimeprase, rNAPc2 and ARC183, as well as other research and drug development activities. The amounts and timing of the expenditures will depend on numerous factors, such as the timing and progress of our clinical trials and research and development efforts, technological advances and the competitive environment for our drug candidates. We expect from time to time to evaluate the acquisition of businesses, products and technologies for which a portion of the net proceeds may be used, although we currently are not planning or negotiating any such transactions.

Results of Operations

Nuvelo`s core business is to discover, develop and market therapeutic drugs for the treatment of human diseases. The following results of operations include those of both Nuvelo Inc. and Callida Genomics, Inc. (Callida), through the disposal of this subsidiary on December 3, 2004. The results of Callida have been reclassified to discontinued operations for all periods presented.

Contract Revenue

Contract revenue was $42,000 in the three months ended March 31, 2005, as compared to $78,000 in the corresponding period of 2004. A one-time upfront fee of $2.0 million related to the new NU206 collaboration agreement with Kirin was received in April 2005 and will be recognized ratably as revenue over the estimated performance period under the contract, commencing in the second quarter of 2005.

Our revenues may vary significantly from quarter to quarter as a result of licensing or collaboration activities. In the future, we may not be able to maintain existing collaborations, obtain additional collaboration partners or obtain revenue from other sources, which could have a material adverse effect on our revenues, operating results and cash flows.

Research and Development Expenses

Research and development (R&D) expenses, primarily consist of R&D personnel costs, clinical trial and drug manufacturing costs, license, collaboration and royalty fees, outside services, supplies, depreciation and amortization, and allocated facilities expenses.

R&D expenses were $11.1 million in the three months ended March 31, 2005, as compared to $15.4 million in the corresponding period of 2004. The decrease of $4.3 million was primarily due to $7.0 million in upfront fees expensed in the 2004 period related to license and collaboration agreements for our rNAPc2 and ARC183 clinical development candidates, partially offset by increased expenses associated with the start of the alfimeprase Phase 3 trial in 2005.

R&D expenses included in the statement of operations for the three months ended March 31, 2005 and since inception for our significant programs are as follows (including license and collaboration fees):


Year to Since
Program Date Inception
----------- --------- -----------
(in millions)
alfimeprase $ 5.4 $ 32.2
rNAPc2 $ 0.6 $ 6.2
ARC183 $ 0.7 $ 8.4




We expect to expense up to $11.5 million of drug manufacturing costs within the next twelve months as we advance alfimeprase into Phase 3 clinical trials in 2005. We also are required to pay Amgen a milestone fee of $5.0 million in the second quarter of 2005, as a result of dosing of the first patient in the first phase 3 clinical trial for alfimeprase, which occurred on April 15, 2005. We currently do not expect to incur any other milestone expense for alfimeprase or our rNAPc2 and ARC183 drug candidates in 2005. We expect other R&D expenses to increase during 2005 as we continue to dedicate our resources to advance the Phase 3 clinical trials for alfimeprase, as well as work to enhance our pipeline by seeking attractive therapeutic candidates that complement our ongoing development programs, while prosecuting and enforcing our intellectual property rights.

The timing, cost of completing the clinical development of any product candidate, and any potential future product revenues will depend on a number of factors, including the disease or medical condition to be treated, clinical trial design and endpoints, availability of patients to participate in trials and the relative efficacy of the product versus treatments already approved. Due to these uncertainties, we are unable to estimate the length of time or the costs that will be required to complete the development of these product candidates. We do not expect to generate any product revenue until we reach the commercialization stage for any of our drug products, if this ever occurs.



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General and Administrative Expenses

General and administrative (G&A) expenses primarily consist of G&A personnel costs, consulting and professional fees, insurance, facilities and depreciation expenses, and various other administrative costs.

G&A expenses were $3.8 million in the three months ended March 31, 2005, as compared to $1.7 million in the corresponding period of 2004. The increase of $2.1 million was primarily due to a $0.7 million increase in G&A personnel costs, a $0.6 million increase in consulting and professional fees, largely associated with the internal controls documentation, testing and auditing required under the Sarbanes-Oxley Act of 2002, a $0.3 million increase in non-cash stock compensation expense, and a $0.2 million increase in facilities expenses.

We expect general and administrative expenses to increase during 2005 as compared to 2004 in order to support growth in our general operating activities.

Interest Income and Expense, Net

We had net interest income of $0.2 million in the three months ended March 31, 2005, as compared to $0.2 million net interest expense in the corresponding period of 2004. The change resulted from a $0.4 million decrease in investment-related interest expense between the periods.

Loss from Continuing Operations

Since our inception we have incurred significant net losses, and as of March 31, 2005 our accumulated deficit was $270.7 million. During the three months ended March 31, 2005 we incurred a net loss from continuing operations of $14.7 million, as compared to $17.2 million in the corresponding period of 2004.

We expect to continue to incur significant losses from continuing operations for the foreseeable future, which may increase substantially as we continue development of our clinical stage drug candidates, alfimeprase, a thrombolytic agent, rNAPc2, an anticoagulant, ARC183, a novel thrombin inhibitor, and our preclinical stage drug candidate, NU206, a gastrointestinal growth factor. In addition, we expect to incur significant costs as we further expand research and development of our potential biopharmaceutical product candidates, potentially in-license other drug candidates, and continue to prosecute and enforce our intellectual property rights.

Loss from Discontinued Operations

On December 3, 2004, we sold our subsidiary, Callida Genomics, Inc. (Callida). In accordance with Statement of Financial Accounting Standards No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets", the operating results of Callida have been reclassified to discontinued operations for all periods presented. During the three months ended March 31, 2004, we incurred a net loss from discontinued operations of $0.5 million, related to Callida.


Liquidity and Capital Resources



Cash, cash equivalents and short-term investment balances at March 31, 2005 and
December 31, 2004 were as follows:



March 31, December 31,
2005 2004
---------- --------------
(in thousands)
Cash and cash equivalents $ 66,968 $ 16,811
Short-term investments 39,724 33,814
-- ------- -- -----------
Cash, cash equivalents and short-term investments $ 106,692 $ 50,625




Cash flows from operating, investing and financing activities in the three months ended March 31, 2005 and 2004 were as follows:


Three Months Ended March 31,
-----------------------------------
2005 2004
--------------- -------------
(in thousands)
Cash flows from operating activities $ (12,359 ) $ (8,827 )
Cash flows from investing activities (5,937 ) 7,493
Cash flows from financing activities 68,453 68,835
-- ------------ -- -- ---------- -
Net increase in cash and cash equivalents $ 50,157 $ 67,501




Cash, Cash Equivalents and Short-Term Investments

As of March 31, 2005, we had total cash, cash equivalents and short-term investments of $106.7 million, as compared to $50.6 million as of December 31, 2004. The increase of $56.1 million resulted primarily from net proceeds of $68.5 million from a public offering in February 2005, partially offset by cash used in operating activities.

As of March 31, 2005, all of our short-term investments in marketable securities have maturities of less than one year, and have been classified as available-for-sale securities, as defined by Statement of Financial Accounting Standards No. 115, "Accounting for Certain Investments in Debt and Equity Securities" (SFAS 115). These securities are recorded at their fair value and consist of corporate debt and asset-backed securities. We make our investments in accordance with our investment policy. The primary objectives of our investment policy are liquidity, safety of principal and diversity of investments.



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Sources and Uses of Capital

Our primary sources of liquidity to date have been cash from financing activities, collaboration receipts and our merger with Variagenics in January 2003. We plan to continue to raise funds through additional public and/or private offerings and collaboration activities in the future.

In February 2005, we raised $68.5 million in a public offering, net of underwriters` fees and stock issuance costs of $4.8 million, from the sale of 9,775,000 shares of our common stock, including 1,275,000 shares related to the exercise of an over-allotment option granted to the underwriters, at a public offering price of $7.50 per share.

In August 2004, we entered into a Loan and Security Agreement (Loan Agreement), with Silicon Valley Bank that provides us with a $6.0 million term loan facility and a $4.0 million revolving credit line and grants Silicon Valley Bank a security interest over certain of our assets, excluding intellectual property. As a condition precedent to the Loan Agreement, we agreed, among other things, to certain covenants and reporting requirements. In December 2004, we completed a planned $2.6 million initial draw-down on the term loan, the proceeds of which were used entirely to repay a note for the same amount that was owed to AMB Property, LP in relation to the termination of a lease agreement for facilities at Humboldt Court, Sunnyvale, California. In March 2005, we completed a second draw-down under the term loan, of $1.5 million, with $0.6 million of these proceeds being used to pay off certain capital leases. We have not drawn-down any of the funds available under the revolving credit line, which is currently being used to collateralize a $4.0 million letter of credit issued to the Irvine Company related to the lease for the facility at 985 Almanor Avenue in Sunnyvale, California. The proceeds of all other term loan draw-downs and the revolving credit line may be used solely for our working capital or other general business requirements. Our term loan borrowings, except for the second draw-down, shall bear interest at a fixed rate per annum equal to the 36-month Treasury Rate in effect on the funding date plus 3.25%, and, in any event, shall not be less than 6.43% per annum, which is the rate applicable to the initial draw-down. The second draw-down was at a rate equal to the 36-month Treasury Rate in effect on the funding date plus 2.75%, being 6.78%. Our revolving credit line borrowings shall bear interest at Silicon Valley Bank`s prime rate in effect from time to time. As of March 31, 2005, we had received waivers for any breaches of related covenants and reporting requirements.

Dr. Rathmann, the chairman of our board of directors, provided us with a $20.0 million line of credit in August 2001, of which we have drawn down $11.0 million, with the remaining $9.0 million having expired unused. The related promissory note bears interest at the prime rate plus 1%. In November 2003, we began repaying the outstanding balance over 48 months with equal principal payments of $0.2 million. Accrued interest will be paid with the final payment in October 2007. As of March 31, 2005, the remaining principal and accrued interest to date totaled $8.6 million. The outstanding principal and interest under the note may be repaid at any time upon mutual agreement, by conversion into shares of our common stock at a price based upon the average price of our common stock over a 20-day period ending 2 days prior to the conversion or, if in connection with an equity financing, at the offering price. As of March 31, 2005, 1,248,175 shares would be issuable to fully repay the principal and interest outstanding upon conversion.

We issued Affymetrix a five-year promissory note for $4.0 million in November 2001, bearing a fixed annual interest rate of 7.5 %. Accrued interest will be paid with the final principal payment in November 2006. As of March 31, 2005, the remaining principal and accrued interest to date totaled $5.0 million. The outstanding principal and interest under the note may be repaid in whole or in part at any time, at our option, by conversion into shares of our common stock at a price based upon 90% of the average price of our common stock over a 10-day period ending 2 days prior to the conversion. As of March 31, 2005, 832,779 shares would be issuable to fully repay the principal and interest outstanding upon conversion. Affymetrix has the ability to declare all outstanding principal and interest under the note immediately due and payable if our market capitalization is under $50.0 million and Affymetrix reasonably determines that the loan evidenced by the note is impaired, and we have an obligation to prepay amounts owing under the note to the extent that the amounts outstanding exceed 10% of our market capitalization. Moreover, we have registered for resale a portion of these shares issuable to Affymetrix on a registration statement that has been declared effective by the SEC.

Our primary uses of capital resources to date have been to fund operating activities, including research and clinical development expenses, license payments and spending on capital items. We used cash of $12.4 million and $8.8 million for operating activities, and cash of $0.1 million and $0.2 million for the purchase of capital items, in the three months ended March 31, 2005 and 2004, respectively.

In August 2002, we amended our lease on the property at 985 Almanor Ave. to . . .

[Bombenleger]

Nuvelo Announces Completion of Enrollment of Phase 2a Clinical Trial in Acute Coronary Syndromes (ACS)
Tuesday May 24, 6:30 am ET
-- Company Plans to Initiate Proof of Concept Study Evaluating rNAPc2 as First-Line Therapy for Patients With ACS --
-- Management to Provide Update on Clinical Research and Development During Annual Meeting Today at 2:15 p.m. Eastern Time, 11:15 a.m. Pacific Time Available Via Webcast at www.nuvelo.com --


SUNNYVALE, Calif., May 24 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the completion of patient enrollment in its Phase 2a clinical trial of recombinant nematode anticoagulant protein c2 (rNAPc2), showing that rNAPc2 has an acceptable safety profile and is well tolerated in doses up to 10 microgram/kg, in patients with non-ST-elevation acute coronary syndromes (ACS).
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ACS is a potentially life-threatening heart condition that accounts for over one million hospitalizations annually in the United States. ACS occurs when an atherosclerotic plaque ruptures in a coronary artery, which triggers the coagulation cascade resulting in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle, depriving it of oxygen and results in either acute myocardial infarction or unstable angina.

This multi-center, double-blind, placebo-controlled, ascending dose-escalation study, known as ANTHEM (Anticoagulation with NAPc2 To Help Eliminate Mace)/TIMI 32, was conducted with the TIMI Study Group led by Eugene Braunwald, M.D., of Brigham and Women`s Hospital and Harvard Medical School. The trial investigated the safety of rNAPc2 in combination with other anticoagulants in 200 patients with ACS.

"The current standard of care for ACS is a combination of traditional anticoagulants, such as aspirin and heparin, as well as anti-platelet and anti-thrombin agents. However, based upon the significant number of patients with ACS who continue to experience poor outcomes such as recurrent angina, myocardial infarction or death, we believe there is a clear need for better antithrombotic therapy," said Steven Deitcher, M.D., vice president, medical affairs for Nuvelo. "The full data set for the TIMI 32 trial is being analyzed now, which we plan to present at a major medical meeting in the second half of 2005."

The study consisted of a dose ranging phase and a dose confirmation phase. Each of the study`s 200 patients was treated with one of seven escalating doses of rNAPc2 (1.5, 2.0, 3.0, 4.0, 5.0, 7.5 and 10 microgram/kg), with 25 patients per dose group. Doses were given intravenously and were compared to matching placebo doses in a 4:1 randomization. The primary focus of dose ranging was to identify a safe and active dose as measured by major or minor hemorrhage occurring in the period from randomization to seven days after the last dose of study drug, and the presence of ischemia measured by the Holter monitor. In the dose confirmation phase, 25 patients received 10 microgram/kg, the highest safe and active dose evaluated, compared to placebo in a 4:1 randomization. All patients received low molecular weight heparin or unfractionated heparin and aspirin. Use of clopidogrel was strongly encouraged per the ACC/AHA Guidelines.

Based on the encouraging safety results from this Phase 2a trial, Nuvelo plans to initiate a "proof of concept" study in the second half of 2005 to assess the potential of rNAPc2 to replace heparin as a first-line therapy in ACS. This second Phase 2 trial, called TIMI 32b, will include up to 100 patients and will provide supplementary efficacy data.

"Given the additional data that we anticipate from our upcoming heparin replacement study, we will have data in approximately 800 subjects from various Phase 1 and 2 trials with rNAPc2," said Ted W. Love, M.D., president and chief executive officer of Nuvelo. "We believe that we have identified a cost-effective strategy to generate safety and efficacy data that will facilitate our objective to secure a strategic partner to further support development and commercialization of rNAPc2 for ACS."

About rNAPc2

Novel anticoagulant, rNAPc2, is a naturally occurring protein that was originally isolated from a nematode. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease complex, which is responsible for the initiation of the process leading to blood clot formation. Unlike heparin, thrombin inhibitors and other agents which exert their effects at later stages of the blood coagulation cascade, rNAPc2 shows the potential to block the first step in the cascade, inhibiting coagulation before it starts.

Annual Meeting Webcast Information

Nuvelo will hold a webcast of its 2005 Annual Shareholders Meeting today at 2:15 p.m. Eastern Time (11:15 a.m. Pacific Time) during which management will provide an overview of the Company`s research and development programs including details of the alfimeprase Phase 3 program for CO. The webcast can be accessed at Nuvelo`s website at www.nuvelo.com or by visiting Thomson/CCBN`s individual investor portal, powered by StreetEvents, at www.fulldisclosure.com. Institutional investors can access the webcast via Thomson`s password-protected event management site, StreetEvents (www.streetevents.com).

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the completion of patient enrollment for its Phase 2a clinical trial of rNAPc2 to treat patients with non-ST-elevation acute coronary syndromes. The timing and progress of Nuvelo`s Phase 2 program, and the potential improvement or benefit that current clinical trial programs may demonstrate which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Appoints Michael A. Fleming as Vice President, Commercial Operations
Tuesday May 24, 6:30 am ET


SUNNYVALE, Calif., May 24 /PRNewswire-FirstCall/ -- Nuvelo Inc., (Nasdaq: NUVO - News) today announced the appointment of Michael A. Fleming as vice president, commercial operations. Mr. Fleming, who has nearly 20 years of experience in the pharmaceutical industry, joins Nuvelo as a member of the management team and will be responsible for leading the commercial activities at Nuvelo.
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"Michael has a strong commercial background with a consistent pattern of success through innovative marketing approaches to support diverse commercial initiatives," said Ted W. Love, M.D., president, chief executive officer and director of Nuvelo. "We have added Michael to our management team at a critical juncture in the development of our lead product candidate, alfimeprase. We recently began a Phase 3 program of alfimeprase for acute peripheral arterial occlusion and plan to initiate a Phase 3 program for catheter occlusion in the second half of this year. His substantial experience in commercial operations will be of tremendous importance as we work to advance our entire acute cardiovascular franchise and bring alfimeprase to market."

Mr. Fleming joins Nuvelo from Genentech, where he held a senior position in their commercial organization and was responsible for marketing efforts associated with their hematology franchise, overseeing the U.S. Rituxan hematology/oncology commercial strategy and operations.

Prior to joining Genentech, Mr. Fleming spent nearly 16 years with GlaxoSmithKline (GSK) and its precursor companies in both the United States and Canada. Most recently, he served as senior director of global commercial strategy for oncology, where he was responsible for leading the global commercial strategy and lifecycle management of oncology assets to enable successful worldwide commercialization. While with GSK, Mr. Fleming also served as vice president of the HIV, oncology and vaccines business unit in Canada and was a member of the Canadian management team. In addition, Mr. Fleming served on the management team of the Canadian operating company of SmithKline Beecham, as head of their healthcare policy, strategic relations and market access division. In addition, he was a member of the commercial operations integration taskforce and co-chair of the public affairs and market access integration taskforce during the merger of GlaxoWellcome and SmithKline Beecham in Canada.

Mr. Fleming earned his master`s degree in business administration and his bachelor of science at the University of Toronto, Canada.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding our anticipated timing and progress of Nuvelo`s clinical stage and internal research programs, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.

[Bombenleger]

Nuvelo Announces Design of Phase 3 Alfimeprase Program in Patients With Central Venous Catheter Occlusion
Thursday May 26, 6:30 am ET


SUNNYVALE, Calif., May 26 /PRNewswire-FirstCall/ -- Nuvelo Inc., (Nasdaq: NUVO - News) today announced that it has finalized the design of the Phase 3 program for its lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion (CO).
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The Phase 3 program, known as SONOMA (Speedy Opening of Non-Functional and Occluded Catheters with Mini-Dose Alfimeprase), includes two overlapping, multi-national, trials. The first trial is an efficacy study called SONOMA-2. This study is a randomized, double-blind trial, comparing 3 mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. Two-thirds of the patients will receive alfimeprase and the remainder will receive placebo. The study`s primary endpoint is restoration of function to occluded central venous catheters at 15 minutes. The safety study, SONOMA-3, will be an open-label, single-arm trial evaluating alfimeprase alone in 800 patients.

"The Phase 3 program for alfimeprase in CO is modeled after the Cathflo®Activase® program in this indication," said Michael D. Levy, M.D., senior vice president, research and development for Nuvelo. "We are very excited about the design of this program and are looking forward to initiating the first trial in the SONOMA Phase 3 program, the efficacy trial, in the second half of 2005."

Previously announced results from a Phase 2 multi-center, randomized, double-blind study in 55 patients with occluded central venous catheters, demonstrated the ability of alfimeprase to restore function to occluded catheters in as early as five minutes. In the Phase 2 study, alfimeprase restored flow to 40% and 50% of occluded catheters 5 and 15 minutes after the first dose, respectively, while Cathflo®Activase®, the only treatment currently approved in the U.S. for resolution of occluded catheters, did not restore flow at either time point. In addition, alfimeprase restored flow to 60% at 120 minutes after the first dose and 80% of occluded catheters at 120 minutes after the second dose compared to 46% at 120 minutes after the first dose and 62% at 120 minutes after the second dose with Cathflo®Activase®.

"We believe that alfimeprase has the potential to be a more rapid, and therefore improved therapeutic alternative for restoring the flow of life-saving medications through a catheter," said Ted W. Love, M.D., president and chief executive officer of Nuvelo. "Current treatments for CO are limited by their time-to-efficacy, which takes a toll on both patients in chemotherapy and the clinics where treatment space is at a premium."

About Catheter Occlusion

Delivery of chemotherapy, nutritional support, antibiotics, and blood products as well as the frequent withdrawal of blood samples for laboratory testing are often facilitated via central venous catheters. Each year approximately five million catheters are placed in patients in the United States, of which as many as 25% become occluded. When a catheter becomes occluded, the ultimate goal is to restore flow in a prompt and cost-effective manner with minimal risk to the patient. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter as soon as possible. In the case of thrombolytic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Currently, Cathflo®Activase® is approved in the United States for restoring function to central venous catheters.

About Alfimeprase

Alfimeprase, an enzyme produced by recombinant DNA technology, possesses a unique mechanism of action. It directly degrades fibrin, producing a rapid dissolution of blood clots. In clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing as well as the ability to restore function to occluded catheters in as early as five minutes. In addition, preliminary testing suggests that its lytic activity is localized to the site of delivery because within seconds of moving away from the clot and into the general circulation it is inhibited by alpha-2 macroglobulin, a naturally occurring protein in our blood. This clearance mechanism helps focus the thrombolytic activity to the site of delivery and in clinical testing, appears to minimize bleeding side effects. Alfimeprase is currently being evaluated in a Phase 3 clinical program for the treatment of patients with acute peripheral arterial occlusion (PAO), also known as "leg attack," and a separate Phase 3 clinical program in CO is expected to begin enrollment in the second half of 2005.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo`s clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.

Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the design for its alfimeprase Phase 3 clinical trial program to treat patients with central venous catheter occlusion. The timing and progress of Nuvelo`s Phase 3 program, and the potential improvement or benefit that current clinical trial programs may demonstrate which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management`s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo`s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.




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Source: Nuvelo, Inc.