Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage (Seite 2209)

[360]

Antwort auf Beitrag Nr.: 37.754.288 von basset69 am 11.08.09 14:56:57

einmal mehr komischer Kursverlauf - Vorbörslich meistens Top dann im Handel Flop Nochmals wer kann Vorbörslich handeltn, doch nur Banken und Grosskunden oder??

[basset69]

Antwort auf Beitrag Nr.: 37.750.790 von basset69 am 11.08.09 08:41:33

Na also, geht doch ...

Pre-Market High: $ 5.37
Pre-Market Low: $ 4.97

aktuell 5.22
Volume: 106,493 Pre-Market

[basset69]

Antwort auf Beitrag Nr.: 37.747.346 von basset69 am 10.08.09 18:18:51

http://timesofindia.indiatimes.com/news/... 11-Aug-09 01:21 am

AHMEDABAD: Cadila Pharmaceutical Limited, an Ahmedabad-based unlisted pharma major, hopes to be the first to launch the vaccine for swine flu virus H1N1 by November this year!
CPL had set up a joint venture (JV) on July 9 with the US-based vaccine maker Novavax for manufacturing of vaccines, including one for swine flu. The JV company called CPL Biologicals Pvt Ltd is filling application with Drug Controller General of India (DCGI) this week for phase one clinical trial for swine flu vaccine.

Company officials were confident Cadila will be the first Indian pharma company to produce the swine flu vaccine. “Novavax has already received permission for pre-clinical trials from US Federal Drug Administration,” IA Modi, chairman and managing director, CPL, told TOI.

Modi said the vaccine is expected to be available in November 2009 if permission for clinical trial comes from the government immediately. The government has already decided to clear swine flu related applications on fast track basis.

Modi said to protect from swine flu pandemic, two dosages of the vaccine are required over two weeks. The company initially intends to produce 2 million vaccine on a monthly basis and scale up production to cater to global demand, Modi said. “Sky is the limit as far as production is concerned,” he said.

The JV has already started building a facility costing Rs 100 crore in the CPL campus at Bhat to produce the vaccines. The new facilities will be operational after one-and-a-half years but the company will be able to launch the vaccine in November, using existing manufacturing capacity of CPL.

CPL has 80% equity and Novavax 20% in the JV. It may be pointed out that Cadila Pharma also holds 5.75% equity stake in Novavax Inc USA and has a position on the board of directors of Novavax.

[basset69]

Antwort auf Beitrag Nr.: 37.746.984 von basset69 am 10.08.09 17:43:17

klar, dass sie bei diesen news steigt ..

zur erinnerung:

Novavax of Rockville and Cadila Pharmaceuticals of Ahmedabad, India, have launched their previously announced joint venture in India, CPL Biologicals Pvt. Ltd., to develop and manufacture vaccines, biological therapeutics and diagnostics in India using technology from Novavax and Cadila Pharmaceuticals.

CPL Biologicals also plans to establish manufacturing facilities in India and develop, produce and market products such as seasonal influenza vaccine and other vaccines against dengue fever and chikungunya fever based on Novavax's virus-like-particle vaccine technology.

[basset69]

Antwort auf Beitrag Nr.: 37.735.159 von Magnetfeldfredy am 07.08.09 18:44:25

THE TIMES OF INDIA
NEW DELHI:
Ahmedabad-based Cadila pharma to become the first firm to manufacture vaccine for H1N1 in India. US-based biotechnology firm Novavax, in
which Cadila has equity stake, has developed vaccine for the treatment of H1N1 virus. Two shots of vaccine within 3-week period will immunize person against flu.

Cadila says clinical trials on animals have been completed and tests on humans will begin in Ahmedabad shortly.

Cadila is approaching government for fast track clearance and hopes to manufacture vaccine by 2009 end. Initialy, it plans capacity of 2 million vaccines per month.

NOVAVAX liefert also bald nach Indien ...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 37.734.193 von 360 am 07.08.09 16:50:16

Für mich ist NVAX ein eindeutiger Übernahmekandidat für Impfstoffhersteller wie Novartis, die machen den Impfstoff, Novavax hat die schnellste Technik zum Herstellen, genial oder?

[360]

Antwort auf Beitrag Nr.: 37.733.665 von basset69 am 07.08.09 15:55:54

etwas mehr supply agreements mit anderen Regierungen wäre jetzt nicht schlecht. Geld verdienen ist nun angesagt, nebst den Entwicklungen. Der Kurs weiss auch nicht so recht wo er hin will heute Analystengemeinde hat ein etwas schlechteres Ergebnis erwartet. Hier wird eindeutig die Zukunft gehandelt....

[basset69]

Antwort auf Beitrag Nr.: 37.732.659 von 360 am 07.08.09 14:33:59

Novavax believes that based on the balance of cash and short-term investments at June 30, 2009, along with the proceeds from its transaction with ROVI of $3.0 million and the proceeds of $8.0 million received from additional sales of stock under the ATM program in July 2009, it has sufficient funds to execute its current business plan for at least the next twelve months."

cash - june 30 - 31.2mm
cash - july 31 - 37.6mm

Also im Juli insgesamt 11 Mio eingenommen und bis Juni nur 31 !!

und dazu kommen noch :

"Complete definitive license and supply agreements with ROVI"
Supply heißt ja wohl liefern;
auf Grund dieser Liefervereinbarungen werden also schon bald neue Meldungen eintrudeln.

Und außerdem:
President Barack Obama met with some of his top officials on Thursday to discuss vaccine development and measures Americans should take to deal with the swine flu virus, said John Brennan, White House deputy national security adviser.

[360]

Antwort auf Beitrag Nr.: 37.732.502 von 360 am 07.08.09 14:16:04

ROCKVILLE, Md., Aug. 7 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX - News) today reported a net loss of $8.5 million, or $0.10 per share, for the second quarter of 2009 compared to a net loss of $9.4 million, or $0.15 per share, for the second quarter of 2008.

For the six months ended June 30, 2009, Novavax reported a net loss of $16.9 million, or $0.22 per share, as compared to a net loss of $17.1 million, or $0.28 per share, for the six months ended June 30, 2008. Total cash and short-term investments as of June 30, 2009 were $31.2 million compared to $33.9 million as of December 31, 2008. Net outstanding indebtedness related to the company's convertible notes was reduced by 17.8 million as of June 30, 2009 when compared to December 31, 2008.

Since the first quarter, Novavax continued to advance its vaccine pipeline, improved its balance sheet by raising additional capital and retiring 100% of its convertible debt, and entered into an initial agreement with ROVI Pharmaceuticals of Spain ("ROVI").

Specific accomplishments since the first quarter included the following:


•Completed subject enrollment in the second Phase II study of its trivalent season influenza virus-like-particle ("VLP") vaccine candidate. The company is planning on reporting top-line immunogenicity and safety results from this study by the fourth quarter of this year.
•Improved the company's balance sheet by retiring 100% of its $22.0 million of outstanding convertible notes. The notes carried a coupon rate of 4.75% payable semi-annually and had a maturity date of July 15, 2009. The company retired $17.0 million of the notes in April 2009 by paying 70% of the principal plus accrued and unpaid interest, or $12.1 million, in cash and by issuing 2,040,000 shares of common stock for the remaining 30% of the principal, or $5.1 million. The remaining $5.0 million in outstanding convertible notes matured on July 15, 2009. In accordance with the terms of the notes, the company elected to pay 50% of the principal plus accrued and unpaid interest, or $2.6 million, in cash and issued 1,016,939 shares of common stock to pay the remaining $2.6 million of the principal plus accrued and unpaid interest.
•Entered into an initial agreement to license the company's Seasonal and Pandemic Influenza VLP technology to ROVI to create a comprehensive influenza vaccine solution including a facility for the Spanish government using our proprietary, recombinant VLP vaccine technology. A non-profit foundation, jointly sponsored by ROVI and the Spanish authorities, will be formed and funded to support Phase III clinical development and other studies necessary to achieve market authorization of the VLP-based influenza vaccines in the European Union, which is targeted for 2012.
•Raised $21.9 million from the sale of 7.4 million shares of common stock through the ATM program.
•Launched CPL Biologicals Pvt. Ltd, the previously announced joint venture with Cadila Pharmaceuticals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India.
•Recruited key executives to support the future growth of the company. New appointments include Mr. John Trizzino as Senior Vice President, International and Governmental Affairs, and Mr. Fredrick W. Driscoll as Vice President, Chief Financial Officer and Treasurer.
•Achieved a major production milestone in the Pandemic H1N1 influenza program by manufacturing a cGMP-quality batch of the company's VLP vaccine candidate against this virus within 11 weeks of receiving the genetic sequence of the pandemic virus strain from the Centers of Disease Control.

"Our progress since the first quarter has been transformational," said Novavax Chief Executive Officer, Dr. Rahul Singhvi. "We eliminated 100% of our $22 million outstanding convertible debt and raised net proceeds of $21.9 million through the sale of additional shares under our ATM program. Today, Novavax has a healthy balance sheet with no long term debt and cash and short-term investments of $37.6 million as of July 31, 2009. With this financial strength, we are well positioned to advance our vaccine development programs, and in particular, continue our work on a VLP vaccine candidate against the 2009 pandemic H1N1 strain, so that we are ready to serve public health authorities in the U.S. as well as in foreign countries."

The anticipated milestones for the remainder of 2009 include:


•Release top-line results from the Phase II trial in healthy adults with our trivalent seasonal flu vaccine candidate;
•Initiate a Phase II clinical study of our trivalent seasonal flu vaccine in older adults;
•Continue development of our pandemic H1N1 vaccine candidate;
•Complete definitive license and supply agreements with ROVI; and
•Continue expansion of operations at CPL Biologicals.

2009 Financial Results

Revenue from continuing operations for the second quarter ended June 30, 2009 was $29,000, compared to $0.3 million for the same period in 2008, a decrease of $0.3 million due to the completion of two contracts in 2009.

Research and development costs were $5.3 million for the second quarter of 2009 compared to $5.4 million in the second quarter of 2008, a decrease of $0.1 million. The decrease was due to a $0.2 million decrease in employee costs, partially offset by a $0.1 million increase in outside testing costs associated with continuing clinical trials, preclinical testing, process development, manufacturing and quality related programs.

General and administrative costs were $2.6 million in the second quarter of 2009 as compared to $3.2 million in the second quarter of 2008. The decrease of 19% was due to a reduction in employee costs of $0.2 million, a decrease in facility costs associated with general and administrative functions of $0.1 million, and a $0.1 million decrease in charges to the allowance established for two notes receivable from former directors. The balance of the decrease is attributable to a decrease in professional fees.

Novavax recorded net interest and other expense of $0.7 million for the second quarter of 2009 compared to net interest and other expense of $0.1 million for the second quarter of 2008. The increase in net interest and other expense primarily resulted from an additional other than temporary impairment in the amount of $0.5 million related to one of the company's auction rate securities due primarily to its continued illiquidity and a $0.2 million decrease in interest income due to a decrease in the average cash and short-term investments balance during the quarter.

Accordingly, Novavax's net loss for the quarter ended June 30, 2009 was $8.5 million, or $0.10 per share, compared to a net loss of $9.4 million, or $0.15 per share, for the quarter ended June 30, 2008. The loss for the quarter ended June 30, 2008 includes a loss from discontinued operations of $1.1 million.

As of June 30, 2009, Novavax had $31.2 million in cash and short-term investments (including auction rate securities recorded at their fair value) as compared to $33.9 million as of December 31, 2008. The company's short-term investments consist of investments in five auction rate securities with a par value of $8.1 million and a fair value of $6.0 million. In addition to the other than temporary impairment discussed above, during the second quarter of 2009, the company recorded a $0.5 million unrealized gain, which is included in other comprehensive income related to the recovery of fair value for four of the securities.

The net decrease in cash and short-term investments of $2.7 million was principally due to cash spent for operations and cash paid for principal and interest totaling $12.1 million related to the retirement of $17.0 million of convertible debt, which were partially offset by net proceeds from the sale of common stock to Cadila of $10.7 million and proceeds from the sale of stock under the ATM program of $14.0 million. Novavax believes that based on the balance of cash and short-term investments at June 30, 2009, along with the proceeds from its transaction with ROVI of $3.0 million and the proceeds of $8.0 million received from additional sales of stock under the ATM program in July 2009, it has sufficient funds to execute its current business plan for at least the next twelve months. Novavax may pursue additional funding through the potential sale of equity securities, other non-dilutive financing, or additional partnering agreements, as opportunities arise.

[360]

Antwort auf Beitrag Nr.: 37.731.340 von basset69 am 07.08.09 11:53:36

vorbörslich wollen jedenfalls schon mal einige raus...