Caladrius Biosciences Cell Tech Developer - 500 Beiträge pro Seite

[Shanghai2006]

Summary
Caladrius Biosciences (through its subsidiary PCT) offers an opportunity to profit from the success of cell therapies without taking on company specific risk.
The sale of the subsidiary should have led to a substantial upside re-evaluation of Caladrius Biosciences.
Several factors can explain why the re-evaluation didn't occur yet.
I am convinced that the re-evaluation will occur one way or another after the shareholder’s vote for or against the sale of the subsidiary.
An upside of 200% from current levels ($4.32) as a likely scenario.

Caladrius is a company with $40 million revenue with a sound revenue growth rate of 56.90% and a market cap of around $40 million.
The main source of revenue generation at Caladrius was their subsidiary PCT, which is an industry-leading cell therapy development and manufacturing services provider. PCT was the primary reason for me to invest in Caladrius Biosciences. I saw it as a diversified bet on the success of different cell therapy players.
The logic behind my decision was simple: The more well spread cell therapies will become, the more value PCT will hold. I don't need to search for a winner in the cell therapy industry. I can just buy Caladrius instead and profit from the success of whoever might succeed.

My decision was supported by the vote of confidence Caladrius has received from an institutional investor (Hitachi Chemical), which bought 19.9% of PCT for $19.4 million in March 2016. This fact has reinforced by my original thesis that Caladrius was worth more than the $40 million market cap awarded to it by the market at that point in time.
In March 2017, about one month after my initial investment, Caladrius announced the sale of the remaining stake in PCT (80,1%) to Hitachi Chemical for $ 75 Million. The transaction is subject to shareholder's approval in May 2017. This means that my original reason to invest in Caladrius would no longer exist if the shareholders approve the sale. I am still holding the stock due to one simple reason: The cash value of the PCT sale has not been reflected in the share price so far.

Can the shareholders' approval be taken for granted? According to Seeking Alpha, 28.30% of shares are held by insiders and 17.67% are held by Institutions. I assume that both insiders and institutions (such as Sanford Research and Aspire Capital) will vote in favor of the transaction. I am not aware if a simple or a super majority are required for shareholders' approval. Nevertheless, I consider the approval a more likely scenario.
In this case, Caladrius will become a pure play therapeutics development company with a significant cash position. This will make them (according to the statement of the management during the earnings calls on March 17 2017) eligible for scientific grants that were unavailable to them before, due to their weak cash position.

Case study:
Shareholders' approval
Additionally, an increase in the research-related costs (due to ongoing clinical trials) might be partly offset by the elimination of PCT-related costs. Therefore, I expect Caladrius to maintain a strong cash position throughout 2017. In this case, I don't see how its market cap can stay below its net cash position for a long period of time.

No shareholders' approval
Even if there is no shareholders' approval, I don't consider it critical, because Hitachi Chemical's offer proves that Caladrius is worth significantly more than it is currently being valued by the market.
If shareholders disapprove the sale of PCT, I can imagine that Hitachi Chemical will simply buy out Caladrius while probably paying the same or a slightly higher price as they offered for PCT.
If Caladrius won't get bought by Hitachi Chemical or any other interested party it has enough cash to go through 2017. This statement is based on the following assumptions:
Cash burn rate $6 million quarter (trailing 4 quarters' average).
Cash balance of $14.7 million as of December 31 2017.
CIRM grant of $12.2 million (to be awarded pro rata as certain research milestones are reached).
$2 million from Sanford Research to be received when the 70th patient has been enrolled in the phase 2 T-Rex study.
Hence, the worst-case scenario implies PCT won't be sold, Caladrius won't be acquired and there will be no positive study related news throughout 2017. In such a situation, the stock price might as well fade to 0 by the year-end. However, I consider this to be a highly unlikely hypothetical scenario since Caladrius has valuable assets (PCT), which has already been valued by Hitachi Chemical's offer at $75 million.

Management reputation
Another reason can be a distrust towards management. Caladrius management has a reputation of diluting shareholders on one hand and awarding themselves with sound paychecks on the other hand. Most important, they are being inconsistent with their communication and their commitments. The situation around PCT is a good example.
During the latest CEO & Investor Conference on February 13-14 2017, Caladrius' CEO David Mazzo was referring to PCT as a very important growth area of Caladrius with yet to be realized potential. Less than one month later, he stated in the press release accompanying the sale of PCT:
"Hitachi Chemical's purchase of our remaining interest in PCT unlocks the value of this asset for our Company both by transforming Caladrius into a well-capitalized pure play therapeutics development company and by eliminating our need to contribute the tens of millions of dollars of future capital investment in PCT needed for it to fully realize its cell therapy commercial manufacturing growth goals," said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. "The transaction provides considerable non-dilutive capital to fund the execution of our ongoing Phase 2 trial while also allowing us to exploit compelling therapeutic prospects."
(Source: Press release)
On the other hand, biotech is a fast-lived environment where the management has to be agile to adjust their goals and ways moving forward, not just to become successful but also to survive. I give Caladrius the benefit of the doubt, while I can still imagine that a lot of retail investors who have been around for a long time losing trust and confidence in Caladrius' Management's ability to deliver.
What to expect after the shareholders' meeting in May
I have developed a few simple scenarios of what can happen after the shareholders vote on May 16 2017.
Scenario 1: The sale of PCT is approved:
Scenario 1a) The valuation rises to at least 1x cash Level, which means $10+ levels.
Scenario 1b) For some odd reason the valuation doesn't change.
Scenario 1c) After the transaction is complete, there might be another major event with a negative/dilutive impact on the current shareholders (hypothetical case).

Scenario 2: transaction is disapproved:
Scenario 2a) Hitachi Chemical will acquire Caladrius within a few months at PCT price or slightly below/above.
Scenario 2b) Stock price doesn't change for whatever reason.
Scenario 2c) Stock price falls to cash level due to uncertainty around Caladrius's ability to continue as a going concern.
As a showcase, I prepared a simple scenario calculation where I have awarded each scenario with a certain probability and a dollar outcome. Even when being conservative in my assumption, I came up with an upside of over 51% from the current level of $4.32.

The most likely scenario in my opinion is a shareholder approval with an initial re-evaluation to 1x new cash Level and future upward re-evaluation on any positive news regarding Caladrius's research activity to around 1.5x cash level. This implies a stock price of $10-15 within 2017 and an upside of over 100-200%.

Side note: On April 10, 2017, Monteverde & Associates PC announced an investigation of Caladrius Biosciences for potential securities law violations and/or breaches of fiduciary duties in connection to the sale of PCT. The stock reacted with an intraday move of around -8% and closed down -4.78%.
I checked the website of Monteverde & Associates PC as well as their other cases. Within the last months, they started numerous investigations, which seems to be their primary business model. Therefore, I don't consider it to be something negatively affecting the stock price in the long term.
Please be aware that this might turn out to be another trap for retail investors in the biotech minefield. Invest accordingly.

Disclosure:
This is a very speculative bet. Please only invest the amount of money you can afford to lose completely without hurting your financial situation. I am holding my position through May 2017.

[Shanghai2006]

Caladrius Biosciences Closes the Sale of its Remaining Interest in PCT to Hitachi Chemical for $75 Million
May 18, 2017
Conference Call scheduled for today at 5:00 p.m. Eastern time
BASKING RIDGE, N.J. (May 18, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a clinical stage development company with a cell therapy pipeline focused on immune modulation and select cardiovascular indications, announces that Company has closed on the sale of its remaining 80.1% ownership interest in its PCT subsidiary to Hitachi Chemical Co. America, Ltd. (“Hitachi Chemical”) for $75 million in cash, subject to certain adjustments, including based on PCT’s cash and outstanding indebtedness as of the Closing Date and a potential future milestone payment (the “Purchase Price”).
Caladrius received $5.0 million of the Purchase Price upon the signing of the Interest Purchase Agreement (the “Purchase Agreement”) on March 16, 2017.  The remainder of the Purchase Price was paid as follows:
$60.1 million was paid to Caladrius, taking into account the Purchase Price adjustments based on PCT’s cash and outstanding indebtedness as of the Closing Date;
$5.0 million (the “Escrow Amount”) was deposited into an escrow account to cover potential indemnification claims against the Company pursuant to the terms of the Purchase Agreement;
$4.9 million was used to pay off the remaining balance owed pursuant to the loan and security agreement, dated as of September 19, 2014, among Oxford Finance LLC, as collateral agent and lender, the Company and certain subsidiaries of the Company.
In addition, Hitachi will pay the Company $5.0 million (the “Milestone Payment”) if PCT achieves $125 million in Cumulative Revenue (excluding clinical service reimbursables) (the “Milestone”) for the period from January 1, 2017 through December 31, 2018 (the “Milestone Period”).  For purposes of the Milestone, “Cumulative Revenue” will be calculated based on PCT’s revenue from all customers (including the Company and its subsidiaries) in accordance with the financial accounting and reporting standards set forth in the statements and pronouncements of the Financial Accounting Standards Board, consistently applied.  There can be no assurance that such Milestone Payment will be earned or received.
The Escrow Amount is expected to be released on June 17, 2018 (the “Escrow Release Date”), subject to indemnification claims, if any, that are paid prior to or that exist on the Escrow Release Date.

http://www.caladrius.com/press-release/caladrius-biosciences…

[Shanghai2006]

Caladrius Biosciences to Participate at Upcoming June Conferences

BASKING RIDGE, N.J., June 01, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a clinical stage development company with a cell therapy pipeline focused on immune modulation and select cardiovascular indications, announces today that the Company’s leadership will participate at the following upcoming June conferences:


7th Annual LD Micro Invitational
•Date and Time: Tuesday, June 6, 2017, 8:30 AM PT
•Venue: Luxe Sunset Hotel, Los Angeles, California
•Website: https://www.ldmicro.com/events
•Presentation: Company Presentation
•Speaker: David J. Mazzo, Chief Executive Officer, Caladrius
•Webcast: http://www.caladrius.com/events

14th International Symposium on Stem Cell Therapy & Cardiovascular Innovations
•Venue: Hospital General Universitario Gregorio Maranon, Madrid, Spain
•Website: http://cardiovascularcelltherapy.com/wp-content/uploads/2010…

Session 1
•Date and Time: Thursday, June 15, 2017, 12:00 PM CET
•Panel: What’s New in Cardiovascular Regenerative Medicine?
•Panelist: Douglas W. Losordo, MD, Chief Medical Officer, Caladrius

Session 2
•Date and Time: Thursday, June 15, 2017, 4:20 PM CET
•Panel: The 2017 Debate
•Panelist: Douglas W. Losordo, MD, Chief Medical Officer, Caladrius

https://finance.yahoo.com/news/caladrius-biosciences-partici…

[Shanghai2006]

https://seekingalpha.com/article/4079609-caladrius-bioscienc…

Information about time lines, products,...

[Shanghai2006]

Invetech and Caladrius Biosciences Receive 2017 Good Design Award® for Design of a Counterflow Centrifuge Device for use in the Development of Cell Therapies

June 14, 2017

Breakthrough platform technology enables researchers to more effectively develop new cell-based therapies for the treatment of cancers and other illnesses

San Diego, CA and Basking Ridge, NJ (June 14, 2017) – Invetech, a global leader in instrument development, custom automation and contract manufacturing, in collaboration with Caladrius Biosciences (Nasdaq: CLBS), a cell therapy company with a select therapeutic development pipeline focused on immune modulation, today announced that they have been jointly named recipients of a 2017 Good Design Award®. The Counterflow Centrifuge Device (CFC) was selected as best in category for medical and scientific product design.

In presenting the award to Invetech and Caladrius Biosciences, the jury commented, “the combination of a centrifuge and counterflow represents a significant breakthrough that will greatly enhance the ability of the cell therapy industry in developing new therapies for the treatment of cancers and other illnesses. This is a very comprehensive technology solution.”

The CFC is a unique platform that enables cell therapy developers to wash and concentrate cells in a closed environment. It was designed for incorporation into Good Manufacturing Practice (GMP) equipment as a key element in commercial manufacture of cell therapies. The CFC is designed for use in multiple stages of both research and production for concentration/volume reduction, cell washing, media exchange, particle depletion, and short-term incubation.

“We are very pleased to be selected for this design award, as it underscores our leadership role in cell therapy development. As a technology that combines multiple operations into one automated platform, the CFC provides flexible, more efficient processes to enhance the manufacture of autologous and other patient-specific products in a cost-effective manner,” said David J. Mazzo, President and Chief Executive Officer of Caladrius Biosciences. “This award acknowledges the unique design of the CFC and its capacity to enable researchers and clinicians to more efficiently develop and manufacture new cell-based therapies.”

The CFC consists of an instrumentation platform, a novel disposable flow path, and operating and application software for automated execution of user-selected protocols. The CFC platform provides a flexible small-scale process suitable for GMP manufacturing of autologous and other patient-specific products where small-scale is full-scale, while also supporting efficient development of processes at lower cost prior to transitioning to scaled volumes.

“We collaborated with Caladrius Biosciences on the development of the CFC platform to enable them and other cell therapy companies to undertake process development on production representative equipment and disposables earlier in their clinical trials,” said Richard Grant, Global Vice President, Cell Therapy at Invetech. “We have succeeded in developing a platform washing technology that is not only gentle on cells and maximizes cell yield at high viability, but is also a foundation technology enabling companies to build their manufacturing process. We are thrilled to be recognized by the Good Design judging panel and to have received this coveted award for design and innovation.”

http://www.caladrius.com/press-release/invetech-and-caladriu…

[Shanghai2006]

Caladrius Biosciences Joins Russell Microcap® Index

June 26, 2017

BASKING RIDGE, N.J., (June 26, 2017) — Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cellular therapeutics development company with a pipeline focused on autoimmune disease and select cardiovascular indications, announces today that the Company has joined the Russell Microcap® Index as part of the Russell indexes annual reconstitution, effective after the U.S. financial market opens today.

Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“We are delighted to have been selected by FTSE Russell for inclusion in its microcap index,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “We believe that being part of the Russell Microcap Index will increase the Company’s overall visibility and further broaden our shareholder base. We expect that inclusion in such an index will contribute to improving overall shareholder value in conjunction with the advancement of our Phase 2 clinical trial for our lead product candidate, CLBS03, for the treatment of recent onset type 1 diabetes.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $8.4 trillion in assets are benchmarked against Russell’s U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

http://www.caladrius.com/press-release/caladrius-biosciences…

[Shanghai2006]

Other companies are taking a different approach to working with cells. Instead of replacing those that make insulin, Caladrius Biosciences Inc. and Parvus Therapeutics Inc. seek to salvage and restore function to cells that are damaged.

Parvus drugs reprogram immune cells that harm the body’s own pancreas cells into “regulatory T cells” that suppress diabetes. This is “reprogramming a killer to [be] a peacemaker,” says Parvus Chief Scientific Officer Pere Santamaria. Parvus, based in Calgary, Alberta, has licensed rights to this Navacim technology in Type 1 diabetes to Novartis AG .

Caladrius is harvesting the patient’s own regulatory T cells, which aren’t functioning normally, says Douglas Losordo, senior vice president, clinical, medical and regulatory affairs, and chief medical officer of Caladrius. Caladrius then increases the number of these cells, repairs them and returns them to the patient in a bid to restore balance to the immune system. Caladrius, of Basking Ridge, N.J., is testing the treatment in clinical trials.

https://www.wsj.com/articles/scientists-take-new-approach-to…

[Shanghai2006]

Increased my shares last week.

[Shanghai2006]

Caladrius Biosciences Announces that 50% of Subjects Have Been Treated in the Phase 2 Clinical Trial of CLBS03 for Type 1 Diabetes





GlobeNewswire•July 19, 2017

Comment




BASKING RIDGE, N.J., July 19, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a development stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces that 50% of subjects have been treated in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (T1D). A pre-specified interim analysis of early therapeutic effect will occur after the six-month post-treatment follow-up visit, with results expected to be announced in late 2017 or early 2018. This complete study will enroll a total of approximately 111 subjects age 8 to 17.


CLBS03 is a personalized autologous cell therapy consisting of each patient's own regulatory T cells, or Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone, Ph.D. and renowned researchers at the University of California, San Francisco (UCSF). Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this method.

“We are very pleased to have reached this treatment milestone in our landmark study in T1D and look forward to having the preliminary data around year end. The T-Rex study is being conducted at 10 leading clinical centers throughout the U.S. whose strong interest has allowed us to enroll and treat patients rapidly. We are excited to be advancing this novel T1D therapeutic approach and look forward to treating the second half of study subjects, building on the encouraging earlier data and completing the interim analysis that may inform us as to the initial therapeutic effects of CLBS03 on adolescents with early onset T1D,” noted David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius Biosciences.

Enrollment of the 70th subject in the study, which is expected to occur this summer, will trigger a $2.4 million cash payment with the delivery of an additional 508,475 shares of Caladrius common stock to investors pursuant to the terms of the September 2016 private placements.

Stephen E. Gitelman, MD, a leading pediatric endocrinologist at UCSF, is chairman of the executive steering committee for the T‑Rex Study. Dr. Gitelman, along with Kevan Herold, MD at Yale University, conducted a Phase 1 study funded by the Juvenile Diabetes Research Foundation on what is now known as CLBS03 that demonstrated Treg therapy to be well tolerated, durable and preserving of beta cell function in children. This study was published in Clinical Immunology. Two-year results from that study1 provided evidence for safety and tolerability of autologous expanded polyclonal Treg cell therapy in 14 adults with recent-onset T1D. Additionally, the Tregs retained their T cell receptor diversity and demonstrated enhanced functional activity. These two-year data were published in November 2016 in the peer-reviewed journal Translational Medicine.

CLBS03 has U.S. Food and Drug Administration (FDA) Fast Track designation, European Medicines Agency’s Advanced Therapeutic Medicinal Product classification and FDA Orphan Drug designation as a potential new treatment for recent-onset type 1 diabetes.

1 Bluestone, J., et al. (2015) Type 1 diabetes immunotherapy using polyclonal regulatory T cells. Science Translational Medicine, 7 (315).

About The Sanford Project: T‑Rex Study

The landmark study, which is being conducted in collaboration with Sanford Research, a Sanford Health subsidiary, is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for T1D in approximately 111 subjects age 12 to 17 with recent-onset T1D. Subjects are randomized into one of three groups to receive, through a single administration, either a high dose of CLBS03, a low dose of CLBS03 or placebo. Enrollment of the first cohort of 19 subjects, designated for a preliminary safety evaluation, was completed in August 2016. The evaluation produced favorable safety data and the Company began enrollment of the second cohort of subjects in October 2016. The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1c levels. For more information on The Sanford Project: T‑Rex Study, please visit https://clinicaltrials.gov/ct2/show/NCT02691247.

https://finance.yahoo.com/news/caladrius-biosciences-announc…

[Shanghai2006]

Caladrius Biosciences to Host 2017 Second Quarter Results Conference Call on August 10, 2017 at 4:30 p.m. Eastern Time


August 3, 2017






BASKING RIDGE, N.J., (August 3, 2017) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a development stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces that the Company will release financial results for the three and six months ended June 30, 2017 on Thursday, August 10, 2017.

Caladrius’ management will host a conference call for the investment community beginning at 4:30 p.m. ET on Thursday, August 10, 2017, to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 and providing conference ID 65397809. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.

The webcast will be archived on the Company’s website for 90 days.

http://www.caladrius.com/press-release/caladrius-biosciences…

[Shanghai2006]

Caladrius Biosciences Announces Enrollment of the 70th Subject in the Phase 2 T-Rex Clinical Trial of CLBS03 for Type 1 Diabetes
September 5, 2017
Milestone Achievement Triggered $2.4 Million Payments to Caladrius
BASKING RIDGE, N.J. (September 5, 2017) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces that the 70th subject has recently been enrolled in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (T1D). Pursuant to the terms of September 2016 private placements, the achievement of this enrollment milestone triggered payments of $2.4 million in total cash receipts, which have been received by Caladrius, with the delivery of an additional 508,475 shares of Caladrius common stock to those investors at a purchase price of $4.72 per share.
CLBS03 is a personalized autologous cell therapy consisting of each patient’s own regulatory T cells, or Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone, Ph.D. and renowned researchers at the University of California, San Francisco. Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this product.
“We are pleased that enrollment in the landmark T-Rex study continues according to plan and that we have surpassed the important milestone of treating the 70th patient, triggering a capital infusion. This capital, coupled with support from our research partner, Sanford Research, existing capital on our balance sheet as well as various grants, provides funding for this study and our current operations well beyond the end of 2018,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We look forward to early 2018 and the expected pre-specified interim analysis of safety and potential early therapeutic effect after the six-month post-treatment follow-up visit of the first 56 subjects.”
About The Sanford Project: T‑Rex Study
The landmark T-rex study, which is being conducted in collaboration with Sanford Research, a Sanford Health subsidiary, is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for T1D in approximately 111 subjects age 8 to 17 with recent-onset T1D. Subjects are randomized into one of three groups to receive, through a single administration, either a high dose of CLBS03, a low dose of CLBS03 or placebo. Enrollment of the first cohort of 19 subjects, designated for a preliminary safety evaluation, was completed in August 2016. The evaluation of safety data from this group was satisfactory and the Company began enrollment of the second cohort of subjects in October 2016. The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1c levels. For more information on The Sanford Project: T‑Rex Study, please visit https://clinicaltrials.gov/ct2/show/NCT02691247.

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Increased.

[Shanghai2006]

Caladrius Biosciences to Participate at the 2017 Cell & Gene Meeting on the Mesa
September 28, 2017

BASKING RIDGE, N.J. (September 28, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius Biosciences, will present at the upcoming Cell and Gene Meeting on the Mesa being held October 4-6, 2017 in La Jolla, California.

Dr. Mazzo will present a corporate overview including an update on recent clinical progress in The Sanford Project: T-Rex Study of CLBS03 at the Partnering Forum Event on Thursday, October 5, 2017 at 9:15 a.m. Pacific time.

A live video webcast of the presentation will be available at http://www.caladrius.com/events http://www.meetingonthemesa.com/webcast/and will also be archived for 90 days following the event.

Organized by the Alliance for Regenerative Medicine and the Sanford Stem Cell Clinical Center at UC San Diego, The Cell & Gene Meeting on the Mesa is a three-day conference bringing together senior executives and top decision-makers in the industry with the scientific community to advance cutting-edge research into cures. The meeting features a nationally recognized Scientific Symposium, attended by leading researchers and clinical experts from around the globe, in conjunction with the industry’s premier annual Partnering Forum, the first event of its kind dedicated solely to facilitating connections in this sector. Combined, these meetings attract over 850 attendees, fostering key partnerships through more than 1100 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Caladrius Biosciences Awarded Approximately $2 Million NIH Grant to Support Clinical Study of CLBS14 in Patients with Coronary Microvascular Dysfunction
October 2, 2017

BASKING RIDGE, N.J. (October 2, 2017) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the award of a $1,941,000 Small Business Innovative Research (“SBIR”) grant from the National Heart, Lung and Blood Institute of the National Institutes of Health (“NIH”) to support a clinical study with CLBS14 in patients with Coronary Microvascular Dysfunction (“CMD”). CLBS14 is Caladrius’ propriety CD34+ cell therapy and CMD is a disease manifested by reduced blood flow to the heart muscle, resulting in pain and dysfunction. Under the terms of the grant, the Company expects to receive approximately $750,000 in 2017 with the balance to be received in 2018 and 2019 in conjunction with the advancement of the study.
“One of the body’s natural responses to ischemia is the recruitment of CD34 cells with these cells being pre-programmed to repair damage to the small blood vessels, or microcirculation,” said Douglas W. Losordo, M.D., FACC, FAHA, and Chief Medical Officer of Caladrius Biosciences. “We are excited to advance the clinical development of our CD34+ cells in CMD as there are currently no therapies to address defects in the small blood vessels that contribute to the impairment of patients with acute and chronic ischemia, such as in CMD.”
“Our enthusiasm for this program is underscored by a strong body of preclinical and human clinical data that support CD34 cell therapy as having a beneficial effect in many cardiovascular and peripheral vascular diseases. We look forward to initiating a 20-patient Phase 2 proof-of-concept study of CLBS14 in patients with CMD in early 2018 with the vast majority of the necessary funding being provided by this grant award,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We are particularly pleased to be awarded this SBIR grant as it highlights the NIH’s strong interest in the development of therapies to treat CMD, while also supporting our strategy to advance our clinical pipeline and generate more opportunities within our product portfolio through non-dilutive grants and collaborations.”

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Looking at the Numbers for Caladrius Biosciences, Inc. (NasdaqCM:CLBS)
Nov 3, 2017 Review Staff Writer

Investors are constantly examining different company financial indicators to assess trading opportunities. Caladrius Biosciences, Inc. (NasdaqCM:CLBS) presently has an EV or Enterprise Value of -13755. The EV is used to show how the market assigns value to a company as a whole. EV is basically a modification of market cap, as it incorporates debt and cash for assessing a firm’s valuation. Tracking EV may help when comparing companies with different capital structures. EV can help investors gain a truer sense of whether a company is undervalued or not.

It is no secret that most investors have the best of intentions when diving into the equity markets. Making sound, informed decisions can help the investor make the most progress when dealing with the markets. Often times, investors may think they have everything in order, but they still come out on the losing end. Investors may need to figure out ways to keep emotion out of stock picking. Sometimes trading on emotions can lead to poor results. Making hasty decisions and not paying attention to the correct data can lead to poor performing portfolios in the long-term.

Currently, Caladrius Biosciences, Inc. (NasdaqCM:CLBS)’s ROIC is -1.659771. The ROIC 5 year average is -0.912246 and the ROIC Quality ratio is -2.035181. ROIC is a profitability ratio that measures the return that an investment generates for those providing capital. ROIC helps show how efficient a company is at turning capital into profits. ROIC may be a good measure to view when examining whether or not a company is able to invest wisely. ROIC may also be an important metric for the value investor who is trying to determine the company’s moat. Caladrius Biosciences, Inc. (NasdaqCM:CLBS) has a current Value Composite Score of 46. Using a scale from 0 to 100, a lower score would represent an undervalued company and a higher score would indicate an expensive or overvalued company. This ranking was developed by James O’Shaughnessy using six different valuation ratios including price to book value, price to sales, EBITDA to EV, price to cash flow, price to earnings, and shareholder yield.

Investors seeking value in the stock market may be eyeing the Magic Formula Rank or MF Rank for Caladrius Biosciences, Inc. (NasdaqCM:CLBS). Presently, the company has a MF Rank of 17323. The Magic Formula was devised and made popular by Joel Greenblatt in his book “The Little Book That Beats the Market”. Greenblatt’s formula helps find stocks that are priced attractively with a high earnings yield, or strong reported profits in comparison to the market value of the company. To spot opportunities in the market, investors may be searching for stocks that have the lowest combined MF Rank. 

Market watchers may also be following some quality ratios for Caladrius Biosciences, Inc. (NasdaqCM:CLBS). Currently, the company has a Gross Margin (Marx) ratio of 0.026963. This calculation is based on the research by University of Rochester professor Robert Novy-Marx. Marx believed that a high gross income ratio was a sign of a quality company. Looking further, Caladrius Biosciences, Inc. (NasdaqCM:CLBS) has a Gross Margin score of 60.00000. This score is based on the Gross Margin (Marx) metric using a scale from 1 to 100 where a 1 would be seen as positive, and a 100 would be viewed as negative.

The Price Index is a ratio that indicates the return of a share price over a past period. The price index of Caladrius Biosciences, Inc. (NasdaqCM:CLBS) for last month was 0.78167. This is calculated by taking the current share price and dividing by the share price one month ago. If the ratio is greater than 1, then that means there has been an increase in price over the month. If the ratio is less than 1, then we can determine that there has been a decrease in price. Similarly, investors look up the share price over 12 month periods. The Price Index 12m for Caladrius Biosciences, Inc. (NasdaqCM:CLBS) is 0.87349.

Price Range 52 Weeks
Some of the best financial predictions are formed by using a variety of financial tools. The Price Range 52 Weeks is one of the tools that investors use to determine the lowest and highest price at which a stock has traded in the previous 52 weeks. The Price Range of Caladrius Biosciences, Inc. (NasdaqCM:CLBS) over the past 52 weeks is 0.506000. The 52-week range can be found in the stock’s quote summary.

The C-Score is a system developed by James Montier that helps determine whether a company is involved in falsifying their financial statements. The C-Score is calculated by a variety of items, including a growing difference in net income verse cash flow, increasing days outstanding, growing days sales of inventory, increasing assets to sales, declines in depreciation, and high total asset growth. The C-Score of Caladrius Biosciences, Inc. (NasdaqCM:CLBS) is 2.00000. The score ranges on a scale of -1 to 6. If the score is -1, then there is not enough information to determine the C-Score. If the number is at zero (0) then there is no evidence of fraudulent book cooking, whereas a number of 6 indicates a high likelihood of fraudulent activity. The C-Score assists investors in assessing the likelihood of a company cheating in the books.

Investors might be looking into the magic eight ball trying to project where the stock market will be heading over the next few months. Some analysts believe that the market is ready to take a bearish turn, but others believe that there is still room for stocks to shoot higher. When the markets do have a sell-off, investors may be tempted to sell winners before they give up previous profits. Sometimes this may be justified, but other times this type of panic selling can cause investors to just have to repurchase shares at a higher price after the recovery. Keeping tabs on the underlying company fundamental data can help provide the investor with a better idea of whether to hold on to a stock or let it go. 

Volatility
Stock volatility is a percentage that indicates whether a stock is a desirable purchase.  Investors look at the Volatility 12m to determine if a company has a low volatility percentage or not over the course of a year.  The Volatility 12m of Caladrius Biosciences, Inc. (NasdaqCM:CLBS) is 67.350300.  This is calculated by taking weekly log normal returns and standard deviation of the share price over one year annualized.  The lower the number, a company is thought to have low volatility.  The Volatility 3m is a similar percentage determined by the daily log normal returns and standard deviation of the share price over 3 months.  The Volatility 3m of Caladrius Biosciences, Inc. (NasdaqCM:CLBS) is 36.334600.  The Volatility 6m is the same, except measured over the course of six months.  The Volatility 6m is 44.890100.

Once the individual investor has done all the fundamental homework and found a few stocks that they think are poised to be future winners, they may want to figure out when to best get into the market. Many investors will turn towards technical analysis to accomplish this. Technical analysis can help identify entry and exit points by studying price trends and movements over time. Some technical indicators are very complex and others are very simple. One goal of focusing on technical indicators is to help make confusing price information easier to interpret and understand. Many investors will find signals that they like to follow, but focusing on just one indicator may not provide the full picture of what is really going on. Many investors will combine technical indicators to help round out the spectrum. Although technical analysis can be a very useful tool for the investor, it is important to remember that stock prices are inherently unpredictable. Even the most seasoned investors may have to adjust their charts occasionally if trades are not working out as planned.

https://thewallstreetreview.com/looking-at-the-numbers-for-c…

[Shanghai2006]

Caladrius Biosciences Reports 2017 Third Quarter Results

November 9, 2017

Conference call begins today at 4:30 p.m. Eastern Time

BASKING RIDGE, N.J., (November 9, 2017) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces results for the three and nine months ended September 30, 2017.

Highlights of the 2017 third quarter and recent weeks include:
•Enrolled the 70th subject in The Sanford Project: T-Rex Study (the “T-Rex Study”), a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for recent-onset type 1 diabetes (“T1D”), which triggered a $2.4 million milestone payment and the delivery of 508,475 shares of Caladrius common stock as per the terms of the September 2016 private placements;
•Reached 50% of subjects, or 56 patients, treated in the T-Rex Study, which establishes a timeframe for a prescribed interim analysis when the first 56 patients reach their 6-month follow-up visit; and
•Awarded approximately $2 million as a Small Business Innovative Research (“SBIR”) grant from the National Heart, Lung and Blood Institute of the National Institutes of Health (“NIH”) to support a Phase 2 clinical study with CLBS14 in patients with coronary microvascular dysfunction (“CMD”).

Management Commentary
“Throughout the third quarter and following the sale of our contract manufacturing business to Hitachi Chemical, we made significant progress advancing Caladrius as a purely development-focused biopharmaceutical company and achieved key milestones in a number of our clinical development programs,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Our lead program, the T-Rex study, remains on track to complete enrollment by the end of this year. Additionally, we expect to have the results of a planned pre-specified interim analysis of the data from the six-month follow-up of the first 56 patients around the end of the first quarter of 2018.”

“Furthermore, we continue to execute according to our strategy to advance our pipeline programs with collaborative support, such as grants, partnerships or licensing. During the third quarter 2017, we were pleased to receive an NIH grant to help fund our Phase 2 study of CLBS14 in CMD. We also continue to receive funding from the California Institute for Regenerative Medicine (“CIRM”) grant in support of the T-Rex study,” Dr. Mazzo continued. “The successful sale of our PCT manufacturing subsidiary earlier this year has resulted in Caladrius being well-funded and focused on advancing our clinical development programs, while also allowing us to opportunistically explore compelling therapeutic prospects through a comprehensive, disciplined and data-driven process. We look forward to achieving a number of value-creating milestones during the remainder of the year and into 2018.”

Third Quarter Financial Highlights
Note: Effective with the sale of PCT to Hitachi in the second quarter of 2017, all PCT-related activities and gain on sale results will be reported as discontinued operations. All remaining operations will be reported as continuing operations. In addition, all prior year comparative financial results will restate PCT operations as discontinued operations.

Research and development (R&D) expenses for the third quarter of 2017 of $3.2 million increased 8% compared with $3.0 million in the third quarter of 2016, as the Company focuses its R&D efforts on the ongoing Phase 2 T-Rex Study and preparations for other pipeline programs. Caladrius’ clinical development programs are supported, in part, by grants and collaborations.

General and administrative (G&A) expenses for the third quarter of 2017 remained flat at $2.9 million, compared with $2.8 million in the third quarter of 2016.

The net loss from continuing operations for the third quarter of 2017 was $3.5 million, compared with the net loss from continuing operations of $6.1 million for the comparable 2016 period. The continuing operations net loss includes a tax benefit of $2.4 million, which partially offsets the tax expense reported in discontinued operations.

Loss from discontinued operations during the third quarter of 2016 was $1.2 million. Discontinued operations relate to our sale of PCT to Hitachi in the second quarter of 2017.

Net loss per share from continuing operations attributable to Caladrius common stockholders for the third quarter of 2017 was $0.38 per share compared to net loss per share of $0.95 for the same period in 2016.

Nine-Month Financial Highlights
R&D expenses for the first nine months of 2017 decreased 17% to $11.2 million compared with $13.5 million for the same period in 2016. G&A expenses were $9.1 million for the first nine months of 2017 compared with $10.5 million for first nine months of 2016. The first nine months of 2017 included $1.7 million of equity compensation expense. This unusually high expense was due to the acceleration of employee equity stock and option award vesting triggered by the sale of the Company’s PCT subsidiary to Hitachi.

The net loss from continuing operations for the nine months ended September 30, 2017 was $12.2 million, compared with the net loss from continuing operations of $25.6 million for the same period of 2016. The continuing operations net loss includes a tax benefit of $8.3 million, which partially offsets the tax expense reported in discontinued operations.

Income from discontinued operations during the first nine months of 2017 was $37.3 million, which includes a $40.2 million gain on the sale of PCT (net of $11.6 million taxes), compared with a loss from discontinued operations of $1.6 million in the same period in 2016.

Net loss per share from continuing operations attributable to Caladrius common stockholders for the nine months ended September 30, 2017 was $1.37 per share compared to net loss per share of $4.23 for the same period in 2016.

Balance Sheet Highlights
As of September 30, 2017, Caladrius had cash, cash equivalents and marketable securities of $59.4 million compared with $7.1 million as of December 31, 2016. During the third quarter of 2017, the Company received an additional $4.4 million as a final net cash settlement of the PCT transaction, bringing the total received to $79.4 million. Also during the third quarter of 2017, upon the enrollment of the 70th patient in the T-Rex study, the Company received $2.4 million and delivered 508,475 shares of Caladrius common stock as per the terms of the September 2016 private placements.

Based on existing programs and projections, the Company expects to have more than $50 million in cash and marketable securities at year-end 2017. Caladrius also expects less than $5 million of CLBS03 external spending obligations after 2017 to reach the completion of the T-Rex study, excluding any further CIRM funding. The Company is confident its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan beyond 2018.

Conference Call

Caladrius’ management will host a conference call for the investment community beginning today at 4:30 p.m. Eastern Time to review financial results, provide a Company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 6198497. The call will also be broadcast live on the Company’s website at www.caladrius.com/events.

The webcast will be archived on the Company’s website for 90 days.

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Now 50.000

[Shanghai2006]

Healthcare Biotech Sector Breakout: How High Will It Go In 2018?

https://seekingalpha.com/article/4135436-healthcare-biotech-…

[Shanghai2006]

Caladrius Biosciences Announces Completion of Enrollment of Phase 2 T-Rex Clinical Trial of CLBS03 for Type 1 Diabetes

January 18, 2018

Caladrius Biosciences Announces Completion of Enrollment of Phase 2 T-Rex Clinical Trial of CLBS03 for Type 1 Diabetes

Primary endpoint topline data to be reported in early 2019

BASKING RIDGE, N.J. (January 18, 2018) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the completion of enrollment in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial of 110 patients to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (T1D).

CLBS03 is a personalized autologous cell therapy consisting of each patient’s own regulatory T cells, or Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone, Ph.D. and renowned researchers at the University of California, San Francisco. Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this product.

CLBS03 as a treatment for T1D has U.S. Food and Drug Administration (FDA) Orphan Drug designation, European Medicine Agency Advanced Therapeutic Medicinal Product classification and FDA Fast Track designation, which represents the first T1D program to receive this distinction.

“Completion of enrollment in the landmark T-Rex study is a significant achievement for Caladrius. This program is supported by earlier work conducted by leaders in the field who demonstrated Treg cell therapy to be well tolerated, durable and preserving of beta cell function in children. These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the Journal of Translational Medicine,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We look forward to reporting the topline data from the primary endpoint of the completed study in early 2019.”

The Phase 2 T-Rex study is being conducted with support from Sanford Research, a Sanford Health subsidiary, a grant from the National Institute of Health and a grant from the California Institute for Regenerative Medicine.

About The Sanford Project: T‑Rex Study

The landmark T-rex study, which is being conducted in collaboration with Sanford Research, a Sanford Health subsidiary, is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for T1D in approximately 110 subjects age 8 to 17 with recent-onset T1D. Subjects are randomized into one of three groups to receive, through a single administration, either a high dose of CLBS03, a low dose of CLBS03 or placebo. Enrollment of the first cohort of 19 subjects, designated for a preliminary safety evaluation, was completed in August 2016. The evaluation of safety data from this group was satisfactory and the Company began enrollment of the second cohort of subjects in October 2016. The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1c levels. For more information on The Sanford Project: T‑Rex Study, please visit https://clinicaltrials.gov/ct2/show/NCT02691247.

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Nachgekauft.

[Shanghai2006]

Mar. 7, 2018 4:02 PM ET|About: Celldex Therapeutics, Inc (CLDX)|By: Jignesh Mehta, SA News Editor


•Celldex (NASDAQ:CLDX): Q4 EPS of -$0.03 may not be comparable to consensus of -$0.25.

•Revenue of $3.46M (+85.0% Y/Y) beats by $2.11M.

https://seekingalpha.com/news/3337261-celldex-eps-0_03?uprof…

[Shanghai2006]

Aktuall report 8-K

https://seekingalpha.com/filing/3926356?uprof=45

[Shanghai2006]

Celldex Therapeutics, Inc (CLDX)

FORM 10-K | Annual Report

Mar. 7, 2018 4:11 PM

https://seekingalpha.com/filing/3926509?uprof=45

[Shanghai2006]

Celldex Therapeutics (CLDX) CEO Anthony Marucci on Q3 2017 Results - Earnings Call Transcript
Mar. 7, 2018 8:42 PM AMT

Q4: 03-05-18 Earnings Summary

Celldex Therapeutics, Inc. (NASDAQ:CLDX) Q3 2017 Earnings Conference Call March 8, 2018 4:30 PM ET

Executives

Anthony Marucci - Co-Founder, President, Chief Executive Officer

Dr. Tibor Keler - Co-Founder, Executive Vice President, Chief Scientific Officer

Sam Martin - Senior Vice President, Chief Financial Officer

Sarah Cavanaugh - Senior Vice President, Corporate Affairs and Administration

Analysts

Mara Goldstein - Cantor Fitzgerald

Boris Peaker - Cowen

Joe Pantginis - HC Wainwright

Tony Butler - Guggenheim Securities

Operator

Good day ladies and gentlemen and welcome to the Celldex Therapeutics, Year End 2017 Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this conference is being recorded.

I would now like to introduce your host for today’s conference, Sarah Cavanaugh, you may begin.

Sarah Cavanaugh

Thank you. Good afternoon and thank you for joining us. Today on the call I have Anthony Marucci, Co-Founder, President and CEO of Celldex Therapeutics; Dr. Tibor Keler, Co-Founder, Executive Vice President and Chief Scientific Officer; and Sam Martin, Senior Vice President and Chief Financial Officer.

Before we begin our discussion, I'd like to mention that today's speakers will be making forward-looking statements. Such statements reflect our current views with respect to future events and are based on assumptions subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

Certain of the factors that might cause Celldex's actual results to differ materially from those in the forward-looking statements include those set forth under the headings Risk Factors and management's discussion and analysis of financial condition and results of operations in Celldex's annual report on Form 10-K, quarterly report on Form 10-Q, and its current reports on Form 8-K, as well as those described in Celldex's other filings with the SEC and its press releases.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should carefully review all of these factors and be aware that there may be other factors that could cause these differences. These forward-looking statements are based on information, plans and estimates as of this call, and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.

Please be advised that the question-and-answer period will be held at the close of the call. I’d now like to turn the call over to Anthony.

Anthony Marucci

Thank you, Sarah. Good afternoon everyone and thank you for joining us. On today’s call we will update you on our clinical programs, outline key milestones for the remainder of the year and then Sam Martin will review financial results. As always, we look forward to answering your questions at the close of the call.

We will start first with glembatumumab vedotin, our lead ADC currently in the company sponsored studies in both triple negative breast cancer and metastatic melanoma. As previously disclosed, enrolment in METRIC study in triple negative breast cancer was completed in August 2017 with 327 patients on study. Given the inherent challenges in recruiting an enriched patient population, especially within an orphan indication, achieving this milestone was a significant accomplishment.

We are also very grateful to physician and patients who participated in the METRIC study and are hopeful that glemba will be able to offer patients, families and care givers a potentially new option and indication where there are so few therapies and none that target gpNMB, which is associated with a more aggressive form of the disease.

https://seekingalpha.com/article/4154314-celldex-therapeutic…

[Shanghai2006]

Japan-based study underway for Caladrius Bio's CD34 cell therapy in critical limb ischemia
Mar. 13, 2018 9:15 AM ET|About: Caladrius Biosciences,... (CLBS)|By: Douglas W. House, SA News

The first patient has been dosed in a Phase 2 clinical trial in Japan evaluating Caladrius Biosciences' (NASDAQ:CLBS) CLBS12, a CD34 cell therapy, in patients with no-option critical limb ischemia (CLI) (severely restricted blood flow to the extremities).

The 35-subject study will compare CLBS12 + standard-of-care (SOC) drug therapy to SOC drug therapy alone. The primary endpoint is the time to continuous CLI-free status.
If successful, the company plans to apply for conditional approval there for the indication.

https://seekingalpha.com/news/3338704-japan-based-study-unde…

[Shanghai2006]

Caladrius Snatches Itself A Clinical Candidate For Heart Disease
Mar. 7, 2018 11:09 AM ET|8 comments| About: Caladrius Biosciences, Inc. (CLBS), Includes: SHPG

Summary
Caladrius Biosciences adds late-stage cell therapy treatment for heart disease to its pipeline.
The CD34+ cell therapy treatment was licensed from Shire.

The purchase of the CD34+ program was based on positive data stemming from multiple clinical trials proving that the drug works in the intended population.

Caladrius states it has enough cash past 2018, but a cash raise will likely be needed before the end of 2018.

It is highly likely that the company may have to run its own phase 3 study to confirm clinical findings before it can file for regulatory approval for the newly acquired CD34+ cell therapy.
Shares of Caladrius Biosciences (CLBS) closed higher by 9% on Tuesday, after it announced that it had acquired rights to a heart disease drug.

https://seekingalpha.com/article/4154149-caladrius-snatches-…

[Shanghai2006]

Caladrius Bio's CLBS12 nabs accelerated review status in Japan for critical limb ischemia
Apr. 10, 2018 11:30 AM ET|About: Caladrius Biosciences,... (CLBS)|By: Douglas W. House, SA News

The Japanese Ministry of Health, Labor and Welfare designates Caladrius Biosciences' (CLBS -4.3%) CLBS12 for SAKIGAKE status for the treatment of critical limb ischemia (CLI), a condition characterized by significantly reduced blood flow to the legs and feet due to artery blockage.

CLBS12 is currently being evaluated in a Japan-based Phase 2 study in patients with no-option CLI (high amputation risk).

SAKIGAKE, akin to Breakthrough Therapy status in the U.S. and PRIME status in the EU, is aimed at promoting R&D in Japan for new medical products that satisfy certain criteria and provides for accelerated review of the marketing application.

CLBS12 is an autologous CD34 cell therapy. In an ischemic situation, the body directs CD34 cells to affected tissues where they repair damage to small blood vessels.
Previously: Japan-based study underway for Caladrius Bio's CD34 cell therapy in critical limb ischemia (March 13)

https://seekingalpha.com/news/3344704-caladrius-bios-clbs12-…

[Shanghai2006]

Caladrius Biosciences Receives SAKIGAKE Expedited Review Designation in Japan for CLBS12 for Treating Critical Limb Ischemia
April 10, 2018

BASKING RIDGE, N.J. (April 10, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that the Company has received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare (“MHLW”) for CLBS12 for the treatment of critical limb ischemia (“CLI”). CLBS12 is currently in a Phase 2 trial in Japan for the treatment of no-option CLI, a severe obstruction of arterial blood flow to the extremities in patients that results in severe pain at rest and/or non-healing ulcers, which carry a risk of amputation.
The SAKIGAKE designation is part of Japan’s effort to accelerate the development and approval of regenerative medicines. The Pharmaceutical and Medical Devices Act (“PMDA”) enables an expedited path to conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy in Phase 2 study and is similar to the Breakthrough Therapy Designation in the United States. The strategy of SAKIGAKE includes a system for designating products for which prominent effectiveness (i.e. radical improvement compared to existing therapy) can be expected. For more information on SAKIGAKE, please visit (http://www.mhlw.go.jp/english/policy/health-medical/pharmace…
“We are very pleased to receive SAKIGAKE status for CLBS12 in Japan. As a designated medicine under the SAKIGAKE Designation system, CLBS12 will have prioritized consultation, a dedicated review system to support the development and review process, as well as reduced review time from the normal 12 to 6 months. This is great news not only in practical terms, but also because we believe that it reflects the recognition by MHLW and PMDA of the therapeutic potential of CLBS12 for the patient population in desperate need of therapeutic options,” Douglas W. Losordo, MD, FACC, FAHA, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer of Caladrius. “CLBS12 has the potential to offer a non-surgical therapeutic option to reverse critical limb ischemia in patients who have exhausted all other treatment modalities. We look forward to continuing to work with regulatory authorities in Japan to efficiently and rapidly complete development of CLBS12 and to offering this treatment to patients in need if approved.”

https://www.caladrius.com/press-release/caladrius-bioscience…

[Shanghai2006]

Caladrius Biosciences Acquires an Exclusive License to a Late Stage CD34+ Cell Therapy Program for the Treatment of Refractory Angina

GlobeNewswire•March 6, 2018



Caladrius Biosciences Acquires an Exclusive License to a Late Stage CD34+ Cell Therapy Program for the Treatment of Refractory Angina

BASKING RIDGE, N.J., March 06, 2018 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that the Company acquired from Shire plc (SHP.L) (SHPG) an exclusive worldwide license to data from a late stage CD34+ cell therapy program for the treatment of chronic myocardial ischemia targeting refractory angina. Under the terms of the agreement, Caladrius acquired the exclusive worldwide rights to the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. In exchange, Shire will receive undisclosed up-front consideration, milestones and a royalty on product sales.

The comprehensive data set that Caladrius licensed includes preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.

The program is supported by data from 3 randomized placebo controlled trials.1,2,3 A recent publication in the European Heart Journal, entitled “Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials” combines the data from all three studies encompassing over 300 patients and reveals statistically significant improvements in mortality, exercise capacity and chest pain frequency.
(See the publication at https://doi.org/10.1093/eurheartj/ehx764.)

“Prior to joining Caladrius, I designed and was principal investigator of the Phase 1 and Phase 2 studies of this CD34+ therapy that were conducted with the support of Baxter. I also designed and launched the Phase 3 study at Baxter prior to its spinoff of Baxalta and Baxalta’s subsequent merger with Shire. Given my intimate knowledge of this clinical program, I am very excited by our acquisition of this data license and remain positive about the prospects for this therapy as a treatment for patients suffering with refractory angina,” stated Douglas W. Losordo, MD, FACC, FAHA, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer of Caladrius. “Preclinical studies have established the mechanism of action of CD34+ cell therapy in restoring microcirculation and improving myocardial tissue perfusion and clinical trials have shown clinical benefit in a patient population that had exhausted all other available therapeutic options.4,5,6 We believe that the growing body of clinical data in support of CD34+ cell therapy as a treatment for refractory angina is very encouraging and we believe that Caladrius is uniquely positioned to advance this late-stage program through to potential regulatory approval.”

“This transaction offers an ideal opportunity for Caladrius to obtain a promising late-stage development asset complementary to our existing pipeline of CD34+ cell therapy development programs in ischemic repair,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually.7 We look forward to discussing with the FDA the most expeditious regulatory path aimed at registration for this CD34+ cell therapy program and to bringing this potentially restorative therapy to patients in need.”

About Refractory Angina
It is estimated that as many as one million people in the United States have chronic symptomatic coronary artery disease (often referred to as refractory angina) that is recalcitrant to medical therapy and unamenable to conventional revascularization procedures. Patients have reproducible lifestyle-limiting symptoms of chest pain, shortness of breath, and easy fatigability. These symptoms are often due to totally occluded coronary arteries or diffuse coronary atherosclerosis that makes revascularization problematic. As the population ages and the incidence of diabetes mellitus increases, this clinical condition will become more prevalent. Patients with this condition have significant morbidity and experience a lower quality of life.

https://finance.yahoo.com/news/caladrius-biosciences-acquire…

[Shanghai2006]

Teile verkauft zu 4.60 Euro und fuer 4,00 Euro neu geordert.

[Shanghai2006]

For Diabetes Patients, Management Solutions Are As Critical As Medications

For diabetes sufferers, it’s not just effective medications that are necessary, but effective self-management. The challenge with diabetes, both type 1 and type 2, is not necessarily that the medications we have available today are just not good enough. The problem is, the disease has to be managed constantly, from the moment you wake up to the moment you go to sleep, every day of your life with no breaks.

Medication dosages must constantly change depending on what and how much you eat, how much you exercise and a myriad of other factors that most of us never consciously pay attention to. Many diabetes patients manage their conditions quite well, but it’s a war of attrition, and at some point blood sugar levels will go out of range, which could even be life threatening.

Take the case of Mark Andrews, diagnosed with type I diabetes when he was 9 years old. Andrews is not your average guy who only periodically checks on his health. He’s the tight end for the NFL’s Baltimore Ravens, so his livelihood depends on near perfect control of his blood sugar levels, or as perfect as he can possibly maintain them.

Yet, even for a professional football player, at one point or another, levels get way out of range, and for Andrews that once almost cost him his life. Back in 2014 as a college football player, Andrews’ roommate found him on his bed staring vacantly at the ceiling, motionless. Not responding, his roommate stuffed fruit chews in his mouth and Andrews quickly regained consciousness.

Like many sufferers, Andrews wears an insulin pump on his hip which helps him manage his condition automatically. He only takes it off when playing football. It was only in 2016 when the world’s first artificial pancreas was approved by the FDA, developed and manufactured by Medtronic (NYSE:MDT). The demand for the product was so high that Medtronic could not supply enough of them at first due to manufacturing bottlenecks, but has since met demand.

The artificial pancreas may yet see some more improvement with a new insulin undergoing human trials this year, a concentrated ultra-rapid acting insulin aiming to compete with Novo Nordisk’s (NYSE:NVO) NovoRapid and Eli Lilly’s (NYSE:LLY) Humalog, which are rapid-acting but not ultra-concentrated. Until now, nobody has succeeded in developing an ultra-concentrated rapid-acting insulin, the goal of these being to enable insulin pumps to be as small and unnoticeable as possible. The new insulin was developed by private pharma firm Arecor in partnership with diabetes charity JDRF. Trials are set to begin this year.

But an artificial pancreas isn’t for everyone. Carrying around a pump attached to your hip at all times may suit some lifestyles, but others find it impractical, or simply unaffordable. A simpler solution could lay in a smartphone app.

This week, a company founded in 2016 known as Ascensia Diabetes Care, an outgrowth of Bayer (PNK:BAYRY) and Panasonic (PNK:PCRFY), released a new version of its Contour Diabetes app that includes the ability to recognize 14 different patterns and use 11 testing plans. The patterns are based on behavioral science models and the fact that diabetes patients need actionable information and behavioral skills in order to improve their self-management habits. By charting patterns in blood glucose levels that patients may not at first recognize, the goal of the app is to train users on how to more effectively manage the disease long term, rather than manage it for them outright like an artificial pancreas would. Even the artificial pancreas, though, needs calibration and can make mistakes.

Yet another solution on the diabetes management horizon may end up coming from an oral reformulation of insulin. Even if you wear an artificial pancreas, insulin must still be injected, and this is quite uncomfortable for many sufferers. Oramed Pharmaceuticals (NASDAQ:ORMP) is working on the world’s first oral insulin pill that is now undergoing a 90-day Phase II trial to see if it can lower long term blood glucose levels consistent with what would be needed for approval. The trial should complete later this year, and markets will soon know if oral insulin – a diabetes Holy Grail that has been sought for a century – is possible.

Finally, a more futuristic option that could obviate the need for type I diabetes self-management is an immune therapy coming out of biotech firm Caladrius Biosciences (NASDAQ:CLBS) called CLBS03. It is currently recruiting 113 patients for a Phase II study with results due by March of next year. The idea behind the treatment is that since type I diabetes is an autoimmune disorder, if immune cells can be rebalanced and taught not to attack the pancreas shortly after diagnosis when a patient still has functional pancreatic beta cells, then the organ can be spared before the disease fully sets in. The treatment takes a patient’s own immune cells called T-regs, which autoimmune sufferers have too few of compared to healthy patients, multiplies them, and reintroduces them, with the goal of rebalancing the system. It is of course a long way from getting to market if it ever does, but it is certainly a hopeful option that would make self-management a thing of the past for type I diabetes sufferers, if successful.

The post For Diabetes Patients, Management Solutions Are As Critical As Medications appeared first on Market Exclusive.

https://finance.yahoo.com/news/diabetes-patients-management-…

[Shanghai2006]

Caladrius Receives FDA Regenerative Medicine Advanced Therapy Designation for CD34+ Cell Therapy for Treating Refractory Angina
Tue June 19, 2018 8:00 AM|GlobeNewswire|About: CLBS

BASKING RIDGE, N.J., June 19, 2018 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that the U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to the Company’s late-stage CD34+ cell therapy program for the treatment of refractory angina.

The FDA grants the RMAT designation to regenerative medicine therapies intended to treat a serious condition for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition. The RMAT designation affords regenerative therapies the advantages of expedited development and review of marketing applications as are available to drugs that receive breakthrough therapy designation, including increased meeting opportunities, early interactions to discuss potential surrogate or intermediate endpoints, shortened biologics license application (“BLA”) review times and the potential of accelerated approval.

“We are delighted and encouraged that the FDA has recognized our CD34+ cell therapy program with an RMAT designation. Refractory angina is a serious condition with high morbidity and no known effective treatments. We look forward to working with the FDA to define a path to registration for our therapy with the aim of providing expeditious treatment to patients suffering from this condition,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
Caladrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. This includes manufacturing procedures, preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.

About Refractory Angina
It is estimated that as many as one million people in the United States have chronic symptomatic coronary artery disease (often referred to as refractory angina) that is recalcitrant to medical therapy and not amenable to conventional revascularization procedures. Patients have reproducible lifestyle-limiting symptoms such as chest pain and shortness of breath, and are easily fatigued. These symptoms are often due to totally occluded coronary arteries or to diffuse coronary atherosclerosis that makes revascularization problematic. As the population ages and the incidence of diabetes mellitus increases, this clinical condition is expected to become more prevalent. Patients with this condition have significant morbidity and experience a lower quality of life.

https://www.caladrius.com/press-release/caladrius-receives-f…

[Shanghai2006]

Caladrius Biosciences Strikes Gold With Acquisition Of Late-Stage Refractory Angina Therapy From Shire

Jun. 25, 2018 8:07

Summary
Acquisition of CD34+ program to treat refractory angina from Shire with all regulatory filings gives Caladrius a mature product with good potential for approval.
CD34+ refractory angina program granted Regenerative Medicine Advanced Therapy status last week.
With promising pipeline and clinically mature CD34+ program and $54M in cash with no debt, stock significantly undervalued with only $65M market cap.

The recent re-emergence of Caladrius Biosciences (CLBS) could very well provide investors a nice return in the coming months. Many will remember the company as NeoStem from a few years ago who rode the wave of stem cell hype. They had put all their resources into a dendritic cell immunotherapy to treat advanced-stage melanoma but although they were seeing promising results and initiated a Phase 3 clinical trial, they discontinued the program when checkpoint inhibitors hit the market and set the bar extremely high for monotherapy response. Of course, the stock tanked and they changed focus to their T regulatory cell therapy for diabetes. Although I find the data for this and other cell therapy candidates in Caladrius' pipeline intriguing.

Sometimes It's Better To Be Lucky Than Good
In March, Caladrius was able to pick up the global rights to Shire's (SHPG) late-stage CD34+ stem cell therapy to treat no-option refractory angina. It's the classic drug development story where the program had been passed down through acquisitions, starting at Baxter (NYSE:BAX) then to the spinout Baxalta which was then bought by Shire. As cell therapy was not part of Shire's primary strategy, their focus and funding shifted to other programs. In fact, Shire has unloaded a lot of its pipeline recently, including its oncology assets, to align more with the recently proposed Takeda (OTCPK:TKPYY) merger. The selection by Shire to pick Caladrius, which will only owe Shire milestones based on success, is anything but random. Caladrius has a lot of experience in cell therapy and specifically with the delivery of CD34+ cells with its current pipeline and from its NeoStem days. Probably most important is the connection between Caladrius' Chief Medical Officer Dr. Douglas Losordo and the therapy. Dr. Douglas joined from Baxter and was the main investigator for the Phase 1 and Phase 2 clinical trials for the CD34+ refractory angina therapy program while there. There's likely nobody in the world more familiar with the program than him. Both sides win. Caladrius gets a familiar late-stage clinical program which has already accumulated very impressive data and all the accompanying regulatory filings for basically nothing. Shire gets the most experienced and likely partner to be able to bring the therapy to market and receive milestone and royalty payments. For investors, it's plain and simple, this was the break Caladrius badly needed.

Last Week, Awarded The Elusive RMAT Designation
The good fortune continued last week when the therapy was granted The Regenerative Medicine Advanced Therapy (RMAT) status by the FDA, which is given to therapies that treat serious conditions and address unmet medical needs. This is extremely important as it rewards the company with expedited drug development, special interactions with the agency to discuss endpoints, and the potential for accelerated approval. Earning RMAT status also allows the treatment to be submitted to the FDA for approval without the need for late-stage clinical trials. This is important as I'll discuss below as the Phase 3 clinical trial was stopped prematurely by Baxter. Being rewarded RMAT designation is a very big deal and not easy. As of last year, the FDA had received 34 RMAT requests and has granted only 11 of them. Justifiably, the stock skyrocketed nearly 200% last week when slapped with the RMAT tag and has since settled back down to a ~70% gain. I began to take notice and started researching the acquired therapy and quickly realized how undervalued the stock currently is.

CD34+ Therapy For No-Option Refractory Angina Clinical Trial Data Impressive
No-option refractory angina, which impacts over a million people in the US alone, is defined as chronic heart pain due to blockage of blood flow to the heart. It is a very serious condition with high morbidity and no effective treatment options. Simply put, to treat refractory angina, you must repair the blood flow to the heart. Enter CD34+ cell therapy. These stem cells have demonstrated the ability to restore microcirculation and enhance myocardial tissue perfusion. The data is mature with preclinical, Phase 1, Phase 2, and partial Phase 3 clinical trials completed by Baxter.

To date, CD34+ cell therapy results have been impressive and consistent in the double-blind, placebo-controlled clinical trials. In total, the studies have included 304 patients with 24 in Phase 1, 168 in the Phase 2 ACT-34 and ACT-34 extension studies, and 112 in the pivotal Phase 3 RENEW study. The Phase 3 trial was cut short not because of safety or efficacy but due to financial considerations by Baxter. Cardiologists from the leading academic institutions in the world continue to discuss and present the data from the clinical trials as some of the best ever for this patient population. The Phase 3 trial was supposed to enroll 444 patients with 200 assigned to CD34+ therapy, 100 placebo, and 100 standard of care, but at time of cancellation had enrolled 112 total patients with 57 in CD34+ group, 27 placebo, and 28 in standard of care.

Dr. Timothy Henry, the director of cardiology at Cedars-Sinai Heart Institute expressed his frustration at the cancellation of the Phase 3 by Baxter at The Society for Cardiovascular Angiography and Interventions Scientific Sessions in 2016:
The trial was working very well and enrollment was proceeding very well. After Baxter made its decision, we tried in the midst of the trial to find alternative sponsors, and there was definite interest.
The primary outcome of the study was to determine the change in exercise time between the CD34+ cohort and the placebo group. Obviously, one's ability to exercise is heavily dependent on blood flow to the heart. The results did not disappoint. Exercise time in the CD34+ group increased nearly 1 minute compared to the placebo group at 6 months and more than 30 seconds at 12 months. Likewise, angina or severe chest pain was decreased in the CD34+ group at 6 months (RR = 0.57; 95% CI, 0.36-0.92). Probably most interesting is the data at the 2-year follow-up with mortality rate of 3.7% in the CD34+ group and 10% in the placebo group.

Cardiologist Dr. Thomas Povsic from the Duke Clinical Research Institute summed up the promise of the partial Phase 3 data and frustration of Baxter cutting the trial short:
We think it's particularly attractive to use angiogenic cells in patients with refractory angina whose issue is lack of blood flow," he said. "We hope someone else will take up the call.
Although the Phase 3 clinical trial was cut short, there is a significant data set already generated when analyzing all of the data together from the 3 clinical trials. Last May, Dr. Povsic presented this data at the 2017 Society for Cardiovascular Angiography and Interventions Annual Meeting. It was also recently published this year in the European Heart Journal. Data for the pooled analysis was very similar to the Phase 3 partial data.

Patients treated with CD34+ cells (n=187) increased total exercise time by 46.6 s [3 months, 95% confidence interval (CI) 13.0 s-80.3 s; P = 0. 007], 49.5 s (6 months, 95% CI 9.3-89.7; P = 0.016), and 44.7 s (12 months, 95% CI 2.7 s-92.1 s; P = 0.065) compared to the placebo group (n=89).
*Image from European Heart Journal, Volume 39, Issue 23, 14 June 2018, Pages 2208-2216.
Improvement in angina was statistically significant at all three time points, 0.78 (95% CI 0.63-0.98; P = 0.032), 0.66 (0.48-0.91; P = 0.012), and 0.58 (0.38-0.88; P = 0.011) at 3, 6, and 12 months in the CD34+ group compared with placebo patients.

As seen in the Phase 3, pooled analysis showed a very significant decrease in mortality rate in the CD34+ group compared to placebo (12.1% vs. 2.5%; P = 0.0025) at 2 years.

Importantly, there were no safety signals or risks associated with the therapy. The cardiologist from Duke did not mince words when discussing the promise of the therapy:
"We believe that this type of cell therapy for refractory angina is particularly promising and may improve both functional status and mortality. It is imperative to explore methods to bring this therapy to patients."
He also foreshadowed the therapy being rewarded RMAT status:
I personally believe this therapy has more data for efficacy and safety than any other therapy for the treatment of refractory angina. There is a new opportunity with passage of the 21st Century Cures Act, where regenerative therapy has a special category called Regenerative Advanced Therapy that allows for a therapy that fulfills a particular medical need to undergo expedited approval. Whether or not these data could be sufficient to allow for consideration of this therapy to be approved… that's something we would like to explore.

Financials And Risks
As biotech investors know, big rewards do not come without risks. As with all small-cap biotechs, there are substantial risks that Caladrius may not be successful in bringing their new refractory angina asset to market. It is also unclear how much additional work and therefore, funding will be required by the FDA. Although their newly granted RMAT status should help, it is likely they will still have to complete a Phase 3 study either before or following conditional approval. Further insight following Caladrius meeting with the FDA will be helpful. Cash burn rate fluctuates but is close to $5M quarterly. With ~$54M of cash on hand, management anticipates this will fund the company into 2020. Management has also done a good job at funding programs through governmental research grants.

Conclusion
With a very promising late-stage clinical cell therapy with RMAT status now in their pipeline and over $50M in cash on hand with no debt, I am shocked to see the stock only trading with a $65M market cap. I could easily see the stock doubling from current levels.

Disclosure: I am/we are long CLBS.

https://seekingalpha.com/article/4183875-caladrius-bioscienc…

[Shanghai2006]

Quarter 3 report:

https://seekingalpha.com/filing/4230920

[Shanghai2006]

Form 8-K report

https://seekingalpha.com/filing/4231039

[Shanghai2006]

Caladrius Bio up 8% premarket on accelerated review status for CLBS12 in Europe
Jul. 15, 2019 9:04 AM ET|About: Caladrius Biosciences,... (CLBS)|By: Douglas W. House, SA News Editor

Thinly traded nano cap Caladrius Biosciences (NASDAQ:CLBS) is up 8% premarket on light volume on the heels of its announcement that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) status for cell therapy candidate CLBS12 for the potential treatment of critical limb ischemia (low blood flow to the lower extremities due to severely blockage of arteries).

Benefits of ATMP status include more intensive EMA guidance on development and fee reductions for regulatory advice.

https://seekingalpha.com/news/3477669-caladrius-bio-8-percen…

[Henning1706]

Ist hier noch jemand aus dem Forum investiert ? Die Pipeline sieht sehr vielversprechend aus, die Firma ist bis Ende 2021 durchfinanziert und mit einer Marketcap von 28 Mio $ unter Cashbestand zu haben , Angesichts der Upside ist hier doch noch deutlich Bewertungsluft nach oben !

[Marleau]

Antwort auf Beitrag Nr.: 66.285.218 von Henning1706 am 04.01.21 22:38:05

Zitat von Henning1706: Ist hier noch jemand aus dem Forum investiert ? Die Pipeline sieht sehr vielversprechend aus, die Firma ist bis Ende 2021 durchfinanziert und mit einer Marketcap von 28 Mio $ unter Cashbestand zu haben , Angesichts der Upside ist hier doch noch deutlich Bewertungsluft nach oben !

Neues Kursziel 😀. Vorbörse über 100 Prozent im Plus.

[Henning1706]

Antwort auf Beitrag Nr.: 66.520.454 von Marleau am 20.01.21 11:49:54

Na da hat mich mein Riecher mal nicht enttäuscht , hab den Großteil rausgenommen und ne kleine Posi stehen lassen. Viel Glück allen mitinvestierten !

[janlove25]

Schaut euch mal das heutige Offering an.
Shares zu 2,45 und warrants zu 2,90.
Wir liegen bei 2,2.

Zum offering werden noch News folgen. Vermutlich Phase 3 OLOGO

[Luke2805]

Antwort auf Beitrag Nr.: 66.983.021 von janlove25 am 12.02.21 18:15:19

Zitat von janlove25: Schaut euch mal das heutige Offering an.
Shares zu 2,45 und warrants zu 2,90.
Wir liegen bei 2,2.

Zum offering werden noch News folgen. Vermutlich Phase 3 OLOGO

Das ist spannend. Vor gut einer Woche ist OCUGEN bei ca 5.4usd aus dem Handel gegangen, Sonntag kam die Meldung dass es ein Offering zu ca. 7.4usd geben wird. Die Kurse am Montag sind unter anderem daraufhin, aber auch der Anpassung einiger ratings, explodiert...
Hoffen kann man ja 😃

[Vakataka]

Antwort auf Beitrag Nr.: 66.987.761 von Luke2805 am 12.02.21 22:54:06

Offering ist beendet.

https://finance.yahoo.com/news/caladrius-biosciences-inc-clo…

Hmm. die haben jetzt mehr Geld wie die Marktkapitalisierung?

[Shizogenie]

Hat sich nicht viel getan mit Beendigung des Offering.

[Luke2805]

https://seekingalpha.com/article/4410399-caladrius-bioscienc…

[Luke2805]

http://www.globenewswire.com/news-release/2021/03/08/2188642…

[Vakataka]

Caladrius Biosciences Receives $1.4 Million of Non-Dilutive Capital Through New Jersey Technology Business Tax Certificate Transfer Program

https://www.stocktitan.net/news/CLBS/caladrius-biosciences-r…