Programs to create a new center for the study of stem cells and to increase capacity to deal with global health issues were among 7 scientific initiatives announced 2/25/10 by NIH Director Francis S. Collins, MD, PhD.
The 7 research programs are supported through the NIH Common Fund, which encourages collaborative research programs across the NIH institutes and centers (IC) to accomplish work that no single IC could do alone. These programs are all scheduled to begin during FY10. The research programs will distribute $17.8 M in NIH Common Fund support in FY10 and additional funds in future years. These projects capitalize on emerging scientific opportunities and technology advances to fuel biomedical discovery, strengthen the biomedical community nationally and globally and hasten the translation of science discoveries into new and better treatments.
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Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas. OSIR’s Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease. Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.
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BCLI.OB announced that it has entered into agreements with 3 investors with each investing $500 K for a total of investment of $1.5 M with issuance to each of 3 investors, 2 M shares of stock based on the 30 day average share price as of 2/11/10 of $0.25 per share and 1 M warrants with an exercise price of $0.50 per share for a total issuance of 6 M shares and 3 M warrants. These investments provide BCLI.OB with the necessary funds to conduct its upcoming Phase I/II ALS clinical trial with a collaborative agreement with Hadassah Medical Center to conduct its ALS clinical trials at the Hadassah Ein Kerem Hospital, Israel.
Reiterating from our 2/10/10 blog, BLCI.OB’s might be able to demonstrate creation of neurotrophic-factor secreting cells (glial cells) from in-vitro differentiated bone marrow cells that produce neurotrophic factors (NTF) including GDNF, BDNF, NGF and IGF-1.
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The objective of the filed IND Application is to start a Phase I/II study at multiple centers. The study would involve the use of retinal cells, which have been developed from the stem cells of the embryo for the treatment of patients suffering Stargardt’s Macular Dystrophy (SMD).
As stated in our blog/post of 2/22/10: “The NIH is … expanding its definition for what constitutes a human embryonic stem cell as acceptable lines for federal funding… If approved, it would be among the 1st clinical tests of embryonic stem cells. As proposed in the Federal Register, the new definition will cover “early stage embryos up to and including the blastocyst stage”. The NIH, in changing the definition, explicitly acknowledged that ACTC.OB’s application contributed to the decision.
The ruling, which will have limited impact for the overall stem cell industry, carries broad implications for ACTC.OB; essentially, re-writing its definition.
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The resulting effect of the reverse stock split is that every 8 shares of the issued/outstanding common stock prior to the opening of trading will be combined into 1 issued without any change in the par value of shares with the number of authorized but unissued shares of the common stock proportionally reduced. As a result, ASTM (D) could have approximately (rough calculation) 30 M shares outstanding with a total fully diluted value of 40 M including warrants and options.
Bottom line, this reverse split should satisfy the $1.00 minimum bid price requirement for continued listing on NASDAQ. Concurrent with the effectiveness of the reverse stock split, the ticker symbol will change from ASTM to ASTMD; but will revert back to ASTM on 3/18/10. On 1/21/10, ASTM completed the sale of units with warrant attachment (including the exercise of its over-allotment option) at a public offering price of $0.26 per unit. ASTM received approximately $12.4 M in net proceeds bringing the total cash to $25.5 M.
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ASTM continues its cardiovascular clinical programs and expects to aggressively to advance these programs in 2010. Net loss was $4.575 M or $.03 per share. Total revenues were $16 K. Total costs and expenses were $4.6 M. R&D expenses increased to $3.283 M (reflecting continued expansion of clinical development activities and share based compensation expense). G&A expenses decreased to $1.316 M (due to an offset of stock compensation expense). At 12/31/09, the company had $14.7 M in cash. Post the completion of the public offering 1/10 ($12.4 M in net proceeds), ASTM now has $25.5 M in cash. The burn rate should average $1.4 M per month. Timing is everything, at this share price ($0.18 with a Mtg Cap of $31.49), the new CEO’s vision will be better articulated and focused!
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International Stem Cell Corporation (NASDAQ:ISCO.OB) is a biotech focused on therapeutic and research products.
- ISCO.OB develops pluripotent stem cells that are comparable in function to embryonic stem cells from which cells for human transplant are derived; and techniques to cause those cells to be differentiated into the specific cell types required for transplant, as well as manufactures protocols to produce these cells without contamination with animal by-products.
Focus: ISCO.OB creates human cells for the treatment diabetes, liver disease, corneal disease, and retinal disease through cell transplant therapy, as well as engages in the development of therapeutic products. Read more…
ReNeuron is a UK-based stem cell company. Their primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need. RENE.L’s shares are traded on the London AIM market.
Focus: ReNeuron’s stem cell products are derived from non-embryonic human tissue sources. RENE.L’s stem cell therapy program have been built around stem cell expansion technology, c-mycER. This platform enables, from a single tissue sample, the growth of selected human stem cells into banks of quality-assured stem cell lines. These stem cell lines contain enough stem cells to treat many thousands of potential patients. This capability has enabled RENE.L to focus on developing non-patient-specific or allogeneic, stem cell treatments addressing diseases with large patient populations. The stem cell expansion process is fully regulated by way of a chemically induced safety switch so that cell growth can be arrested before implantation of the stem cells into the patient.
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MultiCell Immunotherapeutics specializes in developing primary liver cell immortalization technologies to produce cell-based assay systems for use in drug discovery by leveraging patented technology and expertise to develop therapeutics to treat serious diseases including multiple sclerosis, type-1 diabetes, and infectious disease.
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The public offering/ financing further strengthened its’ balance sheet and to complete ongoing Phase II clinical trials:
- Receiving approximately $12.4 M from the sale of units including the over-allotment,
- The 52,077,100 units consisted of 52,077,100 shares of common stock, Class A Warrants to purchase an aggregate of 39,057,825 shares of common stock and Class B Warrants to purchase an aggregate of 26,038,550 shares of common stock,
- Each Class A Warrant entitles the holder to acquire 1 share of common stock upon payment of $0.3718 per share, exercisable for a 5 year period commencing on a date 6 months after the closing date and each whole Class B Warrant entitles the holder to acquire 1 share of common stock upon payment of $0.26 per share, exercisable for a 6 month period,
- The public offering format was better then a PIPE or an RDO as retail investors could participate,
- The stock tumbled to $0.23 after ASTM priced the offering at $0.26 a share,
- The GOOD news … the “pre-baked” offering was over-subscribed … as a few investors could not get in,
- The offering was done at $0.26 while the stock was trading lower, now at $0.236, up $0.007 and continuing to … edge-up,
- Investors (and ME) should have realized something was in the air when ASTM amended (12/09) its Restated Articles of Incorporation that increased the authorized shares of common stock from 250 M to 500 M,
- The fully diluted value is heavy with approximately 230 M (+) of outstanding shares plus warrants plus the incentive options,
- But, the reverse is … still … DUE … to eliminate by 3/31/10 the NASDAQ listing issue,
- So, the question is creating a share price balancing act of appreciation to the future,
- News is the … only factor as interim clinical data from its cardiac and limb ischemia trials are due,
- The pure risk benefit … made sense … unfortunately price depreciation was inevitable … as in biotech, dilution is a constant,
- The REAL choice was the value of money, now or later,
- However, the proxy vote for the reverse split defined a range of 5 to 8 for 1,
- We can all multiply the current price against/with the current price but no one wants a post-reverse sell-off,
- Responding to our 1/15/10 post: the new CEO, Tim Mayleben deserves credit for a big and bold move … with this market slipping as it has: he raised $$, added a few institutions/hedge funds but, the piper (reverse) still has to be paid,
- Ranked a … BUY … as still below the offering pricing and news is due.
