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Henry McCusker
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Editor and Publisher ... Henry enters his thirteen (13) year at RegMed Investors which aggregates, curates and creates bottom-line content of regenerative medicine - stem, gene and cell therapy news providing a "vetted" selection of relevant and high-impact synthesis. He was VP -... More
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Scimitar Equity-Regenerative Medicine Investors
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Scimitar Equity Blog
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  • Q2/10 Financial Results, Aastrom Biosciences (NASDAQ: ASTM)

    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 K   (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!

    Looking forward to the reporting of results from late-stage clinical programs …

    • The US Phase 2 IMPACT-DCM clinical trial (surgical delivery for treatment of dilated cardiomyopathy or DCM) has enrolled 40 patients at 5 sites. ASTM anticipates reporting 6 month interim data from this trial upon completion of visits for all patients during Q3/10,
    • ÂSTM also announced approval by FDA to initiate a 2nd randomized, controlled, prospective, open-label, Phase 2 clinical trial investigating the delivery of Cardiac Repair Cells (CRCs) via catheter injection for the treatment of DCM.  ÂSTM is expect to initiate patient enrollment in this clinical trial during Q1/10,
    • The US Phase 2b RESTORE-CLI clinical trial continues to evaluate the use of Vascular Repair Cells (VRCs) in the treatment of patients suffering from critical limb ischemia (NYSE:CLI), the most severe form of peripheral arterial disease (PAD).  The 1st 30 patients in the RESTORE-CLI trial have completed the 12-month follow-up visits and 46 patients’ 6-month follow-up visits.  ÂSTM expects to report top-line data from the interim analysis in Q1/10,
    • Reiterating, the timing of the recent  reverse stock split is intended to increase the per share trading price of ASTM’s common stock to satisfy the $1.00 minimum bid price requirement; however, the resulting depreciation lower the bar and a lot of focus is needed to attract new investors.

    Feb 10 12:01 PM | Link | Comment!
  • Therapeutic Applicability and Immune Rejection Advantages of hpSC Technology, International Stem Cell (NASDAQ: ISCO.OB)

    ISCO.OB is focused on using hpSC to treat severe diseases of the eye, the nervous system and the liver where cell therapy has been proven … clinically … yet is limited by the availability of safe immune-matched human cells. ISCO.OB is about to demonstrate the therapeutic applicability and potential immune rejection advantages of hpSC lines relative to other stem cell classes. Its new production facility for clinical-grade stem cell products has passed final building inspection consisting of separate suites to further develop and produce different cell types from the their human parthenogenic stem cell (hpSC) technology.  These parthenogenetic stem cells have the medical advantage of allowing immune-matching to large segments of the population and the ethical advantage of not requiring the use of human embryos.

    Reiterating, ISCO.OB has developed a new stem cell technology called “parthenogenesis” that promises to significantly advance the field of regenerative medicine by addressing the significant problem of immune-rejection.

    • Human parthenogenetic stem cells have therapeutic potential,
    • Parthenogenesis utilizes unfertilized human eggs to create “parthenogenetic” stem cells (hpSC) that could be immune-matched,
    • Like hESCs, hpSCs are pluripotent yet avoid ethical issues associated with destruction or use of viable human embryos,
    • Unlike iPSCs, hpSCs do not require manipulation of gene expression back to a less differentiated stage, which may prove to be a safety or regulatory obstacle,
    • Unlike both ESCs and iPSCs, hpSCs can be created in a homozygous form such that each line can be an immunological match for millions of patients,
    • While researchers are ecstatic with the new outlook on hESC-based research, many have voiced concerns over the decision to prevent funding for cell lines created through parthogenesis as well as another technique called somatic cell nuclear transfer,
    • The NIH states that the guidelines reflect the fact that there is no clear consensus … yet … about the ethical process.
    Feb 09 9:48 AM | Link | Comment!
  • 1 for 8 Reverse Stock Split, Aastrom Biosciences (NASDAQ: ASTM)

    Aastrom has approved a 1 for 8 reverse stock split of the common stock effective on 2/18/10. The reverse stock split should help ASTM’ shares reflect the value created through their clinical programs and might help attract more institutional ownership of the stock.  The reverse stock split is intended to increase the per share trading price of ASTM’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on NASDAQ.  Following the reverse stock split, ASTM expects to have approximately 28.3 M shares of common stock outstanding.

    ASTM is currently conducting late-stage clinical trials of their cardiac and vascular repair cell technology and should report the results of the  limb ischemia clinical trial later this month and the dilated cardiomyopathy study later this year.

    • As a result of the recent $13.5 M stock offering and much stronger balance sheet,  ASTM now has the resources to complete patient enrollment in these trials, initiate new clinical studies in these indications in 2010 and execute these programs.

    ASTM filed an amendment to its articles of incorporation to affect the reverse stock split, which was authorized by shareholders at Aastrom’s annual meeting in 12/09.

    • As a result of the reverse stock split, every 8 shares of ASTM’s  common stock that were issued and outstanding immediately prior to the opening of trading on 2/18/10 will automatically be combined into 1 issued and outstanding share without any change in the par value of such shares and the number of authorized but un-issued shares of ASTM’s common stock will be proportionally reduced.
    • .No fractional shares of common stock will be issued as a result of the reverse stock split and shareholders of record will receive cash in lieu of fractional shares to which they would otherwise be entitled, based upon the closing price of Aastrom’s common stock on 2/17/10.
    Feb 09 9:47 AM | Link | 2 Comments
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