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IntelliCell BioSciences, Inc. Message Board

hwmccusker 3 posts  |  Last Activity: Aug 22, 2014 2:35 PM Member since: Jan 8, 2010
  • UP +$0.27 to $3.91. Many traders will be “whacking” these numbers while their 3 ATM “temporary holders” will be selling into the appreciation to REDUCE their … positions

    READ ... the “study limitations” in the “published” paper!!

    Just ANOTHER case of selective DISCLOSURE – SELL!

    ASTM had their P2a clinical studies of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM) published in the peer-reviewed journal Circulation Research.
    In an article entitled "Safety and Efficacy of Ixmyelocel-T: An Expanded, Autologous Multi-Cellular Therapy, in Dilated Cardiomyopathy," results showed that treatment with ixmyelocel-T reduced the incidence of major adverse cardiovascular events (MACE) in patients with ischemic DCM.

    • In 2 separate open-label studies, a total of 61 patients were randomized and
    • 59 were treated or received standard of care. The combined results among ischemic DCM patiendemonstrated that patients treated with ixmyelocel-T experienced fewer MACE events during follow up compared to control patients.

    Heart failure (HF) exacerbation was the most common MACE. Relative to the control patients, ischemic DCM patients treated with ixmyelocel-T also experienced an improvement in symptoms as measured by the New York Heart Association classification system.

    The Bottom Line: The P2b trial replicated … PREVIOUS results. However, they are INSIGNIFICANT for such a small study which is just REITERATING a safety trial which always seems to be EFFECTIVE particularly when using the body’s own cells ! What are the statistics for comparison?
    Read the "Safety and Efficacy of Ixmyelocel-T: An Expanded, Autologous Multi-Cellular Therapy, in Dilated Cardiomyopathy,"

    A couple of observations: Open label – only people getting therapy had a bone marrow aspirate and underwent a catheter procedure (i.e.: the patient and doctors know). With very small numbers, a few events either way changed the outcome –

    Sentiment: Strong Sell

  • As I stated on Monday’s pre-open -Harvard apparatus (HART) is … grossly overpriced and is over-pumped! A further definition was needed; HART was spun-out of Harvard Bio (HBIO) with $15 M and assets of the RegMed business. The initial capitalization was from HBIO and a fund raise was anticipated .
    The Q1/14 net loss was $3 M, or $0.39 per diluted share, for Q1/14 compared to a $2 M net loss or $0.26 per diluted share for Q1/13. The “unfavorable” year-to-year quarterly net loss comparison was primarily due to an increase in non-cash stock-based compensation expense related to the initial stock option grants made to employees and directors at the time of the spin-off from HBIO in 11/13. Non-cash stock-based compensation expense was approximately $1.2 M for Q1/14 compared with approximately $100 K for Q1/13.
    With SG&A running ahead of R&D they pay themselves … very, very well for a start-up, oops – a spin-out!
    WHAT supports a $9.49 share price and a $74.14 market capitalization – the “whiff” of a potential, the$12.6 M in cash , a very HIGH SG&A, a small R&D budget, a 2015 IND filing, NO trial status? HART has had its FIRST IND meeting with the FDA as part of Q1 results yet … no word has been heard about proposed global clinical trial design for its HART-Trachea product?
    Its technology has been used in 8 human trachea transplants to date approved under compassionate use exemptions, but NONE of their products are yet approved by ANY government regulatory agencies. SELL

    Sentiment: Strong Sell

  • ASTM paid $4 M in cash and $2.5 M in a promissory note to acquire the CTRM business, which includes 3 marketed products in the US and the EU with manufacturing and production centers in the US and Denmark.

    The Bottom Line: The prisoners' dilemma is a recognized example of a “game” analyzed in game theory that shows why 2 purely … "rational" individuals might … NOT cooperate, even if it APPEARS that it is in their best interests to do so.

    The 3 marketed autologous cell therapy products acquired by ASTM are Carticel® Epicel® and MACI®. Although deficiencies were NOT mentioned nor included in ASTM’s “perfunctory” release but, were noted in its subsequent 8K filing with the SEC ASTM … it has no issued patents or pending patent applications relating to Epicel, issued patents relating to Carticel are scheduled to expire by 8/16 in the US and by 2022 in Europe, while issued patents relating to MACI are scheduled to expire by 8/18 in the U.S. and 8/17 in Europe. Furthermore, ASTM added that the patents they do own “may be subject to increased competition and (our) opportunity to establish or maintain product revenue could be substantially … reduced or … eliminated.

    Two of the most prominent RegMed analysts commented … “what were they thinking” and the second stated “this is a case of a “typhoid” stem cell deal that could “infect” the RegMed universe!
    It fits with ASTM's usual “radio silence” concerning the "MURKY" ... and full specifics of the ... MATERIAL effects of the deal on-going!

    Sanofi dumped a “dud” with NO liability. A further question evolves … has Sanofi also dumped the Forest City – 2 ½ year lease of the Sidney Street manufacturing site obligation … that’s about $3 M a year. ASTM had 3/31/14 had $8.8 M with a Q operating expense of $4.6 M and now having spent $4 M of cash with promissory note of $2.5 M.

    Sentiment: Strong Sell

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