Wednesday, July 01, 2015 10:31:15 AM
jca408harvard
• Jun 26, 2015 6:09 PM
How we went from $7 to $2 but will be at $10 by June 2016
The primary driver of the stock back in November ($7.23 pps) was the assumption that NBS10 (AMR-001) phase 2 data would be a success. CLBS10 (cardiac) did in fact have a successful phase 2 study in terms of morbidity and mortality. This is good in terms of eventual FDA approval but the trial design was incredibly poor. SPECT imaging to show perfusion at six months was an extremely risky endpoint at that early of a measurement. Angiogenesis takes time and the size of new vessels are extremely hard to detect initially (especially seeking such from a SPECT image). Phase 1 data showed significant perfusion improvements and management really overreached to try to match those results. Due to this overconfidence in the perfusion endpoint they focused far too strongly on that and severely neglected other measures (specifically dose dependency and cell yield) as ways to control confounding in the design phase of the trial. This was an enormous strategic error, left the treatment with good mortality data but no mechanistic insight, had a failed endpoint and led to a coordinated short attack that crushed the stock and has it currently broken.
Robin Smith was rightfully removed as CEO within 2 months of this debacle. In addition to her massive error in the trial design she also failed to secure long-term financing for the oncology and Tregs platforms when the stock was much higher. Again, this was based on her misguided overconfidence in the perfusion endpoint and it taking the pps much higher. The stock is now stuck in a series of easily identifiable manipulation and panic selling. It will only take a couple of good pieces of news to break the current cycle, cause a squeeze and give longs more courage to avoid panic and hold long. Those of us in the cardiac field know the potential of CLBS10 (the CXCR4 component is wonderful from biochemistry standpoint) so a partnership and a thoughtfully crafted trial design will come. Everything else with CLBS is very good.
The reason the stock is languishing right now is because it is currently broken. It is quite easily manipulated and leads to panic selling from longs who have already suffered significant losses. Any gains are walked back down with no catalysts in the immediate future...but CLBS is getting closer to those catalysts. The reason we didn't take a jump with the other biotechs today was because of our removal from the Russell Index. Here's how we get to $10 based on a late-July price of $2.50:
1.) CLBS10 (cardiac) partnership will happen. It is not a matter of if but when. The recent scientific advisory board is a top-notch, stellar group of cardiology experts. This is a direct preparation for partnership with application in multiple areas. This will add $2. I appreciate that Mazzo is taking his time with this to weigh all options in the partnership offers.
2.) CLBS03 (Tregs) are the platform that I am most excited about. Fantastic potential. Unfortunately, they are furthest from market right now. A partnership to begin its phase 2 trial must be near. The FDA has already approved the protocol and it doesn't do CLBS any good to have it currently not in development. This will add $2.
3.) CLBS will be cash positive by 4Q of this year. This adds $1.
4.) I am projecting 30% growth in PCT and am being conservative. This adds $1.50.
5.) I will assign a small $1 value to pure momentum of these events happening one after another.
We are clearly undervalued at this time because we have a phase 3, fully funded, fast-tracked immuno-oncology therapeutic and we are trading under $2.
We're trading at $1.87 but we are in really good shape for the future
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