Sunday, November 29, 2015

Cleveland BioLab, ($CBLI) May go Nuclear on Entolimod EUA approval



Catalyst:
Reverse split, low float, emerging biotech with a Russian billionaire strategic investor with a near term pending  FDA Emergency Use Authorization (EUA) approval for Entolimod in support of use as a medical radiation countermeasure.

 
A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results  demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals 

Based on these stellar results, in September 2014, the FDA "greenlighted" the Pre-EUA Entolimod submission:
 Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, stated, "The outcome of our FDA meeting is very positive and we are pleased with the agreements we have reached with the agency. Our achievement of animal-to-human dose conversion and the FDA's acknowledgement of the conceptual soundness of our dose-conversion methods are significant milestones in Entolimod's development under the FDA's Animal Rule."

6/15/15 -The Company filed a Pre-EAU dossier for Entolimod which would be indicated for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a nuclear disaster. There are currently no approved available alternatives and once pre-EAU status is achieved, Entolimod may be purchased by the US government  and possibly foreign nations for  stockpiling.   Radiation countermeasure is a $200M US and global market. Project Bioshield established the Strategic National Stockpile (SNS), and procurement contracts to date have totaled $3.3B, with mean awards for anthrax, smallpox etc of $301M each. The Company recently responded to FDA questions on its pre-EAU submission and expects the review will continue into early 2016.

Yakov Kogan, PhD, MBA, Chief Executive Officer, stated, "We are very pleased to have achieved this significant milestone. We believe that Entolimod efficacy and operational feasibility are best in class and that our pre-EUA submission is compelling and aligned with our previous FDA discussions. Our top priority will be to work with the FDA to facilitate their review of our application. There is no Prescription Drug User Fee Act (PDUFA) goal associated with review of a pre-EUA. However, we estimate a 6- to 9-month period for evaluation of our application, depending on the extent of the FDA's comments and questions. We have submitted the dossier electronically with the intent of facilitating the review process. We believe that a positive review of our submission may serve as the basis for the future commercialization of Entolimod."


Capital structure:-9/30/15
10.7M O/S shares ( 13.3M fully diluted)
2.2M warrants,  ( $13.95 exercise price)
3.2M Float
$43M market cap
$22.6M cash or $2.11 cash per/sh
$13.2M working capital
 0 LTD



**6/25/15-Strategic Investor, David Davidovich, Russion billionaire, buys 6.5M shares at $3.87, (35% premium).  The stock reacted strongly this day trading from $2.75 to $7.24 on massive volume of 21.8M shares.  Mr. Davidovich stated, "I believe in the strong potential of CBLI's products and its team and hope that my investment will provide the company with the necessary support to fully realize its goals."
 
Conclusion:  
 As traders actually start researching this very near term catalyst situation,especially as it pertains to the current world terror environment, they will see that Entolimod has a very high probability of obtaining EUA approval for radiation exposure from a nuclear attack. After all, the DoD has already granted  CBLI $15M in contracts and the FDA "greenlighted" the EUA  filing based on Entolimod meeting its primary endpoint and reporting strong, 3 fold survival results (p=.0001). Traders will also see that CBLI is a reverse splitter, has a  very clean balance sheet and also has a Russian billionaire that controls a majority of the float. Once EUA approval is secured, speculation (50M doses @ $20 etc) will abound as to what the actual contract awards will be. An eventual USA stockpiling award of $100M-$200M (2-4x+ mkt cap) will not be surprising to me. Other ex USA countries may follow suit shortly thereafter.

Technically, the stock has strong support in the $3.50 area and on 11/27 the price peaked above the 50EMA as the MACD bottomed.  Looking ahead, a break above $4.50, 200 EMA resistance, could signal that the run has started, a move above $5.20 on volume could bring the 7/25/15 spike high of $7.24 into play. Above that level anything is possible as witnessed by the recent spectacular gains in KBIO.

Disclosure: I am long CBLI. I may Buy, Sell or Hold this security at my sole discretion. I wrote this article myself,  this is NOT investment advice, it expresses my own opinions and is informational ONLY. I am not responsible for any errors or omissions contained herein. Do your own due diligence before making any investment. I am not receiving compensation for it. I have no business relationship with Cleveland Biolabs, Inc. SEE FULL DISCLOSURE BELOW