Cleveland BioLabs Submits Pre-EUA Dossier for Entolimod to FDA

BUFFALO, NY--(Marketwired - Jun 15, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the company has submitted an application for pre-Emergency Use Authorization (pre-EUA) to the U.S. Food and Drug Administration (FDA) in support of use of entolimod as a medical radiation countermeasure. Entolimod would be indicated for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster.

Pre-EUA is the regulatory path through which the FDA determines that certain unapproved medical products may be used in an emergency when there are no adequate, approved, and available alternatives. Products with pre-EUA status can be purchased by the US government for stockpiling in the event of a disaster. Achieving pre-EUA status in the United States can also support partnerships and foreign government interest in this program.

In July 2014, the Company met with the FDA and confirmed that the entolimod efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-EUA submission for entolimod. CBLI has now prepared an application under the FDA Animal Rule that demonstrates drug efficacy in animals and safety in humans. A pivotal efficacy study in 179 nonhuman primates showed that a single intramuscular injection of entolimod given 25 hours after high-dose, whole-body irradiation increased survival from 27.5% in control animals to 75% in entolimod-treated animals. Clinical studies of entolimod in 176 human subjects have characterized the safety profile of entolimod and documented dose-dependent effects on the same efficacy biomarkers that were correlated with survival benefit in animals. 

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."

In a separate, parallel initiative, CBLI continues negotiations regarding two proposals with the Department of Defense office of Congressionally Directed Medical Research Programs. Awards under these proposals would fund additional studies supportive of future full licensure of entolimod under a Biologics License Application.

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and through two joint ventures, Panacela Labs, Inc. and Incuron LLC. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words and phrases such as "plan," "potential," "will," "look forward" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the submission of our pre-EUA for entolimod; the effects of a successful review of our pre-EUA submission by the FDA, the conduct and results of our various clinical trials; the efficacy of our therapeutic products; our ability to successfully complete planned clinical studies; and our ability to obtain regulatory approval for our therapeutic products. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 

These factors include, among others, the Company's inability to obtain regulatory approval in a timely manner or at all; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.