Cleveland Biolabs Inc. Announces Publication Of Studies Demonstrating Efficacy Of Entolimod As A Radiation Countermeasure Up To 48 Hours After Exposure Of Nonhuman Primates To Lethal Radiation

BUFFALO, NY--(Marketwired - September 16, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the publication in the scientific journal, PLOS ONE, of studies demonstrating the ability of entolimod to reduce radiation injury and improve survival when the drug is administered up to 48 hours after lethal radiation exposure in nonhuman primates.

Entolimod is a Toll-like receptor 5 (TLR5) agonist currently under development by Cleveland BioLabs as a both a medical radiation countermeasure (MRC) and an anti-cancer agent. The publication in PLOS ONE reported data from several exploratory studies conducted in lethally irradiated nonhuman primates treated with a single intramuscular injection of entolimod between 1 and 48 hours after exposure to whole body irradiation leading to 50-75% mortality among irradiated animals.

Among the results reported in the publication was that intramuscular injection of a single efficacious dose of entolimod reduced radiation-induced mortality, providing an absolute improvement in survival of 40 to 60% compared to that observed in the placebo control arm. Survival benefit was accompanied by accelerated recovery of the hematopoietic and immune systems, with decreased severity and duration of thrombocytopenia, neutropenia, and anemia in entolimod-treated animals compared to control animals. Entolimod treatment also reduced radiation-induced damage and accelerated recovery in the gastrointestinal tract. These positive effects of entolimod occurred in the absence of intensive, individualized supportive care.

Andrei Gudkov, Ph.D., D.Sc., Chief Scientific Officer of Cleveland BioLabs, Senior Vice President of Basic Science at Roswell Park Cancer Institute and one of the corresponding authors of the paper, commented: "Our research team is very pleased to share these results with the scientific community. They demonstrate entolimod's potential as a life-saving treatment for victims exposed to severe irradiation. To our knowledge, these are the first published data documenting significant increases in the survival of nonhuman primates using a pharmacological agent administered as late as 2 days after lethal radiation exposure. These findings suggest that entolimod is a highly promising single dose MRC candidate for use in mass-casualty radiation disasters."

Cleveland BioLabs has submitted an application for pre-Emergency Use Authorization (pre-EUA) to the Food and Drug Administration (FDA) in support of use of entolimod as a MRC. 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 certain US government stakeholders for stockpiling in the event of a disaster.

The Company also recently announced the award of a contract valued at up to $9.2 million from the Department of Defense (DoD) office of Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) to support further development of entolimod as an MRC. The DoD contract will fund pivotal animal studies designed to support future submission of a Biologics License Application (BLA) for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. BLA approval, if received, would be the final step necessary to reach full marketing authorization.

The publication can be found online at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0135388

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, oncology immunotherapy, and vaccines. 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 a joint venture with OJSC Rusnano, Panacela Labs, Inc. 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," "support," "potential," "look forward" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding 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 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 inability to obtain regulatory approval in a timely manner or at all; 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.