Cleveland Biolabs (CBLI) Posts Narrower Q2 Loss

August 15, 2016 8:40 AM EDT
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Cleveland Biolabs (NASDAQ: CBLI) reported Q2 EPS of ($0.17), versus ($1.12) reported last year. Revenue for the quarter came in at $575.03 thousand, versus $329.91 thousand reported last year.

As of June 30, 2016, the Company had $16.4 million in cash, cash equivalents and short-term investments, which, based on the Company's current operational plan, is expected to fund the Company's operating requirements beyond one year.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "Since our last update in March of this year, CBLI has submitted a proposal to the FDA to address their request for demonstration of in vivo biocomparability between the entolimod drug formulation proposed for use under the pre-EUA and the drug formulation used in previously conducted preclinical and clinical studies. We have subsequently engaged in active discussions with the FDA regarding the proposed study design, in which the FDA has requested side-by-side analytical comparability data before initiating an in vivo biocomparability study. This analytical analysis is currently in progress with an expected completion date in the fourth quarter of 2016 after which the biocomparability study may start. Once we have finalized the biocomparability study design and confirmed timing of the study with our vendors, we will update guidance on this point. Preliminarily, we expect the biocomparability study will require approximately 6 months to complete."

"In addition, we are evaluating steps needed to file a Marketing Authorization Application ('MAA') for entolimod as a medical radiation countermeasure with the European Medicines Agency ('EMA'). As a prelude to filing an MAA, the EMA requires an agreement between the agency and the sponsor on a pediatric investigational plan ('PIP'), which recently has been filed with the EMA. We cannot currently estimate when an agreement on the PIP will be reached or if any additional studies will be required for an MAA submission."

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