On May 15, 2017 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2017 (Press release, Cleveland BioLabs, MAY 15, 2017, View Source [SID1234519125]).

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Cleveland BioLabs reported a net loss of $(1.7) million, excluding minority interests, for the first quarter of 2017, or $(0.15) per share, compared to a net loss, excluding minority interests, of $(0.7) million, or $(0.06) per share, for the same period in 2016. The increase in net loss was primarily due to an increase in the non-cash adjustment to our warrant liabilities and decreased revenues and expenses due to the completion of our development contracts with the Russian Federation Ministry of Industry and Trade ("MPT"), which was partially offset by reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure.

As of March 31, 2017, the Company had $13.1 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of commercialization for entolimod as a medical radiation countermeasure remains our top priority. As previously announced, we are excited to have received agreement from the FDA to commence the in vivo biocomparability study in non-human primates. Following completion of this study and discussion of the study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."

"We are also excited to have received a positive opinion from EMA on our pediatric investigational plan and are diligently working on assembling our MAA for submission to EMA," added Dr. Kogan.


Other Operational Highlights

• Entolimod Oncology Indications. We have completed dosing of 40 patients in a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery. This study was conducted in Russia and partially funded by the development contract with the MPT. The goal is to accumulate additional clinical data regarding immune cell response to administrations of entolimod to guide future oncology development. The analysis of the data is ongoing.

• CBLB612 is a synthetic molecule that activates the Toll-like heterodimeric receptor 2/6 and stimulated white blood cell generation in preclinical studies. Recently we have completed dosing in a Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy and data analysis of this study is in progress.

• Mobilan is a recombinant non-replicating adenovirus that directs expression of TLR5 and its agonistic ligand, a secretory non-glycosylated version of entolimod we are also developing through our subsidiary, Panacela Labs, Inc. Two randomized, placebo-controlled, dose-ranging studies of Mobilan in men with prostate cancer are currently ongoing in the Russian Federation.


Further Financial Results

Revenue for the first quarter of 2017 decreased to $0.6 million compared to $0.8 million for the first quarter of 2016. The net decrease was primarily attributable to reduced revenue from our development contracts with MPT which completed in 2016. This decrease was partially offset by increased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the first quarter of 2017 decreased to $1.4 million compared to $1.9 million for the first quarter of 2016. The reduction in research and development costs is due to completion of our development contract with MPT and was offset, in part, by continued preclinical development along with other drug manufacturing activities associated with our JWMRP contract.

General and administrative costs for the first quarter of 2017 decreased to $0.8 million compared to $1.2 million for the first quarter of 2016. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.