On November 14, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2019 (Press release, Cleveland BioLabs, NOV 14, 2019, View Source [SID1234551294]).
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Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the third quarter of 2019, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.1) million, or $(0.10) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a decrease in the non-cash adjustment to our warrant liabilities.
As of September 30, 2019, the Company had $1.9 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into September 2020.
As previously disclosed, in recent fiscal quarters, our research and development activity related to our development of entolimod as a treatment for acute radiation syndrome has declined as we were first awaiting the results of the bioequivalence study we undertook in response to the request of the Food and Drug Administration (the "FDA"), which study compared the historical drug formulation used in prior preclinical and clinical studies with the to-be-marketed drug product lots. Thereafter, we were awaiting the FDA’s confirmation that it agreed with our findings on bioequivalence, without which agreement the FDA had indicated it would not move forward to consider our pre-Emergency Use Authorization ("pre-EUA") application.
Since our submission of the bioequivalence study results, we have not received what we believe is a complete and fully satisfactory response from the FDA. Accordingly, we have been in ongoing discussions with the FDA, but our management has not been pleased with the pace or results of these discussions. We are therefore actively seeking ways to accelerate the FDA’s review and/or elevate within the management hierarchy of the FDA its consideration of our pre-EUA application.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our main priority and focus."
Further Financial Results
Revenue for the third quarter of 2019 decreased to $0.27 million compared to $0.28 million for the third quarter of 2018. The net decrease was primarily attributable to decreased revenue from our service contract with Incuron, 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 third quarter of 2019 decreased to $0.26 million compared to $0.84 million for the third quarter of 2018. The reduction in research and development costs is due to a $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, a $0.18 million decrease in spending for biodefense applications of entolimod, and a $0.14 million decrease in expenses related to curaxins.
General and administrative costs for the third quarter of 2019 decreased to $0.53 million compared to $0.71 million for the third quarter of 2018. This decrease was primarily attributable to a $0.11 million decrease in CBLI’s legal and professional fees related to the GPI investment in 2018 and a $0.04 million decrease in property taxes.