On March 6, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported that financial results and development progress for the fourth quarter and year ended December 31, 2017 (Filing, 8-K, Cleveland BioLabs, MAR 6, 2018, View Source [SID1234524411]).
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Cleveland BioLabs reported a net loss, excluding minority interests, of $(1.2) million for the fourth quarter of 2017, or $(0.10) per share, compared to a net loss of $(1.2) million, or $(0.11) per share, for the fourth quarter of 2016. Net loss, excluding minority interests, for full year 2017 was $(9.7) million, or $(0.87) per share, compared to a net loss of $(2.7) million, or $(0.24) per share, for full year 2016.
As of December 31, 2017, the Company had $8.8 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-K.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The past year was one of substantial progress for the company and our Entolimod and Mobilan programs. We continued our pursuit of a pre- Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and submitted a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure ("MRC"), and continued clinical exploration designed to further substantiate the potential of our Toll-like receptor 5 agonists, entolimod and Mobilan."
"The pursuit of approval by the FDA and EMA and commercialization of entolimod as a medical radiation countermeasure continue to be the company’s most important priorities and goals," continued Dr. Kogan. "Per FDA request and as part of its review of our pre-EUA application, we collated and submitted manufacturing information (Module 3) to the agency and initiated the in vivo biocomparability study in non-human primates, which is currently ongoing. Following completion of this study and discussion of the study results with the FDA, we expect the agency to resume review of our pre-EUA dossier".
"We are also pleased to announce submission in the European Union of a MAA for use of entolimod as a MRC," added Dr. Kogan. "Our application was recently validated by the EMA and is currently undergoing agency review. Filing of the MAA represents a significant milestone for the company and another major step toward making entolimod available worldwide as a life-saving and practical treatment of acute radiation syndrome for mass-casualty radiation and nuclear disaster scenarios."
Further Financial Results
Revenue for the fourth quarter of 2017 was $0.9 million compared to $1.0 million for the fourth quarter of 2016. Revenue for full year 2017 was $1.9 million compared to $3.5 million for full year 2016. The revenue changes are primarily due to decreased revenue from our MPT contracts at BioLab 612 and Panacela which were completed in 2016 partially offset by a slight increase in revenue from our DoD JWMRP contract.
Research and development (R&D) costs for the fourth quarter of 2017 were $1.5 million compared to $2.2 million for the fourth quarter of 2016. R&D costs for the full year 2017 decreased to $5.0 million compared to $6.5 million for the full year 2016. The research and development changes were primarily attributable to significant reductions of funds spent on Entolimod for oncology indication due to the completion of a clinical
study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naive patients with primary colorectal cancer, reduction in spending related to CBLB612 due to the completion of a clinical study in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy, and the
reduction in Panacela product candidate spending due to the completion of the active recruitment stage of the ongoing clinical studies with Mobilan. These reductions were partially offset by increased expenses on Entolimod’s biodefense indication for continued preclinical development along with other drug manufacturing activities associated with our JWMRP contract and expenses associated with our regulatory efforts with the EMA to prepare a pediatric investigational plan and other activities in support of filing a MAA with EMA.
General and administrative costs (G&A) for the fourth quarter of 2017 were $0.6 million compared to $0.7 million for the fourth quarter of 2016. G&A costs for full year 2017 decreased to $2.5 million compared to $3.4 million for full year 2016. These decreases were primarily attributable to reductions in personnel and outside professional costs.
At December 31, 2017 the Company had 11,279,834 shares of common stock outstanding. In addition, the Company has 211,487 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $36.94 and 710,174 shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $8.95.