Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the third quarter ended September 30, 2016.
Cleveland BioLabs reported net income of $1.1 million, excluding minority interests, for the third quarter of 2016, or $0.10 per share, compared to a net loss, excluding minority interests, of $(3.1) million, or $(0.31) per share, for the same period in 2015. Net loss, excluding minority interests, for the first nine months of 2016 was $(1.4) million, or $(0.13) per share, compared to a net loss, excluding minority interests, of $(11.2) million, or $(1.93) per share, for the same period in 2015. The reduction in net loss for both periods due to operating results was attributable to increased revenues and lower costs with the most significant being a reduction in the non-cash adjustment to our warrant liabilities and reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization (“pre-EUA”) for entolimod with the U.S. Food and Drug Administration (“FDA”). Additionally, the weighted average outstanding shares for the nine month period significantly increased, which thereby lowers the per share results, due to the issuance of approximately 6.5 million shares in July 2015.
As of September 30, 2016, the Company had $14.9 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, “The side-by-side analytical comparability analysis of two formulations of entolimod is on schedule to be completed in the fourth quarter of 2016. Once we have this data and once the FDA has finalized the biocomparability study design, the biocomparability study in non-human primates (“NHP”) may commence. We expect the NHP study will require approximately 6 months to complete, and we will update guidance on this point after the FDA has completed its reviews and our vendors have confirmed timing.”
“In addition, we are in ongoing discussions with the European Medicines Agency (“EMA”) for a pediatric investigational plan (“PIP”) for entolimod as a medical radiation countermeasure. A proposed PIP was filed with the EMA. The EMA requires an agreement on a PIP with the sponsor as a prerequisite to filing a Marketing Authorization Application (“MAA”). 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.”
“Clinical oncology studies with entolimod, CBLB612 and Mobilan are progressing in the Russian Federation,” added Dr. Kogan. “Recruitment was completed in a Phase 2 study of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer and a Phase 2 study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy. The data from these studies are being analyzed. Panacela Labs is now dosing Mobilan in two dose-escalation Phase 1 studies evaluating single and double injection regimens administered directly into the prostate of patients with prostate cancer. All of these studies are supported by development contracts with the Russian Federation Ministry of Industry and Trade.”
Further Financial Results
Revenue for the third quarter of 2016 increased to $1.1 million compared to $0.5 million for the third quarter of 2015. Revenue for the first nine months of 2016 increased to $2.5 million compared to $1.4 million for the first nine months of 2015. These increases were primarily attributable to work performed under contracts from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.
Research and development costs for the third quarter of 2016 decreased to $1.1 million compared to $2.1 million for the third quarter of 2015. Research and development costs for the first nine months of 2016 decreased to $4.3 million compared to $5.2 million for the first nine months of 2015. The reduction in research and development costs for both periods is due to our streamlined focus primarily on pursuing a pre-EUA with the FDA.
General and administrative costs for the third quarter of 2016 decreased to $0.8 million compared to $1.3 million for the third quarter of 2015. General and administrative costs for the first nine months of 2016 decreased to $2.7 million compared to $5.2 million for the first nine months of 2015. This decrease was primarily attributable to reductions in personnel and outside professional costs.
As of October 31, 2016 the Company had approximately 11 million shares of common stock outstanding. In addition, the Company has approximately 0.2 million shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $42.50 and approximately 2.1 million shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $11.04.
About Cleveland BioLabs
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 as a medical radiation countermeasure 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 Joint Stock Company 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 athttp://www.cbiolabs.com.
