On February 22, 2016 Cleveland BioLabs, Inc. (NASDAQ: CBLI) reported financial results and development progress for the fourth quarter and year ended December 31, 2015.
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Cleveland BioLabs reported a net loss, excluding minority interests, of $(1.4) million for the fourth quarter of 2015, or $(0.13) per share, compared to net income of $11.3 million, or $3.95 per share, for the fourth quarter of 2014. Net loss, excluding minority interests, for full year 2015 was $(12.6) million, or $(1.79) per share, compared to a net income of $1.6 million, or $0.60 per share, for full year 2014. The 2014 periods reported net income due to a $14.2 million gain on the deconsolidation of the Company’s joint venture, Incuron LLC. Excluding the gain on the deconsolidation of Incuron, net loss per share for the fourth quarter of 2014 was $(1.02) and net loss per share for full year 2014 was $(4.66).
As of December 31, 2015, the Company had $19.6 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 past year was one of significant momentum and accomplishment for CBLI. We strengthened our financial resources through the addition of a $25 million strategic investor and the award of $15.8 million in funding from the Department of Defense Congressionally Directed Medical Research Programs for continued development of entolimod’s biodefense indication. We streamlined our corporate structure with the sale of Incuron, while retaining a royalty on Incuron’s future success. We achieved several major milestones with our development programs, including the submission of a pre-Emergency Use Authorization (pre-EUA) dossier for entolimod as a radiation countermeasure and presentation of clinical oncology data for entolimod at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). And, we commenced or continued clinical studies designed to further substantiate the potential of our Toll-like receptor agonists, entolimod, CBLB612 and Mobilan."
"The pursuit of commercialization for entolimod as a radiation countermeasure remains our top priority," continued Dr. Kogan. "We continue to work with the U.S. Food and Drug Administration to facilitate the review of our pre-EUA dossier. Products with pre-EUA status may be purchased by certain US government stakeholders for stockpiling in the event of a disaster and we believe achievement of this status may also increase interest from foreign governments. We recently initiated a regulatory process with the European Medicines Agency, which has granted entolimod orphan drug designation for the treatment of acute radiation syndrome, and we continue to evaluate other foreign markets."
Other Recent Operational Highlights
Studies elucidating immunotherapeutic mechanisms through which entolimod suppresses metastasis were published in Proceedings of the National Academy of Sciences of the United States of America (PNAS). The studies presented in the PNAS publication decipher the cascade of cell-signaling events that are triggered by entolimod activation of the TLR5 pathway in the liver. (View Source )
Dosing commenced in a Phase 2 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 is being conducted in the Russian Federation.
A Phase 2 clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy started dosing in the Russian Federation.
Panacela Labs continued dosing in a Phase 1 study with Mobilan evaluating single injections administered directly into the prostate of patients with prostate cancer. This study is being conducted in the Russian Federation.
All of the studies being conducted in the Russian Federation are supported by development contracts with the Russian Federation Ministry of Industry and Trade, or MPT.
Further Financial Results
Revenue for the fourth quarter of 2015 was $1.3 million compared to $1.4 million for the fourth quarter of 2014. Revenue for full year 2015 was $2.7 million compared to $3.7 million for full year 2014. These decreases are primarily due to the completion of an Incuron research contract with the Skolkovo Foundation in 2014. Other offsetting variances include new revenue from recently awarded Department of Defense contracts, offset by reduced revenue from MPT contracts due largely to variations in the foreign currency exchange rate.
Research and development costs for the fourth quarter of 2015 were $1.9 million compared to $2.8 million for the fourth quarter of 2014. Research and development costs for full year 2015 decreased to $7.1 million compared to $9.7 million for full year 2014. These decreases primarily resulted from the deconsolidation of Incuron and nonrecurring drug production costs for Mobilan, both occurring in 2014. Somewhat offsetting were reductions in entolimod’s biodefense program due to the completion and subsequent submission of the pre-EUA dossier in the second quarter of 2015, offset by increases in entolimod’s oncology development largely due to the clinical activities commenced in the Russian Federation.
General and administrative costs for the fourth quarter of 2015 were $1.2 million compared to $2.0 million for the fourth quarter of 2014. General and administrative costs for full year 2015 decreased to $6.4 million compared to $8.5 million for full year 2014. Approximately 40% of this net decrease was attributable to the deconsolidation of Incuron, with the remainder primarily attributable to reductions in personnel and outside professional costs.
At December 31, 2015 the Company had approximately 11 million shares of common stock outstanding. In addition, the Company has 343,643 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $46.60 and 2.2 million shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $13.98.