On February 9, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended December 31, 2015 (Press release, Cel-Sci, FEB 9, 2016, View Source [SID:1234509023]).
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Key corporate and clinical developments during first quarter fiscal year 2016 include:
Enrolled an additional 98 patients in the global pivotal Phase 3 head and neck cancer trial. As of January 31, 2016, 697 patients have been enrolled in the study.
Raised net proceeds of approximately $10.6 million to finance the Phase 3 head and neck cancer trial.
Increased Ergomed’s investment in our Phase 3 head and neck cancer trial. Ergomed added another $2 million to its existing $10 million investment for a total investment of $12 million. Ergomed will receive its funds back only from future sales of Multikine* (Leukocyte Interleukin, Injection).
Secured litigation funding for our ongoing arbitration against the former CRO of our Phase 3 trial from Lake Whillans, a firm that specializes in litigation funding. Pursuant to the agreement, CEL-SCI will receive up to $5.0 million in funding and Lake Whillans will get its funds back only from the proceeds derived from the arbitration.
Granted a new European patent on Multikine. The patent is important because it recites a mechanism of action of Multikine by which Multikine changes the type of T cells that enter the tumor microenvironment. This change results in the tumor becoming "visible" to the immune system, resulting in a robust and sustainable anti-tumor immune response.
Received acceptance into a new program for technology commercialization and niche analysis of our LEAPS rheumatoid arthritis vaccine candidate from the U.S. National Institutes of Health (NIH).
Continued patient enrollment in the Phase 1 trial of Multikine in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center and University of California, San Francisco (UCSF). The study in expected to be complete in the second half of 2016.
"During the first quarter of fiscal 2016 we received funding from two strategic sources, Ergomed and Lake Whillans, which we believe affirm the strength of both our Phase 3 trial and our arbitration claims against the former CRO. We are confident in our partners as we move towards the completion of enrollment in our Phase 3 trial," stated CEL-SCI Chief Executive Officer Geert Kersten.
CEL-SCI reported an operating loss of ($5,783,132) for the quarter ended December 31, 2015 versus an operating loss of ($9,995,741) for the quarter ended December 31, 2014. Research and development expenses remained relatively consistent and increased by approximately $286,000 compared to the three months ended December 31, 2014. General and administrative expenses decreased by approximately $4,560,000 compared to the three months ended December 31, 2014. Major components of the decrease include approximately $2,296,000 in a gain on the derecognition of legal fees recognized pursuant to the agreement with Lake Whillans offset by approximately $316,000 net increase in other general and administrative expenses. Also during the quarter ended December 31, 2014, there was approximately $2,620,000 in additional employee compensation costs related to the issuance of shareholder approved shares of restricted stock released upon meeting predetermined milestones.
CEL-SCI’s net income (loss) available to common shareholders for the quarter ended December 31, 2015 was $2,341,813 or $0.02 per basic share, versus ($7,845,318) or ($0.11) per basic share during the quarter ended December 31, 2014. The income was primarily attributable to an unrealized gain on the fair value of warrants, as a result of the change in the stock price between reporting periods.
About Multikine
Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.