On May 10, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended March 31, 2016 (Press release, Cel-Sci, MAY 10, 2016, View Source [SID:1234512270]).
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Key corporate and clinical developments during second quarter fiscal year 2016 include:
Enrolled an additional 186 patients in the global pivotal Phase 3 head and neck cancer trial during the first six months of FY 2016, a 32% increase in enrollment compared to the first six months of FY 2015.
Enrolled a monthly record of 41 patients in April 2016, following the end of Q2.
A total of 797 patients have been enrolled in the study as of April 30, 2016.
The Company’s CEO and CSO provided informative updates in multiple interviews, including Fox Business News.
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).
Received significant litigation funding for arbitration lawsuit against former CRO that led to a narrowing of G&A expense and operating loss in Q2 FY 2016.
CEL-SCI reported an operating loss of ($6,273,603) for the quarter ended March 31, 2016 versus an operating loss of ($7,759,343) for the quarter ended March 31, 2015. The operating loss for the six months ended March 31, 2016 was ($12,056,735) versus ($17,755,084) during the six months ended March 31, 2015. The decrease in operating loss in the first half of fiscal 2016 was mostly attributable to a decrease in general and administrative expenses of approximately $5,803,000, as compared to the first half of fiscal 2015. A major component of the decrease is the approximate $3,254,000 gain on the derecognition of legal fees recognized pursuant to an agreement with Lake Whillans for funding litigation expenses in the Company’s arbitration against its former CRO. Additionally, during the first half of fiscal 2015, there was approximately $2,726,000 in employee compensation costs related to the issuance of shareholder approved shares of restricted stock released upon meeting predetermined milestones. Research and development expenses remained relatively consistent and decreased by $176,000 during the six months ended March 31, 2016.
CEL-SCI’s net loss available to common shareholders for the quarter ended March 31, 2016 was ($8,844,855) or ($0.07) per basic and diluted share, versus ($12,556,236) or ($0.17) per basic and diluted share during the quarter ended March 31, 2015. The net loss available to common shareholders for the six months ended March 31, 2016 was ($6,503,042) or ($0.06) per basic and diluted share, versus ($20,401,554) or ($0.27) per basic and diluted share during the same six months ended March 31, 2015. The decrease in net loss for the three and six month periods of 2016 as compared to the same periods in 2015 was primarily attributable to the decrease in operating loss and reduced loss and unrealized gain, respectively, on the fair value of warrants as a result of the change in the stock price between reporting periods.
About Multikine (Leukocyte Interleukin, Injection)
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 (not yet treated) 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.