On May 8, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended March 31, 2015 (Filing, Q2, Cel-Sci, MAY 8, 2015, View Source [SID:1234506595]).
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Recent key clinical developments include:
Reported new record high patient enrollment numbers – 24 patients in January, 25 patients in February and 29 patients in March in the Phase III head and neck cancer trial; with continued increase post-Q2 of 31 patients in April.
A total of four hundred thirty-seven (437) patients have been enrolled in the Phase III study as of April 30, 2015.
Trial received clearance in Romania, the Philippines, Malaysia and Belarus.
Reached milestone of trial approval in 21 countries as originally planned; trial to expand into additional countries based on strong interest.
Continued patient enrollment in the Phase I trial in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center.
"We have enrolled approximately half of the 880 patients planned for our Phase III head and neck cancer trial. Twenty-one countries have cleared the trial and clinical centers around the world are actively recruiting patients. We are pleased with the progress we have made. Our CROs are putting forth their best efforts to complete patient recruitment by the end of 2015. We are conservatively estimating completion in the first quarter of 2016," stated CEL-SCI Chief Executive Officer Geert Kersten.
CEL-SCI reported an operating loss of ($7,759,343) for the quarter ended March 31, 2015 versus an operating loss of ($6,226,435) for the quarter ended March 31, 2014. The operating loss for the six months ended March 31, 2015 was ($17,755,084) versus ($12,160,745) during the six months ended March 31, 2014. The rise in operating loss was attributable to an increase in research and development expenses of approximately $1,717,000 in the first half of fiscal year 2015 compared to the first half of fiscal year 2014. R&D expenses increased primarily because of the increase in patient enrollment in the Company’s Phase 3 clinical study for head and neck cancer. In addition, the general and administrative expenses increased by approximately $4,027,000 for the first half of fiscal year 2015 compared to the first half of fiscal year 2014. G&A expenses increased primarily because of an increase of approximately $3,043,000 in employee compensation costs related to the issuance of shareholder approved shares of restricted stock and an increase in legal fees of approximately $872,000 primarily related to the arbitration with the Company’s former clinical research organization (CRO).
CEL-SCI’s net loss available to common shareholders for the quarter ended March 31, 2015 was ($12,556,236) or ($0.17) per basic share, versus ($13,365,580) or ($0.24) per basic share during the quarter ended March 31, 2014. The net loss available to common shareholders for the six months ended March 31, 2015 was ($20,401,554) or ($0.27) per basic share, versus ($18,817,445) or ($0.36) per basic share during the same six months ended March 31, 2014. The increase in net loss for the three and six month periods of 2015 as compared to the same periods in 2014 was primarily attributable to the increase in operating loss off-set by the reduced loss reported of the non-cash charge for the change in value of derivative instruments caused by a decrease in the Company’s common stock.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would 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. The trial is expected to expand into a total of approximately 100 clinical centers in about 25 countries.
Multikine is also being tested in a Phase I study under a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has entered into two co-development agreements with Ergomed to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.