CEL-SCI CORPORATION REPORTS SECOND QUARTER FISCAL YEAR 2015 FINANCIAL RESULTS

Vienna, VA, May 8, 2015 -- CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended March 31, 2015.

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.

About CEL-SCI Corporation

CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen plus SOC as compared to subjects treated with current SOC only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA.

CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.

When used in this report, the words "intends," "believes," "anticipated", "plans" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2014. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

CEL-SCI Corporation
Statement of Operations
Three Months Ended March 31, 2015 and 2014
(unaudited)

Statement of Operations

 

 

CEL-SCI Corporation
Statement of Operations
Six Months Ended March 31, 2015 and 2014
(unaudited)

Statement of Operations