CEL-SCI CORPORATION REPORTS FIRST QUARTER 2015 FINANCIAL RESULTS

Vienna, VA, February 6, 2015 -- CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended December 31, 2014.

Key corporate and clinical developments during Q1 fiscal year 2015 include:

  • Enrolled an additional 63 patients with advanced primary, not yet treated, head and neck cancer into the global pivotal Phase III trial. As of January 31, 2015, 352 patients have been enrolled in the study.
  • Expanded the Phase III trial to more clinical sites.
  • Began screening patients at new clinical centers in France, Turkey, Poland, Sri Lanka, Russia and Taiwan. As of December 31, 2014, 17 countries have cleared our Phase III study to allow patient enrollment. In January 2015, Romania became the 18th country to clear our Phase III study.
  • Continued patient enrollment in the Phase I trial of Multikine* (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center. The study in expected to be complete in the second half of 2015 and is being conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy.
  • Raised gross proceeds of approximately $7,000,000 through public and private offerings.

CEL-SCI reported an operating loss of ($9,995,741), of which approximately $3,346,000 were non-cash related expenses, for the quarter ended December 31, 2014 versus an operating loss of ($5,934,310), of which approximately $820,000 were non-cash related expenses, for the quarter ended December 31, 2013. Research and development expenses increased by approximately $835,000 compared to the three months ended December 31, 2013 due to the increased level of activity associated with conducting the Company's Phase III clinical study for head and neck cancer. General and administrative expenses increased by approximately $3,250,000 compared to the three months ended December 31, 2013. The major components of the increase include approximately $2,605,000 (non-cash) in employee compensation costs related to the issuance of shareholder approved shares of restricted stock, increased legal fees of approximately $503,000 as a result of the arbitration with the Company's former Clinical Research Organization (CRO), and approximately $122,000 in increased accounting fees.

CEL-SCI's net loss available to common shareholders for the quarter ended December 31, 2014 was ($7,845,318) or ($0.09) per basic share, versus ($5,451,865) or ($0.11) per basic share during the quarter ended December 31, 2013.

"We believe that 2015 can be a very successful year for CEL-SCI. We expect 3 major events to come to the forefront: 1) The full enrollment of the Phase III clinical trial for Multikine, something that 18 months ago seemed not possible since the prior CRO was enrolling so few patients every month. Now patient enrollment in the study is hitting new monthly records and is up over 1,000% from the time we dismissed the prior CRO, 2) the $50 million arbitration against the prior CRO should reach its final conclusion, and 3) we expect to have data from our study with the U.S. Navy of Multikine in HIV/HPV co-infected patients with anal warts, potentially a faster way to market," stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in a 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. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015.

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 as compared to subjects treated with current standard of care 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 recently received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for RA with researchers from Rush University Medical Center in Chicago, Illinois. 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 press release, 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 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
STATEMENTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2014 and 2013
(UNAUDITED)

Statement of Operations