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

Vienna, VA, August 7, 2015 -- CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended June 30, 2015.

Recent key corporate and clinical developments include:

  • Reported record patient enrollment numbers in April with 31 patients, 26 patients in May and 25 patients in June in the Phase 3 head and neck cancer trial.
  • A total of five hundred twenty one (521) patients have been enrolled in the Phase 3 study as of July 31, 2015 after new record patient enrollment of 33 in July.
  • Completed expansion of the Phase 3 trial to 24 countries - received clearance in Spain, Italy, and Thailand.
  • Added several clinical trial sites for the Phase 3 trial, among them Aintree University Hospital in the UK. This site is headed by Professor Richard Shaw, a leading European head and neck cancer key opinion leader.
  • Added a second clinical site and key opinion leader to the Phase 1 trial in HIV/HPV co-infected men and women with peri-anal warts. The University of California, San Francisco (UCSF) was added in July and world renowned key opinion leader in HPV and anal cancer, Dr. Joel Palefsky joined as a Principal Investigator.
  • Continued patient enrollment in the Phase 1 trial in at San Diego Naval Medical Center.
  • Raised approximately $16 million, prior to deducting placement agent commissions and offering expenses.

"We continued to build momentum in both our Phase 3 and Phase 1 trials for Multikine through the addition of new clinical sites and increased patient enrollment. Multikine offers a different type of therapy in the fight against cancer, leveraging the body's natural immune system in the fight against tumors and other infectious diseases like HPV that can be a precursor to cancer. We are encouraged by the progress in our clinical trials and look forward to a strong second half of 2015," stated CEL-SCI Chief Executive Officer Geert Kersten.

CEL-SCI's net loss available to common shareholders for the quarter ended June 30, 2015 was ($4,429,137) or ($0.05) per basic share, versus ($2,444,480) or ($0.04) per basic share during the quarter ended June 30, 2014. The net loss available to common shareholders for the nine months ended June 30, 2015 was ($24,830,691) or ($0.32) per basic share, versus ($21,261,925) or ($0.38) per basic share during the same nine months ended June 30, 2014. The increase in net loss for the three and nine month periods of 2015 as compared to the same periods in 2014 was primarily attributable to the increase in operating loss and the non-cash charge for the loss on a debt extinguishment off-set by the gain reported of the non-cash charge for the change in value of derivative instruments caused by a decrease in the Company's common stock.

CEL-SCI reported an operating loss of ($8,201,475) for the quarter ended June 30, 2015 versus an operating loss of ($6,901,329) for the quarter ended June 30, 2014. The operating loss for the nine months ended June 30, 2015 was ($25,956,559) versus ($19,062,074) during the nine months ended June 30, 2014.

During the nine and three months ended June 30, 2015, the rise in operating loss was attributable to an increase in research and development expenses by approximately $2,956,000 and $1,239,000 compared to the nine and three months ended June 30, 2014. R&D expenses increased primarily because of the increase in patient enrollment of the Company's Phase 3 clinical study for head and neck cancer.

About Multikine

Multikine* (Leukocyte Interleukin, Injection) 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.

Multikine is also being tested in a Phase 1 study through two clinical sites including the U.S. Naval Medical Center, San Diego under a Cooperative Research and Development Agreement ("CRADA") and the University of California San Francisco. The Phase 1 study is evaluating Multikine as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited 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 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current SOC as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of 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 1 trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase 1 trial at two clinical sites including the U.S. Naval Medical Center, San Diego, under a CRADA and the University of California San Francisco.

CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 that 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 filings with the Securities and Exchange Commission, 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.

* 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.

 

CEL-SCI Corporation
Statement of Operations
Three Months Ended June 30, 2015 and 2014
(unaudited)

Statement of Operations

 

 

CEL-SCI Corporation
Statement of Operations
Nine Months Ended June 30, 2015 and 2014
(unaudited)

Statement of Operations