CEL-SCI CORPORATION REPORTS THIRD QUARTER FISCAL YEAR 2016 FINANCIAL RESULTS
Vienna, VA, August 10, 2016 -- CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended June 30, 2016 and updates shareholders in regards to the upcoming date for the Company's arbitration hearing against its former Clinical Research Organization (CRO).
Key corporate and clinical developments during the quarter include:
- Enrolled an additional 92 patients in the global pivotal Phase 3 head and neck cancer trial during the third quarter of FY 2016 which is a 12% increase over the third quarter of FY 2015.
- Enrolled another 29 patients in July 2016, following the end of the quarter.
- A total of 877 patients have been enrolled in the study as of July 31, 2016.
- 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).
- Raised $5 million to finance the Phase 3 head and neck cancer trial.
CEL-SCI's net loss for the quarter ended June 30, 2016 was ($3,849,324) or ($0.03) per basic and diluted share, versus ($4,429,137) or ($0.05) per basic share and ($0.06) per diluted share during the quarter ended June 30, 2015. The net loss for the nine months ended June 30, 2016 was ($10,352,366) or ($0.09) per basic and diluted share, versus ($24,830,691) or ($0.32) per basic and diluted share during the same nine months ended June 30, 2015.
CEL-SCI reported an operating loss of ($6,382,747) for the quarter ended June 30, 2016 versus an operating loss of ($8,201,475) for the quarter ended June 30, 2015. The operating loss for the nine months ended June 30, 2016 was ($18,439,482) versus ($25,956,559) during the nine months ended June 30, 2015.
Geert Kersten, CEL-SCI's Chief Executive Officer said, "The current focus remains the completion of the Phase 3 clinical trial with Multikine and the upcoming arbitration hearing ("trial") against the Company's former CRO scheduled for September 7, 2016."
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.
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 standard of care (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 in conjunction with the U.S. Naval Medical Center, San Diego, under a CRADA and UCSF. CEL-SCI has issued patents on Multikine from the US, Europe, China and Japan.
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.
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 for the year ended September 30, 2015. 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 (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's 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 have 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. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is currently in progress.
Statement of Operations
Three Months Ended June 30, 2016 and 2015
Statement of Operations
Nine Months Ended June 30, 2016 and 2015