CEL-SCI CORPORATION REPORTS FIRST QUARTER FISCAL 2016 FINANCIAL RESULTS
Vienna, VA, February 9, 2016 -- CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended December 31, 2015.
Key corporate and clinical developments during first quarter fiscal year 2016 include:
- Enrolled an additional 98 patients in the global pivotal Phase 3 head and neck cancer trial. As of January 31, 2016, 697 patients have been enrolled in the study.
- Raised net proceeds of approximately $10.6 million to finance the Phase 3 head and neck cancer trial.
- Increased Ergomed's investment in our Phase 3 head and neck cancer trial. Ergomed added another $2 million to its existing $10 million investment for a total investment of $12 million. Ergomed will receive its funds back only from future sales of Multikine* (Leukocyte Interleukin, Injection).
- Secured litigation funding for our ongoing arbitration against the former CRO of our Phase 3 trial from Lake Whillans, a firm that specializes in litigation funding. Pursuant to the agreement, CEL-SCI will receive up to $5.0 million in funding and Lake Whillans will get its funds back only from the proceeds derived from the arbitration.
- Granted a new European patent on Multikine. The patent is important because it recites a mechanism of action of Multikine by which Multikine changes the type of T cells that enter the tumor microenvironment. This change results in the tumor becoming "visible" to the immune system, resulting in a robust and sustainable anti-tumor immune response.
- Received acceptance into a new program for technology commercialization and niche analysis of our LEAPS rheumatoid arthritis vaccine candidate from the U.S. National Institutes of Health (NIH).
- 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). The study in expected to be complete in the second half of 2016.
"During the first quarter of fiscal 2016 we received funding from two strategic sources, Ergomed and Lake Whillans, which we believe affirm the strength of both our Phase 3 trial and our arbitration claims against the former CRO. We are confident in our partners as we move towards the completion of enrollment in our Phase 3 trial," stated CEL-SCI Chief Executive Officer Geert Kersten.
CEL-SCI reported an operating loss of ($5,783,132) for the quarter ended December 31, 2015 versus an operating loss of ($9,995,741) for the quarter ended December 31, 2014. Research and development expenses remained relatively consistent and increased by approximately $286,000 compared to the three months ended December 31, 2014. General and administrative expenses decreased by approximately $4,560,000 compared to the three months ended December 31, 2014. Major components of the decrease include approximately $2,296,000 in a gain on the derecognition of legal fees recognized pursuant to the agreement with Lake Whillans offset by approximately $316,000 net increase in other general and administrative expenses. Also during the quarter ended December 31, 2014, there was approximately $2,620,000 in additional employee compensation costs related to the issuance of shareholder approved shares of restricted stock released upon meeting predetermined milestones.
CEL-SCI's net income (loss) available to common shareholders for the quarter ended December 31, 2015 was $2,341,813 or $0.02 per basic share, versus ($7,845,318) or ($0.11) per basic share during the quarter ended December 31, 2014. The income was primarily attributable to an unrealized gain on the fair value of warrants, as a result of the change in the stock price between reporting periods.
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 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 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 December 31, 2015 and 2014