CEL-SCI REPORTS FISCAL 2015 FINANCIAL RESULTS AND CLINICAL & CORPORATE DEVELOPMENTS
Vienna, VA, December 11, 2015 -- CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported financial results today for the fiscal year ended September 30, 2015. The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2015.
Clinical and Corporate Developments Included:
- CEL-SCI raised net proceeds of approximately $21.15 million during fiscal 2015 and an additional $10.6 million subsequent to the end of the fiscal year, to finance its expanding Phase 3 trial in the treatment of head and neck cancer.
- During fiscal year 2015 we added 7 countries to our Phase 3 study and we enrolled another 304 patients in the study. This represented a 115% increase in enrollment over fiscal year 2014. We are continuing this trend in the first quarter fiscal 2016.
- We had 2 very important corporate developments that suggest our Phase 3 trial is going well and that we have a strong case in our $50+ million arbitration against the former Clinical Research Organization ("CRO"):
- In October 2015 Ergomed, the new CRO running our Phase 3 trial, added another $2 million to its existing $10 million investment in our Phase 3 clinical trial, for a total investment of $12 million. Ergomed will receive its funds back only from a successful drug.
- Also in October 2015, we signed a funding agreement with Lake Whillans, a firm that specializes in litigation funding. Pursuant to the agreement, CEL-SCI will receive up to $5.0 million in funding for litigation expenses to support arbitration claims against the former CRO. This case is scheduled for "hearing" (trial) in the spring of 2016. Lake Whillans will get its funds back only from the proceeds derived from the arbitration. CEL-SCI now spends $0 on this arbitration.
- CEL-SCI expanded the ongoing Phase 1 study with Multikine in HIV/HPV co-infected men and women by adding a another clinical site and a world renowned key opinion leader in the field. Dr. Joel Palefsky of the University of California, San Francisco (UCSF) joined the study in July 2015 as a Principal Investigator. The study is also being conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy at the San Diego Naval Medical Center.
CEL-SCI reported an operating loss of ($34.30) million in fiscal year 2015 versus an operating loss of ($27.57) million in fiscal year 2014. Of the 2015 fiscal operating loss, the cash used by the company totaled $23.8 million. The legal expenses for the arbitration were $3.6 million and those expenses will not be repeated in 2016 since the company signed an agreement with the litigation funding firm Lake Whillans to fund any remaining arbitration legal fees. This will allow CEL-SCI to focus its expenditures on the Phase 3 trial.
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.
The rise in operating loss was largely attributable to an increase in research and development expenses to $20.95 million in fiscal year 2015 compared to $17.0 million in fiscal year 2014. This expense increased based on the additional activity level of the Phase 3 clinical trial, including more clinical centers joining the study and more patients enrolled.
Geert Kersten, CEL-SCI's Chief Executive Officer said, "We are rapidly enrolling patients in our Phase 3 trial in head and neck cancer and the trial date for our arbitration is near. Both of these efforts are proceeding well, and we look forward to a positive 2016."
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.
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 in conjunction with the U.S. Naval Medical Center, San Diego, under a CRADA, and at 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 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 (Leukocyte Interleukin, Injection). 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
Years Ended September 30, 2015 and 2014