VIENNA, Va.--(BUSINESS WIRE)--
CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended December 31, 2013.
Key corporate and clinical developments during Q1 fiscal year 2014 include:
- Signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Center, San Diego to conduct a Phase I study of our investigational immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts.
- Signed a co-development and profit sharing agreement with Ergomed whereby Ergomed will assume up to $3 million in clinical and regulatory costs for Multikine in HIV/HPV co-infected men and women with peri-anal warts.
- Signed a co-development and profit sharing agreement with Ergomed whereby Ergomed will assume up to $3 million in clinical and regulatory costs for Multikine in HIV/HPV co-infected women with cervical dysplasia.
- Received country approval to expand the Phase III head and neck cancer trail into Croatia and Bosnia-Herzegovina.
- Raised gross proceeds of approximately $21,100,000 through two common stock offerings.
- Listed warrants issued in connection with the October 2013 public offering.
- Initiated an arbitration claim against former clinical research organization inVentiv for at least $50 million in damages. CEL-SCI’s arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud.
CEL-SCI reported an operating loss of ($5,934,310) for the quarter ended December 31, 2013 versus an operating loss of ($5,044,457) for the quarter ended December 31, 2012. The rise in operating loss was mostly attributable to an increase in research and development expenses to $4,019,541 in the first quarter of fiscal 2014 compared to $2,924,722 in the first quarter of fiscal year 2013. R&D expenses increased because of the increased level of activity associated with conducting the Company’s Phase III clinical study for head and neck cancer.
CEL-SCI's net loss available to common shareholders for the quarter ended December 31, 2013 was ($5,451,865) or ($0.11) per basic share, versus ($2,310,246) or ($0.08) per basic share during the quarter ended December 31, 2012. On December 31, 2013 the Company had approximately $13,500,000 in cash and cash equivalents.
“The first quarter of fiscal year 2014 was marked by key achievements on numerous fronts including fund raising that significantly improved our balance sheet. We signed co-development agreements to pursue two additional indications for Multikine, while we continue to expand our site approval and patient enrollment for our Phase III head and neck cancer study,” stated CEL-SCI Chief Executive Officer Geert Kersten.
“During, and subsequent to, the first quarter of 2014, working with our partners, including Ergomed and the U.S. Navy, we demonstrated our ability to execute on all fronts. The U.S. Navy CRADA we entered into during the first quarter of fiscal year 2014 led to the Navy’s approval in January to commence our Phase I study. The warrants which we listed during the first the quarter of fiscal year 2014 were approved for trading on the NYSE MKT in February. We expect to continue to deliver solid clinical progress in the balance of fiscal year 2014,” Kersten concluded.
Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is in a global 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 enrollments of subjects by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in 20 countries.
In November 2013, CEL-SCI announced that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine investigational new drug immunotherapy was completed by the Independent Data Monitoring Committee (IDMC). The Committee, which is comprised of world class leaders in head and neck cancer, concluded that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* 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 report, 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, 2013. 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.
|STATEMENTS OF OPERATIONS|
|THREE MONTHS ENDED DECEMBER 31, 2013 AND 2012|
|Research and development (excluding|
R&D depreciation of $41,673 and $104,864 respectively, included below)
|Depreciation and amortization||56,699||133,450|
|General & administrative||1,971,214||2,001,285|
|Total operating expenses||6,047,454||5,059,457|
|GAIN ON DERIVATIVE INSTRUMENTS||1,610,817||2,746,198|
|ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS||(1,117,447||)||-|
|NET LOSS AVAILABLE TO COMMON SHAREHOLDERS||$||(5,451,865||)||$||(2,310,246||)|
|NET LOSS PER COMMON SHARE|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
- Health Care Industry
Gavin de Windt, 703-506-9460