VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended June 30, 2014.
Recent key corporate and clinical developments include:
- Enrolled 54 patients in the Company’s Phase III head and neck cancer trial during the quarter, a 93% increase in sequential quarterly patient enrollment; Subsequently in July, achieved milestone of total 232 patients enrolled to date, representing over one-quarter of the total enrollment for the study.
- Added four clinical sites in the U.S. and additional clinical centers around the world for Multikine, an investigational immunotherapy being studied in a global pivotal Phase III head and neck cancer trial.
- Expanded the Phase III head and neck cancer trial into the United Kingdom during the quarter, with additional expansions post-quarter into Austria, Sri Lanka, Turkey and France.
- Raised approximately $9.84 million in net proceeds through the sale of common stock and warrants in a public offering and from the exercise of previously issued and outstanding warrants.
CEL-SCI reported an operating loss of ($6,901,329) for the quarter ended June 30, 2014 versus an operating loss of ($5,513,199) for the quarter ended June 30, 2013. The operating loss for the nine months ended June 30, 2014 was ($19,062,074) versus ($14,796,535) during the nine months ended June 30, 2013. The rise in operating loss was mostly attributable to an increase in research and development expenses to $12,627,269 in the nine month ended June 30, 2014 compared to $9,208,900 in the nine months ended June 30, 2013. R&D expenses increased because of the expansion of the Company’s Phase III clinical study for head and neck cancer and an associated increase in patient enrollment.
CEL-SCI's net loss available to common shareholders for the quarter ended June 30, 2014 was ($2,444,480) or ($0.04) per basic share, versus ($4,507,074) or ($0.15) per basic share during the quarter ended June 30, 2013. The net loss available to common shareholders for the nine months ended June 30, 2014 was ($21,261,925) or ($0.38) per basic share, versus ($7,530,621) or ($0.25) per basic share during the same nine months ended June 30, 2013. The increase in net loss for the three and nine month periods of 2014 as compared to the same periods in 2013 was primarily attributable to a non-cash charge for the change in value of derivative instruments caused by the fluctuation in the Company’s common stock share price.
During the nine months ended June 30, 2014, the Company raised approximately $31.5 million in net proceeds through the sale of common stock and warrants in a public offering and from the exercise of previously issued and outstanding warrants.
“We enrolled 54 patients in our Phase III head and neck cancer trial for the quarter ended June 30, 2014 which was the best quarter ever for us. Since the end of June, we have added four countries to the study, including two in Western Europe, and added more clinical sites in order to continue building patient enrollment. With the progress being made expanding the study by our partners and CROs, we believe our Phase III study will reach full enrollment by the end of 2015,” stated CEL-SCI Chief Executive Officer Geert Kersten.
Mr. Kersten continued, “We are also working closely with our partners, Ergomed and the U.S. Navy, to complete patient enrollment in our Phase I study for HIV/HPV co-infected men and women with peri-anal warts.”
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in a randomized, controlled, global pivotal 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 enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop 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 III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include 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 I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement).
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has recently received a Phase I SBIR Grant from the NIH to develop LEAPS as a potential treatment for RA with Rush University researchers. 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 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 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.
| CEL-SCI CORPORATION | ||||||||
| STATEMENTS OF OPERATIONS | ||||||||
| THREE MONTHS ENDED JUNE 30, 2014 AND 2013 | ||||||||
| (unaudited) | ||||||||
| 2014 | 2013 | |||||||
| OTHER INCOME | $ | 15,914 | $ | 113,728 | ||||
| OPERATING EXPENSES: | ||||||||
| Research and development (excluding | ||||||||
| R&D depreciation of $43,877 | ||||||||
| and $47,931, respectively, included below) | 4,453,730 | 3,769,538 | ||||||
| Depreciation and amortization | 65,042 | 79,008 | ||||||
| General & administrative | 2,398,471 | 1,778,381 | ||||||
| Total operating expenses | 6,917,243 | 5,626,927 | ||||||
| OPERATING LOSS | (6,901,329 | ) | (5,513,199 | ) | ||||
| GAIN ON DERIVATIVE INSTRUMENTS | 4,467,776 | 1,079,392 | ||||||
| INTEREST INCOME | 30,795 | 29,027 | ||||||
| INTEREST EXPENSE | (41,722 | ) | (42,763 | ) | ||||
| NET LOSS | (2,444,480 | ) | (4,447,543 | ) | ||||
| MODIFICATION OF WARRANTS | - | (59,531 | ) | |||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (2,444,480 | ) | $ | (4,507,074 | ) | ||
| NET LOSS PER COMMON SHARE | ||||||||
| BASIC | $ | (0.04 | ) | $ | (0.15 | ) | ||
| DILUTED | $ | (0.11 | ) | $ | (0.18 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES | ||||||||
| OUTSTANDING | ||||||||
| BASIC | 64,664,274 | 30,930,650 | ||||||
| DILUTED | 64,664,274 | 30,930,650 | ||||||
| CEL-SCI CORPORATION | ||||||||
| STATEMENTS OF OPERATIONS | ||||||||
| NINE MONTHS ENDED JUNE 30, 2014 AND 2013 | ||||||||
| (unaudited) | ||||||||
| 2014 | 2013 | |||||||
| OTHER INCOME | $ | 196,215 | $ | 144,133 | ||||
| OPERATING EXPENSES: | ||||||||
| Research and development (excluding | ||||||||
| R&D depreciation of $127,268 and $208,750 | ||||||||
| respectively, included below) | 12,627,269 | 9,208,900 | ||||||
| Depreciation and amortization | 173,185 | 302,871 | ||||||
| General & administrative | 6,457,835 | 5,428,897 | ||||||
| Total operating expenses | 19,258,289 | 14,940,668 | ||||||
| OPERATING LOSS | (19,062,074 | ) | (14,796,535 | ) | ||||
| (LOSS) GAIN ON DERIVATIVE INSTRUMENTS | (1,053,755 | ) | 7,363,854 | |||||
| INTEREST INCOME | 93,434 | 89,394 | ||||||
| INTEREST EXPENSE | (122,083 | ) | (127,803 | ) | ||||
| NET LOSS | (20,144,478 | ) | (7,471,090 | ) | ||||
| ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS | (1,117,447 | ) | - | |||||
| MODIFICATION OF WARRANTS | - | (59,531 | ) | |||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (21,261,925 | ) | $ | (7,530,621 | ) | ||
| NET LOSS PER COMMON SHARE | ||||||||
| BASIC | $ | (0.38 | ) | $ | (0.25 | ) | ||
| DILUTED | $ | (0.38 | ) | $ | (0.50 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES | ||||||||
| OUTSTANDING | ||||||||
| BASIC | 56,343,806 | 30,038,324 | ||||||
| DILUTED | 56,343,806 | 30,038,324 | ||||||
