VIENNA, Va.--(EON: Enhanced Online News)--CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported financial results today for the fiscal year ended September 30, 2016. The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2016.
Clinical and Corporate Developments included:
- CEL-SCI raised net proceeds of approximately $21.42 million during fiscal 2016.
- During fiscal year 2016 CEL-SCI enrolled another 365 patients in the study before, on September 26, 2016, the FDA placed the study on partial clinical hold. We are completely focused on working diligently with the FDA to obtain a release of this partial clinical hold. As of September 26, 2016, 928 patients had been enrolled in the Phase 3 head and neck cancer study.
- The arbitration hearing on the merits against the former clinical research organization (CRO) began on September 26, 2016.
- The ongoing Phase 1 study with Multikine in HIV/HPV co-infected men and women continues at the University of California, San Francisco (UCSF). The Principal Investigator is a world renowned key opinion leader in the field, Dr. Joel Palefsky.
CEL-SCI reported a net loss of ($11.46) million in fiscal year 2016 versus a net loss of ($34.67) million in fiscal 2015. CEL-SCI reported an operating loss of ($25.55) million in fiscal year 2016 versus an operating loss of ($34.30) million in fiscal year 2015.
The reduction in operating loss was largely attributable to a decrease in general and administrative expenses to $6.5 million in fiscal year 2016 compared to $13.9 million in fiscal year 2015. Major components of the decrease are 1) Lake Whillans Litigation Finance took over payment of legal fees which were about $4.4 m in fiscal year 2015 in the arbitration against the former CRO that used to run the Company’s Phase 3 trial, 2) a $2.8 million decrease in share-based employee compensation costs, which relates to the timing of vesting for the incentive stock bonus plan and 3) other miscellaneous decreases netting to approximately $200,000.
Geert Kersten, CEL-SCI’s Chief Executive Officer said, “Our full focus is on two issues very important to our company: 1) the release of the partial clinical hold on the Company’s Phase 3 trial and 2) bringing to a successful conclusion the arbitration against the former CRO that used to run the Phase 3 study. That hearing on the merits, which is equivalent to a trial in a court case, started on September 26, 2016 and is ongoing.”
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 immunotherapy, 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. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an 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 (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has 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’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, 2016. 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 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. 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 in progress and that is currently subject to a clinical hold on enrollment of additional new patients.
|STATEMENTS OF OPERATIONS|
|YEARS ENDED SEPTEMBER 30, 2016 and 2015|
|GRANT INCOME AND OTHER||$||285,055||$||657,377|
|Research and development||19,351,779||21,098,147|
|General & administrative||6,486,501||13,855,775|
|Total operating expenses||25,838,280||34,953,922|
|GAIN ON DERIVATIVE INSTRUMENTS||14,013,726||282,616|
|LOSS ON DEBT EXTINGUISHMENT||-||(620,457||)|
|INTEREST INCOME (EXPENSE), net||73,001||(40,260||)|
|ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS||-||-|
|NET LOSS AVAILABLE TO COMMON SHAREHOLDERS||$||(11,466,498||)||$||(34,674,646||)|
|NET LOSS PER COMMON SHARE|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
|BASIC and DILUTED||121,655,108||82,519,027|