CEL-SCI Corporation Reports Second Quarter Fiscal 2018 Financial Results
VIENNA, Va.--(BUSINESS WIRE)--May 15, 2018--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2018. The Company also reported key clinical and corporate developments achieved during the quarter.
Clinical and Corporate Developments included:CEL-SCI’s Phase 3 head and neck cancer study has been fully enrolled since September 2016. All 928 patients are being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the 298 deaths have occurred and it can be determined if the primary endpoint has been met. Closing arguments in the arbitration against the former clinical research organization (CRO) for the Phase 3 trial concluded on April 25, 2018. The parties are now awaiting a decision from the arbitrator. The U.S. Patent and Trademark Office allowed a patent for CEL-SCI’s LEAPS technology for methods of inducing immune responses.
“We expect two significant and material outcomes in the near term. In the very near term we are awaiting a decision from the arbitrator in our case against our former CRO. The read out of the Phase 3 study is expected to take longer than the decision by the arbitrator, however, based on overall survival data available in the scientific literature for the study’s patient population and the fact that the last patient was enrolled in the study over 1.5 years ago, we believe that the end of the Phase 3 trial is approaching as well,” said CEL-SCI’s Chief Executive Officer, Geert Kersten. “Separately, we continue to advance our LEAPS technology through preclinical studies in preparation for human clinical studies. The current work with the Rheumatoid Arthritis vaccine is funded by a $1.5 million grant from the National Institutes of Health.”
During the six months ended March 31, 2018, CEL-SCI’s cash increased by approximately $0.7 million. Significant components of this increase include net proceeds from the sale of CEL-SCI’s common stock of approximately $7.1 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $6.4 million.
CEL-SCI reported an operating loss of ($4,205,745) for the quarter ended March 31, 2018 versus an operating loss of ($7,906,557) for the quarter ended March 31, 2017. The operating loss was ($9,117,175) for the six months ended March 31, 2018 versus an operating loss of ($12,844,565) for the six months ended March 31, 2017.
The research and development expenses decreased by approximately $4.8 million compared to the six months ended March 31, 2017. The majority of CEL-SCI’s research and development expense relates to its on-going Phase 3 clinical trial. Clinical trial costs tend to be higher during the enrollment phase of the study and because the study is fully enrolled, the expenses incurred over the last six months have decreased. The general and administrative expenses increased by approximately $1.3 million compared to the six months ended March 31, 2017. This increase is primarily due to an increase of approximately $1.0 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan, and a net increase of approximately $0.3 million in other general and administrative expenses primarily for accounting fees and public relations services.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection), BEFORE they have received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. CEL-SCI has received patents for Multikine from the US, Europe, China and Japan.
The Company’s LEAPS technology is being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. 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, 2017. 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.
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CONTACT: CEL-SCI Corporation
Gavin de Windt, 703-506-9460
KEYWORD: UNITED STATES NORTH AMERICA DISTRICT OF COLUMBIA VIRGINIA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS INFECTIOUS DISEASES ONCOLOGY
SOURCE: CEL-SCI Corporation
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PUB: 05/15/2018 04:20 PM/DISC: 05/15/2018 04:20 PM