On December 29, 2017 CEL-SCI Corporation (NYSE American: CVM) reported financial results today for the fiscal year ended September 30, 2017 (Press release, Cel-Sci, DEC 29, 2017, View Source [SID1234522862]). The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2017.
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Clinical and Corporate Developments included:
Full enrollment was achieved in CEL-SCI’s pivotal Phase 3 head and neck cancer study. The study’s Independent Data Monitoring Committee (IDMC) completed its most recent review of the data from all 928 patients enrolled in the study and recommended continuing the study as constituted, as there was no evidence of any significant safety questions.
CEL-SCI’s LEAPS vaccine for the treatment of rheumatoid arthritis received a $1.5 million grant from the U.S. National Institutes of Health (NIH). The grant provides funding for CEL-SCI to advance its first LEAPS product candidate, CEL-4000, towards an Investigational New Drug (IND) application. Preclinical data on CEL-4000 were presented at several scientific conferences and published in a scientific journal during fiscal 2017.
In the $50 million arbitration suit brought by CEL-SCI against its former clinical research organization (CRO), the testimony phase of the arbitration has concluded, and all that remains at the trial level are closing statements and post-trial submissions.
CEL-SCI raised approximately $14.7 million gross proceeds during fiscal 2017.
"While we went through a challenging period during fiscal 2017, we are pleased to move forward with the achievement of our biggest milestone to date, completion of enrollment and treatment of all 928 patients in the world’s largest head and neck cancer study," stated CEL-SCI CEO, Geert Kersten. "The study is now fully enrolled. Per the recommendation of the study’s IDMC to continue the study, in accordance with the study protocol, the enrolled patients are being followed for survival outcome. After 298 patient deaths have occurred in the two comparator arms of the study the company will be able to determine if the study’s endpoint is achieved."
CEL-SCI reported a net loss of ($14.36) million in fiscal year 2017 versus a net loss of ($11.51) million in fiscal 2016.
The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.