On February 10, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2019 (Press release, Cel-Sci, FEB 10, 2020, View Source [SID1234554101]).
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In October 2019, the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) performed an official review of the study data and recommended that the trial continue until the appropriate number of events has occurred. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. The IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."
The Company is now awaiting final study results for the Phase 3 trial, which is the largest study in the world in head and neck cancer. All that remains to be done is to continue to track patient survival until the required number of events have occurred and all of the data have been reviewed and recorded in the study database to allow a determination to be made if the primary endpoint has been met. The primary endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus standard of care (SOC) vs. SOC alone, the two main comparator arms of the study.
"Our study has now been running for 9 years with the last patients being enrolled in September 2016. We believe that the delay in reaching 298 events is a good sign for the study because patients appear to be living longer than was expected when the study was planned. However, we would be surprised if the study did not end soon. Since the study is well controlled and the SEER data base shows no improvement in the survival of patients treated with standard of care since the study began, it seems illogical that the patients living longer than expected would be patients receiving the standard of care therapies only. We are therefore preparing for commercial scale production of Multikine at our manufacturing facility," stated CEL-SCI CEO, Geert Kersten.
In December 2019, the Company raised gross proceeds of approximately $5.5 million through an underwritten public offering of 606,395 shares of its common stock at a price of $9.07 per share. In January 2020, the underwriters fully exercised the over-allotment option of an additional 90,959 shares of common stock at a price of $9.07 per share bringing the total gross proceeds to approximately $6.325 million.
CEL-SCI reported a net loss of approximately $5.5 million for the quarter ended December 31, 2019 versus net income of approximately $1.2 million for the quarter ended December 31, 2018. The net income decrease was mainly due to the non-cash derivative gain of approximately $0.8 million for the three months ended December 31, 2019 versus a gain on derivative instruments of approximately $5.6 million for the three months ended December 31, 2018. Net interest expense also decreased by approximately $0.2 million for the three months ended December 31, 2019 compared to the three months ended December 31, 2018.
CEL-SCI’s total operating expense increased by approximately $1.6 million for the quarter ended December 31, 2019 versus the quarter ended December 31, 2018. General and administrative expenses increased by approximately $0.9 million compared to the three months ended December 31, 2018. Approximately $0.7 million of the change relates to an increase in the non-cash employee stock compensation expense. Research and development expenses increased by approximately $0.7 million compared to the three months ended December 31, 2018. Major components of this increase include approximately $0.7 million of cost incurred preparing the manufacturing facility for the potential commercial manufacture of Multikine, $0.5 million increase in non-cash employee stock option expense and $0.2 million increase in depreciation expense on the manufacturing facility as a result of adopting the new leasing standard. These increases were offset by a decrease of approximately $0.7 million in expenses related to the Company’s on-going Phase 3 clinical trial.