On February 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2018 (Press release, Cel-Sci, FEB 14, 2019, View Source [SID1234533333]).

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CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016.
The U.S. Patent and Trademark Office issued two new patents for CEL-SCI’s LEAPS platform technology. The inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating immune response through the use of specific peptides.
During the first quarter, CEL-SCI’s LEAPS platform technology continued its development program as a therapeutic vaccine for rheumatoid arthritis under a $1.5 million grant from the U.S. National Institutes of Health (NIH).
Between January 1, 2019 and February 13, 2019, the Company received approximately $2.1 million through the exercise of warrants to purchase shares of the Company’s common stock.
"During the first quarter of fiscal 2019, we continued to follow patients in our Phase 3 head and neck cancer trial, as we await a readout of topline results from this pivotal study, which may result in the first new approved first line therapy for advanced primary (not yet treated) head and neck cancer in over 60 years. Concurrently, we continue to advance our LEAPS platform through studies with the NIH while fortifying our intellectual property around this unique vaccine technology," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net income of $1.2 million for the quarter ended December 31, 2018 versus a net loss of $6.2 million for the quarter ended December 31, 2017. The net income increase was mainly due to the non-cash derivative gain of approximately $5.6 million for the three months ended December 31, 2018 versus a loss on derivative instruments of approximately $1.0 million for the three months ended December 31, 2017. Net interest expense also decreased by approximately $0.6 million for the three months ended December 31, 2018 compared to the three months ended December 31, 2017. The total operating expense remained constant for the quarter ended December 31, 2018 versus the quarter ended December 31, 2017.