On May 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2019 (Press release, Cel-Sci, MAY 14, 2019, View Source [SID1234536282]). The Company also reported key clinical and corporate developments achieved during the quarter.
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Clinical and Corporate Developments included:
At the end of March 2019, the IDMC (Independent Data Monitoring Committee) had an official review of the Phase 3 study and recommended to "continue the trial until the appropriate number of events has occurred".
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 (deaths) 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 Journal of Clinical & Cellular Immunology published an article titled, "Why Don’t We Have a Vaccine Against Autoimmune Diseases?" co-written by Dr. Ken Rosenthal of Roseman University College of Medicine, and CEL-SCI’s Roy Carambula, Research Associate and Daniel Zimmerman Ph.D., Senior Vice President of Research, Cellular Immunology. As presented in the article, vaccines for autoimmune diseases need to be therapeutic and focused on cellular immunity as CEL-SCI’s LEAPS vaccine platform does, as compared to most current vaccines that elicit a specific antibody response.
On May 11, 2019, Dr. Zimmerman presented new data for its LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis at the American Association of Immunologists 103rd Annual Meeting. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois.
CEL-SCI’s LEAPS platform technology was selected by the U.S. National Institutes of Health (NIH) for sponsorship to exhibit and showcase its presentation at the BIO International Convention, to be held June 3-6, 2019 in Philadelphia.
The U.S. Patent and Trademark Office issued two patents to CEL-SCI for its LEAPS platform vaccine technology. One is titled "Method for inducing an immune response and formulations thereof" and the other is titled "Method for inducing an immune response for treatment of cancer and autoimmune diseases or conditions".
Between April 1, 2019 and May 13, 2019, the Company received approximately $7.6 million through the exercise of warrants to purchase shares of the Company’s common stock.
"During the second quarter of fiscal 2019, we were pleased to receive the IDMC’s recommendation to continue with our Phase 3 study until the appropriate number of events have occurred. Since the IDMC reviews study data that is blinded to us, we believe their recommendation affirms the study’s potential to meet the primary survival endpoint. We believe this is a very positive sign," stated CEL-SCI CEO, Geert Kersten. "In addition to the Phase 3 head and neck cancer, we continue to advance the development of our LEAPS vaccine platform through new patents, new published scientific papers, and ongoing studies with the National Institutes of Health."
CEL-SCI reported a net loss of $5.2 million for the six months ended March 31, 2019 versus a net loss of $10.9 million for the six months ended March 31, 2018. CEL-SCI reported a net loss of $6.4 million for the quarter ended March 31, 2019 versus a net loss of $4.7 million for the quarter ended March 31, 2018.
During the six months ended March 31, 2019, the Company’s cash decreased by approximately $4.8 million. Significant components of this decrease included net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $7.8 million and approximately $0.2 million to purchase long term assets. The decrease was offset by net proceeds from the exercise of warrants of approximately $3.3 million.