On December 16, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2019 (Press release, Cel-Sci, DEC 16, 2019, View Source [SID1234552408]). The Company also reported key clinical and corporate developments achieved during fiscal 2019.
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Clinical and Corporate Developments included:
In March and 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) had 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. At the most recent IDMC meeting in October 2019 the IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."
CEL-SCI is now awaiting final study results in its Phase 3 head and neck cancer trial. 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 of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone will be met. The primary endpoint 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 be available soon, since the last cancer patients were treated in September 2016, and the first cancer patients in the study were treated in early 2011.
On May 11, 2019 and July 3, 2019, new data were presented on CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois. In June 2019, CEL-SCI was also an exhibitor and showcased its presentation at the BIO International Convention where it was selected to be part of the Innovation Zone sponsored by the U.S. National Institutes of Health (NIH). The focus was the Company’s experimental LEAPS platform technology and CEL-SCI’s ongoing development of a LEAPS based therapeutic antigen-specific treatment for rheumatoid arthritis.
The U.S. Patent and Trademark Office granted CEL-SCI two patents for its LEAPS technology during fiscal 2019. As announced in January 2019, the patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
Two scientific articles regarding CEL-SCI’s LEAPS program were published in March and July 2019. The Journal of Clinical & Cellular Immunology published "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 Cellular Immunology. International Immunopharmacology published "Lessons From Next Generation Influenza Vaccines For Inflammatory Disease Therapies" authored by Dr. Zimmerman and two other CEL-SCI scientists, along with Dr. Rosenthal of Northeast Ohio Medical University and Roseman University.
On June 28, 2019, CEL-SCI joined the broad-market Russell 3000 Index that was effective after the US market opened on July 1, 2019.
CEL-SCI raised approximately $14.5 million during fiscal 2019 through the exercise of warrants.
"Following the two most recent data reviews of our Phase 3 head and neck cancer trial, the Independent Data Monitoring Committee (IDMC) recommended we continue the study until the appropriate number of events (deaths) have occurred in the two main groups. We found this recommendation very encouraging because it has been almost nine years since our study started, and more patients in our trial are surviving longer than had been anticipated," stated CEL-SCI CEO, Geert Kersten.
"Since CEL-SCI is blinded to the study results, we do not know what proportion of the patients who are living longer than expected were treated with the Multikine regimen and what proportion received Standard of Care. However, it seems reasonable that a significant proportion of the patients who are living longer than predicted would have received the Multikine regimen because, to our knowledge, there has been no reported improvement in survival of the Standard of Care patients since our study began. We also believe the IDMC would not have recommended that we continue with this Phase 3 study if, after review of the clinical data, they had not seen that Multikine helps these cancer patients."
"The goal of our Phase 3 study is to keep patients alive longer by improving the current ‘intent to cure’ first line cancer treatment. We believe the delay in reaching the required number of events, 298, to conclude our study may be a predictor of a better overall survival outcome than we originally hypothesized. Yervoy, the first approved cancer immunotherapy blockbuster drug had a similar situation in its Phase 3 trial and this turned out to be a huge blessing for both patients and Bristol-Myers Squibb shareholders. At CEL-SCI, we are hoping for a similar outcome," Kersten concluded.
CEL-SCI reported a net loss of $22.1 million in fiscal year 2019 versus a net loss of $31.8 million in fiscal 2018. The decreased net loss in 2019 was mainly due to the non-cash derivative loss of approximately $0.8 million and $8.6 million recorded during the years ended September 30, 2019 and 2018, respectively, and the decrease in net interest expense of approximately $2.4 million during the year ended September 30, 2019 compared to the year ended September 30, 2018. The decrease in interest expense was primarily due to interest incurred relating to CEL-SCI’s convertible debt, all of which was converted by September 30, 2018. The derivative loss variation was the result of the change in fair value of the derivative liabilities during the period which was caused by an increase in the share price of CEL-SCI’s common stock.
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.