On August 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2019 (Press release, Cel-Sci, AUG 14, 2019, View Source [SID1234538742]). The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

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 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 was 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.
On June 3-6, 2019, CEL-SCI was an exhibitor and showcased its presentation at the BIO International Convention. CEL-SCI 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 NIH has funded research studies for CEL-SCI’s LEAPS technology in the treatment of rheumatoid arthritis through a $1.5 million grant. There was a lot of corporate interest in the LEAPS technology for rheumatoid arthritis.
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.
Following this quarter, between July 1, 2019 and August 13, 2019, the Company received over $2.5 million through the exercise of warrants to purchase shares of the Company’s common stock.
"We look forward to the readout of our Phase 3 data, as we believe Multikine immunotherapy may increase the success rate of the first ‘intent to cure’ cancer treatment regimen by adding the tumor cell killing ability of the still healthy immune system to the known anti-tumor effects of surgery, radiation and chemotherapy. Multikine is unique in cancer immunotherapy because it can potentially be effective when administered for just three weeks, right after diagnosis and prior to surgery, as compared to other immuno-oncology drugs on the market today that are used to treat people with recurrent cancer, or end stage disease," stated CEL-SCI CEO, Geert Kersten. "Our experimental LEAPS vaccine platform continues to show promise as we continue IND-enabling studies in conjunction with the NIH."

CEL-SCI reported a net loss of $17.3 million for the nine months ended June 30, 2019 versus a net loss of $16.9 million for the nine months ended June 30, 2018. The net loss increase was in large part due to the change in value of the non-cash derivative instruments that were caused mainly by fluctuation in the share price of the Company’s common stock.

During the three months ended June 30, 2019, the Company’s cash increased by approximately $4.0 million, as compared to the second quarter of fiscal 2019, to $9.5 million. Significant components of this increase included net proceeds from the exercise of warrant and stock options of approximately $8.4 million and the purchase of common stock by officers and directors of approximately $0.2 million. The increase was offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.6 million.