On May 11, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2020 and provided an update on clinical developments (Press release, Cel-Sci, MAY 11, 2020, View Source [SID1234557525]):
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On May 4, 2020, CEL-SCI announced it has been notified that it reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The database is now being prepared for database lock. Once the database has been locked, the final analysis of the trial results can be performed.
In April 2020, 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 a review of the study data and recommended to continue the trial without change. 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.
In March 2020, CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. CEL-SCI signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop the LEAPS COVID-19 immunotherapy. Initial studies with COVID-19 corona virus aim to replicate prior successful preclinical experiments of LEAPS against H1N1pandemic flu in mice conducted with National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of animals treated with the LEAPS-H1N1 construct as compared to controls. We believe that our COVID 19 approach is unique for several reasons: 1) we focus on a non-changing part of the virus and 2) our immunotherapy has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
CEL-SCI raised approximately $16.1 million in gross proceeds during the six months ended March 31, 2020 through the sale of common stock through public offerings and the exercise of warrants.
"We have completed and will soon evaluate data from our pivotal global Phase 3 study, which is the world’s largest Phase 3 study in head and neck cancer. A successful study result will provide definitive proof of the concept established in our Phase 2 head and neck cancer studies, that immunotherapy should be given as the initial treatment of cancer right after diagnosis, before surgery, chemotherapy, and radiation which severely weaken the immune system. Should the study meet its primary endpoint, we expect CEL-SCI will gain the first FDA approval for a first-line treatment for advanced primary squamous cell carcinoma of the head and neck in about 60 years. We are grateful to all the patients, clinicians and investigators, clinical sites, and the entire team at CEL-SCI and our current CROs for completing this very large pivotal Phase 3 global study." stated CEL-SCI CEO, Geert Kersten.
During the six months ended March 31, 2020, the Company’s cash increased by approximately $5.9 million. Significant components of this increase include approximately $12.9 million in net proceeds from the sale of common stock through public offerings and approximately $2.1 million in proceeds from the exercise of warrants and options, offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $8.0 million, approximately $0.8 million of equipment and leasehold improvement expenditures and approximately $0.4 million in lease payments.
CEL-SCI reported a net loss of $14.5 million for the six months ended March 31, 2020 versus a net loss of $5.2 million for the six months ended March 31, 2019. CEL-SCI reported a net loss of $9.0 million for the quarter ended March 31, 2020 versus a net loss of $6.4 million for the quarter ended March 31, 2019. The variance is largely due to the change in fair value of the derivative liabilities at the respective period ends. These changes were caused mainly by fluctuation in the share price of the Company’s common stock.