On August 11, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2020 and provided an update on clinical developments (Press release, Cel-Sci, AUG 11, 2020, View Source [SID1234563449]):
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CEL-SCI reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its global pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The study is currently in the database lock and analysis phase. CEL-SCI will be advised of the results when the analysis is finalized, and the study results will be announced to the public and investors at that time.
CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The initial animal experiments showed that after only one injection, LEAPS COVID-19 conjugates induced antibody responses faster and in much higher titers than expected against a non-mutating region of the virus that causes COVID-19. These animal experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19, at the University of Georgia Vaccine Center.
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 aim to replicate prior successful preclinical experiments of LEAPS against the H1N1pandemic flu virus in mice conducted at and in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of H1N1 infected animals treated with the LEAPS-H1N1 construct as compared to controls. CEL-SCI believes its COVID-19 approach is unique for two reasons: 1) LEAPS focuses on a non-changing part of the virus; and 2) LEAPS has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
CEL-SCI raised approximately $27.0 million in gross proceeds during the nine months ended June 30, 2020 through the sale of common stock through public offerings and the exercise of warrants.
"Our goal is to create the first non-toxic cancer drug that is effective in increasing survival. This is the first cancer drug in decades that would be used to improve the success rate of the current first ‘intent to cure’ head and neck cancer standard of care treatment. Now that the long Phase 3 study is finished, the organizations who run the study are responsible for cleaning up/collecting all final data and analyzing it. This is a very big job since the study ran for 9.5 years in 100 hospitals in 24 countries. Once we know the final study results, we will share them with our shareholders. We believe that our Multikine will help these patients," stated CEL-SCI CEO, Geert Kersten.
During the nine months ended June 30, 2020, the Company’s cash increased by approximately $11.7 million. Significant components of this increase include approximately $14.0 million in net proceeds from the sale of common stock through public offerings, approximately $12.1 million in proceeds from the exercise of warrants and options and employee stock purchases of approximately $0.2 million, offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $11.7 million, approximately $1.6 million of equipment and leasehold improvement expenditures, approximately $0.7 million for payments of stock issuance costs and approximately $0.6 million in lease payments.
CEL-SCI reported a net loss of $24.7 million for the nine months ended June 30, 2020 versus a net loss of $17.3 million for the nine months ended June 30, 2019. CEL-SCI reported a net loss of $10.2 million for the quarter ended June 30, 2020 versus a net loss of $12.1 million for the quarter ended June 30, 2019.