ORGANIZATION

12 Months Ended

Sep. 30, 2020

ORGANIZATION

1. ORGANIZATION

1.

ORGANIZATION

CEL-SCI Corporation (the Company) was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products. The Company is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has recently reached the end of the pivotal Phase 3 study for its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), involving head and neck cancer, for which the Company has received Orphan Drug Status from the United States Food and Drug Administration (FDA). The Phase 3 study is in the final statistical analysis phase. Unlike other immune therapies, Multikine is administered locally at the site of the tumor as a first line treatment right after diagnosis, before surgery, radiation and/or chemotherapy. The goal is to help the intact immune system kill the micro metastases that usually cause recurrence of the cancer. CEL-SCI is investigating a peptide-based immunotherapy (CEL-4000) as a vaccine for rheumatoid arthritis using its LEAPS technology platform. CEL-SCI is in the process of completing pre-IND studies for CEL-4000 and hopes to start human studies with CEL-4000 in 2021. CEL-SCI is also investigating LEAPS COVID-19 conjugates as a potential treatment of COVID-19 in hospitalized and at-high-risk patients at the University of Georgia’s Center for Vaccines and Immunology. Initial animal experiments showed that LEAPS COVID-19 conjugates induced faster and much higher than expected antibody responses against a non-mutating region of the virus that causes COVID-19, after only one injection. These experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19. These SARS-CoV-2 challenge studies being conducted at UGA’s Center for Vaccines and Immunology seek to repeat the success of animal challenge studies conducted previously at the National Institutes for Allergies and Infectious Diseases (NIAID) emerging diseases laboratory during the threatened H1N1 flu pandemic.