CEL-SCI Corporation Reports First Quarter Fiscal 2021 Financial Results

2/16/21

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2020, as well as key clinical and corporate developments.

Clinical and Corporate Developments include:

  • In December 2020, CEL-SCI updated the status of its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection). Data lock has been completed, and the study entered its final stage of statistical analysis. CEL-SCI remains blinded to the study data and is not involved in this process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define the clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The analysis looks at multiple parameters to gain the most information on the possible benefits of using Multikine immunotherapy as a first line treatment before standard of care for these patients.
  • CEL-SCI continued expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction, which began in 2020, is expected to be completed in the coming months and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
  • In December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse model as compared to 0% survival in the two control groups. These studies were conducted at the University of Georgia Center for Vaccines and Immunology. As COVID-19 mutations increase, LEAPS COV-19’s mechanism of action which targets the non-mutating part of the SARS-CoV-2 virus is becoming more important.
  • In December 2020, CEL-SCI sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. On December 31, 2020, CEL-SCI’s cash position was approximately $21.9 million. After December 31, 2020, CEL-SCI has received approximately $3.9 million through the exercise of warrants and stock options.

“As the data analysis for our Phase 3 trial is being conducted, we are focused on expanding manufacturing of Multikine so that we will be ready to produce significant commercial quantities for this unmet medical need. We believe that Multikine may add substantial clinical benefit and help these patients.” stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of approximately $7.9 million for the quarter ended December 31, 2020 versus net loss of approximately $5.5 million for the quarter ended December 31, 2019.

During the three months ended December 31, 2020, CEL-SCI incurred approximately $3.6 million in costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.5 million, of which approximately $6.7 million has been incurred through December 31, 2020.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck, are treated with the investigational product Multikine first, BEFORE they received surgery, radiation and/or chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen right after diagnosis and prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 (death) events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the statistical analysis phase.

The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment for COVID-19 infection. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.