The company previously received notice on July 12, 2018, indicating that the company was not in compliance with Section 1003(a) (i), Section 1003(a) and Section 1003(a) of the listing requirements of the Exchange since it reported a stockholders' equity deficit as of March 31, 2018 and had net losses in its 5 most recent fiscal years ended September 30, 2017.
Specifically, the company has resolved the continued listing deficiency with respect to Section 1003(a) (i), Section 1003(a) and Section 1003(a) of the company Guide referenced in the Exchange's letter dated July 12, 2018 by having a total value of market capitalization of at least USD 50m , at least 1.1m publicly held shares with a market value of at least USD 15m and 400 round lot shareholders.
The exchange also indicated that as is the case for all listed issuers, the company's continued listing eligibility will continue to be assessed on an ongoing basis.
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 treats patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine first, before they receive surgery, radiation and/or chemotherapy.
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's 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 are treated with the Multikine treatment regimen for three weeks prior to the Standard of Care which involves surgery, chemotherapy and/or radiation.
Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby better 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.
The company's LEAPS technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
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