On December 22, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, DEC 22, 2021, View Source [SID1234597625]).

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Clinical and Corporate Developments included:

On October 22, 2021, CEL-SCI announced it completed the commercial scale expansion of its dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures its immunotherapy Multikine (Leukocyte Interleukin, Injection)*. The construction, which began in 2020, was designed to ensure it will be compliant with all requirements of the U.S. Food and Drug Administration’s (FDA) and European cGMP regulations as the facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it receives regulatory approval.
On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for Multikine in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant (two-sided p=0.0236, HR=0.68), robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): the Multikine treatment arm showed 62.7% overall survival versus the control arm which showed only 48.6% overall survival.
The OS benefit of 14.1% at 5 years for this treatment arm exceeded the 10% OS benefit set out for the study population in the protocol. The results from the Phase 3 cancer study proved that Multikine met all of protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies.
Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with the FDA for approval of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the head and neck patients scheduled to receive surgery and radiation as their primary treatments. CEL-SCI’s trial was conducted in over 20 countries in which marketing clearance applications may also be filed subsequent to FDA filing and/or approval.
CEL-SCI raised net proceeds of approximately $54.1 million during fiscal 2021 through the sale of common stock and the exercise of warrants and options. As of September 30, 2021, CEL-SCI had $42.2 million in cash, cash equivalents and U.S. Treasury Bills.
"Having conducted and completed the largest ever study in head and neck cancer, we are filing for regulatory approval with confidence that Multikine extends life in this severely unmet medical need. Our team has delivered and continues to work hard at preparing our BLA filing, validating and preparing our manufacturing facility for commercial production and publishing our data in peer reviewed journals. With a solid cash runway, we are optimistic about the future and the potential for Multikine to improve the lives of head and neck cancer patients and their families," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of $36.4 million in fiscal year 2021 versus a net loss of $30.3 million in fiscal year 2020. The increase in net loss was predominantly due to an increase in research and development expenses by approximately $5.3 million, or 30%, and an increase in general and administrative expenses by approximately $1.4 million, or 12%, compared to the year ended September 30, 2020. With the conclusion of the Phase 3 study, the expenditures for fiscal 2022 are expected to be lower.