On May 16, 2024 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, MAY 16, 2024, View Source [SID1234643415]).

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Clinical and Corporate Developments include:

In May 2024, CEL-SCI received the go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer based on very strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The survival benefit for the target population treated with Multikine vs standard of care alone was so strong and clear that the confirmatory study only needs to enroll 212 people. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).

According to statisticians, the Registration Study is highly likely to succeed because it aims to confirm prior findings and to show a 10% absolute survival benefit vs control at 5 years following treatment. In the Phase 3 study, Multikine demonstrated the following in the target population:
28% absolute survival benefit vs control at 5 years
Risk of death cut in half compared to control at 5 years
73% survival for Multikine vs 45% in the control at 5 years
No safety signals or toxicities vs standard of care
More detailed results may be viewed here: LINK
In February 2024, CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a regulatory approval of Multikine.
In January 2024, the European Medicines Agency’s Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union. The waiver is a significant step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
CEL-4000, CEL-SCI’s LEAPS vaccine technology, was featured in an article titled "Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines" published in the peer reviewed journal Frontiers in Immunology. The article articulates how CEL-4000 may deliver a safe and effective therapy for rheumatoid arthritis by rebalancing inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may.
"We are eager to commence our FDA Registration Study to confirm the remarkable overall survival benefits Multikine delivered for patients in our target population. The FDA has acknowledged the great unmet need in this patient population. Through the wealth of data produced in our Phase 3 trial, we were able to identify the precise selection criteria for patients and the corresponding diagnostics to identify these patients prior to surgery. This achievement paved the way for us to get FDA agreement to conduct a study on what could become a pre-surgical standard of care in head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We believe the Registration Study is de-risked, thereby building even more confidence in CEL-SCI and our prospects for Multikine in other solid-tumor cancers."

Financial Results

Research and development expenses decreased by $2.5 million, or 22%, to approximately $9 million during the six months ended March 31, 2024, compared to $11.5 million for the six months ended March 31, 2023. General and administrative expenses in the six months ended March 31, 2024 were $4.6 million compared to $4.4 million in the six months ended March 31, 2023. During the six months ended March 31, 2024, net loss narrowed by $2.2 million or 14% to $14.0 million, approximately $5.3 million of which are non-cash expenses, from $16.4 million in the prior year period. CEL-SCI raised gross proceeds of approximately $7.75 million through a public offering of common stock during the second fiscal quarter.