CEL-SCI Corporation Announces Q2 Fiscal 2024 Financial Results

CEL-SCI Corporation, listed on the NYSE American under the ticker CVM, released its financial results for the quarter ending on March 31, 2024, along with significant clinical and corporate updates. Here are the key developments and financial outcomes for the period.

Clinical and Corporate Advancements:

In May 2024, CEL-SCI received approval from the U.S. Food and Drug Administration (FDA) to initiate a confirmatory Registration Study for Multikine in treating head and neck cancer. This decision was based on impressive safety and efficacy data from a completed Phase 3 study involving 928 patients. The data showed a notable survival benefit for patients treated with Multikine compared to those receiving standard care alone. Because of the strong results, the new study will only need to enroll 212 patients. The FDA also endorsed the pre-surgical selection criteria for patients who would most likely benefit from Multikine. The chosen group includes those diagnosed with advanced primary head and neck cancer who have no lymph node involvement and low PD-L1 tumor expression.

Statisticians predict a high likelihood of success for the Registration Study. The goal is to confirm previous findings and demonstrate a 10% absolute survival benefit compared to the control group five years after treatment. In the Phase 3 study, Multikine showed a 28% absolute survival benefit over the control at five years, halving the risk of death compared to the control group. The survival rate was 73% for Multikine-treated patients versus 45% for the control group. Importantly, there were no significant safety issues or toxicities observed compared to the standard care.

In February 2024, CEL-SCI completed the commissioning of its cGMP manufacturing facility, marking a vital step toward regulatory approval for Multikine. Additionally, in January 2024, the European Medicines Agency’s Paediatric Committee granted CEL-SCI a waiver, removing strict requirements for cancer drug commercialization in the European Union. This waiver is a substantial milestone for the commercialization of Multikine in Europe.

CEL-SCI’s LEAPS vaccine technology, CEL-4000, was highlighted in an article published in the journal Frontiers in Immunology. The article discussed the potential of CEL-4000 to provide a safe and effective treatment for rheumatoid arthritis by rebalancing the inflammatory response without compromising critical immune defense mechanisms, thus avoiding the risks associated with current treatments.

Financial Results:

Research and development expenses dropped by $2.5 million, or 22%, to around $9 million for the six months ending on March 31, 2024, compared to $11.5 million for the same period the previous year. General and administrative expenses slightly increased to $4.6 million from $4.4 million. The net loss for the six months narrowed by $2.2 million, or 14%, to $14.0 million, with approximately $5.3 million of this amount being non-cash expenses, from $16.4 million in the prior period. CEL-SCI also raised approximately $7.75 million in gross proceeds through a public stock offering during the second fiscal quarter.

About CEL-SCI Corporation:

CEL-SCI aims to enhance a patient’s immune system while it remains intact to maximize survival chances. Multikine is designed to help the immune system target tumors when the immune system can still mount an effective attack. In the completed Phase 3 study, CEL-SCI focused on patients newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck, administering Multikine before standard treatments like surgery, radiation, or chemoradiation. This approach is unique, as most other cancer immunotherapies are only used after conventional therapies have failed.

The Phase 3 study data helped better define the target population for Multikine, specifically those with locally advanced primary head and neck cancer without lymph node involvement and low PD-L1 tumor expression. The study showed statistically significant survival benefits in this group, reducing the risk of death by half over five years compared to the control. Multikine (Leukocyte Interleukin, Injection) has received Orphan Drug designation from the FDA for neoadjuvant therapy in head and neck cancer patients.

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