CEL-SCI

Innocan Pharma achieved significant milestones in 2024, including FDA agreement on preclinical and Phase 1 clinical development plans for its liposome-cannabidiol technology (LPT-CBD) for chronic pain treatment. The FDA also acknowledged LPT-CBD under the 505(b)(2) pathway, accelerating patent utilization and commercialization. Additionally, the FDA's Center for Veterinary Medicine granted Innocan a fee waiver and an Investigational New Animal Drug (INAD) number for LPT-CBD's veterinary development. These advancements position Innocan to accelerate its development in 2025, aiming to deliver innovative pain management solutions for both human and veterinary applications.

CEL-SCI's FDA-approved 212-patient study of Multikine in head and neck cancer focuses on patients with 73% survival rate vs 45% in controls. The study targets newly diagnosed, locally advanced, primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression. Multikine showed significant tumor regression in 3 weeks of pre-surgical therapy, with 5 complete regressions in the Phase 3 study. Selection criteria are supported by strong statistical significance (p=0.0015) and align with Multikine's biological mechanism.

Phibro Animal Health Corporation sued FDA for allegedly violating the Administrative Procedure Act by withdrawing carbadox approvals without a hearing. The court dismissed the case, citing prudential ripeness, as FDA had not yet denied Phibro's hearing request, and noting that appeals of such orders fall under federal courts of appeals jurisdiction.

CEL-SCI Corporation plans to offer up to $150M of common, preferred, convertible preferred stock, rights, warrants, and units. The securities will be sold at prices and terms determined at or prior to the time of sale, considering market conditions. The offering includes reoffering shares held by certain shareholders. Specific terms will be detailed in accompanying prospectus supplements. CEL-SCI may sell securities directly, through agents, or underwriters. The securities are speculative and involve high risk, suitable only for those who can afford to lose their investment. CEL-SCI's common stock trades on the NYSE American under the symbol 'CVM'.

The FDA’s CVM hosts a virtual One Health symposium on Nov. 19, 2024, focusing on animal drug safety, development for minor species, cell-based products, and novel food ingredients. The event offers 4 hours of RACE CE credit for live attendees.

CEL-SCI selects Ergomed as CRO for FDA confirmatory study of Multikine® in head and neck cancer, targeting 212 patients with no lymph node involvement and low PD-L1 expression. Study to commence Q1 2025.