CEL-SCI launches confirmatory study for head and neck cancer drug

CEL-SCI launches confirmatory study for head and neck cancer drug

Gold slides as U.S.-Iran conflict lifts oil, hawkish Fed bets grow VIENNA, Va. - CEL-SCI Corporation (NYSE American:CVM) announced today it is launching a global confirmatory registration study of Multikine as a neoadjuvant treatment for newly diagnosed, resectable, locally advanced head and neck cancer. The company, with a market capitalization of $24.1 million, has seen its stock price gain nearly 9% over the past week to $1.38, though shares remain down 73% over the past six months as investors await regulatory progress. The multi-center study will enroll approximately 212 patients in the United States, Europe, Asia, and South America, according to a press release statement.

Orient EuroPharma, the company’s strategic partner in Taiwan, will oversee and fund patient enrollment within its territory. The partnership comes as InvestingPro data shows CEL-SCI is quickly burning through cash with a current ratio of 0.6, indicating short-term obligations exceed liquid assets. The company reported negative levered free cash flow of $16.7 million over the last twelve months.

InvestingPro subscribers have access to 11 additional ProTips about CVM’s financial health and market position. The study targets patients with newly diagnosed, previously untreated, resectable, locally advanced squamous cell carcinoma whose tumors exhibit low or zero PD-L1 expression and who present with no clinical lymph node involvement at entry. The study is designed with approximately 97% statistical power to detect a previously observed 0.34 hazard ratio based on overall survival.

In CEL-SCI’s completed 928-patient Phase 3 study, 114 patients in the target cohort who received a three-week regimen of Multikine prior to standard of care experienced a 73% five-year overall survival rate compared to 45% for patients treated with standard of care alone. The previous Phase 3 study showed a pre-surgical objective response rate of 13% in the Multikine arm versus 0% in the control arm within the target population. Pre-surgical downstaging was observed in 35% of Multikine-treated patients compared to 13% of controls.

CEL-SCI stated it intends to utilize early, pre-surgical objective responses to support potential accelerated or conditional approval applications globally. Multikine is an investigational cancer immunotherapy designed to be administered prior to surgery, radiation, or chemotherapy. The drug has been administered to over 740 patients across its clinical development program and has received Orphan Drug designation from the FDA for neoadjuvant therapy of squamous cell carcinoma of the head and neck.

Multikine has not been licensed or approved for sale by the FDA or any other regulatory agency. Despite current financial challenges, analysts maintain a bullish outlook with a price target of $25, suggesting substantial upside from current levels. According to InvestingPro analysis, the stock appears undervalued based on Fair Value calculations.

Investors can explore more undervalued opportunities on the Most Undervalued Stocks list, along with comprehensive financial health scores and expert insights available exclusively to InvestingPro subscribers. In other recent news, CEL-SCI Corporation has announced several significant developments. The company completed a public offering of 6,000,000 shares at $1.20 per share, raising approximately $7.2 million in gross proceeds, and also closed another stock offering of 2,500,000 shares at $1.00 per share, generating about $2.5 million.

These offerings were facilitated by ThinkEquity, which served as the sole placement agent. Furthermore, CEL-SCI signed a distribution agreement with Saudi Amarox for the commercialization of its investigational cancer immunotherapy, Multikine, in Saudi Arabia and potentially other Gulf Cooperation Council countries, pending regulatory approvals. This agreement was formalized during the BIO International Convention 2026 in San Diego.

Additionally, CEL-SCI plans to initiate a confirmatory registration study for Multikine targeting locally advanced head and neck cancer. The study will involve 212 newly diagnosed patients with specific tumor characteristics who showed promising results in a previous Phase 3 study. This patient group achieved a 73% five-year overall survival rate when treated with Multikine before surgery and standard therapy, compared to a 45% survival rate with standard care alone.

These recent activities underscore CEL-SCI’s ongoing efforts to advance its cancer treatment initiatives and expand its market reach.