CEL-SCI Corp Stock Price, News & Analysis

The FDA has approved Merck's Keytruda for treating PD-L1 positive head and neck cancer patients, which CEL-SCI (NYSE: CVM) views as a positive precedent for its Multikine therapy. While Keytruda showed a 30% reduction in recurrence risk for PD-L1 positive patients without improving overall survival, CEL-SCI's Multikine demonstrated a 66% reduction in death risk for PD-L1 low/negative patients, extending 5-year survival rates from 45% to 73%. The FDA's approval of Keytruda based on interim Phase 3 results suggests potential accelerated approval pathway for Multikine, which has received FDA clearance for a 212-patient confirmatory Registration Study. Notably, about 70% of patients in CEL-SCI's Phase 3 study had low to zero PD-L1 levels, and Multikine-treated patients showed an almost 4-year median overall survival advantage compared to standard care.

CEL-SCI Corporation (NYSE American: CVM) has announced the closing of its public offering of 2,000,000 shares of common stock at $2.50 per share, raising gross proceeds of $5 million. The clinical stage cancer immunotherapy company has granted underwriters a 45-day option to purchase up to 190,000 additional shares for over-allotments. The net proceeds will fund the development of Multikine, general corporate purposes, and working capital. ThinkEquity served as the sole book-running manager for the offering, which was conducted under a shelf registration statement filed with the SEC.

CEL-SCI Corporation (NYSE American: CVM) has announced the pricing of an underwritten public offering of 2,000,000 shares of common stock at $2.50 per share, aiming to raise $5 million in gross proceeds. The company has granted underwriters a 45-day option to purchase up to 190,000 additional shares for over-allotments. The offering is expected to close on May 23, 2025. CEL-SCI plans to use the proceeds to fund the development of Multikine, general corporate purposes, and working capital. ThinkEquity is serving as the sole book-running manager for this offering, which is being conducted under a shelf registration statement filed with the SEC.

CEL-SCI Corporation (NYSE: CVM), a clinical stage cancer immunotherapy company, has announced plans for a proposed underwritten public offering of common stock and/or pre-funded warrants. The company intends to use the proceeds to fund the continued development of their Multikine product, along with general corporate purposes and working capital. ThinkEquity will serve as the sole book-running manager for the offering.

The securities will be offered through a shelf registration statement on Form S-3 filed with the SEC. The offering's completion, size, and terms are subject to market conditions and are not guaranteed. A preliminary prospectus supplement and base prospectus will be available through the SEC website and ThinkEquity's offices.

CEL-SCI Corporation (CVM) has completed its Breakthrough Medicine Designation application for Multikine, an immunotherapy treatment for newly diagnosed head and neck cancer, for submission to the Saudi Food and Drug Authority (SFDA). The application will be submitted by CEL-SCI's prospective Saudi partner in the coming weeks.

Key highlights:

• Multikine increased 5-year survival rates to 73% vs 45% in standard care
• 5-year death risk reduced from 55% to 27%
• SFDA typically responds within 60 days
• If approved, Multikine could be available by Summer 2025
• Head and neck cancers represent 5% of Saudi Arabia's cancer cases

CEL-SCI Corporation (NYSE American: CVM) announced a 1-for-30 stock combination effective May 20, 2025, following shareholder authorization at their annual meeting. The company's ticker symbol will remain CVM, but will trade under a new CUSIP number 150837 706. The combination will automatically adjust all outstanding warrants and options proportionally, with fractional shares rounded to the nearest whole share. CEO Geert Kersten explained the move aims to address two key issues: the current low stock price preventing fund investments and meeting major US stock exchanges' preference for higher share prices. The company anticipates major catalysts in the coming months and believes this will enhance trading accessibility for both institutional and retail investors.

CEL-SCI Corporation (CVM) reported its fiscal Q2 2025 financial results and key developments. The company plans to file for Multikine approval with Breakthrough Therapy Designation in Saudi Arabia based on Phase 3 study data. The study showed significant quality of life improvements, with 95.1% of complete responders reporting improved QoL, and complete responders achieving 100% improvement in 60% of quality of life measures.

The company is preparing to launch a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients, concurred by the FDA. CEL-SCI is also in discussions with potential partners. Financial results showed a net loss of $6.6 million for Q2 2025, compared to $7.2 million in the prior year period, with net loss per share improving to $0.08 from $0.14.

CEL-SCI (NYSE: CVM) has announced plans to submit a regulatory filing for Multikine cancer immunotherapy in Saudi Arabia following a successful meeting with the Saudi Food and Drug Authority (SFDA). The company will seek Conditional Approval with Breakthrough Therapy designation for Multikine as a neoadjuvant treatment for newly diagnosed locally advanced head and neck cancer.

The submission will be based on data from CEL-SCI's completed 928-patient randomized controlled Phase 3 study. The SFDA's typical response time for such applications is approximately 60 days after filing. The company is exploring partnerships with local Saudi companies for commercialization, clinical trials, and manufacturing facilities to serve the Middle East and North Africa (MENA) market.

This initiative aligns with Saudi Arabia's Vision 2030 National Biotechnology Strategy, which aims to establish the Kingdom as a regional biotech hub. The MENA region faces a significant health challenge, with head and neck cancer incidence expected to double by 2030, growing at twice the projected worldwide rate.

CEL-SCI (NYSE American: CVM) has received support for its strategy to seek early approval for Multikine in head and neck cancer treatment. A new study in Cancer Cell validates that pre-surgical tumor responses lead to improved survival outcomes.

Key findings from CEL-SCI's Phase 3 trial showed that patients treated with Multikine before surgery achieved a 73% five-year survival rate compared to 45% in the control group. The study demonstrated 45 objective early responders, including 5 complete pathological responders, with a significant 306% overall survival prolongation. Responders showed a notably lower death rate of 22.2% versus 54.1% for non-responders.

The company has received FDA approval for a 212-patient Confirmatory Registration Study to verify these results. Multikine is administered as a neoadjuvant therapy immediately after diagnosis and before surgery.