CEL-SCI Corp Stock Price, News & Analysis

CEL-SCI Corporation (NYSE:CVM) has announced a significant advancement for its cancer immunotherapy Multikine in Saudi Arabia. The company has signed an MOU with a leading Saudi pharmaceutical company that has filed for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA).

The designation, which has an approximate 60-day review timeline, would enable immediate patient access and reimbursement/sale of Multikine in Saudi Arabia. In Phase 3 trials, Multikine demonstrated remarkable efficacy, increasing 5-year survival rates to 73% versus 45% in standard care, while reducing death risk from 55% to 27% in head and neck cancer patients.

A final partnership agreement is expected in Q3 2025, with several Saudi funds expressing interest in investing in CEL-SCI and a potential joint venture for the MENA region.

CEL-SCI Corporation (NYSE American: CVM), a clinical stage cancer immunotherapy company, has completed a $5.7 million best-efforts offering of 1,500,000 common stock shares at $3.82 per share, priced at-the-market under NYSE American rules.

The company plans to use the net proceeds to fund the continued development of Multikine, their investigational immunotherapy treatment designed to boost patients' immune systems before cancer treatments. Multikine has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck squamous cell carcinoma patients and has been administered to over 740 patients.

ThinkEquity served as the sole placement agent for the offering, which was conducted under a shelf registration statement previously filed with the SEC.

CEL-SCI Corporation (NYSE American: CVM), a clinical stage cancer immunotherapy company, has announced a $5.7 million best-efforts offering of 1,500,000 common stock shares priced at $3.82 per share. The offering, expected to close on July 14, 2025, is priced at-the-market under NYSE American rules.

The company plans to use the proceeds to fund the continued development of Multikine, their investigational immunotherapy treatment for head and neck cancer that has received FDA Orphan Drug designation, along with general corporate purposes and working capital. ThinkEquity is serving as the sole placement agent for this offering, which is being conducted under a shelf registration statement filed with the SEC.

CEL-SCI Corporation (NYSE:CVM) has announced a significant partnership agreement with a leading Saudi Arabian pharmaceutical company for Multikine, their immunotherapy treatment for head and neck cancer. The partnership encompasses regulatory and commercial activities in Saudi Arabia, with plans to file for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA).

The agreement could enable rapid market access, with patient access and reimbursement possible within approximately 60 days following the filing. Several Saudi funds have expressed interest in investing in CEL-SCI and a potential joint venture to serve the broader Middle East and North Africa (MENA) market. Clinical data shows Multikine increased 5-year survival rates to 73% versus 45% in patients treated with standard care alone, reducing the risk of death from 55% to 27%.

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