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CEL-SCI Corporation develops cancer immunotherapy programs centered on Multikine (Leukocyte Interleukin, Injection), an investigational neoadjuvant therapy for squamous cell carcinoma of the head and neck. Company news commonly covers Multikine regulatory interactions, FDA Orphan Drug designation for neoadjuvant use, confirmatory registration-study preparation, and the company's positioning of the therapy before surgery, radiation, and chemotherapy.
Updates also include financial results, public equity offerings used to fund Multikine development, investor presentations, and regional commercialization or regulatory-affairs agreements, including activity in Saudi Arabia. CEL-SCI's disclosures often connect clinical development with working-capital needs and potential international market access.
CEL-SCI (NYSE American: CVM) reported its fiscal Q3 2025 results and significant developments for its cancer treatment Multikine. The company is poised to enter a crucial partnership in Saudi Arabia, where Multikine could become commercially available within 60 days following Breakthrough Medicine Designation approval.
Key financial highlights include a net loss of $5.7 million ($1.36 per share) for Q3, improved from $7.5 million loss year-over-year. The company raised $10.7 million through two stock offerings in May and July 2025. Notable developments include management's purchase of 32,116 restricted shares and preparation for a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients.
Clinical data shows Multikine reduced death risk by 66% in PD-L1 low/negative patients, positioning it strongly in the market segment.
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%.
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