Welcome to our dedicated page for CEL-SCI news (Ticker: CVM), a resource for investors and traders seeking the latest updates and insights on CEL-SCI stock.
CEL-SCI Corporation (NYSE American: CVM) is a clinical stage cancer immunotherapy company whose news flow centers on the development, financing, and regulatory progress of its lead investigational product, Multikine (Leukocyte Interleukin, Injection). As a developer of biological products for head and neck cancer, CEL-SCI regularly issues updates on clinical plans, regulatory interactions, and capital markets activity that are relevant to investors and observers of the biotechnology sector.
News releases from CEL-SCI highlight key milestones for Multikine, including the completed Phase 3 study in head and neck cancer, the FDA’s concurrence on target patient selection criteria, and preparations for a 212-patient confirmatory Registration Study in newly diagnosed locally advanced head and neck cancer patients with specific PD-L1 and lymph node characteristics. The company also reports on efforts to seek early approval in the U.S. based on pre-surgical tumor response data and cites third-party scientific publications that support its development strategy.
CEL-SCI’s news coverage features international regulatory developments, particularly in the Kingdom of Saudi Arabia. The company has announced the filing of a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority through a local pharmaceutical partner, a Memorandum of Understanding for commercialization in Saudi Arabia, and growing interest from Saudi investment funds and potential joint ventures aligned with Saudi Arabia’s Vision 2030 and National Biotechnology Strategy.
In addition, CEL-SCI issues frequent updates on public offerings of common stock, including pricing and closing announcements, and related Form S-3 shelf registration usage. These items provide insight into how the company funds the continued development of Multikine, as well as its general corporate purposes and working capital. Visitors to this news page can review a chronological record of CEL-SCI’s clinical, regulatory, partnership, and financing announcements related to CVM.
CEL-SCI (NYSE American: CVM) reported fiscal 2025 results and clinical progress for Multikine in head and neck cancer. The company received FDA clearance to proceed with a 212-patient Confirmatory Registration Study with enrollment expected to begin in Spring 2026 and plans to seek early U.S. approval based on pre-surgical response data by 2028. CEL-SCI filed for Breakthrough Medicine Designation in Saudi Arabia and completed manufacturing of Multikine doses for the confirmatory study at its validated U.S. cGMP facility. Fiscal 2025 highlights: R&D $15.9M (-13%), Net loss $25.4M, Operating cash expenditures $17.1M, and Gross proceeds raised $28.3M. The audited financials include an explanatory going concern paragraph.
CEL-SCI (NYSE American: CVM) will present at the LD Micro "Main Event" investor conference on October 21, 2025 at 9:30 a.m. PST. Geert Kersten, Chief Executive Officer, will deliver a 20-minute virtual corporate presentation outlining the company's strategic roadmap for continued development of Multikine. Investors can register to watch the live webcast at the LD Micro registration page.
CEL-SCI (NYSE American: CVM) announced that CEO Geert Kersten will present at the LD Micro "Main Event" investor conference on October 21, 2025 at 9:30 a.m. PST.
The conference runs October 19–21, 2025 at the Hotel Del Coronado in San Diego. Kersten will deliver a 20-minute corporate presentation outlining the company's strategic roadmap for the continued development of Multikine and will be available for one-on-one investor meetings during the event.
CEL-SCI Corporation (NYSE American: CVM), a clinical stage cancer immunotherapy company, has successfully closed a $10 million public offering of 1,111,200 common stock shares at $9.00 per share.
The offering was conducted under a shelf registration statement and managed by ThinkEquity as the sole placement agent. The company plans to use the proceeds to fund the development of Multikine, their investigational cancer therapy that has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck squamous cell carcinoma patients. Multikine has been administered to over 740 patients and is designed to boost patients' immune systems before conventional cancer treatments.
CEL-SCI Corporation (NYSE American: CVM) has announced the pricing of a public offering of 1,111,200 shares of common stock at $9.00 per share, aiming to raise approximately $10 million in gross proceeds. The offering, expected to close on August 29, 2025, is being conducted through ThinkEquity as the sole placement agent.
The company plans to use the proceeds to fund the continued development of Multikine, their investigational cancer immunotherapy treatment that has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck squamous cell carcinoma patients. Multikine has been administered to over 740 patients and is designed to boost patients' immune systems before conventional cancer treatments begin.
CEL-SCI Corporation (NYSE American: CVM), a clinical stage cancer immunotherapy company, has announced its intention to conduct a best-efforts public offering of common stock and/or pre-funded warrants. The offering will be made through a shelf registration statement that was declared effective on August 12, 2025.
The company plans to use the proceeds to fund the continued development of its Multikine product, along with general corporate purposes and working capital. ThinkEquity is serving as the sole placement agent for this offering. The final size and terms of the offering will depend on market conditions.
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.
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