CEL-SCI Corp Stock Price, News & Analysis

CEL-SCI (NYSE American: CVM) has announced a best-efforts offering of 16,000,000 shares of common stock or pre-funded warrants, expected to raise approximately $2.56 million in gross proceeds. The offering is set to close on March 18, 2025, with ThinkEquity acting as sole placement agent.

The company plans to use the net proceeds to fund the continued development of Multikine, their cancer immunotherapy treatment, along with general corporate purposes and working capital. The securities will be offered through a shelf registration statement on Form S-3.

Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, has been administered to over 740 patients. The FDA has approved a confirmatory Registration Study that will enroll 212 newly diagnosed head and neck cancer patients with specific criteria, targeting a potential annual patient pool of about 100,000.

CEL-SCI (NYSE: CVM) has received FDA clearance for its head and neck cancer Registration Study protocol for Multikine treatment. The FDA required no response to their comments on the Statistical Analysis Plan (SAP) submitted in December 2024.

The company's 73,000 square foot Multikine manufacturing facility can produce over 12,000 treatments annually, representing a $200 million investment in facility and processes. CEL-SCI is currently in discussions with potential partners for non-dilutive funding of the 212-patient confirmatory Registration Study.

The company's previous Phase 3 study involving 928 patients across 23 countries showed significant results: 73% five-year survival rate in the target patient population treated with Multikine before standard care, compared to 45% in the control group. Notably, Multikine shows promise for approximately 70% of head and neck cancer patients with low PD-L1 tumor expression, where current PD-L1 inhibitors are ineffective.

CEL-SCI (NYSE: CVM) reports that a JAMA Oncology study published on March 6, 2025, supports Multikine's potential as a neoadjuvant treatment for head and neck cancer patients with low PD-L1 expression. The DEPEND study demonstrates that while checkpoint inhibitor nivolumab works best with high PD-L1 levels, it's less effective with low levels.

Multikine stands out as the only neoadjuvant oncology drug showing overall survival benefit in head and neck cancer patients with low PD-L1 expression, which represents approximately 70% of patients. In CEL-SCI's Phase 3 trial, the 5-year survival rate for the target patient population increased to 73% with Multikine treatment compared to 45% in the control group.

The company has received FDA approval to proceed with a confirmatory Registration Trial, focusing on previously untreated resectable stage 3 and 4 head and neck cancer patients with low PD-L1 tumor expression and no lymph node involvement.

CEL-SCI (NYSE American: CVM) announced the launch of a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients. The study aims to confirm results from a previous Phase 3 trial where 5-year survival rates increased to 73% in treated patients versus 45% in control groups.

The study targets previously untreated resectable stage 3 and 4 head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression. Key highlights include: full enrollment expected by Q2 2026, plans for early approval based on tumor responses, and FDA concurrence with the study design. The final clinical protocol was submitted to FDA in December 2024.

The company reports over 95% chance of success for this Registration Study, as it focuses on the target population that showed the most benefit in the prior Phase 3 study, with Multikine extending median overall survival by nearly 4 years.

CEL-SCI (CVM) reported Q1 2025 financial results and key developments. The FDA concurred with CEL-SCI's plan to use PD-L1 as a biomarker for a Phase 3 confirmatory trial of Multikine in head and neck cancer. Previous Phase 3 data showed patients with low PD-L1 expression had 73% 5-year survival vs 45% in control group (p=0.0015). Multikine demonstrated pre-surgical tumor regression in just 3 weeks.

Financial highlights: R&D expenses were $4.4 million, G&A expenses increased to $2.5 million from $2.1 million YoY. Net loss was $7.1 million vs $6.7 million in prior year. Net loss per share improved to $0.11 from $0.14. Cash spent during Q1 was $5.1 million.

CEL-SCI (CVM) reported fiscal year 2024 results and announced preparations for a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients. The study, expected to complete enrollment by Q2 2026, focuses on PD-L1 low newly diagnosed patients.

Key financial results include a reduced net loss of $26.9 million compared to $32.2 million in 2023. Research and development expenses decreased 19% to $18.2 million, while general and administrative expenses fell 9% to $8.2 million.

The FDA has approved the confirmatory study based on previous Phase 3 results, where Multikine demonstrated 73% survival rate versus 45% in control patients at 5 years. The company plans to seek early approval based on pre-surgical response rates and aims to establish Multikine as the first new treatment in over 50 years for newly diagnosed locally advanced head and neck cancer.

CEL-SCI (NYSE American: CVM) has closed its previously announced best-efforts offering, raising approximately $5 million in gross proceeds through the sale of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share. The proceeds will fund the development of Multikine, a first-line cancer therapy that has received FDA Orphan Drug designation for head and neck cancer treatment, along with general corporate purposes and working capital. ThinkEquity served as the sole placement agent. The offering was conducted under the company's effective shelf registration statement. The company is preparing for a confirmatory Registration Study of 212 patients focusing on newly diagnosed head and neck cancer patients with specific criteria.

CEL-SCI (NYSE American: CVM) announced a best-efforts public offering of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share, expecting to raise approximately $5 million in gross proceeds. The offering is set to close on December 31, 2024, with ThinkEquity acting as sole placement agent.

The company plans to use the net proceeds to fund the continued development of Multikine, their first-line cancer therapy which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients. The FDA has approved CEL-SCI's plans for a confirmatory Registration Study of 212 patients with newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer.

CEL-SCI (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 company plans to use the net proceeds to fund the continued development of Multikine, general corporate purposes, and working capital. ThinkEquity is serving as the sole placement agent for the offering. The securities will be offered through a shelf registration statement on Form S-3 filed with the SEC. The completion, size, and terms of the offering are subject to market conditions and are not guaranteed.