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CEL-SCI Corp (CVM) is a clinical-stage biotechnology leader advancing innovative immunotherapies for cancer, infectious diseases, and autoimmune conditions. This page provides investors and researchers with timely updates on the company’s clinical trials, regulatory milestones, and strategic initiatives.
Access authoritative reporting on Multikine Phase 3 head and neck cancer trials, LEAPS platform developments, and collaborative research with institutions like the University of Georgia. Our curated news collection ensures you stay informed about material events influencing CEL-SCI’s scientific and operational trajectory.
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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.
CEL-SCI (NYSE: CVM) has published new data from its Phase 3 study of Multikine in the Pathology and Oncology Research journal, showing significant quality of life improvements for head and neck cancer patients.
Key findings from the study revealed that 95.1% of complete responders to Multikine reported improved quality of life, with 100% improvement in 60% of measures. Additionally, 89.4% of partial responders reported enhanced quality of life metrics.
The quality of life improvements included:
- Reduction or elimination of head and neck pain
- Enhanced ability to eat, drink, and swallow
- Improved self-care capabilities
- Better emotional wellbeing
The study, which was the largest ever conducted for newly diagnosed locally advanced head and neck cancer, demonstrated 45 objective early responders in the Multikine treated group compared to zero in the control group. Multikine is now proceeding to a final confirmatory Registration Study.
CEL-SCI (NYSE American: CVM) has announced the closing of a $2.5 million best-efforts offering, consisting of 16,000,000 shares of common stock or pre-funded warrants. The offering's gross proceeds, before deducting placement agent fees and expenses, reached approximately $2,560,000.
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. ThinkEquity served as the sole placement agent for this offering, which was conducted under CEL-SCI's effective shelf registration statement.
Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, is currently proceeding with a confirmatory Registration Study. This study will enroll 212 newly diagnosed patients with specific criteria, targeting a potential annual patient pool of about 100,000.
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.
