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.
Overview
CEL-SCI Corp is a biotechnology company with a robust focus on immunotherapy and clinical research, specializing in the innovation and development of treatments designed to harness the human immune system. Established in 1983 and headquartered in Vienna, Virginia, the company has a longstanding history in researching advanced therapies to address cancer and a spectrum of infectious and autoimmune diseases. Utilizing its proprietary research platforms, CEL-SCI Corp develops investigational therapies with a goal to modulate immune responses and provide new approaches to medical treatment challenges. Its work is anchored in comprehensive drug discovery, rigorous clinical research protocols, and advanced development methods that target critical areas unmet by traditional therapeutic approaches.
Technology and Innovation
At the forefront of CEL-SCI Corp's operational model is its commitment to pioneering technology and innovative treatment strategies. The company has developed cutting-edge research platforms such as its unique Ligand Epitope Antigen Presentation System (LEAPS), a pre-clinical patented process that modulates T-cell responses. This technology is designed to stimulate the immune system to tackle a wide range of conditions including bacterial, viral, and parasitic infections, as well as autoimmune disorders. By integrating advanced immunological insights into its R&D process, CEL-SCI Corp positions itself as not only a developer of investigational therapies but as a contributor to the broader knowledge base within immunotherapy and drug development.
Product Pipeline and Research Focus
CEL-SCI Corp maintains a diverse suite of developmental candidates that target several high-need therapeutic areas. Its lead investigational product, Multikine, is undergoing advanced clinical trials aimed at treating head and neck cancers, reflecting the company’s commitment to addressing challenging oncological conditions. Alongside Multikine, the company is developing several other promising candidates through its LEAPS platform. These include product candidates that are tailored for the treatment of conditions such as rheumatoid arthritis and infectious diseases like COVID-19 and H1N1, as well as therapies related to transplantation and allergic reactions. Each candidate in the pipeline is underpinned by innovative technology that seeks to expand treatment possibilities and modulate immune responses in a controlled and effective manner.
Market Position and Collaborations
Within a competitive biotechnology landscape, CEL-SCI Corp differentiates itself through its deep-seated expertise in immunotherapy research and its strategic focus on complex diseases. Its research-driven approach is enhanced by key collaborations and partnerships, such as its agreement with the University of Georgia's Center for Vaccines and Immunology, which leverages academic and research excellence to further develop its product candidates. Such collaborations provide a multi-faceted perspective to clinical development and underscore the company’s commitment to high-quality, evidence-based research. This collaborative environment not only fuels innovative therapeutic solutions but also solidifies CEL-SCI Corp’s reputation as a key research entity in the sector.
R&D and Clinical Development
CEL-SCI Corp’s model emphasizes rigorous scientific inquiry and the execution of robust clinical trials. Its R&D framework is strategically structured to assess complex immunological mechanisms and translate these insights into actionable treatment solutions. The company's process involves extensive pre-clinical evaluations, followed by multi-phase clinical trials that rigorously test the safety and efficacy of its investigational products. Each step of this process is designed to ensure that its therapy candidates meet stringent regulatory and scientific standards, reinforcing the company’s overall commitment to excellence and credibility in the biotechnological arena.
Key Considerations
The company’s operations are characterized by a steadfast focus on addressing some of the most challenging medical conditions through scientific innovation. CEL-SCI Corp leverages its proprietary LEAPS platform to stimulate targeted T-cell responses, which are crucial for mounting effective defenses against various diseases. This targeted approach underscores a broader trend in pharmaceutical research where precision immunotherapy is becoming increasingly vital. Investors and stakeholders looking for insight into comprehensive drug development strategies will find CEL-SCI Corp a compelling study in how methodical research and strategic technology partnerships contribute to long-term research endeavors. The company’s broad portfolio of candidates not only reflects its technical versatility but also emphasizes its dedication to transforming immunotherapy research from the lab bench to potential clinical applications.
Conclusion
In summary, CEL-SCI Corp exemplifies the integration of advanced scientific research with dedicated clinical development. Its strategic focus on immunotherapy positions the company as a significant player in the biotechnology sector, with a diversified pipeline spanning cancer, infectious diseases, and autoimmune disorders. Through its innovative LEAPS technology and rigorous research methodologies, CEL-SCI Corp continues to contribute valuable insights and advancements in the field of therapeutic development, underlining its commitment to scientific excellence and the pursuit of novel treatment modalities.
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.
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.
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