CEL-SCI Stock Price, News & Analysis

CEL-SCI Corporation (NYSE American: CVM) is a clinical stage cancer immunotherapy company in the biological product manufacturing industry. According to company disclosures, CEL-SCI focuses on research and development aimed at improving the treatment of cancer and other diseases by using the immune system, the body's natural defense system. The company’s work centers on its investigational cancer immunotherapy Multikine (Leukocyte Interleukin, Injection), and on its LEAPS (Ligand Epitope Antigen Presentation System) technology.

Core focus on cancer immunotherapy

CEL-SCI describes itself as a clinical stage cancer immunotherapy company. Its primary product candidate, Multikine, is an investigational immunotherapy designed to be administered before surgery, radiotherapy and chemotherapy have damaged the immune system. The company states that boosting a patient’s immune system while it is still relatively intact should provide the greatest possible impact on survival by helping the immune system "target" the tumor at an earlier stage.

Multikine: head and neck cancer program

Multikine (Leukocyte Interleukin, Injection) is being developed as a treatment for newly diagnosed, previously untreated head and neck cancer. CEL-SCI reports that Multikine is given right after diagnosis and before surgery, and that it has been dosed in over 740 patients. The company states that Multikine received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.

Based on a completed randomized controlled Phase 3 study involving 928 patients, CEL-SCI reports that the FDA concurred with its target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. This confirmatory study is planned to enroll 212 patients with newly diagnosed, locally advanced, not yet treated, resectable head and neck cancer, with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). The company indicates that this target population represents about 100,000 patients annually.

Regulatory pathway and PD-L1 focus

CEL-SCI highlights PD-L1 as a predictive biomarker and diagnostic in cancer. The company emphasizes that its confirmatory Registration Study is focused on patients whose tumors show low to zero PD-L1 expression. CEL-SCI reports that, in its prior Phase 3 study, Multikine reduced the risk of death by 66% compared to standard of care in this target population, and that long-term survival with Multikine was 73% versus 45% without Multikine. The confirmatory Registration Study is designed to evaluate Multikine in those patients who showed the best type of tumor responses and survival in the prior Phase 3 study.

CEL-SCI also references external scientific work, noting that a third-party study published in Cancer Cell on CD8+ T cell dynamics in neoadjuvant cancer immunotherapies supports its strategy to seek early approval in the U.S. based on tumor responses before surgery. The company links this concept to regulatory precedents where tumor responses have been used to support accelerated approval of cancer drugs.

International regulatory initiatives: Saudi Arabia

CEL-SCI reports significant regulatory and commercial activity in the Kingdom of Saudi Arabia. The company states that a Breakthrough Medicine Designation application for Multikine in head and neck cancer has been filed with the Saudi Food and Drug Authority (SFDA) by a leading Saudi pharmaceutical and healthcare company. CEL-SCI has signed a Memorandum of Understanding with this Saudi partner for the commercialization of Multikine in Saudi Arabia and indicates that a final partnership agreement is expected.

According to CEL-SCI, the SFDA’s Breakthrough Medicine Program is designed to facilitate and accelerate development and review of new drugs that address unmet medical needs in serious or life-threatening conditions. The company notes that, based on SFDA guidance, the response time to a Breakthrough Medicine Designation application is approximately 60 days, and that, following the granting of such designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. CEL-SCI also reports growing interest from Saudi investment funds in Multikine, CEL-SCI, and potential joint ventures to serve the wider Middle East and North Africa market, and states that its plans align with Saudi Arabia’s Vision 2030 and National Biotechnology Strategy.

Manufacturing capabilities

CEL-SCI reports that it has a cGMP state-of-the-art dedicated manufacturing facility for Multikine. The company states that commissioning of this facility was validated and that manufacturing of Multikine for the confirmatory Registration Study has been completed. CEL-SCI indicates that, should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on Breakthrough Medicine Designation, it is prepared to manufacture and ship doses from its U.S. facility while working with Saudi partners to diversify its geographic manufacturing base.

Corporate structure, location and capital markets activity

According to SEC filings, CEL-SCI Corporation is incorporated in Colorado and files reports under Commission file number 001-11889. The company’s principal executive offices are located in Vienna, Virginia (without specifying a street address in this description), and CEL-SCI states that it has operations in Vienna, Virginia and near/in Baltimore, Maryland.

CEL-SCI’s common stock trades on the NYSE American under the ticker symbol CVM. The company has used public equity offerings as a source of funding. In multiple press releases and corresponding Form 8-K filings, CEL-SCI describes best-efforts and other public offerings of common stock, with proceeds intended to fund the continued development of Multikine, general corporate purposes, and working capital. Placement Agency Agreements with ThinkEquity LLC are disclosed in Form 8-K filings, including information about fees, lock-up agreements for directors and officers, and use of shelf registration statements on Form S-3.

Shareholder rights and governance

In recent Form 8-K filings, CEL-SCI reports amendments to its Shareholder Rights Agreement. On October 30, 2025, the Board of Directors amended the agreement, originally adopted in 2007, to extend its expiration date to October 30, 2030. On November 18, 2025, the Board approved further revisions to the Shareholder Rights Agreement, with the revised agreement attached as an exhibit to the filing. These filings indicate ongoing attention to shareholder rights and corporate governance structures.

Additional technology platform

In addition to Multikine, CEL-SCI’s broader technology base includes its LEAPS (Ligand Epitope Antigen Presentation System) platform. According to prior company descriptions, LEAPS is being developed for the potential treatment of rheumatoid arthritis. This reflects CEL-SCI’s stated interest in applying immune system–based approaches beyond oncology, although the recent news flow centers primarily on Multikine and head and neck cancer.

Business model and development stage

CEL-SCI characterizes itself as a late clinical-stage biotechnology company. Its business model, as described in its releases and filings, is centered on advancing Multikine through clinical development, regulatory review, and potential commercialization, while also pursuing partnerships and regional agreements such as those in Saudi Arabia. The company’s SEC filings and press releases emphasize research and development spending, public offerings to raise capital, and preparation for confirmatory clinical trials, which are typical features of a development-stage biotechnology company.

Geographic footprint

The company states that it has operations in Vienna, Virginia and near/in Baltimore, Maryland. It also reports active regulatory and commercial initiatives in Saudi Arabia through local pharmaceutical partners and potential investment relationships, indicating an international dimension to its development and commercialization plans.

Risk and going concern disclosure

In its fiscal 2025 financial results press release, CEL-SCI notes that its audited financial statements contained an audit opinion with an explanatory paragraph related to the company’s ability to continue as a going concern. This type of disclosure is common among clinical stage biotechnology companies that rely on external financing and have not yet brought a product to market.

Summary

Overall, CEL-SCI Corporation is a clinical stage biotechnology company focused on immunotherapy for cancer, particularly head and neck cancer, with its lead candidate Multikine in a planned confirmatory Registration Study and with regulatory initiatives in both the U.S. and Saudi Arabia. The company operates in the biological product manufacturing sector, maintains facilities in Virginia and near Baltimore, and funds its research and development through public equity offerings and strategic partnerships.