CEL-SCI Reports Fiscal Second Quarter 2026 Results

Key Terms

breakthrough medicine designation regulatory

A breakthrough medicine designation is a formal status granted by a drug regulator that signals a new treatment shows substantial promise for a serious condition and qualifies for faster, more intensive review. For investors it matters because the designation can shorten development time, reduce some regulatory hurdles and raise the likelihood of eventual approval, similar to giving a promising product a VIP fast‑track through the approval process which can boost a company’s value and investor interest.

confirmatory registration study medical

A confirmatory registration study is a large, carefully designed clinical trial intended to prove a drug or medical product works and is safe enough for regulators to grant full marketing approval. Investors care because the study’s outcome often determines whether the product can be sold widely, what claims can be made about it, and how much revenue the company can expect—think of it as the final exam that decides whether a product can enter the market and earn money.

u.s. fda regulatory

The U.S. FDA is the federal agency that reviews and approves drugs, vaccines, medical devices and food products for safety and effectiveness before they can be sold in the United States. For investors, FDA actions act like a gatekeeper — approvals can open the door to large sales and higher company value, while rejections, delays or safety warnings can sharply cut a product’s market potential and a company’s revenue outlook.

saudi food and drug authority (sfda) regulatory

Saudi Food and Drug Authority (SFDA) is the national regulator that sets and enforces safety and quality rules for food, medicines, medical devices and cosmetics in Saudi Arabia. Its approvals, inspections and rules act like traffic signals for companies — green lights let products be sold and grow revenue, while delays or restrictions can limit market access, affect sales and change a company’s investment risk and value.

On Track to Commence Pivotal Confirmatory Head and Neck Cancer Registration Study by Summer/Fall 2026

Signed Key Partnership with Amarox to Advance Multikine Approval and Commercialization in Saudi Arabia

50%/50% revenue sharing agreement for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation

CEL-SCI’s CEO continues to invest in the Company acquiring a cumulative ~$930,000 worth of stock over the past 10 months

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported financial results for three months ended March 31, 2026, as well as key recent corporate, commercial, regulatory, and clinical developments for Multikine (Leukocyte Interleukin, Injection)*.

“During the fiscal second quarter, we made significant progress advancing Multikine toward potential commercialization and regulatory approval in multiple markets,” stated CEL-SCI CEO Geert Kersten. “Our strategic partnership with Amarox represents an important milestone for CEL-SCI, providing a pathway to potential early commercialization and revenue generation for Multikine in Saudi Arabia through the SFDA’s Breakthrough Medicine Designation process as well as potential market access in the GCC countries. At the same time, we are starting efforts to initiate patient enrollment in our pivotal U.S. FDA Confirmatory Registration Study later this summer/fall. We believe the study’s design, which allows for rapid assessment of pre-surgical tumor response following a short course of Multikine treatment, may provide an opportunity to pursue accelerated approval in the U.S. With strengthening financial support, continued management investment in the Company, and increasing international interest in Multikine, we believe CEL-SCI is entering an inflection point.”

Clinical and Corporate Developments:

• CEL-SCI entered a strategic partnership with Amarox, one of Saudi Arabia’s fastest growing pharmaceutical companies for regulatory affairs, marketing and commercialization of Multikine in the treatment of head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates. Amarox will support and coordinate the local regulatory process with the Saudi Food and Drug Authority (SFDA) including seeking the SFDA’s Breakthrough Medicine Designation. Amarox has been ranked #1 for SFDA applications for critical and unavailable medicine for 3 consecutive years. Upon receipt of the designation, Multikine would be available for the treatment of head and neck cancer, as well as reimbursement/sale for the indication in Saudi Arabia. The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis.

• CEL-SCI is starting up its 212-patient U.S. FDA Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. Pre-surgical tumor responses, following a very short treatment with Multikine, can be assessed within weeks after full enrollment for rapid confirmation of Multikine’s anti-tumor activity, creating the potential for early accelerated approval in the U.S. CEL-SCI plans to seek accelerated approval based on early tumor response data.

• Gross proceeds of approximately $7.2 million were raised by CEL-SCI in May 2026.

• Following the $7.2 million financing, CEL-SCI’s CEO purchased 400,000 CEL-SCI shares for about $480,000. This follows his earlier purchases of $450,000 worth of CEL-SCI stock between July 2025 and January 2026.

Financial Results

During the three months ended March 31, 2026, research and development expenses were $3.8 million compared to $4.0 million for the three months ended March 31, 2025. General and administrative expenses for the three months ended March 31, 2026 were $1.6 million compared to $2.4 million for the three months ended March 31, 2025. Net loss was $5.5 million for the three months ended March 31, 2026 compared to $6.6 million in the prior year period. Cash used for operating activities during the three months was $4.0 million. Basic and diluted net loss per common share was $0.67 for the three months ended March 31, 2026, compared to $2.33 for the three months ended March 31, 2025.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and agreed to the conduct of a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2025. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460

Source: CEL-SCI Corporation