On May 18, 2026 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)*.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
(Press release, Cel-Sci, MAY 18, 2026, View Source [SID1234665842])