On August 17, 2026 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended June 30, 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!

"This was a quarter of important progress across our clinical, regulatory and commercialization programs as we move Multikine closer to patients," stated CEL-SCI CEO Geert Kersten. "Our recently published peer-reviewed data identified the biomarkers that allow us to prospectively select the patients most likely to benefit from Multikine—the same population in which our Phase 3 study demonstrated a 73% five-year survival rate compared with 45% for standard of care alone. By focusing our 212-patient Confirmatory Registration Study on this biomarker-selected population, we believe we have substantially increased the likelihood of confirming Multikine’s survival benefit and achieving a successful trial outcome. At the same time, our partnership with Amarox is advancing a potential near-term path to commercial availability in Saudi Arabia. With enrollment in our registration study set to commence globally, we believe we have never been better positioned to bring Multikine to patients and advance it toward commercialization."

Clinical and Corporate Developments:

A leading peer-reviewed journal, Oral Oncology , published biomarker selected population and survival data from CEL-SCI’s Phase 3 clinical study, the largest trial of its kind in the world. The article provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study. Low and zero (0%) tumor PD-L1 expression and no lymph node involvement were identified as biomarkers for selecting patients most likely to benefit from Multikine pre-surgery treatment. The published study concludes that Multikine represents the first neoadjuvant treatment in decades to demonstrate an overall survival benefit in biomarker-selected patients with locally advanced resectable oral cancer. Multikine neoadjuvant treatment also demonstrated a statistically significant improvement in progression-free survival with a 49% reduction in the risk of disease progression in the same biomarker-selected patients.
CEL-SCI is set to commence enrollment in its 212-patient U.S. FDA Confirmatory Registration Study evaluating Multikine in newly diagnosed, locally advanced head and neck cancer patients at clinical sites in the U.S., Europe, Asia and South America. Because Multikine is administered for a short period before surgery, pre-surgical tumor responses can be evaluated within weeks following full enrollment, providing an early assessment of Multikine’s anti-tumor activity. CEL-SCI plans to use these early tumor response data to pursue potential accelerated approval in the U.S. while patients continue to be followed for overall survival.
CEL-SCI entered a strategic partnership with Amarox , one of Saudi Arabia’s fastest growing pharmaceutical companies to pursue regulatory approval, marketing and commercialization of Multikine for 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 regulatory process with the Saudi Food and Drug Authority (SFDA), including pursuit of Breakthrough Medicine Designation—the granting of which could lead to immediate availability of Multikine for reimbursement/sale in Saudi Arabia. Amarox has ranked #1 for SFDA applications for critical and unavailable medicines for 3 consecutive years. CEL-SCI and Amarox will share net revenue from Saudi Arabian Multikine sales on a 50%/50% basis.
Gross proceeds of approximately $9.7 million were raised by CEL-SCI during the quarter.
Financial Results

During the three months ended June 30, 2026, research and development expenses were $3.6 million compared to $3.7 million for the three months ended June 30, 2025. General and administrative expenses for the three months ended June 30, 2026 were $1.9 million compared to $1.7 million for the three months ended June 30, 2025. Cash used for operating activities during the three months ended June 30, 2026 was $4.0 million. Net loss was $5.7 million for the three months ended June 30, 2026, unchanged from the second quarter of 2025. Basic and diluted net loss per common share was $0.47 for the three months ended June 30, 2026, compared to $1.36 for the three months ended June 30, 2025.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, AUG 17, 2026, View Source;storyId=5803345550585143 [SID1234670185])