CEL-SCI (CVM) Stock News

CEL-SCI (NYSE American: CVM) reported that a peer-reviewed study of its neoadjuvant immunotherapy Multikine, from the IT-MATTERS trial, has been published in the journal Oral Oncology. The article identifies low and zero tumor PD-L1 expression (TPS <10%) and absence of lymph node involvement (N0) as prognostic biomarkers for selecting oral cancer patients most likely to benefit from Multikine before surgery.

In this biomarker-selected group, Multikine plus surgery and standard of care achieved a 73.4% five-year overall survival versus 45.8% with surgery and standard of care alone, a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute survival improvement. Progression-free survival improved with a 49% reduction in risk of progression or death (HR 0.51; p=0.0197). According to CEL-SCI, these data support the biomarker strategy for a planned 212-patient global Confirmatory Registration Study in newly diagnosed, locally advanced resectable head and neck oral cancer, designed with about 97% statistical power to confirm the observed survival benefit.

CEL-SCI (NYSE American: CVM) announced that a manuscript based on its Phase 3 IT-MATTERS trial of Multikine in head and neck cancer has been accepted for publication in the peer-reviewed journal Oral Oncology. The paper focuses on newly diagnosed, treatment-naïve, locally advanced, resectable oral/head and neck cancer patients with low tumor PD-L1 expression.

According to CEL-SCI, a well-defined subgroup with low PD-L1 expression and no lymph node involvement treated with Multikine before standard of care achieved a 73% five-year overall survival, versus 45% for standard of care alone. Multikine is being developed for low PD-L1 patients, described as an underserved group with limited options. CEL-SCI is preparing to begin enrollment in a global, 212-patient Confirmatory Registration Study designed with approximately 97% statistical power to detect the previously observed overall survival hazard ratio of 0.34 in the same predefined population.

CEL-SCI (NYSE American: CVM) announced the launch of a global, 212-patient Confirmatory Registration Study of Multikine as a neoadjuvant treatment for newly diagnosed, previously untreated, resectable, locally advanced head and neck squamous cell carcinoma with low or zero PD-L1 and no lymph node involvement at entry.

The multi-center trial will run in the U.S., Europe, Asia and later South America, with Orient EuroPharma funding enrollment in Taiwan. The study is designed with about 97% statistical power to confirm a previously observed 0.34 hazard ratio for overall survival. In CEL-SCI’s completed Phase 3 trial target cohort, Multikine plus standard of care achieved 73% five-year survival vs. 45% with standard of care alone, with a 13% pre-surgical objective response rate and 35% downstaging versus 0% and 13% in controls. These early tumor responses may support accelerated or conditional approval applications while overall survival follow-up continues in blinded fashion.

CEL-SCI (NYSE American:CVM) held a strategic agreement signing ceremony with Saudi Amarox at BIO 2026, strengthening U.S.–Saudi cooperation in oncology.

The partnership covers regulatory support, marketing, distribution and a revenue sharing agreement for Multikine® in head and neck cancer in Saudi Arabia, with an option to extend to Gulf Cooperation Council countries, subject to regulatory approvals.

CEL-SCI highlights its Phase 3 trial in 928 head and neck cancer patients across 23 countries and three continents.

CEL-SCI (NYSE American:CVM) closed a best-efforts offering of 2,500,000 common shares at $1.00 per share, raising approximately $2.5 million in gross proceeds. Net proceeds are intended for continued development of Multikine, general corporate purposes, and working capital, with ThinkEquity as sole placement agent.

CEL-SCI (NYSE American:CVM) outlined a dual-track strategy for its Multikine immunotherapy in head and neck cancer, combining a U.S. Confirmatory Registration Study expected to start in summer 2026 with a Saudi Arabia regulatory and commercialization partnership.

The 212-patient U.S. trial will target newly diagnosed, locally advanced, resectable head and neck cancer with low PD-L1 expression and no lymph node involvement, the subgroup that in a prior Phase 3 study showed a 73% five-year overall survival rate with Multikine plus standard of care versus 45% with standard of care alone. In Saudi Arabia, partner Amarox will lead local regulatory work, act as exclusive distributor upon approval, and share net revenue 50/50 upon Breakthrough Medicine Designation, with an option to expand distribution across GCC countries.

CEL-SCI (NYSE American:CVM) priced a best-efforts offering of 2,500,000 common shares at $1.00 per share, targeting gross proceeds of $2.5 million. Closing is expected on June 16, 2026, with proceeds for Multikine development, general corporate purposes, and working capital.

CEL-SCI (NYSE American: CVM) will hold a formal signing ceremony with Saudi Amarox at BIO 2026 on June 22, 2026. The event advances their strategic agreement to commercialize and distribute Multikine in Saudi Arabia, with a planned 50%/50% revenue share after Breakthrough Medicine Designation.

Amarox will lead Saudi-FDA interactions and be exclusive distributor upon approval, with an option to expand into GCC countries. The collaboration aligns with Saudi Arabia’s Vision 2030 and growing cancer immunotherapy market, projected to reach $2.7 billion by 2033.

CEL-SCI (NYSE American:CVM) reported fiscal Q2 2026 results and key updates on Multikine. The company is preparing a 212-patient U.S. FDA Confirmatory Registration Study in head and neck cancer, targeting start by summer/fall 2026.

CEL-SCI signed a 50%/50% revenue-sharing partnership with Amarox/b) for Multikine in Saudi Arabia, tied to potential SFDA Breakthrough Medicine Designation, and raised approximately in May 2026. Q2 2026 net loss was $5.5 million, with R&D at $3.8 million and G&A at $1.6 million, both lower year over year.