Leukocyte interleukin (CEL-SCI)

Patient enrollment expected to commence at clinical centers in the U.S., Europe, Asia and later on in South America The 212-patient confirmatory study is powered at approximately 97% to confirm a previously observed 0.34 hazard ratio, representing a 66% reduction in the risk of death In the target population, Multikine followed by standard of care increased the 5-year survival rate to 73% versus 45% with standard of care alone Pre-surgical tumor responses will be assessed and may serve as the basis for an early conditional or accelerated approval application with the FDA VIENNA, Va.--(BUSINESS WIRE)-- $CVM #Multikine --CEL-SCI Corporation (NYSE American: CVM) today announced it is launching its global Confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection)* as a neoadjuvant treatment for newly diagnosed, previously untreated, resectable, locally advanced primary head and neck cancer. The global, multi-center study will enroll patients in the United States, Europe, Asia, and South America. Orient EuroPharma, CEL-SCI's strategic partner in Taiwan, will oversee and fund patient enrollment within its territory. The study is highly optimized and designed with approximately 97% statistical power to detect a previously observed 0.34 hazard ratio based on overall survival (OS). The Confirmatory Study will enroll approximately 212 patients presenting with newly diagnosed, previously untreated, resectable, locally advanced squamous cell carcinoma (head and neck cancer) whose tumors exhibit low or zero PD-L1 expression and who present with no clinical lymph node involvement at entry. This precise cohort represents the patient population that demonstrated the most profound clinical benefit in CEL-SCI’s completed 928-patient randomized controlled Phase 3 study. The patients in the confirmatory study will be required to possess the same disease characteristics as the patients who showed the excellent survival benefit in the completed Phase 3 study. By isolating this specific high-responder group of patients identified in the prior randomized controlled trial, the confirmatory study maintains robust statistical power while requiring a substantially smaller, more efficient patient enrollment target. "Our Confirmatory Registration Study marks a definitive milestone toward establishing Multikine as the new immunotherapy standard of care for newly diagnosed head and neck cancer with low or zero levels of PD-L1," said Geert Kersten, CEO of CEL-SCI. "Enrollment will span premier clinical centers across the U.S., Europe, Asia, and South America, targeting the exact population where our previous Phase 3 trial demonstrated compelling, statistically significant improvements in overall survival, quality of life, and safety. Backed by approximately 97% statistical power to confirm this survival advantage, we believe this registration-enabling study provides an exceptional opportunity to validate our earlier Phase 3 results and bring this much-needed therapy to patients." Clinical Rationale & Phase 3 Data Foundation In the target cohort of CEL-SCI's completed Phase 3 study, 114 patients who received a 3-week regimen of Multikine prior to receiving standard of care (SOC) experienced a significant reduction in the risk of death, achieving a 73% five-year overall survival rate compared to 45% for patients treated with SOC alone. Furthermore, neoadjuvant administration of Multikine induced rapid, statistically significant pre-surgical tumor responses, including complete tumor responses confirmed by pathology, within 3 weeks of Multikine treatment. In the target population, the pre-surgical objective response rate was 13% in the Multikine arm versus 0% in the control arm. Pre-surgical downstaging was observed in 35% of Multikine-treated patients compared to 13% of controls. Because these early, pre-surgical objective responses were demonstrated to be highly prognostic and appear to be predictive of long-term overall survival, CEL-SCI intends to utilize these early endpoints to support potential accelerated or conditional approval applications globally. Concurrently, overall survival follow-up will continue to be assessed in a blinded manner until the required event threshold is met. About Head and Neck Cancer Head and neck cancer remains one of the world's most challenging oncology indications, with approximately 900,000 new diagnoses annually. Despite modern iterations of surgery and chemoradiation, long-term survival outcomes have stalled, highlighting a critical global need for non-toxic neoadjuvant immunotherapies that directly improve survival. About Multikine Multikine (Leukocyte Interleukin, Injection) is a novel, patented investigational cancer immunotherapy designed to be administered immediately following diagnosis, prior to surgery, radiation, or chemotherapy. By treating patients before any other treatment, while their immune systems are still intact, Multikine aims to stimulate a robust anti-tumor immune response before the immune system is compromised by conventional treatments. Multikine has been administered to over 740 patients across its clinical development program and has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the neoadjuvant therapy of squamous cell carcinoma of the head and neck. About CEL-SCI Corporation CEL-SCI is a clinical-stage biotechnology company focused on activating the immune system to fight cancer at the earliest stage of clinical intervention. The Company maintains primary operations in Vienna, Virginia, and manufacturing/operations near 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, inability to finalize a partnering agreement 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. Contacts COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703) 506-9460

Ceremony highlights shared commitment to oncology innovation, healthcare advancement, and international collaboration Strategic partnership spans regulatory, marketing, distribution, and revenue sharing agreement for Multikine® in the treatment of head and neck cancer in Saudi Arabia with option to extend to Gulf Cooperation Council countries VIENNA, Va.--(BUSINESS WIRE)-- $CVM #BIO2026 -- CEL-SCI Corporation (NYSE American: CVM) today announced the successful conclusion of a formal signing ceremony with Saudi Amarox (“ Amarox ”) during the BIO International Convention 2026 on June 22 nd in San Diego, marking a significant step forward in U.S.–Saudi cooperation in healthcare innovation and oncology. The ceremony brought together executives from CEL-SCI and Amarox, along with representatives from Saudi healthcare, investment, and trade organizations, highlighting the growing partnership between the U.S. and the Kingdom of Saudi Arabia in advancing medical innovation and improving patient care. Under the agreement, Amarox will support activities related to the planned introduction and commercialization of Multikine®* in Saudi Arabia and potentially other counties in the region, subject to regulatory approvals. "We are pleased to work with Amarox and our Saudi partners as Saudi Arabia continues to invest in healthcare innovation and advanced medical technologies,” said Geert Kersten, Chief Executive Officer of CEL-SCI. “International collaboration has been central to CEL-SCI's development strategy for many years, and we look forward to contributing our experience and expertise to support oncology care throughout the region." CEL-SCI conducted the world's largest Phase 3 trial in newly diagnosed advanced head and neck cancer, enrolling 928 patients across 23 countries, three continents, and approximately 100 clinical sites. The scale and geographic diversity of the study underscore CEL-SCI's role as an international oncology innovator and its commitment to advancing cancer care through global scientific cooperation. Abdullah Alzomaie, CEO and Founder of Amarox, commented, "Saudi Arabia is investing significantly in healthcare transformation and access to innovative medicines. We believe this collaboration supports those objectives while strengthening international partnerships that can help bring promising therapies to patients throughout the Kingdom and the broader region." Saudi Arabia's Vision 2030 initiative places significant emphasis on healthcare modernization, innovation, and international collaboration. The Kingdom has made substantial investments in healthcare infrastructure, biotechnology, pharmaceutical development, and research capabilities as it expands its regional center for advanced healthcare and life sciences. About Multikine Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated 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%. About Head and Neck Cancer Head and neck cancer is the 6 th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need. 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. 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, inability to finalize a partnering agreement 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. Contacts Gavin de Windt CEL-SCI Corporation (703) 506-9460