Multikine (leukocyte interleukin injection) / Hetero, CEL-SCI, Teva, Orient Europharma, Byron BioPharma - LARVOL DELTA

CEL-SCI Study Published in Peer-Reviewed Oral Oncology Supports Multikine's Biomarker Strategy and Potential Overall Survival Benefit Ahead of Head and Neck Cancer Confirmatory Registration Study (Businesswire) - "In this biomarker-selected patient population, patients receiving the Multikine treatment regimen prior to surgery followed by standard of care achieved a 73.4% five-year overall survival (OS) rate compared with 45.8% for patients receiving surgery followed by standard of care alone, corresponding to a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute improvement in five-year survival. The published study also demonstrated a statistically significant improvement in progression-free survival (PFS), with a 49% reduction in the risk of disease progression or death (PFS hazard ratio 0.51; p=0.0197) compared to control in the same patient population....CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study..."

Biomarker • New P3 trial • P3 data • Oral Cancer • Squamous Cell Carcinoma of Head and Neck

A novel neoadjuvant immunotherapy confers improved overall survival in oral cancer patients with low tumor PD-L1 expression The IT-MATTERS Clinical trial - Prognostic role of tumor PD-L1 expression. (PubMed, Oral Oncol) - P3 | "Significant OS prolongation was observed in ITT population for LI + CIZ + SOC vs SOC, in LR and in ITT LR cN0, PD-L1TPS < 10% cohort having locally advanced squamous cell carcinoma tumors in oral cavity/soft-palate."

Biomarker • IO biomarker • Journal • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • PD-L1

Leading Oncology Journal Accepts For Publication New CEL-SCI Multikine Phase 3 Data Demonstrating Overall Survival Benefit in Underserved Head and Neck Cancer Patients (Businesswire) - "In accordance with the journal's publication policies, CEL-SCI will disclose the scientific findings following publication in Oral Oncology....In CEL-SCI’s Phase 3 study, a well-defined population of newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low tumor PD-L1 expression and no lymph node involvement treated with Multkine before receiving standard of care had a 73% five-year overall survival rate compared to 45% in patients receiving standard of care alone."

P3 data • Head and Neck Cancer • Oral Cancer

CEL-SCI to Launch FDA Registration-Enabling Phase 3 Confirmatory Study to Bring Multikine to Market for Newly Diagnosed Head and Neck Cancer (Businesswire) - "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."

New P3 trial • Squamous Cell Carcinoma of Head and Neck

CEL-SCI and Saudi Amarox Hold Strategic Agreement Signing Ceremony at BIO 2026, Advancing U.S.–Saudi Cooperation in Cancer Care (Businesswire) - "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."

Licensing / partnership • Head and Neck Cancer

CEL-SCI Corporation Announces Pricing of Offering (Businesswire) - "Total gross proceeds from the offering, before deducting the placement agent’s fees and offering expenses, are expected to be $2.5 million. The offering is expected to close on June 16, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the proceeds for the continued development of Multikine, general corporate purposes, and working capital."

Financing • Squamous Cell Carcinoma of Head and Neck

CEL-SCI and Saudi Amarox to Conduct Signing Ceremony at BIO 2026 for Strategic Agreement to Advance Commercialization and Distribution of Multikine in Saudi Arabia (Investing News Network (INN)) - "The signing ceremony follows the strategic agreement previously announced by CEL-SCI and Amarox to collaborate on regulatory, commercialization and distribution activities for Multikine in Saudi Arabia. The terms of the agreement include a 50%/50% revenue share for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation. Amarox, ranked #1 for Saudi-FDA (SFDA) applications for critical and unavailable medicine for 3 consecutive years, will act as the local regulatory representative and lead all communications with the SFDA. In addition to being the exclusive commercial distributor of Multikine in Saudi Arabia, upon SFDA approval, Amarox has the option to expand the agreement into the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates."

Licensing / partnership • Head and Neck Cancer

CEL-SCI Reports Fiscal Second Quarter 2026 Results (PharmiWeb) - "On Track to Commence Pivotal Confirmatory Head and Neck Cancer Registration Study by Summer/Fall 2026...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...CEL-SCI plans to seek accelerated approval based on early tumor response data."

New trial • Head and Neck Cancer

CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia (Businesswire) - "Amarox will support and coordinate the local regulatory process with SFDA, including seeking the SFDA’s Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available to patients in Saudia Arabia, representing a pivotal shift in CEL-SCI’s commercial trajectory. The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis....Amarox to be exclusive commercial distributor of Multikine in Saudi Arabia, upon SFDA approval, with optional expansion to GCC countries."

Licensing / partnership • Squamous Cell Carcinoma of Head and Neck

CEL-SCI (NYSE: CVM) targets $13.7M to fund Multikine confirmatory trial (StockTitan.net) - "The company plans to use the cash mainly to fund development of its lead cancer immunotherapy Multikine and for general corporate purposes."

Financing • Squamous Cell Carcinoma of Head and Neck

CEL-SCI, in conjunction with its CRO Ergomed, expects to start patient enrollment in the summer of 2026 for the 212-patient U.S. Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. (Businesswire) - "Ergomed is providing comprehensive global clinical operations support to ensure the timely and efficient execution of the trial."

New trial • Head and Neck Cancer

CEL-SCI is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. (Businesswire) - "The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028."

Clinical data • IND • New trial • Head and Neck Cancer

CEL-SCI Presentation at LD Micro "Main Event" Available on Tuesday, October 21, 2025 (Nasdaq) - "Mr. Kersten will deliver a 20-minute corporate presentation highlighting the Company's strategic roadmap for the continued development of Multikine."

Clinical • Squamous Cell Carcinoma of Head and Neck

CEL-SCI Corporation to Present at LD Micro "Main Event" Investor Conference (Newsfile) - "Mr. Kersten will deliver a 20-minute corporate presentation highlighting the Company's strategic roadmap for the continued development of Multikine and will also be available for one-on-one meetings with investors throughout the event."

Clinical • Squamous Cell Carcinoma of Head and Neck

CEL-SCI Announces Pricing of $10 Million Public Offering (Businesswire) - "The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital."

Financing • Squamous Cell Carcinoma of Head and Neck

CEL-SCI’s Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline (Businesswire) - "CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025....Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and a potential joint venture to serve the wider Middle East and North Africa (MENA) market."

Breakthrough therapy • Commercial • Head and Neck Cancer

CEL-SCI Announces Closing of $5.7 Million Offering Priced At-The-Market Under NYSE American Rules (Businesswire) - "CEL-SCI Corporation...announced the closing of its best-efforts offering of 1,500,000 shares of its common stock. Each share of common stock was sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5.7 million....The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital."

Financing • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

CEL-SCI to Sign Partnership Agreement With Leading Saudi Arabian Pharma Company for Multikine in the Treatment of Head & Neck Cancer (Businesswire) - "CEL-SCI Corporation...announced it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia. The formal agreement is expected to be signed with the Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market."

Commercial • Head and Neck Cancer

CEL-SCI Announces Closing of Public Offering (Businesswire) - "CEL-SCI Corporation...announced the closing of its underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, were $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine, for general corporate purposes, and working capital."

Financing • Squamous Cell Carcinoma of Head and Neck

CEL-SCI’s Multikine Investigational Cancer Medicine Potentially Available for Commercialization by Summer 2025 in Saudi Arabia (Businesswire) - "CEL-SCI Corporation...today announced it has completed its Breakthrough Medicine Designation application for Multikine (Leukocyte Interleukin, Injection) for submission to the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer....According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days."

Breakthrough therapy • Squamous Cell Carcinoma of Head and Neck

CEL-SCI Reports Fiscal Second Quarter 2025 Financial Results (Businesswire) - "Plans to file for approval with Breakthrough Therapy Designation in Saudi Arabia based on completed Phase 3 results."

Breakthrough therapy • Filing • Squamous Cell Carcinoma of Head and Neck

Neoadjuvant leukocyte interleukin injection immunotherapy improves overall survival in low-risk locally advanced head and neck squamous cell carcinoma -the IT-MATTERS study. (PubMed, Pathol Oncol Res) - P3 | "Randomization 3:1:3 to LI+/-CIZ (cyclophosphamide, indomethacin, and zinc)+SOC, or SOC (standard of care) alone. No excess safety issues were reported for LI over SOC alone post-surgery. NCT01265849, EUDRA:2010-019952-35."

Clinical • Journal • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL2

CEL-SCI Reports New Data: Treatment with Multikine Resulted in up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients (Businesswire) - P3 | N=928 | IT-MATTERS (NCT01265849) | Sponsor: CEL-SCI Corporation | "Data published in peer-reviewed scientific journal Pathology and Oncology Research; Quality of life improvements included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing; Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures; 89.4% of partial responders to Multikine reported improved quality of life measures; Multikine is headed into a final confirmatory Registration Study in head and neck cancer."

New trial • P3 data • Squamous Cell Carcinoma of Head and Neck

Journal of the American Medical Association (JAMA) Study Provides Further Evidence that CEL-SCI’s Multikine Can Treat Unmet Need in ~70% of Head and Neck Patients Based on PD-L1 Expression (Businesswire) - P2 | N=36 | DEPEND (NCT03944915) | "CEL-SCI Corporation...announced that a third-party study published on March 6, 2025 in JAMA Oncology...provided data that support Multikine’s use as a neoadjuvant treatment in patients with tumors having low PD-L1 expression in its upcoming confirmatory head and neck cancer Registration Trial....The DEPEND study demonstrates that checkpoint inhibitor nivolumab (Opdivo) works best with high levels of PD-L1 biomarker, but does not work well with low levels of PD-L1."

P2 data • Squamous Cell Carcinoma of Head and Neck

CEL-SCI Announces Closing of $2.5 Million Offering (Businesswire) - "The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital."

Commercial • Squamous Cell Carcinoma of Head and Neck