Slide 1: Multikine: A First-In-Class Cancer Immunotherapy
Multikine “A First-In-Class Cancer Immunotherapy” Activating the immune system to fight cancer BEFORE the ravages of surgery, radiation and chemotherapy August 2026 NYSE American: CVM
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties. Please refer to our public filings for full disclosure. This presentation contains “forward-looking statements” standards; our expectations regarding federal, state by applicable la
Slide 3: CEL-SCI's Story in Short: Strong Phase 3 Head & Neck Cancer Data
CEL-SCI’s Story in Short: Strong Phase 3 Head & Neck Cancer Data • We have developed an immune based cancer drug designed to increase the “cure” rate of cancer patients. • This drug is called Multikine (many cytokines) and is not toxic. • Multikine is designed to activate the immune system to fight
Slide 4: U.S. Confirmatory Registration Study Ready for Patient Enrollment
U.S. Confirmatory Registration Study Ready for Patient Enrollment • One single study of 212 patients is needed for registration. • This study is a repeat, enrolling only the target population from the Phase 3 study—the type of patients who showed the best survival in a highly statistically significa
Slide 5: Consistent Signals Across Efficacy Measures
Consistent Signals Across Efficacy Measures: Tumor Responses, Downstaging and Progression Free Survival Converge to Validate Overall Survival U.S. Confirmatory Registration Study will only enroll the target population that had these results in the Phase 3 study • 73% overall survival (OS) with Multi
Slide 6: Multikine Survival Data Superior to Keytruda in Locally Advanced Resectable HNSCC
Multikine Survival Data Superior to Keytruda in Locally Advanced Resectable HNSCC CEL-SCI to confirm Multikine’s prior survival results in its 212-patient Confirmatory Registration Study Merck: Keytruda (Pembrolizumab) CEL-SCI: Multikine Newly diagnosed, resectable locally advanced Newly diagnosed,
Slide 7: Multikine Survival Data Compare Favorably with $40 Billion Oncology Asset
Multikine Survival Data Compare Highly Favorably with One of Oncology’s Most Highly Valued Investigational Assets at $40 Billion Revolution Medicines (Nasdaq: RVMD) demonstrates how the market can value a late-stage oncology asset that delivers a major survival benefit. If CEL-SCI confirms Multikine
Slide 8: The Need for Innovation in Head & Neck Cancer
The Need for Innovation in Head & Neck Cancer Head & neck cancer: • 6th most common cancer • ~900,000 newly diagnosed patients per year • Global head and neck cancer market: $2.58 billion in 2024, projected to reach $7.68 billion 1 by 2034 • Severe unmet medical need • The targeted patient populatio
Slide 9: Multikine Treatment Sequence
Multikine Treatment Sequence • Multikine is given before the standard therapies, right after diagnosis. It enhances the immune system when it is strongest. • The Phase 3 study showed survival benefit for the group of patients who were treated with surgery and radiotherapy, but not for those who also
Slide 10: Our Registration Study Design
Our Registration Study Design Stage 1: Treatment Period Stage 2: Follow-up period Treatment Arm Multikine treatment first then standard of care n=106 Assess overall survival as the primary Randomized 1:1 between the efficacy endpoint, and then treatment arm and the control arm histopathology biomark
Slide 11: Market Opportunity: Targeting a Significant Patient Population
Market Opportunity: Targeting a Significant Patient Population Multikine is poised to address a substantial segment of the head and neck cancer market, particularly patients with low or zero PD-L1 expression who are not served by the current blockbuster immunotherapy Keytruda. This represents a sign
Slide 12: Multikine Improved Survival in the Completed Phase 3 Study
Multikine Improved Survival in the Completed Phase 3 Study Target Population (No lymph node involvement & PD-L1 low) for Confirmatory Study • No safety signals or toxicities vs standard of care • 5-year survival: 73% (Multikine) vs. 45% (Control) Multikine • Statistically significant (log rank p = 0
Slide 13: How Multikine Works
How Multikine Works N0 means intact local immune architecture can • Multikine is a mix of mount an effective immune natural cytokines that attack on the tumor prime immune cells • Administered near tumor and draining lymph nodes before surgery • Helps immune cells overcome tumor defenses • Higher ef
Slide 14: Tumor Cell Death Without And With Multikine
Tumor Cell Death Without And With Multikine Without Multikine With Multikine How the Tumor Defense How Multikine May Circumvent T cells T cells Mechanisms Can The Tumor Defense Mechanisms! Circumvent An Anti-tumor LYMPH Immune Response LYMPH NODE NODE T DC cells T Kill Tumor DC DC cells (GzmB, PFN;
Slide 15: Some Patients Have Complete Tumor Elimination in Just 3 Weeks
Some Patients Have Complete Tumor Elimination in Just 3 Weeks, Confirmed by Pathology Oral Squamous Cell Carcinoma (Locally Advanced Primary H&N Cancer) Histological appearance of necrosis in Oral Squamous Cell Carcinoma (OSCC) [HE staining]: Non-Multikine treated Multikine treated Lack of necrosis
Slide 16: Increased Pre-Surgical Tumor Responses Predict Survival Across All Patients
Increased Pre-Surgical Tumor Responses Predict for Survival Across All Patients (n=928) in the Phase 3 Trial 16
Slide 17: Even Higher PSR/PSD Rates in the Target Population
As Expected, Even Higher PSR/PSD Rates in the Target Population (n=114) 17
Slide 18: Potential Commercialization in Saudi Arabia
Potential Commercialization in Saudi Arabia Saudi FDA encouraged us to apply for Breakthrough Designation; Filed August 2025 If Breakthrough Designation is granted, Multikine would be available for sale and reimbursement in 2026 We entered a strategic commercial agreement with Saudi Amarox, a leadin
Slide 19: Amarox – Strategic Partner in Saudi Arabia
Amarox – Strategic Partner in Saudi Arabia In May 2026, CEL-SCI signed a strategic partnership, distribution, and revenue sharing agreement with Amarox for regulatory affairs, marketing and potential commercialization of Multikine • 50%/50% revenue sharing agreement for Multikine sales in Saudi Arab
Slide 20: Manufacturing Readiness: Prepared for Global Supply
Manufacturing Readiness: Prepared for Global Supply An investment of over $200 million has been made into Multikine manufacturing, ensuring that Multikine can be produced at scale to meet anticipated global demand upon potential approval. +$200 M Decades Barrier to competition – Process of manufactu
Slide 21: Investment Highlights
Investment Highlights • Strong Phase 3 Survival Benefit: Multikine demonstrated a 73% five-year survival rate in the target head & neck cancer population versus 45% in the control group, with a hazard ratio of 0.34 (95% CIs [0.19, 0.66]). Patients also showed meaningful tumor shrinkage, and some had
Slide 22: Thank you!
Thank you! NYSE American: CVM