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 2025 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: What are main things a patient looks for in a cancer drug?
What are main things a patient looks for in a cancer drug? 1) Patients want to be cured or live much longer 2) Patients are concerned about toxicity and side effects Our Multikine cancer immunotherapy addresses both: • Multikine increases the survival rate at 5 years from 45% to 73%. • The Multikine
Slide 4: What is Multikine?
What is Multikine? • Investigational Phase 3 cancer immunotherapy • Activates immune system before it is weakened by surgery, radiation and chemotherapy • Targets newly diagnosed patients, not those who have failed prior therapy • Completed 928-patient Phase 3 trial in head & neck cancer • Potential
Slide 5: How Multikine Works
How Multikine Works • Multikine is a mix of natural cytokines that prime immune cells • Administered near tumor and draining lymph nodes before surgery • Helps immune cells overcome tumor defenses • Mass-produced and non-toxic, becomes tumor-specific at site 5
Slide 6: The Need for Innovation in Head & Neck Cancer
The Need for Innovation in Head & Neck Cancer Head & neck cancer: • 6th most common cancer • about 900,000 newly diagnosed patients p.a. • multi-billion $ market • Severe unmet medical need • The targeted patient population has no viable alternatives Multikine emerges as a beacon of hope as an inves
Slide 7: Current Standard of Care for These Very Sick Head & Neck Cancer Patients
Current Standard of Care for These Very Sick Head & Neck Cancer Patients Treatment sequence: Multikine is given before the standard therapies, right after diagnosis. It enhances the immune system when it is strongest. Current Standard Of Care Locally advanced primary (Stage 3 and 4) head and neck ca
Slide 8: Clinical Breakthrough: Transforming Patient Outcomes
Clinical Breakthrough: Transforming Patient Outcomes In a 928 patient Phase 3 study of head & neck cancer patients, Multikine has demonstrated unprecedented survival benefits in a specific subpopulation. These results are not just statistically significant; they represent a clinically meaningful ext
Slide 9: 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 10: 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 very significant (log rank
Slide 11: 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 12: Regulatory Outlook: A Clear & De-Risked FDA Pathway
Regulatory Outlook: A Clear & De-Risked FDA Pathway Productive discussions with the U.S. FDA have outlined a clear and de-risked path forward for Multikine. The path involves a targeted confirmatory study for drug approval with an over 95% probability of success, underscoring the robustness of the e
Slide 13: Navigating Challenges: A Strategic Dual-Track Approach
Navigating Challenges: A Strategic Dual-Track Approach A robust dual-track strategy is in place to accelerate Multikine's path to approval for patients globally. Track 1: Saudi Arabia Focus Track 2: U.S./Global Partnering Saudi FDA encouraged us to apply for Ongoing U.S. and Global Partner Breakthro
Slide 14: Saudi Arabia: Strategic Gateway
Saudi Arabia: Strategic Gateway • Likelihood of success: The Saudi Arabian Food and Drug Authority (SFDA) encouraged CEL-SCI to apply for Breakthrough Medicine Designation based on the Multikine Phase 3 data. If granted, Multikine would be available for sale/reimbursement potentially by early fall 2
Slide 15: 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 approval. $2 B +$200 M Decades Barrier to competition – Process of manufacture →
Slide 16: NYSE American: CVM
NYSE American: CVM • 6.8 million shares outstanding. • Clean cap structure. No warrants, convertibles, etc. • Very actively traded stock. • Geert Kersten, CEO of CEL-SCI, purchased $200,000 worth of CEL-SCI restricted stock in late July 2025. 16
Slide 17: The Vision: A Transformative Future for Patients
The Vision: A Transformative Future for Patients Multikine represents more than just a drug; it is a potential paradigm shift in cancer care (by activating an anti-tumor immune response before surgery, radiation and chemotherapy). Our immediate goal is to bring this life-extending therapy to head an
Slide 18: Thank you!
Thank you! NYSE American: CVM