Slide 1: Multikine “First In Class Cancer Immunotherapy”
Multikine “First In Class Cancer Immunotherapy” Activating the immune system to fight cancer BEFORE the ravages of surgery, radio and chemotherapy June 2025 NYSE American: CVM 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements” standards; our expectations regarding federal, state by applicable laws and regulations, we undertake no within the meaning of the Private Securities Litigation and foreign regulatory requirements; the therapeutic obl
Slide 3: What is Multikine?
What is Multikine? • Multikine is an investigational cancer immunotherapy with little to no toxicity that activates the immune system of cancer patients. It is given before surgery, radiotherapy and chemotherapy have compromised or destroyed the immune system. • THIS IS A FUNDAMENTAL CHANGE IN THE W
Slide 4: How Does Multikine Work?
How Does Multikine Work? • Multikine is a mixture of natural cytokines (regulators of our immune system). • It helps the body’s immune cells recognize a tumor when the immune system is strongest, before surgery, radiotherapy and chemotherapy. • Published studies of cancer patients have shown anti-tu
Slide 5: This is the Current Standard of Care for These Very Sick Patients
This is the Current Standard of Care for These Very Sick Patients Multikine would be added to the current standard of care, delivered locally via injections around the tumor and adjacent to the draining lymphatic chain area before surgery: Current Standard Of Care Locally advanced primary (Stage 3 a
Slide 6: The Urgent Need for Innovation in Head & Neck Cancer
The Urgent Need for Innovation in Head & Neck Cancer Head & neck cancer represents a significant global health challenge, with a multi-billion dollar market. For decades, patients have faced limited advancements in treatment options, highlighting a critical unmet need. Multikine emerges as a beacon
Slide 7: 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 PD-L1 expression who are not optimally served by current blockbuster immunotherapies. This represents a significant g
Slide 8: Clinical Breakthrough: Transforming Patient Outcomes
Clinical Breakthrough: Transforming Patient Outcomes Multikine has demonstrated unprecedented survival benefits in a specific subpopulation of head & neck cancer patients. These results are not just statistically significant; they represent a clinically meaningful extension of life, offering profoun
Slide 9: 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 Data Presented at ESMO 2023 • No safety signals or toxicities vs standard of care • Statistically significant (log rank Multikine p = 0.0015) • Hazard ratio = 0
Slide 10: Some Patients Have Complete Tumor Responses in Just 3 Weeks
Some Patients Have Complete Tumor Responses in Just 3 Weeks 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 in the epithelial nests of
Slide 11: Navigating Challenges: A Strategic Dual-Track Approach
Navigating Challenges: A Strategic Dual-Track Approach While the current biotech financing environment is challenging, a robust dual-track strategy is in place to secure funding and accelerate Multikine's path to patients globally. This is a funding challenge, not a drug efficacy or regulatory viabi
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. This involves a targeted confirmatory study with an over 95% probability of success, underscoring the robustness of the existing clinical data
Slide 13: Why Saudi Arabia?
Why Saudi Arabia? • High Likelihood of Regulatory and Market 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 Breakthrough Designation is granted, Multikine would be available for comme
Slide 14: 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 15: The Vision: A Transformative Future for Patients
The Vision: A Transformative Future for Patients Multikine represents more than just a drug; it's a potential paradigm shift in cancer care. Our immediate goal is to bring this life-extending therapy to head and neck cancer patients globally, starting with strategic early market access and progressi
Slide 16: Thank you!
Thank you! NYSE American: CVM