Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (November 2025)
22 slides from Cel-sci's investor presentation, November 2025
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 November 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 global Phase 3 trial in head & neck cancer, the
Slide 5: How Multikine Works
How Multikine Works • Multikine is a mix of N0 means intact local natural cytokines that immune architecture can mount an effective immune prime immune cells attack on the tumor • Administered near tumor and draining lymph nodes before surgery • Helps immune cells overcome tumor defenses • Higher ef
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 • ~900,000 newly diagnosed patients p.a. • Multi-billion $ market • Severe unmet medical need • The targeted patient population has no viable alternatives—Recently approved Keytruda only effective in high PD-L
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. • The Phase 3 study showed great survival benefit for the group of patients who
Slide 8: Clinical Breakthrough: Transforming Patient Outcomes
Clinical Breakthrough: Transforming Patient Outcomes In the 928 patient Phase 3 study of head & neck cancer patients, Multikine has demonstrated unprecedented survival benefits in a specific subpopulation. FDA requested a small confirmatory study. These results are not just statistically significant
Slide 9: Market Opportunity: Targeting a Significant Patient Population
Market Opportunity: Targeting a Significant Patient Population The specific indication is newly diagnosed stage 3 and 4 patients with advanced squamous cell carcinoma of the head and neck, with no lymph node involvement and low PD-L1; about 100,000 patients. This is a substantial segment of the head
Slide 10: A Strategic Dual-Track Approach to Global Commercialization
A Strategic Dual-Track Approach to Global Commercialization Commercialization in Saudi Arabia in 2025 to turbo charge FDA approval path—CEL-SCI to conduct a small confirmatory study to validate Phase 3 target population results Track 1: Saudi Arabia Focus Track 2: U.S./Global Partnering Saudi FDA en
Slide 11: Saudi Arabia: Strategic Gateway
Saudi Arabia: Strategic Gateway • Likelihood of Success: The Saudi Food and Drug Authority (SFDA) encouraged CEL-SCI to apply for Breakthrough Medicine Designation based on the Multikine Phase 3 data. Dallah Pharma, a leading Saudi company, filed it in August 2025. If granted, Multikine would be ava
Slide 12: Our FDA Confirmatory Trial Is Highly Likely To Succeed
Our FDA Confirmatory Trial Is Highly Likely To Succeed Confirmatory studies have a much higher chance of success than normal Phase 3 studies. Our confirmatory study is expected to have an even higher chance of success for the following reason: A normal confirmatory cancer study seeks to show that tu
Slide 13: 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 14: Some Patients Have Complete Tumor Elimination in Just 3 Weeks, Confirmed by Pathology
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 15: Multikine's Phase 3 Subgroup Analysis is Highly Reliable
Multikine’s Phase 3 Subgroup Analysis is Highly Reliable There is a well-established literature for evaluating the credibility of subgroup analyses. The ten criteria proposed by Sun et al (2012) [1] to assess whether or not a subgroup analysis is reliable are separately assessed in support of our po
Slide 16: We Can Rely on This Subgroup Analysis to Predict the Next Study
We Can Rely on This Subgroup Analysis to Predict the Next Study The 10 criteria for establishing a credible subgroup are listed below. The CEL-SCI analysis meets all of them. That means that we have established that this is a credible and dependable subgroup. FDA must have concluded the same before
Slide 17: The Study is Powered for Success
The Study is Powered for Success • The study will have 97% power to detect the observed 0.34 hazard ratio for OS 17
Slide 18: 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 19: Top-Tier Physician Consultants
Top-Tier Physician Consultants Barbara Burtness, MD Marshall Posner, MD • Anthony N. Brady Professor of Medicine (Medical Oncology) at • Consultant for CEL-SCI since 2005 Yale School of Medicine • Principal Investigator and Chair of the IDMC in CEL- • Chief Translational Research Officer, Yale Cance
Slide 20: 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 21: NYSE American: CVM
NYSE American: CVM • 8 million shares outstanding • Clean cap structure; No warrants, convertibles, etc. • Very actively traded stock • Raised over $20 M in clean equity since May 2025 • Geert Kersten, CEO of CEL-SCI, purchased $200,000 worth of CEL-SCI restricted stock in late July 2025 21
Slide 22: Thank you!
Thank you! NYSE American: CVM