Slide 1: Multikine “First In Class Cancer Immunotherapy”
Multikine “First In Class Cancer Immunotherapy” First Indication: Head & Neck Cancer Neoadjuvant (Pre-surgery) Immunotherapy January 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: Why is CEL-SCI so Valuable for Cancer Patients and Investors?
Why is CEL-SCI so Valuable for Cancer Patients and Investors? We all know people who were treated for their cancer, but then the cancer came back. Most recurrences end in death. Therefore, we seek to make the first treatment more successful and stop cancer recurrences. We do this by activating the i
Slide 4: Unique De-Risked Opportunity in Cancer Immunotherapy
Unique De-Risked Opportunity in Cancer Immunotherapy • Multikine has been extensively tested in clinical studies, including a 928-patient Phase 3 study NYSE American: CVM in newly diagnosed head and neck cancer: • 46.5-month (nearly 4 years) survival benefit over control when patients About $35 M Ma
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: 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 7: 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 8: Highly De-Risked Confirmatory Study With Potential Approval by 2026
Highly De-Risked Confirmatory Study With Potential Approval by 2026 • Statistically the chance of success in the confirmatory study is estimated at over 95%. • Potential accelerated/conditional approval by 2026, based on tumor responses predictive of survival. • Better overall survival (OS) benefit
Slide 9: The Value of Cancer Drugs That Increase OS is Very High
The Value of Cancer Drugs That Increase OS is Very High Acquisition Date Deal Description Price $10 Billion 2024 AbbVie acquired ImmunoGen for its antibody-drug conjugate (ADC) for ovarian cancer; ImmunoGen had one FDA approved drug with a few others in Phase 1 and 2 at the time of acquisition $21 B
Slide 10: Investment Catalysts: Head & Neck Caner is Multi-Billion Market
Investment Catalysts: Head & Neck Caner is Multi-Billion Market Strong Plan to Statistically, Survival FDA Approval Request 95% Chance of Study Starts Data Pathway: As Accelerated/ Success for Q1 2025 for Unmet Early as 2026 Conditional Confirmatory Medical Need Approval Study The goal of the confir
Slide 11: More on CEL-SCI, Multikine and Pathway to Approval
More on CEL-SCI, Multikine and Pathway to Approval 11
Slide 12: 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. Normally cancer drugs are developed for r
Slide 13: 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-tumor im
Slide 14: Multikine Mechanism of Action
Multikine Mechanism of Action 14
Slide 15: Tumor Cell Death Without and With Multikine
Tumor Cell Death Without and With Multikine Without Multikine With Multikine How the Tumor Defense Mechanisms Can How Multikine May Circumvent T cells T cells Circumvent An Anti-tumor Immune Response The Tumor Defense Mechanisms! LYMPH LYMPH NODE NODE T DC cells T Kill Tumor DC DC cells (GzmB, PFN;
Slide 16: Multikine’s Target Population for the Confirmatory Registration Study
Multikine’s Target Population for the Confirmatory Registration Study 16
Slide 17: Target Population for Confirmatory Study
Target Population for Confirmatory Study The 212-patient confirmatory study will focus on these Kaplan-Meier Overall Survival for Multikine target population (n=114) in the Phase 3 study patients: → Newly diagnosed locally advanced primary (stage 3 and 4) head and 5-year survival 73% neck cancer pat
Slide 18: Why “N0” (No Cancer in the Lymph Nodes)?
Why “N0” (No Cancer in the Lymph Nodes)? These stage 3 and 4 very sick cancer patients are the ones who have the best survival with Multikine and also the best tumor responses and tumor elimination as shown in the prior study. Why? • “N0”, no cancer in the lymph nodes, means a more functional immune
Slide 19: Why Low PD-L1 Tumor Expression?
Why Low PD-L1 Tumor Expression? 70% of the patients treated in our Phase 3 study had low or zero levels of PD-L1 expressed by their tumors. These patients had both the best tumor responses and the best survival with Multikine. PD-L1 is a brake on the immune system. Multikine works better if there is
Slide 20: We Focus on Those Cancer Patients Checkpoint Inhibitors Cannot Help
We Focus on Those Cancer Patients Checkpoint Inhibitors Cannot Help We are not competing with checkpoint inhibitors Keytruda and Opdivo, the most successful cancer drugs in the world, selling over $40 billion per year. • They extend survival in patients who have high levels of PD-L1 since they inhib
Slide 21: Why Is The Chance of Success for the Study so High?
Why Is The Chance of Success for the Study so High? Very strong statistical significance shows likelihood of success in excess of 95%. CEL-SCI's subgroup is based on a large number of patients (n=114). “N0” (no cancer in the lymph nodes) selection was pre-specified in the protocol. The selection for
Slide 22: Data From the Bias Analysis
Data From the Bias Analysis Phase 3 Study Selected Target Population N0, TPD-L1 <10 (n=114, baseline characteristics, demographics) Baseline Covariate Covariate Level MK+CIZ+SOC (n=60) SOC Only (n=54) Percents Percents Age Mean 56.9 58.0 (Range) (33-76) (35-80) Sex % Male 76.7 88.9 Race % Asian 0.0
Slide 23: Tell Me About the Design of the Confirmatory Study
Tell Me About the Design of the Confirmatory Study 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 h
Slide 24: Who Will Lead the Confirmatory Registration Study?
Who Will Lead the Confirmatory Registration Study? • Dr. Nabil F. Saba, MD, FACP will serve as the global clinical trial Lead for CEL- SCI’s upcoming confirmatory registration study. • Nationally and internationally recognized expert in head and neck cancer and is professor. Director of the Head and
Slide 25: When Can the Study Lead to an Approval?
When Can the Study Lead to an Approval? Per the FDA, we will be allowed to see the tumor response data after full enrollment, which we expect by Q2 2026. At that time, we plan to discuss with the FDA and other countries’ regulators an early approval based on pre-surgical tumor responses shown to pre
Slide 26: Increased Pre-Surgical Tumor Responses Predict for Survival Across All Patients
Increased Pre-Surgical Tumor Responses Predict for Survival Across All Patients (n=928) in the Phase 3 Trial 26
Slide 27: Higher PSR/PSD Rates in the Target Population (n=114)
Higher PSR/PSD Rates in the Target Population (n=114) 27
Slide 28: Manufacturing Facility Ready for Commercial-Scale Production of Multikine
Manufacturing Facility Ready for Commercial-Scale Production of Multikine 28
Slide 29: Dedicated State-of-the-Art Manufacturing Facility as Requested by FDA
Dedicated State-of-the-Art Manufacturing Facility as Requested by FDA c GMP and BSL-1 facility near Washington, DC, USA → Built specifically for Multikine → State-of-the art facility → Over 73,000 ft 2 of Manufacturing and R&D space available → About 45,000 ft 2 fully developed → Proprietary automat
Slide 30: Stellar Management & Medical Advisory Team
Stellar Management & Medical Advisory Team 30
Slide 31: Experienced Management Team
Experienced Management Team Geert Kersten, Esq. Eyal Talor, PhD Giovanni Selvaggi, MD Chief Executive Officer & Director Chief Scientific Officer since 2009 CEL-SCI Acting Chief since 1995 Inventor / developer of Multikine® Medical Officer since Experience in finance and law 2024 30 years at CEL-SCI
Slide 32: Top-Tier Physician Consultants Who Accompanied Us to Regulators
Top-Tier Physician Consultants Who Accompanied Us to Regulators Barbara Burtness, MD Marshall Posner, MD Anthony N. Brady Professor of Medicine (Medical Consultant for CEL-SCI since 2005 Oncology) at Yale School of Medicine Principal Investigator and Chair of the IDMC in CEL-SCI’s Phase 3 Chief Tran
Slide 33: Thank you!
Thank you! NYSE American: CVM