Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (January 2025)
35 slides from Cel-sci's investor presentation, January 2025
Slide 1: Multikine First In Class Immunotherapy Cancer Therapy
Multikine “First In Class Immunotherapy” Cancer Therapy 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: Who is CEL-SCI?
Who is CEL-SCI? We are a Washington, DC area based biotechnology company. Our goal is to treat and hopefully cure cancer by activating the immune system BEFORE surgery, radiotherapy and chemotherapy destroy it. We have completed the largest ever Phase 3 study in head and neck cancer, one of the most
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 NYSE American: CVM study in newly diagnosed head and neck cancer • Headed into a small final FDA confirmatory marketing Registration Study in Q1 2025 base
Slide 5: 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 head and n
Slide 6: Confirmatory Registration Study in Q1 2025 in Patients with Best Survival Benefit
Confirmatory Registration Study in Q1 2025 in Patients with Best Survival Benefit • Results of our randomized 928-patient head and neck cancer open label, controlled Phase 3 study: • 46.5-month (nearly 4 years) survival benefit over control when patients were treated with Multikine followed by surge
Slide 7: Multikine Improved Survival in the Completed Phase 3 Study
Multikine Improved Survival in the Completed Phase 3 Study Target Population (N0 & 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 = 0.35 (95% CIs [0.19, C
Slide 8: 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 9: 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 or conditional approval by 2026, based on tumor responses predictive of survival • Better overall survival (OS) benefit
Slide 10: Investment Catalysts
Investment Catalysts Strong Plan to We Believe in Survival FDA Approval Request a Positive Study Starts Data Pathway: As Accelerated/ Outcome of the Q1 2025 for Unmet Early as 2026 Conditional Confirmatory Medical Need Approval Study The goal of the confirmatory Confirmatory study of Study expected
Slide 11: What is Multikine?
What is Multikine? 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. Multikine is used as a neo-adjuvant to ma
Slide 13: How Does Multikine Work?
How Does Multikine Work? Multikine is a consistent mixture of natural cytokines (regulators of our immune system). It helps the body’s immune cells recognize a tumor. It does so when the immune system is strongest, before surgery, radiotherapy and chemotherapy. Published studies of cancer patients h
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: Why Does Multikine Not Work in Patients Treated with Chemotherapy?
Why Does Multikine Not Work in Patients Treated with Chemotherapy? • Cisplatin chemotherapy is given by IV every 3 weeks and kills the immune cells activated by Multikine. • All of these stage 3 and 4 patients are very sick, but those who also receive chemotherapy, are even sicker. In fact, that is
Slide 18: 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 19: Patients Who Benefit Most from Multikine: N0
Patients Who Benefit Most from Multikine: N0 (No Cancer in the Lymph Nodes) Using the 928 patient Phase 3 data, as permitted by FDA, we determined how to best predict who will likely be treated with radiotherapy after surgery (without chemotherapy). Advancements in imaging technology have made this
Slide 20: Patients Who Benefit Most from Multikine: Low PDL-1 Tumor Expression
Patients Who Benefit Most from Multikine: Low PDL-1 Tumor Expression Seventy percent (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 best tumor responses to Multikine and survival. Since Multikine activates the imm
Slide 21: PD-L1: Are Multikine and Checkpoint Inhibitors in Competition? NO!
PD-L1: Are Multikine and Checkpoint Inhibitors in Competition? NO! • Checkpoint Inhibitors (CI) (e.g., Keytruda, Opdivo) are currently approved in head and neck cancer for use after the first treatments have failed. We are pursuing the treatment of newly diagnosed patients. Why is PD-L1 level used t
Slide 22: Why Did Regulators Like This Patient Population?
Why Did Regulators Like This Patient Population? FDA gave the go-ahead for this confirmatory study after review of all data. Regulators have told us that the ethics are much stricter for newly diagnosed patients since they “are more delicate” (meaning some will survive with the current standard of c
Slide 23: 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 24: Strong Biological Basis Why Multikine Works in These Patients
There is a Strong Biological Basis Why Multikine Works in These Patients The results in the selected subgroup are based on factors that tie directly to Multikine’s biological mechanism of action. • N0 selection (no cancer in the lymph nodes) results in selecting patients who have a better ability to
Slide 25: 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 26: Who Will Lead the Confirmatory Registration Study?
Who Will Lead the Confirmatory Registration Study? • Dr. Nabil F. Saba, MD, FACP will serve as the confirmatory global Phase III clinical trial Lead, as a member of the Study Steering Committee, for CEL-SCI’s upcoming confirmatory registration study • Nationally and internationally recognized expert
Slide 27: 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. We hope to achieve full enrollment 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 re
Slide 28: Increased Pre-Surgical Tumor Responses Predict for Survival
Increased Pre-Surgical Tumor Responses Predict for Survival Across All Patients (n=928) in the Phase 3 Trial 28
Slide 29: Higher PSR/PSD Rates in the Target Population
Higher PSR/PSD Rates in the Target Population (n=114) 29
Slide 30: Manufacturing Facility Ready for Commercial-Scale Production of Multikine
Manufacturing Facility Ready for Commercial-Scale Production of Multikine 30
Slide 31: 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 32: Stellar Management & Medical Advisory Team
Stellar Management & Medical Advisory Team 32
Slide 33: 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 34: 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 35: Thank you!
Thank you! NYSE American: CVM