Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (May 2024)
27 slides from Cel-sci's investor presentation, May 30, 2024
Slide 1: Multikine “True First-Line” Cancer Therapy
Multikine™ “True First-Line” Cancer Therapy First Indication: Potential Blockbuster Head & Neck Cancer Immunotherapy May 2024 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: Pipeline
Pipeline Candidate Preclinical Phase 1 Phase 2 Phase 3 Confirmatory study Multikine Head and neck cancer: Enroll the first – therapy administered right after diagnosis, before the first surgery patient in Q4 2024 HPV: – Cervical dysplasia in HIV/HPV co-infected patients (Univ. of Maryland) LEAPS Rhe
Slide 4: What is unique about Multikine?
What is unique about Multikine? → Multikine is a cancer immunotherapy. It is a controlled mixture of natural cytokines and biological molecules that is given right after diagnosis, before surgery, radiation and chemotherapy have damaged the immune system. → This approach is unique compared to normal
Slide 5: FDA Agreed to Confirmatory Registration Study
FDA Agreed to Confirmatory Registration Study Kaplan-Meier Overall Survival → Multikine has been tested in about 750 patients in clinical studies for Multikine target population (n=114) conducted in the U.S., Canada, Europe, Israel and Asia. In these in the Phase 3 study studies, it has been adminis
Slide 6: Success Is Likely
Success Is Likely Statisticians tells us that the 212-person confirmatory study is highly likely to succeed because: → Our data have established that the survival rate of the targeted patient population is higher than that which is required for approval. → We already know the Hazard Ratio for the ta
Slide 7: Confirmatory Trial Likely To Succeed: Data Better Than Needed For Approval
Our Confirmatory Trial Is Likely To Succeed Because the Data From Multikine Treated Patients in Previous Studies Were Better Than What Is Needed For Approval. Multikine in the Target Population Standard for Success (Selected From Phase 3 Data) Survival benefit above absolute 10% Absolute 28% surviva
Slide 8: In the Target Population: Improved Survival In Patients
In the Target Population: Improved Survival In Patients Kaplan-Meier Overall Survival for Multikine target population (n=114) in the Phase 3 study Data Presented at European Society for Medical Oncology in October 2023 No safety signals or toxicities vs standard of care Multikine 73% survival for Mu
Slide 9: Multikine’s Path Forward With FDA
Multikine’s Path Forward With FDA → The ethical standards for exposing patients to an experimental drug are much stricter for newly-diagnosed patients than for terminal patients, who are already expected to die from the cancer. → We were able to meet FDA’s stricter standards. FDA has accepted our pa
Slide 10: Increased Pre-Surgical Tumor Responses Appear to Lead to Increased Survival
Increased Pre-Surgical Tumor Responses Appear to Lead to Increased Survival p < 0.005 80% ...................................................................................................................................................................................... p < 0.005 p < 0.005 75% ...
Slide 11: What is the Target Population?
What is the Target Population? The confirmatory study will focus on these patients: → Newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). • Physicians routinely assess the
Slide 12: Supported by the Biological Mechanism of Action
Supported by the Biological Mechanism of Action Why N0 (no cancer found in the regional lymph nodes)? ↪ The immune system needs the lymph nodes to work. If nodes are damaged by disease, then the immune system is less effective. Patients with “N0” can mount the strongest immune attack. Why PET scan?
Slide 13: Safety Observed Across the Entire 750 Patient Population
Safety Observed Across the Entire 750 Patient Population No Multikine-related systemic AEs (Adverse Effects) or SAEs (Serious Adverse Effects). No Multikine-related delays of surgery. No Multikine-related interference with post-surgical treatment. No Multikine-related deaths. 13
Slide 14: Multikine’s Path Forward: An FDA-Accepted Confirmatory Trial
Multikine’s Path Forward: An FDA-Accepted Confirmatory Trial Stage 1, enroll and treat 212 patients Stage 2, survival follow-up Early Read-Out Overall survival Other endpoints (EFS, QoL, etc.) Pre-surgical responses Can be assessed within weeks after full enrollment Rapid confirmation of Multikine a
Slide 15: Dedicated State-of-the-Art Manufacturing Facility
Dedicated State-of-the-Art Manufacturing Facility cGMP and BSL-1 facility near Washington, DC, USA → Built specifically for Multikine → State-of-the art facility → Over 73,000 ft2 of Manufacturing and R&D space available → About 45,000 ft2 fully developed → Proprietary automated cold fill to ensure
Slide 16: Investment Highlights and Milestones
Investment Highlights and Milestones Addressing Commissioned Strong FDA approval Enrollment De-risked an unmet manufacturing survival data pathway commences clinical trial medical need facility The goal of the No drug is approved as Confirmatory study of The commissioning of Expected in Q4 2024. Wit
Slide 17: Multikine Partners
Multikine Partners Teva Pharmaceuticals Orient EuroPharma Ergomed MD Anderson International pharmaceutical company Taiwan based pharmaceutical company Leading Clinical Research Organization for radiation qualification (CRO) for head and neck cancer 17
Slide 18: Opinion of a Key Opinion Leader
Opinion of a Key Opinion Leader “ in Head and Neck Cancer? Multikine in the curative setting is unique. The confirmatory study is an opportunity to improve overall survival in the eligible patient population without increasing toxicity. It is a potential game changer in the management of oral cavity
Slide 19: Multikine Mechanism of Action
These studies support Multikine’s three-part mechanism of action, which is (1) to overcome Multikine Mechanism of Action suppression of the local immune system by the tumor; (2) to enable a local antitumor immune response to occur; and (3) to break down the tumor’s tolerances to such an attack. This
Slide 20: CD4 Increased In Multikine Treated Patients
CD4 Increased In Multikine Treated Patients (Phase 2, Tímár 2005) OUR FOUNDATION: MULTIKINE’S MECHANISM OF ACTION Figure 3 CD4 Increased In Multikine Treated Patients (Phase 2, Tímár 2005) You can see the effect of Multikine clearly under the microscope. One of the clearest examples is from a Phase
Slide 21: 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 Circumvent An Anti-tumor Immune Response T cells The Tumor Defense Mechanisms! LYMPH LYMPH NODE NODE T DC cells DC T Kill Tumor DC cells (GzmB, PFN;
Slide 22: The CEL-SCI Team
The CEL-SCI Team Geert Kersten, Esq. Eyal Talor, PhD Giovanni Selvaggi, MD Chief Executive Officer since 1995 Chief Scientific Officer since 2009 CEL-SCI Medical Advisor Experience in investment Inventor / developer of Multikine® since 2024 banking and law 30 years at CEL-SCI in R&D, CMO at Xcovery
Slide 23: Top-Tier Physician Consultants
Top-Tier Physician Consultants Barbara Burtness, MD Marshall Posner, MD Anthony N. Brady Professor of Medicine (Medical Oncology) Consultant for CEL-SCI since 2005 at Yale School of Medicine Principal Investigator and Chair of the IDMC in CEL-SCI’s Phase 3 study Chief Translational Research Officer,
Slide 24: Board of Directors
Board of Directors Robert Watson Geert R. Kersten, Esq. Chairman of the Board of Directors Director and Chief Executive Officer Mr. Watson has been a director of CEL-SCI since December 2017. Geert Kersten has served in his current leadership role at CEL-SCI He is an accomplished business leader with
Slide 25: Final Thoughts
Final Thoughts → We are developing the first pre-surgical cancer drug in head and neck cancer. Multikine should become standard of care once successful. → After testing 750 patients we have identified the patient population where Multikine provides the best and a very large survival benefit. We prop
Slide 26: Equity Summary
Equity Summary CEL-SCI Corporation NYSE: CVM Treated 750 patients in Phase 1, 2 & 3 studies. Having defined Clinical Trial Stage the most successful treatment group, will start confirmatory registration study of 212 patients in fall 2024. Shares Outstanding ~ 54 million shares; clean cap structure 2
Slide 27: Thank you!
Thank you! NYSE American: CVM