Slide 1: Multikine First In Class Immunotherapy Cancer Therapy
Multikine™ “First In Class Immunotherapy” Cancer Therapy First Indication: Head & Neck Cancer Neoadjuvant Immunotherapy September 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: Company Overview
Company Overview → Multikine is a pre-surgical (neo-adjuvant) cancer immunotherapy initially focused on newly diagnosed stage 3 and 4 head and neck cancer patients, later on other cancers too. → Tested in a 928 patient randomized controlled Phase 3 study. Patients treated with Multikine followed by
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: 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 6: 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 7: 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 8: The Multikine Treatment Regimen
The Multikine Treatment Regimen Multikine would be added to the current standard of care, delivered locally via injections around the tumor and adjacent lymph nodes for three weeks, 5 days per week before surgery: Current Standard Of Care Locally advanced primary head and neck cancer Radiotherapy Di
Slide 9: What is the Target Population?
What is the Target Population? Kaplan-Meier Overall Survival The 212 patient confirmatory study will for Multikine target population (n=114) in the Phase 3 study focus on these patients: 5-year survival → Newly diagnosed locally advanced primary head and neck cancer 73% patients with no lymph node i
Slide 10: Why N0, PET Scan, and Low PD-L1?
Why N0, PET Scan, and Low PD-L1? 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? ↪ PET Scan prov
Slide 11: 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 12: Bias Analysis Results
Bias Analysis Results → Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial’s findings are reliable, the conclu
Slide 13: Data From the Bias Analysis
Data From the Bias Analysis Phase 3 Study Population N0, TPDL1 <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 7.4 % Black/AA 3.
Slide 14: What If We Could Avoid All Chemotherapy Through a Better Selection Process
What If We Could Avoid All Chemotherapy Through a Better Selection Process → The selection process included 35 patients out of 114 who received chemotherapy → We know that chemotherapy is something to be avoided with Multikine → The data shows that removal of chemotherapy would increase 5-year survi
Slide 15: Our Registration Study Design
Our Registration Study Design 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 Randomized 1:1 between the primary efficacy endpoint, and then treatment arm and the control arm histopathology biomark
Slide 16: Increased Pre-Surgical Tumor Responses Lead to Increased Survival
Increased Pre-Surgical Tumor Responses Appear to Lead to Increased Survival Across All Patients in the Phase 3 Trial p < 0.005 80% .........................................................................................................................................................................
Slide 17: Higher PSR/PSD Rates in the Target Population
Higher PSR/PSD Rates in the Target Population p < 0.009 35% ............................................................................................................................................................................................ ...................................................
Slide 18: Safety Observed Across the Entire 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. 18
Slide 19: Why Do We Believe Our Confirmatory Study Will Be Successful?
Why Do We Believe Our Confirmatory Study Will Be Successful? → 73% survival for Multikine in the target population vs 45% in the control, at 5 years. Statistically significant (log rank p = 0.0015). → Hazard ratio = 0.35 in the target population, (95% CIs [0.19, 0.66]). This means we observed that p
Slide 20: Multikine Partners
Multikine Partners 1 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 1 Represents partners from our previously complet
Slide 21: 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 22: The CEL-SCI Team
The CEL-SCI Team Geert Kersten, Esq. Eyal Talor, PhD Giovanni Selvaggi, MD Chief Executive Officer & Director Chief Scientific Officer since 2009 CEL-SCI Medical Advisor since 1995 Inventor / developer of Multikine® since 2024 Experience in investment banking 30 years at CEL-SCI in R&D, CMO at Xcove
Slide 23: 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 24: 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 25: 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 26: Opinion of a Key Opinion Leader
Opinion of a Key Opinion Leader “ in Head and Neck Cancer? As a surgical oncologist who has treated oropharyngeal cancer for 45 years, and witnessed the results of our often failure to control the disease (whether by surgery, radiation, chemotherapy or any combination of all three), I was impressed
Slide 27: Investment Highlights and Milestones
Investment Highlights and Milestones Addressing Our belief Strong FDA approval Enrollment an unmet on the survival data pathway commences medical need clinical trial The goal of the confirmatory No drug is approved as a pre- Confirmatory study of Enrollment expected to Given the results of the prior
Slide 28: Thank you!
Thank you! NYSE American: CVM