Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (October 2022)
30 slides from Cel-sci's investor presentation, October 2022
Slide 1: Multikine Cancer Immunotherapy
Multikine (Leukocyte Interleukin, Inj.) Cancer Immunotherapy Activating the immune system of cancer patients before surgery and radiation October 2022 CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vienna, VA 22182, USA Officer Phone: (703) 506-9
Slide 2: Forward Looking Statements
Forward Looking Statements This presentations contains “forward-looking safety profile and related adverse events of our and uncertainties, the forward-looking events statements” within the meaning of the Private product candidates; our ability to manufacture and circumstances described in this pres
Slide 3: Summary
Summary 1. Our novel concept is to activate the immune system to fight cancer before it is destroyed by surgery, radiation, etc. 2. We ran the largest and longest (10 years) Phase 3 study ever in head and neck cancer. 3. We picked advanced primary head and neck cancer as a first target because no on
Slide 4: Our Goal was to Create a Non-Toxic Cancer Medicine
Our Goal was to Create a Non-Toxic Cancer Medicine The immune system is key to our fight against cancer. • Activate it to fight cancer BEFORE surgery and radiation have damaged it. • Cancer immunotherapy drugs are typically given after those first treatments. Our immunotherapy is called Multikine* •
Slide 5: Phase 3 Data Shows we did Create a Novel Non-Toxic Cancer Medicine
Phase 3 Data Shows we did Create a Novel Non-Toxic Cancer Medicine Survival and tumor elimination data from the largest head and neck cancer study in the world. • There is a 4 year survival benefit for head and neck cancer patients receiving our Multikine followed by surgery and radiotherapy. • Some
Slide 6: What is Multikine?
What is Multikine? Multikine is a consistent mixture of cytokines. Research at the US National Institutes of Health (NIH) has shown that the cytokines (shown in yellow) are the ones that are required to reject a tumor. IL-1 α IL-1β IL-2 IL-3 TNF-α IFN-γ GM-CSF Major cytokines and other cellular prod
Slide 7: How Does Multikine Work?
How Does Multikine Work? Multikine is injected 5 days a week for 3 weeks before any other cancer therapy around the tumor and near adjacent lymph nodes to stimulate the immune system to recognize the cancer cell antigens. THE GOAL: Activate an anti-tumor immune response and increase survival. Once t
Slide 8: Why advanced primary head and neck cancer was selected as first indication
Why was advanced (stages III and IV) primary (not yet treated) head and neck cancer selected as the first indication? Last FDA approval of a therapy for advanced primary head and neck cancer was over 50 years ago. If approved, Multikine It represents a severe unmet medical need. should become the fi
Slide 9: Head and Neck Cancer Populations
Head and Neck Cancer Populations Worldwide about 890,000 new head and neck cancer patients are diagnosed per year. CEL-SCI’s target population when filing for FDA approval is about 210,000 patients U.S. Europe About 68,000 new patients p.a. About 150,000 new patients p.a. ● 90% of head and neck canc
Slide 10: A Severe Unmet Medical Need
A Severe Unmet Medical Need The last FDA approval for advanced primary head and neck cancer was in the late 1950’s. Recent failures to develop effective SCCHN treatments Manufacturer Drug Trial Outcome Pfizer & Merck Bavencio JAVELIN 100 Terminated March 2020 AstraZeneca Durvalumab KESTREL Failed Fe
Slide 11: State-of-the-Art Facility & Proprietary Manufacturing Process
State-of-the-Art Facility & Proprietary Manufacturing Process: Potential Barriers to Competition 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 develop
Slide 12: CEL-SCI Phase 3 Study Trial Design & Summary Study Results
CEL-SCI Phase 3 Study Trial Design & Summary Study Results “Head and neck cancer is possibly the most horrific of all cancers. Not only does it take your life, but it takes your beauty, your voice and your dignity.” — from a discussion with a head and neck oncologist 12
Slide 13: Phase 3 Study Design - Timing of Multikine Treatment Regimen
Phase 3 Study Design -Timing of Multikine Treatment Regimen Advanced Primary Head and Neck Cancer •“Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck Current 1st Line SOC* (SCCHN): Using pretreatment da
Slide 14: Phase 3 Results Published at ASCO
Phase 3 Results Published at ASCO Overall survival advantage for patients with surgery and radiation: • There is a 14.1% absolute advantage (62.7% vs 48.6%) in overall survival (OS) in surgery followed by radiotherapy treatment arm (lower risk for recurrence) at 5-years in patients with locally adva
Slide 15: Phase 3 Trial Results: Summary Of Survival Benefit
Phase 3 Trial Results: Summary Of Very Significant Survival Benefit Ten-year clinical trial of Multikine Five-year overall survival 14.1% absolute survival Additional 14 advantage in patients receiving out of 100 people still alive surgery + radiation Five-year overall survival 62.7% 48.6% Treatment
Slide 16: Phase 3 Results Published at ASCO
Phase 3 Results Published at ASCO Partial and complete tumor responses before surgery (Early responses) • 8.5% of Multikine-treated patients (45 of 529) in the overall intent-to-treat (ITT) population (n=923) • 16.0% of Multikine-treated patients (34 of 212) in the surgery plus radiation treatment a
Slide 17: Phase 3 Results
Phase 3 Results Histopathological analysis confirmed the effect of Multikine • 61 markers, ratios, and combinations showing a statistically significant effect (two-sided p<0.05) favoring the Multikine+CIZ cohort versus the SOC alone (control) • For overall survival, progression-free survival, and lo
Slide 18: Overall Survival of the Study Lower Risk Population (n=380)
Overall Survival (OS) of the Study Lower Risk Population (n=380) Kaplan-Meier (K-M) life tables for the study lower risk population. Group 1 = LI (MK)+CIZ+SOC; Group 2 = LI (MK)+SOC; Group 3 = SOC alone. ULR = Unstratified Logrank, SRL = Stratified Logrank OS From Randomization: Lower Risk ITT (n=38
Slide 19: Overall Survival: Lower Risk Responders vs Non-Responders vs SOC
Overall Survival: ITT Population . Lower Risk [LR] (N= 380) Responders vs Non-Responders vs SOC 19
Slide 20: Overall Survival: ITT Population Responders vs Non-Responders vs SOC
Overall Survival (OS): ITT Population (N= 923) . Overall Risk Responders vs Non-Responders vs SOC 20
Slide 21: Phase 3 Trial Results: Ten-Year Clinical Trial In Patients
Phase 3 Trial Results: Ten-Year Clinical Trial In 928 Patients • 8.5% of patients saw partial or complete tumor response in the three weeks prior to surgery • Vs. zero (0) tumor response before surgery in control group In the entire population: • Tumor response → lower death rate (22.2% vs 54.1%) •
Slide 22: Early Response Conclusions
Early Response Conclusions Early tumor response was prognostic and predictive of survival in the subjects who exhibited early response irrespective of their risk group allocation. These data set the stage for an overall survival advantage confirmation. For the lower risk LI (MK)+CIZ+SOC group, there
Slide 23: Who is Working with us on the FDA Application
Who is Working with us on the FDA Application, other than our own team? 1. We have retained the services of two leading CROs to help: ICON and Ergomed 2. Phil Lavin, our statistician, has a team of experts working with us: Dr. Lavin is a well-known biostatistician with a long history supporting clin
Slide 24: Steps In The Process For FDA Approval
Steps In The Process For FDA Approval Using the study data, we have identified and validated a way to determine what patient is supposed to receive We are working on peer radiotherapy as opposed to review in top scientific radiotherapy plus chemotherapy journals and top scientific following surgery
Slide 25: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Working on marketing approval Market Capitalization ~$150 million Trading Volume ~ 0.5 million shares per day Shares Outstanding ~ 43 million shares Share Price ~ $3.50 Cash on Hand $29 million, per the last quarterly filing
Slide 26: Reference slides for Early Tumor response and its Implications on Patient Survival
. Reference slides for Early Tumor response and its Implications on Patient Survival: 26
Slide 27: Early Tumor Response Rates: Overall and NCCN Risk-based
Early Tumor Response Rates: Overall and NCCN Risk-based •Among all 923 subjects and within lower/higher/missing risk populations: LI (MK)+CIZ+SOC LI (MK)+SOC Combined LI (MK) Metric SOC (n=394) (n=395) (n=134) (n=529) Overall ITT 8.1% (32/395) 9.7% (13/134) 8.5% (45/529) 0% (0/394) Lower Risk 15.2%
Slide 28: Early Tumor Response Results in Decreased Death Rate
Early Tumor Response Results in Decreased Death Rate (Prognostic and Predictive of Survival): In Randomized ITT Population – LI (MK) Early Response (CR/PR) prior to surgery Early Responders Deaths % LI (MK) Early Responders / Hazard Ratio ([CR+PR]/n), (%) Remaining LI (MK)-Treated (n) (HR) [95% CI]
Slide 29: OS ITT Lower Risk: % Alive at 36, 48 and 60 Months
OS ITT Lower Risk Entry -> Exit: % Alive 36, 48 and 60 Months (n=380) Treatment Group Delta LI (MK)+SOC Population Milestone LI (MK)+CIZ+SOC (’1’) (‘2’) SOC (‘3’) ‘1’ vs ‘3’ 78.8% 67.5% ITT (99.5%) 36 months 72.4% (64.4%, 78.9%) (65.0%, 87.7%) (59.7%, 74.1%) 4.9% 29 62.3% 57.8% ITT (99.5%) 48 months
Slide 30: CEL-SCI Corporation contact
CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vienna, VA 22182, USA Officer - Phone: (703) 506-9460