Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (April 2023)
29 slides from Cel-sci's investor presentation, April 2023
Slide 1: Multikine Cancer Immunotherapy
Multikine (Leukocyte Interleukin, Inj.) Cancer Immunotherapy Activating the immune system of cancer patients before surgery and radiation and creating a non-toxic cancer drug April 2023 NYSE: CVM CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vie
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking safety profile and related adverse events of our and uncertainties, the forward-looking events and circumstances described in this presentation statements” within the meaning of the Private product candidates; our ability to manu
Slide 3: CEL-SCI Management Team
CEL-SCI Management Team • CEO since 1995; joined in 1987 • CSO since 2009; joined in 1993 • 30+ years pioneering field of cancer • 29+ years of managing clinical R&D development for immunotherapy immunotherapy application • Previously worked at the law firm of Finley & • Served as Director of Clinic
Slide 4: Our Goal was to Create a Cancer Medicine that Activates the Immune System and is Not Toxic
Our Goal was to Create a Cancer Medicine that Activates the Immune System and is Not Toxic 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.
Slide 5: The First Non-Toxic Cancer Medicine
• The First Non-Toxic Cancer Medicine • 10-year study in head & neck cancer for treatment naïve patients receiving Multikine followed by surgery and radiotherapy (lower risk for recurrence) • 14.1% absolute 5-year overall survival benefit (MK 62.7% and Control 48.6% at 5 years) • Near 4-year median
Slide 6: Pursuing FDA Approval for Patients Receiving Surgery and Radiation
Pursuing FDA Approval for Patients in the Treatment Arm Receiving Surgery and Radiation Considerations for FDA approval: • pre-specified in the protocol and the Statistical Analysis Plan before Database lock • treatment arm was determined per NCCN guidelines by treating physicians, not by CEL-SCI •
Slide 7: 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 IL-6 IL-8 TNF-β G-CSF RANTES MIP-1α MIP
Slide 8: How Does Multikine Work?
How Does Multikine Work? Multikine is injected 5 days a week for 3 consecutive 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 surv
Slide 9: Why Locally Advanced Primary Head and Neck Cancer Was Selected as First Indication
Why was locally 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 becom
Slide 10: 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 - globally U.S. Europe About 68,000 new patients p.a. About 150,000 new patients p.a. ● 90% of head a
Slide 11: 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 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: We Conducted The Largest and Longest Phase 3 Study in Head and Neck Cancer
We Conducted The Largest and Longest Phase 3 Study in Head and Neck Cancer 1. We enrolled 928 patients in our study in advanced primary head and neck cancer. 2. The study was run in about 100 hospitals in 20 countries on 3 continents at a cost of over $100 m. 3. The study lasted almost 10 years beca
Slide 14: 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 selection process for assigning risk/disease- directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and Current 1st Line SOC* neck (SCCHN): Using pretre
Slide 15: Multikine + Surgery-plus-radiation Treatment Arm Results
In the Multikine (MK) + Surgery-plus-radiation treatment arm (n=380, prespecified): • 14.1% absolute 5-year overall survival benefit • That means the difference between survival of MK 62.7% and Control 48.6% at 5 years • Nearly 4-year median overall survival benefit over Control • 16.0% of patients
Slide 16: Phase 3 Trial Results: Summary of Survival Benefit
Phase 3 Trial Results: Summary Of Very Significant Survival Benefit 14.1% absolute survival 14 out of 100 advantage in patients receiving people still alive surgery + radiation Five-year overall survival 62.7% 48.6% Treatment arm Control arm (Multikine (surgery+radiation, treatment+surgery+radiation
Slide 17: Overall Survival of the Study Lower Risk Population
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 18: Overall Survival ITT Lower Risk: % Alive at 36, 48 and 60 Months
Overall Survival 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% 18 62.3% 57.8% ITT (99
Slide 19: 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 20: Overall Survival: ITT Population
Overall Survival: ITT Population . Surgery plus radiotherapy (LR) (N= 380) Responders vs Non-Responders vs SOC 20
Slide 21: 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 22: Early Response Conclusions
Early Response Conclusions • Early response was prognostic and predictive of survival in early response subjects irrespective of their risk group. • For the lower risk MK+CIZ+SOC group, early responders had 306% survival prolongation for 15.2% in this treatment group. • Overall early responders had
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 cl
Slide 24: Steps In The Process For FDA Approval
Steps In The Process For FDA Approval Multikine’s ORR leads to great MK ORR 15.2% survival benefit (p<0.0000001) MK First ever neoadjuvant with responses and survival benefit Advanced primary SCCHN still results in >50% death at 5 There is nothing years like Multikine 24
Slide 25: Multikine Compares Favorably
Multikine Compares Favorably Multikine Compares Favorably To Two FDA-Approved Drugs (Keytruda and Opdivo) SCCHN Multikine Keytruda Opdivo Newly-diagnosed patients Recurrent or metastatic tumors Recurrent or metastatic tumors Indication before surgery and radiation following the SOC following the SOC
Slide 26: 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 27: Extremely Important for Approval
Extremely Important for Approval • No significant safety signals. • Multikine did not delay surgery or subsequent disease directed therapy. • We have developed a way to determine the lower risk for recurrence patient population at screening/entry BEFORE surgery. The information was presented at ASCO
Slide 28: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Completed Phase 3 cancer immunotherapy study Market Capitalization ~$123 million Trading Volume ~ 0.25 million shares per day Shares Outstanding ~ 43.7 million shares Share Price ~ $2.83 Cash on Hand $18 million, per the last
Slide 29: 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