Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (October 2021)
20 slides from Cel-sci's investor presentation, October 2021
Slide 1: Multikine (Leukocyte Interleukin, Inj.) Cancer Immunotherapy
Multikine (Leukocyte Interleukin, Inj.) Cancer Immunotherapy Activating the immune system of cancer patients before the ravages of surgery and radiation October 2021 CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vienna, VA 22182, USA Officer Pho
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: Our Goal is to Create a Novel Non-Toxic Cancer Drug
Our Goal is to Create a Novel Non-Toxic Cancer Drug ● We believe that 1) the immune system is key to our fight against cancer and that 2) the immune system must be activated to fight cancer BEFORE surgery and radiation have damaged the immune system. Typically cancer immunotherapy drugs are given af
Slide 4: Multikine Supplies The Cytokines Needed for Tumor Rejection
Multikine Supplies The Cytokines Needed Major Cytokine(s) and other Cellular for Tumor Rejection Products in Multikine ● Multikine is a consistent mixture of cytokines. The cytokines listed to the right are those known to be present in Multikine ● Research at the US National Institutes of Health (NI
Slide 5: State-of-the-Art Facility & Proprietary Manufacturing Process: Potential Barriers to Competition
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 devel
Slide 6: Topline Results: Large 5-Year Survival Benefit - CEL-SCI to File for FDA Approval
Topline Results: Large 5-Year Survival Benefit - CEL-SCI to File for FDA Approval ● Almost 10-year 928 patient advanced primary head and neck cancer study ● Multikine immunotherapy was given following cancer diagnosis for 3 weeks prior to the current standard of care ● Multikine produced a very sign
Slide 7: Why Head and Neck Cancer as a First Target?
Why Head and Neck Cancer as a First Target? ● Advanced (stages III and IV) primary (not yet treated) head and neck cancer was selected as the first indication because: ○ It represents a severe unmet medical need ○ Last FDA approval of a therapy for advanced primary head and neck cancer was over 50 y
Slide 8: Head and Neck Cancer Market
Head and Neck Cancer Market 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 60,000 new patients p.a. About 105,000 new patients p.a. ● 90% of head and neck cancers a
Slide 9: Mechanism of Action Stimulates an Immune Response at the Injection Site
Mechanism of Action Stimulates an Immune Response at the Injection Site Multikine (perilymphatic) Tumoricidal / Tumoristatic Local / Regional Necrotic (e.g., TNFα) Antigen Presenting Cells (Dendritic Cells, Macrophages) Micro Metastases Neutrophils Tumor CD4 + T Cells Lymph Nodes Multikine (peritumo
Slide 10: Multikine – How it Helps the Immune System Kill Cancer Cells
Multikine – How it Helps the Immune System Kill Cancer Cells How Multikine is Designed to Circumvent the Tumor Defense Mechanisms In patients not treated with Multikine, CD8+ T-cells and NK cells are “blocked” by the tumor. Therefore they are unable to trigger a potential anti-tumor immune response.
Slide 11: Multikine – How it Helps the Immune System Kill Cancer Cells
Multikine – How it Helps the Immune System Kill Cancer Cells How Multikine is Designed to Circumvent the Tumor Defense Mechanisms Following Multikine administration, tumor-specific activated DC Tcells CD4+ (helper T) cells “rescue” and activate tumor-residing Lymph NK cells, which then trigger a pot
Slide 12: Observed Effects Following Multikine Treatment Regimen – Phase 2
Observed Effects Following Multikine Treatment Regimen – Phase 2 An Apparent Shift in Tumor Microenvironment MK Treated (n=17) CD4 MK Treated CD4 / CD8 > 2.5 CD8 P<0.05 [+2 CR] P<0.05 CD4 Control (n=20) Control CD8 CD4 / CD8 < 0.5 0 50 100 150 Density of cells/HPF (Mean ± SEM) Multikine Treatment Ef
Slide 13: CEL-SCI Phase 3 Study Trial Design & Summary Study Results
CEL-SCI Phase 3 Study Trial Design & Summary Study Results As one physician wrote: "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." 13
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 Current 1st Line SOC* 4 weeks Usual Drug Development Path Focuses Radiotherapy Surgery on Recurrent Cancer Diagnosis Multikine Treatment Radiochemotherapy Keytruda (3 weeks) Proposed New 1st Line SOC* f
Slide 15: Patients fall into one of two Treatment Arms per NCCN Guidelines
Patients fall into one of two Treatment Arms per NCCN Guidelines • 928 patients randomized • Intent to Treat (ITT) group was 923 patients, 99.5% of the 928 randomized • 2 treatment arms determined by risk of recurrence post-surgery following National Cancer Comprehensive Network (NCCN) guidelines •
Slide 16: Phase 3 Topline Results
Phase 3 Topline Results • The survival benefit in the ITT population increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over the control arm (n=380, total study patients treated with surgery plus radiation), control arm 4
Slide 17: Filing for FDA Approval for Patients in the Treatment Arm Receiving Surgery and Radiation
Filing for FDA Approval for Patients in the Treatment Arm Receiving Surgery and Radiation • The analysis for the successful treatment arm of Multikine followed by surgery and radiotherapy was pre-specified in the protocol and conducted per the Statistical Analysis Plan before unblinding. This means
Slide 18: Summary: Phase 3 Clinical Trial in Advanced Primary Head and Neck Cancer
Summary: Phase 3 Clinical Trial in Advanced Primary Head and Neck Cancer ● We have run the largest and longest study ever in head and neck cancer ● We are the first in the world to show that neoadjuvant cancer immunotherapy, used BEFORE surgery and radiation, increases overall survival ● No safety i
Slide 19: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Completed Phase 3 cancer immunotherapy study Market Capitalization ~$450 million Trading Volume ~ 1 million shares per day (last 90 days) Shares Outstanding ~ 43 million shares Share Price ~ $11 Cash on Hand $47.1 million (Ju
Slide 20: 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