Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (September 2021)
20 slides from Cel-sci's investor presentation, September 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 September 2021 CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vienna, VA 22182, USA Officer P
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: FDA Disclaimer Statement
FDA Disclaimer Statement Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, bar
Slide 4: Our Goal is to Bring our Novel Non-Toxic Cancer Drug to Patients in Need
Our Goal is to Bring our Novel Non-Toxic Cancer Drug to Patients in Need ● We believe the immune system is key to our fight against cancer ● We further believe the immune system must be activated to fight cancer BEFORE surgery and radiation have damaged the immune system. Typically cancer immunother
Slide 5: Topline Results: 14.1% 5-Year Survival Benefit - CEL-SCI to File for FDA Approval
Topline Results: 14.1% 5-Year Survival Benefit - CEL-SCI to File for FDA Approval ● Multikine immunotherapy produced a very significant 14.1% 5-year survival benefit (62.7% vs 48.6%) in the treatment arm receiving surgery plus radiotherapy (n=380), but not in the treatment arm that had chemotherapy
Slide 6: 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 an unmet medical need and everyone agrees that the current treatments are horrible ○ Last FDA approval of a therapy
Slide 7: 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 8: 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 9: 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 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 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 11: 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." 11
Slide 12: 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 40% Diagnosis Multikine Treatment Chemoradiotherapy Keytruda (3 weeks) 60% Proposed New 1st Lin
Slide 13: Multikine Phase 3 Trial Design
Multikine Phase 3 Trial Design Schematic: Randomization and Treatment of Enrolled Patients Current 1st Line SOC Group 1 Multikine 5X/week for 3 weeks (+ CIZ*) RTx 3 Radiotherapy (60 - 70 Gy, 30 - 35 fractions over 6 - 7 Weeks) RANDOMIZE SURGERY** ENROLL -OR- 1 Group 2 Multikine 5X/week for 3 weeks (
Slide 14: 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 15: Multikine Phase 3 Study Endpoints
Multikine Phase 3 Study Endpoints • Primary Endpoint: ○ Overall Survival • Secondary Endpoints: ○ Progression Free Survival ○ Local/Regional Control ○ Safety ○ Histopathology of Tumor infiltrate ○ Quality of Life • Tertiary Endpoint: o Tumor Response 15
Slide 16: Phase 3 Topline Results
Phase 3 Topline Results • The treatment arm receiving Multikine (plus CIZ) followed by surgery and radiation showed a long-term 5-year overall survival (OS) benefit that was robust and durable, with no safety issues. The survival benefit increased over time and at 5-years the overall survival benefi
Slide 17: Filing for FDA Approval for Patients in the Treatment Arm Receiving Surgery and Radiation only
Filing for FDA Approval for Patients in the Treatment Arm Receiving Surgery and Radiation only • The analysis for the successful treatment arm of Multikine (plus CIZ) followed by surgery and radiotherapy was pre- specified in the protocol and conducted per the Statistical Analysis Plan before unblin
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 cancer immunotherapy used BEFORE surgery and radiation increases survival ● No safety issues were reported ●
Slide 19: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Completed huge Phase 3 cancer immunotherapy study Market Capitalization ~$500 million Trading Volume ~ 1.7 million shares per day (last 90 days) Shares Outstanding ~ 43 million shares Share Price ~ $12 Cash on Hand $47.1 mill
Slide 20: CEL-SCI Corporation Geert Kersten Chief Executive Officer
CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Vienna, VA 22182, USA Officer - Phone: (703) 506-9460