Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (October 2023)
24 slides from Cel-sci's investor presentation, October 2023
Slide 1: Multikine Pre-Surgical Cancer Therapy
Leukocyte Interleukin, Injection For Head And Neck Cancer Multikine™ Pre-Surgical Cancer Therapy Pre-surgical, Tumor responses Longer local therapy before surgery life NYSE: CVM SLIDE 1
Slide 2: Forward Looking Statements
Forward Looking Statements SLIDE 2
Slide 3: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Completed 928-patient, global, multicenter, Phase 3 cancer immunotherapy study Market Capitalization ~$65 million Avg. Daily Trading Volume ~ 1 million shares per day Shares Outstanding ~ 47.25 million shares; completely clea
Slide 4: What Is Multikine? Multikine Treatment Regimen
What Is Multikine? Multikine is a true first line immunotherapy — 3 weeks before surgery. It is a mixture of cytokines and biological molecules. Multikine induces a local immune anti-tumor attack before the immune system has been compromised by treatment or disease. Multikine Treatment Regimen
Slide 5: Why are we confident in gaining approval of our drug?
Why are we confident in gaining approval of our drug? Simply put: OUR DATA 928 patients in 20 countries Completed Pivotal 100 hospitals, 20 countries, $100+ million Phase 3 Randomized Controlled Good Clinical Practices and fully audited data Trial Results presented at ASCO, ESMO, ECHMO, AHNS SLIDE 5
Slide 6: Excellent Safety Profile
Excellent Safety Profile No Multikine-related deaths. Multikine-related adverse events before surgery were local and resolved after surgery. Adverse event rates in the Multikine and control groups were not significantly different. SLIDE 6
Slide 7: Our Data: Multikine Leads To Better Survival
Our Data: Multikine Leads To Better Survival Multikine 73% vs 45% Control SLIDE 7
Slide 8: Our Data: Multikine Leads To Better Survival
Our Data: Multikine Leads To Better Survival 60% Risk of death, 55% Reduction in death risk 5-year risk of death 50% 40% Control Multikine cut the 5-year risk 30% Risk of death, 27% of death IN HALF in the target population 20% Multikine 10% 0% SLIDE 8
Slide 9: We Know How Multikine Works And Can Target This
We Know How Multikine Works And Can Target This 1. 2. 3. Multikine leads to Pre-surgical responses Therefore, Multikine pre-surgical responses. lead to better survival. leads to better survival. SLIDE 9
Slide 10: Multikine Leads To Pre-Surgical Responses
Multikine Leads To Pre-Surgical Responses >30% reduction in Reductions (PSR) tumor dimensions Stage IV to III, Downstages (PSD) Stage III to II SLIDE 10
Slide 11: Multikine Leads To Pre-Surgical Responses
Multikine Leads To Pre-Surgical Responses SLIDE 11
Slide 12: Pre-Surgical Responses Lead To Better Survival
Pre-Surgical Responses Lead To Better Survival SLIDE 12
Slide 13: Therefore, Multikine Leads To Better Survival
Therefore, Multikine Leads To Better Survival Multikine 73% vs 45% Control SLIDE 13
Slide 14: Higher Response Rates In The Target Population
Higher Response Rates In The Target Population SLIDE 14
Slide 15: Positive Results In The Target Population
Positive Results In The Target Population 73% survival for Multikine vs 45% in the control, at 5 years 28% jump in 5-year absolute survival 5-year risk of death cut from 55% to 27% Statistically significant p = 0.0015 Hazard ratio = 0.35 (95% CIs [0.19, 0.66]) Tumor reduction rate >13%
Slide 16: Positive Results In The Target Population
Positive Results In The Target Population The target population are patients who present with: • No nodal involvement and no extracapsular spread (via PET scan) • Low PD-L1 tumor expression (defined as TPS<10, via biopsy) (Note, this differentiates Multikine from high PD-L1 checkpoint inhibitors.)
Slide 17: Bottom Line: The Data Proves That Multikine Works
Bottom Line: The Data Proves That Multikine Works 1. 2. 3. Multikine leads to Pre-surgical Therefore, pre-surgical responses lead to Multikine leads to responses. better survival. better survival. SLIDE 17
Slide 18: CEL-SCI Plans To Seek Immediate Approval
CEL-SCI Plans To Seek Immediate Approval Europe, UK, Canada, USA Seeking approval based on current data Goal: get approval first, then do confirmatory study if required Submissions filed 3Q23-1Q24 Certification of manufacturing plant completed by 1Q24 Earliest informal indication of like
Slide 19: Top-Tier Physician Consultants
Top-Tier Physician Consultants Barbara Burtness, MD • Anthony N. Brady Professor of Medicine (Medical Oncology) at Yale School of Medicine • Chief Translational Research Officer, Yale Cancer Center • Chief, Head and Neck Cancers/Sarcoma and Co-Leader, Developmental Therapeutics, Yale Cancer Center •
Slide 20: Top-Tier Physician Consultants
Top-Tier Physician Consultants Marshall Posner, MD • Consultant for CEL-SCI since 2005 • Principal Investigator and Chair of the IDMC in CEL-SCI’s Phase 3 study • Director, Head and Neck Oncology, Mt. Sinai NY • Co-Leader, Cancer Clinical Investigation Program, Tisch Cancer Institute • More than 250
Slide 21: State-Of-The-Art Manufacturing Facility
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 no loss of
Slide 22: CEL-SCI's Value Proposition
CEL-SCI’s Value Proposition Initial capacity 12,000 treatments per year, if approved Cancer drugs $65 million that save lives market cap are worth many billions. ~$150,000 per treatment SLIDE 22
Slide 23: Upcoming Catalysts
Upcoming Catalysts Complete the commissioning of our manufacturing facility Potential Commercialization in Canada as Early as 2024 • We are preparing application for NOC/C approval as they suggested, hopeful to file 1Q24 • If NOC/C granted, then possible to begin commercialization in Canada late 202
Slide 24: Thank you.
Thank you. Pre-surgical, Tumor responses Longer local therapy before surgery life NYSE: CVM SLIDE 24