Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (November 2023)
23 slides from Cel-sci's investor presentation, November 2023
Slide 1: Multikine Pre-Surgical Cancer Therapy
Leukocyte Interleukin, Injection For Head And Neck Cancer Multikine™ Pre-Surgical Cancer Therapy 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 ~$125 million Avg. Daily Trading Volume ~ 1 million shares per day Shares Outstanding ~ 50 million shares; completely clean
Slide 4: Company Overview
Company Overview Our Mission Create first pre-surgical cancer treatment, first for head and neck cancer, then other cancers. Multikine is an immune boosting drug which is administered right after diagnosis, before surgery Introducing Multikine and other treatments have damaged the immune system. Mul
Slide 5: 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 6: Why Are We Confident In Gaining Approval of Our Drug?
Why Are We Confident In Gaining Approval of Our Drug? Multikine 73% vs 45% Control SLIDE 6
Slide 7: 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 7
Slide 8: The Key is our Ability to Define The Target Population
The Key is our Ability to Define The Target Population The target population are advanced primary head and neck 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 Multi
Slide 9: We Know How Multikine Works And Can Target This
We Know How Multikine Works And Can Target This 1. 2. 3. We observed statistically Pre-surgical responses Therefore, selecting significant pre-surgical lead to better survival. more patients predicted responses after Multikine to have a pre-surgical treatment. response should lead to much better sur
Slide 10: Pre-Surgical Responses Observed in the Phase 3 Trial
Pre-Surgical Responses Observed in the Phase 3 Trial A “pre-surgical response” is a significant change in disease before surgery. Pre-surgical responses lead to better survival. Reductions (PSR) >30% reduction in We saw two kinds of responses in the Phase 3 trial: tumor dimensions First, the
Slide 11: All Phase 3 Study Patients: Multikine leads to Pre-Surgical responses
All Phase 3 Study Patients: Multikine leads to Pre-Surgical responses SLIDE 11
Slide 12: All Phase 3 Study Patients: Pre-Surgical Responses Lead To Better Survival
All Phase 3 Study Patients: Pre-Surgical Responses Lead To Better Survival SLIDE 12
Slide 13: Higher Response Rates In The Target Population
Higher Response Rates In The Target Population SLIDE 13
Slide 14: Therefore, Multikine Leads To Better Survival
Therefore, Multikine Leads To Better Survival Multikine 73% vs 45% Control SLIDE 14
Slide 15: 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 15
Slide 16: Why Are We Confident In Gaining Approval of Our Drug?
Why Are We Confident In Gaining Approval of Our Drug? 73% survival for Multikine vs 45% in the control, at 5 years 28% jump in 5-year absolute survival Statistically significant p = 0.0015 5-year risk of death cut from 55% to 27% Hazard ratio = 0.35 (95% CIs [0.19, 0.66]) Tumor reduction
Slide 17: 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 complete confirmatory study if required Submissions filed 3Q23-1Q24 Commissioning of manufacturing plant completed by 1Q24 SLIDE 17
Slide 18: 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 19: CEL-SCI's Value Proposition
CEL-SCI’s Value Proposition Initial capacity 12,000 treatments per year, if approved Cancer drugs $125 million that save lives market cap are worth many billions. ~$150,000 per treatment SLIDE 19
Slide 20: Upcoming Milestones & Investment Highlights
Upcoming Milestones & Investment Highlights We have observed statistically significant survival data in the final target population vs control in a Phase 3 study conducted for Multikine. Multikine focuses on the 70% of patients not well served by the two leading approved drugs, Keytruda and Opdivo,
Slide 21: The CEL-SCI Team
The CEL-SCI Team Geert Kersten, Esq. Eyal Talor, PhD John Cipriano • Chief Scientific Officer since 2009 • Senior VP of Regulatory Affairs since 2004 • CEO since 1995 • Inventor / developer of Multikine® • Former FDA Deputy Director, Division of • Experience in investment banking and law • 30 years
Slide 22: Top-Tier Physician Consultants
Top-Tier Physician Consultants Marshall Posner, MD Barbara Burtness, MD • Consultant for CEL-SCI since 2005 • Anthony N. Brady Professor of Medicine (Medical Oncology) at Yale School of Medicine • Principal Investigator and Chair of the IDMC in CEL-SCI’s Phase 3 study • Chief Translational Research
Slide 23: Thank you.
Thank you. Pre-surgical, Tumor responses Longer local therapy before surgery life NYSE: CVM SLIDE 23