Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (January 2024)
25 slides from Cel-sci's investor presentation, Jan 25, 2024
Slide 1: Multikine Pre-Surgical Cancer Therapy
Leukocyte Interleukin, Injection For Head And Neck Cancer Multikine™ Pre-Surgical Cancer Therapy January 25, 2024 NYSE: CVM SLIDE 1
Slide 2: Forward Looking Statements
Forward Looking Statements SLIDE 2
Slide 3: Equity Summary
Equity Summary CEL-SCI Corporation New York Stock Exchange (American): CVM Clinical trial stage Completed 928-patient, global, multicenter, randomized Phase 3 trial Market capitalization ~ $145 million (as of January 25, 2024) Average trading volume ~ 0.7 million shares per day Shares outstanding ~
Slide 4: Company Overview
Company Overview Create the first pre-surgical cancer treatment, initially for head and neck cancer, and then Our mission for other cancers. Activate the immune system to fight cancer before it is weakened by surgery, radio and chemotherapy. Our flagship drug Multikine injected locally around the tu
Slide 5: Multikine: What, When, How, Who, & Why
Multikine: What, When, How, Who, & Why Multikine is a mixture of immune-boosting cells (cytokines) and other small molecules Natural that naturally occur in our bodies. Multikine is given right after diagnosis, before surgery, when the immune system is First-line (neoadjuvant) strongest (before radi
Slide 6: The Multikine Treatment Regimen
The Multikine Treatment Regimen • Multikine would be added to the current standard of care. Current Standard Of Care Locally advanced primary head and neck cancer Radiotherapy Diagnosis Multikine Surgery -OR- (3 weeks) Chemoradiotherapy 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. • Cytokines in Multikine are not toxic because they are given l
Slide 8: Why Are We Confident In Gaining Approval of Our Drug?
Why Are We Confident In Gaining Approval of Our Drug? 5-year survival Multikine 73% vs 45% Control SLIDE 8
Slide 9: Our Target Population Is Clearly Defined And Well-Understood
Our Target Population Is Clearly Defined And Well-Understood • Advanced primary head and neck patients who present with: • No lymph node involvement (via PET scan) • Low PD-L1 tumor expression (via biopsy) • (Note, this differentiates Multikine from high PD-L1 checkpoint inhibitors) • Physicians rou
Slide 10: The Clinical Data Shows How Multikine Works And How To Target This
The Clinical Data Shows How Multikine Works And How To Target This. 1. 2. 3. The Multikine regimen Pre-surgical responders More pre-surgical responders led to pre-surgical responses. saw better survival. leads to better survival in the target population. SLIDE 10
Slide 11: Pre-Surgical Responses In The Phase 3 Trial
Pre-Surgical Responses In The Phase 3 Trial • A pre-surgical response is a significant change in disease before surgery. • These emerged just a few weeks after treatment onset. • We saw two kinds of responses in the Phase 3 trial: • “Tumor reductions” • “Disease downstages” • Pre-surgical responders
Slide 12: Multikine Significantly Increased PSRs/PSDs Across The Entire Phase 3 Study
Multikine Significantly Increased PSRs/PSDs Across The Entire Phase 3 Study SLIDE 12
Slide 13: PSRs/PSDs Led To Significantly Better Survival Across The Entire Phase 3 Study
PSRs/PSDs Led To Significantly Better Survival Across The Entire Phase 3 Study SLIDE 13
Slide 14: Even Higher PSR/PSD Rates In The Target Population
Even Higher PSR/PSD Rates In The Target Population SLIDE 14
Slide 15: Therefore, Multikine Leads To Better Survival In The Target Population
Therefore, Multikine Leads To Better Survival In The Target Population 5-year survival Multikine 73% vs 45% Control SLIDE 15
Slide 16: Multikine Cut The Risk Of Death At 5-years In Half In The Target Population
Multikine Cut The Risk Of Death At 5-years In Half In The Target Population 60% Risk of death, 55% Reduction in death risk 5-year risk of death 50% 40% Control Risk of death, 30% 27% 20% Multikine 10% 0% SLIDE 16
Slide 17: Why We Are Confident That Multikine Will Be Approved
Why We Are Confident That Multikine Will Be Approved. 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 18: CEL-SCI Plans To Seek Approval Before Completion of Confirmatory Study
CEL-SCI Plans To Seek Approval Before Completion of Confirmatory Study Europe, UK, Canada, USA. Seeking approval based on: • current data or • current data plus early data from a confirmatory study. Goal: get approval, then complete confirmatory study if required. Commissioning of manufactur
Slide 19: 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 20: CEL-SCI's Value Proposition
CEL-SCI’s Value Proposition Initial capacity 12,000 treatments/year, if approved Cancer drugs that save $125 million lives are worth market cap many billions. ~$150,000 per treatment SLIDE 20
Slide 21: Upcoming Milestones and Investment Highlights
Upcoming Milestones and Investment Highlights Positive Phase 3 clinical data on efficacy and safety. Unmet medical need: Multikine focuses on patients who are not served by leading immunotherapies. We plan to submit the target population data to the FDA in Q1 2024. We will collaborate with the FDA o
Slide 22: 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 23: Top-Tier Physician Consultants
Top-Tier Physician Consultants Barbara Burtness, MD Marshall Posner, MD • Anthony N. Brady Professor of Medicine (Medical Oncology) at Yale • Consultant for CEL-SCI since 2005 School of Medicine • Principal Investigator and Chair of the IDMC in CEL- • Chief Translational Research Officer,Yale Cancer
Slide 24: End of 2023 Biotech M&A Activity
End of 2023 Biotech M&A Activity ImmunoGen, Inc. Cerevel Therapeutics Holdings, Inc. Horizon Therapeutics PLC Seagen Inc. (Nasdaq:IMGN) (Nasdaq:CERE) Completed: 10/06/2023 Announced: 11/30/2023 Announced: 12/06/2023 Completed: 12/14/2023 Target: Horizon Therapeutics PLC Target: ImmunoGen
Slide 25: Thank you.
CEL*Scl Thank you. >) © ) ® e%@ ®, Pre-surgical, i) Tumor responses @_ local therapy before surgery @ @2,e° NYSE: CVM Cesc SLIDE 25