Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (February 2024)
26 slides from Cel-sci's investor presentation, February 2024
Slide 1: Multikine Pre-Surgical Cancer Therapy
Leukocyte Interleukin, Injection For Head And Neck Cancer Multikine Pre-Surgical Cancer Therapy February 2024 NYSE American: CVM SLIDE 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking expectations regarding federal, state and presentation speak only as of their respective statements” within the meaning of the Private foreign regulatory requirements; the dates. Except to the extent required by Securities Litiga
Slide 3: 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 4: 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. First-line Multikine is given right after diagnosis, before surgery, when the immune system is (neoadjuvant) strongest (before radi
Slide 5: The Multikine Treatment Regimen
The Multikine Treatment Regimen Multikine would be added to the current standard of care, delivered locally via injections around the tumor and adjacent lymph nodes for three weeks, 5 days per week before surgery: Current Standard Of Care Locally advanced primary head and neck cancer Radiotherapy Di
Slide 6: Excellent Safety Profile
Excellent Safety Profile • No Multikine-related deaths. Percentage of subjects with AEs by study time period (N=879) 100% • Multikine-related adverse 90% Control, 90.2% Multikine, 82.5% events before surgery were 80% local and resolved after 70% surgery. 60% 50% Multikine, 42.3% Control, 40.9% Multi
Slide 7: 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 (N0) (via PET scan) • Low PD-L1 tumor expression (via biopsy) • (Note, this differentiates Multikine from high PD-L1 checkpoint inhibitors) • Physician
Slide 8: 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. We observed statistically Pre-surgical responders More pre-surgical responders significant pre-surgical saw better survival. leads to better survival in the responses after Multikine target population. treatment. SLIDE 8
Slide 9: 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” - There were “reductions” in the size of the tum
Slide 10: We Observed Significantly Increased PSRs/PSDs Across The Entire Phase 3 Study
We Observed Significantly Increased PSRs/PSDs Across The Entire Phase 3 Study SLIDE 10
Slide 11: 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 11
Slide 12: Even Higher PSR/PSD Rates In The Target Population
Even Higher PSR/PSD Rates In The Target Population SLIDE 12
Slide 13: Overall Survival in Multikine Target Population
Overall Survival in Multikine Target Population 5-year survival Multikine 73% vs 45% Control SLIDE 13
Slide 14: 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 14
Slide 15: 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 16: Multikine Accelerated Approval Pathway with the U.S. FDA
Multikine Accelerated Approval Pathway with the U.S. FDA • We plan to submit the proposed protocol for the confirmatory trial to the FDA in Q1 2024. • Get FDA buy-in for the confirmatory clinical trial (n=212); discussion of potential accelerated approval timing and endpoints needed. • New law (Food
Slide 17: Other Multikine Approval Pathways
Other Multikine Approval Pathways We are hopeful for meetings in H1 2024 to understand if conditional approval can be given with a promise to do a confirmatory study after conditional approval or if it is possible to get a conditional approval with the enrollment of patients in the confirmatory stud
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: 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 20: 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 Cance
Slide 21: Upcoming Milestones and Investment Highlights
Upcoming Milestones and Investment Highlights We have observed statistically significant survival data in the final target population vs control in a Phase 3 Strong survival data: study conducted for Multikine. Addressing an Multikine focuses on the 70% of patients not well served by the two leading
Slide 22: Appendix
CEL*Scl Appendix Ce’ Sci
Slide 23: Pipeline
Pipeline Marketing Candidate Preclinical Phase 1 Phase 2 Phase 3 Approval MULTIKINE Head and Neck Cancer Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck administered right after diagnosis, before the first standard cancer treatment – Global Pivotal Phase 3 Study HPV
Slide 24: What is Multikine?
What is Multikine? • Multikine investigational immunotherapy is comprised of a mixture of cytokines; it is not one cell or one protein. • It is a combination of proteins derived from the stimulation of a normal immune system cell culture. • Multikine is allogeneic and not made from the patient’s own
Slide 25: Mechanistic Support For Multikine Mechanism of Action
Mechanistic Support ForMechanism Multikine The Target Population Definition of Action • Multikine and Multikine activated immune cells potentially may: N0 means intact local immune architecture can mount an • Recognize and/or bind to multiple (different) effective immune attack on the antigens (or r
Slide 26: Thank you.
Thank you. NYSE American: CVM SLIDE 26