Slide 1: Multikine “True First-Line” Cancer Therapy
Multikine “True First-Line” Cancer Therapy First Indication: Potential Blockbuster Head & Neck Cancer Immunotherapy May 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: Pipeline
Pipeline Confirmatory Candidate Preclinical Phase 1 Phase 2 Phase 3 study MULTIKINE Head and neck cancer: – right after diagnosis, therapy administered right after diagnosis, before the first surgery HPV – Cervical dysplasia in HIV/HPV co-infected patients (Univ. of Maryland) LEAPS Rheumatoid Arthri
Slide 4: Why Invest In CEL-SCI Now?
Why Invest In CEL-SCI Now? We believe CEL-SCI’s market cap should be here or above. CEL-SCI’s market cap is about $75 million https://www.stifel.com/newsletters/investmentbanking/bal/marketing/healthcare/biopharma_timopler/biopharmamarketupdate_04.01.2024.pdf SLIDE 4
Slide 5: De-Risked Unique Investment Opportunity
De-Risked Unique Investment Opportunity Where we were… Recent catalysts… Where we are headed… FDA agreed to 212-person 928-patient Phase 3 completed confirmatory Registration Study Approval: Head & Neck Cancer Robust data demonstrating high efficacy De-risked Registration Study needs only Cancer dru
Slide 6: Our Confirmatory Trial Is Highly Likely To Succeed
Our Confirmatory Trial Is Highly Likely To Succeed • Confirmatory studies have a much higher chance of success than normal Phase 3 studies. Our confirmatory study is expected to have an even higher chance of success for the following reason: A normal confirmatory cancer study seeks to show that tumo
Slide 7: Our Confirmatory Trial Is Highly Likely To Succeed Because the Data Is Better Than Needed
Our Confirmatory Trial Is Highly Likely To Succeed Because the Data From The Completed Trial Is Better Than What Is Needed For Approval Multikine in the Target Population Standard for Success (Selected From Phase 3 Data) Survival benefit Absolute 28% survival benefit above absolute10% Hazard ratio 0
Slide 8: What Is Multikine Pre-Surgery Therapy?
What Is Multikine Pre-Surgery Therapy? Multikine is . . . - a true first-line cancer immunotherapy given right after diagnosis, before surgery. - a mixture of natural cytokines and biological molecules. - mass produced at CEL-SCI’s dedicated GMP manufacturing facility near Baltimore. - initially tar
Slide 9: What is the big deal about Multikine?
What is the big deal about Multikine? • Multikine is given right after diagnosis, before surgery, radiation and chemotherapy have damaged the immune system. It acts when the immune system is strongest. • This approach is unique compared to normal cancer drug development, which focuses on late-stage
Slide 10: Summary of Prior Clinical Data
LI Treatment Regimen Summary of Prior Clinical Data • Multikine has already been in clinical trials in over 750 patients. • Completed a 928-patient head and neck cancer Phase 3 study. • Why are we valued at under $100 m as opposed to $5 billion? o Large survival benefit for patients who had Multikin
Slide 11: Safety Across the Entire Patient Population
Safety Across the Entire Patient Population No LI-Related AEs, Deaths, Or Delays • No Multikine-related systemic AEs (Adverse Effects) or SAEs (Serious Adverse Effects). • No Multikine-related delays of surgery. • No Multikine-related interference with post-surgical treatment. • No Multikine-related
Slide 12: Increased Pre-Surgical Tumor Responses Appear to Lead to Increased Survival
Increased Pre-Surgical Tumor Responses Appear to Lead to Increased Survival Across The Entire Phase 3 Study SLIDE 12
Slide 13: Focusing the Target Population
Focusing the Target Population • The greatest benefit was in the targeted population: Newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). o Physicians routinely assess the
Slide 14: Supported by the Biological Mechanism of Action
Supported by the Biological Mechanism of Action • Why N0? • The immune system needs the lymph nodes to work. If nodes are damaged by disease, then the immune system is less effective. Patients with “N0” (no cancer found in the regional lymph nodes) can mount the strongest immune attack. Also, physic
Slide 15: Supported by the Biological Mechanism of Action
Supported by the Biological Mechanism of Action N0 means intact local immune architecture can mount an effective immune attack on the tumor PD-L1 is associated with an immune Low PD-L1 tumor expression environment rich in CD8 T cells; low PD-L1 reduces the tumor’s ability to tumor expression means l
Slide 16: In the Target Population: Improved Survival In Patients From The Phase 3 RCT
In the Target Population: Improved Survival In Patients From The Phase 3 RCT Data Presented at European Society for Medical Oncology in October 2023 73% survival for Multikine vs 45% in the control, at 5 years Absolute 28% jump in 5-year absolute survival Statistically significant p = 0.0015
Slide 17: Multikine’s Path Forward
Multikine’s Path Forward • The ethical standards for exposing patients to an experimental drug are much stricter for newly- diagnosed patients than for terminal patients, who are already expected to die from the cancer. • We were able to meet FDA’s stricter standards. FDA has accepted our patient se
Slide 18: Multikine’s Path Forward: An FDA-Accepted Confirmatory Trial
Multikine’s Path Forward: An FDA-Accepted Confirmatory Trial Stage 1, enroll and treat 212 patients Stage 2, long term follow-up Early Read-Out Overall survival Pre-surgical responses Other endpoints (EFS, QoL, etc.) Can be assessed within weeks after full enrollment Rapid confirmation of
Slide 19: Multikine Approval Pathway With The US FDA
Multikine Approval Pathway With The US FDA • We received FDA go-ahead for the confirmatory clinical trial in meeting minutes received from FDA in May ‘24. • Food and Drug Omnibus Reform Act, enacted Dec ‘22, requires enrollment to be “substantially complete” before accelerated approval will be consi
Slide 20: Dedicated State-of-the-Art Manufacturing Facility
Dedicated 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
Slide 21: 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 22: Investment Highlights and Milestones
Investment Highlights and Milestones The goal of the confirmatory study is to show an absolute 10% survival benefit. The analysis of these Strong survival data: patients in the completed study showed an absolute 28% survival benefit. No drug is approved as a pre-surgical treatment in head & neck can
Slide 23: Final Thoughts
Final Thoughts • We have identified the exact patient population where Multikine provides a very large survival benefit. FDA has agreed with this selection and has given the go-ahead for the confirmatory trial. • Statistically speaking and when you look at the large survival benefit seen in the prio
Slide 24: Equity Summary
Equity Summary CEL-SCI Corporation NYSE American: CVM Completed 928-patient, global, multicenter, Phase 3 cancer immunotherapy study, Clinical Trial Stage preparing for confirmatory study of 212 patients Market Capitalization ~$77 million Avg. Daily Trading Volume ~ 330,000 shares per day Shares Out
Slide 25: Thank you.
Thank you. NYSE American: CVM SLIDE 25