Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (October 2019)
37 slides from Cel-sci's investor presentation, Oct 25, 2019
Slide 1: Corporate Presentation
Corporate Presentation October 25, 2019 CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Officer Vienna, VA 22182, USA - Phone: (703) 506-9460
Slide 2: Forward Looking Statements
Forward Looking Statements This presentations contains “forward-looking safety profile and related adverse events of our and uncertainties, the forward-looking events statements” within the meaning of the Private product candidates; our ability to manufacture and circumstances described in this pres
Slide 3: FDA Disclaimer Statement
FDA Disclaimer Statement Multikine is the trademark that CEL-SCI has Potential conclusions could only be drawn registered for this investigational therapy, if the initial observations in the early-phase and this proprietary name is subject to FDA studies relating to the potential adverse events revi
Slide 4: Working to Create the First Cancer Drug to Be Administered Before Surgery
Working to Create the First Cancer Drug to Be Administered Before Surgery Multikine is administered to previously untreated, newly diagnosed head and neck cancer patients right after diagnosis for three weeks before the current standard of care treatments (surgery followed by radiation or combined r
Slide 5: Phase 3 Study Design - Timing of Multikine Treatment Regimen
Phase 3 Study Design -Timing of Multikine Treatment Regimen Advanced Primary Head and Neck Cancer Current 1st Line SOC* 4 weeks Radiotherapy Usual Drug Development Path Focuses Surgery or Chemo / Radiotherapy on Recurrent Cancer Diagnosis Multikine Treatment Keytruda (3 weeks) Proposed New 1st Line
Slide 6: Introducing The Management Team
Introducing The Management Team Geert R. Kersten Eyal Talor, Ph.D. Director and CEO Chief Scientific Officer • CEO since 1995; joined in 1987 • CSO since 2009; joined in 1993 • 30+ years pioneering field of cancer • 23+ years of managing clinical R&D immunotherapy development for immunotherapy appli
Slide 7: Introducing The Management Team
Introducing The Management Team Officer Title Joined CVM Years of Exp. Background Patricia B. Prichep 1992 40+ • Former Manager of Quality and Productivity for the NASD SVP of Operations • BA from the University of Bridgeport Daniel Zimmerman, Ph.D. 1996 40+ • Author of over 40 scientific publicatio
Slide 8: Product Candidates
Product Candidates Candidate Preclinical Phase 1 Phase 2 Phase 3 Marketing 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
Slide 9: Boosting the Immune System Before the Ravages of Radiation/Chemotherapy
Boosting the Immune System Before the Ravages of Radiation/Chemotherapy ● Give immune system drugs while the immune system is still strong, before surgery, radiation and chemotherapy ● Increase success rate of first cancer treatment by adding our immune stimulating product candidate Multikine to the
Slide 10: What is Multikine?
What is Multikine? Major Cytokine(s) and other Cellular Products in Multikine ● Multikine is an investigational patented mass produced biological product manufactured following Good Manufacturing Practice (GMP) requirements from ”Source Leukocytes” – an FDA licensed product - at CEL-SCI’s IL-1 α IL-
Slide 11: 11 Clinical Studies Have Been Completed Across Indications for Multikine
11 Clinical Studies Have Been Completed Across Indications for Multikine Phase Indication No. of subjects Countries Published paper Phase 1/2 Head & Neck Cancer Recurrent 16 U.S. & Canada N/A Pilot Study Head & Neck Cancer Recurrent 4 U.S. Arch Otolaryngol Head and Neck Surgery Phase 1/2 Head & Neck
Slide 12: Why Head and Neck Cancer as a First Target?
Why Head and Neck Cancer as a First Target? ● Advanced (stages 3 and 4) primary (not yet treated) head and neck cancer was selected as the first indication because: ○ Represents an unmet medical need ○ Last FDA approval of a therapy for advanced primary head and neck cancer was about 60 years ago ○
Slide 13: Head and Neck Cancer Market
Head and Neck Cancer Market ● World-wide about 650,000 new head and neck cancer patients diagnosed per year U.S. Europe About 60,000 new patients p.a. About 105,000 new patients p.a. ● Advanced primary head and neck cancer constitutes about 2/3 of all head and neck cancer patients ● Neoadjuvant trea
Slide 14: Mechanism of Action Stimulates an Immune Response at the Injection Site
Mechanism of Action Stimulates an Immune Response at the Injection Site Multikine (perilymphatic) Tumoricidal / Tumoristatic Local / Regional Necrotic (e.g., TNFα) Antigen Presenting Cells (Dendritic Cells, Macrophages) Micro Metastases Neutrophils Tumor CD4 + T Cells Lymph Nodes Multikine (peritumo
Slide 15: Multikine Showed Measurable Anti-Tumor Responses in 3 Weeks Only
Multikine Showed Measurable Anti-Tumor Responses in 3 Weeks Only The final “Proof of Concept” Phase 2 study, following multiple Phase 2 studies that tested different treatment regimens, selected the best treatment for patients. The treatment regimen in this final Phase 2 study is the same as used in
Slide 16: Multikine Increased Overall Survival (OS) by 33%
Multikine Increased Overall Survival (OS) by 33% Approximately three years after the same “Proof of Concept” Phase 2 study we obtained the patients’ and their families’ consents for a survival follow-up Survival results in this Final “Proof of Concept” Phase 2 study were compared to results from 55
Slide 17: Pathology: Non-Treated vs. Multikine Treated (Final Phase 2 study)
Pathology: Non-Treated – vs. – Multikine Treated (Final Phase 2 study) Oral Squamous Cell Carcinoma (Locally Advanced Primary H&N Cancer) Histological appearance of necrosis in Oral Squamous Cell Carcinoma (OSCC) [HE staining]: Non-Multikine treated Multikine treated Lack of necrosis in the epitheli
Slide 18: Phase 3 Trial Partners
Phase 3 Trial Partners National Institutes of Teva Pharmaceutical Orient Europharma Co. Ergomed PLC, UK Health, USA Industries Ltd., Israel Ltd., Taiwan (NYSE:TEVA) — — — — genetic and molecular licensee for several licensee for several Far CRO that completed Phase markers from tumor samples countri
Slide 19: Multikine Exhibits a Consistent Safety Profile Across Phase 1 and 2 Studies
Multikine Exhibits a Consistent Safety Profile Across Phase 1 and 2 Studies ● Multikine is administered in supra-physiological doses locally (near or close) to the tumor and the adjacent lymph nodes. The known cytokines contained in Multikine are present in amounts well below any published levels th
Slide 20: How Does the Multikine Patient Population Differ from Checkpoint Inhibitor Population?
How Does the Multikine Treatment Patient Population Differ from the Checkpoint Inhibitor Patient Population? The checkpoint inhibitor Keytruda® by Merck was approved for head and neck cancer in June 2019, but it was approved for a very different patient population than that which CEL-SCI is pursuing
Slide 21: State-of-the-Art Facility & Proprietary Manufacturing Process: Potential Barriers to Competition
State-of-the-Art Facility & Proprietary Manufacturing Process: Potential Barriers to Competition ● cGMP and BSL-1 facility ○ Built specifically for Multikine – but could easily be Multi-use ○ State-of-the art facility ○ Over 73,000 ft2 of Manufacturing and R&D space available ○ About 35,000 ft2 full
Slide 22: Intellectual Property Protection for Multikine
Intellectual Property Protection for Multikine Patents and other protection for Multikine: ● Composition of matter patent protection until 2024 ○ US Patent # 6,896,879 ○ European Patent (Germany) # 1,773,395 ○ European Patents: #1,753,452; #1,773,368; #1,879,618 ○ Chinese Patent # ZL200480025403.6 ○
Slide 23: When Will the Phase 3 Study End?
When Will the Phase 3 Study End? ● The study started in early 2011 and the last patient was enrolled in September 2016. o All cancer patients have been in the study for 3 to 8.5 years. • Patients are currently being followed for overall survival and other protocol specified endpoints. Two hundred ni
Slide 24: Estimated Overall Survival Using the SOC for the Study Population
Estimated Overall Survival (OS) using the SOC for the Study Population Enrolled in CEL-SCI’s Phase 3 Clinical Trial Year OS Estimate 95% Confidence Bound 1 71.42% (69.84%, 72.92%) ● Three (3) Year OS – Approximately 47% 2 53.86% (52.09%, 55.59%) ● Five (5) Year OS – Approximately 37% 3 46.59% (44.74
Slide 25: Who Has the Unblinded Data from the Phase 3 Study?
Who Has the Unblinded Data from the Phase 3 Study? ● CEL-SCI is blinded to the study results ● Only the regulators, the Independent Data Monitoring Committee (IDMC) and select members of the CRO have unblinded information ● The FDA and 23 other regulators have reviewed detailed annual reports from t
Slide 26: Why is the Multikine Study an Event Driven Study?
Why is the Multikine Study an Event Driven Study? ● By now it is well established that cancer immunotherapy has a “delayed survival” benefit. In a time driven study you end the study at a certain time point (e.g., two years after the last drug was administered). Under this scenario, the study may be
Slide 27: Can the study not end early if things look good?
Can the study not end early if things look good? ● Looking good is not “good enough” in an event driven study. You need an adequate level of statistical power (at least 80%) to prove that the drug works. If you end the study short of the required 298 events, you may lack the required statistical pow
Slide 28: Key Developments Pointing to Likelihood of Success of Phase 3 Study
Key Developments Pointing to Likelihood of Success of Phase 3 Study ● To prove a 10% improvement in overall survival, the study requires CEL-SCI to wait until 298 events have occurred among the two main groups. In Phase 2 studies, Multikine increased survival by 33%. ● We believe a delay in reaching
Slide 29: The next slide was presented by Dr. Chen, Executive Director of Global Biometrics Sciences
The next slide was presented by Dr. Chen, Executive Director of Global Biometrics Sciences with Bristol-Myers Squibb, at the EMA-CDDF Joint Meeting, London, UK in February 2016. It discusses the final clinical trial for Yervoy (Ipililumab), the first cancer immunotherapy blockbuster drug. This trial
Slide 30: Lessons Learned (Event-Driven vs. Time-Driven Design)
Lessons Learned (Event-Driven vs. Time-Driven Design) ● Ipilimumab in front-line metastatic melanoma – Estimated study duration: 3 years ● 3 years after study start – ~85% of anticipated number of events – Decreasing event rate – ~84% statistical power ● Study continued for another 1.5~2 years for t
Slide 31: CEL-SCI Stock Chart and Key Events - August 1, 2018 through October 25, 2019
CEL-SCI Stock Chart and Key Events - August 1, 2018 through October 25, 2019 31
Slide 32: Top 5 Institutional Investors
Top 5 Institutional Investors 32
Slide 33: Late Stage Cancer Company Acquisitions in the Past 2 Years
Late Stage Cancer Company Acquisitions in the Past 2 Years Company Ticker Sales price Phase, Indication(s) and Acquisition • Phase 1&2/3 Solid Tumors, ALL,NHL, Multiple Kite Pharma Myeloma, CLL, AML • Acquired by Gilead for $11.9 B Bought by Gilead KITE $11.9 B (August 2017) • Phase 1 & 2 NHL, ALL,
Slide 34: LEAPS: A Separate Technology
LEAPS: A Separate Technology CEL-SCI’s LEAPS technology is a platform technology for therapeutic vaccines ● A patented new class of drug with a novel approach, acting earlier in the pathway of the specific disease ● Efficacy demonstrated in six human diseases by animal challenge models; three autoim
Slide 35: Summary
Summary ● Multikine is administered before surgery, radiation and chemotherapy because that is the time when the patient's immune system is the strongest. By doing so we hope to either cure the patient or delay the time to recurrence ● Phase 3 overall survival (OS) data results are expected soon ● E
Slide 36: Closing
Closing The Multikine Phase 3 trial is the largest head and neck cancer study ever. Head and neck cancer is one of the biggest cancers worldwide with about 650,000 new patients per year. CEL-SCI’s Phase 3 study enrolled the last of its 928 patients about three years ago and the final data read out i
Slide 37: CEL-SCI Corporation Geert Kersten Chief Executive Officer
CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Officer Vienna, VA 22182, USA - Phone: (703) 506-9460