Cel-sci Corporation · AMEX:CVM
Cel-sci — Investor Presentation (February 2019)
30 slides from Cel-sci's investor presentation, February 2019
Slide 1: Corporate Presentation
Corporate Presentation 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: Immunotherapy Works Best in Less Sick Cancer Patients
Immunotherapy Works Best in Less Sick Cancer Patients The idea that immunotherapy may actually work best in less sick cancer patients is logical, since the immune system’s natural role is to destroy nascent tumors. “It’s not yet prime time ... but in the long run I think we will move immunotherapy t
Slide 5: 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 6: 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 7: 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 8: 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 (3 weeks) Proposed New 1st Line SOC* (upo
Slide 9: Boosting the Immune System Before the Ravages of Radiation/Chemotherapy
Boosting the Immune System Before the Ravages of Radiation/Chemotherapy ● Increase success rate of first cancer treatment by adding our immune stimulating product candidate Multikine to the current standard of care (SOC) for advanced primary (not yet treated) head and neck cancer ● Give immune syste
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 primary (not yet treated) head and neck cancer was selected as the first indication because: ● World’s largest Phase 3 trial in advanced primary head and neck cancer ○ Last FDA approval of a therapy for advanced primary head and neck cancer was ab
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: 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 15: 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 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: 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 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: When Will the Phase 3 Study End?
When Will the Phase 3 Study End? ● The study is fully enrolled with 928 patients ● Approximately 135 patients were enrolled in the study from 2011 to 2013, about 195 were enrolled in 2014, about 340 in 2015, and about 260 in 2016 ● The last patient was enrolled in the study in September 2016 ● The s
Slide 20: Cancer Immunotherapy in Head and Neck Cancer
Cancer Immunotherapy in Head and Neck Cancer The best known cancer immunotherapy treatments are checkpoint inhibitors Keytruda (Merck) and Opdivo (BMS). These two drugs have been rapidly approved for sale, in many cases on the basis of small studies only, in multiple cancer indications. They are als
Slide 21: Multikine Compared to Keytruda and Opdivo in SCCHN
Multikine Compared to Keytruda and Opdivo in SCCHN Multikine Keytruda (Merck) Opdivo (BMS) Indication: Advanced primary previously untreated SCCHN Recurrent metastatic SCCHN Recurrent metastatic SCCHN Dosing: Intracutaneous (IC) one course injected 5 times a week x 3 weeks around Intravenous (IV) ev
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: State-of-the-Art Facility & Proprietary Manufacturing Process
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 24: 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 25: Late Stage Cancer Company Acquisitions in the Past 18 Months
Late Stage Cancer Company Acquisitions in the Past 18 Months Company Ticker Sales price Phase, Indication(s) and Acquisition • Phase 1&2/3 Solid Tumors, ALL,NHL, Multiple Kite Pharma Myeloma, CLL, AML Bought by Gilead KITE $11.9 B • Acquired by Gilead for $11.9 B (August 2017) • Phase 1 & 2 NHL, ALL
Slide 26: Why is CEL-SCI so Undervalued?
Why is CEL-SCI so Undervalued? ● 8 year clinical trial - The Phase 3 trial was supposed to be a 5 year study, instead it has lasted about 8 years so far (lack of enrollment by the former CRO that ran the study from 2011-2013). In the ongoing Phase 3 study we hope to repeat the Phase 2 success that s
Slide 27: The Reality of the Phase 3 Study is This
The Reality of the Phase 3 Study is This ● The FDA and 23 regulators have reviewed detailed annual reports from the Phase 3 study for the last eight years and never had any questions ● The removal of the clinical hold by FDA in August 2017 had to legally meet the standards of 21CFR312.22 of the Food
Slide 28: Summary
Summary ● Phase 3 overall survival (OS) data results are expected soon ● Endpoint of 10% improvement in overall survival (OS) over comparator arm in Phase 3 study. In our completed Phase 2 we saw a 33.1% improvement over the average OS for the current SOC (from scientific literature) at 3.3 years po
Slide 29: 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 2.5 years ago and the final data read out is
Slide 30: 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