Quoin Pharmaceuticals. Ltd · NASDAQ:QNRX
Quoin Pharmaceuticals — Cellect Biotechnology — IPO Roadshow (July 2016)
28 slides from Quoin Pharmaceuticals's IPO roadshow presentation, Jul 25, 2016
Slide 1: Cellect Biotechnology Ltd Corporate Presentation
STEVEN KILMER INVESTOR RELATIONS ADVISOR JULY 2016 FUNCTIONAL STEM CELL SELECTION CELLECT BIOTECHNOLOGY LTD CORPORATE PRESENTATION JULY 25, 2016 Issuer Free Writing Prospectus Filed Pursuant to Rule 437 Registration No. 333 — 212432 July 25, 2016
Slide 2: Forward-looking statements
This presentation constitutes a “free writing prospectus,” or a portion thereof, required to be filed by the Company with the Commission or retained by Cellect Biotechnology Ltd . ( “we”, “us” or “our”) under Rule 433 to the Securities Act of 1933 , as amended, or the Act . All statements in this co
Slide 3: Free Writing Prospectus Statement
This presentation highlights basic information about us and the offering to which this communication relates . Because it is a summary, it does not contain all of the information that you should consider before investing in our securities . We have filed a registration statement (including a prospec
Slide 4: Company Overview
3 Broad, Enabling Technology Platform HSCT – Initial Development ▪ Developing Powered by Cellect technology platform o Functionally selects stem cells from a mixed population of cells o Potential to improve safety and efficacy of multiple regenerative medicine stem cell therapies ▪ First product und
Slide 5: Investment Highlights
5 ▪ Powered by Cellect platform represents potentially transformational technology ▪ Potential to dramatically improve major procedure (HSCT) with clear unmet medical need Should reduce immune related adverse effects ( Graft - versus - Host - Disease or GvHD), lower treatment costs and shorten lengt
Slide 6: Strong Management Team
Strong Management Team 6 Dr. Shai Yarkoni (MD, PhD), CEO, Co - Founder S enior executive in the biotechnology industry. Founder and CEO of Target - In Ltd., a cancer biotech therapeutics company. Founded and, until recently, managed Bio - Negev. Ronen Twito (CPA), Deputy CEO & CFO More than 15 years
Slide 7: Hematopoietic Stem Cell Therapy (HSCT): The Promise
• Hematopoietic stem cells are blood and lymph - forming cells found in bone marrow and blood • HSCT has been in use for over 50 years* • HSCT replaces bone marrow that has been destroyed by disease and disorders • Bone marrow is the primary source of stem cells for a wide variety of current and pot
Slide 8: HSCT: The Challenge
• HSCT is most commonly used cell based therapy, but is severely limited by very high mortality (up to 50%) and morbidity* • Main complications of HSCT are Graft - versus - Host - Disease (GvHD ) and other immune related complications** • GvHD occurs when transplanted mature cells attack host cells
Slide 9: HSCT: What is Transplanted Today?
Implant Rejection Risk of GvHD Large quantity of mature blood cells Small quantity of stem cells New immune system reconstituted in recipient 9 HSCT: What is Transplanted Today?
Slide 10: Current Process and Trade-Offs
If biomarker selection, reduction in engraftment If no biomarker selection, >50% GvHD Current Process 10 • Lab procedure aims to lower GvHD • Procedure is complex, inefficient and expensive • Significant unmet medical need for a safe, yet efficient selection process • Trade - off for GvHD reduction
Slide 11: Unmet Need = Market Opportunity
0 5,000 10,000 15,000 20,000 25,000 2010 2011 2012 2013 USA Europe Rising number of Allogeneic HSCT Procedures in U.S. and Europe 11 • There were ~23,000 allogeneic HSCT procedures in US & Europe in 2013* • About 35 – 50% of allogeneic HSCT recipients will develop acute GvHD** • Incidence of chronic
Slide 12: Our Solution: Powered by Cellect
12 • Takes advantage of functional characteristic of stem cells: their differential sensitivity to apoptosis (programmed cell death) o When mature cells are introduced to apoptotic ligands they commit suicide o In contrast, stem cells flourish in environments where normal cells die o Stem cells are
Slide 13: Powered by Cellect: How it Works
Preclinical studies show differential sensitivity to apoptosis signals allows selection of stem cells and elimination of mature immune cells Apoptosis Signal Stem cells resistant to Apoptosis flourish Mature immunogenic cells eliminated 13 Powered by Cellect : How it Works
Slide 14: ApoTainer Product Family
Various containers (infusion bag, test tubes, industrial drums) with an apoptotic environment for selection of stem cells from various sources 14 ApoTainer Product Family Effective and non - toxic graft
Slide 15: ApoTainer Development
Process POC established for developing off - the - shelf product Product (CL101) Stem Cell Mature Cell Death Signal 15 x Improved BMT by apoptotic selection x Successful binding of apoptotic protein to plastic surface ( Entegris collaboration) x Preserved apoptosis by coated plastic sheets x First p
Slide 16: ApoGraft Process
ApoGraft Process Wash 22 Donor ‘tn wash buster #1 ‘Auction of cat cous See aon x4 $Boctose cota ‘tn nglbaton meaum Resuspension ‘wash x1 “Transfusion within 4 Plasmo-tyte+s% HSA. wn wach butler #1. Incubation for2 he fous va mer 2c Test 2 Set conaaton eee otgi Fact {0-200x10%6 colahm, twas buter #2
Slide 17: ApoGraft vs. Current Practice
Current Procedures ApoGraft GvHD 60 – 80% 0 – 10 % Chemotherapy Wide Minimal Rate of Infection High Low Procedure and hospitalization Months Several Days Procedure Cost ~ $70,000 Significantly lower Total cost of procedure ~ $300,000 Significantly lower 17 ApoGraft Value - Added: • Improved engraftm
Slide 18: Powered by Cellect: Pre-clinical Results
• Based on 15 years of academic research • Significant reduction of cells that attack the immune system • Reduction of GvHD morbidity and mortality (20 – 100% to <10%) • Increase in percentage of stem and progenitor cells in sample • Preservation of successful engraftment and anti - tumor activity 1
Slide 19: Powered by Cellect: Pre-clinical Results
• Based on 15 years of academic research 1. Significant reduction of cells that attack the immune system 2. Full preservation of stem and progenitor cells 19 Powered by Cellect : Pre - clinical Results
Slide 20: Pre-clinical Results (cont'd)
3. Reduction of GvHD morbidity and mortality ( 20 – 100 % to < 10 %) 4 . Preservation of successful engraftment ( 95 % engraftment by Contract Research Organization) 5 . Preserved anti - tumor activity 20 Pre - clinical Results (cont’d) 5 4 3 5
Slide 21: Planned Phase 1-2 Clinical Trial
Israel (Rambam Medical Center in cooperation with Shaarei Tzedek Hospital) Location Clinical Trial Phase I/II Hematopoietic stem cell transplantation (HSCT) of Leukemia patients Open Label Status 12 patients Quantity of Patients Safety and efficacy Trial Purpose Approximately 18 months Trial Length
Slide 22: Regulatory Pathway for ApoTainer
Regulatory Pathway for ApoTainer 22 • ApoGraft™ is the stem cells of bone marrow devoid of the toxic mature cells. This process is incorporated into a single device called “ ApoTainer“. • A poGraft process is now in initial clinical studies (Phase I/II in Leukemia patients) • According to non - form
Slide 23: R&D Milestone Summary (2016-2017)
x Regulatory approval from IRB received for Phase 1 / 2 clinical trial ( Q 2 2016 ) x Complete human testing in healthy volunteers x Complete preliminary product design, a prototype ApoTainer 01 (H 1 2016 ) • Clinical trial in leukemia patients undergoing HSCT (Q 3 2016 ) • Pre - IND meeting (Q 4 20
Slide 24: Development Collaborations
• Entegris (NASDAQ:ENTG, $2B market cap) agreement to co - develop ApoTainer 01 • Collaboration agreement with leading Israeli stem cell company, Accellta, to evaluate Cellect’s platform technology on Accellta’s stem cell culturing technologies 24 Development Collaborations
Slide 25: Commercial Strategy
• Our goal is to achieve rapid validation of Powered by Cellect platform via shorter time to market approach o Device for allogeneic HSCT targeting leukemia • Expand horizontally to additional indications (diabetes, solid organ transplantation) • Expand vertically to other sources of stem cells (fat
Slide 26: Opportunity is Well Protected
• Patent to use apoptosis as selection tool, issued globally (U.S. until 2029) • Patent for special - purpose containers (National level patent until 2032, pending allowance) • Patents covering methods of use • Patents for manufacturing methods • Patents specific for Mesenchymal cells Multiple paten
Slide 27: Investment Highlights
27 ▪ Powered by Cellect platform represents potentially transformational technology ▪ Potential to dramatically improve major procedure (HSCT) with clear unmet medical need Should reduce immune related adverse effects ( Graft - versus - Host - Disease or GvHD), lower treatment costs and shorten leng
Slide 28: Thank You. Questions?
CELLECT BIOMED LTD CORPORATE PRESENTATION JULY 2016 THANK YOU. QUESTIONS? CELLECT BIOTECNOLOGY LTD