Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (May 2024)
22 slides from Orgenesis's investor presentation, May 2024
Slide 1: Investor Presentation May 2024
I N V E S T O R P R E S E N T A T I O N N A S D A Q : O R G S M A Y 2 0 2 4
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements in
Slide 3: Cell & Gene Therapies
Cell & Gene Therapies • Cell and gene therapy is a fast-growing field of personalized medicine, driving medical innovation and revolutionizing health care in applications such as oncology, immunology, genetic and metabolic disorders, and more. • Autologous cell and gene therapies use the patient’s e
Slide 4: We Believe Cell & Gene Therapies are the Future
We Believe Cell & Gene Therapies are the Future Global Cell & Gene Therapies Market Global Cell & Gene Therapeutic Clinical Trials (Volume in USD bn) ~$78.0 bn 23% CAGR ~2,406 Expected CGT market Expected between Clinical trials Underway size by 2032 2022-2032 with CGT 23% CAGR 846 1338 222 Phase 1
Slide 5: About Us
Orgenesis is a global biotech company committed to transforming the About Us processing of cell and gene therapies (CGT) through the introduction of a paradigm shifting decentralized cell processing (“DCP”) platform featuring both our proprietary therapies and a suite of CGT Services available to th
Slide 6: Orgenesis is Unlocking the Potential of CGT
Orgenesis is Unlocking the Potential of CGT AVAILABLE Process development focused on quality control (QC) & regulatory compliance - combined with custom closed-loop and automated systems - integrated into standardized mobile processing units. ACCESSIBLE Regional centers enable flexible localization
Slide 7: Orgenesis is Unlocking the Potential of CGT
Orgenesis is Unlocking the Potential of CGT Orgenesis is primarily focused on pioneering a paradigm-shifting decentralized approach to CGT therapies utilizing an automated and/or closed approach validated for compliant production at or near the patient care site (“Decentralized Cell Processing or DC
Slide 8: Evolution Story - Historical Overview
Orgenesis Evolution Story- Historical Overview Liver-derived AIP Product Next NK based CAR-T-CD19 - for B Anti-Viral Ranpirnase CARTIL-S, TS Gene Therapy cell malignancies Autologous Insulin Development, IND Generation Cancer product platform Chondroseal- AD-MSC for Blood Producing Cells enabling st
Slide 9: Management
Orgenesis Management Vered Caplan Victor Miller, CFA Evan Fishman, CPA Greg Roumeliotis Board Chairman & CEO CFO at Orgenesis Inc CFO at Orgenesis Israel GM at Orgenesis Greece Kamedis & GammaCann Baxter, Neos & Hycor Minicomm Advanced System Breakthrough Gen., Veritas Joseph Carpinelli Pierre Lamme
Slide 10: Professional Team
Orgenesis Professional Team Prof. Heiko von der Leyen, MD - Head of Global Clinical Development A strong, educated, multi-disciplinary team of Heiko is the head of the Coordination Center for Clinical Studies at Hannover Medical School (HCTC-KKS). He was co-founder and scientists, physicians, biomed
Slide 11: Newly Created Orgenesis Strategic Advisory Board
Newly Created Orgenesis Strategic Advisory Board Murray Bacal Experienced senior executive with a proven track record in strategic advising, finance, marketing, and mergers. Proficient in leading companies to success. Previous roles include Senior Strategic Advisor to Miracle Leaf Health Centers, Co
Slide 12: Evolution Story - Next Phase
Orgenesis Evolution Story- Next Phase Decentralized Therapies Integrated into DCP Platform / Release of clinical data for Oncology product / 2024 / Orgenesis Therapies Development / Production and Supply chain / 2024 Octomera consolidation Orgenesis developed best-in-class decentralized therapies to
Slide 13: Decentralized Platform - Global Footprint
Decentralized Platform –Global Footprint Acceleration of CGT therapies development providing high quality services and products “I do not see a Clinical Clinical Centers centralized approach Development with a few hubs being able to deliver products to people that need these therapies”. Nirav Shah,
Slide 14: Working with Leading Clinical Centers
Working with Leading Clinical Centers “Decentralized model for cell therapy manufacturing at a suitable scale to be a part of each of the major oncology institutions across the world” - Evan Zynda Thermo Fisher Scientific United States Middle East Europe Asia Maryland Israel Spain Italy China Massac
Slide 15: Mobile Processing Units and Labs: OMPUL
Orgenesis Mobile Processing Units and Labs: OMPULTM OMPULs to scale-up and 1/31 the cost of traditional centralized processing • Potential to reduce the cost of processing cells to 1/3 versus current • OMPULs are designed to shorten the implementation time of centralized processing platforms using o
Slide 16: ORGS Therapies - CGT Asset Creation & Out-Licensing
ORGS Therapies - CGT Asset Creation & Out-Licensing Product life cycle Immuno-Oncology Metabolic disorders R&D co Regional CGT product development Out licensed Commercial- strategic creation under ORGS to a regional ization and partner covers (in-licensed network strategic revenue local clinical or
Slide 17: Orgenesis CAR-T
Orgenesis CAR-T Chimeric Antigen Receptor technology utilizes the patient’s own immune Innovative Hinge Technology 01 system to attack cancer cells. GS linker VL • Product GMP development completed, adaptation to Decentralized platform enabling 02 low-cost production and rapid capacity increase scFv
Slide 18: Race CAR Program - Potential Next generation CAR-T
Race CAR Program – Potential Next generation CAR-T Potential Reduction in Processing Time / Potential CAR-T manufacturing – to shorten timelines reduce costs and improve cell quality / Platform may allow the use of any CAR with minimal changes / Process optimization (activation, transduction, T cell
Slide 19: Kyslecel
Kyslecel Autologous Pancreatic-derived Islets for Auto-Transplantation Pancreas resected from patient 01 Total Pancreatectomy with Islet Auto-Transplantation (TP-IAT): Pancreatectomy is performed to remove the pain/inflammation-causing pancreas which is then transported to the Koligo processing cent
Slide 20: Approved Grants From Leading Agencies Around the Globe
Approved Grants From Leading Agencies Around the Globe / Biotechnology Fund in Greece, Commercialization Pathway: €32M / CIRM - Collaborative C> Mfg Network- $300K / DGO6 Wallonia : €1M / DGO6 Wallonia - Exofastrack: €1.6M / EIS Pathfinder - AI for iPSC manufacturing: €4M / PNRR Italy: €1.5M 20
Slide 21: Roadmap Through 2026
Roadmap Through 2026 / Roll out OMPULs at or near points of care globally leveraging our commercial partnership with Germfree Laboratories / Incoming revenues to date generated from co-development and Licensing of ORGS therapies $50M / Phase I/II of potential groundbreaking CD19 CAR-T therapy / Expa
Slide 22: Investment Opportunity
Investment Opportunity Shortage of production capacity in the cell and gene therapy space; Expand partnerships, regions and market access strategy to capitalize on the growing demand Be a part of Orgenesis’ journey to democratize advanced therapies These amazing curative therapies aim to transform p