Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (November 2020)
23 slides from Orgenesis's investor presentation, Nov 12, 2020
Slide 1: Unlocking the Power of Cell and Gene Therapy for All
‘ ay ; 4 orgenesis we Unlocking the Power of Cell and Gene Therapy for All
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 i
Slide 3: Corporate Overview
Corporate Overview — Established in 2011 Orgenesis is a global biotech company working to realize affordable breakthroughs in advanced medicines with a proprietary POCare Platform. Publicly traded (NASDAQ: ORGS) To unlock the curing powers of cell and gene therapy and make it accessible fo alll. 100
Slide 4: Achievements
Achievements Built contract development manufacturing organization (CDMO) Masthercell from ~$3 million to >$33 million revenue in 5 years (2014-2019) and sold for $315 million in February 2020 with net proceeds of $127 million Developed a three component POCare Platform as a harmonized framework for
Slide 5: What are Cell & Gene Therapies
What are Cell & Gene Therapies @ Traditional biopharmaceutical treatments use proteins for therapeutic applications @ Cell therapies use manipulated genes and cells for therapeutic applications @ Autologous cell and gene therapies use a patient’s own cells to create the treatment 1k Colls harvested
Slide 6: Cell & Gene Therapies are the Future
Cell & Gene Therapies are the Future Harvesting and manipulating individual (autologous) human cells or cell material that are given back to the patient as therapies has tremendous potential for applications in oncology, immunology, genetic and metabolic disorders, and more. Global Cell & © Globo! m
Slide 7: What's Holding CGTs Back?
What’s Holding CGTs Back? Centralized, non-automated processes that are high risk, high cost and have complicated logistics. These innovative drugs ultimately cannot be commercialized because of the complexity and cost. Tumor Cell fi Collection Apheresis iti Collection Therapy at To Patient Pricing
Slide 8: How is Orgenesis Changing This?
How is Orgenesis Changing This? The Orgenesis POCare Platform overcomes conventional processing challenges by enabling sterile, scalable onsite processing making CGTs: Available: Process development is focused on quality control (QC), regulatory compliance and harmonization of integrated closed syst
Slide 9: Quality at the Heart of Everything
Quality at the Heart of Everything Orgenesis puts quality at the heart of the organization with the ambition to “Design Global and Adapt Local” through Global Quality Harmonization standards aimed at ensuring quality comparability across the network and application of good biopharmaceutical practice
Slide 10: POCare Platform
POCare Platform The Orgenesis POCare Platform is built on three components to expedite development and production of advanced medicines. All work is validated for GMP compliance and harmonized for reproducibility. POCare Therapies: Produced at the point of care for better outcomes with drastically l
Slide 11: POCare Therapies Pipeline
Program Immuno-Oncology ORGCARIO (CDI9 CAR-T) MOTC (Metabolic Optimized T-Cells) DUVAC (Cellular Vaccine) ORGCARI9.22 (CDI9.22 CAR-T) CAR-NK Viral Diseases SVF-COV RanTop AutoVac Metabolic & Autoimmune Diseases Kyslecel™ AIP Bioxome™ MscP Vascular & Musculoskeletal Diseases Cartil-S , Chondroseall S
Slide 12: KYSLECEL for chronic pancreatitis
KYSLECEL™ for chronic pancreatitis “3D-v" platform KT-PC Pipeline & long-term development Koligo Therapeutics Acquisition Treatment for chronic pancreatitis: total pancreatectomy + auto-islet transplant (TP+IAT) US target patient population ~8000 per year US sales authorized under FDA “361” pathway
Slide 13: Metabolically Optimized T Cells
Metabolically Optimized T Cells (MOTC) TILs Therapy — Clinical/Commercial Stage Adoptive cell therapy (ACT) using Tumor-Infiltrating Lymphocytes (TILs) for metastatic melanoma patients Autologous CD4+ and CD8+ T lymphocytes expanded from tumors in the presence of interleukin-2 (IL-2) alone, or in co
Slide 14: Autologous CD19.22 CAR-T Therapy
Autologous CD19.22 CAR-T Therapy CD19.22 bispecific Chimeric Antigen Receptor T-Cells (CAR-T) for the treatment of B-lineage acute lymphoblastic leukemia (B-ALL) VL B-ALL is an aggressive neoplasm of B-lymphocyte precursors that VH 0 express the pan-B-cell marker CD19 in almost all cases. ScFV The t
Slide 15: DUVAC (Dual Vaccination Therapy)
DUVAC (Dual Vaccination Therapy) Antigen presenting cells based anti-cancer immunotherapy targeting ney Tumor-Associated Antigens (TAAs) for hard-to-treat solid tumors Induction Dual vaccine cell-based immunotherapy harnesses the immune fees) UMD | conscton system’s natural ability to recognize and
Slide 16: Licensed Therapies and Technology Milestones
Licensed Therapies and Technology Milestones H2 2018 2019 2020 02 2020 Partnered for Closed Loop Systems for Cell H1 2018 08 2018 Ae Processing Bloxomes for Intracellular Delivery | cell-based Cancer Immunotherapy 2017 a aigramesfeneceterpawvery | cel-posea Concer immuno bees Disorders and Atopic De
Slide 17: An Expanding POCare Network
An Expanding POCare Network Orgenesis Development and Service Centers align with global partners, research institutes and hospitals for an expanding number of research programs and clinical trials = Network Hospitals & Partners ; South America Europe Asia 4 (US) 2ournamenca - esia United States (US)
Slide 18: Bringing Point of Care Processing to the Hospital
Bringing Point of Care Processing to the Hospital = Orgenesis takes a stepwise approach to building an easy to scale, complete solution for POCare Therapies to be produced onsite at hospitals with POCare Technologies. Research Collaboration Therapy licensing Clinical trial & regulatory planning Qual
Slide 19: In Development: Orgenesis Mobile Processing Units & Labs
In Development: Orgenesis Mobile Processing Units & Labs (OMPULs) Short Setup Small Time Footprint Cost Reduction Modular Viral/Non-Viral Robust Processing Onsite Capabilities Production aa . Scalable a of
Slide 20: OMPULs = High Margin, Easily Scalable Business Model
orgenesis OMPULs = High Margin, Easily Scalable Business Model Mobility & Flexibility OMPULs will be available as grade A/B or B/C ISO 3 cleanrooms for Current Good Manufacturing Practice (cGMP) compliant processes that can be placed anywhere. Closed Processing OMPULs will be fitted with fully enclo
Slide 21: Meet Our Board of Directors
Meet Our Board of Directors —— Vered Caplan Yaron Adler Ashish Nanda Board Chairman & CEO Board Director Board Director r 4 Guy Yachin David Sidransky Mario Phillips Board Director Board Director Board Director
Slide 22: Financial Highlights
Financial Highlights —=— F Listing NASDAQ Symbol ORGS Average Daily Volume (30 Day) 53,960 Shares Outstanding (as of 21 September) 22.09M Market Cap (as of 23 October) $110.03 M Cash & Cash Equivalents $98.10 M Long-Term Debt (at $7/share conversion) $10.30M Ownership of Directors & Executive Office
Slide 23: Orgenesis Contact
“ ? 4 orgenesis ve Vered Caplan | CEO vered.c@orgenesis.com David Waldman | Investor Relations dwaldman@crescendo-ir.com Beth Willers | Media Relations beth.w@orgenesis.com