Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (July 2022)
29 slides from Orgenesis's investor presentation, July 2022
Slide 1: Investor Presentation
“ i 4 orgenesis Ae NASDAQ: ORGS INVESTOR PRESENTATION
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 inv
Slide 3: Orgenesis is a global biotech company transforming CGT processing
Orgenesis is a global biotech company committed to transforming the processing of cell and gene therapies (CGT) by accelerating clinical development and commercialization through a POCare™ Platform 11+ years Global footprint Operating in 15 Publicly traded of experience US, EU, Israel & East Asia co
Slide 4: Established Corporate Milestones
Established Corporate Milestones Initiated Metabolic R&D activity Expanded therapeutic R&D activity Commencing CDMO activity through a fully owned subsidiary, MaSTherCell Viral vector processing capabilities for internal needs Initiated delivery technologies Initiated automation processing Listed on
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 oe ° | ‘Altered cells pro
Slide 6: Cell & Gene Therapies - Market Growth
Cell & Gene Therapies - Market Growth Regenerative Medicine Market Size ( $B) Global Industry-Sponsored Cell & Gene Therapeutic Clinical Trials $149.8 -1,320 Clinical trials underway 23.5% (ss 2021-2028 $27.7 2020 2028E Regenerative Medicine Market size was valued at USD 27.7 billion in 2020 . and i
Slide 7: Cell & Gene Therapies - Services
Cell & Gene Therapies - Services Enormous market potential 2020 global market size for CGT manufacturing was $2.7 billion andis projected to reach $11.2 billion by 2027 Global Market for CGT Manufacturing by CMO/CDMOs, 2020-2027 49 28 27 2.2 2.2 17 15 12 og 12 10 13 os 15 08 07 0 [| “eH call «coal N
Slide 8: Industry Landscape Today
Industry Landscape Today 2,648 trials industry & non-industry sponsored groups 50 average annual batches / trial 132,400 = annual batches Oncology* 1,354 50/50 industry vs. non-industry sponsored groups Infectious diseases" 166 Industry sponsored Non-industry Cenral Nervous System 165 Clinical trial
Slide 9: 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. Need for more efficient and cost-effective manufacturing model u COSTS CGT affor
Slide 10: 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 POCare™ Centers, enabling flexible lo
Slide 11: POCare Global Spread
POCare™ Global Spread Clinical Centers Hospital exemption, investigator trials Directly or indirectly through biotech companies licensing Biotech companies Supplying ATMP products for hospitals Capacity Regional POCare™ Centers scale-out
Slide 12: How Does it Work?
How Does it Work? Integration of custom fit solutions within the POCare™ Center providing high quality services and products Process Clinical development Centers e VF 2 vA 4 o » Quality control we Academic (Qc) I centers Orgenesis POCare Center Processing units Biotech OMPULs™ companies
Slide 13: Value Creation Assets
Value Creation Assets The services we provide The therapies we provide The technologies we use Harmonized Global POCare™ Processing Capacities Immuno-oncology therapies Orgenesis MD POCare™ Umbrella OMPUL™ Maryland GMP implementation & operation Metabolicinerapies Automation (Processing, QC) Orgenes
Slide 14: Harmonization of Supply at POCare Centers
Harmonization of Supply at POCare™ Centers Design Global and Adapt Local Global Quality Harmonization standards aimed at ensuring quality comparability across the network and application of good practices (GxP) across all activities and throughout therapy lifecycles. Key Principles Global QA system
Slide 15: POCare Centers at a Glance
POCare™ Centers at a Glance Where we develop and supply BIO-ISOLATOR CLOSED CONTAINMENT SYSTEM PROCESS DEVELOPMENT LABS cGMP CLEANROOM PROCESS DEVELOPMENT LAB NEW GMP FACILITY UNDER CONTRUSTION
Slide 16: OMPUL | Orgenesis Mobile Processing Units and Labs
OMPUL™ | Orgenesis Mobile Processing Units and Labs -- 5 oe esis
Slide 17: OMPUL approach focusing on three innovative pillars
OMPUL™ OMPUL™ approach is focusing on three innovative pillars: Orgenesis Mobile Processing Units and Labs™ Orgenesis specializes in development of engineered solutions Mobile clean rooms for complex biological processes in CGT processing by developing OMPUL™ to be a fully integrated, closed loop al
Slide 18: Inside the OMPUL
Inside the OMPUL™
Slide 19: POCare Centers - Revenue Phasing
POCare™ Centers - Revenue Phasing Contracts: typically, 4-8 quarters per activity Activity 1# : Process development and technology transfer are the first critical steps of collaboration Activity 2# : GMP processing (Operations, QC, QA/QP, logistics) ASEPTIC PROCESS RUNS ) simutation TRANSFER RUNS RU
Slide 20: POCare Capacity Roll-Out
POCare™ Capacity Roll-Out POCare™ Country 2021 2022-4 Name Australia ] Belgium ] China ] Germany ] Greece ] India ] Israel ] Italy 1 Korea, republic of Slovenia The Netherlands ] Total 7 9
Slide 21: Products Currently Serviced by POCare
Products Currently Serviced by POCare™ Program Indications Preclinical IND Enabling Studies — Clinical Trials Clinical Use Immuno-Oncology ORGCARI9(CDI9 CAR-T) Celyvir MOTC™ (Metabolic Optimized T-Cells) DUVAC™ (Cellular Vaccine) Cure-NK Activated T cells Metabolic & Autoimmune Diseases Kyslecel™ Bi
Slide 22: Metabolically Optimized T Cells (MOTC)
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 c
Slide 23: Autologous CD19 CAR-T Therapy
Autologous CD19 CAR-T Therapy Autologous Products for the Treatment of B-Cell Lymphoma GS linker VE VH 0 B-ALL is an aggressive neoplasm of B-lymphocyte precursors that express the pan-B- scFv ~ cell marker CD19 in almost all cases. 0 The therapy targets a unique sequence of CD-19 inducing a T-cell
Slide 24: DUVAC (Dual Vaccination Therapy)
DUVAC™ (Dual Vaccination Therapy) —=—~ Anti-tumor Immunity Induction Antigen presenting cells based anti-cancer immunotherapy targeting intradermal Blood Tumor-Associated Antigens (TAAs) for hard-to-treat solid tumors injections Collection Dual vaccine cell-based immunotherapy harnesses the immune s
Slide 25: Cartil-S/Chondroseal
Cartil-S/Chondroseal ‘Small biopsy of Autologous Products for the Treatment of Osteoarthritis Therapy Osteoarthritis occurs due to cartilage defects of degenerative origin. Cartil-S is an autologous injectable product that helps delay/stop the progression of osteoarthritis, involving the patient’s o
Slide 26: Kyslecel
Kyslecel™ Autologous Pancreatic-derived Islets for Auto-transplantation room poten rom patient Therapy Chronic Pancreatitis is an inflammatory painful condition, leading to pancreas degeneration and diabetes in most patients. Kyslecel™ is made from the patient’s own insulin-producing pancreatic isle
Slide 27: Financial Highlights - Strong Revenue Growth
Financial Highlights - Strong Revenue Growth Quarterly revenue ($ in millions) $6.9 (S.lx $2.2 Q4 2020 Q4 2021 Full year revenue ($ in millions) $35.5 2020 2021
Slide 28: Meet our Board of Directors
Meet our Board of Directors @ Vered Caplan Board Chairman & CEO Guy Yachin Board Director fy Yaron Adler Board Director David Sidransky Board Director A Ashish Nanda Board Director Mario Phillips Board Director ¢ Cc O
Slide 29: Thank you
“v ~ » ergenesis we (ca 4 ‘ Thank you