Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (August 2024)
18 slides from Orgenesis's investor presentation, Aug 29, 2024
Slide 1: Orgenesis
‘\ ‘4 orgenesis NASDAQ: ORGS AUGUST 29, 2024
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. All statements contained in this pr
Slide 3: Orgenesis CAR-T Program
Orgenesis CAR-T Program Encouraging clinical data Real-world study data In a private Chinese hospital demonstrates proof of concept clinical efficacy & favorable safety! Potentially Disruptive Clinical Model 1s in class decentralized cell processing enables fast delivery at an estimate of 1/3 the co
Slide 4: Orgenesis Anti-CD19 CAR-T technology
Orgenesis Anti-CD19 CAR-T 01 Chimeric Antigen Receptor technology utilizes the patients own immune system to attack cancer cells. « Product GMP development completed, adaptation to POCare 02 platform enabling low-cost production and rapid capacity increase « Successful GMP batches production * Clini
Slide 5: CD19 CAR-T Intellectual Property - Composition Patents
CD19 CAR-T Intellectual Property - Composition Patents Orgenesis Proprietary Construct: Innovative Hinge Technology CD19 Modified CD& US application 18/050,461 27-Oct-2022 National Phase ORG Inc,, Broaden hinge (CD8-GG) CHIMERIC ANTIGEN RECEPTOR BioScience and WITH MODIFIED HINGE REGION Technology (
Slide 6: Existing FDA Approved CAR-T Therapies
Existing FDA Approved CAR-T Therapies lh Bristol Myers Squibb” Breyanzi* (lisocabtagene mareleuce) sss Diffuse Large B-cell Lymphoma (DLBCL) TAbe (ceca vl a Multiple Myeloma (MM) Ub NOVARTIS $350k-$500k/treatment Market Prices (US & EU) Diffuse Large B-cell Lymphoma (DLBCL) Acute Lymphoblastic Leuke
Slide 7: Potential Significant Oncology CAR-T Opportunity
Potential Significant Oncology CAR-T Opportunity ORGENESIS CAR-T High-Level Value Proposition* Orgenesis Positioning | Orgenesis Competitors CAR-T Cost! Greater than 67% cost $100K-$200K/patient $350K - $500K/patient reduction Will allow greater access Safety? Reduced risk of Proprietary optimized C
Slide 8: Paradigm Shift: Decentralized Cell Processing CoGs Summary
Paradigm Shift: Decentralized Cell Processing CoGs Summary Decentralized platform can reduce the costs of CAR-T batch costs from $152,500 to $41,750 per batch or 75% compared to traditional centralized manufacturing site*. Economics of Scale analysis shows that the total batch cost can be reduced to
Slide 9: Cost: Background
Cost: Background What's Holding CGTs Back? Historically, centralized manufacturing has been the dominant model for bulk production of active Geniraized, pharmaceutical ingredients!? because it allows better resource management, process control and Decentralized product quality!and can lower manufact
Slide 10: Cost: Background
Cost: Background * Hodgson et. al, Cellares Cost-Benefit, 2023 Analysis Total Existing Centralized CAR-T Batch Manufacturing Cost $152,500* Processing & Maierials 64% Breakdown: Logistics Upstream Logistics (Patient Cells Collection & Transport) Downstream Logistics (Product Distribution & Patient D
Slide 11: Cost Analysis
Cost Analysis Comparison Traditional Aspect Facility OMPUL Traditional Cleanroom Facility vs Decentralized Cost Reduction Rationale Upstream Logistics (Patient Cells Collection & Transport) $15,000 Downstream Logistics (Product Distribution & Patient Delivery) $10,000 Simplified logistics that are a
Slide 12: Economics of Scale
Economics of Scale* Configuration Factor Year 1 Year 2 Year 3 Totals CapEx/Batch al a2 Q3 Q4 al Q2 Q3_ a4 al Q2___3 Qa CapEx 12 24 48 96 192 384 768 15.2 0 0 0 oO | $115.2M Total # of units 0 0 1 2 4 8 16 32 64 9% 9% 9% 96 OMPUL Batches in parallel (processing units) 0 0 4 8 16 32 64 128 | 256 384 3
Slide 13: Detailed Value Proposition to Patients, Providers & Payors
Detailed Value Proposition to Patients, Providers & Payors Potentially IRGS CART Better Product “Vein-to-Vein" T-Cell Source Final product Reduced Therapy Administration Time 10 days from blood collection Option for whole blood High potency reduces safety risk (lower titer) ready for immediate treat
Slide 14: Overall Complete Response Rate in B-ALL Patients with >5% Blasts at Baseline
Overall Complete Response Rate’ in B-ALL Patients with >5% Blasts at Baseline * Analysis of a subset of 33 adult and 21 pediatric (<18) patients with baseline BM Blasts (>5%) and data available at day 28 was done to emulate the populations in pivotal studies. * Overall Complete Response Rate (CR+CRi
Slide 15: Minimal Residual Disease
Minimal Residual Disease* Minimal Residual Disease (MRD) is a powerful prognostic indicator in ALL. MRD was characterized in the patients at baseline and throughout the first 28 days after treatment by Flow Cytometric Immunoassay. MRD at day 28 was undetectable or < 0.1% in 91% of tested patients. M
Slide 16: Cytokine Release Syndrome
Cytokine Release Syndrome Cytokine Release syndrome (CRS) is a systemic reaction to an exaggerated immune response to immunotherapy and is a safety issue of CAR-T treatment, resulting in ICU hospitalization and possibly life threatening in severe cases CRS occurs with the first days after CAR-T infu
Slide 17: Incidence of Severe CRS is Low, Indicating a Favorable Safety Profile
Incidence of Severe CRS is Low, Indicating a Favorable Safety Profile Orgenesis | Pivotal Orgenesis | Real pts with studies!2 overall World >5% blasts studies>4 N=4] N=71 N=125 N=152 Any CRS 88% 92% 69% 82% Adults Severe CRS 7% 26% 2% 9% (Grade 23) N=39 N=75 Ne=lI15 N=185 Any CRS 95% 77% 59% 63% Ped
Slide 18: Appendix-Cost References
Appendix-Cost References 1.\ Wang, K. et al. A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies. Cytotherapy 21, 1081-1093 (2019). 2, Srai, J. S, Badman, C,, Krumme, M,, Futran, M. & Johnston, C. Future supply chains enabled by continuous p