Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (January 2018)
34 slides from Orgenesis's investor presentation, Jan 9, 2018
Slide 1: Orgenesis MaSTherCell Investor Presentation
@ orgenesis” MaSTherCell ‘The global celland gene therapy CDMO partner Investor Presentation January 2018 OTC: ORGS
Slide 2: Forward Looking Statements
Forward Looking Statements This Presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking reflect management's current expectations, as of the date of this Presentation, and involve certain risks and uncertainties. Al
Slide 3: About Orgenesis
About Orgenesis Fully-Integrated Cell Therapy Company; Leading the Revolution in Regenerative Medicine Y Direct benefits of operating global CDMO businesses while developing proprietary platform fuel investments for technology extension at optimized manufacturing costs MaSTherCell Manufacturing Tech
Slide 4: Investment Highlights
Investment Highlights ( + Rapid revenue growth & world-class customer base , a : High margin, scalable business model Established position as a leading global CDMO rr * Current CDMO customers have the significantly large in cell manufacturing “revenue as they advance through clinical development to
Slide 5: Market Overview — Cell Therapy
( E orgenesis” Market Overview — Cell Therapy
Slide 6: Rising Opportunity in Cell Therapy
Rising Opportunity in Cell Therapy Cell Therapy Market Opportunity Cell therapy is the prevention or treatment of human disease by the administration of cells that have been selected, multiplied and manipulated outside the body (ex vivo ~ manufacturing process) Regenerative medicine: cell therapy to
Slide 7: Immuno oncology
Immuno oncology Cell Therapy Market Opportunity 934 rial ts prrens ta cinta regenerative medicine technologies f 2 ® ee Tey cxotranoy are “* 566 607 Phase | 212 192 6 Phase Il 315 370 8 Phase Ill 39 45 4 Demand is large, but high barriers to entry for manufacturers: v v v Quality by design ~ process
Slide 8: Fast-Paced and Active M&A Market
Fast-Paced and Active M&A Market Cell Therapy Market Opportunity Total Global Financings by Type, by Year Deal making and investment activity in regenerative medicine is strong over the last years, with FOLLOW. continuing strategic alliances, both cross-industry and industry-academia, agonnonate Big
Slide 9: Addressing Key Market Challenges
Addressing Key Market Challenges MaSTherCell® Global Reach? Limited number of players Lonza MaStTherCell Insufficient industry capacity Tegan entend yoru ens COO a Lack of a CDMO with global reach Pindidad ey cogs tee Prorma Ct @cr Lack of expertise/knowledge No quality comparability Highicest and i
Slide 10: Addresses Key Market Challenges
Addresses Key Market Challenges MaSTherCell® ¥ Leading CDMO, with rapidly growing global operations offering a one-stop-shop service + Process and assay development, manufacturing and quality services + High quality accredited contract manufacturing services = Logistics services for the collection o
Slide 11: Global Footprint
Global Footprint MaSTherCell® This truly international footprint will give a unique competitive advantage to MaSTherCell filling the gap of Biotechnology Companies requirement “quality comparability” between the respective regional footprints. — Integrated and harmonized QMS MaSTherCell MaSTherCell
Slide 12: Global Facilities: Gosselies, Belgium
[Grgensne Subsidy MaSTharGell Ralnes§miluon Euro Equily Investment from Global Facilities eersr MaSTherCell® 9 Gosselies, Belgium oe Center of excellence & Process development, cGMP cell & gene manufacturing, Analytical development and testing, release services and logistics ‘f& 1200 sqm GMP facilit
Slide 13: Global Facilities: Atvio, Haifa, Israel
Global Facilities Location Clean Rooms = Employees Technology com “0 ATVvio Biotech Ltd Haifa, Israel neighboring the Technion institute 700 sqm (development lab and 2 rooms for mfg service) 15 Technology innovation center, Process ‘engineering and automation, Unique platform design and optimization
Slide 14: Manufacturing Vision
Manufacturing Vision MaSTherCell® « Be the worldwide best in class quality COMO company offering global one-stop-shop manufacturing and logistics services and breakthrough technologies enabling promising therapies to go faster to the market at a {fraction of the costs » ‘Ag [aa Yesterday vs Tomorrow
Slide 15: Services Offered: Full support from Science to Commercialization
Services Offered: Full support from Science to Commercialization MaSTherCell® Revenue Model Logistics Cell Therapy Company Pe » my, Ca ‘6 Ca ‘ey e an! Patient Tech Transfer = Critical Materials Supply {eg virus manufacturing) www.orgenesis.com 15
Slide 16: Services Offered
Services Offered ATVIO® Revenue Model Analytics & Quality y Kay Bioreactor Material Creating a competitive edge by Innovative Process Development Reducing Cost of Goods by innovative solutions Optimizing the processes to achieve higher yields Integrating sensor to insure quality and reduce cost and
Slide 17: Instrumental in Clinical Development
Instrumental in Clinical Development MaSTherCell® Revenue Model + Ability to support customers from early clinical trials to commercial manufacturing leads to long-term collaboration, faster time-to-market, and cost of goods optimization + Customers include leading pharmaceutical/biotech companies,
Slide 18: Advancing Each Development Phase Boosts Incoming Revenues
Advancing Each Development Phase Boosts Incoming Revenues MaSTherCell® Revenue Model PHASE II PHASE It Commercialization + clinical trials 500 a5 | Significant number of iis 56 ‘companies are going to reach Commercial 300 nat stage in the coming 2-3 200 ee se “years offering ie is #8) emendous =a ma
Slide 19: Orgenesis, Ltd.
( eS orgenesis” Orgenesis, Ltd.
Slide 20: Proprietary Transdifferentiation Platform
Proprietary Transdifferentiation Platform Development Pipeline Strategy A unique, proprietary and patented platform technology whereby an | adult cell is converted into another type of cell with distinct + phenotype and function ! (Does not use stem cells, but rather offer @ much more targeted appro
Slide 21: Insulin-Dependent Diabetes
Insulin-Dependent Diabetes Development Pipeline Strategy Type | Diabetes + Autoimmune disorder that destroys pancreatic cells In Adults In Children + Noiinsulin produced a + Requires daily insulin Type Il Diabetes + Little insulin produced or not properly used * Obesity increases risk + Treatment in
Slide 22: Background: AIP Cells
Background AIP Cells The first indication for the Company's unique cell-based therapy, was development of Autologous Insulin Producing ("AIP") cells Mechanism: physiologically glucose-responsive insulin-producing cell, designed to provide long-term insulin independence ad Transforms the patient's ow
Slide 23: Expansion Cell Manufacturing Process
Expansion Cell Manufacturing Process AIP Cells Completing the scale-up Expansion Cell Manufacturing Process development of cells manufacturing process in large- scale industrial XP 50 bioreactor at \/ \ Pall USA, The Al? cells produced on FS ore = XPS0 bioreactor under GMP-like environment were ship
Slide 24: 2018 Near-Term Clinical Milestones
2018 Near-Term Clinical Milestones Pipeline Development Strategy www.orgenesis.com 24
Slide 25: Clinical Indications
Clinical Indications Development Pipeline Strategy ‘Stvce ube do Ware Country Study Population | (PC Source Design G@ Phase I/lla [ee femme | ictictcrfeanen | Pancreatectomy AO sublets: portal vas suoeepre tascam ‘administration — ha’ Phase t/lla Post- ver pc | SPOnSOr Initiated Study yw, Pancreatec
Slide 26: Senior Management Team
Senior Management Team Appendix Vered Caplan | Chie Executive Officer ‘One of the most active entrepreneurs in the Israel! ife-science arena. She has been involved in the founding of a variety of biotech companies and has led them in Various stages at top management positions from inception to marke
Slide 27: Board of Directors
Board of Directors Appendix br. David iranskyisa renowned oncologist an research sclntisnared an pofed by TIME magazine 2001 as on of he tp physilans and scents in Ameria, ecagized fr hs work wth ety detection of cancer. Since 1994, Or Sidansty har been the Dector ofthe Head ana Neck Cancer Research
Slide 28: Investment Highlights
Investment Highlights + Rapid revenue growth & world-class customer base’ s in, scalable business model Established position as a leading global COMO oa elles + Current COMO customers have the potential to generate bi ‘manufacturing revenue as they advance through clinical development to commerciali
Slide 29: Thank you
( eS orgenesis” Thank you. www.orgenesis.com
Slide 30: Appendix
( > orgenesis” Appendix
Slide 31: The Procedure
The Procedure AIP Cells 5 simple steps: ™ n. 1, Patient arrives to an out-patient clinic for standard liver biopsy procedure and is sent home the same day 2. The biopsyis then delivered to Orgenesis core lab where we take part of the biopsy for bio banking and the remainder for producing AIP cells;
Slide 32: Patient Advantages
Patient Advantages AIP Cells * Releases patients from daily blood glucose monitoring, numerous insulin injections and watching food intake and exercise. + Allows the continuous control of blood glucose levels, which prevents diabetes related complications * Overcomes the shortage in tissue available
Slide 33: Detected Insulin-Stained Human Cells in Rat Kidney
Detected Insulin-Stained Human Cells in Rat Kidney after 71 Days Preclinical Development Pdx-1 and Insulin positive cells in mouse kidney capsule beans AIP cells tracking in the liver of injected rats 33
Slide 34: Insulin Secretion Detection by C-Peptide Secretion Assay
Insulin Secretion Detection by C-Peptide Secretion Assay Preclinical Development in-vitro C-Peptide secretion of cells in 3D In vivo C-Peptide levels in NUDE mice 25 16 By mH92 mH94 = 12 21s 5 Loa 0.8 Soa g 2 0.4 gos S 0 - i 0 Day 10 Day 11 Pre 2Weeks 4 Weeks 7 Weeks Cells produced on XP50 at Pall U