Investor Presentation March 2020 Forward Looking Statements This - - PowerPoint PPT Presentation

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Investor Presentation March 2020 Forward Looking Statements This - - PowerPoint PPT Presentation

Transforming development & commercialization of cell and gene therapies (CGTs) through point-of-care (POCare) solutions. Investor Presentation March 2020 Forward Looking Statements This Presentation contains forward-looking statements


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Investor Presentation

March 2020

Transforming development & commercialization

  • f cell and gene therapies (CGTs) through

point-of-care (POCare) solutions.

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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 involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to

  • predict. Our actual results, performance or achievements could differ materially from those expressed or implied

by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance

  • n, and our ability to grow, our point-of-care cell therapy platform, our ability to effectively use the net proceeds

from the sale of Masthercell, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans-differentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended November 30, 2018, and in our other filings with the Securities and Exchange Commission. We undertake no

  • bligation to revise or update any forward-looking statement for any reason.
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Investment Highlights

 Cell & gene therapy industry estimated to grow from $26.7B in 2018 to $150B in 2025  Orgenesis rapidly built and sold its contract development manufacturing organization (CDMO) business for $315M in February 2020—generating approximately $127 million net proceeds and significant value for shareholders  Therapeutic pipeline built around academic and hospital collaborations  Rolling out next generation point-of-care (POCare) platform

 Cell processing and treatment within the patient care setting  Highly scalable & cost-effective model  Growing global network of leading healthcare facilities

 Clean capital structure and solid balance sheet

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Cell & Gene Therapy Market

Source: Roland Berger FocusCell & Gene Medicine, September 2017

Early stage development candidates represent near-term opportunity in anticipated rapidly growing cell therapy market

21 23 26 30 36 44 56 75 105 150 20 40 60 80 100 120 140 160

2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Global Cell & Gene Medicine Market

Global market volume [USD bn] Global annual growth rate (CAGR, %)

~$150 billion

Market volume anticipated by 2025

+15% +33%

+33%

Annual growth expected between 2020-2025

~$26 billion

Current value of global Cell & Gene medicine market

113 170 30 106 144 9 90 225 38 5 11 5 50 100 150 200 250 Phase 1 Phase 2 Phase 3

Gene Therapy Gene-modified Cell Therapy Cell Therapy Tissue Engineering

Global Cell & Gene Medicine Clinical Trials

946

Clinical trials underway that utilize cell & gene technologies

53%

Clinical trials underway are in oncology

(estimated) (2017)

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Built and Sold CDMO Subsidiary for $315 Million

  • Built and sold contract development manufacturing organization (CDMO) business for

$315M, generating approximately $127 million net proceeds to Orgenesis

  • Sale reflects culmination of successful CDMO strategy initiated in 2015
  • CDMO segment revenue increased from a run-rate of just $3 million in 2015 to a run-rate of

approximately $30 million at the end of 2019

  • Masthercell achieved a 59% 5-year CAGR of Masthercell under Orgenesis’ leadership
  • Orgenesis determined it was the right time to sell Masthercell to maximize value for

shareholders and focus efforts around next generation POCare solutions

  • Net proceeds from this transaction intended to accelerate rollout of POCare platform
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Cell & Gene Therapy - Unmet Need

Iyer RK, Bowles PA, Kim H and Dulgar-Tulloch A (2018) Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges.

  • Front. Med. 5:150.

doi: 10.3389/fmed.2018.00150

  • Costs associated with inefficiencies in workflow - preventing broader clinical accessibility
  • Lack of global regulatory standardization
  • Hospitals do not have the resources or business expertise to take innovative therapies from

the research lab to the market and into patients at scale

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POCare Business Model

IN-LICENSES OUT-LICENSES

  • Orgenesis receives reduced fees + equity in therapeutics/technologies in exchange for:
  • Therapeutic product development assistance
  • POCare processing, manufacturing and production expertise
  • Therapeutic regulatory and clinical assistance
  • Therapeutic product commercialization and distribution
  • Initial out-licenses to regional partners providing development funding for therapies
  • Scalable business model design to maximize value for shareholders
  • Reduced risk and faster pathway to market versus traditional biotech drug development

model

Biotech company with unique development, processing, manufacturing and distribution model

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Advanced Therapy Medicinal Products (ATMPs)

Source: Roots Research Report: Cell Therapy Manufacturing Market, 2017-2027 European Medicines Agency: Advanced therapy medicinal products, 2nd international awareness session

Somatic Cell Therapy Medicinal Products Genetically Modified Therapy Medicinal Products Tissue Engineered Products Combined Advanced Therapy Medicinal Products ATMPs TEPs STMPs GTMPs Combined ATMPs

+ medical device component

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Licensed Therapeutics and Technology Milestones

Sep 2017 Next Generation Scaffold/microca rriers

Biodegradable and Injectable Cell PGS microcarriers

June 2018 Single use Sensors for Bioreactors Nov 2018 Next Generation Scaffold/microcar riers

Vascularized Immune Tolerating Scaffold and Dissolvable Microcarriers

Next generation 3D bio-printing

Generation of islets- like spheroids

Dec 2018

Next Generation Scaffold/microca rriers

Advanced gene delivery platforms using Baculovirus vector

Feb 2019 Aug 2018 Feb 2012 Insulin Dependent Diabetes

Liver-derived Autologous Insulin Producing Cells (AIPs)

May 2018 Liver-Derived Metabolic Disorders

Utilizing liver derived mesenchymal- like cells to treat and manage liver diseases

May 2018 Cell-based Cancer Immunother apy

NK-NHP - NK cells homing protein targeting solid tumours

Bioxomes for Intracellular Delivery

Bioxosome and Redoxome for Liver Disorders and Atopic Dermatitis

Nov 2018 Hematological Disorders

Human Postnatal Hemogenic Endothelial Cells (Hu-PHECs) for Replacing Bone Marrow Transplants

Tumor cell-based vaccine

DUVAC cancer vaccine for Pancreatic, Hepatic and Cholangiocarcinoma cancers

Jan 2019 Apr 2019 Cell-based Cancer Immunotherapy

CAR-T-VAC69 - Ovarian cancer and Multiple Myeloma

Metabolically

  • ptimized T

cells

Metabolically

  • ptimized T cells

for Colorectal cancer and Melanoma

Nov 2018

Kecelletics Biotech..

Cell-based Cancer Immunotherapy

CAR-T-CD19 - for B-lineage acute lymphoblastic leukemia (B-ALL)

Nov 2019 Sep 2019 Automated QC Technology Closed loop Systems for cell processing Feb 2020

Validation of IP Strategy

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B Cell Acute Lymphoblastic Leukaemia

Autologous CD-19.20 CAR-T

CD 19 CD 20

CD19 Antigen CD20 Antigen Anti- CD20 Anti- CD19 Modified from: Fry TJ et al. , Mol Ther Oncolytics, 2018

  • B-lineage acute lymphoblastic leukemia (B-ALL) is an aggressive

neoplasm of B-lymphocyte precursors that express the pan B-cell marker CD19 in almost all cases

  • CD19.20 bi-specific CAR-T cells therapy for treatment B-ALL patients
  • The CAR construct targets unique sequence of CD-19 and CD-20
  • The anti-CD20-CD19 bispecific CAR induced a full T cell

response upon engagement of CD19 or CD20 on target cells in B-ALL patients

  • The anti-CD20-CD19 bispecific CAR T cells may also

reduce the risk of relapse through antigen-loss of leukemic cells in the long-term

  • A total of 200 patients were enrolled in clinical trials

at Daopei Hospital

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CAR-T Clinical Data

  • 200 cases of CD19 CAR-T treatment were conducted at

Daopei Hospital

  • All cases were B-ALL patients with various complications
  • Most of the patients were under 20 years of age
  • Cell fusion: 3x105 cells/kg of patient weight: very low

dosage

  • High efficacy: 97% completed remission achieved
  • Good safety profile: 92% patients had grade 2 or less

Cytokine release syndromes (CRS)

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  • Tumor cell-based vaccine offers an approach to boost the immune

system and direct it against cancer cells.

  • Current technology is based on utilization of patients’ dendritic cells and

macrophages pulsed with relevant modified cancer cells antigens.

  • This approach utilizes whole cancer cells as a most comprehensive

source of antigens. Targeting the entire repertoire of tumor cell antigens leaves little or no possibility for cancer cells to evade the immune system.

  • This approach provides superior method by delivering a full set of cancer

antigens for stimulating a robust and long-lasting humoral B-cell and cellular T-cell immune response in vivo.

  • Ultimately, setting up a flexible hospital-based platform focused on

clinical grade manufacturing, reducing cost of goods while ensuring high quality and availability for a variety of tumor types.

  • Compassionate use human clinical studies carried out in Maimonides

Universidad in Buenos Aires Argentina demonstrated significant improvement in quality and duration of life in lung cancer and ovarian cancer patients post vaccination. .

Cellular Vaccination for Pancreatic, Hepatic and Cholangiocarcinoma Cancers

Figdor CG et al, Nature Materials, 2018

12

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Competitive Advantages of Orgenesis Personalized Cancer Vaccine

Semi-Personalized Flexibility: effectiveness could bedemonstrated in prophylactic as well as therapeutic regimens Capability to produce a procedure-based vaccine as a product Synergy between developmental components Integrating basic components:simple,fast, affordable Potential on-top-of- therapy approach

  • No specific tumor Ag needed; Response to

multiple tumor Ag; based off of tumor cell lines which are readily available.

  • This approach utilizes whole cancer cells as a

most comprehensive source of antigens.

  • Targeting the entire repertoire of tumor cell

antigens leaves little or no possibility for cancer cells to evade the immune system.

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Tumor Infiltrating Lymphocytes (TILs)

  • Solid tumor cells contain Tumor Infiltrating Lymphocytes (TILs) that

recognize tumor antigens.

  • TILs can be expanded ex-vivo by culturing them in presence
  • f interleukin 2 (IL-2).
  • Exhausted T cells in the tumor microenvironment show
  • verexpressed inhibitory receptors, decreased effector cytokine

production and cytolytic activity, leading to the failure of cancer elimination.

  • Orgenesis is developing a novel sterile flow system that enable a

faster, safer and metabolically optimal culturing and expansion process.

  • The expanded TILs posse's higher metabolic activity thus referred as

MOTC.

  • Currently our pipeline is focusing on TILs therapy to treat Advanced

Colorectal Cancer and Metastatic Melanoma.

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Current T Cell Biomanufacturing Versus Orgenesis Proprietary System

Current T cell biomanufacturing process presents several weaknesses:

  • Low efficiency of oxygen and nutrient transfer results in heterologous cellular metabolism, low cell viability and

poor product quality.

  • Ineffective process parameter control causes low bioprocess robustness.
  • Lack of checkpoints in the early and middle stages of biomanufacturing for precise quality control limits the

integrity and reproducibility of T cells for potential clinical use. Orgenesis Solution:

  • An advanced cellular biomanufacturing platform using end to end, fully automated

closed system to produce high-quality and large-scale human T cells.

  • ORG system has the advantages of efficient mass transfer of oxygen and nutrients, high robustness of

bioproduction, and outstanding scalability due to the precise process control of pH, temperature, dissolved

  • xygen (DO), agitation, gas sparging, and nutrients feeding that allows optimal harvest of MOTC.
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The Trans-differentiation Process Re-Programs Adult Cells

Transdifferentiation / Re-programming process

Description

Liver tissue

  • 1-2 gram of liver tissue is taken from patient
  • Collagenase enzyme helps break the tissue
  • Cells are being isolated
  • During amplification phase the amount of cells

is being increased

  • After having increased the amount of cells they

are ready for bio-banking Mesenchymal liver-cells-like

  • Hepatic de-differentiation takes place by

infecting the cells with gene/protein PDX1 & NEUROD1 Progenitor beta cells-like

  • Within the process of endocrine differentiation

the protein MAFA is added Pre-mature beta cells-like

  • 1-2 bn pre-mature beta like cells are produced

within the transdifferentiation process 1 2 3 4

Endocrine Differentiation

MAFA

Processing Amplification (P4) Mincing Overnight incubation in collagenase

1-2 billion of liver-derived Insulin producing cells

Expansion (3-4 weeks) Hepatic De-differentiation

PDX1 & NEUROD1

1 2 3 4

Mesenchymal liver-cells- like Progenitor beta cells-like Pre-mature beta cells-like Liver tissue Cryopreservation 40M cells minimum

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Representative Advanced Cell Technologies

Biodegradable and Injectable cell PGS scaffold Secant Group B Single use sensors for Bioreactors MIRCOD C Bioxome and redoxome Excellbio Ltd

D

Automated point of care immune cells processing system A

  • An innovative automated end-to-end T cell

manufacturing cGMP system for CAR T’s, TLR’s, TIL’s, DC and NK cells

  • The system will eventually allow full automation of the

process

  • Designed with a closed disposable set which will allow

use outside of Grade B/C hospital clean rooms

  • Dramatically the cost and complexity of cell processing
  • Development of a proprietary and first of a kind biodegradable scaffold for

cell culturing of engineered poly glycerol sebacate (PGS)

  • The scaffold will allow injection of the cells in their 3D structure resulting in

higher viability and efficacy

  • This technology will help to achieve higher yields of cells due to

the high surface to volume ratio and reduce the downstream steps resulting in reduced cost of goods, improved quality and safety for the Insulin Producing Cells and other adherent cells such as MSC’s

  • Bioxome mimicking exosome self-assembly natural membrane

enter the cell through fusion and endocytosis with the cell membrane, delivering designed target cargo

  • This technology can be applied for in-vitro and in-vivo delivery

platforms such as cell transfection, in-vitro toxicity assays, animal modeling, gene therapy

  • Biological sensing with wireless charging for clinical

development and manufacturing projects

  • Data is monitored and recorded in real-time and stored

securely for further evaluation

  • A fully integrated approach for monitoring and powering the

monitors ensures that there is no contamination because it maintains a closed environment and no loss of power to sensors

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POCare platform: Potential Creation of Novel Technologies

(illustrative)

Biodegradable and Injectable cell PGS scaffold Secant Group Single use sensors for Bioreactors MIRCOD Automated point of care immune cells processing system

  • An innovative automated end-to-end T cell manufacturing cGMP

system for CAR T’s, TLR’s, TIL’s, DC and NK cells

  • The system will eventually allow full automation of the process
  • Designed with a closed disposable set which will allow use outside of

Grade B/C hospital clean rooms

  • Dramatically reduce the cost and complexity of cell processing
  • Development of a proprietary and first of a kind biodegradable scaffold

for cell culturing of engineered poly glycerol sebacate (PGS)

  • The scaffold will allow injection of the cells in their 3D structure resulting

in higher viability and efficacy

  • This technology will help to achieve higher yields of cells due to

the high surface to volume ratio and reduce the downstream steps resulting in reduced cost of goods, improved quality and safety for the Insulin Producing Cells and other adherent cells such as MSC’s

  • Biological sensing with wireless charging for clinical development and

manufacturing projects

  • Data is monitored and recorded in real-time and stored securely for

further evaluation

  • A fully integrated approach for monitoring and powering the monitors

ensures that there is no contamination because it maintains a closed environment and no loss of power to sensors

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Next Generation Point-of-Care (“POCare”) Solutions

  • Utilizing closed systems and advanced technologies to provide cell processing

and treatment within the patient care setting

  • Delivering unique cell and gene therapy capabilities in a cost effective, high

quality and scalable manner

  • Establishing a global network of leading healthcare facilities to deliver

autologous cell therapy products

  • Growing therapeutic pipeline based on academic and hospital collaborations

Represents a paradigm shift in the industry and poised to play a major role in the future of the cell and gene therapy market

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POCare Cell Therapy Platform

POCare Model: Orgenesis’ Solution to Overcome Industry Challenges

Manufacturing technology lacking behind A No industrial and distribution infrastructure C Disconnect between hospitals and industry D Challenges Orgenesis’ solution No defined commercial pathway B

  • Apply industrial manufacturing know-how
  • Higher automation levels and closed systems
  • Provide key processing components
  • Comprehensive portfolio of ATMPs
  • Continuous in-licensing of autologous therapies and associated technologies
  • Out-licensing hospital and academic based therapies
  • Global network of “distributed” production
  • Harmonized quality system across network
  • Distribution and production based on point-of care
  • Joint Ventures (“JVs”) with regional partners
  • Partnerships with local hospitals
  • Utilizing hospital network for clinical development of therapies

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Bioreactor - Immune Cells (Suspension) Bioreactor - Adherent cells - AIP, MSCs, BM alternatives Viral Vector Production system development (Lenti, AAV, AV) Exosomes / Secretome Extraction NK-NHP

Solid tumor

CAR-T/NK

Ovarian cancer and Melanoma

CAR-T CD-19

B-ALL

MOTC

Melanoma, Sarcoma, Colorectal cancer

AIP

Diabetes Type 1

DUVAC

Pancreatic, Hepatic and Cholangio carcinoma cancers

Cord tissue/ liver cells (HU- PHECS)

Alternative To Bone Marrow Transplants (Leukemia)

HepaCell

Liver metabolic diseases

Bioxomes

Liver damage

Exosomes, MSCs secretomes

Atopic Dermatitis

Small scale viral manufacturing for personalizes TCR therapy

Systems Development Plan Summary

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Closed Bioreactor Production Systems

Simplification

  • Reduce open manipulation
  • Reduce steps (min. unit operations)
  • Automate
  • Reduce cost of goods
  • Single use

Flexibility

  • Volumes
  • Cell concentrations
  • Dosages
  • Cell types

Enabling production in Open Class C facilities = Reducing capex and operating costs

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Bio-Isolators

Conventional (OPEN) unit - key parameters:

  • HVAC system : preventing from cross-contamination and ease traffic and logistics
  • Control System: partners may offer breakthrough monitoring technologies
  • Cleanroom envelope : resist to contamination, deterioration and ease activities and material cleaning
  • All components are compliant with cGMP guidelines
  • Wall system : agility by design (non-progressive system for quick disassembly)
  • Ceiling and Floor system
  • Doors Interlock system
  • Power outlets utilities

Breakthrough (CLOSED) unit - key parameters:

  • Sealed environment: allow location in Grade D reduction of classified area.
  • Bio-isolator has no physical constraint for duplication
  • Multi-patients in the same isolator: Due to the VPHP sterilization and single batches modules, no-cross contamination

can occur. Time saving and maximum efficiency.

  • Laminar flow and Grade A: Continuity of Grade A inside the isolator.
  • Less QA/QC activities due to closed system.
  • Digital connection: Maximum monitoring level. Continuous control even by remote location. Secured traceability batch

by incorporated PLC & SCADA system.

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Accellix Workflow solution

Fully Automated

  • Sample prep to data acquisition to analysis
  • Results in 15-30 minutes

Cell Phenotyping and Enumeration

  • Six-color panels
  • Custom assays

Single Use Microfluidic Cartridge

  • Modular design
  • Built in controls (beads)

Unitized and Dried Reagents

  • Stable ambient storage

Portable and easy to use

  • Small footprint
  • Minimal maintenance
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Hospital Based Collaboration Model

How Setting up a network of leading healthcare facilities with interest in developing our autologous therapy products. Leverage IP, technical and processing expertise to allow a closed system processing approach for our development stage products.

Goal

Bring autologous therapies in a cost effective, high quality and scalable manner to patients.

Why

Hybrid therapies fall between a traditional drug and a procedure such as bone marrow transplant.

Why Orgenesis?

5 years and $40M + invested to date in industrial capability, the best people, network, services, know-how & IP. Focused on gaining and sharing expertise in an emerging scientific field.

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POCare Cell Therapy Platform: Global Network

Partners throughout North America, Europe, Asia and Middle East

North America Europe Asia Middle-East

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Basis for Hospital R&D Collaborations

Unique Know-How

  • Innovative Industrial

processes

  • Operational excellence
  • Process development and
  • ptimization
  • QC assays development
  • Quality management

system

  • Regulatory expertise

Innovation Technology

  • Utilizing Sensor technology

& AI based systems for biological production

  • Closed system devices for

processing cells

  • Proprietary virus/ media

technologies

  • Partnerships with key

system providers

Systems Therapies Portfolio

  • Unique portfolio of

immuno-oncology related technologies

  • MSC and Liver based

therapies

  • Secretome based

therapies

Cell & Gene Products Infrastructure / Distribution Channels

  • Installation of Point of Care

systems in major hospitals

  • Key geographies include:

Europe, North America, Asia, South America, etc.

  • Regional and international

system network serve as distribution channels

Distribution 1 2 3 4 Grow internal asset pipeline Leverage unique know-how and expertise Provide modular cell production cGMP systems Enable commercialization and distribution

Four Pillars of Point of Care Model

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Implementation & Cost Reduction Plan

High costs of Immuno-Oncology products of ~$300k are considered the main

  • bstacle for cell therapies – An efficient POCare system could potentially lower

cost to ~$30k

Rationale

  • With new and state of the art

production solutions and automation, the estimated cost of production of a CAR T therapy could potentially be 84% lower than conventional manufacturing

  • Cost drivers that could be

significantly lowered with Orgenesis’ highly efficient processes and technology for POCare cell production: 1.Labor costs 2.Logistics 3.Quality control 4.Disposables 5.Cleaning costs

Costs of conventional manufacturing vs. automated POCare production

+ + Production costs

Automation Level

$250,000–$350,000 $80,000–$140,000 $25,000–$40,000

2018 2019 2024 Year Production costs for CAR T batch Current market prices Potential costs with Orgenesis technology & processes

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Board of Directors

David Sidransky – Director

  • Dr. David Sidransky was appointed as a director on July 18, 2013. Dr. Sidransky is a renowned oncologist and research scientist

named and profiled by TIME magazine in 2001 as one of the top physicians and scientists in America, recognized for his work with early detection of cancer. Since 1994, Dr. Sidransky has been the Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine's Department of Otolaryngology and Professor of Oncology, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at the John Hopkins University School of Medicine. Dr. Sidransky is one of the most highly cited researchers in clinical and medical journals in the world in the field of oncology during the past decade, with over 460 peer reviewed publications. Dr. Sidransky is a founder of a number of biotechnology companies and holds numerous biotechnology

  • patents. Dr. Sidransky has served as Vice Chairman of the Board of Directors, and was, until the merger with Eli Lilly, a director of

ImClone Systems, Inc., a global biopharmaceutical company committed to advancing oncology care. He is serving, or has served

  • n, the scientific advisory boards of MedImmune, LLC, Roche, Amgen Inc. and Veridex, LLC (a Johnson & Johnson diagnostic

company), among others and is currently on the board of Galmed and Rosetta Genomics Ltd. and chairs the board of Advaxis and Champions Oncology, Inc. Dr. Sidransky served as Director from 2005 until 2008 of the American Association for Cancer Research (AACR). He was the chairperson of AACR International Conferences during the years 2006 and 2007 on Molecular Diagnostics in Cancer Therapeutic Development: Maximizing Opportunities for Personalized Treatment. Dr. Sidransky is the recipient of a number

  • f awards and honors, including the 1997 Sarstedt International Prize from the German Society of Clinical Chemistry, the 1998 Alton

Ochsner Award Relating Smoking and Health by the American College of Chest Physicians, and the 2004 Richard and Hinda Rosenthal Award from the American Association of Cancer Research. We believe Mr. Sidransky is qualified to serve on our Board

  • f Directors because of his education, medical background, experience within the life science industry and his business acumen in

the public markets. Mario Philips - Director

  • Mr. Philips was appointed as a director on January 9, 2020. He is Chief Executive Officer of PolyNeuroS, a drug company based in

France that has developed a diagnostic platform technology for neurodegenerative diseases in combination with a therapy to cure neurodegenerative diseases such as ALS and Parkinson’s. Mr. Philips also acts as strategic partner for the private equity fund, Archimed, and is Chairman of the Board for its portfolio company, Clean Biologics. Prior to that, in 2017 Mr. Philips acted as Vice President and General Manager for Danaher Pall’s (“Pall”) biotech business, with full P&L responsibility for a $1.3 billion business

  • unit. Mr. Philips has also held several board member positions in the life sciences industry with Austar Life Sciences (China),

Disposable Lab (France) and Artelis (Belgium). Mr. Philips earned an Engineering degree in Biochemistry at CTL, Gent, and has a postgraduate degree in Marketing from Groep T Leuven.

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Board of Directors (continued)

Ashish Nanda - Director Ashish Nanda was appointed a director on February 22, 2017. Since 1990, Mr. Nanda has been the Managing Director of Innovations Group, one of the largest outsourcing companies in the financial sector that employs close to 14,000 people working across various financial sectors. Prior to that, from 1991 to 1994, Mr. Nanda held the position of Asst. Manager Corporate Banking at Emirates Banking Group where he was involved in establishing relationship with business houses owned by UAE nationals and expatriates in order to set up banking limits and also where he managed portfolios of USD $26 billion. Mr. Nanda holds a Chartered Accountancy from the Institute of Chartered Accountants from India. We believe that Mr. Nanda is qualified to serve on our Board because of his business experience and strategic understanding of advancing the valuation

  • f companies in emerging industries.

Yaron Adler - Director Yaron Adler was appointed as our director on April 17, 2012. In 1999 Mr. Adler co-founded IncrediMail Ltd. and served as its Chief Executive Officer until 2008 and President until 2009. In 1999, prior to founding IncrediMail,

  • Mr. Adler consulted Israeli startup companies regarding Internet products, services and technologies. Mr. Adler

served as a Product Manager from 1997 to 1999, and as a software engineer from 1994 to 1997, at Tecnomatix Technologies Ltd., a software company that develops and markets production engineering solutions to complex automated manufacturing lines that fill the gap between product design and production, and which was acquired by UGS Corp. in April 2005. In 1993, Mr. Adler held a software engineer position at Intel Israel Ltd. He has a B.A. in computer sciences and economics from TelAviv University. We believe Mr. Adler is qualified to serve on our Board of Directors because of his education, success with early-stage enterprises and his business acumen in the public markets.

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Board of Directors (continued)

Guy Yachin - Director Guy Yachin has served as a director since April 2, 2012. Mr. Yachin has served as CEO of NasVax Ltd., a company focused on the development of improved immunotherapeutics and vaccines and as CEO MultiGene Vascular Systems Ltd., a cell therapy company focused on blood vessels disorders, leading the company through clinical studies in the U.S. and Israel, financial rounds, and a keystone strategic agreement with Teva Pharmaceuticals Industries Ltd. He was CEO and founder of Chiasma Inc., a biotechnology company focused on the oral delivery of macromolecule drugs, where he built the company's presence in Israel and the U.S., concluded numerous financial rounds, and guided the company's strategy and operation for over six years. Earlier he was CEO of Naiot Technological Center Ltd., and provided seed funding and guidance to more than a dozen biomedical startups such as Remon Medical Technologies Ltd., Enzymotec Ltd. and NanoPass Technologies Ltd. He holds a BSc. in Industrial Engineering and Management and an MBA from the Technion - Israel Institute of Technology. We believe Mr. Yachin is qualified to serve on our Board of Directors because of his education, experience within the life science industry and his business acumen in the public markets. Vered Caplan - President, Chief Executive Officer and Director Vered Caplan has been the CEO since August 14, 2014, prior to which she was Interim President and CEO since December 23,

  • 2013. Since 2008, Ms. Caplan has been Chief Executive Officer of Kamedis Ltd., a company focused on utilizing plant extracts for

dermatology purposes. From 2004 to 2007, Ms. Caplan was Chief Executive Officer of GammaCan International Inc., a company focused on the use of immunoglobulins for treatment of cancer. During the previous five years, Ms. Caplan has been a director of the following companies: Opticul Ltd., a company involved with optic based bacteria classification; Inmotion Ltd., a company involved with self-propelled disposable colonoscopies; Nehora Photonics Ltd., a company involved with noninvasive blood monitoring; Ocure Ltd., a company involved with wound management; Eve Medical Ltd., a company involved with hormone therapy for Menopause and PMS; and Biotech Investment Corp., a company involved with prostate cancer diagnostics. Ms. Caplan has a M.Sc. in biomedical engineering from TelAviv University specializing in signal processing; management for engineers from TelAviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion-Israel Institute of Technology specialized in software and cad systems.

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Summary: POCare Business Model

IN-LICENSES OUT-LICENSES

  • Orgenesis receives reduced fees + equity in therapeutics/technologies in exchange for:
  • Therapeutic product development assistance
  • POCare processing, manufacturing and production expertise
  • Therapeutic regulatory and clinical assistance
  • Therapeutic product commercialization and distribution
  • Initial out-licenses to regional partners providing development funding for therapies
  • Scalable business model design to maximize value for shareholders
  • Reduced risk and faster pathway to market versus traditional biotech drug delivery model

Biotech company with unique development, processing, manufacturing and distribution model

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Key Statistics

Ticker: ORGS Exchange: NASDAQ Share Price (03/09/20) $3.70 Shares Outstanding (3/9/20) 18.4 M Market Cap (03/09/20) $67.9 M Pro Forma Cash and Cash Equivalents (12/31/20)*: $139.0 M Security Ownership of Directors & Executive Officers (09/20/19): 8.6%

*Includes approximately $127 million net proceeds from the sale of the CDMO business

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Thank You

Contact Us Vered Caplan, CEO E-mail: vered.c@orgenesis.com Investor Relations: David Waldman President & CEO Crescendo Communications Office: +1 212 671 1020 Mobile: +1 917 355 2239 Dwaldman@crescendo-ir.com www.crescendo-ir.com