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promethera.com PROMETHERA ® BIOSCIENCES CORPORATE PRESENTATION JOHN TCHELINGERIAN, Ph.D. PRESIDENT & CEO RESTORING LIVER HEALTH FEBRUARY 2020

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Page 1: PROMETHERA BIOSCIENCES€¦ · promethera.com 2 DISCLAIMER • This presentation has been prepared by the management of Promethera® Biosciences SA (the “Company”) to provide

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PROMETHERA® BIOSCIENCES CORPORATE PRESENTATION

JOHN TCHELINGERIAN, Ph.D.PRESIDENT & CEO

R E S T O R I N G L I V E R H E A L T H

FEBRUARY 2020

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DISCLAIMER• This presentation has been prepared by the management of Promethera® Biosciences SA (the “Company”) to provide an overview of the Company

and its subsidiaries.

• By accepting delivery of this document you agree that you will keep this presentation and its contents confidential and you will not distribute this presentation outside your organisation.

• The information included in this presentation has been provided to you solely for your information and background and is subject to updating, completion, revision and amendment and such information may change materially. No person is under any obligation to update the information contained in this presentation and any opinions expressed in relation thereto are subject to change without notice.

• No representation or warranty, express or implied, is given by or on behalf of the Company as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this presentation or its contents. This document has not been reviewed or approved by any regulatory or supervisory authority.

• This presentation includes forward-looking statements that reflect the Company's intentions, beliefs or current expectations. These forward-looking statements can be identified by the use of forward-looking terminology. These forward-looking statements include all matters that are not historical facts. These forward-looking statements are subject to risks, uncertainties and and other factors that could cause the Company's actual results, operations, activities, condition, performance, prospects, growth or opportunities to differ materially from those expressed in, or suggested by, these forward-looking statements, such as the Company’s outcomes in future pre-clinical studies and clinical trials. As a result, you are cautioned not to place any undue reliance on such forward-looking statements. In addition, even if the Company's results, condition, and growth and the development of the industry in which the Company operates are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments in future periods.

• This presentation does not constitute an offer of securities, nor does it purport to give legal, tax or financial advice.

• PROMETHERA®, HepaStem™, HepaScreen™, H2Stem®, H3Stem™, H3Screen™, Cytonet®, Heparesc™ and Hepabridge® are registered trademarks or trademarks of PROMETHERA® in the Benelux, the United States and other countries.

Promethera® Corporate Presentation

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OUR COMPANY

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PROMETHERA® BIOSCIENCES – OVERVIEW A unique set of technological assets and exclusive IP & know-how

RESTORING LIVER HEALTH

Promethera®’s mission is to bring patients life-saving treatmentsto reduce the need for liver transplantation

3 TECHNOLOGICAL PLATFORMS & PRODUCTS

HepaStem™

Lead cell therapy product with potential applications in fibro-inflammatory liver diseases

H2Stem®

Cell-based therapy likely to have tissue repair role

Atrosimab

Antibody therapy with potential anti-inflammatory activity

SECURITY OF SUPPLY

Largest liver sourcing & unique supply chain on a global basis

GLOBAL PRESENCE & ROBUST INVESTOR CONSORTIUM

Well positioned to benefit from positive regulatory environment & strong EU/Asian markets

Promethera® Corporate Presentation

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PRODUCT PIPELINEDeveloping alternatives to liver transplantation for end-stage liver diseases

Promethera® Corporate Presentation

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BLUE OCEAN STRATEGY IN LIVER CIRRHOSISL

IV

ER

F

UN

CT

IO

N

Multiple therapeutic

options with 2 proprietary

technologies

(standalone or combo)

F i b r o s i s

C h r o n i c h e p a t i c

d e c o m p e n s a t i o n

M O R T A L I T Y

I n f l a m m a t i o n

Atrosimab

NAFLD, NASH

D I S E A S E P R O G R E S S I O N

Targeting a multibillion dollar market in ACLF & NASH

ACLF

HepaStem™

C o m p e n s a t e d

c i r r h o s i s

D e c o m p e n s a t e d

c i r r h o s i s

Acute insult / second hit

Promethera® Corporate Presentation

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PROMETHERA® BIOSCIENCES – A ROBUST IP PLATFORM

EXPIRATION DATES BETWEEN 2026 & 2039

7 PRIORITY APPLICATIONS SINCE DECEMBER 2018

28 Patent families deployed worldwide >450 Patents &

patent applications(all assets included)

Global exclusive license rights on HepaStem™: product, medical use all fields, manufacturing process, commercial (including rights to sub-license)

UCL originated patents granted in the US, the EU, Japan in particular and ROW

Patent on clinical-grade cGMP produced HepaStem™, fully owned by Promethera®: allowed in US, pending in other countries

11 REGISTERED TRADEMARKS AND/OR PENDING IN THE BENELUX, EU, USA AND THE REST OF THE WORLD

Promethera® Corporate Presentation

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FULLY INTEGRATED PRODUCT SOURCING, PRODUCTION AND SUPPLY CHAINMastering the supply chain for an off-the-shelf allogeneic cell therapy product

Liver Sourcing

CellIsolation

Cell Expansion

Storage & Delivery

Reconstitution & Application

Organs unsuitable for transplantation

Cell isolation of liver stem cells and hepatocytes

GMP aseptic manufacturing

Cells are frozen for storage and

delivered direct to the patient’s bedside

Reconstitution and application via

intravenous delivery at the bedside

D O N O R1 L I V E R

H u n d r e d s o fP A T I E N T S

NEW PRODUCTION FACILITIES IN GOSSELIES, BELGIUM READY IN 2020

Own production capabilities and HQ of 35.500 sq. ft.

Promethera® Corporate Presentation

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OUR SCIENCE

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HEPASTEM™ SHOWS MULTIPLE MECHANISMS OF ACTION IN VITROImmunomodulatory & anti-fibrotic potential builds on regenerative support function

HGFSupports recovery

IDO, PGE2Immunomodulation

HGFInhibits HSC activation

MMPSExtracellular matrix degeneration

Hepatocyte damage and apoptosis

T-lymphocyte infiltration and release of pro-inflammatory cytokines + activation of dendritic cells

Hepatic stellate cell activation

Collagen deposition

HE

PA

ST

EM

Leading to fibrosis

Leading to cirrhosis

Injury & inflammation

MORTALITY

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HEPASTEM™ INTRAVENOUSLY INJECTED THROUGH A PERIPHERAL VEIN – LIVER HOMING FEATURES

Systemic infusion (peripheral vein-IV) for current studies First-in-man

• Intravenous delivery is a well established non-invasive technique/clinical practice

• IV-administration is one of the key drivers of applicability

• Cells have a first passage in the lungs and are further distributed in other organs, mainly the liver, without lung trapping

• Pre-clinical and first clinical study started

Early data from first-in-man study

“After intravenous infusion of Indium labelled HepaStem-like cells, the cells are transiently trapped in the lung, which decreases rapidly, while a clear homing to the liver can be observed, which remains stable until the end of the 5-day observation period. A mild presence of labelled cells can be seen in the spleen. A hot spot of cells can be observed in the right ankle, which was the site of chronic hemarthrosis in the patient, showing the homing of cells to inflammatory sites.” (Sokal & al, Transplantation 2017, Aug;101(8):1845-1851)

Promethera® Corporate Presentation

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HEP101 STUDY – PIONEERING CELL-BASED THERAPY FOR ACLF (completed study)Multicenter Phase 2a Safety & Preliminary efficacy study of 2 dose regimens of HepaStem™ in 24 patients with ACLF

Primary Objectives Secondary Objectives

To assess the safety of different dose regimens of HepaStem™ in cirrhotic patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.

PRELIMINARY EFFICACY:To evaluate clinical and biological efficacy parameters following HepaStem™ infusion up to Day 28, up to Month 3 and up to Year 1 post first HepaStem™ infusion. LONG-TERM SAFETY:To assess the safety of HepaStem™ up to Month 3 and Year 1 post first HepaStem™ infusion.

Promethera® Corporate Presentation

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STRATEGY FOR NASH CLINICAL TRIALS

Bridging from our ACLF gate indication to F4-NASH early decompensation

*Including early decompensation

ACLF

Gr0 Gr1 Gr2 Gr3

Less Severe More Severe

MELD > = 22

NAFLD / NASHTransition

Less Severe More SevereF1 F2 F3 F4*

Competitive pressure zone

MELD < = 21

HepaStem™

ACLF – HEP101 Phase 2ain patients with AD, Gr1, Gr2

Safety supporting data for clinical trial application,

same route of infusion

Promethera® Corporate Presentation

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COMPANY FACTS

[footer information]Promethera® Corporate Presentation

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FINANCING & SHAREHOLDING

Broad investor base from Asia and Europe supporting the move into NASH & ACLF

Promethera® Financing Shareholding Structure

FUNDING TILL DATE :

Round A (2009-2010) € 5.3 M

Round B (2012) € 17.0 M

Round C (2014 & 2016) € 26.3 M

Round D (2018 – 1st Closing) € 10.0 M

Round D (2019 – 2nd Closing) € 18.5 M

Round D (2019 – 3rd Closing) € 11.2 M

Round D (2019 – Extension) € 7.5 M

Conversion of ACB’s € 21.9 M

TOTAL CAPITAL RAISED € 117.7 M

Convertible Bonds € 4.0 M

Non-Dilutive funding € 24.1 M

TOTAL PROCEEDS € 145.8 M

Promethera® Corporate Presentation

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STRATEGY FOR FAST EXECUTION IN ASIAN MARKETS

• Local branch office led by Group CFO, building business development and investor relations teams

• Attracted strategic alliance with Itochu • One of the largest Japan-based business

conglomerates• Invested €10M in Promethera® Biosciences• Supports the company in advancing Promethera®’s

product and business development strategy in Asia

• Complemented by a diverse set of Asian investors• 40% Promethera® shares are held by Asian

institutions and partners

• Specialized partners by geography, product type and expertise

Japanese presence paired with strong mix of strategic partners and investors

Our Asian Partnerships

Promethera® Corporate Presentation

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EXPERIENCED MANAGEMENT TEAM

JOHN TCHELINGERIAN, PhDPresident & CEO

NATHALIE BELMONTE, PhDCOO

Promethera® Corporate Presentation

LUC OTTEN, MD, PhDCSO

ETIENNE SOKAL, MD, PhDFounder & Group CMO

MICHIHIRO MAEDAGeneral Manager of Promethera® Japan Branch

BERTRAND LELLOUCHE, MBAGroup CFO

PAUL SMITHVP of Regulatory Affairs

NATHALIE CLERGET, PhDVP of Clinical Development

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PROMETHERA® BIOSCIENCES - SUMMARYAllogeneic off-the-shelf cells therapies to restore liver health

Targeting liver disease areas with multibillion dollar market potential and significant commercial opportunitiesACLF, Late-Stage NASH

Robust IP Portfolio through innovation and proprietary platform technologies / Own production capabilities28 patents families, more than 450 patents & patent applications

Well-funded and backed by highly regarded healthcare investors>$120 Million raised to date

Asian & European focused strategy expanding soon to USItochu Corporation, MEDIPAL HOLDINGS Corporation, LifeLiver & Shibuya Corporation

Proven international management team with expertise in liver disease and regenerative medicineLeadership of international experts located in Europe, US and Japan

Near-term clinical milestones across ACLF & NASHDHELIVER, PANASH – Phase 2 stage studies

Promethera® Corporate Presentation

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JOHN TCHELINGERIAN, PHDPRESIDENT & CEO

RESTORING LIVER HEALTH

Company ContactPromethera® Biosciences SA (Promethera® Group)[email protected]

Promethera® Corporate Presentation