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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.
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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
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PRODUCT PIPELINEDeveloping alternatives to liver transplantation for end-stage liver diseases
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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
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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
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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.
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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)
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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.
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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
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COMPANY FACTS
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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
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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
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EXPERIENCED MANAGEMENT TEAM
JOHN TCHELINGERIAN, PhDPresident & CEO
NATHALIE BELMONTE, PhDCOO
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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
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JOHN TCHELINGERIAN, PHDPRESIDENT & CEO
RESTORING LIVER HEALTH
Company ContactPromethera® Biosciences SA (Promethera® Group)[email protected]
Promethera® Corporate Presentation