Corporate Presentation June 2019...PBI-4050 is a potential first - in-class therapy to reduce...
Transcript of Corporate Presentation June 2019...PBI-4050 is a potential first - in-class therapy to reduce...
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Prometic Life Sciences Inc.
Corporate PresentationJune 2019
© Prometic Life Sciences Inc. 2019 2
Safe Harbour
Forward Looking StatementThis presentation contains forward-looking statements about Prometic’s objectives, strategies and businesses that involve risks and uncertainties. Thesestatements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates andassumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect ourbusiness, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Prometic’s ability to develop,manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, thesuccessful and timely completion of clinical studies, the ability of Prometic to take advantage of business opportunities in the pharmaceutical industry,uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that couldcause actual events or results to materially differ from our current expectations in the Annual Information Form for the year ended December 31, 2018, underthe heading “Risk Factors”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update anyforward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicablesecurities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.
Copyright noticeThe information contained in this presentation (including names, images, logos and descriptions portraying Prometic's products and/or services) is theproperty of Prometic Life Sciences Inc., of its divisions and / or of its subsidiaries (“Prometic”) and is protected by copyright, patent and trademark law and / orother intellectual property rights. Neither this presentation nor any part may be reproduced or transmitted in any form or by any means, electronic ormechanical, including printing and photocopying, or by any information storage or retrieval system without prior permission in writing from Prometic.
DisclaimerPrometic reserves the right to make improvements, corrections and/or changes to this presentation at any time.
© Prometic Life Sciences Inc. 2019 3
Company Overview
Key Business Attributes
Small MoleculesPBI-4050 & PBI-4547
BioseparationsAffinity Chromatography
PlasmaRyplazim ™
(plasminogen)
CAD75 MM of cash raised April 2019 Operations in Canada, UK, USA
Ken Galbraith appointed CEO
Small Molecule TherapeuticsPBI-4050 and PBI-4547
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Small Molecule Program Targeting Fibrosis in Liver, Renal and Respiratory Disease
First-in-class, dual-mechanism GPR84 antagonist/GPR40 agonist small
molecules
Two compounds currently in clinical development: PBI-4050 and PBI-4547
Research focused on antifibrotic pathway regulated by two fatty acid
receptors: GPR40 and GPR84
Lead indication using PBI-4050 to treat Alström Syndrome (ALMS)
• PBI-4050 Phase 3 in ALMS to begin in H2-2019• PBI-4050 Phase 2 in ALMS completed successfully with
dramatic impact on fibrosis in multiple organ systems
Multiple additional clinical studies to be underway in 2019 and 2020 to explore potential in disease indications beyond ALMS
• PBI-4050 Phase 2b in IPF to begin Q4-2019• PBI-4050 Phase 2 in NASH to begin Q4-2019• PBI-4547 Phase 1 in healthy volunteers to begin H2-2019
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Rich Pipeline of Early and Late Stage Small Molecule Therapeutics
Product Candidates Indications Segment Pre-clin Ph 1 Ph 2 Ph 3 NDA / BLA
PBI-4050
PBI-4050
PBI-4050
PBI-4547
Alström Syndrome
F2-F3 Liver Fibrosis/Steatosis
Idiopathic Pulmonary Fibrosis
TBD
Small molecule
Small molecule
Small molecule
Small molecule
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PBI-4050 An Anti-inflammatory And Anti-fibrotic Agent
Evaluated in over 250 subjects, dosed up to 1,200 mg daily, in 8 clinical studies
Reduces fibrosis via regulation of macrophages, fibroblasts/myofibroblasts,
and epithelial cells
3-pentylbenzeneacetic acid sodium salt with a molecular weight of 228.3, derived from a structure-activity study of sodium
decanoate, a salt of the naturally-occurring medium-chain fatty acid,
decanoic acid
Demonstrated across multiple disease models:• chronic kidney disease (CKD); • diabetic kidney disease (DKD);• lung fibrosis, liver fibrosis;• heart fibrosis, Crohn’s disease, scleroderma
and osteoporosis.
Safety and tolerability well-established; most adverse events are mild and discontinuations
from clinical studies are rare
First-in-class, dual-mechanism GPR84 antagonist/GPR40 agonist
Composition of matter patent coverage in major markets until May 2030
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Dual-Mechanism GPR84 Antagonist/GPR40 Agonist
GPR84The Good Cop: GPR40
The down regulation of GPR40 promotes fibrosis.
PBI-4050 ‘stimulates’ or up regulates this receptor to promote healing.
The up regulation of GPR84 promotes fibrosis.
PBI-4050 inhibits the up regulation of this receptor to promote healing.
GPR40
PBI-4050
Epithelial cells Macrophages
Myofibroblasts Podocytes
Macrophages
Fibrosis in Kidney, Heart, Liver, Lung, Pancreas, Skin
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Peer-Reviewed Publications of PBI-4050 Mechanism of Action
"PBI-4050 reduces stellate cell activation and liver fibrosis throughmodulation of intracellular ATP levels and LKB1-AMPK-mTOR pathway"
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Lead Indication: Alström Syndrome (ALMS)
Rare autosomal recessive genetic disorder with 500 to 1,000 ALMSpatients worldwide
Progressive and severefibrosis affecting heart,kidney, lung and liver Childhood onset with
multiple clinical features
Early onset Type 2 diabetes with
severe insulin resistance
Increasing systemic fibrosis develops, often leading to organ failure
ALMS patient lifeexpectancy rarely exceeds
50 years of age
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Transforming ALMS Patient Care
No effective or approved treatments for ALMS patients PBI-4050 is a potential first-
in-class therapy to reduce fibrosis in ALMS patients
Phase 2 clinical study of 12 ALMS patients showed a dramatic impact on fibrosis in multiple organ systems
FDA granted both orphan drug designation and rare pediatric disease designation, EMA granted orphan drug status and UK MHRA granted Promising Innovative Medicine (PIM) status for PBI-4050 in ALMS
Phase 3 clinical study expected to begin by H2-2019
Potential to expand clinical program to other rare diseases similar to ALMS
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PBI-4050 Liver Fibrosis Reduction in ALMS Patients
FibroScan score reduced or stabilized in 9 out of 10 patients treated for at least 36 weeks
*Richard Steeds et al manuscript in preparation
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Cardiac MRI data for Individual Patients: PBI-4050 Reversing Historical Trend (when MRI historical data is available for ≥ 3 years)
Years
MRI Scoreworsening[% annualChange]
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#1001#1003
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#1005
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#1009
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Improvement Trend when on PBI-4050 TreatmentFibrosis Worsening Historical Trend
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1 2 3 4 5 6*Richard Steeds et al manuscript in preparation
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Changes In Cardiac T1 Before And After Treatment
*Richard Steeds et al manuscript in preparation
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PBI-4050 ALMS Phase 3 Clinical Study Update
Three FDA Type C meetings held in 2018
and 2019
Clinical study protocol to be finalized after final
comments from FDA/EMA, including composite primary endpoints as
agreed with FDA/EMA
European regulatory input ongoing and investigators
recruited in North America and Europe
Enrollment goal of approximately 42 ALMS subjects, 27 adults and
15 pediatric
Working with well-established international ALMS patient advocacy organizations to assist in
conduct of study
Principal Investigator: Dr. Clair Francomano,
University of Indiana
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Proposed NASH Phase 2 Clinical Study
Clinical data from treatment of ALMS patients suggests role for
PBI-4050 in treatment of liver fibrosis in NASH patients with
stage F1-3 liver fibrosis
Principal Investigator: Dr. Stephen Harrison,
Pinnacle Clinical Research, San Antonio,
Texas
Protocol follows FDA Guidance for Industry “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment”
Start Q4-2019 and primary data in 2021
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Significant Small Molecule Milestones Expected During 2019-2021
2019
Initiate Phase 3 study of PBI-4050 in ALMS
Initiate Phase 2b study of PBI-4050 in IPF
Initiate Phase 2 study of PBI-4050 in NASH
Commence Phase 1SAD/MAD study of PBI-4547
2020 2021
Initiate Phase 2 study ofPBI-4547 (liver/renal
indication TBD)
Filing of NDA with FDA/EMAfor PBI-4050 in ALMS
Topline data for PBI-4050in IPF and NASH
Topline data forPBI-4050 in ALMS
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Prometic Bioseparations
Established 30 years
Portfolio of commercial chromatography adsorbents
ISO9001:2015 accredited (BSI)
cGMP-standard/clean room manufacture
Regulatory support
Custom development and manufacturing services(adsorbents and DSP’s)
Large scale adsorbent manufacture (275 litre batch size – increasing to
1,000L imminently)
18 Prometic adsorbents used in FDA/EMEA licenced products/processes
Applications in columnsup to 2m diameter
Plasma-Derived TherapeuticsRyplazim™ (plasminogen)
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Ryplazim™ Overview
Rare Pediatric Disease, Orphan Drug and Fast Track designations received from FDA for Ryplazim™
Significant interest from outside parties and out-licensing/divestiture discussions ongoing and active
Proprietary plasma purification technology enables commercial production of
Plasminogen at scale and positions Prometic as sole global supplier of GMP
Plasminogen (“Ryplazim™”)
Re-filing of BLA with FDA for Ryplazim™ for congenital plasminogen
deficiency on track for Q4-2019
Substantial market opportunity
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Rich Pipeline of Plasma-Derived Therapeutics
Product Candidates Indications Segment Pre-clin Ph 1 Ph 2 Ph 3 NDA / BLA
Ryplazim™ IV
Ryplazim™ IV
Congenital Deficiency
Therapy in Acute Conditions
Plasma-derived
Plasma-derived
Priority Indications
IVIG
Plasminogen Sc
Primary Immunodeficiency Diseases
Various Wound Healing
Plasma-derived
Plasma-derived
Development stage assets for prioritization and/or monetization
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Ryplazim™ Update
Re-filing of BLA with FDA for Ryplazim™ IV for congenital plasminogen deficiency on track for Q4-2019
Additional regulatory filings for Ryplazim™
outside of USA planned for 2020
Rare Pediatric Disease, Orphan Drug and Fast Track designations received from FDA
Out-licensing process ongoing and active
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Ryplazim™ IV Publication of Clinical Data in Blood Journal
CorporateHighlights2019 - 2021
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Investment Summary
Potential for first-in-class therapy for PBI-4050 in ALMS and multiple opportunities for
expansion and growth
Rich, late-stage pipeline with potential best-in-class drugs
for fibrosis in treatment of liver, renal and respiratory
diseases
PBI-4050 and PBI-4547 clinical development plans ready to
execute, with significant expected milestones over next
12-24 months
Exceptional management team and board, with significant support from recognized
institutional investors
Ryplazim™ partnerships and strategic divestiture expected to further strengthen balance
sheet in 2019 and 2020
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Management team
Bruce Pritchard, BA, CA, FioDChief Operating Officer - International & Chief Financial Officer
Patrick Sartore, B.Sc., LLB.Chief Operating Officer - North America & Chief Legal Officer & Corporate Secretary
John Moran MD, FRACP, FACPChief Medical Officer
Martin LeclercChief Talent Officer
Kenneth Galbraith BCom, CAChief Executive Officer
Mr. Kenneth Galbraith was appointed Chief Executive Officer in April 2019, having previously served for 3 years on Prometic’sboard of directors. Mr Galbraith has over 30 years’ experience as director, executive and investor in the Life Science sector. He has led many successful cross-border listings for Canadian companies and has a track record of bringing therapies to market, as well as creating value for investors.
Mr. Bruce Pritchard is the Chief Operating Officer – International and Chief Financial Officer of Prometic Life Sciences (PLI)An accountant by training, he has spent over two decades working in the life sciences and pharmaceutical industry. He has more than twelve years’ experience with PLI and has held a number of senior global positions across the organisation.
Mr. Patrick Sartore is the Chief Operating Officer – North America and Chief Legal Officer & Corporate Secretary of Prometic Life Sciences (PLI). A lawyer by training, he has spent over eighteen years working in the life sciences and pharmaceutical industry. He has more than twelve years’ experience with PLI and has held a number of senior global positions across the organization.
Dr. John Moran is the Chief Medical Officer of Prometic Life Sciences (PLI). He has served as Chief Medical Officer of Prometic since March 1, 2014. From 2010 until joining the Corporation, Dr. Moran was Vice President, Clinical Affairs – Home modalities at DaVita Healthcare Partners Inc.
Martin Leclerc is the Chief Talent Officer of Prometic. After working as a consulting actuary for more than 10 years at the beginning of his career, he has since held a number of senior positions in the human resources field within large global corporations. Martin joined Prometic in May 2017.
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Board of Directors
Stefan V. Clulow
Chair of the Board, Prometic
Prof. Simon Best
Lead Independent Director, Prometic.
Kenneth Galbraith
CEO, Prometic.
Zachary Newton
Director, Thomvest Asset Management Inc.
Board member, Ecobee Inc.
Gary J. Bridger
Board member, X4 Pharmaceuticals.
Former Executive VP R&D, Xenon Pharmaceuticals Inc.
Neil A. Klompas
Chief Financial Officer. Zymeworks Inc.
Timothy S. Wach
Managing Director & Board Member of Taxand.
Key: Audit, Risk and Finance Committee HR and Corporate Governance Committee
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Multiple Opportunities To Further Strengthen Balance Sheet during 2020 and 2021
Financials Small Molecule segment
CorporatePlasma segment
NASDAQ listing in 2019
Ryplazim™ commercialization deal upside if indications beyond Congenital Plasminogen Deficiency licensed
Monetisation of royalty streams from Ryplazim™
Potential for Priority Review Vouchermonetisation: Ryplazim™ (H1/20)
Potential to sell unused tax losses to controlling shareholder
Potential partnering of PBI-4050 and/or PBI-4547
Monetisation of assets outside of PBI-4050 and PBI-4547
Potential for Priority Review Voucher monetisation: Alström Syndrome (Q4/21)