Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (December 2020)
23 slides from Paradigm Biopharmaceuticals's investor presentation, Dec 21, 2020
Slide 1: Inaugural R&D Day
Paradigm Biopharmaceuticals (ASX:PAR) Inaugural R&D Day PARADIGM BIOPHARMA 1 Paradigm Biopharma: R&D Presentation 2020
Slide 2: Disclaimer and Forward-Looking Statements
DISCLAIMER AND FORWARD-LOOKING STATEMENTS This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is confidenti
Slide 3: Welcome
WELCOME Paradigm Chief Executive Officer and Interim Chairman Paul Rennie PARADIGM BIOPHARMA 3 Paradigm Biopharma: R&D Presentation 2020
Slide 4: Introduction
INTRODUCTION PARADIGM BIOPHARMA…UNLOCKING POTENTIAL Paradigm Biopharma is a commercially focused drug repurposing company. Our approach: • Take an existing, approved drug with demonstrated safety in its approved indication, • Repurpose to a new patented therapeutic application with high unmet need.
Slide 5: Confident of Clinical Success
CONFIDENT OF CLINICAL SUCCESS Ø Multiple modes of action Ø Previous Phase IIb, SAS and EAP experience Ø Global harmonised clinical trial consultation PARADIGM BIOPHARMA 6 Paradigm Biopharma: R&D Presentation 2020
Slide 6: Agenda
AGENDA Topic Presenter OA Clinical Program Update – Trial Outputs and Dr Donna Skerrett Milestones Safety and MPS Update Dr Michael Imperiale R&D Pipeline Dr Ravi Krishnan Revenue Timeline & Summary Dr Jeannie Joughin Q&A Panel Dr Donna Skerrett, Dr Michael Dr Ravi Krishnan, Chief Medical Imperiale,
Slide 7: OA Clinical Program Update
OA CLINICAL PROGRAM UPDATE DR DONNA SKERRETT PARADIGM BIOPHARMA 8 Paradigm Biopharma: R&D Presentation 2020
Slide 8: Feedback from EMA + FDA = Global Harmonisation
FEEDBACK FROM EMA + FDA = GLOBAL HARMONISATION Conducted additional pre-clinical evaluations Submit FDA: Pre-IND EMA Scientific FDA: Type C meeting Advice meeting Global Harmonized IND OA Program Feb 2020 Sep 2020 Dec 2020 Q1 2021 Revised Clinical Trial Program will: • Confirm minimally effective do
Slide 9: Phase 3 Clinical Program for OA Treatment of Pain associated with Knee OA
Phase 3 Clinical Program for OA Treatment of Pain associated with Knee OA OA_003 First subject treated OA_003 All subjects recruited OA_003 Data OA_002 All subjects OA_002 First subject treated OA_002 Dose selection OA_002 Data Readout Readout recruited 2021 Q2 Q3 Q4 Q1 2022 Q2 Q3 Q4 Q1 2023 Q2 Q3 2
Slide 10: Overall Clinical Program for OA
Overall Clinical Program for OA NB: This reflects current plans and is subject to change FSFV = First patient treated, LSLV = Last subject treated, OA_007 IA IA Safety = safety interim analysis Safety OA_009 IA Safety OA_010 LSLV OA_009 FSFV OA_003 LSFV OA_006 FSFV OA_010 FSFV OA_002 LSLV OA_008 LSL
Slide 11: Pivotal Studies for Registration
PIVOTAL STUDIES FOR REGISTRATION Study Region N PPS Selected Placebo Subjects for Dose (initial Safety DB course) PARA_OA_002 (Phase 2b/3) US/AU 938 352 352 352 PARA_OA_006 (2b/3 US/AU 750* 282 - 282 Extension) PARA_OA_003 (PH3 confirm) EU/US 700 350 350 350 PARA_OA_007 (PH3 EU/US 560* 280 - 60 Exte
Slide 12: Pivotal Studies for Registration News Flow
PIVOTAL STUDIES FOR REGISTRATION* NEWS FLOW OA_002 All Subjects Recruited OA_009 First Subject Treated OA_010 First Subject Treated OA_009 All Subjects Recruited OA_006 All Subjects Recruited OA_008 First Subject Treated OA_003 First Subject Treated OA_007 First Subject Treated OA_008 All Subjects O
Slide 13: Safety and MPS
SAFETY AND MPS DR. MICHAEL IMPERIALE PARADIGM BIOPHARMA 14 Paradigm Biopharma: R&D Presentation 2020
Slide 14: Pharmacovigilance / Safety at Paradigm
PHARMACOVIGILANCE / SAFETY AT PARADIGM Michael Imperiale Head of Global Safety This will insure accurate and consistent safety data to manage our Inga Greblikiene patients and support a Safety Physician successful NDA submission. Synteract Safety Vendor PARADIGM BIOPHARMA 15 Paradigm Biopharma: R&D
Slide 15: Update on MPS Orphan Designation in EU and US
UPDATE ON MPS ORPHAN DESIGNATION IN EU AND US MPS 1 - Australia MPS 6 - Brazil • Women's and Children's Hospital Adelaide • A double-blind placebo-controlled trial with 12 subjects. Dosed weekly for 24 weeks. • An open label trial currently enrolling up to 10 subjects. Dosed weekly for 12 weeks then
Slide 16: R&D Pipeline
R & D PIPELINE DR RAVI KRISHNAN PARADIGM BIOPHARMA 17 Paradigm Biopharma: R&D Presentation 2020
Slide 17: The Multiple Mechanisms of Action of PPS
THE MULTIPLE MECHANISMS OF ACTION OF PPS PARADIGM BIOPHARMA 18 Paradigm Biopharma: R&D Presentation 2020
Slide 18: R&D Pipeline
R&D PIPELINE Multiple mechanisms of action allow the repurposing of PPS across a number of acute and chronic medical indications with unmet needs. Indication / Action of PPS Stage of Development Alphavirus induced arthralgia • Preclinical Proof-of concept for CHIK-V: • Anti-inflammatory target: NF-k
Slide 19: Revenue Timeline & Summary
REVENUE TIMELINE & SUMMARY DR JEANNIE JOUGHIN PARADIGM BIOPHARMA 20 Paradigm Biopharma: R&D Presentation 2020
Slide 20: Timeline to First Revenue - Australia
TIMELINE TO FIRST REVENUE - AUSTRALIA Pay-For-Use Special Access Scheme TGA Provisional Approval Arthralgia OA OA associated with Submission Q3 Ross River Virus Q3 CY2021 CY2022 after After Study _002 has completion of _008 Q2 CY2021 completed recruitment Sales - CY2024 Potential for milestone payme
Slide 21: Summary
SUMMARY ü Highly confident that we will receive global registration once the pivotal Phase 3 clinical trials are successfully completed. ü Highly qualified and experienced team to design and execute on our Phase 3 program. ü When IND is open, we have a Phase 3-desirable asset for partnering, for OA
Slide 22: Q&A Opportunity
Q&A OPPORTUNITY PANEL PARADIGM BIOPHARMA 23 Paradigm Biopharma: R&D Presentation 2020
Slide 23: For more information please visit
For more information please visit: www.paradgimbiopharma.com or email any queries to investorrelations@paradigmbiopharma.com PARADIGM BIOPHARMA 24 Paradigm Biopharma: R&D Presentation 2020
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