Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (October 2023)
38 slides from Paradigm Biopharmaceuticals's investor presentation, Oct 30, 2023
Slide 1: Capital Raising Presentation
October 2023 Capital Raising Presentation Not for release to US wire services or distribution in the United States
Slide 2: Disclaimer
Paradigm Biopharma OCT 2023 2 Disclaimer This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd ASX:PAR (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is con
Slide 3: Summary: Recent News flow
Paradigm Biopharma OCT 2023 3 Summary • PAR has provided two material market updates in Oct-2023 relating to the Phase 2 PARA_OA_008 trial • Demonstrated 12-month durability of effect with significant reduction in pain and functional improvement. First OA drug to demonstrate durability of effect at
Slide 4: Summary: Partnering Update
Paradigm Biopharma OCT 2023 4 Summary • An additional 40 sites were added to the Phase 3 PARA_OA_002 trial following interest from clinicians and patients in the US vs original budget of 80 sites. Accelerated recruitment via additional sites and changes in FX have resulted in higher than budgeted co
Slide 5: Near-term News flow
Paradigm Biopharma OCT 2023 5 Near-term News flow Event Target Date MPS VI phase 2 clinical trials – top-line data. Q4 CY2023 Phase 3 OA program – FDA protocol review next stage of Phase 3 program. Q1 CY2024 TGA Provisional Approval OA - submission for next stage determination application. Q1 CY2024
Slide 6: Offer Summary
Paradigm Biopharma OCT 2023 6 Capital raise of approximately $30.1m comprising: •A 1 for 10 non renounceable accelerated institutional and retail entitlement offer (Entitlement Offer) of shares (Shares) to eligible shareholders at the Record Date to raise up to approximately A$12.1m, Offer Offer str
Slide 7: Funding Position
Paradigm Biopharma OCT 2023 7 Funding Position • Capital raising of approximately A$30 million will fund the company through to mid CY25 (without additional licensing revenue), past the expected announcements of: • Commencement of the next stage of the Phase 3 OA program, subject to regulatory feedb
Slide 8: Indicative Offer Timetable
Paradigm Biopharma OCT 2023 8 Indicative Offer Timetable Event Melbourne, Australia time Trading halt Monday, 30 October 2023 Announcement of completion of Placement and Institutional Offer and recommencement of trading Wednesday, 1 November 2023 Record date for Retail Offer Wednesday, 1 November 20
Slide 9: Therapy Options OA
PARA)|G) Therapy Options OA
Slide 10: Blockbuster market opportunity
Paradigm Biopharma OCT 2023 10 Blockbuster People affected by OA in 20203 Knee and Hip (Global) market opportunity 72m+ 69 % of all OA Zilosul® aims to OA patients dissatisfied with current meet a significant People affected by OA by 20303 treatments1 unmet need in osteoarthritis. FDA Fast Track 120
Slide 11: Market Demand
Paradigm Biopharma OCT 2023 11 Effective Non-validated Ineffective Market Analgesics, NSAIDS Corticosteroids Demand Opioids *Platelet-rich Plasma, *Stem Cells, There are no *Royal Australian College of General Practitioners hold a ‘strong against’ recommendation *Viscosupplementation, *Orthokine eff
Slide 12: Target pricing: achievable price range
Paradigm Biopharma OCT 2023 12 Target pricing Pricing potential of Zilosul in P&F and DM compared to price benchmark Price points for comparators Weak opioids CS IA HA IA • Achievable for Pain 8000 Achievable price range (USD year) and Function (P&F) 7000 $6K+ 6000 with PAR current 5000 clinical pro
Slide 13: Precedent OA transactions
Paradigm Biopharma OCT 2023 13 Total Deal Upfront Date Licensee/Acquirer Licensor Phase Value Region (US$m) (US$m)# Taiwan Liposome Jun-22 Endo International 3 30 140 USA Company Precedent Apr-22 Juniper Biologics Kolon Life 3 n/a 600 APAC, OA Science MEA Flexion Oct-21 Pacira Biosciences Marketed n
Slide 14: Development Program Knee OA
Paradigm Biopharma OCT 2023 14 Consistent positive data for iPPS in clinical and real-world settings. • Special Access Scheme in Australia (>600 patients) • Expanded Access Program in US • Phase 2 clinical trials investigating iPPS versus placebo. Clinical Program • 2018 phase 2 PARA_OA_005 (complet
Slide 15: Optimal Dose
Paradigm Biopharma OCT 2023 15 iPPS optimal dose 2 mg/kg twice-weekly • A lot of clinical experience with 2 mg/kg twice-weekly: o PARA_005, 121 participants total. o PARA_OA_008, 61 participants total. o TGA Special Access Scheme (SAS), >600 patients o US FDA Expanded Access Program (10 ex-NFL playe
Slide 16: OA Clinical Development
Paradigm Biopharma OCT 2023 16 OA Clinical Development 2017-2018 2021 2022 2023 2024 2025 OA_005 NDA Phase 2 OA OA_008 Phase 3 Pivotal Pivotal + duration of effect OA_006 (002 extension) Confirmatory + Phase 3 Confirmatory duration of effect OA_007 (006 extension) OA Label OA_009 (retreatment) Exten
Slide 17: PARA_OA_008 Top-Line Results
Top-Line Results PARA_OA_008
Slide 18: Recap PARA_OA_008
Paradigm Biopharma OCT 2023 18 Exploring the durable effects of iPPS on pain, function and OA disease progression. Biomarker study assessing change from baseline in multiple objective measures associated with disease progression of OA. • 61 participants received iPPS once or twice weekly, or placebo
Slide 19: PARA_OA_008 Changes in WOMAC pain from baseline
Paradigm Biopharma OCT 2023 19 PARA_OA_008 Top-Line Clinical Endpoints at Day 365 0 Day 56 Day 168 Day 365 Changes in WOMAC pain from baseline LS Meam Percentage Change from Baseline -10 • Twice-weekly iPPS treatment showed significant improvement at Day 56 -20 (p=0.045) and Day 365 (p=0.054) in WOM
Slide 20: PARA_OA_008 Changes in WOMAC function from baseline
Paradigm Biopharma OCT 2023 20 PARA_OA_008 Top-Line Clinical Endpoints at Day 365 0 Changes in WOMAC function from baseline LS Mean percentage change from Baseline -10 • Significant improvements in function at Day 56 (p=0.017) and Day 365 (p=0.048) in -20 iPPS twice-weekly compared to placebo. -30 P
Slide 21: iPPS Durability Compared to Current OA Therapies
Paradigm Biopharma OCT 2023 21 Market Demand iPPS Durability Compared to Current OA Therapies Current OA medication effect duration. Representative infographic reflecting current literature on the timing of the peak and estimated duration of treatment effect of currently available OA medications* an
Slide 22: PARA_OA_008 Quantitative MRI Results: Cartilage Thickness
Paradigm Biopharma OCT 2023 22 PARA_OA_008 Top-Line Day 168 Quantitative MRI Results Changes in Cartilage Thickness from baseline • Twice weekly iPPS arm, demonstrated a consistent pattern across regions of cartilage thickening over 6 months • Placebo showed a loss in cartilage thickness in all medi
Slide 23: PARA_OA_008 Quantitative MRI Results: Cartilage Volume
Paradigm Biopharma OCT 2023 23 PARA_OA_008 Top-Line Day 168 Quantitative MRI Results Changes in Cartilage Volume from baseline • iPPS showed an average increase in cartilage volume of 4.6%, in the medial femorotibial compartment compared to baseline, whereas the placebo arm showed a loss of cartilag
Slide 24: PARA_OA_008 Cartilage thickness representative images
Paradigm Biopharma OCT 2023 24 Placebo Cartilage thinning in medial compartment Cartilage Twice-weekly iPPS thickness PARA_OA_008 Cartilage thickness representative improvement in medial images Baseline Day 168 compartment
Slide 25: PARA_OA_008 Summary
Paradigm Biopharma OCT 2023 25 PARA_OA_008 Summary of phase 2 randomised controlled clinical trial iPPS demonstrated efficacy on both objective and subjective measures compared to placebo OBJECTIVE DATA MEASURES Reported Day 56 & 168 Improvement in synovial fluid biomarkers associated with OA diseas
Slide 26: Mucopolysaccharidosis
Paradigm Biopharma OCT 2023 26 Mucopolysaccharidosis
Slide 27: MPS
Paradigm Biopharma OCT 2023 27 MPS Potential benefits Phase 2 Rare Disease Asset PPS reduces tissue GAGs2,3 • PPS has FDA & EMA Orphan Designation for MPS • Unmet need for patients who experience pain and symptoms that reduce their quality of life PPS attenuates the NGF pain pathway4 • PPS is being
Slide 28: Mucopolysaccharidosis (MPS)
Paradigm Biopharma AUG 2022 28 Mucopolysaccharidosis (MPS) MPS I – Australia – Completed Phase 2 Asset in rare pediatric disease associated with inflammation and ongoing musculoskeletal pain – PPS has FDA and EMA orphan • Open label trial dosing subjects weekly SC for 12-weeks, then every other desi
Slide 29: Paul Rennie, Simon White
Paradigm Biopharma OCT 2023 29 Paul Rennie Managing Director Email: prennie@paradigmbiopharma.com Simon White Director IR Email: swhite@paradigmbiopharma.com For more information please visit: paradigmbiopharma.com
Slide 30: Appendix
Appendix
Slide 31: Mechanism of action
Paradigm Biopharma OCT 2023 Mechanism Pentosan Polysulfate Sodium (PPS) of action • Multiple modes of action NF-κB • Previous phase 2B, SAS, and EAP experience • New phase 2 data Inflammation Pain Tissue Preservation Improved Blood OA TNF-α, IL-1β, IL-6 Flow NGF, Prostanoids ADAMTS-4 & -5, MMPs Cell
Slide 32: Extensive market protection
Paradigm Biopharma OCT 2023 32 32 Extensive market protection Exclusive supply Complex molecule Alphavirus • Molecular platform technology and a Heart ? Failure complex trade-secret manufacturing process makes it extremely difficult to replicate Severe OA Arthroplasty Pain • The starting material is
Slide 33: Risk Factors
Paradigm Biopharma OCT 2023 37 Risk Factors Shareholders should consider the investment in the context of their individual risk profile for speculative investments, investment objectives and individual financial circumstances. Each Shareholder should consult their own stockbroker, solicitor, account
Slide 34: Risk Factors Continued
Paradigm Biopharma OCT 2023 38 Risk Factors Continued Research and Development Activities: Paradigm’s future success is dependent on the performance of Paradigm in current and planned future clinical trials using Pentosan Polysulfate Sodium (PPS) and whether it proves to be a safe and effective trea
Slide 35: Risk Factors Continued
Paradigm Biopharma OCT 2023 39 Risk Factors Continued Manufacturing: There is a risk that scale-up of commercial supplies of Pentosan Polysulfate Sodium (PPS) may present technical and supply difficulties. Any unforeseen difficulty relating to manufacturing or supply of commercial GMP quantities of
Slide 36: Risk Factors Continued
Paradigm Biopharma OCT 2023 40 Risk Factors Continued Economic Risks: General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the Company’s activities, as well as on its ability to fund those activities. Taxation: The acquisiti
Slide 37: International Offer Restrictions
Paradigm Biopharma OCT 2023 41 International Offer Restrictions This document does not constitute an offer of new ordinary shares (“New Shares”) and free-attaching options (“Options”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distribute
Slide 38: International Offer Restrictions Continued
Paradigm Biopharma OCT 2023 42 International Offer Restrictions Continued Singapore This document and any other materials relating to the New Shares and Options have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, th
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