Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (August 2022)
31 slides from Paradigm Biopharmaceuticals's investor presentation, Aug 15, 2022
Slide 1: Capital Raising Presentation August 2022
Capital Raising Presentation August 2022
Slide 2: Disclaimer
Paradigm Biopharma AUG 2022 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: Leadership
Paradigm Biopharma AUG 2022 3 Paul Rennie, Marco Polizzi, Dr. Donna Skerrett, Chairman CEO CMO & Executive Director Leadership Experienced team to drive clinical execution of Paradigm’s multiple clinical and R&D programs. Dr Ravi Krishnan, Justin Cahill, CFO CSO
Slide 4: About Paradigm
Paradigm Biopharma AUG 2022 4 Proven FDA-approved drug with 60-year track record of treating inflammation, pentosan Molecule polysulfate sodium for subcutaneous use (PPS, iPPS, ZILOSUL®). About Paradigm Osteoarthritis (OA) • Phase 3 clinical program commenced. • Sites enrolling in US, UK and AUS wit
Slide 5: Recent Company Milestones
Paradigm Biopharma AUG 2022 5 Recent Company Milestones • FDA Fast Track designation granted for OA program • First phase 3 OA subjects dosed in US • Further IP protection reported with acceptance of AUS patent • 100% recruitment in phase 2 synovial fluid biomarker trial – near term clinical data •
Slide 6: Upcoming Catalysts
Paradigm Biopharma AUG 2022 6 Upcoming Catalysts Upcoming Near-term Catalysts PARA_OA_008 Phase 2 study • PARA_OA_008 top-line data readout September 2022 • Top-line results September 2022 • Canine OA model preliminary data readout Q3 CY2022 • Biomarker study assessing change from baseline in multip
Slide 7: Osteoarthritis
Paradigm Biopharma 01/04/21 AUG 2022 77 Osteoarthritis OA
Slide 8: Blockbuster market opportunity
Paradigm Biopharma AUG 2022 8 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 People affected by OA by 20303 meet a significant treatments1 unmet need in osteoarthritis. At 10% market 120m+
Slide 9: Osteoarthritis - Global Phase 3
Paradigm Biopharma 01/04/21 AUG 2022 99 Osteoarthritis - Global Phase 3 PARA_OA_002 Global Progress United States • Approximately 56 sites have been selected • 41 sites activated and participant screening commenced late in Q1 CY22 following site activation. • Large pool of subjects being screened by
Slide 10: Timeline for OA
Paradigm Biopharma AUG 2022 10 Timeline for OA 2021 2022 2023 2024 2025 2026 OA_002 Pivotal & confirmatory OA_003 NDA OA_006 Duration of effect OA_007 PE 6mth 12mth OA_008 Biomarkers Canine Study Label OA_009 extension OA_010 Study Objective Key Milestone 002 NDA pivotal DSMB Review Q4 2022, dose se
Slide 11: Disease Modification Potential
Paradigm Biopharma AUG 2022 11 Disease Modification Potential Current programs to inform of Zilosul® potential as a DMOAD1 PARA_OA_008 - Australia Canine OA Study DMOAD Label • Biomarker study assessing change from • 21 Dogs with OA of the stifle joint are A label claiming disease modification has b
Slide 12: Mucopolysaccharidosis
Paradigm Biopharma 01/04/21 AUG 2022 1212 Mucopolysaccharidosis
Slide 13: Mucopolysaccharidosis (MPS)
Paradigm Biopharma AUG 2022 13 Mucopolysaccharidosis (MPS) MPS I - Australia • Open label trial dosing subjects weekly SC for 12-weeks, then every Phase 2 Asset in rare pediatric disease associated with other week for a total of 52-weeks. inflammation and ongoing musculoskeletal pain – PPS has FDA •
Slide 14: Capital Raising and Use of Funds
Paradigm Biopharma AUG 2022 14 Capital Raising and Use of Funds Paradigm is undertaking a capital raising of approximately $66.0 million at $1.30 per share via a: • Institutional placement of A$45.7 million under Paradigm's existing LR7.1 capacity; and • 1 for 15 pro-rata non renounceable entitlemen
Slide 15: Summary
Paradigm Biopharma AUG 2022 15 Summary • A substantially de-risked phase 3 asset in blockbuster indication • FDA Fast-Track designation for OA program • Promising clinical pipeline across multiple indications • New CEO with significant experience commercialising new drugs • Five major clinical data
Slide 16: Capital Raising Overview
Paradigm Biopharma 01/04/21 AUG 2022 1717 Capital Raising Overview
Slide 17: Offer Summary
Paradigm Biopharma AUG 2022 18 Fully underwritten capital raising of approximately $66.0 million comprising: • an institutional placement (Placement) of approximately $45.7 million under Paradigm's existing Offer Offer structure and size • LR7.1 capacity; and a 1 for 15 pro-rata non renounceable ent
Slide 18: Indicative Offer Timetable
Paradigm Biopharma AUG 2022 19 Indicative Offer Timetable Event Sydney, Australia time Trading halt Thursday, 11th August 2022 Announcement of completion of Placement and recommencement of trading Monday, 15th August 2022 Record date for Entitlement Offer Thursday, 18th August 2022 Settlement of New
Slide 19: Appendix Slides
Paradigm Biopharma 01/04/21 AUG 2022 2020 Appendix Slides
Slide 20: Paradigm Appoints Experienced US-Based CEO
Paradigm Biopharma AUG 2022 21 Paradigm Appoints Experienced US-Based CEO • Experienced pharmaceutical industry executive joined Paradigm as Chief Executive Officer (CEO) on 1 July 2022. • 30 years of experience in the pharmaceutical industry in various commercially focused roles, including the crea
Slide 21: Development Pipeline
Paradigm Biopharma AUG 2022 22 Development Pipeline Preclinical Phase Phase Phase Registration 1 2 3 REG Multiple Market Opportunities Protocol supports simultaneous Dose confirmation and efficacy registration in Key Markets. Osteoarthritis Program designed to inform of the Para_OA_008 Synovial flui
Slide 22: Mechanism of action
Paradigm Biopharma AUG 2022 23 Mechanism PPS of action • Multiple modes of action • Previous phase 2B, SAS and NF-kB EAP experience OA Inflammation Pain Tissue Preservation Improved Blood Flow MPS TNF-a, IL-1ẞ, IL-6 NGF, Prostanoids ADAMTS -4 & -5, MMPs Cell-adhesion molecules ARDS HA Anti-thromboti
Slide 23: Strong Patents & IP Position
Paradigm Biopharma 12/01/22 24 Strong Patents & IP Patent protection using Minimum life on patents is 2030 and beyond for Position PPS for new indications more recent patents i.e. 2035 - 2040 • Exclusive supply and ongoing Established regulatory Patents for LSD + Orphan exclusivity and development a
Slide 24: Risk Factors
Paradigm Biopharma AUG 2022 25 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 25: Risk Factors Continued
Paradigm Biopharma AUG 2022 26 Risk Factors Continued Research and Development Activities: Paradigm’s future success is dependent on the performance of Paradigm in clinical trials and whether it proves to be a safe and effective treatment. Paradigm’s lead product is an experimental product in clinic
Slide 26: Risk Factors Continued
Paradigm Biopharma AUG 2022 27 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 27: Risk Factors Continued
Paradigm Biopharma AUG 2022 28 Risk Factors Continued Dilution Risk: Eligible shareholders that do not take up all or part of their entitlements will be diluted by not participating to the full extent in the Entitlement Offer and by the Institutional Placement, but and will not be exposed to future
Slide 28: International Offer Restrictions
Paradigm Biopharma AUG 2022 29 International Offer Restrictions This document does not constitute an offer of new ordinary shares ("New Shares") of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may
Slide 29: International Offer Restrictions
Paradigm Biopharma AUG 2022 30 International Offer Restrictions Hong Kong WARNING: This document has not been, and will not be, registered as a prospectus under the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong, nor has it been authorised by the Securities and
Slide 30: Termination Events
Paradigm Biopharma AUG 2022 31 Termination Events The Underwriting Agreement includes the following termination events Part 1 – Immediate Termination Events i. the Company ceases to be admitted to the official list of ASX or the Shares are suspended from trading for more than 2 business days on, or
Slide 31: Termination Events
Paradigm Biopharma AUG 2022 32 Termination Events Part 2 –Termination Events requiring a material adverse effect (as defined in the underwriting agreement) before termination i. the Public Information includes a statement which is or becomes misleading or deceptive or likely to mislead or deceive or
Paradigm Biopharmaceuticals — Investor Presentation (August 2022) on 6ix