Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Shareholder Meeting (November 2024)
20 slides from Paradigm Biopharmaceuticals's shareholder meeting presentation, Nov 19, 2024
Slide 1: Chairman's Address to 2024 Annual General Meeting
ASX RELEASE 19 November 2024 Chairman’s Address to 2024 Annual General Meeting Dear Shareholders, Welcome everyone to the 2024 Annual General Meeting of Paradigm Biopharmaceuticals. It’s a pleasure to extend a warm welcome to all our shareholders here today and to those joining us through the Automi
Slide 2: About Paradigm Biopharmaceuticals
Board is working on ways to reward loyal shareholders, particularly those who have held their PAR stock over the past 12 months. Together, we are advancing Paradigm’s vision of providing new hope to those affected by OA and other musculoskeletal diseases. Yours Sincerely, Paul Rennie About Paradigm
Slide 3: Annual General Meeting | 19 Nov 2024
ANNUAL GENERAL MEETING | 19 NOV 2024
Slide 4: Welcome Board of Directors
Paradigm Biopharma NOV 2024 2 PAUL DR. DONNA RENNIE SKERRETT Founder & Managing Executive Director & Director Chief Medical Officer Welcome Board of Matthew AMOS Directors Fry Non-Executive Director MELTZER Non-Executive Director Experienced team to drive clinical success and commercialisation
Slide 5: Agenda
Paradigm Biopharma NOV 2024 3 Company Update Agenda • Company Update • Notice of meeting & formal business • Questions relating to Company Paul Rennie, Update Managing Director
Slide 6: Disclaimer
Paradigm Biopharma NOV 2024 4 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 7: What we set out to achieve
Paradigm Biopharma NOV 2024 5 Phase 3 OA program protocol acceptance from US FDA for progression with lowest effective dose (2 mg/kg twice weekly). Regional licensing agreement(s) in OA and MPS. Pivotal study commencement of recruitment. 2024 TGA provisional approval determination application submis
Slide 8: 2024 | Key Company Milestones
Paradigm Biopharma NOV 2024 6 2024 | Key Company Milestones OARSI Conference: Bio International Conference: Manuscript Completion and FDA Approval: Anticipated FDA Paradigm presented phase 2 data Paradigm executives attended the event Peer Review Submission: review and agreement of phase 3 at the Os
Slide 9: Osteoarthritis
Paradigm Biopharma NOV 2024 7 Osteoarthritis OA
Slide 10: Lead Program Osteoarthritis Global Phase 3 Achievements
Paradigm Biopharma NOV 2024 8 Achievements January • Type D meeting with US FDA to discuss stage 1 PARA_OA_002 results and optimal dose to progress development program. April • Submission of key documents to the US FDA in April 2024, for review and agreement on the progression of the Phase 3 clinica
Slide 11: Summary of FDA Feedback
Paradigm Biopharma NOV 2024 9 FDA Type D Meeting Response • Positive feedback and recommendations from the Agency with key feedback items: o Acceptability of 2mg/kg dose regimen. Summary o Reduction to safety monitoring and mitigation compared to prior stage. of FDA o Recommendations on statistical
Slide 12: Phase 3 PARA_OA_012 Clinical Program: Key Details
Paradigm Biopharma NOV 2024 10 Phase 3 PARA_OA_012 Clinical Program: Key Details Program Focus • De-risked, efficient program with high probability of success. Primary Endpoint • Change from baseline in pain. Key Secondary Endpoints • Pain and function assessments (change from baseline) up to Day 40
Slide 13: PARA_OA_012 Phase 3 trial design
Paradigm Biopharma NOV 2024 11 PARA_OA_012 Phase 3 trial design Treatment Period 6 weeks Follow-up Period 46 weeks PPS 2mg/kg (max 200 mg) N = 233* Screening Placebo N = 233* 39 56 84 112 140 168 224 280 336 404 Day 1 First Injection Last Inj. Interim End of Study Analysis Primary endpoint: Change f
Slide 14: Key Expected Milestones Next 12 Months
Paradigm Biopharma NOV 2024 12 Key Expected Milestones Next 12 Months Key plans for the next 12 months for Paradigm's global Phase 3 OA program include: • FDA Protocol Review and Approval: Complete the FDA review of the Phase 3 protocol, expected by November 2024, to proceed with the Pivotal clinica
Slide 15: Company Update
Paradigm Biopharma NOV 2024 1313 02/12/21 C o m p a n y UPDATE
Slide 16: Partnering Update
Paradigm Biopharma NOV 2024 14 Commercial strategy for iPPS Ongoing Commercial Partnering Efforts • Active engagement with key potential partners to support and co-fund late- stage development and future commercialisation. • Feedback: FDA phase 3 trial acceptance is a critical milestone to further t
Slide 17: Significant Reduction in Cash Burn Achieved
Paradigm Biopharma NOV 2024 15 Significant Reduction in Cash Burn Achieved Targeted Reduction: • Cash outflows for recent quarters under forecast, with September quarter reduced to $4.72M, below the $7M guidance. Strategic Financial Management: • December quarter forecast to remain at or below $7M,
Slide 18: Exploring Multiple Funding Pathways
Paradigm Biopharma NOV 2024 16 Exploring Multiple Funding Pathways Focus on Non-Dilutive Funding: • Priority on securing non-dilutive or less dilutive sources, including government grants, R&D rebates, and milestone payments or direct investment from potential commercial partnerships. Strategic Part
Slide 19: Near-term News flow: Upcoming Catalysts
Paradigm Biopharma NOV 2024 17 Near-term News flow Event Target Date FDA Phase 3 Protocol Review - FDA Agreement to proceed to with PARA_OA_012 study Q4 CY2024 TGA Provisional Approval OA - TGA Determination Decision Q4 CY2024 Q4 CY2024 Upcoming Australian Ethics Submission – Phase 3 PARA_OA_002 Cat
Slide 20: Thank you for your attendance
Paradigm Biopharma NOV 2024 18 Thank you for your attendance For more information please visit: paradigmbiopharma.com or email any queries to investorrelations@paradigmbiopharma.com
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