Percheron Therapeutics Limited · ASX:PER
Percheron Therapeutics — Shareholder Meeting (December 2021)
21 slides from Percheron Therapeutics's shareholder meeting presentation, Dec 15, 2021
Slide 1: AGM Presentation December 2021
(ASX: ANP) AGM Presentation December 2021
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward‐looking statements regarding the Company’s business & the therapeutic & commercial potential of its technologies & products in development. Any statement describing the Company’s goals, expectations, intentions or beliefs is a forward‐loo
Slide 3: Charmaine Gittleson MD, Board Chair
Charmaine Gittleson MD Board Chair 3
Slide 4: ANP Corporate Video
ANP Corporate Video 4
Slide 5: Key Strategic Factors for ANP Success
Key Strategic Factors for ANP Success Expand on value proposition Refine ANP Deliver on Leverage business ATL1102 research model for future promise Leverage expertise 5
Slide 6: Proposed Strategic Plan
Proposed Strategic Plan 2022 2023 2024 2025 2026 Deliver on Trial sites Futility Study EU market Potential FDA ATL1102 initiated analysis results approvals approval promise First patient in Q3 2023 Q3 2024 Q4 2024 2025 / Q1 2026 Leverage Board composition review / renewal expertise Key opinion leade
Slide 7: Mark Diamond, Managing Director and CEO
Mark Diamond Managing Director and CEO 7
Slide 8: Antisense Corporate Overview
Antisense Corporate Overview Share Price Performance Company Details • Market Capitalisation @ $0.185 = $122M** • Ordinary fully paid shares on issue = 658M** • Cash Balance as at 30 September 2021 = $4.7M* • Largest shareholder – Platinum Asset Management (5.23%) * On 5th November the Company annou
Slide 9: Lead Program: ATL1102 in DMD - Profile Summary
Lead Program: ATL1102 in DMD ‐ Profile Summary ATL1102 clear differentiation in DMD space positions it for global success within high‐growth multi‐billion‐dollar DMD market • Novel and Differentiated MOA: ATL1102 is the only therapy in development for DMD targeting CD49d to slow disease progression
Slide 10: Clinical Development EU
Clinical Development EU EU Phase IIb/III Clinical Trial • ANP will conduct a multi‐centre, randomised, double‐blind placebo‐controlled Phase IIb/III study of ATL1102 in non‐ ambulant patients dosed with ATL1102 for 12 months at two dose levels as a potentially pivotal (approvable) trial with a follo
Slide 11: EU Clinical Trial Process & ATL1102
Sponsor - ANP EU Clinical Trial Process Develops protocol and clinical Regulator Create Clinical Trial Applications development plan 1 &ATL1102 Trial protocol substantial amendments Obtains National Competent Authority / country and EMA advice on protocol PDCO/EMA Create Submission Packages Requests
Slide 12: EU Phase IIb/III Study Program
EU Phase IIb/III Study Program A multicentre, randomised, double‐blind, placebo‐controlled study to assess the efficacy, safety, and pharmacokinetic profile of two dose levels of ATL1102 to be conducted in 108 (114 randomised) DMD non‐ambulant participants in ~9 countries across >30 trial sites with
Slide 13: Anticipated EU Phase IIb/III Study Timeline
Anticipated EU Phase IIb/III Study Timeline Defined Terms: CTA: Clinical Trial Application CSR: Clinical Study Report LOI: Letter of Intent EUR Com Decision: European Commission Decision 13 Note: The above timeline is indicative and illustrative only and is not a forecast or projection or any assura
Slide 14: Clinical Development US
Clinical Development US US Regulatory Plans • Protocol synopsis submitted to the FDA for a nine‐month chronic monkey toxicology study to support the dosing of patients with ATL1102 beyond six months in US for DMD or any other clinical application of ATL1102 ‐ expecting feedback in 1Q’22. • Given the
Slide 15: FDA Interactions ATL1102
FDA Interactions Sponsor - ANP Regulator - FDA ATL1102 Create Clinical Trial Applications Protocol and clinical development plan IND Six month study & 25 mg ATL1102 substantial amendments (partial hold) Nine month toxicology design submitted to FDA for review Rare Paediatric Disease Create Submissio
Slide 16: ATL1102 New Indications
ATL1102 New Indications • Focus on advancing ATL1102 for DMD towards commercialisation whilst expanding the clinical application of ATL1102 beyond DMD • capitalising on the investment to date and the extensive data package generated on this asset • to deepen the product pipeline to add further value
Slide 17: ATL1102 New Indications (continued..)
ATL1102 New Indications (continued..) • Collaboration with Murdoch Children's Research Institute (MCRI) the largest child health research institute in Australia • Study 1 ‐ mdx model in combination with other DMD agents including the dystrophin restoration drugs • Study 2 ‐ another animal model of m
Slide 18: Capital Management
. Capital Management • Placement monies received $20 million • ANP is funded into 2H’23 calendar year including costs associated with setup of the Phase IIb/III DMD trial in Europe • Entitlement offer to raise $16.8 million, closing 17 December 2021 o Use of funds: progressing Phase IIb/III DMD tria
Slide 19: Commercialisation considerations
Commercialisation considerations • Company is focused on preparations for EU Phase IIb/III trial initiation • Trial with its OLE phase is set up as a registration (approval) study • Company is gearing up to potentially take ATL1102 all the way to through approval in the Europe and possibly to market
Slide 20: Major Achievements and Upcoming Key Activities
Major Achievements and Upcoming Key Activities Regular progress and key market updates during the Phase IIb/III trial – multiple value creation opportunities ATL1102 Phase ATL1102 IIb / III Futility ATL1102 Phase IIb/III Analysis Report Phase IIb / III ATL1102 Phase Open Label Recruitment ATL1102 Ne
Slide 21: For more information
For more information: Investment enquiries: Mark Diamond Gennadi Koutchin Managing Director XEC Partners +61 (0)3 9827 8999 +61 (0)423 500 233 www.antisense.com.au gkoutchin@xecpartners.com.au
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