Pyc Therapeutics Limited · ASX:PYC
Pyc Therapeutics — Q3 2023 Earnings Presentation
9 slides from Pyc Therapeutics's earnings presentation, Sep 27, 2023
Slide 1: Q3 Investor Call, September 2023
For personal use only Life-changing science Q3 Investor Call September 2023
Slide 2: Disclaimer
Disclaimer For personal use only The purpose of this presentation is to provide an update of the business of PYC Therapeutics Limited (ASX:PYC) [‘PYC’]. These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. A
Slide 3: Executive Summary
Executive Summary • An overview of the VP-001 drug candidate for the treatment of RP type 11 For personal use only • Progress in Q3 • US FDA Fast Track designation received • Repeat dose tox. study results enable transition to Phase 2 • First patient cohort dosed in Phase 1 Single Ascending Dose (SA
Slide 4: Looking back: VP-001 has made material progress in Q3 2023
Looking back: VP-001 has made material progress in Q3 2023 For personal use only 2x Repeat Dose GLP Tox FDA Fast Track Generating Human Study Outcomes1 Designation2 Safety Data3 July 2023 August 2023 September 2023 ✓ Complete non-clinical safety ✓ Accelerated path to market ✓ Key milestone • Conduct
Slide 5: PYC now has initial human safety data in support of VP-001
PYC now has initial human safety data in support of VP-001 Safety Review Committee (SRC) has approved escalation of VP-001 dosing to ‘mid-dose’ cohort1 • Following evaluation of 4-week safety/tolerability data from the first ‘low-dose’ cohort of patients For personal use only • The first patient in
Slide 6: Looking forward: VP-001 has a high-velocity path to market
Looking forward: VP-001 has a high-velocity path to market VP-001 DEVELOPMENT PLAN For personal use only ONGOING PLANNED Deep dive on 2023/2024 on next page Ph2/3 MAD*/ Registrational New Drug Ph1 SAD Scenario 1 Application Control: Sham Ph3 Registrational Ph1b Open Label MAD extension* New Drug Sce
Slide 7: Current status: VP-001 is progressing through the Phase SAD
Current status: VP-001 is progressing through the Phase 1 SAD For personal use only Objective: establish two safe and well-tolerated doses of VP-001 to be used in pivotal studies 2023 2024 SAD1 Phase 2/3 (MAD)4 We are here 3 x 90 µg + 24 week High dose IND 4 weeks3 follow up 3 x 30 µg + Safe2 3 x 10
Slide 8: PYC is measuring patient progression across multiple endpoints
PYC is measuring patient progression across multiple endpoints in order to ensure that the efficacy signal is observed Degenerative sight of an C Registrational Functional vision Visual function RP11 patient For personal use only endpoints O 6 YEARS OLD M Structural Markers Visual Field Visual Acuit
Slide 9: Q&A
For personal use only Life-changing science Q&A September 2023