Quarterly Activities/Appendix 4C Cash Flow Report

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Stock PYC Therapeutics Ltd (PYC.ASX)
Release Time 21 Jul 2025, 8:42 a.m.
Price Sensitive Yes
 PYC Therapeutics Provides Q2 2025 Shareholder Update
Key Points
  • Progress made in all four of the Company's drug development programs through Q2 2025
  • Dosing of the first subject in the combined Phase 1a/1b clinical trial of the PKD drug candidate
  • Presentation of clinical proof of concept data demonstrating improved vision in patients enrolled in the ongoing Phase 1/2 studies of the RP113 drug candidate
Full Summary

PYC Therapeutics, a precision medicine company creating life-changing RNA therapeutics, provided a Q2 2025 shareholder update on the progress of its four drug development programs. The company made progress in all four programs, including dosing the first subject in the combined Phase 1a/1b clinical trial for its polycystic kidney disease (PKD) drug candidate and completing dosing in cohorts 1 and 2 of Part A of the Single Ascending Dose (SAD) study. For its lead blinding eye disease (RP113) program, the company presented clinical proof of concept data demonstrating improved vision in patients enrolled in the ongoing Phase 1/2 studies and aligned with the FDA on the framework for the proposed registrational trial. The company also completed dosing in patient cohort 2 in the SAD study for its second blinding eye disease (ADOA) program and received approval to escalate dosing to the third and final cohort. For the Phelan-McDermid Syndrome (PMS) program, the company presented pre-clinical data supporting progression into human trials in 2026. All four programs are expected to progress through important milestones in the second half of 2025 as PYC continues its progression to becoming a commercial-stage company.

Guidance

PYC expects to complete the dose escalation study in healthy volunteers in Part A of the Phase 1a/1b PKD study, initiate Part B of the Phase 1a/1b study in PKD patients, and initiate repeat dose studies of its PKD drug candidate in patients within the coming 12 months. The company also expects to release updated data from the ongoing Phase 1/2 trials for its RP113 drug candidate, re-engage the FDA to finalize the plans for the registrational trials, and prepare for the initiation of the global registrational trial.