• Completed dosing of Phase 1 SAD cohorts for lead program PYC-003 in Polycystic Kidney Disease
• Presented positive NHP data for PYC-002 in Phelan McDermid Syndrome, on track for IND filing in 2027
• Progressed VP-001 for Retinitis Pigmentosa Type 11 into open-label extension study

PYC Therapeutics, a clinical-stage biotechnology company developing a pipeline of precision RNA therapies, reported progress across its four lead drug development programs in the half-year ended 31 December 2025. The company completed dosing of the Phase 1 Single Ascending Dose (SAD) cohorts for its lead program PYC-003 in Polycystic Kidney Disease (PKD) and commenced Part B of the study, involving the first administration of the drug candidate to patients with ADPKD. Safety data from Part A was presented at a medical conference. For PYC-002 in Phelan McDermid Syndrome (PMS), the company presented positive results from successful Non-Human Primate (NHP) studies, complementing earlier data from patient-derived brain cells. The PMS program is progressing through GLP toxicology studies, with PYC on track to submit an IND application to the FDA in early 2027. In its Retinitis Pigmentosa Type 11 (RP11) program, VP-001 progressed into an Open Label Extension (OLE) of the Multiple Ascending Dose (MAD) study, with data showing sustained vision improvement in treated patients. The company also finalized preparations for a Type D meeting with the FDA in early 2026 to discuss the design of a registrational trial. For PYC-001 in Autosomal Dominant Optic Atrophy (ADOA), PYC completed dosing of the Phase 1 SAD study and commenced a global repeat-dose study aimed at establishing clinical proof of concept. Subsequent to the reporting period, the company launched a $653 million capital raising to extend its cash runway and advance all four pipeline programs through key human efficacy readouts.

The company reported a 13% decrease in revenues from ordinary activities to $11,039,678 and an 11% decrease in loss after tax to $22,828,638 for the half-year ended 31 December 2025, compared to the prior corresponding period.

PYC Therapeutics remains focused on advancing its pipeline of precision RNA therapies, with key milestones expected across its four lead programs in 2026 and 2027, including IND submissions, initiation of first-in-human trials, and presentation of clinical data.