Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) reported a cash balance of A$12.32 million at September 30, following a Share Purchase Plan and placement that together raised A$9.8 million before costs at A$0.04 per share, supporting the phase 2 programme for first-in-class cancer therapy PTX-100.
Net operating cash outflow was A$4.1 million for the quarter, including A$2.8 million on research and development and clinical activities. The company noted timing effects, with A$2.7 million of June 30 payables settled in the period, skewing the reported 3.1-quarter runway; operating expenditure incurred and settled in the quarter was A$1.4 million. Payments to related parties were A$85,000 for non-executive director fees.
Prescient advances PTX-100 trial with EMA review and expanded sites
Prescient Therapeutics has progressed its PTX-100 clinical programme, submitting a European Medicines Agency (EMA) application with an expected decision around mid-December 2025, and appointing France as the lead country reviewer. If approved, the company plans to open three sites in France and three in Italy.
Seven clinical trial sites are currently active across Australia and the United States (US), with up to sixteen sites envisaged globally, including Europe. Two additional sites are slated to open in the coming quarter. Patient recruitment is underway, with six patients enrolled and in dosing, and further candidates in screening.
An orphan drug designation (ODD) application for PTX-100 in the European Union was lodged with the EMA on 29 August, with a decision expected later this year. If granted, ODD would confer ten years of market exclusivity following EMA approval. This would add to the previously reported United States Food and Drug Administration (FDA) ODD for T cell lymphoma (TCL) and Fast Track Designation for relapsed and refractory cutaneous T cell lymphoma (r/rCTCL).
During the quarter, Prescient closed the Phase 1b study in T cell lymphoma (TCL) and finalised the clinical study report, enabling a sub-analysis in r/rCTCL. Among seven evaluable patients, the overall response rate was 43%, with 100% deriving clinical benefit and a 12.4-month response duration. No serious adverse events related to PTX-100 were identified. Prescient retains interest in peripheral T cell lymphoma (PTCL), with further work gated to the recommended Phase 2 dose from the Phase 2a cutaneous T cell lymphoma (CTCL) trial.
Collaborations advancing
Prescient advanced CellPryme-M collaborations and reported progress on improved OmniCAR molecular variants, with further validation to select a lead.
An online investor briefing is scheduled for Monday, October 20 at 11:00 AEDT.
Register here https://prescienttherapeutics.investorportal.com.au/investor-briefing/