Prescient clears PTX-100 review hurdle with A$6 million funding secured

PTX-100 reaches first dose review threshold

Prescient Therapeutics Limited (ASX:PTX) has reached a key checkpoint in the Phase 2a study of PTX-100 in relapsed or refractory cutaneous T-cell lymphoma, with 20 evaluable patients now enrolled across the trial’s two dosing arms. That clears the pre-specified threshold for the first Dose Optimisation Committee review, which is scheduled for December 2026.

The committee will examine safety and efficacy data from both arms and provide guidance on whether the study should continue into further development. The company is explicit that this is a planned milestone in the study’s dose-optimisation design, not completion of the trial, and the filing contains no new efficacy data.

Capital raise extends the development runway

The clinical milestone arrives alongside a completed A$6.0 million funding package, comprising A$4.8 million from the Share Purchase Plan and about A$1.2 million from a placement. Shares were issued at 6.5 cents each on 30 September, with the proceeds received on 1 October. The raise had been positioned as funding to carry PTX-100 beyond the December review, a thread covered in the earlier A$6 million funding raise.

Prescient ended September with A$5.8 million in cash, down from A$9.03 million three months earlier. On a pro forma basis including the post-quarter-end raise, cash stood at A$11.8 million. The distinction matters: the Appendix 4C reports 1.80 quarters of funding using the quarter-end balance, rising to 3.67 quarters on a pro forma basis after the raise.

Recruitment continues toward 40 evaluable patients

Three patients joined the study during the quarter, taking total enrolment to 29 by 30 September. Recruitment slowed during the Northern Hemisphere summer, when most trial sites are located, but continues across Australia, the United States and Italy, with additional sites being prepared in France. The planned target remains 40 evaluable patients.

Operating cash outflow was A$3.2 million for the quarter, including A$1.97 million on research and development and clinical activities. Prescient said it expects near-term operating outflows to remain broadly consistent as PTX-100 development continues. One patient also remains on compassionate access, consistent with a clinical response previously observed, while the company is assessing potential future PTX-100 studies in peripheral T-cell lymphoma after the recommended CTCL Phase 2 dose is selected.

Dr Rosalind Wilson began as chief medical officer in July and now leads clinical development and execution. The immediate test for the new clinical leadership and the newly replenished balance sheet is the December committee recommendation: whether the data support continued development, and whether the study’s two dosing arms point clearly enough towards a recommended Phase 2 dose.