Prescient Therapeutics Ltd (ASX:PTX) reported meaningful regulatory progress during the December 2025 quarter, with the European Medicines Agency granting Orphan Drug Designation for PTX-100 for the treatment of cutaneous T-cell lymphoma (CTCL). The designation covers both mycosis fungoides and Sézary syndrome and is expected to provide 10 years of market exclusivity in the European Union following marketing approval.
The company also received authorisation through the European Clinical Trials Information System to initiate its Phase 2a clinical trial in relapsed or refractory CTCL, enabling site activation and patient recruitment across Europe.
Global trial sites expand as recruitment continues
During the quarter, Prescient opened two additional clinical trial sites across Australia and the United States as part of its global Phase 2a program, which is expected to include up to 16 sites worldwide. Subsequent to quarter end, the first Italian site was activated, lifting the total number of active global sites to 10.
Patient identification and screening continued across all active sites during the period, with enrolment increasing to nine patients following the addition of three patients in the United States in early January. The Phase 2a study is designed to enrol up to 40 patients.
Solid cash position underpins ongoing development
Prescient ended the quarter with cash reserves of $9.7 million, compared with $12.3 million at the end of September, with net operating cash outflows of $2.6 million. This included $1.3 million spent on research and development and clinical activities.
Subsequent to the reporting period, the company received a $4.3 million R&D Tax Incentive refund in January 2026, extending its estimated funding runway to about 5.46 quarters on a pro-forma basis.