Phase 2 progress strengthens the commercial outlook for PTX-100 in hard-to-treat T-Cell Lymphoma

Prescient Therapeutics (ASX: PTX) is progressing through a critical development phase with its lead drug candidate, PTX-100, currently in a global Phase 2 clinical trial for relapsed/refractory Cutaneous T-Cell Lymphoma (r/r CTCL). The drug is believed to be the only GGT-1 inhibitor in clinical development worldwide, placing it in a highly differentiated position within oncology drug development. Earlier clinical data delivered encouraging response rates and durability in a patient group with very limited treatment options.

PTX-100 works by blocking a cancer growth enzyme involved in key cellular signalling pathways linked to uncontrolled tumour growth. Results from Phase 1 showed an overall response rate above 40%, durable responses exceeding 12 months, and importantly, no serious adverse events recorded to date. These characteristics compare favourably with existing approved therapies in this disease setting and underpin the investment thesis behind the current Phase 2 study.

The ongoing Phase 2 trial is being conducted across 16 planned global sites, with seven sites active as of October 2025, including the prestigious VCU Massey Comprehensive Cancer Centre in the United States. The trial is structured in two stages: a dose optimisation phase followed by a larger efficacy and safety evaluation. Prescient anticipates that, given the severe nature of the disease and the lack of effective existing treatments, Phase 2 could potentially serve as the pivotal trial, potentially eliminating the need for a costly Phase 3 study.

From a financial perspective, the company strengthened its balance sheet following a successful capital raising, closing the September 2025 quarter with $12.3 million in cash. Pitt Street Research’s valuation for Prescient remains between $0.11 and $0.16 per share, reflecting upside potential driven primarily by PTX-100, with additional optionality from the CellPryme and OmniCar programs. Several catalysts lie ahead, including further site activations, potential European orphan drug designation, and ongoing clinical updates.

As with all early-stage biotechnology companies, Prescient faces execution, regulatory, funding and commercialisation risks. However, the combination of strong early-stage efficacy, a favourable safety profile, and a potentially shortened regulatory pathway positions PTX-100 as a closely watched emerging oncology asset.

For the full valuation model, detailed trial design, upcoming milestones and key risks, download the complete Prescient Therapeutics research report.