Funding Risks Linger as Prescient Advances PTX-100 with FDA Fast Track

Financial Performance and Operational Highlights

Prescient Therapeutics Limited (ASX, PTX) reported a net loss of $7.32 million for the year ended 30 June 2025, marking an 11.1% improvement compared to the prior year’s $8.24 million loss. The company’s financials reflect continued investment in its clinical-stage oncology pipeline, particularly its lead candidate PTX-100, alongside a modest reduction in corporate expenses and an increase in employment and share-based payments due to expanded staffing.

Research and development tax incentives recognised rose to $4.36 million, up from $3.71 million in FY2024, providing a valuable offset to the company’s R&D expenditure. Despite a decrease in cash and cash equivalents to $6.9 million at year-end, Prescient bolstered its balance sheet post-period with a $3 million placement and a $6.8 million share purchase plan, collectively raising $9.8 million to support ongoing clinical development.

Clinical Progress, PTX-100 and Regulatory Milestones

PTX-100, Prescient’s first-in-class targeted therapy for cutaneous T-cell lymphoma (CTCL), has advanced from Phase 1b to Phase 2a clinical trials during the year. The Phase 1b trial demonstrated a promising 45% overall response rate among evaluable patients, underpinning the transition to the Phase 2a study, which commenced with the first patient dosed in Perth and additional sites activated globally.

Significantly, the U.S. Food and Drug Administration (FDA) granted PTX-100 Fast Track and Orphan Drug designations for relapsed or refractory mycosis fungoides, the most common CTCL subtype. These designations facilitate accelerated development and regulatory review, positioning PTX-100 for potential expedited approval pathways. The company is actively engaging with regulatory authorities and key opinion leaders to refine trial design and accelerate clinical milestones.

Advancements in Cell Therapy Platforms

Beyond PTX-100, Prescient continues to develop its proprietary cell therapy platforms, OmniCAR and CellPryme. The OmniCAR platform, designed to deliver modular and controllable CAR-cell therapies, showed encouraging preclinical results with improved safety and efficacy profiles in vitro and in vivo. CellPryme technology aims to enhance the durability and effectiveness of existing cell therapies, with ongoing collaborations involving leading research institutions such as the Peter MacCallum Cancer Centre and CSIRO.

Leadership and Corporate Governance

The year saw key leadership transitions with Dr James Campbell appointed Chair in March 2025 and James McDonnell assuming the CEO role in January 2025. The board was further strengthened by the appointments of Non-Executive Directors Melanie Farris and Gavin Shepherd, bringing extensive biotech and healthcare expertise. These changes reflect Prescient’s strategic focus on clinical advancement and commercialisation readiness.

Auditor William Buck issued an unmodified opinion on the financial statements, affirming compliance with accounting standards and the company’s ability to continue as a going concern, supported by recent capital raises and ongoing R&D incentives.