Highlights

• Pathkey.AI Ltd (ASX: PKY) Subsidiary TrialKey has signed a $25,000 services agreement with Paradigm Biopharmaceuticals (Administrators Appointed) to independently evaluate its Phase 3 PARA_OA_012 osteoarthritis study.

• TrialKey will assess whether changes to study design, conduct or analysis could have affected the interim futility outcome of Paradigm's Phase 3 trial.

• TrialKey's platform now has 14 live services, with internal testing demonstrating improved predictive performance across nine clinical trial outcomes, including an 8.3% relative uplift in predicting primary endpoint success.

• The Paradigm appointment is TrialKey's first contracted project engagement, with further priorities including delivery, additional biotech engagements and CRO pilot licensing.

Pathkey.AI Ltd (ASX:PKY), an Australian technology company developing AI-powered solutions for data-intensive industries, has announced that its subsidiary TrialKey Pty Ltd has signed a services agreement with Paradigm Biopharmaceuticals Ltd (Administrators Appointed) to provide an independent evaluation of Paradigm's Phase 3 osteoarthritis clinical study. The engagement represents TrialKey's first contracted project work and validates the commercial application of its clinical trial design and assessment platform.

The Paradigm Engagement and TrialKey's Role

Paradigm's PARA_OA_012 trial evaluated injectable pentosan polysulfate sodium for knee osteoarthritis. Following an independent Data Safety Monitoring Board decision in September 2026 that the interim efficacy result did not reach the threshold for continuation, Paradigm identified differences between US and rest-of-world results and noted missing assessments and dosing interruptions as matters requiring further analysis. TrialKey has been engaged to examine the protocol, statistical analysis plan and de-identified study data to identify potential reasons for the outcome and assess scientifically justified alternatives to trial design, conduct and analytical approach.

TrialKey's deliverables include an integrated technical report with recommendations on study design, endpoints, sample size, missing-data management and trial conduct, generated using its AI platform. The engagement demonstrates how TrialKey's assessment and planning capability can be applied to existing late-stage clinical programmes, beyond its core use case in forward-looking trial design. It is noted that Paradigm is in voluntary administration and that the work does not establish treatment efficacy or guarantee any future outcome for Paradigm's programme.

TrialKey Platform Capabilities and Predictive Performance

TrialKey uses machine-learning models trained on historical clinical trial data to generate predictive insights, risk assessments and design recommendations. The platform now has 14 live services. Internal retrospective testing recorded improvements across all nine outcomes assessed when document-derived features were incorporated alongside public registry data. The largest improvement was in predicting whether a trial meets its primary endpoint, with the AUC improving from 0.745 to 0.807 — an 8.3% relative improvement. The company is pursuing further validation, including independent prospective assessment, and aims to expand commercial use through additional biotech engagements and CRO pilot licensing.

Commercial Strategy and Parent Company

Pathkey.AI operates two AI platform subsidiaries: TrialKey for clinical trial design and optimisation, and Chipforge for semiconductor chip design. Both platforms combine large language model functionality with neuro-symbolic reasoning in an agent-based architecture. TrialKey's commercial routes to Revenue include scoped assessment and design engagements for biotech sponsors and pilot licensing through clinical research organisations (CROs). The Paradigm contract is a project-based engagement, not a recurring licence, but the company views CRO licensing as a priority pathway for scaling the platform across multiple sponsor studies.

Key Insights

The Paradigm contract is a commercially meaningful milestone — it converts TrialKey's platform into a revenue-generating project engagement and validates its applicability to real-world clinical trial assessment needs.

The 8.3% relative improvement in primary endpoint prediction AUC is a noteworthy performance gain, though the company appropriately notes these are internal retrospective results pending independent validation.

Paradigm's distressed status and the relatively modest contract value ($25,000) mean this is a proof-of-concept engagement rather than a major revenue driver, with its significance lying in the market validation it provides.

The future commercial priority of CRO licensing is strategically sound, as CROs operate across many sponsor studies simultaneously, providing Leverage and scale that biotech-by-biotech engagement cannot.