Proteomics International Laboratories reported a $6.07 million loss for H1 FY26, driven by key commercial launches and a US reimbursement milestone that set the stage for growth.
- Controlled market launches of Promarker D and Promarker Eso in Australia
- US CMS reimbursement pricing established for Promarker D effective January 2026
- Expansion of regulated laboratory capabilities in Australia and the US
- Strengthened intellectual property with new US and Canadian patents
- Leadership changes including appointment of David Morris as CEO and suspension of Direct-to-Consumer strategy
Half-Year Financial Performance
Proteomics International Laboratories Ltd (ASX: PIQ) has reported a net loss of $6.07 million for the six months ending 31 December 2025, marking a 35% increase compared to the previous corresponding period. This loss reflects the company’s intensified investment in transitioning from development to early commercial execution of its precision diagnostic products.
Revenue, including grants and other income, declined by 10% to $868,749, while expenses rose 27% to nearly $6.93 million. Despite the widening loss, the company maintained a solid cash position of $7.67 million at period end, supported by a $2.2 million R&D tax incentive and ongoing capital discipline.
Commercial Milestones and Market Readiness
FY26 H1 was a pivotal period for Proteomics International, with multiple value-defining milestones achieved. The company successfully launched controlled market availability of its flagship diagnostic tests Promarker D (for diabetic kidney disease) and Promarker Eso (for esophageal adenocarcinoma) in Australia. These launches represent a critical step from clinical validation to commercial availability within a regulated laboratory framework.
Significantly, the US Centers for Medicare & Medicaid Services (CMS) established reimbursement pricing for Promarker D effective 1 January 2026, setting a US$391 price point. This reimbursement milestone is a key prerequisite for broader US adoption and enhances the company’s positioning with payers, clinicians, and potential distribution partners. Proteomics International also expanded its regulated laboratory capabilities, achieving ISO 15189 accreditation in Australia and CAP accreditation in the US, underpinning its multijurisdictional commercial platform.
Intellectual Property and Strategic Focus
The company strengthened its intellectual property portfolio during the period, securing new patents for Promarker Eso in the US and Canada. This expanded protection supports future commercialisation and partnering opportunities across major healthcare markets.
Strategically, Proteomics International refined its focus to prioritise near-term commercial execution, clinical validation, reimbursement progress, and capital discipline. This included suspending its Direct-to-Consumer (DTC) strategy in both the US and Australia to concentrate resources on established healthcare channels and partnerships.
Leadership and Outlook
Leadership changes marked the period, with David Morris appointed CEO and Managing Director in January 2026, succeeding Dr Richard Lipscombe who retired in February. The company also welcomed Ms Vicki Robinson as a new independent Non-Executive Director and increased director fees to reflect its evolving governance needs.
Looking ahead to the second half of FY26, Proteomics International aims to accelerate clinician adoption, advance US reimbursement and coverage activities, progress controlled market launches in the US, and complete validation for Promarker Endo (endometriosis). The company remains confident in the long-term commercial potential of its diagnostic portfolio, balancing growth ambitions with prudent capital and risk management.
Challenges and Considerations
Despite progress, the company acknowledges material uncertainty regarding its ability to continue as a going concern, dependent on successful capital raising and cost management. Commercial uptake remains at an early stage, and US payer coverage beyond CMS pricing is still subject to review, posing execution risks.
Bottom Line?
Proteomics International’s foundational progress sets the stage for growth, but funding and market adoption remain critical hurdles.
Questions in the middle?
- How quickly will US private insurers follow CMS in reimbursing Promarker D?
- What impact will the suspension of the DTC strategy have on revenue growth?
- Can the company secure distribution partnerships to scale US market penetration?