InhaleRx’s Loss Widens to $854K as Phase 2 Trial for IRX211 Grows
InhaleRx Limited reported a widening half-year loss as it accelerates clinical trials for inhaled drug-device therapies, supported by a substantial $38.5 million funding facility.
- Half-year loss increased to $854,332
- Secured $38.5 million funding facility from Clendon Biotech Capital
- Expanded Phase 2 trial for IRX211 Breakthrough Cancer Pain treatment
- Phase 1 trial preparations underway for IRX616a Panic Disorder treatment
- No dividends declared; net liability position persists
Financial Performance and Funding
InhaleRx Limited has reported a loss of $854,332 for the half-year ending 30 June 2025, marking an increase from the $737,576 loss recorded in the same period last year. Despite the widening deficit, the company has secured a significant $38.5 million funding facility from Clendon Biotech Capital, earmarked exclusively for clinical trial costs through to the completion of Phase 2 trials. This financial backing is critical as InhaleRx continues to develop its inhaled drug-device combinations targeting pain and anxiety relief.
Clinical Trial Progress
Central to InhaleRx’s pipeline is IRX211, a treatment for Breakthrough Cancer Pain (BTcP). The company received Human Research Ethics Committee approval for an expanded Phase 2 trial design, increasing participant numbers from 60 to 156, with a target of 78 completions. This expansion aims to enhance the statistical power of the trial, potentially accelerating regulatory approval and market entry. Manufacturing of trial drugs is underway, with patient recruitment expected to commence by the end of September 2025.
In parallel, InhaleRx is advancing IRX616a, a drug-device combination for Panic Disorder. The company has appointed a clinical site in Adelaide and lodged an ethics submission for its Phase 1 trial. Manufacturing specifications for the trial drug have been completed, with production set to begin following ethics approval.
Operational and Strategic Developments
Expenditure on product development surged to over $1 million in the half-year, reflecting intensified R&D efforts compared to $186,363 in the prior period. The company also received $489,526 in Research & Development tax incentives, supporting its innovation activities. Intellectual property remains a focus, with an innovation patent approved and provisional patents lodged during the period. InhaleRx is exploring novel IP opportunities arising from unique properties observed in its IRX211 formulation.
Despite a net liability position of $877,114 and current liabilities exceeding current assets, the board remains confident in the company’s ability to continue as a going concern. This confidence is underpinned by the secured funding facility, positive cash flow forecasts, and the ability to defer non-essential expenditures if necessary. The company is also planning additional capital raises to support working capital needs.
Governance and Outlook
The half-year report was reviewed without qualification by auditors RSM Australia Partners, who noted a material uncertainty regarding going concern but did not modify their conclusion. The board, led by Chairman Sean Williams, continues to oversee the company’s strategic direction as it navigates the critical clinical development phase. Investors will be watching closely for clinical trial milestones and capital raising updates that will shape InhaleRx’s path forward.
Bottom Line?
InhaleRx’s next chapters hinge on clinical trial progress and successful capital management amid ongoing losses.
Questions in the middle?
- Will the expanded IRX211 trial achieve the statistical significance needed to expedite approval?
- How soon can InhaleRx secure additional capital beyond the Clendon facility to sustain operations?
- What novel intellectual property developments might emerge from the unique IRX211 formulation?
