InhaleRx Accelerates Inhaled Drug Trials with $38.5M Funding and Ethics Green Light
InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.
- Ethics approval granted swiftly for IRX-211 Phase 2 trial resubmission
- Manufacturing commenced for IRX-211 trial drugs and planning underway for IRX-616a Phase 1 trial
- First $248k drawdown from $38.5m Clendon funding facility executed
- Received $489k in Australian Government R&D incentives during the quarter
- Net cash inflow of $170k from operating activities with disciplined cost management
Clinical Progress and Regulatory Milestones
InhaleRx Limited (ASX – IRX), an Australian clinical-stage drug developer, has reported significant progress in its inhaled medicine programs targeting breakthrough cancer pain (BTcP) and panic disorder (PD). The company’s two lead candidates, IRX-211 and IRX-616a, are advancing through critical clinical and regulatory stages, with recent ethics approvals and manufacturing milestones positioning them well for upcoming trials.
During the June 2025 quarter, InhaleRx secured swift Human Research Ethics Committee (HREC) approval for the resubmission of its IRX-211 Phase 2 clinical trial, following adjustments to increase sample size and improve the likelihood of demonstrating efficacy. This approval came with minimal queries, underscoring the robustness of the trial design. Concurrently, manufacturing of the trial drugs for IRX-211 commenced as scheduled, with clinical site activation underway at the lead site in Melbourne and additional Australian sites being evaluated to accelerate patient recruitment.
Advancing IRX-616a and Operational Readiness
On the mental health front, InhaleRx executed a Letter of Intent with CMAX, a leading clinical site in Adelaide, to initiate clinical operations for the Phase 1 trial of IRX-616a, a novel inhaled treatment for panic disorder. Preparations for the HREC submission are in progress, with the company poised to respond rapidly to any queries to facilitate a First Patient In (FPI) event anticipated in the fourth quarter of 2025. Manufacturing refinement for IRX-616a’s trial drugs has been completed, clearing the way for investigational medicinal product production.
Financial Position and Capital Management
InhaleRx’s clinical development efforts are underpinned by a $38.5 million funding facility secured from Clendon Biotech Capital Pty Ltd in October 2024. The company executed its first drawdown of $248,000 during the quarter to cover manufacturing costs for IRX-211’s Phase 2 trial drugs, with further drawdowns expected to support ongoing development activities. This funding arrangement provides confidence that over 90% of forecast clinical development expenditure for the next two to three years is covered.
The company also benefited from $489,000 in Research & Development Tax Incentive (RDTI) receipts from the Australian Government, bolstering its cash position. Despite ongoing investment in clinical trials and corporate costs, InhaleRx reported a net cash inflow of $170,000 from operating activities for the quarter, reflecting disciplined expenditure management.
Strategic Outlook
InhaleRx remains focused on achieving New Drug Approvals (NDA) from the US Food & Drug Administration for both IRX-211 and IRX-616a. The company’s strategy leverages rapid and cost-effective regulatory pathways, such as the 505(b)(2) route, to bring innovative inhaled therapies to market addressing significant unmet needs in pain management and mental health. With no currently approved non-opioid inhaled treatments for breakthrough cancer pain and no FDA-approved options for panic disorder, InhaleRx’s programs target substantial market gaps.
Looking ahead, the company aims to activate clinical sites, complete trial drug manufacturing, and commence patient dosing in the coming quarters, setting the stage for pivotal data readouts that could validate these novel therapies.
Bottom Line?
InhaleRx’s clinical and financial momentum sets the stage for critical trial milestones that could reshape treatment options for pain and anxiety.
Questions in the middle?
- How quickly will patient recruitment progress across multiple clinical sites for IRX-211 Phase 2?
- What are the timelines and key hurdles anticipated before NDA submissions to the FDA?
- How will InhaleRx manage capital needs beyond the current Clendon funding facility as trials advance?
