InhaleRx recorded a half-year net loss of $854,000 for the six months ending June 30, 2025, a 15.8% increase on its loss from the same period the year before.
The company said its efforts during the reporting period "continued to be on developing its unique inhaled medicinal drug-device products to address unmet medical needs in the pain management and mental health sectors".
Spending across those programs reached $1 million for the half-year, a sharp rise from $186,000 in the prior corresponding period. The company also received $490,000 in research and development tax incentive payments tied to FY23 and FY24.
Cash and cash equivalents at the close of the period stood at $481,000, up from $333,000 at the end of June 2024.
Over the half-year, InhaleRx secured Human Research Ethics Committee (HREC) approval for a revised trial design for its planned phase II clinical study of inhaled synthetic THC formulation IRX211, targeting breakthrough cancer pain.
The revised design expanded the trial to 156 participants with a completion target of 78, compared to the previous design of 60 participants with a completion target of 24.
The company said the expanded scope would improve the likelihood of the trial reaching statistical significance, "potentially reducing the amount of future clinical trial requirements and expediting the path to market".
Production of the trial drugs has begun and planning for patient recruitment is now underway.
InhaleRx also executed a study order with its contract research organisation partner for a planned phase I clinical trial of IRX616a, its synthetic CBD treatment for panic disorder.
The Adelaide-based clinical site CMAX was appointed to host the trial during the half-year, and an HREC submission has been lodged.
Manufacturing specifications for the trial drug were finalised earlier in the year, with production set to begin once HREC approval is granted.
In October 2024, InhaleRx entered into a $38.5m funding facility with Clendon Biotech Capital designed to cover the full clinical trial costs for both IRX-211 and IRX-616a through to the end of phase II.
During the half-year, the company drew down $248,000 from that facility to fund manufacturing requirements for the IRX-211 trial drugs.
UPDATE (August 28, 2025): InhaleRx has now received HREC approval to commence the first-in-human phase I clinical trial of IRX-616a.
