InhaleRx reported a half-year loss of $854,000 for the six months to June 30, 2025, widening its loss by 15.8% compared to the previous corresponding period.
The firm said its focus for 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”.
Expenditure on these programs totalled $1million for the half-year, up from $186,000 in 2024. The company received $490,000 in research & development tax incentive payments related to FY23 and FY24.
It ended the reporting period with cash and cash equivalents of $481,000 up from $333,000 at the end of June 2024.
During the half year, InhaleRx received Human Research Ethics Committee (HREC) approval for an updated trial design for a planned phase II clinical trial of its inhaled synthetic THC formulation IRX211 for breakthrough cancer pain.
The updated design expanded the trial to 156 participants, with a target of 78 to complete (versus the previous design of 60 participants, with a target of 24 to complete).
The firm said the move would increase the chances of the trial achieving statistical significance, “potentially reducing the amount of future clinical trial requirements and expediting the path to market”.
Manufacturing of the trial drugs has commenced and patient recruitment planning is underway.
The company also entered into a study order with its contract research organisation partner in relation to a planned phase I clinical trial of its synthetic CBD treatment for panic disorder, IRX616a.
A clinical site, CMAX in Adelaide, was appointed as the trial site during the half year and an HREC submission has been lodged.
Manufacturing specification of the trial drug was completed earlier in the year, with production to commence as soon as HREC approval is received.
In October 2024, InhaleRx entered into a $38.5m funding facility with Clendon Biotech Capital to fully cover the clinical trial costs for IRX-211 and IRX-616a through to the completion of phase II.
The company drew down $248,000 during the half year to cover 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.