InhaleRx Limited (ASX: IRX) Reports Quarterly Activities and Updates
Operational Highlights
InhaleRx Limited (ASX: IRX) reported cash reserves of $194,000 as of December 31, 2024. The company utilised $97,000 in net cash for operating activities during the quarter. Notably, InhaleRx signed a $38.5 million funding agreement with Clendon Biotech Capital to cover the clinical trial costs for its drug candidates, IRX-211 and IRX-616a.
The company received approval from the Human Research Ethics Committee to commence a Phase 2 trial for IRX-211, aimed at treating breakthrough cancer pain (BTcP). The appointment of Ingenu CRO Pty Ltd as the contract research organisation for overseeing upcoming clinical trials has also been confirmed. Additionally, the completion of the Phase 1 clinical trial for IRX-211 was marked by the finalisation of the Clinical Study Report.
Funding Developments
The funding agreement with Clendon Biotech Capital fully supports the clinical and non-clinical work leading to Phase 2 trials. The agreement allows for gradual funding drawdown and establishes options for Clendon, which could significantly impact repaying associated loan amounts upon successful completion of the clinical programs.
Drug Development Updates
InhaleRx’s primary focus for the quarter included updating the IRX-211 trial design to potentially increase the sample size to 156 participants. This step reflects commitment to obtaining statistically significant results suitable for pivotal data submission to the FDA.
Moreover, the company filed an international patent application under the Patent Cooperation Treaty for IRX-211, aimed at expanding its competitive edge in securing global market rights and protecting its innovations against replication by competitors.
Future Outlook
Looking ahead, InhaleRx is committed to delivering outcomes in a cost-effective manner while optimizing regulatory pathways for NDA submissions to the FDA. Essential next steps include finalising agreements with the CRO, advancing manufacturing specifications, and preparing for clinical trial batch production for impending studies.
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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