InhaleRx Limited has progressed its clinical trials for three drug candidates targeting cancer pain, panic disorder, and treatment-resistant depression, while securing additional funding and preparing for a company rebrand.
- Raised $857,730 through Placement and Entitlement Offer to fund operations
- Extended $12.6 million funding agreement to support SRX-25 through Phase 3 readiness
- IRX-211 Phase 2 trial delayed but site budget issues now resolved
- IRX-616a Phase 1 trial preparations underway with site activation planned for Q1
- Company to rebrand as Nexalis Therapeutics to reflect expanded oral drug focus
Clinical Progress and Funding Boost
InhaleRx Limited (ASX, IRX), an Australian drug development company, has reported steady progress across its pipeline of three clinical-stage drug candidates. These include IRX-211 for breakthrough cancer pain, IRX-616a for panic disorder, and SRX-25 targeting treatment-resistant depression. The company successfully raised a combined $857,730 through a Placement and Entitlement Offer to support ongoing operations and clinical development activities.
Additionally, InhaleRx extended its funding agreement with Linlithgow Family Office Pty Ltd by $12.6 million, earmarked to cover the clinical development costs of SRX-25 through to Phase 3 readiness. This extension brings the total committed funding under the facility to approximately $52.3 million, providing a solid financial runway for the company’s near-term milestones.
Clinical Trial Developments and Delays
The IRX-211 Phase 2 trial, which targets a significant unmet need for non-opioid inhaled treatments for breakthrough cancer pain, has faced delays in patient screening due to protracted site budget negotiations. These issues, largely outside the company’s direct control, have now been resolved with the lead site Vitalis, and agreements with other clinical sites are expected to be finalised shortly. Manufacturing of trial drugs is complete, and site personnel have been trained, positioning the trial to commence patient dosing soon.
Meanwhile, preparations for the IRX-616a Phase 1 trial, focused on inhaled treatment for panic disorder, are advancing well. The company has executed clinical trial agreements with CMAX in Adelaide, completed drug manufacturing, and plans to initiate patient screening and dosing in the first quarter of 2026. This trial will assess safety, tolerability, and pharmacokinetics in healthy volunteers, setting the stage for a Phase 2 trial.
New Oral Asset and Strategic Rebranding
InhaleRx has added a new oral drug candidate, SRX-25, designed to overcome limitations in current treatment-resistant depression therapies by enabling oral administration of esketamine with enhanced bioavailability. The company is progressing the Phase 1 protocol and investigator’s brochure, aiming to commence clinical trials shortly. This asset broadens the company’s therapeutic scope beyond inhaled medicines.
Reflecting this strategic shift, InhaleRx plans to rebrand as Nexalis Therapeutics Limited, subject to shareholder approval at an upcoming general meeting. The rebrand aligns with the company’s expanded focus on both inhaled and oral drug development, signalling a new chapter in its evolution.
Financial and Operational Discipline
During the December quarter, InhaleRx reported a net cash outflow of $628,000, with $485,000 spent on clinical development. The company continues to manage operational costs prudently while advancing multiple clinical programs. No cash payments were made to directors during the quarter, with entitlements paid in performance rights, underscoring a disciplined capital management approach.
Looking ahead, the company is focused on activating clinical sites, accelerating patient recruitment, and advancing its regulatory strategy to secure FDA New Drug Approvals for its pipeline. A town hall meeting is scheduled for February 12 to update stakeholders on progress.
Bottom Line?
With funding secured and clinical milestones approaching, InhaleRx’s transformation into Nexalis Therapeutics marks a pivotal step towards delivering innovative treatments to market.
Questions in the middle?
- How quickly will patient recruitment accelerate now that site budget issues are resolved?
- What are the key regulatory hurdles anticipated for the SRX-25 oral formulation?
- How will the rebranding impact investor perception and market positioning?