Nexalis Reports $350k Clinical Spend as Phase 1 and 2 Trials Progress

Phase 1 Trial Launch Marks Clinical Execution Milestone

Nexalis Therapeutics (ASX:NX1) has transitioned decisively from clinical preparation to active trial execution, highlighted by the initiation of dosing in its Phase 1 study of IRX-616a for panic disorder. This first-in-human, randomised, double-blind, placebo-controlled trial in healthy volunteers has progressed through its initial cohorts under independent Safety Review Committee oversight, with dosing now underway in the third cohort. The study aims to establish pharmacokinetics, safety, and tolerability, providing a foundation for future Phase 2 development in acute anxiety-related indications.

IRX-211 Phase 2 Program Expands Clinical Footprint

Meanwhile, the inhaled therapy IRX-211 for breakthrough cancer pain is advancing its Phase 2 program, with three clinical sites secured and recruitment activities ramping up. The lead site in Melbourne is joined by two additional Genesis Care sites in NSW, Victoria, and Western Australia, broadening the potential patient pool. Despite some delays caused by site resourcing constraints and recruitment lead times, the company is actively managing these challenges to maintain momentum. This program remains a key value driver, targeting a significant unmet need with a non-opioid rapid-onset therapeutic approach, as detailed in the recent Phase 2 IRX-211 trial.

SRX-25 Oral Therapy Progresses Intellectual Property Strategy

The SRX-25 program, an oral esketamine plus CYP450 inhibitor combination targeting treatment-resistant depression, has completed its Phase 1 clinical trial protocol and is advancing its intellectual property positioning with patent counsel. This asset aims to improve accessibility and patient adherence compared to existing therapies. The company plans to appoint a Contract Research Organisation in the September quarter to support the upcoming Phase 1 trial, marking a significant step in diversifying its pipeline beyond inhaled therapies.

Rebranding Reflects Strategic Evolution and Pipeline Diversification

Reflecting its broadened clinical focus, the company formally rebranded from InhaleRx Limited to Nexalis Therapeutics Ltd in February 2026, adopting the ticker NX1. This change underscores the addition of oral therapies alongside inhaled candidates, positioning the company as a diversified clinical-stage drug developer targeting both pain management and mental health indications. The rebrand aligns with the company’s goal of pursuing US FDA approval via efficient regulatory pathways and enhancing market awareness of its clinical and commercial potential.

Capital Raise Supports Fully Funded Clinical Development

Financially, Nexalis completed a $750,000 Placement in November 2025, issuing approximately 30 million shares at $0.025 each, with attaching options subject to shareholder approval. A subsequent Entitlement Offer raised $107,730 with the issuance of new shares and options, though a shortfall of shares and options remained unplaced by the March 2026 closing date. The company drew $281,000 under a $52.3 million funding facility from Linlithgow Family Office to cover clinical costs, maintaining a strong cash position of $511,000 at quarter-end. Operating expenses included $350,000 in clinical development costs and $114,000 in corporate overheads. Nexalis continues to emphasise disciplined capital allocation and efficient trial execution, supported by its substantial funding facilities, as highlighted in the recent $150k Placement and New Options update.

Governance and Cost Management

The company did not make cash payments to directors during the quarter, intending to satisfy current year entitlements via performance rights pending shareholder approval. Salaries paid to key management personnel totalled $19,000. The company’s approach to capital management and trial progression reflects a cautious balance between advancing clinical milestones and preserving shareholder value.