• Phase 1 trial of IRX-616a for Panic Disorder commences with first patient dosed
• Safety Review Committee meeting scheduled for early April to assess dose escalation
• Trial on track to dose final participant before end of June 2026

Nexalis Therapeutics Ltd ('NX1' or the 'Company') has announced that dosing has commenced in its Phase 1 clinical trial of IRX-616a for the treatment of Panic Disorder ('PD'). PD is a debilitating anxiety condition characterized by recurrent, unexpected panic attacks and persistent concern about future episodes, often leading to significant functional impairment. The Phase 1 study (Protocol IRX616-003) is a first-in-human, randomised, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the pharmacokinetics ('PK'), safety and tolerability of IRX-616a in healthy adult volunteers. IRX-616a is a carefully designed drug-device inhalation aerosol delivered via a pressurised metered-dose inhaler, providing 2.5 mg of Cannabidiol ('CBD') per actuation. The inhalation route is intended to deliver rapid systemic absorption while bypassing first-pass hepatic metabolism, supporting a fast onset profile for acute indications. Up to 24 healthy participants will be enrolled across three sequential dose cohorts, with dose escalation overseen by an independent Safety Review Committee ('SRC'). A SRC meeting is planned for early April to review emerging safety data and assess the suitability of dose escalation for the second cohort. The Phase 1 trial remains on track to dose the final participant before the end of June 2026, after which the Company plans to initiate a Phase 2 study in the target patient population.

The overarching goal is to pursue U.S. FDA approval and registration using rapid and cost-effective regulatory pathways, such as 505(b)(2). Bringing new approved medications to market will address critical gaps whereby there's currently mismatched treatment options that can carry dependency concerns.