• Major clinical milestone achieved with first patient screened in Phase 2 trial of IRX-211 for Breakthrough Cancer Pain
• Large and growing market opportunity, with the global cancer pain market estimated at ~US$11bn by 2028
• Phase 2 trial is a multicentre, randomised, double-blind, placebo-controlled cross-over study with dose titration

Nexalis Therapeutics Ltd (ASX: NX1) has announced a key clinical milestone with the first patient screened in the Company's Phase 2 clinical trial evaluating IRX-211 for the treatment of Breakthrough Cancer Pain (BTcP). This milestone represents the transition of IRX-211 into controlled clinical evaluation in its intended patient population, marking a significant advancement in the development program. The Phase 2 study is a multicentre, randomised, double-blind, placebo-controlled, cross-over trial with an initial open-label titration phase in adult cancer patients experiencing BTcP despite stable background opioid therapy. The study plans to enrol approximately 156 patients, from multiple sites with at least 78 of those achieving an effective dose in Part A proceeding to complete the randomised cross-over phase in Part B. The completed Phase 1 program in healthy volunteers demonstrated an excellent safety profile, rapid systemic exposure and consistent pharmacokinetics, supporting further clinical development. BTcP represents a high-burden and inadequately addressed condition within oncology supportive care, as BTcP episodes are rapid in onset, often escalating within minutes, while many currently available opioid treatments have delayed onset, creating a meaningful treatment gap. The global cancer pain market is projected to grow at a CAGR of 6.4% from USD 8.87b in 2026 to USD 12.91b in 2032. IRX-211 is designed as a proprietary inhaled therapy to deliver rapid, predictable and patient-controlled relief, aligning with the clinical needs of BTcP patients.

Nexalis Therapeutics CEO, Darryl Davies, said 'Screening the first patient in our Phase 2 study represents a significant milestone for Nexalis and the IRX-211 program, and importantly marks the beginning of generating efficacy data in patients with Breakthrough Cancer Pain. BTcP remains poorly served by existing therapies, particularly given the rapid onset of pain episodes and limitations of current opioid options. IRX-211 has been specifically designed to address this gap through fast-acting, patient-controlled delivery. We believe this study provides a strong foundation for demonstrating clinical benefit, while positioning the program for future development and potential partnering opportunities'.