Nexalis Therapeutics Limited · ASX:NX1
Nexalis Therapeutics — InhaleRx — Corporate Update (July 2025)
20 slides from Nexalis Therapeutics's corporate update, Jul 23, 2025
Slide 1: Developing Tomorrow's Inhaled Therapies
Town Hall Meeting 23 July 2025 DEVELOPING TOMORROW’S INHALED THERAPIES
Slide 2: Disclaimer
InhaleRx Ltd 23 July 2025 DISCLAIMER This presentation contains summary information about InhaleRx Limited (“InhaleRx” or “IRX” or “Company”) and its activities current as at the date of this presentation. It should be read in conjunction with InhaleRx’ other periodic and continuous disclosure annou
Slide 3: About InhaleRx
3 InhaleRx Ltd 23 July 2025 ABOUT INHALERX InhaleRx Limited (ASX: IRX) is a clinical stage biotechnology development company focused on developing innovative inhaled therapeutics to address unmet medical needs in pain management and mental health treatment. Two drug/device candidates IP Portfolio in
Slide 4: Developing IRX-211 as a Therapeutic Agent
4 InhaleRx Ltd 23 July 2025 DEVELOPING IRX-211 AS A THERAPEUTIC AGENT IRX-211 will be a registered prescription-only medication to treat Breakthrough Cancer Pain (BTcP). Ph1 1 clinical trial complete, very promising insights and no SAE’s. HREC resubmission approved, and manufacturing has commenced a
Slide 5: Planning to Commence IRX-211
InhaleRx Ltd 23 July 2025 PLANNING TO COMMENCE IRX-211 MILESTONE COMPLETE EXPECTED (QUARTER) Funding Secured Recut of trial design Tender Commenced Spec Work Commenced Component Sourcing HREC Approval for Ph2 trial Additional Sites Secured Protocol Amendment with HREC MRL to the FDA with updated que
Slide 6: Developing IRX-616a as a Therapeutic Agent
6 InhaleRx Ltd 23 July 2025 DEVELOPING IRX-616a AS A THERAPEUTIC AGENT IRX-616a will be a registered prescription-only medication to treat Panic Disorder. Ph1 HREC submission, once complete, this trial will be quickly followed by a Ph2 to demonstrate tolerability, safety and efficacy in the patient
Slide 7: Planning to Commence IRX-616a
InhaleRx Ltd 23 July 2025 PLANNING TO COMMENCE IRX-616a MILESTONE COMPLETE EXPECTED (QUARTER) Funding Secured Medical writing complete Tender Commenced Spec Work Commenced Component Sourcing Tender complete Protocol Development HREC Application Sent To Site HREC Approval Q3 Batch Manufacturing (Pilo
Slide 8: Corporate Structure
8 InhaleRx Ltd 23 July 2025 CORPORATE STRUCTURE
Slide 9: Highlights & Summary
9 InhaleRx Ltd 23 July 2025 HIGHLIGHTS & SUMMARY Funding Partnership the company has fully funded clinical development program with access to $38.5m in funding to accelerate the execution of the trials. Forward Funding in Progress the company is currently working with R&D advisors and forward fundin
Slide 10: Thank You
THANK YOU Please contact me at: Darryl Davies darryl.davies@inhalerx.com.au
Slide 11: IRX-211 Clinical Trial Update
IRX-211 Clinical Trial Update Inhaled Cannabinoid Therapy for Breakthrough Cancer Pain (BTcP)
Slide 12: A Novel, Inhaled Approach to BTcP Relief
A Novel, Inhaled Approach to BTcP Relief IRX-211: Inhaled cannabinoid Developed for opioid-tolerant Designed for rapid relief delivered via handheld device cancer patients during BTcP episodes Incorporates dose personalisation and intra- Now entering multi-site clinical evaluation patient control
Slide 13: Multi-Stage, Intra-Subject Controlled Study
Multi-Stage, Intra-Subject Controlled Study Trial Framework • Observational baseline period • Part A: Dose refinement via titration • Part B: Randomised, double-blind treatment phase (active/placebo) • Each patient acts as their own comparator • Designed in collaboration with experienced BTcP clinic
Slide 14: Understanding Each Patient's BTcP Profile
Understanding Each Patient's BTcP Profile Extended baseline monitoring Captures real-world episode Used to: prior to investigational dosing patterns, response to SOC • Characterise BTcP dynamics per No study drug administered patient • Confirm eligibility and BTcP episode reproducibility • Stabilise
Slide 15: Individualised Dose Identification
Individualised Dose Identification Part A – Dose Refinement Criteria: • Sequential titration across multiple BTcP episodes • Meaningful pain relief within a short time window • Investigator-guided escalation of IRX-211 • Absence of dose-limiting side effects • Goal: Identify lowest effective and tol
Slide 16: Blinded, Crossover Assessment
Blinded, Crossover Assessment Part B – Randomised Treatment Phase Patients receive a sequence of 10 blinded doses • 7 IRX-211 active doses • 3 placebo doses Delivered during actual BTcP episodes Randomised within subject; treatment unknown to both patient and clinician Allows for intra-person compar
Slide 17: Controlling for Inter-Patient Variability
Controlling for Inter-Patient Variability Intra-Patient Comparator Design • Each patient serves as their own control • Minimises confounding from pain tolerance, metabolism, disease stage • Enhances signal detection with fewer subjects • Supports high-precision exposure–response modeling
Slide 18: Global Investigator Engagement
Global Investigator Engagement 1 2 3 Active interest from oncology Study shaped by input from Sites selected for experience in and palliative care units in: senior pain medicine and managing complex cancer pain oncology advisors cohorts • Australia: VIC, NSW, QLD • Southeast Asia: Singapore, Malaysi
Slide 19: A Field with Fewer and Fewer Options
A Field with Fewer and Fewer Options Addressing the Global BTcP Gap • Transmucosal fentanyls (TIRFs) increasingly delisted worldwide • IV opioids impractical for outpatient management IRX-211 offers a fast, non-invasive, non-opioid alternative with titratable delivery • Oral opioids too slow for tru
Slide 20: IRX-211: Targeted, Rapid, Individualised Relief
IRX-211: Targeted, Rapid, Individualised Relief Closing Remarks 1 Fills a growing void in BTcP treatment 2 Aligned with modern cancer pain management priorities 3 Designed with flexibility, control, and patient 4 Supported by experienced investigators across usability in mind key regions