Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Corporate Update (May 2026)
13 slides from Avecho Biotechnology's corporate update, May 25, 2026
Slide 1: Phase III Interim Analysis webinar presentation
ASX Announcement 25 May 2026 Phase III Interim Analysis webinar presentation Melbourne, Australia, 25 May 2026: Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or “the Company”) is pleased to provide the attached presentation for its investor webinar regarding the upcoming Phase III interim analys
Slide 2: About Insomnia and Avecho's Phase III Trial Program
About Insomnia Insomnia is a sleep disorder defined as dissatisfaction with sleep quantity or quality associated with difficulty initiating sleep, difficulty maintaining sleep and the inability to return to sleep on awakening. It can manifest as a primary indication or be symptom of other disorders,
Slide 3: Forward-looking statements disclaimer
adequate or that they will be achieved or prove to be correct. Except for any statutory liability which cannot be excluded, Avecho and its respective officers, employees and advisers expressly disclaim any responsibility for the accuracy or completeness of the forward-looking statements and exclude
Slide 4: Shareholder Update: Path to the Phase III Interim Analysis Result
For personal use only Shareholder Update Path to the Phase III Interim Analysis Result Dr Paul Gavin | Chief Executive Officer www.avecho.com.au | ASX:AVE
Slide 5: The Trial: Phase III design
THE TRIAL Phase III design — what we're testing For personal use only 244 participants randomised for the interim cohort Insomnia — what we're treating Difficulty falling or staying asleep 3 arms 75mg CBD | 150mg CBD | placebo Affects ~10-30% of Australians No approved OTC pharmaceutical product cur
Slide 6: Understanding the Readout: What the interim analysis is
UNDERSTANDING THE READOUT What the interim analysis is For personal use only 1 2 3 What gets tested Who decides What we'll learn The DMB will recommend one of three outcomes: The interim analysis examines whether the CBD An independent Data Monitoring Board reviews 1) Positive - Continue the trial w
Slide 7: Process to Readout
PROCESS TO READOUT From recruitment closed to interim result For personal use only 4 5 ★ 2 March 2026 May 2026 May 2026 June 2026 Late June 2026 Late June 2026 Dosing complete Database locked, Recruitment DMB conducts DMB delivers Avecho announces (244 patients, statistical analysis closed data revi
Slide 8: Trial Design: Why this trial is positioned to deliver a clinical signal
TRIAL DESIGN Why this trial is positioned to deliver a clinical signal For personal use only Three key design features have been built into this trial specifically to maximise the probability of a successful result 01 02 03 Two independent primary endpoints Adaptive design interim analysis Placebo-e
Slide 9: What Happens After the Readout
WHAT HAPPENS AFTER THE READOUT Three possible outcomes For personal use only Stop for futility -- negative Trial continues -- positive Stop for efficacy -- positive The drug is not showing the Base case positive outcome — this Upside scenario — not expected, but required effect is what we are aiming
Slide 10: Base Case in Detail: Continuing the trial
BASE CASE IN DETAIL Continuing the trial — how we fund it, how we execute For personal use only The base case requires ~300 additional patients. The two questions shareholders will ask: how much, and how long? How we fund it How we accelerate What runs in parallel ● Priority: pharmaceutical licensin
Slide 11: Assuming Success: Next months milestones and triggers
ASSUMING SUCCESS Next 12 months — milestones and triggers For personal use only Now → Late June 2026 H2 2026 2027 Trial completion and submission Interim analysis readout Post-readout activation readiness ● Dosing complete; database locked ● Pursue further licensing deals ● Complete Phase III dosing
Slide 12: Closing Argument: Every part of our thesis validated
CLOSING ARGUMENT Every part of our thesis has been independently validated For personal use only For years we have claimed big things for this product. At each step, an external body has validated those predictions. One piece of validation remains. Preclinical US Patent Office TGA Sandoz Market Inte
Slide 13: Questions Welcome
Questions Welcome For personal use only Dr Paul Gavin Melbourne Office Chief Executive Officer Unit A8, 2A Westall Road T. +61 3 9002 5000 Hallmarc Business Park E. pgavin@avecho.com.au Clayton VIC 3168 Australia T: +61 3 9002 5000 E: info@avecho.com.au