• First Data Monitoring Committee meeting approved continuation of XanaMIA phase 2b/3 trial without amendment
• Efficacy of Xanamem was not evaluated at this meeting
• Next DMC meeting in late January 2026 will evaluate safety and efficacy futility

Actinogen Medical Limited (ASX: ACW) announced the positive outcome of the first meeting of its XanaMIA phase 2b/3 trial's independent Data Monitoring Committee (DMC). The DMC, comprising independent clinical and statistical experts, reviewed all available safety data from 153 XanaMIA trial participants and concluded that the trial should continue without amendment. The efficacy of Xanamem was not evaluated at this meeting. In late January 2026, the DMC will meet again to evaluate both safety and efficacy futility in a highly confidential process, using 'unblinded' data for safety and efficacy futility from all available participant visits, including many who will have already completed the 36-week treatment period. The XanaMIA phase 2b/3 Alzheimer's disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate Alzheimer's disease and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 protein biomarker in blood. Patients receive Xanamem 10 mg or placebo, once daily, and its ability to slow progression of Alzheimer's disease is assessed with a variety of endpoints, with the primary endpoint being the internationally-recognized CDR-SB (Clinical Dementia Rating scale - Sum of Boxes).