Actinogen Medical (ACW) FY Earnings Call Presentation

Xanamem Clinical Trial & Results - Xanamem demonstrated clinically and statistically significant benefits in depression symptoms in the XanaCIDD phase 2a trial, with a 2.7-point difference compared to placebo at the post-treatment follow-up (p < 0.05)[5] - Phase 2a data suggests a greater benefit on CDR-SB in high pTau181 patients, with a mean change from baseline of 0.6 units compared to placebo in a study of 34 participants (p = 0.09)[8] - Human PET study shows extensive binding of Xanamem to the 11β-HSD1 enzyme throughout the brain after 7 days of daily dosing at 5mg, 10mg and 20mg doses[10] XanaMIA Trial Design & Expectations - The XanaMIA trial is designed with 220 participants and includes an interim analysis at 24 weeks with N=100, with initial interim results expected in January 2026 and final results in Q4 2026[16] - The primary endpoint for the XanaMIA trial is CDR-SB (functional and cognitive measure) at 36 weeks, with key secondary endpoints including a cognitive test battery and the Amsterdam Activity of Daily Living[16] - The company hopes Xanamem will be better than anti-amyloid drugs on the primary endpoint of CDR-SB and other endpoints[21] Commercialization & Market Potential - The anti-depressant market is currently approximately $20 billion, with significant opportunities for novel mechanisms and better-tolerated drugs[34] - The Alzheimer's market is projected to reach $20 billion by 2030, presenting a major opportunity for a safe and effective oral agent like Xanamem[34] - US neurologists indicate that uptake of a safe and effective oral drug for Alzheimer's would be rapid, potentially positioning Xanamem as a first-line therapy[29]