Actinogen Medical (ACW) investor relations material

Interim Analysis and Clinical Progress

• Independent Data Monitoring Committee recommended continuation of the pivotal XanaMIA trial after clearing pre-specified safety and efficacy/futility hurdles, with no serious adverse events attributed to the drug and a strong safety profile in over 500 patients, many treated for 36 weeks.

• The trial is fully enrolled with 247 patients focusing on mild to moderate Alzheimer's disease, and is on track for top-line results in November 2026.

• Open-label extension will offer all trial participants continued access to Xanamem, providing longer-term safety and efficacy data, with initiation planned for Q1 2026.

• Xanamem demonstrated robust target engagement in the brain and positive effects in both Alzheimer's and treatment-resistant depression in prior studies.

Regulatory and Development Pathway

• Agreement reached with the FDA on the pivotal trial design and next steps, requiring one additional phase III study at the 10 mg dose.

• EMA meeting planned for 2026 to align on the European regulatory pathway, with potential for expedited approval if results are strong.

• The trial uses robust clinical endpoints, including the CDR Sum of Boxes and activities of daily living, to measure both cognitive and functional outcomes.

• Xanamem is positioned as a first-in-class oral inhibitor of brain 11-beta-HSD1, targeting cortisol as a novel mechanism in Alzheimer's disease.

Strategic Positioning and Market Opportunity

• Xanamem’s mechanism addresses elevated brain cortisol, a key risk factor in Alzheimer’s progression, and has shown superior early efficacy compared to leading antibody therapies.

• The drug’s oral, once-daily administration and favorable safety profile are expected to drive patient and clinician preference.

• Market research with U.S. neurologists indicated strong anticipated uptake, with 80% likely to prescribe within six months of launch.

• Multiple potential commercialization partners are reviewing data, with regional and global deals under consideration.

• Large and growing Alzheimer's market in the US, with significant unmet need and potential for Xanamem to outperform current therapies on key endpoints.