Actinogen Medical (ACW) Corporate Presentation summary

Clinical development and regulatory progress

• Xanamem is advancing through a pivotal phase 2b/3 trial for Alzheimer's, with FDA agreement on a streamlined approval pathway requiring one additional pivotal trial and open-label safety studies.

• Interim analysis of safety and efficacy is scheduled for January 2026, with final results expected in late 2026.

• The trial targets biomarker-positive, mild-to-moderate Alzheimer's patients, with CDR-SB as the primary endpoint and cognitive/functional secondary endpoints.

• Positive phase 2a results in depression support further development, and peer-reviewed publication is pending.

• Commercial and partnership planning is underway, with funding secured through at least mid-2026.

Product profile and scientific rationale

• Xanamem is a first-in-class, oral, brain-penetrant 11β-HSD1 inhibitor that controls brain cortisol, a proposed pathogenic mechanism in Alzheimer's and depression.

• Demonstrated full brain target engagement in PET studies and a strong safety profile with over 400 patients treated and no related serious adverse events.

• Differentiated from antibody drugs by oral administration, suitability for general practice, and no need for invasive monitoring.

• Patent protection extends to 2036-2044, with data exclusivity for 5-10 years post-approval.

• Manufacturing is scaled and patented, with tablets produced in the US.

Market opportunity and physician insights

• The US Alzheimer's market is large and growing, with 7.2 million patients in 2025 and costs projected to reach $1 trillion by 2050.

• 91% of neurologists see a high unmet need for disease-modifying therapies (DMTs) for early Alzheimer's, and 86% expect treatment approaches to change as new DMTs launch.

• Over half of current Alzheimer's patients fall within Xanamem's addressable market, with strong physician interest in its oral administration, safety, and novel mechanism.

• Current anti-amyloid therapies offer only modest benefit and face barriers such as cost, logistics, and monitoring requirements.

• Combination therapies are likely needed for meaningful impact, and Xanamem's mechanism aligns with this trend.