Actinogen Medical (ACW) Bioshares Annual Conference Q&A Presentation summary

Clinical development and scientific rationale

• Xanamem is an oral, brain-penetrant 11β-HSD1 inhibitor targeting cortisol to slow Alzheimer's progression and treat depression.

• Clinical benefit demonstrated in depression (n=165) and pilot Alzheimer's data (n=34), with strong scientific rationale for cortisol modulation.

• Human PET studies confirm high brain target engagement at all tested doses, supporting pharmacodynamic activity.

• Unique mechanism allows regional brain cortisol control without affecting adrenal cortisol regulation.

• Over 400 people treated with excellent safety and low drug interaction risk.

Clinical trial results and design

• Phase 2a depression trial showed statistically significant benefits on the MADRS scale, supporting efficacy.

• Phase 2a Alzheimer's trial in high pTau181 patients showed greater benefit on CDR-SB than anti-amyloid antibodies, with a mean difference of 0.6 units.

• XanaMIA pivotal trial in mild-moderate Alzheimer's: 220 participants, double-blind, 36-week treatment, interim analysis at 24 weeks.

• Key inclusion: blood pTau biomarker positive, primary endpoint is CDR-SB, with secondary cognitive and functional measures.

• Interim results expected January 2026, final results Q4 2026, with enrollment at 35 sites across Australia and the US.

Competitive landscape and commercial potential

• Anti-amyloid drugs provide only modest slowing of Alzheimer's; Xanamem aims for better risk-benefit and disease stabilization.

• Xanamem could outperform anti-amyloids on CDR-SB and other endpoints, potentially halting disease progression.

• No serious adverse events reported in over 400 patients; safety profile is a key differentiator.

• US neurologists show strong interest in a safe, effective oral drug; Xanamem could become first-line therapy and is combinable with other treatments.

• Commercial and partnership planning is underway, with the potential for global partnership bids and accelerated regulatory approvals.