Actinogen Medical (ACW) H2 2025 earnings summary

Executive summary

• Advanced Xanamem through pivotal phase 2b/3 Alzheimer's trial, surpassing 100 participants, with interim analysis set for January 2026 and final results expected late 2026.

• Positive phase 2a results in major depressive disorder (MDD) support Xanamem's efficacy, especially as add-on to SSRI therapy.

• Secured $11.1m capital raise, $9.0m R&D tax rebate, and established a $13.8m non-dilutive funding facility, ensuring funding through mid-late 2026.

• Appointed inaugural Chief Commercial Officer and scaled up manufacturing to 15kg API batch for commercial readiness.

• Engaged with FDA and EMA to define regulatory pathways for Alzheimer's and MDD indications.

Financial highlights

• Revenue and other income for FY2025: $6.17m, primarily from R&D tax rebate and interest.

• Net loss after tax: $(14.73)m for FY2025, compared to $(13.04)m in FY2024.

• Cash and cash equivalents at 30 June 2025: $16.5m.

• Total equity: $18.3m as of 30 June 2025.

• No dividends declared or paid.

Outlook and guidance

• Interim analysis of pivotal Alzheimer's trial in January 2026; final results expected late 2026.

• Continued focus on commercial readiness, regulatory engagement, and potential partnerships.

• Confident in funding runway to late 2026 and ability to raise further capital if needed.