Actinogen Medical (ACW) H2 2025 earnings summary

Executive summary

• Advanced pivotal phase 2b/3 trial for Xanamem in Alzheimer's disease, surpassing 100 participants, with interim analysis set for January 2026 and final results in 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 in capital raising, $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 to drive commercialization strategy and expanded manufacturing capacity for future commercial supply.

Financial highlights

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

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

• Cash and cash equivalents at year-end: $16.5m.

• Total equity: $18.3m; contributed equity increased to $115.7m.

• No dividends declared or paid.

Outlook and guidance

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

• Continued focus on regulatory engagement with FDA and EMA for Alzheimer's and MDD programs.

• Commercial readiness activities underway, including market research and advisory board engagement.

• Funding secured to support operations through mid-late 2026, with additional non-dilutive funding options available.