Actinogen Medical (ACW) H2 2024 earnings summary

Executive summary

• Achieved positive phase 2a results for Xanamem in depression, confirming clinical activity and validating its brain cortisol control mechanism; no significant cognitive benefit over placebo observed in the same trial.

• Commenced phase 2b Alzheimer's disease trial (XanaMIA) with 220 patients, focusing on biomarker-positive participants; interim results expected mid-2025, final results in 2026.

• Secured $18.9 million in capital raisings and received a $4.8 million R&D tax incentive rebate, funding operations to late CY2025.

• Received UK MHRA Innovation Passport for Xanamem in Alzheimer's, enhancing regulatory and market positioning.

Financial highlights

• Total revenue and other income for FY2024: $10.2 million, up from $5.3 million in FY2023, primarily due to R&D tax rebates.

• Net loss after tax: $13.0 million (FY2023: $10.8 million), reflecting increased R&D and employment costs.

• Cash and cash equivalents at 30 June 2024: $9.5 million (FY2023: $8.5 million).

• No dividends declared or paid.

Outlook and guidance

• Focus in FY2025 on advancing phase 2b Alzheimer's trial and planning for phase 2b depression trial, with regulatory engagement ongoing.

• Additional $9.0 million R&D tax incentive expected in Q4 CY2024; company funded to late CY2025.

• Anticipates further peer-reviewed publications, regulatory updates, and interim clinical data in 2025.