Actinogen Medical (ACW) Q1 2025 TU earnings summary

Executive summary

• XanaMIA phase 2b/3 Alzheimer's trial is ramping up recruitment, with 25 patients randomized and more US sites to be activated by year-end; interim analysis expected mid-2025, final results mid-2026.

• XanaCIDD phase 2a depression trial showed clinically meaningful and persistent improvement in depression, supporting Xanamem's brain cortisol control mechanism and 10mg dose selection.

• Company is exploring larger MDD trials and engaging with regulators, thought leaders, and potential partners.

• Appointment of Andy Udell as Chief Commercial Officer to support late-stage clinical development and commercial readiness.

Financial highlights

• R&D expenditure for the quarter was $2.29m, moderating as XanaMIA site activation and recruitment continued and XanaCIDD completed.

• Net operating cash outflows for the quarter were $3.58m.

• Cash received from capital raising (net of costs) was $6.6m; $1.1m received from option conversions.

• Cash balance at 30 September 2024 was approximately $13.6m.

Outlook and guidance

• Additional $1.13m from director subscriptions and $3.0m from SPP pending shareholder approval; $9.0m R&D tax incentive expected in December quarter.

• Estimated funding runway extends to mid-late CY2026 with current and anticipated funds.

• Interim results for XanaMIA expected mid-2025; final results mid-2026.