Actinogen Medical (ACW) Q1 2026 TU earnings summary

Executive summary

• Accelerated enrolment in the pivotal XanaMIA phase 2b/3 Alzheimer's disease trial led to early closing of pTau screening and an updated timeline for topline results in mid Q4 2026, with interim analysis in January 2026.

• Successful FDA Type C meeting clarified the regulatory pathway for Xanamem, including agreement on trial design and requirements for NDA submission.

• Commercial formulation of Xanamem demonstrated consistent therapeutic levels, supporting dosing flexibility and ongoing clinical programs.

• Investor engagement enhanced with the launch of a new Investor Hub and increased presence at scientific and investor conferences.

Financial highlights

• Operating expenditure for the quarter was $6.1m, primarily due to increased clinical trial activity.

• Received $5.5m from the first tranche of the FY25 R&D tax incentive, with net proceeds of $2.4m after loan repayment.

• Quarter-end cash balance was $10.4m, with a proforma cash position of $12.4m including pending RDTI receivable.

• Cash runway extends to mid 2026.

Outlook and guidance

• Final topline results for the XanaMIA trial expected in mid Q4 2026, with full enrolment by end of 2025.

• Open-label extension trial for Xanamem in Alzheimer's to commence in Q1 2026.

• Additional RDTI funding of $1.9m anticipated in the current quarter.