Actinogen Medical (ACW) Q3 2026 TU earnings summary

Executive summary

• Achieved a major milestone with a positive interim analysis for the pivotal XanaMIA phase 2b/3 Alzheimer's trial; DMC recommended continuation without amendment, with topline results expected in November 2026.

• Commenced open-label extension (OLE) phase for XanaMIA, with 88% of eligible participants enrolling for extended Xanamem therapy.

• Advanced commercial planning, regulatory engagement, and partnering discussions, including FDA and EMA interactions.

Financial highlights

• Completed a $16.8 million capital raise in February 2026, including a $12 million placement and $4.8 million SPP at 4.2 cents per share.

• Received $1.9 million RDTI rebate in February, totaling $7.3 million for FY2025.

• Secured $4.3 million in non-dilutive funding from Endpoints Capital, backed by the FY26 RDTI rebate.

• Operating expenditure for the March quarter was $7.4 million, mainly for clinical trials.

• Ended the quarter with $21.5 million in cash, extending runway beyond expected XanaMIA results.

Outlook and guidance

• Topline results for the pivotal XanaMIA trial expected in November 2026; planning underway for a second, larger pivotal trial to start mid-2027, subject to funding.

• Exploring accelerated approval pathways with regulators, including the FDA's new policy on single pivotal trials.

• EMA scientific advice on Xanamem development expected in Q2 2026.