Actinogen Medical (ACW) H1 2026 earnings summary

Executive summary

• Focused on late-stage clinical development of Xanamem for Alzheimer's disease, with accelerated enrolment and positive interim safety/efficacy analysis in the pivotal XanaMIA phase 2b/3 trial.

• Achieved regulatory milestones, including FDA agreement on a streamlined approval pathway and commercial readiness activities.

• Received $7.4 million in R&D tax incentive rebates, supporting non-dilutive funding for ongoing trials.

• Engaged in active investor and industry outreach, including major scientific conferences and the launch of an InvestorHub platform.

Financial highlights

• Revenue and other income for the half year ended 31 December 2025: $2.1 million, primarily from R&D tax rebates and interest.

• Net loss after tax: $11.3 million, compared to $8.2 million loss in the prior year period.

• Loss per share: 0.36 cents, up from 0.28 cents year-over-year.

• Cash and cash equivalents at 31 December 2025: $6.5 million, down from $16.5 million at 30 June 2025.

• Net assets: $8.4 million at period end.

Outlook and guidance

• Confident in prospects for FY2026 and beyond, with topline results from the XanaMIA trial expected in November 2026.

• Planning for a second pivotal AD trial to commence in 2027, with ongoing regulatory engagement in the US and Europe.

• Exploring accelerated approval pathways with the FDA, leveraging recent policy changes.