Actinogen Medical (ACW) H2 2026 earnings summary

Executive summary

• Pivotal Alzheimer's disease trial on track for topline results in November 2026 after three positive DMC reviews, including a non-futility efficacy review in January.

• Open-label extension phase of the XanaMIA trial began in March 2026, with 89% of participants transitioning and 108 currently on treatment.

• Achieved alignment with FDA and EMA on streamlined regulatory pathways, with a further pivotal trial planned for 2027.

• Peer-reviewed depression trial manuscript published, showing positive anti-depressant activity.

• Strengthened IP protection with new patents for Xanamem and completed additional manufacturing for ongoing trials.

Financial highlights

• Net loss after tax for FY2026 was $15.38 million, compared to $14.73 million in FY2025.

• Research and development costs were $19.03 million, up from $12.30 million in FY2025, mainly due to clinical trials.

• Cash and cash equivalents at 30 June 2026 totaled $16.73 million, slightly up from $16.50 million a year earlier.

• Received a $7.3 million R&D tax incentive rebate for FY2025 and accrued $10.82 million for FY2026, expected in Q2 FY2027.

Outlook and guidance

• Top priorities for FY2027: complete XanaMIA trial and deliver final data, prepare for next regulatory and clinical phases, and pursue strategic partnerships.

• Xanamem positioned as a potential breakthrough therapy for Alzheimer's, depression, and other neurodegenerative diseases.