Key Highlights

  • The last patient visit in the pivotal XanaMIA phase 2b/3 Alzheimer’s trial was completed in late September, with topline final results on track for November.
  • There are 160 patients on treatment in the open-label extension, with 87% of main trial participants choosing to continue.
  • Cash was $15.9 million at 30 September 2026, with about $6 million of expected R&D tax rebate proceeds taking the pro-forma balance to about $21.9 million.
  • New patents were granted covering Xanamem treatment in cognitively normal people in Australia and Israel and manufacturing in China and Chile.

Actinogen Medical Limited (ASX:ACW) released its quarterly activity report and Appendix 4C for the three months ended 30 September 2026 on 19 October 2026. The report covered the XanaMIA Alzheimer’s disease trial, its open-label extension, patents, partnering activity and funding.

XanaMIA trial status

The pivotal XanaMIA phase 2b/3 trial continued with treatment and follow-up proceeding at participating sites until the last patient visit was completed in late September. The trial remains on track to deliver topline final results in November 2026. Ahead of that, the company is finalising trial data and planning streamlined pathways to regulatory approval. If the topline results are positive, Actinogen said it will move into the final pivotal trial of Xanamem in Alzheimer’s disease, most likely in partnership with one or more development partners. The outcome of the trial is not yet known.

Open-label extension

The open-label extension (OLE) lets current and former participants who completed the randomised phase receive active Xanamem 10 mg once daily for up to 25 months, with no placebo group. There are now 160 patients on treatment, and 87% of participants completing the main trial have rolled over. The OLE is designed to gather extended safety data and observational information on endpoints including CDR-SB, cognition and activities of daily living. Available OLE data will be reviewed with the topline results in November.

Partnering, science and patents

During the quarter Actinogen presented a Xanamem poster and hosted an exhibit at the Alzheimer’s Association International Conference, held a Clinical Trials Science Forum webinar in August, and had a manuscript on cortisol and 11β-HSD1 inhibition in Alzheimer’s disease and major depressive disorder accepted for online pre-publication. It continued discussions with potential global and regional commercialisation partners. First grants were received for patents covering Xanamem treatment of cognitively normal people in Australia and Israel, and manufacturing in China and Chile, expiring in 2040 and 2041 respectively.

Cash and funding

The exercise and underwriting of unlisted options in September provided $5.3 million. Appendix 4C shows net operating cash outflow of $6,206,000, financing inflow of $5,336,000 and closing cash of $15,865,000, with estimated funding of 2.56 quarters at the current rate of outflow. Actinogen said the pro-forma balance of about $21.9 million, including about $6 million of net R&D tax rebate proceeds, provides runway beyond the XanaMIA results to late CY2027 or into CY2028, assuming any new trials are substantially funded through partnerships. Up to $22.5 million may be received from exercise of listed options expiring on 31 May 2027 and 30 September 2027.