Key Highlights

• Actinogen Medical Limited (ASX:ACW) has confirmed that the final participant visit in its pivotal XanaMIA Alzheimer's disease trial took place in the United States on 22 September 2026, completing all patient visits in the study.

• The ASX-listed biotech said topline results from the phase 2b/3 trial of its oral drug candidate Xanamem remain on track for release in November this year.

• The milestone marks the end of the randomised, double-blind treatment phase for the 247 participants enrolled across Australia and the US.

• With patient visits complete, the company's focus now shifts to finalising the trial data ahead of the November readout, a date that Actinogen has consistently pointed to since enrolment closed late last year.

Actinogen Medical Limited (ASX:ACW) has confirmed that the final participant visit in its pivotal XanaMIA Alzheimer's disease trial took place in the United States on 22 September 2026, completing all patient visits in the study. The ASX-listed biotech said topline results from the phase 2b/3 trial of its oral drug candidate Xanamem remain on track for release in November this year.

The milestone marks the end of the randomised, double-blind treatment phase for the 247 participants enrolled across Australia and the US. With patient visits complete, the company's focus now shifts to finalising the trial data ahead of the November readout, a date that Actinogen has consistently pointed to since enrolment closed late last year.

What was announced

In its September 2026 update, Actinogen said the final trial participant visit took place "yesterday in the USA", allowing it to confirm the November timeline for topline results. The company said the trial has now completed all patient visits, with 45% of participants enrolled in Australia and 55% in the US.

XanaMIA is designed as a randomised (1:1), double-blind, placebo-controlled pivotal trial comparing Xanamem 10mg with placebo over 36 weeks. After the randomised phase, all participants may enrol in an open-label extension in which they receive Xanamem 10mg.

How Xanamem works

Xanamem, also known as emestedastat, is an oral, once-daily enzyme inhibitor. According to Actinogen, it is designed to control elevated levels of cortisol, the so-called stress hormone, inside the brain by inhibiting the enzyme 11β-HSD1, without affecting cortisol production by the adrenal glands.

The company's thesis is that chronically elevated brain cortisol is associated with the onset and progression of Alzheimer's disease. Actinogen says it has studied Xanamem in more than 500 volunteers and patients across eight Clinical Trials and describes its safety profile as promising. It also reports that a human PET imaging study showed high levels of target engagement in the brain at doses as low as 5mg daily.

More broadly, Actinogen describes itself as developing therapies for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol, and says it may study Fragile X syndrome and other conditions in the future. Xanamem remains an investigational product and is not approved by the US Food and Drug Administration or any other regulator outside clinical trials.

The trial design in detail

A key feature of XanaMIA is how patients were selected. Participants were required to have elevated levels of pTau181, a protein biomarker, measured with a clinically validated blood test rather than more complex methods such as amyloid brain scans or cerebrospinal fluid testing.

Actinogen said elevated pTau181 selects for patients with a more progressive disease course. The company argues this increases the trial's power to detect a treatment effect over 36 weeks and replicates the diagnostic profile of the earlier phase 2a population, in which it says a large treatment benefit for Xanamem was seen.

The primary endpoint is the CDR-SB, or Clinical Dementia Rating scale Sum of Boxes, a widely used measure of dementia severity. The company says the trial has passed an independent Data Monitoring Committee safety and efficacy futility review.

The key numbers

According to the announcement, enrolled participants have baseline characteristics similar to those reported in other trials of mild to moderate Alzheimer's disease:

• Average age of 75 years

• 49% female

• 66% ApoE4 carriers, the main genetic risk Factor for Alzheimer's

• Mean pTau181 of 2.6 pg/mL

• Mean CDR-SB score of 4.3 points

When final enrolment was announced in December 2025, the company said the 247 participants exceeded its original target of 220.

What management said

Actinogen chief medical officer Dr Dana Hilt said: "Xanamem is a unique oral therapy with the potential to become a transformational treatment option for patients and their families living with Alzheimer's disease."

He added: "Our key focus is to finalise high-quality data from the XanaMIA pivotal trial for release in November while planning streamlined pathways to the fastest possible regulatory approvals for Xanamem."

Those comments reflect management's view of Xanamem's potential. Whether the drug shows a benefit in XanaMIA will not be known until the results are released and analysed.

Why it matters

For Actinogen, XanaMIA is the most important clinical readout in the company's pipeline, and completing the last patient visit removes one source of timing risk ahead of results. Alzheimer's disease remains an area of large unmet need, and an oral, once-daily treatment would be different from the infusion-based antibody therapies that have reached the market in recent years.

The company also runs an open-label extension, XanaMIA-OLE, which began in March 2026 and offers up to 25 months of Xanamem 10mg treatment to former and current XanaMIA participants. That study evaluates safety and a limited number of efficacy measures.

Actinogen has also tested Xanamem outside Alzheimer's. Its XanaCIDD phase 2a trial in 167 patients with moderate, treatment-resistant depression, reported in August 2024, showed what the company described as clinically and statistically significant benefits on depression symptoms, although cognition improved to a similar extent in both the Xanamem and placebo groups.

Risks and what comes next

The next major event is the November 2026 topline readout. Between now and then, the company says its key focus is finalising high-quality data from the trial.

Clinical trials carry binary risk. A phase 2b/3 study can miss its primary endpoint even when earlier trials appear encouraging, and Alzheimer's disease has a long history of late-stage failures across the industry. Even with positive results, regulatory approval is not assured and would require further engagement with agencies such as the FDA.

Actinogen's own disclaimer notes that forward-looking statements are subject to clinical, regulatory, Business and competitive uncertainties, and that actual outcomes may differ materially. Investors watching ASX shares in the biotech sector should treat the November timeline and management's comments on regulatory pathways as forward-looking.

The bottom line

Actinogen has reached the last operational milestone of XanaMIA's randomised phase, with all 247 participants having completed their visits and topline results reaffirmed for November 2026. The readout will be the key test of the company's brain cortisol hypothesis in Alzheimer's disease.