Actinogen Medical advances pivotal XanaMIA trial towards November readout - ICYMI

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) earlier this week reported continued progress across its clinical, regulatory and financial programs during the June quarter, with the pivotal XanaMIA Alzheimer’s disease trial remaining on schedule to deliver topline results in November 2026.

Managing Director and CEO Dr Stephen Gourlay said the upcoming readout represented “a potentially transformational event for the company and for the clinical science, and for patients with Alzheimer’s all around the world”.

The fully enrolled Phase 2b/3 study continued treatment, follow-up and data-cleaning activities across participating sites. An independent Data Monitoring Committee also completed its third review of safety data from all 247 participants and recommended that the trial continue without amendment.

The November readout remains the company’s most significant near-term catalyst. Positive results could provide important clinical validation for Xanamem as a once-daily oral treatment for mild to moderate Alzheimer’s disease and support further regulatory and commercial activity.

Actinogen Medical also reported strong participation in the XanaMIA open-label extension. Around 88% of eligible patients completing the randomised study elected to continue immediately into the extension, with 81 patients receiving Xanamem 10 milligrams once daily for up to 25 months.

Gourlay said the extension would provide longer-term safety information and observational data across measures including cognition, activities of daily living and the Clinical Dementia Rating Scale–Sum of Boxes. The company expects these findings to contribute to future regulatory marketing applications.

Chief Financial Officer Will Souter said Actinogen Medical ended the quarter with $16.7 million in cash, providing funding beyond the XanaMIA results and into mid-2027.

Souter said the stated cash runway did not include other potential sources of capital, including an anticipated research and development tax rebate and proceeds that could arise from the exercise of listed and unlisted options.

Additional potential catalysts include further patent approvals, continuing discussions with the US Food and Drug Administration and the European Medicines Agency, and follow-up data from the open-label extension.

The company also strengthened the broader clinical case for Xanamem during the quarter through the publication of positive depression trial data in the British Journal of Psychiatry. Gourlay said the findings showed that Xanamem 10 milligrams was active in the brain and reduced depression symptoms, providing validation of the molecule and its cortisol-control mechanism.

Gourlay said drug development was “not a short journey”, but added that the program could represent significant potential value for patients, families and investors.

Interview highlights

• Actinogen Medical’s fully enrolled Phase 2b/3 XanaMIA trial remains on schedule to report topline results in November 2026.
• The pivotal study is assessing Xanamem as a once-daily oral treatment for patients with mild to moderate Alzheimer’s disease.
• An independent Data Monitoring Committee completed its third safety review of all 247 participants and recommended that the study continue without amendment.
• Actinogen Medical ended the June quarter with $16.7 million in cash, providing funding beyond the XanaMIA readout and into mid-2027.
• Potential additional funding sources include a research and development tax rebate expected around October or November and proceeds from the possible exercise of listed and unlisted options.
• Around 88% of eligible participants completing the randomised XanaMIA trial elected to enter the open-label extension immediately.
• The open-label extension has enrolled 81 patients, who receive Xanamem 10 milligrams once daily for up to 25 months.
• The extension is intended to collect longer-term safety and observational data covering cognition, activities of daily living and the Clinical Dementia Rating Scale–Sum of Boxes.
• Actinogen Medical expects data from the extension to contribute to future regulatory marketing applications.
• Positive depression trial results were published in the British Journal of Psychiatry, providing further clinical validation of Xanamem and its cortisol-control mechanism.
• The company is continuing to pursue additional patent protection and engage with regulators including the US Food and Drug Administration and the European Medicines Agency.
• The November 2026 XanaMIA readout represents the company’s most significant near-term potential catalyst.

Proactive: Actinogen Medical, a biotechnology company developing a novel therapy for neurological diseases, has released its June quarterly report. Joining us to discuss the highlights are Managing Director and CEO Dr Steven Gourlay and Chief Financial Officer Will Souter. Good morning, gentlemen.

Dr Steven Gourlay: Good morning, Jonathan.

Proactive: Steven, can you give us a quick overview of Actinogen Medical before we discuss the quarterly report?

Dr Steven Gourlay: Actinogen Medical is focused on completing its first pivotal trial in patients with mild to moderate Alzheimer’s disease. We expect topline results from that trial in November 2026.

The company has also been developing Xanamem as a potential treatment for depression. Actinogen Medical is a drug development company based in Sydney, with operations in Australia and the United States.

Proactive: The trials are progressing well, which was central to the June quarter. What were the main highlights?

Dr Steven Gourlay: There were three particularly important highlights, as well as several other achievements.

Most importantly, the pivotal clinical trial of our once-daily oral treatment remains on track to report results in November. This is a potentially transformational event for the company, the clinical science and patients with Alzheimer’s disease around the world.

Secondly, the company is well funded, with more than three quarters of available cash runway extending into the middle of 2027. That is important as we approach the pivotal trial results.

Thirdly, positive depression trial data were published in the peer-reviewed British Journal of Psychiatry. The results showed that Xanamem 10 milligrams was active in the brain and reduced symptoms of depression. This provided important validation for the molecule and its cortisol-control mechanism.

Proactive: Will, can you explain the company’s financial position?

Will Souter: At the end of June, Actinogen Medical had just under $17 million in cash, which is a strong position given how close the trial results are.

Based on the current expenditure rate, the company is funded into mid-2027. Importantly, that does not include other potential sources of capital.

Most of the company’s expenditure continues to relate to research and development activities, particularly the clinical trial. Actinogen Medical is therefore expected to be eligible for another substantial research and development tax rebate, which we anticipate receiving around October or November.

The company also has listed and unlisted options. The unlisted options expire in September and are currently in the money, so some may also be exercised.

Actinogen Medical is therefore entering the results period with cash on hand and a clean balance sheet.

Proactive: Steven, where is the company directing its expenditure?

Dr Steven Gourlay: Actinogen Medical is working to finalise data cleaning for the pivotal clinical trial. Expenditure on the trial will reduce significantly after the results are reported in November.

At the same time, the company has offered participation in an open-label extension to all patients who completed the randomised trial. Patients who previously received either Xanamem or placebo can now receive active Xanamem treatment for up to approximately two years.

The company is also continuing to pursue patent applications around the world to update and extend its intellectual property protection. Several new patents were approved during the quarter, and further national approvals are expected.

Actinogen Medical will also continue working with regulators, including the US Food and Drug Administration and the European Medicines Agency, as it advances the program towards the earliest possible approval.

Proactive: What is your final message for investors?

Dr Steven Gourlay: Actinogen Medical is undertaking important work. The company is testing a promising once-daily therapy for Alzheimer’s disease that has the potential to be safe, effective and transformational for patients and their families.

The November results could represent an important milestone for patients and a transformational opportunity for investors.

Drug development is not a short journey, but it is an important one. We thank shareholders and supporters for their continued support.

Proactive: Stephen and Will, thank you for your time. We look forward to speaking again as developments unfold.

Dr Steven Gourlay: Thanks, Jonathan.

Will Souter: Thank you.