Can Actinogen’s Xanamem Transform Alzheimer’s Treatment? Interim Trial Data Due Jan 2026
Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.
- FY25 net loss of $14.7 million, a 13% increase from prior year
- XanaMIA Phase 2b/3 Alzheimer’s trial over 50% enrolled, interim analysis due January 2026
- Positive Phase 2a XanaCIDD depression trial results reinforce Xanamem’s clinical activity
- Secured $11.1 million capital raise, $9 million R&D tax rebate, and $13.8 million non-dilutive funding
- Commercial readiness advanced with CCO appointment and manufacturing scale-up
Financial Performance and Funding
Actinogen Medical Limited (ASX, ACW) has released its financial results for the year ended 30 June 2025, reporting a net loss after tax of $14.7 million, a 13% increase compared to the previous year. Despite the widening loss, the company strengthened its cash position to $16.5 million, supported by a successful $11.1 million capital raising, a $9 million research and development (R&D) tax incentive rebate, and a $13.8 million non-dilutive R&D funding facility. These financial resources provide a runway extending into mid to late 2026, underpinning ongoing clinical development and corporate activities.
Clinical Progress, Alzheimer’s and Depression Trials
Actinogen’s lead compound, Xanamem (emestedastat), is a novel oral therapy targeting brain cortisol dysregulation, a mechanism implicated in Alzheimer’s disease (AD) and major depressive disorder (MDD). The pivotal XanaMIA Phase 2b/3 trial for AD has surpassed the halfway mark in patient enrollment, with over 50% of the planned 220 participants recruited across 35 sites in Australia and the United States. This trial focuses on patients with mild to moderate AD confirmed by elevated blood pTau181 biomarker levels, aiming to assess Xanamem’s ability to slow disease progression over a 36-week treatment period. An interim analysis by an independent data monitoring committee is scheduled for January 2026, with final topline results anticipated in the fourth quarter of 2026.
Complementing this, the XanaCIDD Phase 2a trial in treatment-resistant depression demonstrated clinically meaningful improvements in depressive symptoms, particularly when Xanamem was used alongside selective serotonin reuptake inhibitors (SSRIs). These findings bolster confidence in Xanamem’s mechanism of action and support its ongoing development in neuropsychiatric indications.
Commercialization and Manufacturing Readiness
In preparation for eventual market entry, Actinogen appointed Andrew Udell as Chief Commercial Officer in October 2024, bringing extensive experience in biotech commercialization. The company has also scaled up manufacturing capabilities, successfully producing a 15-kilogram batch of Xanamem active pharmaceutical ingredient (API) through its contract manufacturer Asymchem in China, with tablet formulation planned in the United States by Catalent. This scale-up is a critical step toward regulatory approval and commercial supply readiness.
Regulatory and Intellectual Property Landscape
Actinogen continues to engage proactively with regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to define efficient pathways for Xanamem’s approval in AD and MDD. The company secured a unique International Nonproprietary Name (INN), emestedastat, recognizing Xanamem as the first-in-class inhibitor of the 11β-HSD1 enzyme. Its intellectual property portfolio remains robust, with patents protecting the molecule’s chemistry, manufacturing processes, and therapeutic applications extending into the mid-2030s.
Governance and Leadership
The company’s leadership team, led by CEO Dr Steven Gourlay, has been instrumental in advancing clinical programs and commercial planning. The Board, chaired by Dr Geoffrey Brooke, maintains strong governance oversight, with all directors actively engaged in strategic decision-making. Remuneration disclosures indicate a balanced approach to incentivizing key management personnel through a mix of fixed salary, short-term cash bonuses tied to performance, and long-term incentives via loan shares and options.
Outlook
Looking ahead, Actinogen is focused on achieving key clinical milestones, notably the XanaMIA interim analysis in January 2026, which will be pivotal in validating Xanamem’s therapeutic potential. The company is also advancing commercialization readiness and exploring strategic partnerships to support global development and market access. While challenges remain inherent in drug development and regulatory approval, Actinogen’s progress positions it well within the competitive landscape of neurodegenerative and neuropsychiatric therapeutics.
Bottom Line?
With pivotal trial milestones approaching and commercial preparations underway, Actinogen Medical stands at a critical juncture that could redefine treatment options for Alzheimer’s and depression.
Questions in the middle?
- Will the XanaMIA interim analysis confirm Xanamem’s efficacy and safety to justify accelerated approval?
- How will Actinogen navigate regulatory pathways in the US and Europe for both Alzheimer’s and depression indications?
- What strategic partnerships or collaborations might Actinogen secure to support late-stage development and commercialization?
