Actinogen Medical has secured approximately $17.0 million through a placement and share purchase plan following positive interim analysis results from its XanaMIA Alzheimer’s disease trial. The biotech firm received firm commitments for a $12.0 million placement at $0.042 per share, with an additional $5.0 million SPP offering eligible shareholders the opportunity to participate on identical terms. The funding extends the company’s cash runway beyond the trial’s final topline results expected in November 2026.
The placement will issue approximately 285.7 million new shares, representing roughly 9% of current shares on issue. CEO Dr Steven Gourlay personally subscribed for $500,000 in the placement, with other directors contributing $167,000 in aggregate, subject to shareholder approval at an extraordinary general meeting expected in March 2026. This Actinogen XanaMIA Trial Funding announcement follows the positive recommendation from an independent Data Monitoring Committee (DMC) that reviewed unblinded safety and efficacy data.
CEO Commentary
“Together with the positive interim analysis recommendation from the independent Data Monitoring Committee as announced on 30 January 2026, the placement represents a material de-risking event for ACW’s XanaMIA phase 2b/3 AD trial, which is progressing towards completion and final topline results in November 2026,” said Dr Steven Gourlay, Managing Director and CEO.
| Capital Structure Detail | Number of Shares |
|---|---|
| Existing shares on issue | 3,191,745,696 |
| New shares from placement (including director participation) | 285,714,286 |
| Maximum new shares from SPP (approximately) | 119,047,619 |
| Total shares post-raise (assuming full SPP subscription) | 3,596,507,601 |
The offer price of $0.042 represents a 6.7% discount to the last traded price of $0.045 on Wednesday, 28 January 2026, and a 13.5% discount to the five-day VWAP of $0.049. New shares will rank equally with existing shares on issue, with Canaccord Genuity (Australia) Limited acting as Lead Manager.
What the positive interim analysis means for investors
The independent DMC reviewed unblinded safety and efficacy futility data and recommended the XanaMIA trial continue without amendment to its final conclusion. This recommendation confirms the trial has cleared a critical pre-specified efficacy futility hurdle, materially increasing the probability of positive final results.
The DMC, chaired by Alzheimer’s disease trials expert Dr Hans Moebius, confidentially reviewed data from all 247 enrolled participants. The efficacy assessment included approximately 37% of the total expected trial dataset, covering Week 12 data (n=136), Week 24 data (n=87), and Week 36 data (n=52). The safety review encompassed all enrolled participants.
Key takeaways from the interim analysis:
- Efficacy futility hurdle cleared: The trial demonstrated sufficient efficacy signal to justify continuation, reducing the binary risk of trial failure
- Safety profile maintained: Unblinded safety data across all participants revealed no concerning signals that would warrant trial modification
- Material de-risking achieved: The positive outcome significantly improves the probability of successful final topline results in November 2026
The trial remains on track for final results following the completion of the 36-week treatment period and four-week follow-up phase in October 2026.
Understanding efficacy futility in clinical trials
Efficacy futility analyses serve as pre-planned checkpoints in clinical trials, allowing independent experts to review unblinded data to determine whether continuing the trial is scientifically justified. These analyses are designed to stop trials early if they demonstrate no reasonable chance of achieving their primary endpoint, protecting both patient welfare and shareholder capital.
An independent Data Monitoring Committee conducts these reviews with access to both safety data and treatment group assignments (the “unblinded” data that remains hidden from trial investigators and sponsors). The committee applies statistical criteria to assess whether the emerging data suggests the trial is likely to succeed or fail.
A recommendation to continue without amendment indicates the data does not suggest the trial is destined to fail. This represents a meaningful positive signal for Actinogen investors awaiting final results, as many biotech trials are terminated at futility checkpoints when interim data reveals insufficient efficacy.
For Actinogen shareholders, the successful passage of this efficacy futility analysis materially reduces the risk profile heading into the November 2026 final readout. The company has now demonstrated both a promising safety profile across approximately 500 patients studied to date and sufficient efficacy signal to justify completing the pivotal trial.
Director participation signals insider conviction
CEO Dr Steven Gourlay’s $500,000 personal investment in the Actinogen XanaMIA Trial Funding placement demonstrates significant insider confidence in the trial’s trajectory. Together with other directors’ $167,000 aggregate participation, total director participation reaches approximately $667,000, all on identical terms to institutional investors.
Director participation requires shareholder approval under ASX Listing Rule 10.11, which the company will seek at an extraordinary general meeting expected to be held in March 2026. The company will issue a Notice of Meeting with further details in due course. Directors may also participate in the SPP in their capacity as eligible shareholders.
The placement attracted several high-quality institutional investors alongside existing shareholders, with new shares to be issued under the company’s Listing Rule 7.1 capacity (excluding director participation). This combination of insider buying and institutional support reflects growing confidence in Xanamem’s commercial potential following the positive interim analysis outcome.
Share Purchase Plan offers retail participation
Eligible shareholders with registered addresses in Australia, New Zealand, and (under limited circumstances by invitation only) the United States can participate in the SPP on the same terms as the institutional placement. The SPP record date is 7:00pm AEDT, 30 January 2026.
Key SPP details:
- Opens: 10 February 2026
- Closes: 5:00pm AEDT, 24 February 2026
- Maximum participation: $30,000 per eligible shareholder
- Issue price: $0.042 per share (same as placement)
- No brokerage or transaction costs
The SPP provides retail shareholders with the opportunity to increase their holdings without incurring brokerage fees. Actinogen reserves the right to increase the size of the SPP, scale back applications, accept oversubscriptions, or close the SPP early in its absolute discretion. Further information, including details on how eligible shareholders may participate, will be provided in an SPP booklet.
Results of the SPP will be announced on Friday, 27 February 2026, with new shares issued on Monday, 2 March 2026 and expected to commence trading on Tuesday, 3 March 2026.
Use of funds and pathway to November catalyst
Proceeds from the Actinogen XanaMIA Trial Funding will be deployed across four key areas, with the majority allocated to completing the pivotal XanaMIA Phase 2b/3 Alzheimer’s trial. The company has provided detailed guidance on fund allocation and confirms the raise extends its cash runway beyond the critical November 2026 topline results milestone.
| Sources and Uses of Funds | Amount ($m) |
|---|---|
| Sources of Funds | |
| Placement and SPP | 17.0 |
| Uses of Funds | |
| XanaMIA Phase 2b/3 Alzheimer’s trial completion | 9.6 |
| XanaMIA open-label extension | 3.4 |
| Other R&D and manufacturing | 0.9 |
| Working capital and offer costs | 3.1 |
| Total | 17.0 |
Combined with additional funding secured through R&D tax incentives and R&D loan proceeds (as announced on 27 January 2026), the placement provides a pro forma cash balance of $29.7 million as at 31 December 2025. This positions Actinogen with clear visibility on funding through the pivotal topline results announcement and removes near-term financing risk.
The XanaMIA open-label extension phase will commence in Q1 2026, offering all current and prior XanaMIA phase 2b/3 trial participants active Xanamem 10 mg treatment for up to 25 months. This extension provides valuable longer-term safety data and observational efficacy endpoints, with the ability to report results at regular intervals (approximately every six months).
Key milestones ahead
Actinogen faces multiple near-term catalysts ahead of the pivotal November 2026 final topline results, providing ongoing newsflow and validation opportunities:
- Q1 2026: XanaMIA open-label extension commences
- Q1 2026: ADPD Alzheimer’s conference presentation (Copenhagen)
- Q2 2026: EMA Scientific Advice meeting for Alzheimer’s disease
- Q2 2026: BIO conference participation (San Diego)
- Q3 2026: AAIC Alzheimer’s conference presentation (London)
- October 2026: Last patient completes 36-week treatment and four-week follow-up
- November 2026: Final topline results announcement
- November 2026: XanaMIA topline results presentation at key Alzheimer’s scientific meeting
Management has indicated that partnership discussions with global biopharma companies are ongoing, with the potential for regional deals if terms prove favourable. The company plans to immediately proceed to the next pivotal phase 3 Alzheimer’s trial following positive results, leveraging the streamlined FDA pathway agreed in recent discussions.
The investment case for Actinogen heading into results
The Actinogen XanaMIA Trial Funding announcement represents a material de-risking event combining both clinical and financial validation. The company has secured funding through its most significant value inflection point while simultaneously clearing a critical efficacy futility hurdle that materially increases the probability of trial success.
Xanamem’s differentiated mechanism targets elevated brain cortisol through inhibition of the 11β-HSD1 enzyme, offering a once-daily oral pill approach that contrasts favourably with currently approved anti-amyloid therapies. The recently approved anti-amyloid treatments (such as Leqembi and Kisunla) require intravenous or subcutaneous administration, infusion centre visits, and ongoing MRI monitoring for potential brain swelling and bleeding. Xanamem’s oral delivery and promising safety profile across approximately 500 patients studied to date positions it as a potentially more accessible treatment option.
The Alzheimer’s disease market represents a significant commercial opportunity. In the United States alone, the number of patients aged 65 and older is projected to grow from 13.8 million in 2025 to over 20 million by 2060. Treatment costs in the US are expected to exceed $1 trillion by 2050, reflecting both increasing patient numbers and the substantial economic burden of the disease.
Actinogen has secured FDA agreement on a streamlined approval pathway requiring one additional pivotal trial of 10 mg versus placebo following XanaMIA results. The company expects to engage with the European Medicines Agency in Q2 2026 for Scientific Advice on the Alzheimer’s programme. This regulatory clarity, combined with positive interim analysis results, positions Actinogen favourably heading into the November 2026 final readout.
Management’s confidence is reflected in both the successful institutional placement and significant director participation led by CEO Dr Steven Gourlay’s $500,000 investment. If final results demonstrate meaningful slowing of Alzheimer’s disease progression, the company could attract substantial partnering interest from global pharmaceutical companies seeking to address the massive unmet need in this indication.
The pro forma cash position of $29.7 million (following the raise and including R&D incentives and loan proceeds) provides Actinogen with financial stability through the critical results readout, eliminating the risk of a poorly timed capital raise that could dilute shareholders ahead of key value inflection.
Want more Biotech breakthroughs delivered to your inbox?
Actinogen’s successful capital raise and positive interim analysis represent exactly the type of clinical and financial validation that can reshape biotech valuations. Investors who track these developments early often gain significant advantages over those who discover breakthrough stories after major catalysts materialise. For readers following the Alzheimer’s disease space or broader biotech sector developments, staying ahead of breaking news has become essential.
Over 20,000 investors already receive FREE breaking news alerts and comprehensive analysis through the Big News Blast service, covering non-resource ASX sectors including Biotech, Healthcare, Technology, Finance, and Industrials. These alerts provide detailed context on capital raises, clinical trial updates, regulatory milestones, and partnership announcements—the catalysts that drive significant price movements. Simply click the “Free Alerts” button in the menu to join subscribers who receive these insights directly to their inbox, ensuring critical developments never slip past unnoticed.