ACW secures funding beyond XanaMIA AD trial final results
Released
Released
Announcement PDF
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
1
ASX ANNOUNCEMENT
Actinogen secures funding beyond XanaMIA Alzheimer’s disease trial topline final
results in November followingpositiveinterim analysis outcome - share placement and
share purchase plan to raise up to approximately $17.0 million
Highlights:
• Following the release of the positive result of its XanaMIA Alzheimer’s trial Interim Analysis on
Friday, Actinogen has received firm commitments for a non-underwritten share placement of
approximately 285.7 million shares to raise approximately $12.0 million1 (before costs) at an issue
price of $0.042 per share
• CEO, Dr Steven Gourlay, subscribed for $500,000 in the placement, while other directors
subscribed for $167,000 in aggregate. All Director participation in the placement is subject to
shareholder approval at an Extraordinary General Meeting (EGM) to be advised
• Funds raised will be used to complete the XanaMIA pivotal trial in Alzheimer’s disease, implement
the open-label extension phase of the XanaMIA trial and for general corporate purposes
• The Company also intends to undertake a non-underwritten share purchase plan (SPP) offer to
eligible shareholders to raise up to an additional $5.0 million (before costs) with the ability to accept
oversubscriptions, subject to ASX Listing Rules.
Sydney, 2 February 2026. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce it has received firm commitments for a share placement to sophisticated and professional investors
and Directors to raise approximately $12.0 million (before costs) through the issue of approximately 285.7
million new fully paid ordinary shares in the Company, at an issue price of $0.042 per share. The issue of the
new shares (excluding Director participation) will be under the Company’s Listing Rule 7.1 capacity.
Proceeds from the placement (including Director participation, which is subject to shareholder approval for
Director participation) will be used to complete the XanaMIA pivotal trial in Alzheimer’s disease, implement the
open-label extension phase of the XanaMIA trial, and for general corporate purposes.
Actinogen's Managing Director and CEO, Dr Steven Gourlay, commented:
“We are delighted with the continued support of existing shareholders and welcome new investors to our
register through the placement, including several high-quality institutional investors.”
“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.”
“We are pleased to offer eligible retail shareholders the opportunity to participate in a share purchase plan on
the same terms as the placement, up to $30,000 per eligible shareholder.”
1
Unless stated otherwise, all financial data is in Australian dollars
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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Webinar today
ACW management will conduct a webinar at 11am today to discuss the Company’s clinical trial program
including the Interim Analysis along with details of the capital raising. Pre-register now, or join at 11am Sydney
time today by clicking on the following link or pasting the address into your browser:
https://investors.actinogen.com.au/webinars/7eXLqe-positive-xanamia-trial-interim-analysis-funding-secured-
beyond-final-results
The webinar presentation is attached to this announcement.
At the conclusion of the presentation, there will be an opportunity for questions from webinar attendees. A
recording of the webinar will be made available as soon as possible after the conclusion of the event on the
Company’s Investor Hub using the same link above to access.
Details of the placement
The Company has received firm commitments fora non-underwritten placement of approximately 285.7 million
new shares to new and existing sophisticated and institutional investors and Directors at an issue price of
$0.042 per share to raise approximately $12.0 million. New shares issued under the placement represent
approximately 9.0% of current shares on issue in the Company.
The issue price under the placement represents a:
• 6.7% discount to the last traded price of $0.045 per share on Wednesday, 28 January 2026; and
• 13.5% discount to the 5-day volume weighted average price (“VWAP”) of $0.049 per share as at
Wednesday, 28 January
New shares issued under the placement will rank equally with existing shares on issue.
Canaccord Genuity (Australia) Limited is acting as Lead Manager to the placement and SPP.
Director participation
Led by CEO and MD Dr Steven Gourlay, ACW’s Directors have committed, subject to ACW shareholder
approval, to participate in the placement on the same terms for an aggregate amount of approximately
$667,000. Shareholder approval under ASX Listing Rule 10.11 in respect of the Director participation will be
sought by the Company at a forthcoming EGM, which is currently expected to be held in March 2026. The
Company will issue a Notice of Meeting with further details of the EGM in due course.
Share purchase plan (SPP)
In addition to the placement, the Company intends to undertake an SPP to raise up to approximately $5.0
million. The proposed SPP will provide eligible shareholders with a registered address in Australia, New
Zealand and (under limited circumstances and by invitation only) the United States as at the SPP Record Date
of 7.00pm (AEDT) on 30 January 2026 with the opportunity to increase their holding by up to $30,000 of new
shares at the same issue price as the placement without incurring any brokerage or transaction costs.
ACW will reserve the right to increase the size of the SPP or scale back applications in its absolute discretion.
The SPP is expected to open on 10 February 2026 and close at 5.00pm (AEDT) on 24 February 2026. Further
information on the SPP, including details on how eligible shareholders may participate, will be provided in due
course.
Pro forma capital structure
The table below sets out, for illustrative purposes only, the existing share capital structure of the Company
(before the placement and SPP) together with the impact of the issue of the new shares under the placement
and SPP. The table below does not account for the impact of any options on issue which may be exercised
prior to the SPP Record Date.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
3
Detail Number
Existing shares on issue 3,191,745,696
Maximum number of new shares to be issued under the placement
(assuming shareholder approval of director participation)
285,714,286
Maximum number of new shares to be issued under the SPP
(approximately)
119,047,619
Maximum number of shares on issue following completion of the
placement and SPP (assuming full subscription under the SPP)
3,596,507,601
Timetable
Outlined below is an indicative timetable of events and dates relating to the placement and SPP.
Indicative Timetable*
Event Date
Record date for SPP 7:00pm (AEDT), Friday, 30 January 2026
Trading halt lifted, announce completion of placement
and conduct of SPP
Monday, 2 February 2026
Settlement of new shares under the placement Friday, 6 February 2026
Allotment and quotation of new shares under the
placement
Monday, 9 February 2026
SPP offer booklet and application form made available to
eligible shareholders
SPP offer opens
Tuesday, 10 February 2026
SPP offer closes 5:00pm (AEDT), Tuesday, 24 February 2026
Announcement of results of SPP Friday, 27 February 2026
Issue of New Shares under SPP Monday, 2 March 2026
Expected commencement of trading of SPP New Shares
on ASX
Tuesday, 3 March 2026
EGM to approve issue of new shares to Directors under
the placement
Expected to be in or around March 2026
Settlement of new shares to Directors under the
placement
Expected to be in or around March 2026
Allotment and trading of New Shares to Directors under
the placement
Expected to be in or around March 2026
*Note: The above timetable is indicative only and subject to change. Subject to the requirements of the Corporations Act 2001 (Cth), the
ASX Listing Rules, the Companyreserves the rightto amend thistimetable at anytime without notice. Allreferencesto time are to Sydney
time.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/PGKKgP
ENDS
Investors Media
Dr Steven Gourlay Michael Roberts George Hazim
CEO & Managing Director Investor Relations Media & Public Affairs Australia
P: +61 2 8964 7401 M: +61 423 866 231 M: +61 417 516 262
E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au E: georgehazim@mediaaffairs.com.au
Announcement authorised by the Board of Actinogen Medical Limited
About Actinogen Medical
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and
neuropsychiatric diseases associated with dysregulated brain cortisol.There is a strong association between cortisol and
detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health.
Cognitive function means how a person understands,remembers and thinks clearly.Cognitive functions include memory,
attention, reasoning, awareness and decision-making.
Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease. It
has also conducted a phase 2 trial in patients with cognitive impairmentand depression andmay study Fragile X Syndrome
and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive
impactin these and many other diseases.The cognitive dysfunction,behavioural abnormalities,and neuropsychological
burden associated with these conditions is debilitating for patients,and there is a substantial unmetmedical need for new
and improved treatments.
Clinical Trials
The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel
group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and
confirmed by an elevated level of the pTau181 protein biomarker in blood.Patients receive Xanamem 10 mg or placebo,
once daily,and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints.The primary
endpointof the trial is the internationally-recognized CDR-SB (Clinical Dementia Rating scale – Sum of Boxes). The trial
is being conducted in Australia and the US. On 30 January, 2026 the independent Data Monitoring Committee
recommended the trial continue without amendmentfollowing an unblinded review of safety and efficacy futility data.The
trial is now closed to recruitment, with final topline results in November 2026.
The XanaMIA-OLE Alzheimer’s disease open-label extension is an open-label phase of up to 25 months treatment
where all participants will receive active Xanamem 10 mg once daily.The trial will evaluate safety and a limited number of
efficacy endpoints such as the CDR-SB. The trial will commence in Q1 2026 and be open to all former and current
participants in the XanaMIA Phase 2b/3 trial.
The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel
group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive
impairment. Participants were evenly randomized to receive Xanamem 10 mg once daily or placebo, in most cases in
addition to their existing antidepressanttherapy,and effects on cognition and depressionwere assessed.Trial results were
reported in August 2024 and showed clinically and statistically significantbenefits on depression symptoms with positive
effects on the MADRS scale (a validated scale of depression symptom measurement) and the PGI-S (a valid patient
reported assessmentof depression severity). Cognition improved markedly and to a similar extent in both Xanamem and
placebo groups.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
5
About Xanamem (emestedastat)
Xanamem’s novel mechanism is to control elevated levels of cortisol (aka the “stress hormone”) in the brain through the
inhibition of the cortisol synthesis enzyme,11β-HSD1,withoutaffecting production of cortisol by the adrenal glands which
is essential for the body’s normal functioning.Xanamem is a first-in-class,once-a-day pill designed to deliver high levels
of cortisol control in key areas of the brain related to Alzheimer’s and other diseases such as the hippocampus and frontal
cortex. To view Xanamem’s two-minute Mechanism of Action animation, click here.
Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be
toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms
has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes
statistically significant benefits on depressive symptoms, further validating the cortisol control mechanism for the
Xanamem 10 mg oral daily dose.
The Company has studied 11β-HSD1 inhibition by Xanamem in approximately 400 volunteers and patients in eightclinical
trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression,patients
with biomarker-positive Alzheimer’s disease and cognitively normal volunteers. High levels of target engagement in the
brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study.
Xanamem is an investigational productand is not approved for use outside of a clinical trial by the FDA or by any global
regulatory authority. Xanamem® is a trademark of Actinogen Medical.
Disclaimer
This announcement and attachments may contain certain "forward-looking statements" that are not historical facts; are
based on subjective estimates,assumptions andqualifications;and relate to circumstances and events thathave nottaken
place and may nottake place.Such forward looking statements should be considered “at-risk statements” - notto be relied
upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business,
economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes
and uncertainties) that may lead to actual results being materially different from any forward looking statement or the
performance expressed or implied by such forward looking statements.You are cautioned not to place undue reliance on
these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any
obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to
reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future
performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of
achievementor reasonableness of any forward-looking statements and there can be no assurance or guarantee that any
forward-looking statements will be realised.
ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS
WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP.
Oral Xanamem®
Controlling brain cortisol to slow progression in Alzheimer’s disease
and treat depression
Investor Presentation
2 February 2026
® Xanamem is a registered trademark of Actinogen Medical Limited
2
This presentation is dated 2 February 2026 and has been prepared by Actinogen Medical Limited. (“Actinogen” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is
provided in summary form and does not contain all information necessary to make an investment decision. It should be read in conjunction with the Company’s most recent financial report and other periodic and continuous disclosure
announcements lodged with the Australian Securities Exchange (”ASX”), which are available at www.asx.com.au under the Company’s ticker code (ASX: ACW).
This presentation does NOT constitute a “Prospectus” or a “Disclosure Document” (as defined in the Corporations Act 2001 (Cth)) and has not been, and will not be, lodged with the Australian Securities and Investments Commission or any
other regulatory authority. Accordingly, it is not required to contain, and may not necessarily contain, all of the information that a Prospectus or like Disclosure Document would be required to contain pursuant to the Corporations Act 2001
(Cth). This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Actinogen, nor does it constitute financial product advice or take into account any
individual’s investment objectives, taxation situation, financial situation or needs. This presentation is not exhaustive of all of the information a potential investor or their professional advisers would require. An investor must not act on the
basis of any matter contained in this presentation but must make its own assessment of Actinogen and conduct its own investigations. Before making an investment decision, investors should consider the appropriateness of the information
having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to their jurisdiction and circumstances. Actinogen is not licensed to provide financial product advice in respect of its
securities or any other financial products. Cooling off rights do not apply to the acquisition of Actinogen securities.
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The New Shares have not been, and will not be, registered under the US Securities Act of 1933 (the “US Securities Act”) and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the
registration requirements of the US Securities Act and applicable US state securities laws.
This presentation contains certain budget information, forecasts and forward looking statements that are based on the Company’s management’s beliefs, assumptions and expectations and on information currently available to management
in respect of which there is NO guarantee of future performance. Such budget information, forecasts and forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results or
performance of Actinogen to be materially different from the results or performance expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to the performance of Actinogen in its
clinical trials including whether it's technology proves to be a safe and effective treatment, market penetration, competition from any other similar products, intellectual property risks (including securing rights in technology and patents) and
global economic conditions. Furthermore, Actinogen's research, product development, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. There is
no guarantee that Actinogen will obtain the required approvals, licences and registrations from the relevant authorities in jurisdictions in which it operates. Actinogen or others could identify product and efficacy issues relating to the safety of
our technology. Accordingly, all forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the political and economic environment in which Actinogen will operate in
the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward
looking statements or other forecast. There is no guarantee that Actinogen will achieve its stated objectives/milestones, that any of its forecasts will be met or that forward looking statements will be realised. You are cautioned not to place
undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of or non-occurrence of any events.
Neither Actinogen nor any other entity or person in or associated with Actinogen guarantee any return (whether capital or income) or generally the performance of Actinogen or the price at which its securities may trade. Any investment in
Actinogen is subject to investment risks including the possibility of loss of capital invested and no return of income or payment of any dividends.
A number of important factors could cause the Company’s actual results to differ materially from the plans, objectives, expectations, estimates and intentions expressed in such forward looking statements, including (without limitation) the
risks and uncertainties associated with the ongoing impacts of the Australian and global economic environment and capital market conditions and the risk factors described in the slides titled "Summary of key risks", with many of these
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Disclaimer
Investor Presentation 2 February 2026
3
Executive summary
Capital raising to progress XanaMIA phase 2b/3 pivotal trial to completion in 2026
Actinogen’s Xanamem
program
• Actinogen is developing a once daily pill called Xanamem/emestedastat for Alzheimer’s disease and expects final topline
results from its first pivotal clinical trial in November 2026 – depression, anxiety and other dementias may be further
investigated in the future, most likely in partnership with a global biopharmaceutical company
• An independent Data Monitoring Committee (DMC) confidentially reviewed unblinded safety and efficacy data in late
January and recommended the trial continue without amendment
• This positive result confirms the trial has cleared the pre-specified efficacy futility hurdle and maintained a promising safety
profile, materially de-risking the program as it advances toward final topline results in November 2026
Company outlook
• Actinogen plans to complete the XanaMIA trial this year and, with positive results in hand, immediately proceed to the next
pivotal, phase 3 Alzheimer’s trial and engage with major, global strategic biopharma companies interested in Alzheimer’s
disease
• A smaller, regional deal may be completed during the year if the terms are favourable
Capital raising
• Actinogen has received firm commitments to raise approximately A$12.0 million (before costs) via a non-underwritten
placement (“Placement”) and is expected to raise up to a further approximately A$5.0 million via a share purchase plan
(“SPP”)
• The net proceeds of the Placement and SPP will be used to complete the XanaMIA pivotal trial in Alzheimer’s disease,
implement the open-label extension phase of the XanaMIA trial and for general corporate purposes
• Company funded beyond topline results in November 2026 after current fundraising round
Director participation
• Director participation of ~A$0.667 million (including CEO Steven Gourlay $0.5m) in the Placement is subject to shareholder
approval at an Extraordinary General Meeting (“EGM”) to be held in or around March 2026
Investor Presentation 2 February 2026 3
Interim analysis positive trial recommendation
Assessments of safety and “efficacy futility”
Recommendation:
• Continue the XanaMIA trial without amendment to its final conclusion for the 247 participants
Methods:
• Independent Data Monitoring Committee (DMC) chaired by Alzheimer’s disease trials expert Dr Hans
Moebius
• Data confidentially reviewed included “unblinded” data on:
✓ Safety (n=247, i.e. all enrolled participants)
✓ Efficacy data from approximately 37% of total, expected trial dataset (code broken to see
treatment group assignment) from Week 12 (n=136), Week 24 (n=87) and Week 36 data (n=52)
Positive result confirms the trial cleared the pre-specified efficacy futility hurdle and unblinded
safety review, materially de-risking the program as it advances toward final topline results in
November
Investor Presentation 2 February 2026 4
5
Management Team
Highly experienced Board and management with strong
track record
Board of Directors
Dr. Geoff Brooke
Chairman
MBBS; MBA
Dr. Steven Gourlay
CEO & MD
MBBS; FRACP; PhD; MBA
Mr. Malcolm McComas
Non-Executive Director
BEc, LLB; FAICD; SF Fin
Dr. George Morstyn
Non-Executive Director
MBBS; PhD; FRACP CD
Dr. Nicki Vasquez
Non-Executive Director
PhD
Dr. Dana Hilt
Chief Medical Officer
MD
Dr. Steven Gourlay
CEO & MD
Will Souter
Chief Financial Officer
BComm, LLB
Andrew Udell
Chief Commercial Officer
MBA
Cheryl Townsend
VP Clinical Operations
RN, M Health Law
Fujun Li
Head of Manufacturing
PhD
Michael Roberts
Head of IR & Comms
B.Ec (Hons), CPA, FFIN
Investor Presentation 2 February 2026 5
Alzheimer’s disease market is large and growing
Growing Alzheimer’s Disease market – U.S.
Large, unsatisfied and growing market
Sources: U.S. burden of Alzheimer’s disease, related dementias to double by 2060 | CDC Online Newsroom | CDC, US Alzheimer’s Prevalence Surpasses 7 Million and The Cost of Dementia in 2025 - April 23, 2025 - USC Schaeffer
Investor Presentation 2 February 2026 6
Xanamem’s unique mechanism of action
Click here for animation video
Investor Presentation 2 February 2026 7
Xanamem has a clear path to Alzheimer’s approval
Phase 2b/3 trial on track, FDA agreement streamlines development, EMA meeting 2026
• Recent FDA agreement confirms development pathway to US marketing approval using
one additional pivotal trial of 10 mg vs. placebo and open-label safety studies
• Clear guidance on manufacturing, ancillary studies
• Ongoing XanaMIA pivotal clinical trial:
✓ Full enrolment in US and Australia
✓ Excellent safety profile, positive first Data Monitoring Committee (DMC) safety review
✓ Positive second DMC review with unblinded interim analysis result confirms the trial
cleared the pre-specified efficacy futility hurdle and unblinded safety review
✓ On-track for final results in November 2026
• Phase 3 planning commencing in parallel with discussions re potential partnerships
Investor Presentation 2 February 2026 8
Highlights of Alzheimer’s treatment landscape
Oral Xanamem is leading the charge with a potential game-changing new mechanism
Mechanistic Admin Comments
Older drugs - boosting acetylcholine or
glutamate
Oral • Marketed since '90s/'00s, symptomatic only. Gastrointestinal
side effects.
Anti-amyloid protein immunotherapies IV/SubQ • Marketed with challenges including variable reimbursement (e.g.
not Aust.). Safety concerns including infusion reactions, brain
swelling / bleeding - MRI monitoring required
Second-gen anti-amyloid with “bra
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