Annual Report to Shareholders
Released
Released
Announcement PDF
Annual Report
2025
Actinogen is advancing a
revolutionary oral therapeutic,
Xanamem®
, through pivotal
trials to transform treatment
for Alzheimer’s disease and
major depressive disorder.
Our vision is to improve lives
by targeting brain cortisol
with precision and innovation.
® Xanamem is a registered trademark of Actinogen Medical Limited
Contents
Who we are IFC
Highlights 2
The Xanamem pipeline 3
MDD trial results 4
XanaMIA phase 2b/3 Alzheimer’s disease trial 6
The Alzheimer’s market 7
Chair’s letter 8
Chief Executive Officer’s letter 10
Vision and strategy 12
Operating & financial review 14
Board of directors 24
Executive leadership team 26
Directors’ report 28
Remuneration report (Audited) 31
Auditor’s independence declaration 44
Financial report 45
Directors’ declaration 70
Independent auditor’s report 71
Shareholder information 75
Corporate directory 78
Disclaimer
This annual report may contain certain "forward-looking
statements" that are not historical facts; are based on
subjective estimates, assumptions and qualifications;
and relate to circumstances and events that have not
taken place and may not take place. Such forward looking
statements should be considered “at-risk statements” -
not to 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 achievement or reasonableness of any forward-looking
statements and there can be no assurance or guarantee
that any forward-looking statements will be realised.
Annual Financial Report 1
Highlights
Planning for
commercial readiness
1 MDD = major depressive disorder
2 USAN = A United States Adopted Name (USAN) is a unique nonproprietary name assigned to a medication marketed in the United States
3 Unless stated otherwise, all financial data is in Australian dollars
Pivotal XanaMIA phase
2b/3 AD clinical trial passes
100th
participant milestone.
Interim analysis scheduled
for Jan 2026; final results
Q4 2026
Conducted successful
Type C regulatory meeting
on MDD1
with the US
FDA to reach common
understanding of path
to marketing approval of
Xanamem for MDD
Appointed experienced
inaugural Chief
Commercial Officer
(CCO), Andy Udell, based
in the USA to manage
commercialization
activities
Delivered another in series
of ’plain English’ Clinical
Trials Science Forum
(CTSF) neuroscience
webinars titled: The critical
importance of preparing for
commercialization
World Health Organization
granted new and unique
International Nonproprietary
Name ‘emestedastat’
to Xanamem and also
accepted in US as USAN2
Published an academic
manuscript in peer-
reviewed journal, Clinical
Pharmacology in Drug
Development detailing the
multiple trials supporting
the utility of Xanamem 10mg
Completed an $11.1m capital-
raising, received a $9.0 million
R&D tax incentive rebate &
established a $13.8m non-
dilutive R&D tax incentive
funding facility. Funding
secured to mid-late CY 20263
Initiated clinical
pharmacokinetic trial and
other ancillary studies.
Commenced preparation for
an ‘open-label’ extension trial
beginning Q1 2026 to allow
XanaMIA trial participants
to continue with active
Xanamem therapy
Announced positive depression
results from XanaCIDD phase
2a trial supporting Xanamem’s
cortisol control mechanism &
confirming clinical activity of
10mg daily dose
Completed production
of 15kg scale-up batch
of drug substance from
contract manufacturer,
Asymchem, to be
manufactured in the
US into Xanamem tablets
Attended & presented at significant
international conferences and
conducted meetings at industry
gatherings to enable evaluation
of potential value-add regional
and global business development
opportunities
Strengthened engagement
and understanding among
external stakeholders
through a high-quality,
two-minute mechanism-of-
action animation
View here
Actinogen Medical Limited
2
The Xanamem pipeline
Progressing Xanamem in Alzheimer’s
disease, major depressive disorder
and other neurological indications
Alzheimer’s
disease
MDD
Fragile X
syndrome
Indication Preclinical Phase 1 Phase 2 Phase 3
Paused after phase 2a pending
phase 2b/3 trial funding
Paused prior to phase 2
Phase 2b/3 interim analysis Jan 2026,
final results late 2026
Open INDs
Frontotemporal
dementia
Lewy-body
dementia
Parkinson’s
disease
Anxiety
disorders
MDD: Major depressive disorder
Potential next indications
Annual Financial Report 3
MADRS depression scores favour Xanamem at Week 6 & 10 in patients
also taking SSRI drugs (n = 76)
Patient Global Impression – Severity scores favour Xanamem from Week 2
in patients also taking SSRI drugs (n = 75)
MADRS
LS
mean
change
from
baseline
(±
SE)
ON TREATMENT
-12
0
Baseline Week 2
Xanamem (n=37) Placebto (n=39)
Week 4 Week 6 Week 10 PT
-2
-4
-6
-8
-10
FOLLOW UP
PT 4.2-point difference
Cohen’s d = 0.64
p = 0.03
EOT 2.6-point difference
Cohen’s d = 0.38
p = 0.15
BETTER
BETTER
-1.4
-1.6
0
-0.4
-0.2
-0.6
-0.8
-1
-1.2
PT 0.59-point difference
Cohen’s d = 0.62
EOT 0.41-point difference
Cohen’s d = 0.43
PGI-S
LS
mean
change
from
baseline
(±
SE)
Xanamem (n=36) Placebo (n=39)
Baseline Week 2 Week 4 Week 6 Week 10 PT
ON TREATMENT FOLLOW UP
Abbreviations: MADRS = Montgomery-Åsberg Depression Rating Scale; EOT: End of Treatment;
PT: Post Treatment; SSRI = selective serotonin reuptake inhibitor;
• A clinically meaningful improvement
in depression symptoms, measured
by the MADRS score, was seen after
6 weeks of therapy vs. placebo, and
was then greater and statistically
significant after four weeks of
“blinded” post-treatment follow up
• The placebo-subtracted treatment
difference of 4.3 MADRS points is
similar to that seen with currently
approved anti-depressants
• These data suggest that Xanamem
could be beneficial as “add-on”
therapy to SSRI drugs
• Developing Xanamem in combination
with SSRI drugs is a viable and
pragmatic pathway to approval in
major depressive disorder
Further exploration of trial results showed
encouraging activity for Xanamem when
patients were also taking background
Selective Serotonin Reuptake Inhibitor
(SSRI) drugs – the commonest class of
anti-depressant therapy in clinical use.
MDD trial results
XanaCIDD depression trial shows positive
Xanamem activity on top of background
SSRI therapy
Actinogen Medical Limited
4
The XanaCIDD depression benefits show that controlling
cortisol levels in key areas of the brain has a clinically
important effect, increasing our confidence in positive
outcomes for trials in depression, Alzheimer’s disease and
other diseases where cortisol plays a role.
Analysis of patients also taking SSRI drugs suggests that
Xanamem’s benefit on depressive symptoms may be
greater in this patient population and points us toward
studying this combination in future clinical trials.
Dr Dana C Hilt
Actinogen’s Chief Medical Officer
Annual Financial Report 5
XanaMIA phase 2b/3 Alzheimer’s disease trial -
rapidly approaching major milestones
NIA-AA=National Institute of Aging - Alzheimer’s Association; CDR-SB Clinical Dementia Rating Scale – Sum of Boxes
Key Inclusion
Criteria
•Blood pTau
biomarker positive
•Mild-moderate
Alzheimer’s by
NIA‑AA criteria
Primary
Endpoint
•CDR-SB (functional
and cognitive
measure) @36
weeks
•Also measured at
12 and 24 weeks
Key Secondary
Endpoints
•Cognitive Test
Battery (7 cognitive
measures
well‑validated in the
Alzheimer’s field)
•Amsterdam Activity
of Daily Living
(functional measure)
Implementation
•Enrolment at 15
Australian & 20
US sites
•Interim analysis
January 2026
(efficacy futility
& safety)
•High quality
endpoint monitoring
2026 2027
and beyond
Interim Analysis
January 2026
Final Results
Late 2026
Q3 2025
More than
50% enrolled
Q4 2025
Target full
enrolment
Q1 2026
Open label
extension commences
Key trial criteria
10mg Xanamem vs Placebo (n=220)
Actinogen Medical Limited
6
The Alzheimer’s market
Large and unsatisfied Alzheimer’s market
Growing Alzheimer’s disease market - U.S.
2025 2025
2060
(Est.)
13.8M
7.2M
64%
38%
32%
31%
18%
12%
8%
13%
$384B
$1T
2050
(Est.)
Number of patients
(65+ years old)
Cost to treat (USD)
Above and right: Spherix Global Insights: Market Dynamix Early Alzheimer’s Disease
(US) Q2 2025 (n=101) and Custom Quantitative Analysis (US) July/August 2025 (n=91)
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
Source: The Cost of Dementia in 2025
- April 23, 2025 - USC Schaeffer
Advantages of Xanamem (Unaided) % of respondents
Oral Safety
profile
Novel
MOA
Efficacy No
ARIA
No
DDI
Tolerability
profile
Other
Positive reaction to Xanamem’s potential advantages per clinician feedback
of neurologists agree
there is a high unmet
need for DMTs for
early AD
91%
of neurologists expect
their approach to
treating early AD
will change over the
next 5 years as novel
DMTs launch
86%
DMTs: Disease modifying therapies
ARIA: Amyloid-related imaging abnormalities
“
Oral agent with distinctive mechanism
of action, no safety concern.”
“
More efficacious, oral, no concern
for ARIA, can be used in more
advanced AD.”
“
It appears to be quite safe. There is
little work to be done on the part of
the clinician or the patient (dosing,
labs, titration, etc.)”
Annual Financial Report 7
Chair’s letter
Dear Shareholder,
I am pleased to present
to you the Actinogen
Medical Annual Report
for the financial year
ended 30 June 2025
reflecting on a period
of significant progress
in a dynamic global
environment.
Actinogen has continued to make excellent progress in the
fulfillment of its business priorities and strategic objectives in
the 2025 financial year.
The past year has been marked by a rebound of interest in
small-cap biotechnology, particularly those advancing into
later stages of clinical development. In both the United States
and Australia, investor sentiment has gradually improved,
buoyed by more favourable economic conditions and renewed
appetite for innovation in healthcare. This has led to a general
rotation of capital into high-quality small- and mid-cap
biotechs, especially those with promising phase 2/3 assets.
Actinogen is in exactly that “sweet spot” with its Xanamem
pivotal trial program.
Against this backdrop, Actinogen has delivered a year
of meaningful progress. Our novel, small molecule asset,
Xanamem, advanced in two major indications—Alzheimer’s
disease and major depressive disorder—both of which
represent areas of significant unmet medical need. For
now, Alzheimer’s disease is the primary focus for company
resources given the immense potential value a new, oral
therapy for this disease represents.
Addressing a significant global health need
Alzheimer’s disease remains one of the most pressing
healthcare challenges of our time. With over 55 million people
affected globally and no cure currently available, the demand
for effective therapies is only growing. Recent drug approvals
for anti-amyloid infusion therapies, that have only modest
benefit, underscore the opportunity for next-generation
therapies such as oral Xanamem.
Actinogen’s focus on modifying the progression of Alzheimer’s
by controlling brain cortisol positions us as unique in this
space. There is no other similar drug in development for CNS
diseases to our knowledge. We are proud to be contributing to
a global effort to slow, halt, or even reverse the functional and
cognitive decline associated with this devastating condition.
Executive leadership
I would also like to commend the outstanding performance
of our high-calibre senior leadership team, impeccably led
by Dr. Steven Gourlay. Their strategic leadership, scientific
knowledge and expertise, and unwavering commitment have
been instrumental in driving the company’s progress. We
also welcomed Mr Andrew (Andy) Udell to the team as Chief
Commercial Officer. His commercial expertise adds valuable
depth to our executive team as we complete later-stage
clinical development and prepare the path to product launch.
I also extend my appreciation to our wider executive
team, dedicated employees, and key contractors. Their
professionalism and dedication have been vital in maintaining
a highly effective and efficient clinical development program
and the corporate operations required of a publicly listed
biotechnology company. Their collective efforts continue to
drive Actinogen forward with purpose and momentum.
Actinogen Medical Limited
8
Board, corporate governance and advisory boards
Our Board remains committed to the highest standards of
corporate governance and management oversight capability.
During the year, we reviewed our governance practices
and reassessed the Board skills matrix to identify areas for
enhancement and future capability needs. We continue to
evolve our governance framework to reflect the company’s
growth and operational complexity.
Our commitment to transparency and accountability remains
strong, with all key corporate policies and governance
materials available on our website. This framework supports
the effective management and execution of both our long-
term strategic vision and annual priorities.
I would like to express my sincere appreciation to my fellow
Board members for their valuable contributions and leadership
throughout the year. Their strategic insight, governance
leadership, and steadfast commitment have been instrumental
in supporting Actinogen as we continue to navigate the
complexities of late-stage clinical development.
The Board also acknowledges the valuable insights and
guidance provided by our scientific and medical advisory
boards, which provide strategic guidance as we navigate
clinical and regulatory pathways.
Further details on the Actinogen corporate board, advisory
boards and senior executive personnel can be found on the
company’s website.
Capital management
We strengthened our financial position through a
successful capital raise of $11.1 million, the completion
of which was announced in October 2024, comprising
an $8.1 million placement and a $3.0 million Share Purchase
Plan. Subscribers also received listed options as part of
the capital raising, so the company now has two series
of options trading on the ASX. This provides flexibility for
shareholders and potential capital for future growth if and
when those options are exercised.
In addition, we received a $9.0 million R&D tax incentive
rebate in October 2024 for the 2024 financial year
and recently secured access to up to A$13.8 million
via a non‑dilutive loan funding facility secured against
the company’s future Research and Development Tax
Incentive (RDTI) rebates.
Annual General Meeting
This year’s Annual General Meeting will be held in person
in Sydney on Wednesday 19 November 2025, and we look
forward to engaging with shareholders on our progress and
future plans. Details of the meeting time and Sydney location
will be announced in due course.
Outlook
We enter the new financial year with optimism. The interim
analysis of efficacy and safety of our pivotal XanaMIA AD trial,
expected in January 2026, will be an important milestone.
Assuming it is positive, it will provide valuable momentum for
the clinical program and support ongoing engagement with
potential partners and stakeholders. It will also mean that we
will be even closer to final topline trial results expected late in
2026, which are keenly anticipated.
In closing, I would like to sincerely thank you, our
shareholders, for your continued support and confidence in
Actinogen. Your backing enables us to pursue our work with
focus and determination, and we are grateful for your ongoing
engagement as we progress through this pivotal phase of
development. We look forward to sharing further updates with
you over the coming year as we continue working to deliver
meaningful innovation for patients and value for shareholders.
Dr Geoff Brooke
Chair
25 August 2025
If you have any questions relating to your
shareholding in Actinogen, please contact Automic
at hello@automicgroup.com.au or on 1300
288 664 (within Australia) or +61 2 9698 5414
(outside Australia).
Visit the Automic website https://investor.
automic.com.au/#/home to register as an ACW
shareholder or log in to your existing account.
Annual Financial Report 9
Chief Executive Officer’s letter
Dear Shareholder,
Approaching key
Xanamem pivotal
trial results in
Alzheimer’s disease.
I am pleased to provide you with an update on Actinogen
Medical’s progress over the past year. Since July 2024,
we have made significant strides in advancing our clinical
programs, strengthening our financial position, and preparing
for commercialization of our lead asset, Xanamem.
Clinical Development Milestones and Peer-Review
Publications
Our commitment to developing Xanamem as a novel therapy
for Alzheimer’s disease (AD) continues to yield promising
results. In June 2025, we reached a major milestone with
the enrolment of the 100th participant in our XanaMIA phase
2b/3 AD trial. This achievement sets the stage for our interim
analysis in January next year, which is expected to provide
valuable insights into the efficacy and safety of Xanamem in
this population. The interim analysis will be conducted by an
Independent Data Monitoring Committee and look at available
data for participants at 12, 24 and 36 weeks of treatment.
Full enrolment of all 220 participants in the XanaMIA trial is
expected by the time of the interim analysis, with topline,
final results for 36 weeks of treatment expected in Q4 2026.
A new “open label” extension trial to provide active Xanamem
to all participants who complete the XanaMIA trial will start
enrolment in Q1 of 2026.
Earlier in the year, our Chief Medical Officer presented positive
depression data from the XanaCIDD phase 2a trial at the
American Psychiatric Association 2025 conference, reinforcing
the therapeutic potential of Xanamem in major depressive
disorder (MDD), AD and other brain diseases. The finding of
clinical benefits on depressive symptoms confirms the clinical
activity in the brain of the 10 mg dose of Xanamem – highly
relevant to the XanaMIA trial where the same dose is used.
The XanaCIDD data were discussed in our Type C meeting
with the FDA in March 2025, where we clarified the regulatory
pathway for Xanamem in MDD, laying the groundwork for
future pivotal trials should the company’s focus shift away
from AD as its lead indication.
We continued to work towards peer-review of all our key
trial results with the publication of a manuscript in the
Clinical Pharmacology in Drug Development journal entitled
“Clinical Pharmacology and Approach to Dose Selection
of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor
for the Treatment of Central Nervous System Disease”.
In addition, multiple academic posters were presented
at scientific AD meetings.
Actinogen Medical Limited
10
Commercialization Preparation
We are actively preparing for the commercialization of
Xanamem, which is likely to be in collaboration with one
or more biopharmaceutical partners. In recognition of the
importance of this work, in October last year we appointed
Mr Andrew (Andy) Udell to the position of Chief Commercial
Officer, based in Connecticut, USA.
In January we announced the award of the generic or official
chemical name for Xanamem of “emestedastat”, determined
by the naming committee of the World Health Organization
and later agreed to by a similar committee in the US. The new
and unique suffix of “- stedastat” acknowledged Xanamem
as the first-in-class inhibitor of its target cortisol production
enzyme, 11β-HSD1.
Our Clinical Trials Science Forum held in May 2025 focused on
the marketing planning activities associated with the transition
towards commercialization. Dana Hilt, CMO, and Andy Udell,
CCO, with AD expert guest Associate Professor Michael
Woodward, discussed the AD field and Xanamem’s position
in it as we look beyond pure clinical development to market
planning and execution, a critical future step in delivering
value to patients and shareholders.
Throughout the year Mr Udell and Dr Hilt have increasingly
engaged with thought leaders in both AD and MDD to
refine the product offering Xanamem will represent to
prescribing physicians and their patients. This included
advisory board meetings, one-on-one interactions and
formal market research.
Manufacturing
During the year, our Head of Manufacturing, Ms Fujun Li,
worked diligently to achieve several key milestones. The most
important of these was the successful scale-up of production
of the active pharmaceutical ingredient (API) of Xanamem to
the 15 kg level. This API will be manufactured into our intended
commercial tablet formulation in the US.
Financial Strength and Funding
Actinogen remains financially robust as a result of
the successful execution of multiple funding initiatives
throughout the year. At the end of June, our cash balance
was $16.5 million, contributing to a cash runway beyond
mid CY2026 in combination with our RDTI future income.
We continue to explore funding from strategic partnerships
and other non-dilutive funding sources to support our growth
while preserving shareholder value.
Strategic Engagements
Actinogen’s visibility in the global biotech community has
grown. We presented at the BIO International Partnering
Conference in June 2025, engaging with potential
collaborators and investors. Similarly, our presence at the
Sachs Neuroscience conference in January 2025 provided
opportunities to update and engage multiple large and mid-
tier biopharmaceutical companies on our progress. These
efforts are part of our broader strategy to attract synergistic
strategic partners and position Actinogen as a leader in AD
drug development.
Looking Ahead
The coming year will be pivotal. We anticipate interim results
from our AD pivotal trial, further regulatory engagement with
both the FDA and European Medicines Agency (EMA) on AD,
and continued progress in our commercialization strategy.
Our team remains focused on executing with excellence
and transparency.
I want to thank you—our shareholders—for your continued
support and belief in our mission. Actinogen is entering a
transformative phase, and your partnership is vital as we
work to bring Xanamem to patients in need.
Warm regards,
Dr Steven Gourlay
CEO & Managing Director
25 August 2025
If you have any questions relating to your
shareholding in Actinogen, please contact Automic
at hello@automicgroup.com.au or on 1300
288 664 (within Australia) or +61 2 9698 5414
(outside Australia).
Visit the Automic website https://investor.
automic.com.au/#/home to register as an ACW
shareholder or log in to your existing account.
Annual Financial Report 11
Vision and strategy
Our fundamentals
In conjunction with the
US FDA and
other regulatory authorities, we strive
for excellence in science and clinical data
within our programs. As a result, we’ve
conducted multiple high-quality clinical
trials to bring our molecule, Xanamem,
to this phase 2/3 stage of development.
Quality
Valued
We are valued and respected by
patients, physicians, and industry
peers to bring Xanamem’s development
forward. Science, data and transparency
guide us to bring hope and potentially
change the world of cognitive
impairment forever.
Bold
Building on the solid scientific rationale
for Xanamem’s action, we are rapidly
developing programs in multiple disease
areas, with a priority on Alzheimer’s
disease and depression.
Next-Gen
Xanamem is a cutting-edge therapy
and world-class product that reduces
cortisol (the “stress hormone”) levels
in the brain. As a result, it is a catalyst
for new approaches in managing
neurodegenerative and other illnesses.
Our Vision
Actinogen is advancing
a revolutionary oral
therapeutic, Xanamem,
through pivotal trials
to transform treatment
for Alzheimer’s disease
and major depressive
disorder.
Our vision is to improve
lives by targeting brain
cortisol with precision
and innovation.
Actinogen Medical Limited
12
FY2026 Strategic priorities
Accelerate clinical
development
of Xanamem in
Alzheimer’s disease
• Meet with FDA and
EMA to define the most
efficient path to approval
• Enrolment of 220
participants with mild to
moderate disease in the
pivotal XanaMIA trial
• Perform an interim safety
and efficacy futility
analysis in January
CY2026
• Efficient prescreening
in XanaMIA to identify
people with progressive
disease using elevated
blood pTau181
• Implement an extension
trial in which all XanaMIA
participants can receive
active Xanamem
• Ensure high quality
rating training and
standardization to
minimize noise in key
efficacy endpoints
• Leverage ‘hands on’
clinical operations and
management model in
Australia and the US
to optimize quality and
reduce cost
Commercial
readiness to
prepare the market
for Xanamem &
support future
partnerships
• Strengthen AD advisory
board and elicit updated
program guidance
• Engage with a broad
range of key opinion
leaders and principal
investigators in AD
• Communicate Xanamem’s
novel mechanism of action
and its differentiated
therapeutic profile via
multiple channels
• Refine Xanamem target
product profile in AD
based on feedback from
market research and
AD experts
Scaled up
manufacturing
and related patent
protection
• Production of a large
batch of Xanamem tablets
by Catalent, US
• Manufacture of an
additional 15 kg of API
by Asymchem, China
• National phase entry
for three manufacturing
patents
Proactively engage
with prospective
development
and commercial
partners
• Identify and partner with
one or more synergistic
regional biopharma
companies
• Continue to develop
relationships with
potential, future large-cap
partners
• Review detailed Xanamem
data with selected parties
under confidentiality
agreements
• Attend key international
and national scientific and
business meetings
• Form collaborative
relationships with all
major global regulatory
authorities
Annual Financial Report 13
14 Actinogen Medical Limited
Operating & financial review
1. PRINCIPAL ACTIVITIES
The principal activity of the company during the year focused on the ongoing clinical development of Xanamem, a
unique inhibitor of the 11β-HSD1 enzyme that achieves target engagement in the brain. It is an oral medication for
neurological diseases amenable to its mechanism of lowering cortisol in brain cells. Brain cortisol is associated with a
number of neurological diseases, including neurodegenerative diseases such as Alzheimer’s Disease (AD),
neuropsychiatric diseases such as major depressive disorder (MDD), and Fragile X syndrome (FXS).
2. OPERATIONS REVIEW
Highlights – Accelerating toward pivotal trial results in Alzheimer’s disease:
Advanced two major clinical trial programs:
• XanaMIA phase 2b/3 AD clinical trial passed 100th participant milestone. Interim analysis scheduled for January
2026 and final results expected Q4 2026
• Completed XanaCIDD phase 2a MDD trial – using the data to support development in Alzheimer’s disease
pending independent funding for additional MDD trials.
World Health Organization (WHO) granted new and unique International Nonproprietary Name (INN) ‘emestedastat’ to
Xanamem
Successfully conducted a Type C regulatory meeting on major depressive disorder (MDD) with the US Food & Drug
Administration (FDA)
Conducted commercial readiness planning in all other major aspects of the business including appointing an
experienced Chief Commercial Officer (CCO) to manage commercialization activities, conducting partnering meetings
& discussions, protecting intellectual property (IP), conducting regulatory meetings, initiating the clinical
pharmacokinetic trial and other ancillary studies
Published an academic manuscript in peer-reviewed journal, Clinical Pharmacology in Drug Development
Completed production of a 15kg scale-up batch of drug substance from contract manufacturer, Asymchem, which
will be manufactured in the US into Xanamem tablets for use in the current and future trials, and confirm readiness for
future commercial quantity production
Completed an $11.1m capital-raising, received a $9.0 million Research & Development (R&D) tax incentive rebate and
established a $13.8m non-dilutive R&D tax incentive funding facility. Funding secured to mid-late CY2026
Delivered another in the series of ’plain English’ Clinical Trials Science Forum (CTSF) neuroscience webinars with the
subject title: The critical importance of preparing for commercialization
CEO, CMO and CCO presented at numerous significant international conferences and conducted meetings at industry
gatherings to continue evaluating potential value-add regional and global business development opportunities.
The Company’s 2025 financial year was marked by robust clinical pipeline progress and several major milestones and
events including planning for the approaching commercialization of Xanamem.
XanaMIA phase 2b/3 AD clinical trial passes 100th participant milestone. Interim analysis scheduled for January
2026 and final results expected Q4 2026
• The pivotal XanaMIA phase 2b/3 AD trial is enrolling 220 participants with elevated levels of the blood biomarker
pTau181, designed to identify participants with biomarker-positive AD whose disease is likely to progress during
the 36-week treatment period of the tri
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