Full Press Release Details
Appendix 4C - Q1 FY26 Quarterly Cash Flow
MELBOURNE, AUSTRALIA AND SAN
FRANCISCO, USA - 31 October 2025: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"),
a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix
4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2025 (Q1 FY26).
"As we near the end of
the calendar year, I am very proud of all we have accomplished in 2025, led by our compelling clinical results in Multiple System Atrophy
(MSA), and I am excited about the prospect of delivering ATH434 to the MSA community," said David Stamler, M.D., Chief Executive
Officer of Alterity.
Dr. Stamler continued, "During
the recent quarter, we reported positive results from our trial in advanced MSA, published important neuroimaging findings from our natural
history study, and completed our commercial assessment indicating a potential market opportunity of approximately USD$2.4 billion dollars.
The totality of the data from our combined studies and interest from the medical and scientific community continues to give us great confidence
in the potential of ATH434 as a first-in-class, disease-modifying therapy for MSA."
"We are actively engaging
with the U.S. Food and Drug Administration (FDA) on ATH434 to conduct a series of meetings to discuss emerging nonclinical and chemistry
and manufacturing data required for Phase 3 conduct. Reaching agreement on these elements with the FDA is critical for ensuring a productive
End-of-Phase 2 meeting to enable us to initiate a Phase 3 trial in MSA," concluded Dr. Stamler.
position on 30 September 2025 was A$54.56M with operating cash outflows for the quarter of A$5.34M. In accordance with ASX Listing
Rule 4.7C, payments of A$108k made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates
directors' fees, consulting fees, remuneration and superannuation at commercial rates.
Operational Highlights
ATH434 Regulatory Update
Alterity has continued to generate
the required data and analyses that are needed to engage regulatory authorities about the path forward for ATH434. With respect to the
U.S. Food and Drug Administration (FDA), this process necessitates a proactive, staged approach.
The Fast Track Designation granted
to ATH434 affords Alterity the opportunity to engage with the FDA in a series of Type C meetings related to the nonclinical and the chemistry,
manufacturing, and controls (CMC) data necessary to support Phase 3. Following these meetings, an End-of-Phase 2 meeting will be held
to align with the FDA on all elements of the Phase 3 program. Conducting these meetings in sequence allows Alterity to focus the End-of-Phase
2 meeting on the clinical development topics, including the Phase 3 protocol, and data requirements to commence the Phase 3 study. This
series of meetings is expected to occur over the next several months with the End-of-Phase 2 meeting in mid-year 2026.
ATH434-201: Randomized, Double-Blind, Placebo Controlled
Phase 2 Clinical Trial in MSA
Subsequent to the end of the
quarter, Alterity presented a new analysis of the modified USMARS I1 data from the ATH434-201 trial at the International Congress
of Parkinson's Disease and Movement Disorders meeting. The analysis, which incorporated baseline orthostatic blood pressure change
as a covariate, led to a strengthened efficacy signal in the 75 mg dose group at 52 weeks of 2.8 points, for a relative treatment
effect of 35%. The baseline differences in the rate of severe orthostatic hypotension (OH)2 largely explains the different
responses in 50 mg and 75 mg treatment groups. In addition, ATH434 demonstrated a beneficial effect on OH symptoms as assessed with the
OH Symptom Assessment, a patient reported outcome. On this scale, placebo patients worsened on average by approximately 6 points over
52 weeks whereas the 50 mg and 75 mg groups were stable over the same period.
Multiple presentations were delivered
on the positive results from the ATH434-201 trial:
ATH434-202: Open-label, Biomarker Phase 2 Clinical
Trial in Advanced MSA
In July 2025, Alterity announced
positive data from the ATH434-202 open-label Phase 2 clinical trial in more advanced MSA than was studied in the double-blind Phase 2
trial. A key objective of the study was met as the 75 mg dose in this study demonstrating comparable efficacy to that observed in the
ATH434-201 double-blind study, including the key efficacy endpoint of UMSARS I and preservation of brain volume. Importantly, biomarkers
demonstrated target engagement and a safety profile that was comparable to prior studies. Overall, the Phase 2 studies confirmed ATH434's
favorable profile and provided further evidence that its mechanism of action has utility in addressing the underlying pathology of disease.
bioMUSE Natural History Study
In July 2025, the Company announced
publication of a study in conjunction with researchers at Vanderbilt University Medical Center on an innovative neuroimaging measure developed
in Alterity's Biomarkers of Progression in Multiple System Atrophy (bioMUSE) Natural History Study. The publication, entitled "The
MSA Atrophy Index (MSA-AI): An Imaging Marker for Diagnosis and Clinical Progression in Multiple System Atrophy", was featured in
the peer-reviewed journal Annals of Clinical and Translational Neurology. Development of the MSA Atrophy Index can enhance the
understanding of MSA progression and provide support for using brain atrophy markers for diagnosis and evaluation of disease-modifying
Corporate Activities
Alterity continues to engage with
the investment community with participation in the Bioshares Biotech Summit and Biotech Showcase events in Australia, as well as a panel
presentation focused on neurodegenerative diseases at the Maxim Growth Summit Healthcare Day in the U.S.
During the period, Alterity completed
an independent commercial assessment of ATH434 in MSA that resulted in a potential worldwide peak sales opportunity of USD$2.4 billion
dollars, if approved. Physicians surveyed noted the importance of inhibiting -synuclein aggregation to address the underlying pathology
of disease as addressed by the targeted mechanism of action of ATH434. The key driver of physician interest in ATH434 was the Phase 2
data that demonstrated a slowing of disease progression and stabilization of orthostatic hypotension, leading more than 70% of the neurologists
surveyed being "extremely likely" or "very likely" to prescribe ATH434.
During the period, Alterity
strengthened its balance sheet with a total of A$20M raised in gross proceeds from a strategic placement, led by high-quality healthcare-focused
funds, to advance its programs.
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical
stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is
initially focused on developing disease modifying therapies in Parkinson's disease and related disorders. Alterity has demonstrated
clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double- blind, placebo-controlled Phase 2 clinical trial in
participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 recently reported positive
data in its open label Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable
chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco,
California, USA. For further information please visit the Company's website at www.alteritytherapeutics.com.
Authorisation & Additional
This announcement was authorized by
David Stamler, CEO of Alterity Therapeutics Limited.
Investor Relations Advisory Solutions
Tiberend Strategic Advisors, Inc.
Forward Looking Statements
This press release contains
"forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities
Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends,"
"hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates,"
and other similar expressions, but these words are not the exclusive means of identifying such statements.
Important factors that could
cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled
"Risk Factors" in the Company's filings with the SEC, including its most recent Annual Report on Form 20-F as well as
reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including,
but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but
not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including,
but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory