Full Press Release Details
Appendix 4C - Q3 FY25 Quarterly Cash Flow
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 30 April 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 31 March 2025 (Q3 FY25).
David Stamler, M.D., Chief Executive
Officer of Alterity, commented, "The third fiscal quarter of 2025 was one of our most successful periods to date for Alterity Therapeutics.
The outstanding results from our ATH434 Phase 2 double-blind trial continue to demonstrate the tremendous potential for ATH434 as a disease
modifying treatment for MSA and are resonating throughout the medical community. For individuals living with MSA, there is currently no
approved therapy to help stabilize or improve their condition, and we believe that ATH434 may be able to change this paradigm."
"During the quarter we also completed
our open-label Phase 2 trial in patients with more advanced MSA. Data from this study are expected mid-year and will provide insights
on the effects of ATH434 treatment in a population that faces severe challenges due to the advanced stage of their illness. We look forward
to engaging with the U.S. Food and Drug Administration and European regulatory authorities as we seek to advance the development of ATH434
for individuals living with MSA," concluded Dr Stamler.
Alterity's cash position on 31
March 2025 was A$17.96M with operating cash outflows for the quarter of A$0.73M. In accordance with ASX Listing Rule 4.7C, payments of
A$80k 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 Activities
ATH434-201: Randomized, Double-Blind, Placebo Controlled
Phase 2 Clinical Trial in MSA
On 30 January 2025, Alterity announced
the positive topline results led by robust clinical efficacy. Subsequent to the quarter end, on 10 April 2025, an oral presentation was
delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting that provided additional data from the trial. Overall, the study
results support continued advancement of ATH434 for the treatment of MSA.
The ATH434-201 Phase 2 clinical trial
is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with MSA. In addition to evaluating the efficacy
of ATH434 and its impact on biomarkers, wearable sensors were employed to evaluate outpatient activity levels relevant to patients with
MSA. The study enrolled 77 individuals with MSA who were randomly assigned to receive one of two dose levels of ATH434 or placebo. Participants
received treatment for 12 months.
The clinical analysis included 71
patients who had at least one post-baseline assessment of the key clinical endpoint, the modified UMSARS1 I activities of daily
living scale. On this endpoint, ATH434 demonstrated a clinically significant reduction in disease severity versus placebo, with a 48%
relative treatment effect at the 50 mg dose (p=0.02)^ and a 30% relative treatment effect at the 75 mg dose (p=0.16) at 52
weeks. Additional efficacy assessments showed improvement consistent with the UMSARS I findings: the Clinical Global Impression of Severity
Scale2 demonstrated improvement compared to placebo at both dose levels, with difference at 50 mg achieving nominal statistical
significance (p=0.0088). On the Orthostatic Hypotension Symptom Assessment (a patient reported outcome), on average placebo patients worsened
by approximately 6 points over 52 weeks whereas both ATH434 treatment groups improved over the same period (p=0.08 at 50 mg, p=0.14 at
75 mg). Increased activity in the outpatient setting was observed at both dose levels as compared to placebo as measured by wearable sensors,
with clinically meaningful improvements in step count, bouts of walking, total walking time, and total standing time. ATH434 was well
tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Regarding neuroimaging,
ATH434 demonstrated target engagement by stabilizing or reducing iron at both dose levels compared to placebo in MSA affected brain regions.
In addition, ATH434 demonstrated trends in reducing brain atrophy at both dose levels compared to placebo. Overall, the study results
support continued advancement of ATH434 for the treatment of MSA.
ATH434-202: Open-label, Biomarker Phase 2 Clinical
Trial in Advanced MSA
On 27 March 2025, Alterity announced
that the last patient in the ATH434-202 Phase 2 trial completed the study. The ATH434-202 is an open label study designed to evaluate
the safety, efficacy and target engagement of ATH434 in participants with advanced MSA. The 202 study gives Alterity the opportunity to
evaluate the effects of ATH434 treatment in an MSA population more advanced than individuals enrolled in the ATH434-201 study. These individuals
face severe challenges due to the stage of their illness. The data from this study will help Alterity guide the MSA development program
given the differences between the 202 study and the double-blind trial. Alterity expects to report topline data from this study in mid-year
Corporate Activities
During the period, Alterity strengthened its
balance sheet with a total of approximately A$15.0M raised in gross proceeds through financing transactions. Subsequent to the end
of the quarter, an additional A$27.1M was raised upon completion of the second tranche of the two-tranche placement. During the
period, Alterity was also granted a settlement in relation to the refund of $1.65M from the Australian Taxation Office under the
Australian Government's Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the
financial year ending 30 June 2020.
The Company expects to use these funds
to accelerate ATH434 regulatory and development activities and to continue research and discovery of novel compounds for additional indications
such as Parkinson's disease.
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 recently reported
positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly
progressive Parkinsonian disorder. ATH434 is also being evaluated in a 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.
1 UMSARS: Unified Multiple System Atrophy Rating
^ All p-values are uncorrected
2 Clinical Global Impression of Severity: a
clinician assessment of the total picture of the subject including the impact of the illness on function and level of distress
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of
Alterity Therapeutics Limited.
Investor and Media Contacts:
Head of Investor Relations and Business Development
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 approval, production and marketing of the Company's drug components, including, but not
limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or
inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent