Full Press Release Details
Appendix 4C - Q2 FY24
Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN
FRANCISCO, USA - 31 January 2024, Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the
Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases
its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 December 2023 (Q2 FY24).
"The second quarter of our
fiscal year was extremely productive and provided great momentum to carry us into the 2024 calendar year," said David Stamler, M.D.,
Chief Executive Officer of Alterity. "Completing enrolment in our ATH434-201 clinical trial in early-stage multiple system atrophy
(MSA) was a major milestone as we look to change the treatment paradigm for individuals living with this rare and devastating disease.
We expect to complete the 201 trial in November 2024 and report topline results in January 2025. For our ATH434-202 trial in more advanced
MSA, we plan to report preliminary six-month data in the first half of 2024."
Dr. Stamler, continued, "During
the quarter, we also had several important data presentations related to ATH434 that validate the treatment approach in our ongoing clinical
trials. Most notably, for the first time we demonstrated the efficacy of ATH434 in a primate model of Parkinson's disease. ATH434
treatment improved both motor performance and general function in this higher order animal, and these benefits were associated with reductions
in iron in affected brain regions. In a separate investigation, a new mechanism was described for ATH434 - direct antioxidant activity.
By protecting vital mitochondrial function, we believe ATH434 has increased potential to slow disease progression."
"During 2024, we will continue
to reap benefits from our bioMUSE natural history study as we deepen our understanding of the biomarker evaluation of MSA. We are excited
about the progress of all of our studies to date and look forward to the data readouts coming over the next year," concluded Dr.
Alterity's cash position
on 31 December 2023 was A$12.3M with operating cash outflows for the quarter of A$4.9M. The company strengthened its balance sheet through
a Two Tranche placement raising approximately A$1.3M during the quarter from qualified institutional investors in Tranche One, with the
balance of approximately A$3.5M from Tranche Two of the Placement raised in January 2024. In conjunction with this offering, a Security
Purchase Plan (SPP) was approved by shareholders at the Extraordinary General Meeting held on 29 December 2023. The SPP results will be
released this week and the Company is pleased to report that there was significant interest from current shareholders.
In accordance with ASX Listing Rule 4.7C, payments
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 Phase 2 Clinical
Trial in Early-State MSA
On 8 November 2023, Alterity announced
that enrollment was successfully completed in the ATH434-201 Phase 2 clinical trial. This randomized, double-blind, placebo-controlled
study enrolled participants with early-stage multiple system atrophy (MSA) across the U.S., Europe, Australia and New Zealand. The ATH434-201
study is treating participants for 12 months and, therefore, the study will complete in November 2024. Once complete, the data from the
trial will be analyzed and the Company expects to report topline results by January 2025.
ATH434-202: Open-label, Biomarker Phase 2 Clinical
Trial in More Advanced MSA
The ATH434-202 trial continues
to enroll participants with more advanced MSA than in the 201 trial. A key aim of the 202 study is to assess the efficacy of ATH434 treatment
on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics.
While the 202 trial is also treating participants for 12-months, it has an open label design that will allow Alterity to perform interim
analyses of biomarker and clinical data while the study is ongoing, providing a potential early indication of efficacy. The Company expects
to report preliminary six-month data from the initial patients enrolled in the ATH434-202 trial in the first half of 2024.
ATH434 for the Treatment of Parkinson's Disease
On 4 December 2023, Alterity
announced that promising new data on the effect of ATH434 in a Parkinson's disease primate model was presented at the Future of
Parkinson's Disease Conference. The poster, entitled, "Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity
for Iron, in Hemiparkinsonian Macaques" demonstrated that ATH434 treatment improved motor performance and general function in monkeys
with experimentally induced Parkinson's disease. Importantly, the improvements in motor skills and general functioning in this higher
order animal - the monkey - parallel human parkinsonism and were associated with reductions in iron in affected brain regions.
Novel Mechanisms for ATH434 as a Treatment for Neurodegenerative
On 16 November 2023, Alterity
announced that promising new data related to ATH434 was presented at the Society for Neuroscience. The poster entitled, "Potent
Antioxidant and Mitochondrial- protectant Effects of ATH434, a Novel Inhibitor of -Synuclein Aggregation with Moderate Iron- binding
Affinity," demonstrated new data indicating that ATH434 can preserve mitochondrial function after oxidative injury and exert direct
anti-oxidant activity independent of its iron binding properties. These features were not observed with another iron binding agent approved
for treating iron overload that was also investigated. The demonstrated mitochondrial protection may reveal additional mechanisms that
augment the ability of ATH434 to slow disease progression and underscores the potential of ATH434 as a treatment for neurodegenerative
bioMUSE Natural History Study
The bioMUSE study continues to generate
invaluable data related to the understanding of MSA and its early presentation and demonstrates that Alterity is leading the way in
biomarker evaluation of this rare disease. On 27 November 2023, a data presentation entitled, "Relationship between
N-acetylaspartate and neurofilament light chain in multiple system atrophy" was presented at the recent 34th International
Symposium on the Autonomic Nervous System (AAS). In the study, the data provided evidence that N-acetylaspartate (NAA) correlates
with levels of neurofilament light chain (NfL) in patients with early MSA. NfL is a widely used biomarker that is a measure of
neuronal damage. The findings suggest that the NAA metabolite may be a useful biomarker for assessing disease severity and treatment
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's
lead asset, ATH434, has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating
patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California,
USA. For further information please visit the Company's web site at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorised by David Stamler, CEO of
Alterity Therapeutics Limited.
Investor and Media Contacts:
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 products coming to market, the uncertainty of obtaining patent protection for
the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company's patent rights and
the uncertainty of the Company freedom to operate.
Any forward-looking statement