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Alterity Therapeutics Announces Presentation of New Data Demonstrating Novel Mechanisms of ATH434 MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA - 16 November 2023: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity"

Key Takeaway: Alterity Therapeutics has announced new data on ATH434, presented at the Society for Neuroscience conference. This data demonstrates ATH434's ability to protect mitochondrial function and exert antioxidant activity independent of its iron-binding properties. The compound is currently undergoing two Phase 2 clinical trials for Multiple System Atrophy and has been granted Orphan drug designation by the FDA and European Commission. The CEO highlighted the potential for ATH434 to slow disease progression in neurodegenerative conditions.

Market Sentiment Analysis

POSITIVE FACTORS

  • New data shows ATH434 has potent antioxidant and mitochondrial-protective effects.
  • The compound has demonstrated potential as a treatment for neurodegenerative diseases like Parkinson's.
  • ATH434 has successfully completed Phase 1 trials, indicating good tolerance and efficacy in preclinical models.

CONCERNS & RISKS

  • Future outcomes depend on the results of ongoing Phase 2 clinical trials.
  • The company acknowledges potential risks related to drug development and approval.

Full Press Release Details

Alterity Therapeutics Announces
Presentation of New Data Demonstrating Novel Mechanisms of ATH434
MELBOURNE, AUSTRALIA AND SAN
FRANCISCO, USA - 16 November 2023: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE)
("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments
for neurodegenerative diseases, today announced promising new data related to ATH434 was presented at the Society for Neuroscience
that took place November 11-15, 2023, in Washington, D.C.
The poster entitled, "Potent
Antioxidant and Mitochondrial-protectant Effects of ATH434, a Novel Inhibitor of -Synuclein Aggregation with Moderate Iron-binding
Affinity," presents 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 study was run under the direction of Dr. Daniel J. Kosman, Distinguished Professor
of Biochemistry at the State University of New York at Buffalo.
David Stamler, M.D., Chief Executive
Officer of Alterity, commented, "These exciting new data underscore the potential of ATH434 as a treatment for neurodegenerative
diseases, including Parkinson's disease and related disorders. We have long known that ATH434 is able to reduce labile iron which,
when elevated, can drive oxidative stress. The demonstrated mitochondrial protection may reveal additional mechanisms that augment its
ability to slow disease progression. We are grateful for the valued contributions from our collaborators in Dr. Kosman's laboratory
The study, authored by Dr. Danielle Bailey,
investigated the efficacy of ATH434 and comparator agents as mitochondrial protectants using a menadione-induced model of oxidative stress
in a neuronal cell line. A suite of in-solution assays detailed the mechanisms underlying ATH434's direct antioxidant capacity.
The poster presentation is attached and can be accessed on Alterity's website under The Science page.
candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration.
ATH434 has been shown preclinically to reduce -synuclein pathology and preserve neuronal function by restoring normal iron
balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various
Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent
is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being
studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in
patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA.
ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission.
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 and is currently being evaluated in two Phase 2 clinical
trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized 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
Any forward-looking statement
made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is
made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time
to time, whether as a result of new information, future developments or otherwise.

Frequently Asked Questions

What is ATH434 developed by Alterity Therapeutics?

ATH434 is an oral treatment designed to inhibit protein aggregation linked to neurodegeneration.

How does ATH434 protect mitochondrial function?

ATH434 preserves mitochondrial function and exhibits direct antioxidant activity independent of iron binding.

What clinical trials are currently studying ATH434?

ATH434 is evaluated in two Phase 2 trials focused on early and advanced stages of MSA.

What neurodegenerative diseases could ATH434 potentially address?

ATH434 may treat Parkinson's disease and various Parkinsonian disorders like Multiple System Atrophy.

What designation has ATH434 received from regulatory bodies?

ATH434 has Orphan Drug designation from both the U.S. FDA and the European Commission.

Last updated: Nov 16, 2023