Alterity Therapeutics Launches ATH434 Phase 2 Clinical Trial in Italy for the Treatment of Individuals with Multiple System Atrophy Recruitment ongoing in Europe, Asia-Pacific, and the U.S. for study of rapidly progressi

Alterity Therapeutics Launches

ATH434 Phase 2 Clinical Trial in Italy for the

Treatment of Individuals with Multiple System Atrophy

Recruitment ongoing in Europe,

Asia-Pacific, and the U.S. for study of rapidly progressive Parkinsonian Disorder

MELBOURNE, AUSTRALIA AND SAN FRANCISCO,

USA - 25 January 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 the Company's

Phase 2 clinical trial of ATH434 for the treatment of patients with Multiple System Atrophy (MSA) is now open for enrollment in Italy.

"Expanding our presence

in another major European country is important as we continue to broaden access to our ATH434 Phase 2 clinical trial to individuals living

with MSA," said David Stamler, M.D., Chief Executive Officer, Alterity. "Current therapies for MSA only treat the symptoms

of the disease whereas ATH434 is a potential disease modifying therapy designed to address the underlying pathology of MSA. Our trial

sites in Europe, Asia-Pacific, and the U.S. are now actively recruiting participants with early-stage MSA as we continue our commitment

to bring a much-needed treatment to individuals living with this devastating condition."

The Phase 2 clinical trial is a

randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect

of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy,

in addition to assessments of safety and pharmacokinetics. The selected biomarkers, including brain iron and aggregating -synuclein,

are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors will

also be employed to evaluate motor activities that are important to patients with MSA. The study is expected to enroll approximately 60

adults to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide an

opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase

2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.

Alterity's lead 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 nerve cells 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 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the

European Commission.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is

a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect

the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive

disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or

rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired

balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein -synuclein

within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects approximately 15,000

individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are

able to slow disease progression and there is no cure.1

1National Institute of Health:

Neurological Disorders and Stroke, Multiple System Atrophy Fact Sheet

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 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, uncertainties relating

to the impact of the novel coronavirus (COVID-19) pandemic on the company's business, operations and employees, 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

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.