Alterity Therapeutics Launches ATH434 Phase 2 Clinical Trial in the United States for the Treatment of Individuals with Multiple System Atrophy U.S. now open for enrollment of rare, rapidly progressive Parkinsonian Disor

Alterity Therapeutics Launches

ATH434 Phase 2 Clinical Trial in the United States

for the Treatment of Individuals with Multiple System Atrophy

U.S. now open for enrollment of rare, rapidly progressive

Parkinsonian Disorder

MELBOURNE, AUSTRALIA AND SAN

FRANCISCO, USA - 9 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 at Vanderbilt

University Medical Center in Nashville, Tennessee.

"Vanderbilt University has

been a tremendous partner for our ATH434 clinical development program, and we are very excited to utilize their expertise as our first

U.S. trial site," said David Stamler, M.D., Chief Executive Officer, Alterity. "ATH434 is a potential disease modifying treatment

for individuals living with MSA, a rapidly progressive Parkinsonian disorder with no approved treatment. The opening of enrollment in

the U.S. is a major milestone for this trial and we are now actively recruiting patients in three regions: Europe, Asia-Pacific, and the

U.S. We expect to add additional sites in the U.S. and Europe over the next few months to increase access to the study."

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.

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

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

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.