Alterity Therapeutics Announces Expanded ATH434 Phase 2 Clinical Development Program - Clinical trial to enroll patients with early-stage Multiple Systems Atrophy (MSA) - - Expanding bioMUSE Natural History Study - MELBO

Alterity Therapeutics Announces Expanded ATH434

Phase 2 Clinical Development Program

- Clinical trial to enroll patients with

early-stage Multiple Systems Atrophy (MSA) -

- Expanding bioMUSE Natural History Study

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA

- 19 October 2021: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology

company dedicated to developing disease modifying treatments for neurodegenerative conditions, today announced an expansion of the clinical

development program for the Company's lead asset, ATH434, in patients with Multiple System Atrophy (MSA), a rare and rapidly progressing

Parkinsonian disorder. ATH434 has been shown to reduce abnormal accumulation of -synuclein by restoring normal iron balance in

the brain with the objective of improving motor function in patients with MSA and Parkinson's Disease.

The Phase 2 clinical trial is a randomized, double-blind,

placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on

imaging and protein biomarkers such as aggregating -synuclein and excess iron, which are important contributors to MSA pathology.

Several other biomarkers and clinical endpoints will permit comprehensive assessment of ATH434 efficacy along with characterization of

safety and pharmacokinetics. Based on consultation with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA)

and clinical experts in MSA, Alterity has established that patients will receive treatment for 12 months in the Phase 2 study. The longer

treatment duration will provide an improved opportunity to detect changes in biomarkers and clinical endpoints to optimize design of a

definitive Phase 3 study.

In addition, the Biomarkers of Progression in

Multiple Systems Atrophy (bioMUSE) natural history study has reached its original enrollment goal and will be expanded to a total of 20

patients with MSA. The study has proved to be invaluable in generating data to inform and de-risk the Phase 2 trial design, and it will

continue to provide longitudinal biomarker and clinical data to characterize disease progression in a patient population that mirrors

those to be enrolled in the Phase 2 study.

"With our planned Phase 2 clinical trial

and the expansion of bioMUSE, we have created a robust development program to advance ATH434 for the treatment of MSA," said David

Stamler, M.D., Chief Executive Officer, Alterity. "By restoring normal iron balance in the brain, ATH434 has the potential to block

-synuclein aggregation, preserve neurons, and treat the underlying pathology of MSA. If successful, this approach to modifying

disease progression will have a profound impact on the quality of life for individuals living with MSA, a devastating disease with very

few treatment options."

Dr. Stamler, continued, "Importantly, our

Phase 2 clinical trial integrates regulatory feedback, expert advice, and critical learnings from bioMUSE to establish an optimal trial

design with an improved overall chance of success. There has been great interest in our program from prospective investigators and we

look forward to initiating the trial in the first quarter of calendar year 2022."

The Phase 2, double-blind clinical trial is a

three-arm study where early stage MSA patients will be randomized to one of two doses of ATH434 or a placebo, with twice daily dosing.

Early-stage patients with a clinical diagnosis of MSA who are ambulatory, have no evidence of severe impairment, and do not have long

standing motor symptoms will be enrolled in the study. The trial is expected to enroll 60 early-stage patients in approximately 30 sites

in Australia, New Zealand, Europe, and the U.S. As reported last month, the initial results from the Company's bioMUSE natural history

study were instrumental in guiding the design of the Phase 2 clinical trial by informing patient selection and confirming that iron content

in the brain is a promising biomarker. Based on these data, Alterity believes that treating patients in the early stage of their disease

will provide the best chance of improvement from ATH434.

Alterity's lead candidate, ATH434, is the

first of a new generation of small molecules 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. In this way, it has excellent potential to treat Parkinson's disease as well as various forms of atypical Parkinsonism

such as Multiple System Atrophy (MSA). ATH434 has successfully completed a Phase 1 clinical trial demonstrating the agent is well tolerated,

orally bioavailable, and achieved brain levels comparable to efficacious levels in animal models of MSA, with the objective of restoring

function in patients with MSA and other Parkinsonian disorders.

ATH434 has been granted Orphan designation for

the treatment of MSA by the U.S. FDA and the European Commission.

Biomarkers of progression in Multiple Systems

Atrophy (bioMUSE) is an ongoing, natural history study that aims to track the progression of patients with MSA, a Parkinsonian disorder

without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under

the direction of Daniel Claassen, MD, Associate Professor of Neurology and Principal Investigator. Natural history studies are important

for characterizing disease progression in selected patient populations. The study has provided rich data for optimizing the design of

Alterity's Phase 2 clinical trial and will be expanded to include a total of 20 patients with MSA. The ongoing study will continue

to provide vital information on early stage MSA patients, inform the selection of biomarkers suitable to evaluate target engagement and

preliminary efficacy, and deliver clinical data to characterize disease progression in a patient population that mirrors those to be enrolled

in the Phase 2 clinical trial.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is a rare, neurodegenerative

disease characterized by a combination of symptoms that affect both the autonomic nervous system and 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 motor impairment, 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 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 forms of Parkinsonian disorders. Alterity also has a broad drug discovery platform generating

patentable chemical 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.

1National Institute of Health: Neurological Disorders and

Stroke, Multiple Systems Atrophy Fact Sheet

Authorisation & Additional information

This announcement was authorized by David Stamler, CEO of Alterity

Therapeutics Limited.

Contact: Investor Relations

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