Alterity Therapeutics Reports Positive Interim Data from ATH434-202 Phase 2 Clinical Trial in Multiple System Atrophy - 43% of Participants Showed Improvement on the UMSARS Activities of Daily Living Scale - - 29% of Par

Alterity Therapeutics Reports

Positive Interim Data from ATH434-202 Phase 2 Clinical Trial in Multiple System Atrophy

- 43% of Participants Showed

Improvement on the UMSARS Activities of Daily Living Scale -

- 29% of Participants had Stable

or Improved Neurological Symptoms -

- Objective Biomarkers Demonstrated Improvement Consistent

with Clinical Findings -

- ATH434 was Well-Tolerated

with No Safety Signals Detected -

AUSTRALIA AND SAN FRANCISCO, USA - 17 July 2024: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or

"the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative

diseases, today announced positive interim data from the ATH434-202 open-label Phase 2 clinical trial in patients with multiple

system atrophy (MSA). ATH434 has been shown preclinically to reduce -synuclein pathology and preserve neuronal function by

restoring normal iron balance in the brain.

The interim analysis included clinical

and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12

months. After 6 months of treatment, 43% of participants showed improvement on the UMSARS1, indicating reduced disability on

activities of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms (clinical responders)

as assessed by both the treating physician and the patient. Importantly, the clinical responders on average had reduced accumulation of

iron on MRI in the substantia nigra, putamen and globus pallidus and stable levels of NFL, a marker of axonal injury, when compared to

participants who declined.

"I am very encouraged by these

positive interim data in advanced MSA patients," said David Stamler, M.D., Chief Executive Officer of Alterity. "As MSA is

a rapidly progressive and unremitting disease, we expected to see decline in all participants. Instead, we saw favorable clinical and

biomarker outcomes in some patients suggesting that ATH434 has the potential to modify the course of this devastating condition. We were

also very pleased to see that the clinical responders had biomarker evidence of stable disease as this provides an objective indication

of potential efficacy."

Dr. Stamler, continued, "In the

ATH434-202 trial, the participants who stabilized or improved with ATH434 treatment had less advanced disease than those who progressed.

This is noteworthy as we have enrolled earlier stage MSA patients in our randomized, double-blind clinical trial ATH434-201. Although

the number of patients studied thus far is small, the new data reinforces that we have taken the right approach in our randomized trial

and increases my overall confidence in the ATH434 development program."

Daniel Classen, M.D., M.S., Professor

of Neurology at Vanderbilt University Medical Center and principal investigator for the ATH434-202 Phase 2 study, commented "I am

gratified to see that the work we have done over the last several years is bearing fruit as we enhance our understanding of MSA. This

has led to improved patient selection and optimized biomarker endpoints in the Alterity Phase 2 trials. The clinical observations in the

ATH434-202 study are supported by the objective biomarkers of brain volume, brain iron, and NfL. These early data increase our confidence

that we have chosen the right biomarker and clinical endpoints to evaluate the potential effect of ATH434 in individuals with MSA. I am

grateful to the study participants and their family members for their contributions to the study."

ATH434-202 Interim Results

A total of 10 participants have been enrolled

in the trial. The interim data reported today is from the 7 patients who have completed six months of treatment with ATH434, 3 of whom

have also completed 12 months of treatment. Only neuroimaging data are available from month 12. The participants in the trial were diagnosed

with MSA using a multimodal approach (clinical, neuroimaging, fluid biomarkers) and treated with oral ATH434 75 mg twice daily.

Clinical, biomarker and safety assessments

were conducted during the study. While the data are preliminary, the Company sees a positive trend with the current participant patient

Clinical Assessments at Month 6

Unified MSA Rating Scale Part I, historical

Impression of Change

Assessments at Month 6 and Month 12

MRI Biomarkers (n=7):

Definitions and References

About ATH434-202 Phase 2 Clinical Trial

The ATH434-202 Phase 2 clinical trial

is an open label study, entitled "A Biomarker Study of ATH434 in Participants with MSA." The Biomarker trial enrolled 10 individuals

with advanced MSA. ATH434-202 study participants will receive treatment with ATH434 for 12-months. The study will assess the effect of

ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics.

The selected biomarkers, including brain volume, iron and aggregating -synuclein, are important contributors to MSA pathology and

are appropriate targets to demonstrate drug activity. The primary objective of this study is to evaluate the impact of 12 months treatment

with ATH434 on brain volume in a more advanced patient population than is being studied in Alterity's randomized Phase 2 trial.

Final, 12-month data from the ATH434-202 trial are expected in the first half of 2025. Additional information on the open label Phase

2 trial can be found at clinicaltrials.gov NCT05864365.

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 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 Multiple System Atrophy

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 at least 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 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.