4E - Preliminary Final Report

Therapeutics Limited

4E - Preliminary Final Report

the year ended 30 June 2019

for announcement to the market

tangible assets per share

Therapeutics Limited recorded revenue of $108,538 for the year ended 30 June 2019 (2018: $201,174), which is interest received

on the Group's bank accounts. Alterity Therapeutics Limited has incurred a loss for the year of $12,337,830 (2018: $8,265,737).

This loss has increased due to the increased research and development expenditure relating to the Phase 1 clinical trial of the

Company's lead product candidate PBT434.

further details relating to the current period's results, refer to the Review of operations and activities contained within

in controlled entities

information required by Listing Rule 4.3A

accounts have been audited. An unmodified audit report is provided with the accompanying financial report.

Non-Executive Director

Non-Executive Director

David Sinclair (appointed 8 April 2019)

Tristan Edwards (appointed 8 April 2019)

George Mihaly (resigned 8 April 2019)

Non-Executive Director

Ira Shoulson (resigned 8 April 2019)

registered office in Australia

Victoria 3053, Australia

Investor Services Pty Ltd

Falls, 452 Johnston Street

85 05 05 (within Australia) & +61 3 9414 4000 (overseas)

PricewaterhouseCoopers

Victoria 3006, Australia

Victoria 3000, Australia

Company has strengthened its position over the past 12 months, and with this new positioning comes our new identity: Alterity

Therapeutics. Alterity means to be in an alternative or different state, and this ties into our science which is based on the

altering of proteins in the brain, and our new development path.

recent completion and results of the Phase 1 clinical trial for PBT434, our lead drug compound, validates Alterity's proposition

and is a key milestone in finding unmet clinical needs for treating neurodegenerative Parkinsonian disorders such as Multiple

system atrophy (MSA). PBT434 is an oral drug that inhibits alpha-synuclein protein in the brain, which is scientifically implicated

in diseases such as MSA, and was found to be safe and well-tolerated in both the elderly and healthy participants in the study.

Participants received repeated doses and had adverse event rates comparable to placebo. Alongside this, the drug crossed the blood-brain

barrier. This is very encouraging as it indicates that the drug has the potential to impact directly those parts of the brain

that are affected by disease, and disrupts the brain's natural design; keeping anything foreign or external out.

are now planning to present the full data set to several scientific conferences and finalizing opportunities for publication in

a peer-reviewed scientific publication.

reset over this last year was supported through an investment led by the Boston-based company Life Biosciences LLC with A$11.44M

received to date. This commitment serves as both an important validation of our drug, and the expertise of our drug development

and commercialization team led by David Stamler, MD. This team has a demonstrable track record in successful drug development

with three drugs approved by the FDA in the neurodegenerative space.

a team of this calibre speaks to the novelty and promise of our approach to treating some of the most devastating neurodegenerative

importance of the completion of the Phase 1 trial to investors is transcended only by the patients that we hope to one day treat;

patients with atypical Parkinsonian diseases who do not respond to existing drugs or have no effective drug options. With no effective

treatments, protein accumulates in their brains and leads to great pain, including slowed movement, muscle rigidity, bowel and

bladder problems, and blood pressure issues.

no known alternative treatments currently for Parkinsonian diseases such as MSA, the estimate peak size of sales for PBT434 to

treat MSA alone is around US$750 million in the US, this is not to mention the other Parkinsonian diseases PBT434 could potentially

treat and jurisdictions outside of the US.

sad treatment predicament for patients with MSA is recognized by global regulators and Alterity was granted Orphan designation

by the FDA earlier this year for the treatment of MSA. Orphan Drug designation by the FDA entitles Alterity to seven years of

market exclusivity for the use of PBT434 in the treatment of MSA and qualifies the sponsor of the drug for various development

incentives of the Orphan Drug Act, including tax credits for qualified clinical testing. Orphan drugs are defined as those intended

for the treatment, prevention or diagnosis of a rare disease or condition.

Company has been strengthening its patent portfolio throughout the year with various potential indications for both PBT2 and PBT434

granted which may provide development opportunities for Alterity in the coming years. We also continue to mine our substantial

drug discovery library for new compounds within and outside of the neurodegenerative space.

recognize that we have much work to do, to re-engage with investors and raise the profile of our strategy and direction at Alterity.

The growing body of evidence in our scientific foundations and PBT434 is not yet reflected in our current market valuation, and

as we continue to progress, we expect that this will also reset.

would like to thank you all for your investment in Alterity. The team is committed to grow Alterity into a world class drug company

that delivers real value for its investors and we thank them for their tireless and unwavering commitment to creating a better

future for those with neurodegenerative disease.

Mr. Geoffrey Kempler

of operations and activities

report provides details of activities and progress for Alterity Therapeutics (formerly Prana Biotechnology) for the year ended

is developing first-in-class therapies to treat neurodegenerative diseases. Its lead drug candidate, PBT434, has demonstrated

pre-clinical evidence as a potential treatment of Parkinsonian disorders and has had encouraging results in its Phase 1 clinical

program, which was completed this year.

scientific hypothesis of PBT434 is that it prevents brain cells from dying by blocking the formation of toxic alpha-synuclein

fibrils. The accumulation of the alpha-synuclein protein within neurons and glial support cells is a pathological hallmark of

Multiple system atrophy (MSA), a Parkinsonian disorder and Alterity's first therapeutic target. PBT434 has previously been

shown in animal models of Parkinson's disease (PD) and MSA to reduce alpha-synuclein aggregation, preserve neurons and improve

Company commenced the year as Prana Biotechnology and following shareholder approval at an Extraordinary General Meeting on 5

April 2019 changed its name to Alterity Therapeutics. The Company will be referred to as Alterity throughout this report.

Lead drug compound PBT434 completes phase 1 clinical trial

prior to the end of the last reporting year, Alterity received ethics committee approval for a clinical trial evaluating the safety

and pharmacokinetics of PBT434 in healthy volunteers. The Phase 1 study, conducted in Australia, recruited 70 adult volunteers

and ten elderly volunteers with the key goals of assessing the safety, tolerability and drug disposition within the body (pharmacokinetics)

of PBT434 after single and multiple oral dose administration.

volunteers in the single ascending dose phase of the study, made up of four cohorts, received progressively higher single oral

doses of PBT434 followed by blood sampling over the next 72 hours. In the multiple ascending dose phase of the study, volunteers

received eight days dosing with PBT434, administered as three successively higher dose levels, with intensive blood sampling for

pharmacokinetics on days 1 and 8. At the two highest multiple dose levels, cerebrospinal fluid was collected at steady state to

determine drug penetration to the site of action in the brain.

trial was successfully completed with systemic exposure to the drug comparable between elderly and healthy volunteers. PBT434

was found to be safe and well tolerated. Adverse event rates were found to be comparable with placebo and no subject experienced

a serious adverse event or an adverse event that led to discontinuation of the study drug.

the results indicated that PBT434 not only crosses the blood brain barrier in humans, confirming previous observations in animal

studies, but that clinically tested doses achieve concentrations in the brain comparable to those associated with efficacy in

animal models of disease.

interim clinical data were presented at the American Academy of Neurology Annual Meeting in Philadelphia, USA in May with plans