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Alterity Therapeutics Limited ACN 080 699 065 Appendix 4E Preliminary Final Report 30 June 2020 Lodged with the ASX under Listing Rule 4.3A. This information should be read in conjunction with the Appendix 4E. Alterity T

Key Takeaway: Alterity Therapeutics Limited Appendix 4E Preliminary Final Report Lodged with the ASX under This information should be read in conjunction with the Appendix 4E. Alterity Therapeutics Limited 4E - Preliminary Final Report For the year ended 30 June 2020 Name of entity Alte

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Alterity Therapeutics Limited
Appendix 4E Preliminary Final Report
Lodged with the ASX under
This information should be read in conjunction with the Appendix 4E.
Alterity Therapeutics Limited
4E - Preliminary Final Report
For the year ended 30 June 2020
Name of entity Alterity Therapeutics Limited
ABN or equivalent company reference 37 080 699 065
Current reporting period 30 June 2020
Corresponding reporting period 30 June 2019
Results for announcement to the market
$
Revenue for ordinary activities Down 84.2 % to 17,117
Net loss after tax (from ordinary activities) for the year attributable to members Down 18.5 % to 10,059,684
Net loss after tax for the year attributable to members Down 18.5 % to 10,059,684
Net tangible assets per share
30 June 2020 30 June 2019
Net tangible asset backing per share (cents) 1.01 1.92
Explanation of results
Alterity Therapeutics
Limited recorded revenue of $17,117 for the year ended 30 June 2020 (2019: $108,538), which is interest received on the
Group's bank accounts. Alterity Therapeutics Limited has incurred a loss for the year of $10,059,684 (2019:
$12,337,830). T his loss has decreased due to the reduced research and development expenditure relating to the Group's
lead product candidate ATH434 following completion of the Phase 1 clinical trial in July 2019.
For further details relating
to the current period's results, refer to the Review of operations and activities contained within this document.
Changes in controlled entities
Other information required
by Listing Rule 4.3A
This preliminary financial
report is based on accounts which are in the process of being audited. The 30 June 2020 financial report, when audited, is likely
to contain an independent auditor's report which includes an emphasis of matter related to a material uncertainty that may cast
significant doubt about the Company's ability to continue as a going concern. Additional disclosure has been included in Note 22(a)(vi)
to the preliminary financial report.
Alterity Therapeutics Limited
Appendix 4E Preliminary Final Report
Contents Page
Corporate directory 1
Review of operations and activities 2
Consolidated financial statements 6
Alterity Therapeutics Limited
Directors Mr. Geoffrey Kempler
Chairman & CEO
Mr. Brian Meltzer
Independent Non-Executive Director
Mr. Peter Marks
Independent Non-Executive Director
Mr. Lawrence Gozlan
Non-Executive Director
Dr. David Sinclair
Non-Executive Director
Mr. Tristan Edwards
Non-Executive Director
Secretary Mr. Phillip Hains
Principal registered office in Australia Level 3, 62 Lygon Street
Carlton Victoria 3053
Australia
+61 3 9824 5254
Share register Computershare Investor Services Pty Ltd
Yarra Falls, 452 Johnston Street
Abbotsford Victoria 3067
1300 85 05 05 (within Australia) & +61 3 9414 4000 (overseas)
Auditor PricewaterhouseCoopers
2 Riverside Quay
Southbank Victoria 3006
Solicitors Quinert Rodda & Associates Pty Ltd
Level 6/400 Collins St
Melbourne Victoria 3000
Website www.alteritytherapeutics.com
Therapeutics Limited
of operations and activities
Review of Operations and Activities
This report provides details
of activities and progress for Alterity Therapeutics Limited for the year ended 30 June 2020.
Alterity is developing first-in-class
therapies to treat neurodegenerative diseases. The Company's lead drug candidate, ATH434 (formerly PBT434), is the first
of a new generation of small molecules designed to block the accumulation and aggregation of alpha-synuclein ( -synuclein).
Alpha-synuclein, when aggregated in the brain, is a pathological hallmark of Parkinsonian conditions and is considered an important
biologic target for treating these neurodegenerative diseases.
ATH434 is an oral small molecule
drug candidate with potential for treating synucleinopathies such as Parkinson's disease and Multiple System Atrophy (MSA), a type
of parkinsonian disorder which has been selected as the first disease target. MSA is a rare and rapidly progressive neurological
disorder affecting adults.
ATH434 has demonstrated pre-clinical
evidence as a potential treatment of MSA and produced encouraging results in its Phase 1 clinical program. The company is in the
preparatory phase of planning for its Phase 2 clinical trial.
Meeting with US FDA provides development pathway
In June 2020, Alterity received
guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 following the successful
completion of its Phase 1 clinical trial. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development
plan for ATH434, including feedback on the Phase 2 study design.
Alterity reached agreement
with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects
of the Company's Phase 2 study design including the proposed patient population, safety monitoring plan and strategy for
evaluating drug exposure during the study.
As there are currently no
approved treatments for MSA and, therefore, no regulatory precedent regarding accepted efficacy endpoints, the FDA and Alterity
will work together to develop an endpoint that is best suited for the MSA patients to be studied. The FDA has also encouraged Alterity
to utilise data from a natural history study that Alterity has planned with clinical and neuroimaging experts at Vanderbilt University
Medical Center in the US.
This natural history study,
referred to as bioMUSE, or biomarkers of Progression in Multiple System Atrophy, will enrol early stage MSA patients and track
change in clinical parameters and biomarkers for up to one year. Natural history studies are important for characterizing disease
progression over time in selected patient populations. Well-conducted, these studies can provide vital information to optimize
clinical trial design and inform the selection of biomarkers to evaluate target engagement of drug candidates.
In parallel with the US strategy,
Alterity is also pursuing a regulatory pathway in Europe and Australia. Given the uncertainty of study conduct and recruitment
in the COVID-19 era, and with the need to target sites that are minimally impacted, it is prudent for the Company to be flexible
in identifying and recruiting sites around the world and maintaining optionality. Planning is underway to meet with European authorities.
European Commission approves Orphan Designation for
The European Commission (EC)
granted Orphan Drug designation to ATH434, which entitles Alterity to ten years of market exclusivity in the European Union for
the use of ATH434 in the treatment of MSA and other benefits including assistance in developing clinical protocols, reduced fees
and access to EU-funded research grants. This followed the US FDA granting ATH434 orphan drug status for the treatment of MSA in
The approval was based on the
recommendation of a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products, which
was announced on the 18th of November 2019.
Therapeutics Limited
of operations and activities
Completion of Phase 1 Clinical Trial
In July 2019 Alterity announced
that it had successfully completed its Phase 1 study of ATH434. The completed trial included data from elderly volunteers receiving
repeated doses and demonstrated that the drug was safe and well-tolerated, with an adverse event profile like adult volunteers.
As was observed in healthy adult volunteers, no elderly subject experienced a serious adverse event or an adverse event that led
to discontinuation of the study drug.
The findings built on the
data from healthy volunteers announced in May 2019 at the American Academy of Neurology Annual Meeting.
Systemic exposure to the drug
was comparable between elderly and healthy volunteers. This information, along with previous results in the Phase 1 study, indicate
that clinically tested doses achieve concentrations in the brain that are comparable with those associated with efficacy in animal
The Phase 1 Clinical Trial
for ATH434 recruited healthy adult and elderly ( 65) volunteers with the primary goals of assessing the safety and tolerability
of ATH434 after single and multiple oral dose administration. Secondary goals included evaluating pharmacokinetics in plasma and
cerebrospinal fluid that enabled determination of how ATH434 is absorbed and metabolized by the body.
Growing scientific interest for ATH434
In May, data on ATH434 was
Last updated: Aug 31, 2020