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Alterity Therapeutics Limited Appendix 4D Half year ended 31 December 2020 Name of entity: Alterity Therapeutics Limited ABN: 37 080 699 065 Half-year ended: 31 December 2020 Previous period: 31 December 2019 Results for

Key Takeaway: Alterity Therapeutics Limited Appendix 4D Half year ended 31 December 2020 Name of entity: Alterity Therapeutics Limited ABN: 37 080 699 065 Half-year ended: 31 December 2020 Previous period: 31 December 2019 Results for announcement to the market A$ Revenue from ordinar

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Alterity Therapeutics Limited Appendix 4D
Half year ended 31 December 2020
Name of entity: Alterity Therapeutics Limited
ABN: 37 080 699 065
Half-year ended: 31 December 2020
Previous period: 31 December 2019
Results for announcement to the market
A$
Revenue from ordinary activities Down 53.6% to 6,553
Net loss after tax (from ordinary activities) for the period attributable to members Up 51.8% to 8,561,862
Net loss after tax for the period attributable to members Up 51.8% to 8,561,862
Net tangible assets per security
31 December 31 December
2020 2019
cents cents
Net tangible asset backing (cents per share) 1.69 1.27
Explanation of results
Alterity Therapeutics Limited recorded
income of $6,553 for the half year ended 31 December 2020 (2019:$14,133) which is interest received on the Group's bank accounts.
Alterity Therapeutics Limited has incurred a loss of $8,561,862 for the half year ended 31 December 2020 (2019: $5,640,258).
An explanation of the key financial elements contributing to
the revenue and result above can be found in the review of operations included within the directors' report.
No dividends have been paid or declared by the Group for the
current financial period. No dividends were paid for the previous financial period.
Changes in controlled entities
There have been no changes in controlled entities during the
period ended 31 December 2020.
Other information required by Listing Rule 4.2A
The interim financial statements have been reviewed by the Group's
independent auditor without any modified opinion, disclaimer or emphasis of matters.
Page
Corporate directory 1
Directors' report 2
Consolidated statement of profit or loss and other comprehensive income 8
Consolidated statement of financial position 9
Consolidated statement of changes in equity 10
Consolidated statement of cash flows 11
Notes to the consolidated financial statements 12
Directors' declaration 22
Independent auditor's report to the members 23
Alterity Therapeutics Limited
Directors Mr. Geoffrey Kempler
Non-Executive Chairman
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
Alterity Therapeutics Limited
Your directors present their report on
the Consolidated Entity (referred to hereafter as the group) consisting of Alterity Therapeutics Limited and the entities it controlled
at the end of, or during, the half-year ended 31 December 2020.
The following persons were directors of
Alterity Therapeutics Limited during the whole of the half-year and up to the date of this report:
Mr. Geoffrey Kempler
Review of operations - 31 December 2020
Detailed below is an update on the status
of the Group's research and development projects and overall operations for the half-year ended 31 December 2020 .
The Group's 30 June 2020 Annual Report
contains detailed background information relating to its operations including its research and development projects and collaboration
partners and should be read in conjunction with this report.
Alterity Therapeutics' lead compound
ATH434 is an orally bioavailable, brain penetrant, small molecule inhibitor of -synuclein aggregation, which is being developed
for Multiple System Atrophy (MSA). Alpha-synuclein aggregation is implicated in the pathology of MSA and Parkinson's disease.
MSA is a rare and rapidly progressive Parkinsonian
disorder. It is a neurodegenerative disease with major sources of disability resulting from motor symptoms characteristic of Parkinson's
disease and impaired ability to maintain normal blood pressure, bowel function and bladder control. Current treatment includes
medications and lifestyle changes to help manage symptoms, but there is no treatment to address the underlying cause and no cure.
The Company's Phase 1 Clinical trial
reported in 2019 found ATH434 was considered safe and well-tolerated in adult and older adult ( 65 years) human subjects, with
an adverse event profile comparable to placebo. The safety profile was similar for adult and older adult volunteers. The results
also indicated that ATH434 crosses the blood brain barrier in humans and that well-tolerated doses achieved concentrations in the
brain that exceed those associated with robust efficacy in animal models.
ATH434 has Orphan drug designation both
with the US FDA and European Commission for the treatment of MSA.
Several significant advancements were achieved
during the reporting period, as well as the continued strengthening of the safety profile of ATH434.
In addition, the company continued to explore
opportunities for PBT2 and identify potential expansion of its therapeutic portfolio.
Alterity Therapeutics Limited
Review of operations - 31 December 2020 (continued)
bioMUSE natural history study for
Patients with MSA are being enrolled in
Alterity's bioMUSE Study in the United States.
BioMUSE is a natural history study that
intends to track the progression of patients with early MSA. The study is being conducted in collaboration with Vanderbilt University
Medical Center in the US 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 will provide vital information
on early stage MSA patients to optimize the design of Alterity's Phase 2 study in MSA. The study will also inform the selection
of biomarkers suitable to evaluate target engagement and preliminary efficacy of ATH434.
The study is enrolling early stage MSA
patients and will track changes in clinical measures and biomarkers for up to one year. Over the course of the study, patients
will undergo comprehensive evaluation with detailed neurological examination and clinical rating scales of motor, autonomic and
activities-of-daily-living symptoms along with specialized neuroimaging and assessment of protein biomarkers in diverse biological
Data from bioMUSE will also be used to
inform patient selection in the Phase 2 clinical trial of ATH434. The US FDA has encouraged Alterity to utilize data from the bioMUSE
study to aid in the development of efficacy endpoints for the Phase 2 study.
Vanderbilt University Medical Centre is
one of the largest academic medical centres in the southeast US managing more than 2 million patients each year. The School of
Medicine's biomedical research program is among the nation's top 10 in terms of National Institutes of Health peer
Next generation compounds to treat
neurodegenerative diseases
In November, the US Patent and Trademark
Office (USPTO) advised allowance of a new composition of matter patent. The new patent is the product of in-house discovery research
and is central to Alterity's next generation drug development portfolio focussed on neurodegenerative diseases.
The patent, entitled "Compounds for
and Methods of Treating Diseases" (Application No. 16/818,641), covers more than 150 novel pharmaceutical compositions that
are designed to redistribute the labile iron implicated in Parkinson's disease, Alzheimer's disease and other neurodegenerative
Alterity's strategy is based on the
hypothesis that its therapeutics can disrupt the underlying pathology of neurodegenerative conditions in which labile iron is implicated
in disease pathology.
This includes Parkinsonian disorders such
as Parkinson's disease and Multiple System Atrophy, as well as Alzheimer's disease. The patent confers on Alterity
20 years of exclusivity, providing a strong basis for continued drug development and commercialization and new compound identification
within its extensive drug discovery library to target important neurodegenerative diseases.
This new patent will support the expansion
of Alterity's drug development portfolio.
Alterity Therapeutics Limited
Review of operations - 31 December 2020 (continued)
New data independently confirms and
extends laboratory findings and expands safety profile of ATH434
New animal data for ATH434 from the laboratory
of Dr Nadia Stefanova, Professor of Translational Neurodegenerative Research at the Medical University of Innsbruck was presented
Last updated: Feb 25, 2021