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Alterity Therapeutics Limited Appendix 4D Half-year ended 31 December 2021 Name of entity: Alterity Therapeutics Limited ABN: 37 080 699 065 Half-year ended: 31 December 2021 Previous period: 31 December 2020 Results for

Key Takeaway: Alterity Therapeutics Limited Half-year ended 31 December 2021 Name of entity: Alterity Therapeutics Limited ABN: 37 080 699 065 Half-year ended: 31 December 2021 Previous period: 31 December 2020 Results for announcement to the market A$ Revenue from ordinary activities

Full Press Release Details

Alterity Therapeutics Limited
Half-year ended 31 December 2021
Name of entity: Alterity Therapeutics Limited
ABN: 37 080 699 065
Half-year ended: 31 December 2021
Previous period: 31 December 2020
Results for announcement to the market
A$
Revenue from ordinary activities Down 79.4% to 1,350
Net loss after tax (from ordinary activities) for the period attributable to members Down (23.1)% to 6,583,559
Net loss after tax for the period attributable to members Down (23.1)% to 6,583,559
Net tangible assets per security
31 December 31 December
2021 2020
cents cents
Net tangible asset backing (cents per share) 1.71 1.69
Explanation of results
Alterity Therapeutics Limited recorded income of $1,350 for the
half-year ended 31 December 2021 (2020: $6,553) which is interest received on the Group's bank accounts. Alterity Therapeutics
Limited has incurred a loss of $6,583,559 for the half-year ended 31 December 2021 (2020: $8,561,862).
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 2021.
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.
Alterity Therapeutics Limited
Interim financial report for the
half-year ended 31 December 2021
Page
Corporate directory 1
Directors' report 2
Consolidated statement of profit or loss and other comprehensive income 7
Consolidated statement of financial position 8
Consolidated statement of changes in equity 9
Consolidated statement of cash flows 10
Notes to the consolidated financial statements 11
Directors' declaration 20
Independent auditor's report to the members 22
Alterity Therapeutics Limited
Directors Mr. Geoffrey Kempler
Chairman
Mr. Brian Meltzer
Independent Non-Executive Director
Mr. Peter Marks
Independent Non-Executive Director
Mr. Lawrence Gozlan
Non-Executive Director
Dr. David Sinclair (resigned 4 January 2022)
Non-Executive Director
Mr. Tristan Edwards (resigned 4 January 2022)
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 2021.
The following persons held office as directors of Alterity Therapeutics
Limited during the financial period:
Mr. Geoffrey Kempler
Dr. David Sinclair (resigned 4 January 2022)
Mr. Tristan Edwards (resigned
Review of operations - 31 December 2021
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 2021.
The Group's 30 June 2021 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.
Product Development Lead compound - ATH434
Alterity Therapeutics' lead compound 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.
ATH434 is orally bioavailable, brain penetrant, and is being developed for Multiple System Atrophy (MSA), a Parkinsonian disorder.
MSA is a rare neurodegenerative disease characterized
by failure of the autonomic nervous system and impaired movement and can include 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.
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. Current treatment includes medications and lifestyle changes to help manage
symptoms, but there is no treatment to slow disease progression and there is 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.
Alterity Therapeutics Limited
Review of operations - 31 December 2021 (continued)
Phase 2 clinical trial for patients with
Alterity is in the advanced stages of planning
for the commencement of its Phase 2 clinical trial for patients with early-stage MSA.
The trial is a randomized, double-blind, placebo-controlled
investigation that 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. Clinical endpoints and other biomarkers will permit comprehensive
assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics. Patients will receive treatment for 12 months
which will provide an opportunity to detect changes in efficacy endpoints in order to optimize design of a definitive Phase 3 study.
The company announced its first clinical location
in December with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) authorizing Alterity to commence recruitment
in that country. This is the first jurisdiction to authorize the trial with further countries to follow in 2022. The trial expected to
open for enrollment in the first quarter of CY 2022.
bioMUSE natural history study for MSA patients
Biomarkers of progression in Multiple Systems
Atrophy (bioMUSE) is a natural history study tracking 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 target patient populations.
bioMUSE has met its initial enrollment goal and
has been expanded to 20 patients. It continues 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. The data generated thus far have been invaluable in informing
and reducing risk in the Phase 2 trial design.
Key data from bioMUSE were presented at the International
Parkinson and Movement Disorder Society Congress and reported that advanced MRI methods employed in the study, referred to as quantitative
susceptibility mapping (QSM), demonstrated pathological iron accumulation in multiple areas of the brain in patients with early MSA.
The study investigators concluded that advanced
MRI methods for measuring iron may improve patient selection in clinical trials of disease modifying therapy and have potential to serve
as a biomarker for assessing treatment induced changes.
Growing scientific validation
Scientific interest and validation in ATH434 continue
to grow with data from the Phase 1 trial presented at several global scientific and clinical conferences.
This included the American Autonomic Society 32nd
Annual International Symposium. The poster, entitled "Cardiovascular safety and pharmacokinetics of ATH434, a novel small molecule
inhibitor of -synuclein aggregation, in adults and older adults", described results from the Company's Phase 1 clinical
trial conducted in healthy volunteers. In this trial, ATH434 was well tolerated in adult and 65-year-old volunteers and demonstrated
no cardiac adverse event signal and no clinically significant changes in blood pressure or heart rate at any dose. ATH434 also demonstrated
dose dependent pharmacokinetics (PK) after single and multiple oral doses and a half-life that supports twice-daily dosing.
Alterity Therapeutics Limited
Last updated: Feb 28, 2022