Full Press Release Details
Therapeutics Limited Appendix 4D
ended 31 December 2022
| Name of entity: | Alterity Therapeutics Limited |
| ABN: | 37 080 699 065 |
| Half-year ended: | 31 December 2022 |
| Previous period: | 31 December 2021 |
for announcement to the market
| A$ | ||||||||||||||||
| Revenue from ordinary activities | Up | 742.9 | % | to | 11,379 | |||||||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Up | 22.0 | % | to | 8,031,937 | |||||||||||
| Net loss after tax for the period attributable to members | Up | 22.0 | % | to | 8,031,937 |
tangible assets per security
| 31 December | 31 December | |||||||
| 2022 | 2021 | |||||||
| cents | cents | |||||||
| Net tangible asset backing (cents per share) | 1.16 | 1.71 |
Therapeutics Limited recorded income of $11,379 for the half-year ended 31 December 2022 (2021: $1,350) which is interest received on
the Group's bank accounts. Alterity Therapeutics Limited has incurred a loss of
for the half-year ended 31 December 2022 (2021: $6,583,559).
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.
dividends have been paid or declared by the Group for the current financial period. No dividends were paid for the previous financial
in controlled entities
have been no changes in controlled entities during the period ended 31 December 2022.
information required by Listing Rule 4.2A
interim financial statements have been reviewed by the Group's independent auditor without any modified opinion, disclaimer or
emphasis of matters.
Therapeutics Limited
financial report for the
ended 31 December 2022
| 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 | |
| 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
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 2022.
following persons held office as directors of Alterity Therapeutics Limited during the whole of the half-year and up to the date of this
Geoffrey Kempler Mr. Brian Meltzer
of operations - 31 December 2022
the first half of FY23, Alterity Therapeutics has delivered material progress on its Phase 2 clinical trial for ATH434 in the treatment
of individuals with Multiple System Atrophy (MSA), formally commencing the study by dosing the first patient in New Zealand. Alterity
continues to expand the study by opening multiple sites across the globe in Australia, the United States, and Europe.
advancement of the trial demonstrates Alterity's ability to deliver on its clinical pipeline, working towards the development of
the first potential disease modifying treatment for MSA that addresses the underlying pathology of the disease.
also continues to de-risk the Phase 2 clinical trial with a natural history study that is improving patient selection and identifying
appropriate biomarkers for demonstrating target engagement and efficacy in MSA. The Company is also conducting nonclinical studies and
filing relevant patents in other neurodegenerative diseases that can expand Alterity's product development pipeline.
30 June 2022 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.
Therapeutics' lead compound ATH434 is the first of a new generation of small molecules designed to inhibit the aggregation of proteins
implicated in the neurodegenerative process. ATH434 is an orally administered tablet that aims to reduce the toxic accumulation of -synuclein,
a pathological hallmark of MSA, and preserve nerve cells by restoring normal iron balance in the brain. Therefore, ATH434 has the potential
to address the underlying pathology of the disease and preserve function in individuals with MSA.
is a rare neurodegenerative disease, like Parkinson's disease, for which there are no known therapies which can slow disease progression.
MSA progresses rapidly 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. The symptoms reflect the progressive loss of function and death of
different types of nerve cells in the brain and spinal cord.
Therapeutics Limited
Review of operations - 31 December 2022 (continued)
preclinical investigation of ATH434, published in the journal Neurotherapeutics in October 2022, demonstrated efficacy in an animal
model of Parkinson's disease. The publication, entitled "ATH434 Rescues Pre-motor Hyposmia in a Mouse Model of Parkinsonism",
assessed the impact of ATH434 on motor and non motor manifestations in experimentally induced Parkinson's disease. The investigation
concluded that treatment with ATH434 prevented the development of motor impairment, which was associated with a reduction in iron levels
and preservation of nerve cells in the brain region affected in Parkinson's. This study confirms ATH434 as a potential disease
modifying therapy for Parkinsonian disorders.
has Orphan drug designation both with the US FDA and European Commission for the treatment of MSA.
2 clinical trial for patients with MSA
the first half of FY23, Alterity has made significant progress on its Phase 2 clinical trial for the treatment of patients with MSA.
Alterity announced in July 2022 the dosing of the first patient in New Zealand, thus commencing the study. During the period, Alterity
also opened new sites for enrolment in Australia and in the United Kingdom. Subsequent to the period, Alterity opened enrolment in the
United States and Italy in January 2023, and secured regulatory approvals in France and Austria in February 2023 to conduct the trial
Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The
study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical
endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. The selected biomarkers, including brain
iron and aggregating -synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug
sensors will also be employed to evaluate motor activities that are important to individuals with MSA. The study is expected to enroll
approximately 60 adults to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which
will provide an opportunity to detect changes in efficacy measures to optimize design of a definitive Phase 3 study.
trial sites in Europe, Asia-Pacific, and the U.S. now actively recruiting participants, Alterity continues to work towards opening additional
trial sites and supporting the local research teams with recruitment of patients. Alterity remains resolute in its commitment to bring
a much-needed treatment to individuals living with this devastating condition.
natural history study for MSA patients
Biomarkers of progression in Multiple Systems Atrophy (bioMUSE) natural history study continues to provide vital information on early
stage MSA patients. Natural history studies are important for characterizing disease progression in target patient populations that are
not receiving experimental therapy. The study informs the selection of biomarkers suitable to evaluate target engagement and preliminary
efficacy and provide clinical data to characterize disease progression in a patient population that mirrors those to be enrolled in the
Phase 2 clinical trial, effectively de-risking the trial design.
study is being conducted in collaboration with Vanderbilt University Medical Center in the US under the direction of Daniel Claassen,
MD, Professor of Neurology, Chief of Behavioral and Cognitive Neurology, and Principal Investigator.
the first half of FY23, Alterity and collaborators at Vanderbilt University Medical Center gave multiple data presentations from the
bioMUSE study at industry events and conferences:
Therapeutics Limited
of operations - 31 December 2022 (continued)
its IP portfolio into other neurodegenerative diseases
December 2022, Alterity announced that a new composition of matter patent had been allowed by the United States Patent and Trademark
Office (USPTO). Entitled "Compounds for and methods of treating diseases", the new patent provides 20 years of exclusivity
and is based on a new scaffold that includes more than 100 novel compounds, at least one of which has demonstrated efficacy in an animal
new patent covers iron chaperones, small molecules capable of binding and redistributing excess iron in the central nervous system, implicated
in the pathology of many important neurodegenerative diseases, including Alzheimer's and Parkinson's diseases, expanding
Alterity's intellectual property estate for treating other major neurodegenerative disorders.
the first half of FY23, Alterity engaged the wider investor community both in Australia and the United States to raise awareness of Alterity's
progress in advancing its lead asset while expanding its pipeline into other neurodegenerative diseases. CEO Dr David Stamler presented
in several virtual and in-person conferences, as well as participated in a roadshow while in Australia in November 2022 ahead of the
Annual General Meeting.
to the end of the second quarter, Alterity received formal notification from The Nasdaq Stock Market in the U.S. confirming that Alterity
had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule"),
which requires that Alterity's American Depositary Shares ("ADS") maintain a minimum bid price of at least US$1.00
per ADS, and that the matter is now closed.