Full Press Release Details
Alterity Therapeutics Limited
Audited Financial Report
For the year ended 30 June 2023
| Name of entity | Alterity Therapeutics Limited |
| ABN or equivalent company reference | 37 080 699 065 |
| Current reporting period | 30 June 2023 |
| Corresponding reporting period | 30 June 2022 |
| Results for announcement to the market |
| $ | |||||||||
| Revenue for ordinary activities | Up | 556.4% | to | 16,436 | |||||
| Net loss after tax (from ordinary activities) for the year attributable to members | Up | 7.5% | to | 13,806,515 | |||||
| Net loss after tax for the year attributable to members | Up | 7.5% | to | 13,806,515 |
Net tangible assets per share
| 30 June 2023 | 30 June 2022 | |||||||
| Net tangible asset backing per share (cents) | 0.94 | 1.48 |
Explanation of results
Alterity Therapeutics Limited recorded
revenue of $16,436 for the year ended 30 June 2023 (2022: $2,504), which is interest received on the Group's bank accounts. Alterity
Therapeutics Limited has incurred a loss for the year of $13,806,515 (2022: $12,847,061).
For further details relating to the current
period's results, refer to the contained within this document.
Changes in controlled entities
Other information required by Listing Rule 4.3A
Other documents accompany this Appendix 4E
This Appendix 4E should be read in conjunction with
the Alterity Therapeutics Limited annual report on the form 20-F, which includes:
This preliminary final report and the associated Directors'
Report are found throughout the various sections of the accompanying Alterity Therapeutics Limited annual report on the form 20-F.
The following table has been provided to assist readers
to locate each section of the Directors' Report within the accompanying annual report on the form 20-F.
| Sections of Directors' Report | Form 20-F Reference | |
| Principal activities | Item 4.A History and Development of the Company | |
| Review of operations and activities | Item 4.B Business Overview Item 5.A Operating and Financial Review and Prospects | |
| Business strategies and prospects for future years | Item 4.B Business Overview Item 5.A Operating and Financial Review and Prospects | |
| Business risks | Item 3.D Risk Factors | |
| Significant changes in the state of affairs | Item 5.A Operat ing and Financial Review and Prospects See subheading - "Significant changes in the state of affairs" | |
| Matters subsequent to the end of the financial year | Item 5.A Operating and Financial Review and Prospects See subheading - "Events since the end of financial year" | |
| Likely developments and expected results of operations | Item 5.A Operating and Financial Review and Prospects See subheading - "Likely developments and expected results of operations" | |
| Environmental regulation | Item 5.A Operating and Financial Review and Prospects See subheading - "Environmental regulation" | |
| Dividends | Item 5.A Operating and Financial Review and Prospects See subheading - "Dividends" | |
| Information on directors | Item 6.A Directors, Senior Management and Employees See subheading - "Directors and Senior Management" | |
| Remuneration report | The Remuneration report starts at Item 6 and ends part way through Item 6.B as indicated | |
| Indemnification of officers | Item 6.C Board Practices See subheading - "Indemnification of Directors and Officers" | |
| Proceedings on behalf of the group | Item 6.C Board Practices See subheading - "Proceedings on behalf of our Group" | |
| Non-Audit Services | Item 6.C Board Practices See subheading - "Non-audit services" | |
| Auditor's independence declaration | Exhibit 15.2 | |
| Directors' Resolution | Item 6.C Board Practices |
These accounts have been audited. An unmodified audit
report is provided with the accompanying financial report.
Alterity Therapeutics Limited
Annual report - June 30, 2023
| Page | |
| CHAIRMAN'S LETTER | i |
| FORM 20-F | 1 |
| SHAREHOLDER INFORMATION | 78 |
| CORPORATE DIRECTORY | 81 |
pleased to present Alterity Therapeutics' Annual Report for 2023. It's been a year of excellent progress for our company on
many fronts as we continue towards our goal of providing a beter future for people with parkinsonian disorders, including Multiple System
MSA has no approved treatment to address the underlying pathology of the disease. Our journey of discovery towards a treatment has led
us to where we are today: near to completing the enrolment of our lead Phase 2 clinical trial.
Our randomized Phase 2 clinical
trial of ATH434 (ATH434-201) for the treatment of early-stage MSA is now enrolling at over 20 sites in six countries: the US, Australia,
New Zealand, UK, Italy, and France, with Austria to open shortly. The trial has been enthusiastically received by physicians across the
board as they implement Alterity's novel methods to diagnose and evaluate early MSA.
We are using state-of-the-art
methods, including advanced MRI techniques and other biomarkers to select MSA patients for study. We are also using wearable sensors for
evaluating motor activities that impact quality of life. The use of such sensors is important because they enable us to determine the
impact of ATH434 on motor impairment and gait stability that may not be captured by neurological examination.
In a notable development after
the close of this reporting year, an independent Data Monitoring Commitee reviewed clinical data from an initial cohort of study participants
in the ATH434-201 trial. The commitee expressed no safety concerns and recommended that our trial continue without modification. The trial
remains on track to complete enrollment in the third quarter of 2023, with top-line data expected in 2024.
exciting development, we commenced a new and separate Phase 2 clinical trial of ATH434 in patients with more advanced MSA (ATH434-202).
This Phase 2 open-label biomarker study complements our randomized Phase 2 trial, allowing us to evaluate the e ect of ATH434 on
patients with di ering levels of severity of MSA. The first patients in this biomarker trial have been enrolled.
We also continue to generate valuable
information from our bioMUSE natural history study that helps to de-risk our Phase 2 trials. The bioMUSE study is improving patient selection
and identifying appropriate biomarkers that will inform future trials in MSA, including our own ATH434-201.
During the year, we made multiple
data presentations from the bioMUSE study at prominent scientific meetings including the American Academy of Neurology Annual Meeting,
the International Congress of Parkinson's disease and Movement Disorders, the American Neurological Association (ANA) Annual Meeting,
and the American Autonomic Society (AAS) 2022 Annual Conference.
Another notable development included an independent
study published in the journal Neurotherapeutics that reported ATH434 prevented the onset of motor and non-motor symptoms in animals
with genetically induced Parkinson's disease. The publication provides further evidence that ATH434 has the potential to address
the underlying pathology of Parkinson's disease and related disorders such as MSA.
In addition to our clinical
progress, our research team continues to produce novel, patentable compounds covering several neurodegenerative diseases. You may be aware
that the US Food and Drug Administration has recently approved drugs for the treatment of Alzheimer's Disease (AD). The hypothesis
for these treatments was developed by Professor Colin Masters, a co-founder of Alterity and a long-term collaborator of ours. In March
2023, we licensed the use of our new patent of 100 compounds and our product candidate for AD, PBT2, to Professor Masters to advance the
compounds for the treatment of Alzheimer's and related diseases.
Professor Masters' research
on the beta amyloid protein (A amyloid) that forms the cerebral plaques in AD has laid the foundation for extensive research on
the disease and recently approved treatments. Our collaboration with Professor Masters broadens the opportunities for our clinical development
exciting year ahead of us. The advancement of our randomized Phase 2 trial continues to show our ability to deliver on our clinical pipeline,
and we look forward to top-line data from the trial by the end of 2024.
On behalf of the Board of Directors,
I thank our CEO Dr David Stamler and our entire clinical, scientific and operational sta . I would also thank our shareholders for
their continued support.
We remain passionate and commited
to our work towards creating an alternative, beter future for people with neurodegenerative diseases.
| Sincerely, | |
| /s/ Geo rey Kempler | |
| Geo rey Kempler | |
| Chairman and Founder |
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2023
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report
Commission file number 000-49843
ALTERITY THERAPEUTICS LIMITED
(Exact name of Registrant as specified in its charter
and translation of Registrant's name into English)
(Jurisdiction of incorporation or organization)
Level 14, 350 Collins Street, Melbourne, VIC
(Address of principal executive offices)
David Stamler, Chief Executive Officer
Level 14, 350 Collins Street, Melbourne, VIC
+61 3 9349 4906 (phone)
(Name, telephone, e-mail and/or facsimile number
and address of company contact person)
Securities registered or to be registered pursuant
to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| American Depositary Shares, each representing 600 Ordinary Shares | ATHE | NASDAQ Capital Market |
Securities registered or to be registered pursuant