Full Press Release Details
Alterity Therapeutics Limited
Appendix 4E - Preliminary
For the year ended 30 June 2022
| Name of entity | Alterity Therapeutics Limited |
| ABN or equivalent company reference | 37 080 699 065 |
| Current reporting period | 30 June 2022 |
| Corresponding reporting period | 30 June 2021 |
Results for announcement to the market
| $ | |||||||||||
| Revenue for ordinary activities | Down | (87.9 | )% | to | 2,504 | ||||||
| Net loss after tax (from ordinary activities) for the year attributable to members | Down | (16.1 | )% | to | 12,847,061 | ||||||
| Net loss after tax for the year attributable to members | Down | (16.1 | )% | to | 12,847,061 |
Net tangible assets per share
| 30 June 2022 | 30 June 2021 | |||||||
| Net tangible asset backing per share (cents) | 1.48 | 1.46 |
Explanation of results
Alterity Therapeutics Limited recorded
revenue of $2,504 for the year ended 30 June 2022 (2021: $20,676), which is interest received on the Group's bank accounts.
Alterity Therapeutics Limited has incurred a loss for the year of $12,847,061 (2021: $15,309,353). This loss has reduced due to
share based payment expense relating to the issue of options to key management personnel, termination payments and increased
consultants' fees in the prior period.
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 Results | |
| Business strategies and prospects for future years | Item 4.B Business Overview Item 5.A Operating Results | |
| Business risks | Item 3.D Risk Factors | |
| Significant changes in the state of affairs | Item 5.A Operating Results See subheading - "Significant changes in the state of affairs" | |
| Matters subsequent to the end of the financial year | Item 5.A Operating Results See subheading - "Events since the end of financial year" | |
| Likely developments and expected results of operations | Item 5.A Operating Results See subheading - "Likely developments and expected results of operations" | |
| Environmental regulation | Item 5.A Operating Results See subheading - "Environmental regulation" | |
| Dividends | Item 5.A Operating Results 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 | Exhibits 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.
Therapeutics Limited
Annual report - June 30, 2022
| CHAIRMAN'S LETTER | i | |
| FORM 20-F | 1 | |
| SHAREHOLDER INFORMATION | 81 | |
| CORPORATE DIRECTORY | 84 |
I'm pleased to present Alterity Therapeutics'
Annual Report for 2022. This has been an exciting year for our company as we have taken significant steps toward providing an alternative
future for people with Parkinsonian diseases such as Multiple System Atrophy (MSA).
We were pleased to announce the commencement of our global
Phase 2 clinical trial for ATH434 for the treatment of patients with early- stage MSA. This is a tremendous milestone for Alterity as
we progress on our path to the validation of our lead compound and come one step closer to commercializing the first drug specifically
targeting the underlying pathology of MSA, providing much-needed hope for patients and their families.
MSA is an extremely debilitating disease that has a significant
impact in patients' lives, most importantly the reduction of life expectancy. Current means of treatment only address the symptoms
but do little to change the course of the disease. That is why our team remains motivated and highly focused on the progress of our research
working towards developing a disease modifying treatment for MSA and other neurodegenerative diseases.
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled investigation of ATH434. Our goal is to enroll a total of 60 patients in the study, aiming to explore the effect of
ATH434 treatment on imaging and protein biomarkers such as aggregating a-synuclein and excess iron which are important contributors to
MSA pathology. The results of our Phase 2 trial will help us design a definitive Phase 3 clinical trial.
We made considerable progress on execution of the trial
during this past year. We opened recruitment and dosed the first patient at our initial site at the New Zealand Brain Research Institute.
We also opened enrolment in the United Kingdom and have received regulatory approval to expand the study in Italy. We continue to engage
with regulators in Australia, the United States, and other European nations to secure approval to host our trial in these countries.
study of MSA, bioMUSE, continues to deliver invaluable observational data that allows us to understand how the disease behaves in
our target patient population. The researchers concluded that advanced MRI methods for measuring iron may improve patient selection
in clinical trials of disease modifying therapy and may serve as a biomarker for assessing treatment induced changes.
The results from bioMUSE have
also served to help our research team optimize the design our Phase 2 clinical trial related to patient population and endpoints, and
thereby maximize the chance of success. The scientific data collected during the bioMUSE study was presented at two relevant industry
events, the International Parkinson and Movement Disorder Society Congress, in September 2021, and the American Academy of Neurology (AAN)
Annual Meeting, in April this year.
During the period, Alterity's Phase 1 clinical
trial results were presented at medical meetings, and preclinical studies with ATH434 were recognized by the highly regarded medical publications
Movement Disorders, the official journal of the International Parkinson and Movement Disorder Society, the Journal of Parkinson's
Disease, and PLOS ONE, showing support from the scientific community to our scientific hypothesis.
In addition to our Phase 2 clinical trial for ATH434,
Alterity continues to identify new drug candidates to expand our portfolio and protect our therapeutic approach to address neurodegeneration.
Lastly, we have strengthened our intellectual property
portfolio with new US patents that will be instrumental in supporting Alterity's drug development portfolio. In July and August
of 2021, Alterity was granted two composition of matter patents on 230 novel compounds that act as a new class of iron chaperones designed
to redistribute the excess iron implicated in many neurodegenerative diseases, including Parkinson's and Alzheimer's diseases.
Despite our significant advancement and increased investor
activity, it has been a challenging year in world capital markets with biotechnology stocks being especially hard hit. We do however remain
resolute in our commitment to building long term shareholder value and we remain steadfastly focused on advancing our clinical program.
On behalf of the Board, I thank our CEO Dr Stamler, his
executive team, and all our scientific and operational staff. And I thank our shareholders for their support over the last year. We are
looking forward to another exciting and productive year for Alterity with the continued progress of our Phase 2 clinical trial, and we
hope to continue to work towards creating an alternate future for people with neurodegenerative diseases.
Chairman and Founder
AND EXCHANGE COMMISSION
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
the fiscal year ended June 30, 2022
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
the transition period from __________ to __________
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
of event requiring this shell company report ___________
file number 000-49843
THERAPEUTICS LIMITED
name of Registrant as specified in its charter and translation of Registrant's name into English)
of incorporation or organization)
3, 460 Bourke Street, Melbourne, VIC 3000, Australia
of principal executive offices)
Stamler, Chief Executive Officer
3, 460 Bourke Street, Melbourne, VIC 3000, Australia
telephone, e-mail and/or facsimile number and address of company contact person)
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 sixty Ordinary Shares | ATHE | NASDAQ Capital Market |
registered or to be registered pursuant to Section 12(g) of the Act: None
for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered
by the annual report:
Shares, as of June 30, 2022 2,406,874,578