Full Press Release Details
Alterity Therapeutics Limited
Annual report - June 30, 2024
| CHAIRMAN'S LETTER | i |
| FORM 20-F | 1 |
| SHAREHOLDER INFORMATION | 83 |
| CORPORATE DIRECTORY | 86 |
I am excited to present the Alterity Therapeutics'
Annual Report as we made tremendous progress over the last year.
MSA Program Hits Several Key Milestones
We currently have three programs ongoing targeting
the rare, parkinsonian disorder known as Multiple System Atrophy (MSA). MSA is an extremely debilitating disease with no approved treatments
to address the underlying condition. Our team is looking to change that paradigm in a truly meaningful way.
First, we started our MSA program by running a natural
history study with our esteemed colleagues at Vanderbilt University in the U.S. This study is concluding and we are analyzing the trajectory
of disease severity in the enrolled patients to garner a deeper understanding of MSA on multiple levels including key biomarkers, MRI
data, and clinical outcomes. Impressively, as we announced in May 2024, the team has utilized machine learning (a form of artificial intelligence)
to optimize specialized MRI methods for measuring brain iron and brain volumes with precision. With the use of this technology, the team
has developed a novel imaging biomarker to assess brain volume in MSA affected regions. The bioMUSE data showed a statistically significant
increase in iron over 12 months in the substantia nigra, and statistically significant decreases in brain volume observed in affected
regions at 12 months. These findings, alongside additional biomarker data presented during the year have informed both of our Phase 2
clinical trials to ensure that we are enrolling the right patients who may receive the most benefit from our lead asset, ATH434.
ATH434 is currently in two Phase 2 clinical trials
in MSA in both early and more advanced patients. This approach will provide data on patients with differing levels of severity as we look
to advance the asset into pivotal trials.
Our key Phase 2 study is a randomized, double-blind,
placebo-controlled trial that enrolled 77 adults with early-stage MSA known as ATH434-201. In November 2023, we announced completion of
enrollment in this study and in May 2024 the Independent Data Monitoring Committee completed its third prespecified review of unblinded
clinical trial data. Consistent with the first two reviews, the DMC expressed no concerns about safety and recommended that the study
continue as planned without modification. This recommendation is important for a chronic treatment as participants are able to safely
tolerate ATH434 as their time on study increases. The ATH434-201 trial remains on track and is expected to be completed in November 2024
with topline data expected in January 2025.
Subsequent to the end of the fiscal year, we reported
positive interim data from our open-label biomarker trial in MSA patients with more advanced disease, known as ATH434-202. After six months
of treatment, 43% of participants showed improvement on the Unified MSA Rating Scale (UMSARS), indicating reduced disability on activities
of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms (clinical responders) as assessed
by the global impression of change by both the treating physician and the patient. Importantly, the clinical responders on average had
reduced accumulation of iron on MRI in key brain regions including the substantia nigra, putamen and globus pallidus, as well as stable
levels of Neurofilament Light Chain (NFL), a marker of neuronal injury, when compared to participants who declined. While these preliminary
findings are in a small number of patients, we are extremely encouraged by these early results.
Promising Non-Clinical Data in Parkinson's Disease
We remain excited about the data we reported in December
2023 showing for the first time that ATH434 can reduce Parkinson's symptoms in a higher order animal, the monkey, with symptoms
that closely parallel human disease. The data showed that the improvements in motor skills and general functioning were associated with
reductions in iron in affected brain regions, validating the approach we are using in our ongoing clinical trials. The data from this
study improve our ability to predict clinical outcomes and increases our confidence level in our ongoing Phase 2 clinical trials in Multiple
Maintaining a Strong Presence at Medical and Scientific
During the year, we made multiple data presentations
at prominent scientific meetings on ATH434, the bioMUSE study, and our clinical trials. These included the annual meetings for the American
Academy of Neurology (AAN), the American Autonomic Society (AAS), the Society for Neuroscience, and the International Congress of Parkinson's
Disease and Movement Disorders (MDS). These events continue to generate excitement about ATH434 within the medical and scientific community
about the approach we are taking to treat Parkinson's disease and related disorders.
We have an exciting year ahead particularly with the
topline data expected from both of our Phase 2 clinical programs.
On behalf of the Board of Directors, I would like
to extend our gratitude to the Alterity team and to the individuals who have participated in our development programs. I would also thank
our shareholders for their continued support as we remain committed to creating an alternative future for people living with neurodegenerative
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, 2024
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
to Section 12(g) of the Act: None
Securities for which there is a reporting obligation
pursuant to Section 15(d) of the Act: None
Indicate 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:
Ordinary Shares, as of June 30, 2024 5,245,115,318
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act.
If this report is an annual or transition report, indicate by check
mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Note - Checking the box above will not relieve any registrant
required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T ( 232.405 of this chapter) during the