Highlights:

• Participant screening closed for ATH434-201 Phase 2 study
• Independent Data Monitoring Committee recommended the ATH434-201 Phase 2 study continue as planned
• Received A$4.74M cash refund under the Australian R&DTI Scheme
• Data presentations from Alterity’s bioMUSE natural history study of Multiple System Atrophy were delivered at the International Congress of Parkinson’s Disease and Movement Disorders
• New composition of matter patent granted by European Patent Office
• Cash balance on 30 September 2023 of A$16.7M

MELBOURNE, Australia and SAN FRANCISCO, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2023 (Q1 FY24).

“Alterity had a great start to the 2024 financial year with significant developments in the first quarter,” said David Stamler, M.D., Chief Executive Officer of Alterity. “Our two Phase 2 clinical trials in Multiple System Atrophy (MSA) are on track as we look to develop a new treatment for this devastating rare disease. Of note, we have closed screening in the ATH434-201 study and expect to close enrollment imminently. In addition, an independent Data Monitoring Committee (DMC) recommended that the trial continue as planned and they expressed no concerns about safety. These events are important milestones in the development of ATH434 for the treatment of early-stage MSA.”

“While the ATH434-201 trial is evaluating individuals with early-stage MSA, we are also conducting a second Phase 2 trial in individuals with more advanced disease. This open label, biomarker study will give us the opportunity to assess the effect of ATH434 in multiple populations and we also expect it to provide preliminary data in the first cohort of participants in the first half of next year,” concluded Dr. Stamler.

The Company’s cash position on 30 September 2023 was A$16.7M with operating cash outflows for the quarter of A$4.1M, offset by a refund of $4.7M from the Australian Taxation Office under the Australian Government’s Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the financial year ending 30 June 2022.

Operational Activities

ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in MSA

Today, Alterity announced that screening has closed for its ATH434-201 Phase 2 clinical trial, an important step to completing enrollment in the study. On 26 July, Alterity announced that an independent DMC recommended the trial continue as planned. The DMC conducted a prespecified review of unblinded clinical data from an initial cohort of study participants. The DMC expressed no concerns about safety and recommended that the study continue without modification.

This randomized, double blind, placebo controlled clinical trial continues to progress with early-stage MSA participants enrolled in seven countries globally. The trial has been well received by the study investigators as they implement Alterity’s state of the art methods to diagnose, treat and track the disease.

ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in MSA

The ATH434-202 trial is enrolling according to plan. The study is assessing the effect of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. The primary objective of this study is to evaluate the impact of 12 months treatment with ATH434 on brain iron by MRI in a more advanced patient population than is being studied in Alterity’s double blind Phase 2 trial. Preliminary data from the first cohort in this study is expected in the first half of 2024.

bioMUSE Natural History Study

Alterity’s bioMUSE natural history study continues to produce meaningful data to address the need for novel approaches to the evaluation of individuals with MSA. The diagnosis of early MSA can be challenging as individuals often present similarly to Parkinson’s disease. On 31 August, presentations from bioMUSE were delivered at the prominent International Congress of Parkinson’s Disease and Movement Disorders (MDS). The presentations addressed the importance of incorporating biomarkers in diagnosis of MSA and support the need for a timely and accurate diagnosis to ensure that the right treatment can be delivered to patients.

Findings from the bioMUSE study are being incorporated into the Company’s Phase 2 studies. Alterity’s unique protocol designs help to ensure they are enrolling the right patient population with confirmed MSA, thus giving ATH434 the best chance at success. Based on the collaboration with clinical and neuroimaging experts from Vanderbilt University Medical Center in the U.S., Alterity is in a unique position to implement this strategy in its development programs.

Composition of Matter Patent Granted in Europe

The European Patent Office granted Alterity a new composition of matter patent. The patent secures broad protection over a new class of iron chaperone drug candidates for treating major neurodegenerative diseases. It is well established that excess iron in the brain is implicated in the pathology of many important neurodegenerative diseases, including Alzheimer’s and Parkinson’s diseasesⁱ.

The composition of matter patent, entitled, “Compounds for and Methods of Treating Diseases”, Patent No. 3938364 covers more than 150 novel pharmaceutical compositions that are designed to redistribute the excess iron implicated in neurodegenerative diseases. The patent will confer on Alterity 20 years of exclusivity over the compounds claimed in the patent, thus providing a strong basis for drug development and commercialization.

About Alterity Therapeutics Limited

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com.

Authorisation & Additional information
This announcement was authorised by David Stamler, CEO of Alterity Therapeutics Limited.

Investor and Media Contacts:

Australia
Hannah Howlett
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+61 4 5064 8064

U.S.
Remy Bernarda
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+1 (415) 203-6386

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

ⁱ Dusek, P. et al. Cerebral Iron Deposition in Neurodegeneration. Biomolecules 2022, 12, 714. https://doi.org/10.3390/biom12050714.