Alterity Therapeutics Limited announced that an independent Data Monitoring Committee (DMC) recommended the ATH434-201 Phase 2 study continue as planned. The ATH434-201 clinical trial is a randomized, double-blind, placebo- controlled investigation of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its progression. 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. The plan for the DMC to review initial safety data was cleared with the U.S. Food and Drug Administration. The ATH434- 201 Phase 2 clinical trial is evaluating 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 activity. ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double- blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA.

ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission. Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The Company has tried to identify such forward-looking statements by use of such words as "ex expects," "intends," "hopes," "anticipates," "bel believes," " may, may, 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. ATH434, and any other statements that are not historical facts. Such statements involve risks and involve risks and risks and risks, and may be considered in the future.