Alterity Therapeutics Receives Positive FDA Feedback Following Type C Meeting on ATH434 Phase 3 Program

Alignment reached on key elements of ATH434 Phase 3 development program

MELBOURNE, Australia and SAN FRANCISCO, March 30, 2026 -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it has received positive regulatory feedback following a Type C Meeting with the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy (MSA).

The Type C Meeting is part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the clinical pharmacology and non-clinical development elements of the program.

“This meeting confirms alignment with the FDA in two key disciplines and represents an important step toward initiation of the Phase 3 program,” said David Stamler, M.D., Chief Executive Officer of Alterity. “In addition, we will also be seeking agreement with the FDA on Chemistry, Manufacturing, and Controls (CMC) and the Phase 3 trial design. Today’s favorable outcome sets the stage for our future discussions, culminating in an End-of-Phase 2 meeting that remains on track for mid-year 2026.”

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 is focused on developing disease modifying therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. Alterity is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, the Company’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with MSA. Alterity has further reported positive data in its open label Phase 2 clinical trial in participants with advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA.

Authorisation & Additional information
This announcement was authorized by the Board of Alterity Therapeutics Limited.

Contacts:

Investors:

Forward Looking Statements