Company: ATHE
Filing Date: 2025-08-29
Form Type: 20-F
Source: 0001213900-25-082027
Chunk: 39

Company: ALTERITY THERAPEUTICS LTD
Filing Date: 2025-08-29
Form: 20-F
Item: Item 4
Chunk 39
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ITEM 4. Information on the Company

A.   History and Development of the Company
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Our legal and commercial name is Alterity Therapeutics Limited (formerly Prana Biotechnology Limited). We were incorporated under the laws of the Commonwealth of Australia on November 11, 1997 and began limited operations shortly thereafter. On April 8, 2019, we changed our name to Alterity Therapeutics Limited. Our registered and principal executive office is located at Level 14, 350 Collins Street, Melbourne, Victoria, 3000, Australia and our telephone number is +-61-3-9349-4906. Our website address is www.alteritytherapeutics.com. The information in our website is not incorporated by reference into this annual report.

Alterity’s mission from inception was to treat neurodegenerative diseases and its mission has remained focused on this class of diseases.

Alterity is developing first-in-class therapies to treat neurodegenerative diseases. Our lead drug candidate, ATH434, is designed to block the accumulation and aggregation of α-synuclein, a protein implicated in neurodegeneration. ATH434 has been shown preclinically to redistribute excess labile iron in the central nervous system (CNS), reduce α-synuclein aggregation and preserve neurons and support cells, to stabilize or improve function. In this way, it has potential to treat iron-mediated diseases including Parkinson’s disease as well as Multiple System Atrophy (MSA), a rare Parkinsonian disorder. ATH434 has been granted Fast Track designation by the US FDA in MSA. The Fast Track Designation is intended to facilitate and expedite the development and review of new drugs for serious conditions with unmet medical needs. The company has also been granted Orphan drug designation for ATH434 for the treatment of MSA by both the US FDA and European Commission. The exclusivity conferred by the Orphan drug designation is expected to persist beyond the term of the patents comprising the ATH434 global patent portfolio.

In MSA, two Phase 2 clinical trials have been completed with topline results reported in the randomized, double-blind, placebo-controlled Phase 2 study.

Our technology is the outcome of many years of intense research from leading scientists in neurodegenerative disorders and other diseases. Beginning with the discovery and patenting of our initial clinical drug candidate, PBT2, the company continued to apply its expertise to inventing and patenting novel molecules with potential to treat neurodegenerative diseases which resulted in ATH434.

In