# EDGAR Filing Document

**Accession Number:** 0001131343
**File Stem:** 0001213900-25-094961
**Filing Date:** 2025-10
**Character Count:** 13331
**Document Hash:** 61522cb934389e30ed0584908f052153
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-094961.hdr.sgml**: 20251002

**ACCESSION NUMBER**: 0001213900-25-094961

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20251002

**FILED AS OF DATE**: 20251002

**DATE AS OF CHANGE**: 20251002

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ALTERITY THERAPEUTICS LTD
- **CENTRAL INDEX KEY:** 0001131343
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** C3
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-49843
- **FILM NUMBER:** 251366991

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** LEVEL 3, 460 BOURKE STREET
- **CITY:** MELBOURNE
- **PROVINCE COUNTRY:** C3
- **BUSINESS PHONE:** 61 3 9349 4906

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** LEVEL 3, 460 BOURKE STREET
- **CITY:** MELBOURNE
- **PROVINCE COUNTRY:** C3

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** PRANA BIOTECHNOLOGY LTD
- **DATE OF NAME CHANGE:** 20010105

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 6-K**

**REPORT OF FOREIGN PRIVATE ISSUER**

**PURSUANT TO RULE 13a-16 OR 15d-163**

**UNDER THE SECURITIES EXCHANGE ACT OF 1934**

**For the month of October 2 2025**

**Alterity Therapeutics Limited**

(Name of Registrant)

**Level 14, 350 Collins Street, Melbourne, Victoria 3000 Australia**

(Address of Principal Executive Office)

**Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.**

Form 20-F ☒ Form 40-F ☐

**This Form 6-K is being incorporated by reference into our Registration Statement on Form S-8 (Files No. [333-251073](http://www.sec.gov/Archives/edgar/data/1131343/000121390020040485/ea130838-s8_alteritytherape.htm), [333-248980](http://www.sec.gov/Archives/edgar/data/1131343/000121390020027969/ea127207-s8_alteritytherap.htm) and [333-228671](http://www.sec.gov/Archives/edgar/data/1131343/000114420418063081/tv508429_s-8.htm)) and our Registration Statements on Form F-3 (Files No. [333-274816](http://www.sec.gov/Archives/edgar/data/1131343/000101376223000033/ea185947-f3_alteritytherape.htm), [333-251647](http://www.sec.gov/Archives/edgar/data/1131343/000121390020044324/ea132148-f3_alteritytherape.htm), [333-231417](http://www.sec.gov/Archives/edgar/data/1131343/000114420419025615/tv521271_f3.htm) and [333-250076](http://www.sec.gov/Archives/edgar/data/1131343/000121390020036934/ea129831-f3_alteritytherap.htm))**

**ALTERITY THERAPEUTICS LIMITED**

**(a development stage enterprise)**

The following exhibits are submitted:

99.1 [Alterity to Deliver Multiple Presentations at MDS Conference](ea025988301ex99-1_alterity.htm)

**<u>SIGNATURE</u>**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | |
|:---|:---|
| **Alterity Therapeutics Limited** | **Alterity Therapeutics Limited** |
| By: | /s/ Geoffrey P. Kempler |
|  | Geoffrey P. Kempler |
|  | Chairman |

---

Date: October 2, 2025

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International <br> Congress of Parkinson's Disease and Movement Disorders**

 

*– Data from ATH434-201 double-blind Phase 2 trial to be featured in oral session and multiple poster presentations –*

 

**MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 2 October 2025:** Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) will be featured at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) taking place October 5-9, 2025 in Honolulu, HI, USA.

"We look forward to presenting data from the Phase 2 double-blind clinical trial of ATH434 at MDS 2025 and educating leaders in the movement disorder community on its potential as a first-ever treatment for MSA," said David Stamler, M.D., Chief Executive Officer of Alterity.

---

| | |
|:---|:---|
| **Type:** | **Oral Platform Presentation** |
| **Session:** | **Atypical and Other Parkinsonisms** |
| **Title:** | **ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy** |
| Presenter: | David Stamler, M.D., Chief Executive Officer, Alterity |
| Date/Time: | Wednesday, October 8, 2025, 12:00-1:00p HST |
| **Type:** | **Poster Presentation** |
| **Title:** | **Relationship Between Alpha-Synuclein Aggregation Profiles, Imaging Biomarkers, and Disease Severity in a Phase 2 Study of ATH434 in MSA** |
| Presenter: | Margaret Bradbury, Ph.D., Vice President, Nonclinical Development, Alterity |
| Date/Time: | Sunday, October 5, 2025, 12:00p – 3:00p HST |
| **Type:** | **Poster Presentation** |
| **Title:** | **Differences Between Clinical and Imaging Phenotypes in Phase 2 Study of ATH434 in Multiple System Atrophy** |
| Presenter: | Paula Trujillo, PhD, Research Assistant Professor, Department of Neurology, Vanderbilt University Medical Center |
| Date/Time: | Sunday, October 5, 2025, 12:00p – 3:00p HST |

---

**About ATH434**

Alterity's lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models. As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). Phase 1 studies have demonstrated the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. Positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated robust clinical efficacy, target engagement on key biomarkers, and a favorable safety profile. Positive data from a second Phase 2 open-label biomarker trial in patients with more advanced MSA reinforced these results. ATH434 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation by the FDA and the European Commission for the treatment of MSA.

**About ATH434-201 Phase 2 Clinical Trial** 

The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of 12 months treatment with ATH434 in patients with MSA. The study evaluated the efficacy, safety and pharmacokinetics of ATH434 as well as the effect of ATH434 on neuroimaging and protein biomarkers. Wearable sensors were employed to evaluate motor activities outside of the clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The data showed that, compared to placebo, ATH434 produced clinically and statistically significant improvement on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. Additional efficacy assessments demonstrated improvement consistent with the positive UMSARS Part I findings including trends in improved motor performance on the Parkinson's Plus rating scale, the Clinical Global Impression of Severity Scale, and the Orthostatic Hypotension Symptom Assessment (a patient reported outcome). Wearable sensor data indicated that ATH434 also led to increased activity in an outpatient setting. Biomarkers were used to evaluate potential drug effect and target engagement relative to placebo. Both dose levels reduced iron accumulation in MSA affected brain regions with trends in preservation of brain volume. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.

**About Multiple System Atrophy**

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects up to 50,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.<sup>1</sup>

 

<sup>1</sup> Multiple System Atrophy \| National Institute of Neurological Disorders and Stroke (nih.gov)

**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 initially focused on developing disease modifying therapies in Parkinson's disease and related disorders. Alterity has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 recently reported positive data in its open label Phase 2 clinical trial in 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. For further information please visit the Company's website at www.alteritytherapeutics.com.

**Authorisation & Additional information**

This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.

**Contacts:**

**Investors**

Remy Bernarda

Investor Relations Advisory Solutions

ir@alteritytx.com

+1 (415) 203-6386

**Media**

Casey McDonald

Tiberend Strategic Advisors, Inc.

cmcdonald@tiberend.com

+1 (646) 577-8520

**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.*