Alterity Therapeutics Limited (ATHE)

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

MELBOURNE, Australia and SAN FRANCISCO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- 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 binding commitments for a capital raising of A$20.0 million (the “Placement”) of fully paid ordinary shares (“New Shares”) to International and Australian professional investors.

MELBOURNE, Australia and SAN FRANCISCO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- 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 David Stamler, M.D., Chief Executive Officer of Alterity, will deliver a corporate update at the Biotech Showcase hosted by Peak Asset Management and Monsoon Communications. The presentation will take place on Wednesday, 3 September 2025 in Australia; Tuesday, 2 September 2025 in the United States.

Highlights Granted U.S. FDA Fast Track Designation for ATH434 to treat Multiple System Atrophy (MSA) Reported positive topline data from open-label Phase 2 clinical trial of ATH434 in MSA Presented additional analyses from the ATH434-201 trial demonstrating continued robust efficacy for the treatment of MSA Cash balance on 30 June 2025 of A$40.66M MELBOURNE, Australia and SAN FRANCISCO, July 30, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2025 (Q4 FY25). “U.S. FDA Fast Track designation for ATH434 in MSA was the highlight of the recent quarter that also featured additional positive clinical data from our Phase 2 double-blind trial,” said David Stamler, M.D.

– ATH434 Demonstrated Clinical Benefit on the Unified MSA Rating Scale and Global Measures of Neurological Symptoms –

– Peer-reviewed publication in Annals of Clinical and Translational Neurology highlights the use of the MSA Atrophy Index developed to diagnose and track disease progression in Multiple System Atrophy –

MELBOURNE, Australia and SAN FRANCISCO, June 23, 2025 (GLOBE NEWSWIRE) -- 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 David Stamler, M.D., Chief Executive Officer of Alterity, will participate in a Fireside Chat hosted by MST Access on Wednesday, 25 June 2025 in Australia / Tuesday, 24 June 2025 in the United States. Dr. Stamler will provide a corporate update with a focus on the progress made on the ATH434 development program in Multiple System Atrophy since the Company released positive Phase 2 data in January.

– ATH434 Phase 2 data demonstrated clinically meaningful efficacy on multiple clinical endpoints – – MSA Atrophy Index (MSAai) enhances MSA diagnosis and monitoring – – bioMUSE Study shows higher α- synuclein concentration is associated with greater burden of orthostatic symptoms – MELBOURNE, Australia and SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- 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 several oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) were featured at the 2025 International MSA Congress. The Congress was presented by Mission MSA, a non-profit organization dedicated to improving the quality of life and building hope for people affected by MSA through support services, educational resources, research funding, and community engagement.

MELBOURNE, Australia and SAN FRANCISCO, May 07, 2025 (GLOBE NEWSWIRE) -- 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 multiple oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) will be featured at the 2025 International MSA Congress taking place May 9 - 11, 2025 in Boston, MA, USA. The Congress is presented by Mission MSA, a non-profit organization dedicated to improving the quality of life and building hope for people affected by MSA through support services, educational resources, research funding, and community engagement.

– Fast Track Designation highlights potential of ATH434 to address high unmet need for individuals with MSA – MELBOURNE, Australia and SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATH434 for the treatment of Multiple System Atrophy (MSA). This designation is intended to accelerate the development and review of novel investigational products such as ATH434 and recognizes its potential as an innovative approach to address the high unmet need for treating MSA, a disease with no approved therapy.

Highlights Reported positive topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) led by robust clinical efficacy Phase 2 data featured in an oral presentation at the American Academy of Neurology Annual Meeting ATH434-202 open-label trial in advanced MSA completed in March 2025 Cash balance on 31 March 2025 of A$17.96M with an additional A$27.1M raised subsequent to the end of the quarter MELBOURNE, Australia and SAN FRANCISCO, April 30, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 March 2025 (Q3 FY25). David Stamler, M.D.

MELBOURNE, Australia and SAN FRANCISCO, April 28, 2025 (GLOBE NEWSWIRE) -- 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 David Stamler, M.D., Chief Executive Officer presented the ATH434-201 Phase 2 clinical trial results at the annual MSA Research Symposium hosted by University College London, Institute of Neurology in partnership with the MSA Trust of the U.K.

– Clinically Meaningful Efficacy Observed on Multiple Assessments – – Confirmed Target Engagement with Reduced Iron Signal in MSA Affected Brain Regions – MELBOURNE, Australia and SAN FRANCISCO, April 10, 2025 (GLOBE NEWSWIRE) -- 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 new presentations related to its Multiple System Atrophy (MSA) program were delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting, one of the premier global neurology meetings. Notably, new data from the ATH434-201 trial was prominently featured via an oral presentation during a Scientific Platform Session on Movement Disorders.

– ATH434 is a Disease Modifying Drug Candidate Targeting Parkinsonian Disorders – – Topline Data Expected Mid-Year 2025 – MELBOURNE, Australia and SAN FRANCISCO, March 27, 2025 (GLOBE NEWSWIRE) -- 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 the last patient in the ATH434-202 Phase 2 trial has completed the study. The ATH434-202 is an open label study designed to evaluate the safety, efficacy and target engagement of ATH434 in participants with advanced multiple system atrophy (MSA).

– Funds to be used primarily to advance development of ATH434 in Parkinsonian Disorders – – Capital raising was strongly supported by domestic and international institutional investors – MELBOURNE, Australia and SAN FRANCISCO, Feb. 10, 2025 (GLOBE NEWSWIRE) -- 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 binding commitments for a capital raising of A$40.0 million via a two tranche placement (the “Placement”) of fully paid ordinary shares (“New Shares”) to Australian and international institutions and other unrelated sophisticated, professional or exempt investors. "We are grateful for the strong response from the investment community and are proud to welcome a number of leading domestic and international institutions as shareholders in support of Alterity as we advance our lead compound ATH434 for the treatment of neurodegenerative diseases,” said David Stamler, M.D.

– Clinically Meaningful Benefit Observed at Both ATH434 Doses Studied – – Achieved Statistical Significance with Up to 48% Slowing of Clinical Progression on UMSARS Rating Scale – – Key MRI Biomarker Shows Iron Stabilization in MSA Affected Brain Regions – – ATH434 Demonstrated a Favorable Safety Profile – – Webcast Held Yesterday with Access to the Recording Below – MELBOURNE, Australia and SAN FRANCISCO, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced positive topline results from the ATH434-201 randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage multiple system atrophy (MSA). The topline data showed that ATH434 produced clinically and statistically significant improvement on the modified UMSARS Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA1.