Highlights
- Aligned with the FDA in two Positive Type C meetings supporting key elements of the planned Phase 3 program for ATH434 in MSA
- Advancing ATH434 toward pivotal Phase 3 program; on track for End-of-Phase 2 FDA meeting mid-year 2026
- Late breaking platform presentation at American Academy of Neurology annual meeting demonstrated consistent evidence of efficacy and reinforces ATH434’s clinical profile
- Strengthened clinical leadership with appointment of Dr. Daniel Claassen as Chief Medical Advisor
- Enhanced Board of Directors with appointment of Ms. Ann Cunningham, bringing extensive global commercial and neurodegenerative disease expertise
- Hosted a virtual KOL event featuring leading experts to highlight clinical progress on MSA program and reinforce the scientific rationale for ATH434
- Alterity continues to engage in discussions with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434
- Cash balance of A$44.53 million at 31 March 2026
MELBOURNE, Australia and SAN FRANCISCO, April 30, 2026 (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 2026 (Q3 FY26).
“We continue to build momentum across our ATH434 program in Multiple System Atrophy (MSA), including productive FDA engagement that supports our path toward Phase 3 initiation,” said, David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics. “Importantly, we reached agreement with the FDA on key elements of our pivotal development program related to clinical pharmacology, non-clinical development and CMC. Confirming alignment with the FDA in these areas provides an important foundation for our planned End-of-Phase 2 meeting that remains on track for midyear. In addition to our regulatory progress, we presented new analyses of our Phase 2 data that demonstrates consistent evidence of slowing disease progression, further strengthening the clinical profile of ATH434 and our overall confidence in the program.”
Dr. Stamler, continued, “We are pleased to welcome Dr. Daniel Claassen to our management team and Ms. Ann Cunningham to our Board of Directors. Their collective expertise strengthens our capabilities as we execute on our next phase of growth. We continue to engage with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434. Together, with our ongoing engagement with the investment and medical communities, we are well positioned to advance ATH434 and deliver on our mission to bring meaningful therapies to patients living with MSA.”
ATH434 Clinical and Regulatory Update
Regulatory Progress
Alterity received significant endorsements from the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in MSA. In March 2026, Alterity received written feedback from a Type C meeting supporting its plans related to clinical pharmacology and non-clinical development elements of its development program. Subsequent to the end of the period, the company received written feedback from a Type C interaction with the FDA on the chemistry, manufacturing, and control (CMC) elements of the program. The Type C Meetings are part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. The planned End-of-Phase 2 meeting with the FDA remains on track for mid-year 2026.
Clinical Program
Subsequent to the end of the period, Alterity presented new data analyses from the ATH434-201 Phase 2 trial showing consistent evidence of clinical efficacy for ATH434 by slowing functional decline in patients with MSA. The presentation described an analysis from the ATH434-201 Phase 2 clinical trial in MSA utilizing a novel endpoint called the MSA Combined Outcome Assessment (MuSyCA). ATH434 slowed disease progression versus placebo on the MuSyCA assessment, with a treatment effect of −1.9 (75 mg dose) to −4.0 points (50 mg dose, p=0.034, relative treatment effect 41%) at Week 52. Beneficial effects were seen on both activities of daily living and neurological examination components, consistent with previously reported results on the established endpoint of UMSARS I1.
The analyses were delivered as an oral presentation by Dr. Daniel Claassen at the American Academy of Neurology (AAN) Annual Meeting during a Late Breaking Science Session: “ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale.”
Strategic Discussions
Alterity continues to engage in discussions with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434. These discussions reflect ongoing interest in the program’s clinical profile, orphan disease status and late-stage development.
Corporate and Financial Update
Governance and Leadership
In March 2026, Daniel O. Claassen, M.D., M.S., was appointed Chief Medical Advisor, bringing deep clinical and development expertise to Alterity. Dr. Claassen was the coordinating investigator for Alterity’s Phase 2 study in MSA and will be instrumental as the Company advances ATH434 into Phase 3. Dr. Claassen is a board-certified neurologist and internationally recognized expert in neurodegenerative diseases, with more than two decades of clinical and translational research in movement disorders and cognitive and behavioral neurology. Dr. Claassen is a sought-after investigator and collaborator in translational neuroscience and has served as principal investigator on numerous clinical trials, working across academic medical centers and industry partnerships to advance new therapies for neurodegenerative disorders.
Subsequent to the end of the quarter, Alterity strengthened the composition of its Board of Directors by appointing Ms. Ann Cunningham to its Board as an independent Non-Executive Director. Ms. Cunningham brings more than 25 years of global pharmaceutical and biotechnology experience, with deep expertise in commercial strategy and leadership across neurodegenerative disease and psychiatry. She has held senior roles at leading global organisations including Eli Lilly and Company and Teva Pharmaceuticals, where she led multiple marketing and sales teams and was responsible for neurodegenerative and psychiatry portfolios.
Investor Engagement
The Company continues to actively engage the investment community with participation in the JP Morgan Healthcare Conference Week in the USA as well as the Bell Potter Healthcare Horizons Summit, the Emergence Life Science Investor Day, and the Impact Invest Summit in Australia.
In April 2026, Alterity hosted a virtual key opinion leader (KOL) event featuring Roy Freeman, MD, Professor of Neurology at Harvard Medical School and Daniel Claassen, MD, MS. Dr. Freeman presented an overview of MSA and the need for new treatments and Dr. Claassen presented new analyses of the Phase 2 data demonstrating a mechanistic link between chaperoning, or redistributing, excess iron and slowing the progression of MSA. The webcast recording of the presentation is available by clicking here.
Cash Position
As of 31 March 2025, Alterity held cash and cash equivalents of A$44.53 million. Operating cash outflows for the quarter were A$4.73 million. The Company believes its strong cash position provides a solid runway to progress regulatory, clinical and commercial objectives while advancing partnering discussions from a position of financial strength.
In accordance with ASX Listing Rule 4.7C, payments of A$406k made to related parties and their associates during the quarter included non-executive directors’ fees, managing director salary and bonus payments, consulting fees, remuneration and superannuation at commercial rates.
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. For further information please visit the Company’s website at https://alteritytx.com.
1 Unified MSA Rating Scale, Part I (historical review) assess activities of daily living. Domains assessed include speech, swallowing, handwriting, cutting food/handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function and bowel function.
Authorisation & Additional information
This announcement was authorized by the Board of Directors of Alterity Therapeutics Limited.
Contacts:
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Remy Bernarda
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Casey McDonald
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