Alterity Therapeutics Releases Appendix 4C – Q1 FY27 Quarterly Cash Flow Report & Corporate Update
Highlights
MELBOURNE, Australia and SAN FRANCISCO, Oct. 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 30 September 2026 (Q1 FY27).
“This was a quarter of meaningful progress for Alterity,” said David Stamler, M.D., Chief Executive Officer. “With the final minutes from our End-of-Phase 2 meeting, we have confirmed alignment with the FDA on the registrational pathway for ATH434 in MSA. That clarity has allowed us to begin the operational start-up activities as we prepare to initiate our Phase 3 trial in MSA.”
“We also strengthened the foundation for ATH434's long-term value. The granting of a new U.S. composition of matter patent for ATH434 extends protection to 2045 and supports its future development in Parkinson’s disease. We continue to build on our scientific work with a peer-reviewed publication from the bioMUSE Natural History Study and new Phase 2 analyses presented at the MDS Congress that adds to the evidence supporting ATH434's clinical profile and iron-chaperone mechanism. Together with the proceeds from the exercise of our listed options and receipt of our R&D tax refund, our position is strengthened as we advance toward Phase 3,” concluded Dr. Stamler.
Secured New ATH434 Intellectual Property Protection
In August 2026, the United States Patent and Trademark Office (USPTO) granted a new composition of matter patent for ATH434. The patent covers a crystalline form of the mesylate salt of ATH434, the form used in the Company’s Phase 2 clinical trials in MSA and planned for use in Phase 3, as well as methods for treating neurological conditions using it. The patent has an expiry of 2045 and is expected to be listed in the FDA’s Orange Book upon regulatory approval of ATH434. Together with existing intellectual property and regulatory designations, including Orphan Drug Designation in the U.S. and EU, the patent provides multi-layered protection for ATH434 in MSA and supports the commercial rationale for future development in Parkinson’s disease and other neurodegenerative diseases where iron dysregulation is implicated.
Continued ATH434 Clinical and Regulatory Progress
During the quarter, the Company received minutes from the U.S. Food and Drug Administration (FDA) End-of-Phase 2 (EOP2) meeting regarding the Phase 3 study design and the registrational pathway for a potential New Drug Application (NDA) for ATH434 in MSA. The minutes confirmed that the FDA agreed with the proposed Phase 3 design, including the study population, treatment regimen, and primary endpoint ‒ the 11-item UMSARS Part I 1 rating scale, a functional measure of activities of daily living affected in MSA. Agreement was also reached on selection of key secondary endpoints. The FDA indicated that a single pivotal trial plus confirmatory evidence could provide the data necessary to support approval, with the Company anticipating that the data from its ATH434-201 Phase 2 clinical trial will provide the required confirmatory evidence.
The Phase 3 study is expected to enroll approximately 200 patients who will be randomized 1:1 to ATH434 50 mg or matching placebo treatment twice daily for 12 months. Alterity has begun Phase 3 operational activities including finalizing the protocol, selecting vendors, identifying and qualifying clinical trial sites, and successfully manufacturing the first registration batch of ATH434 for use in the pivotal trial.
Scientific Engagement
Alterity continues to actively engage with the global neurology community through peer-reviewed publications and scientific presentations at leading international congresses. These activities form an important component of the Company’s strategy to disseminate clinical data, engage with key opinion leaders and specialists, and further interpret Phase 2 results for ATH434 in MSA.
During the quarter and subsequent to quarter end, Alterity presented the following new analyses and peer-reviewed publication, which are available on the Publications and Presentations page of the Company’s website:
Investor and Strategic Partner Engagement
Alterity continues to engage with the investment communities in Australia and the U.S. with presentations at several conferences in the United States: Canaccord Genuity Growth, Cantor Global Healthcare, BTIG Biotech, and Craig-Hallum Biotech. Presentations in Australia included BioShares, ASX SMIDcaps, and the Canaccord Genuity Drug and Device Conference.
Alterity continues to evaluate a range of strategic and funding alternatives to support the advancement of ATH434, including ongoing discussions with a number of pharmaceutical companies. The Company is progressing a structured evaluation process, with the assistance of external advisers, to assess these opportunities alongside other potential funding and development pathways.
The Company remains focused on maintaining strategic flexibility while pursuing the pathway that best supports the advancement of ATH434 and maximizes long-term shareholder value.
Corporate and Financial Update
In July 2026, the Company received its research and development (R&D) tax refund for the 2025 financial year totaling A$3,982,992 (including A$43,117 of interest), under the Australian Government’s R&D Tax Incentive.
In August 2026, the Company entered into an underwriting agreement with MST Financial Services Pty Ltd to underwrite the exercise of up to 8,400,000 of the 15,918,235 ATHO listed options on issue at the agreement date (exercisable at A$0.50 and expiring on 31 August 2026). In the quarter ending 30 September 2026, 3,191,983 options were exercised by option holders prior to expiry and 8,400,000 shortfall shares were issued under the underwriting, raising total proceeds of approximately A$5.5 million after costs. Proceeds will support continued late-stage clinical development of ATH434 in MSA and general working capital.
As of 30 September 2026, Alterity held cash and cash equivalents of A$41.3 million. Operating cash outflows for the quarter were A$1.34 million.
In accordance with ASX Listing Rule 4.7C, payments of A$323k made to related parties and their associates during the quarter included non-executive directors’ fees, managing director salary, consulting fees, remuneration and superannuation at commercial rates.
The full financial report can be found in the ASX filing here.
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 for Parkinson’s disease and related disorders. Alterity is preparing to initiate a Phase 3 pivotal trial in Multiple System Atrophy (MSA), a rare and rapidly progressive neurodegenerative disease without an approved treatment. ATH434, the Company’s lead asset, 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.
References
1 11-item UMSARS Part I (previously described as modified UMSARS I): Unified Multiple System Atrophy Rating Scale, 11-Items include: Orthostatic symptoms, Swallowing, Speech, Handwriting, Cutting food, Dressing, Hygiene, Walking, Falling, Urinary and Bowel function.
Authorization & Additional Information
This announcement was authorized by the Board of Directors of Alterity Therapeutics Limited.
Contacts:
Investors
Elyse Shapiro
ir@alteritytx.com
Remy Bernarda
Investor Relations Advisory Solutions
ir@alteritytx.com
+1 (415) 203-6386
Media
Melissa Tempra
NWR Communications
melissa@nwrcommunications.com.au
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.