Alterity Therapeutics Releases Appendix 4C – Q1 FY27 Quarterly Cash Flow Report & Corporate Update

Phase 3 preparations have begun, while Alterity continues evaluating funding and pharmaceutical partnering alternatives.

Rhea-AI Summary

Alterity Therapeutics (NASDAQ: ATHE) reported FDA agreement on its proposed ATH434 Phase 3 trial design for multiple system atrophy (MSA). FDA minutes indicated that one pivotal trial plus confirmatory evidence could support approval; Alterity expects its Phase 2 data to supply that evidence. Phase 3 start-up activities are underway, and the first registration batch has been manufactured.

New Phase 2 analyses showed approximately 52% slower functional decline versus placebo at Week 52 with ATH434 50 mg. A new U.S. patent extends protection to 2045. At September 30, 2026, cash was A$41.3 million, including an A$3,982,992 research tax refund and approximately A$5.5 million in net option-exercise and underwriting proceeds. Quarterly operating cash outflows were A$1.34 million. Alterity continues evaluating funding and partnering alternatives to support Phase 3 development.

9 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointFDA agreement covers the proposed Phase 3 design, including population, treatment regimen and primary and key secondary endpoints.
• Moderate pointSeptember 30, 2026 cash and cash equivalents totaled A$41.3 million.
• Moderate pointOption exercises and underwriting raised approximately A$5.5 million after costs for late-stage development and working capital.
• Minor pointAdditional Phase 2 analysis showed approximately 52% slower functional decline versus placebo at Week 52 with ATH434 50 mg.
• Minor pointPhase 3 operational activities are underway, including successful manufacturing of the first registration batch.

4 minor points

• Minor pointNew U.S. ATH434 patent provides protection to 2045.
• Minor pointFiscal 2025 research tax refund received in July totaled A$3,982,992, including A$43,117 interest.
• Minor pointBioMUSE publication linked skin α-synuclein deposition with autonomic dysfunction in early MSA.
• Minor pointBaseline CSF NfL, a spinal-fluid biomarker, predicted functional decline, supporting its use in Phase 3 severity adjustment.

Negative

• Moderate pointFinancing issued 8,400,000 shortfall shares plus shares from 3,191,983 option exercises; options were exercisable at A$0.50.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Approval pathway requires confirmatory evidence alongside the pivotal trial; Alterity expects Phase 2 data to provide it.
• Minor pointQuarterly operating cash outflows were A$1.34 million.

News Explained

During the quarter, holders exercised 3,191,983 options and Alterity issued 8,400,000 shortfall shares under the underwriting. Together, these transactions raised approximately A$5.5 million after costs for the company, while the new shares increase the share base and dilute existing holders’ proportional ownership if their holdings do not change.

Key Figures

Cash balance: A$41.3 million Operating cash outflows: A$1.34 million Option exercise proceeds: Approximately A$5.5 million +5 more

Cash balance

A$41.3 million

As of 30 September 2026

Operating cash outflows

A$1.34 million

Quarter ended 30 September 2026

Option exercise proceeds

Approximately A$5.5 million

Raised after costs during the quarter

Patent expiry

2045

New U.S. composition of matter patent for ATH434

Phase 3 enrollment

Approximately 200 patients

Planned MSA trial

ATH434 dose

50 mg twice daily

Planned Phase 3 treatment regimen

Trial duration

12 months

Planned Phase 3 treatment period

Slowing of functional decline

Approximately 52%

ATH434 50 mg versus placebo on the 11-item UMSARS at Week 52

Historical Context

1 past event · Latest: Oct 05

1 event

1. Oct 05

   Phase 2 data

   24h Move

   -6.7%

   Phase 2 reanalysis showed 52% slowing, but the primary imaging endpoint was not met.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

new drug application, orphan drug designation, primary endpoint, csf nfl, +1 more

5 terms

new drug application regulatory

"registrational pathway for a potential New Drug Application (NDA) for ATH434 in MSA"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

orphan drug designation regulatory

"including Orphan Drug Designation in the U.S. and EU"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

primary endpoint medical

"and primary endpoint ‒ the 11-item UMSARS Part I1 rating scale"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

csf nfl medical

"Baseline CSF NfL predicted the rate of functional decline"

CSF NfL is the level of neurofilament light chain protein measured in cerebrospinal fluid, the clear liquid that cushions the brain and spine. It rises when nerve cells are damaged, so researchers use it like a smoke alarm to detect or track neurological injury or disease. For investors, changes in CSF NfL in clinical studies can signal whether a drug is slowing nerve damage and therefore affect a therapy’s development prospects and market value.

mesylate salt technical

"a crystalline form of the mesylate salt of ATH434"

A mesylate salt is the chemical form created when a basic drug molecule (usually one containing an amine group) is combined with methanesulfonic acid to make a stable, crystalline salt. Pharmaceutical mesylate salts are used to change a drug’s physical properties—such as water solubility, stability, manufacturability and how the body absorbs it—without altering the drug’s core active molecular structure; because the salt adds mass, doses are sometimes expressed with the salt name to reflect the correct amount of active base.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Highlights

• FDA End-of-Phase 2 meeting minutes confirmed the Phase 3 trial design and registrational pathway for ATH434 in Multiple System Atrophy (MSA)
• New U.S. composition of matter patent granted for ATH434, extending protection to 2045 and supporting future development in Parkinson’s disease
• Peer-reviewed publication in Clinical Autonomic Research from the bioMUSE Natural History Study linked skin α-synuclein deposition to autonomic dysfunction in early MSA
• Phase 3 operational activities underway
• Continued evaluation of strategic funding and partnering alternatives to support Phase 3 development and maximize long-term shareholder value
• Cash balance of A$41.3 million at 30 September 2026, inclusive of A$3.98 million Australian R&D Tax Incentive refund and approximately net A$5.5 million raised through the exercise of ATHO listed options

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 I¹ 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:

• October 2026 – International Congress of Parkinson’s Disease and Movement Disorders (MDS Congress): Poster presented additional analyses from the ATH434-201 Phase 2 trial in MSA. Using statistical methods planned for Phase 3, the analysis showed that ATH434 50 mg significantly slowed functional decline in MSA by approximately 52% versus placebo on the 11-item UMSARS¹ at Week 52. Baseline CSF NfL predicted the rate of functional decline, supporting its use as a severity covariate in Phase 3.
• August 2026 – Peer-reviewed publication in Clinical Autonomic Research from the Company’s bioMUSE Natural History Study described phosphorylated α-synuclein deposition in the skin biopsies of study participants. At baseline, α-synuclein strongly correlated with the drop in blood pressure on standing (orthostatic hypotension), and after 12 months α-synuclein deposition was correlated with higher autonomic symptom scores. The findings support skin biopsy as a minimally invasive tool to support the diagnosis and monitoring of progression in MSA clinical trials.

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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA agree to for Alterity's ATH434 Phase 3 trial?

The FDA agreed with the proposed Phase 3 design, including the study population, treatment regimen, primary endpoint and selection of key secondary endpoints. The primary endpoint is the 11-item UMSARS Part I scale, which measures daily activities affected by MSA. One pivotal trial plus confirmatory evidence could provide the data needed to support approval.

How will Alterity's ATH434 Phase 3 trial be conducted?

The study is expected to enroll approximately 200 patients, randomized 1:1 to ATH434 50 mg or matching placebo twice daily for 12 months. Start-up activities include finalizing the protocol, selecting vendors, and identifying and qualifying trial sites.

What does Alterity's new ATH434 patent cover?

The new U.S. patent covers a crystalline form of ATH434's mesylate salt and methods of treating neurological conditions using it. This form was used in Phase 2 MSA trials and is planned for Phase 3. Alterity expects the patent to be listed in the FDA's Orange Book upon regulatory approval.

What did Alterity's bioMUSE skin biopsy study find?

At baseline, skin α-synuclein deposition strongly correlated with the drop in blood pressure on standing; after 12 months, deposition correlated with higher autonomic symptom scores. The findings support skin biopsy as a minimally invasive tool for diagnosis and monitoring progression in MSA clinical trials.