Alterity Therapeutics (NASDAQ: ATHE) secures long-term US patent for ATH434

Rhea-AI Filing Summary

Alterity Therapeutics Limited reports that the U.S. Patent and Trademark Office has granted a new composition of matter patent for ATH434, its lead clinical asset for Multiple System Atrophy (MSA), Parkinson’s disease and related disorders. The patent covers a crystalline form of ATH434 mesylate and associated treatment methods and extends protection to at least 2045, adding a key layer of intellectual property as ATH434 moves toward planned Phase 3 development in MSA by year-end 2026. The company notes that this protection supports potential commercial value, partnership opportunities and expansion of ATH434 into Parkinson’s disease and other neurodegenerative indications, alongside existing Fast Track and Orphan Drug Designations for MSA.

Positive

• USPTO grants new composition of matter patent for ATH434, extending protection to at least 2045 and strengthening the lead asset’s intellectual property position as it advances toward planned Phase 3 development in Multiple System Atrophy.
• The new patent supports future development of ATH434 in Parkinson’s disease and other neurodegenerative disorders, potentially broadening the asset’s commercial scope beyond Multiple System Atrophy.
• ATH434 already has Fast Track Designation and Orphan Drug Designation for Multiple System Atrophy from U.S. and European regulators, adding regulatory incentives to the strengthened patent protection.

Negative

• None.

Filing Explained

The patent grant is current, but its stated Orange Book listing remains contingent on regulatory approval.

The August 12, 2026 Form 6-K reports a granted U.S. patent for ATH434 and says the report is incorporated by reference into specified S-8 and F-3 registration statements.

The company says the patent is expected to be listed in the FDA’s Orange Book only upon regulatory approval; that listing is therefore a future, conditional step rather than a current listing.

Key Figures

Patent protection horizon: at least 2045 MSA prevalence U.S.: up to 50,000 individuals Parkinson’s disease prevalence U.S.: nearly one million people +2 more

5 metrics

Patent protection horizon at least 2045 Estimated expiration date of new U.S. composition of matter patent for ATH434

MSA prevalence U.S. up to 50,000 individuals Estimated number of people affected by Multiple System Atrophy in the United States

Parkinson’s disease prevalence U.S. nearly one million people Number of people living with Parkinson’s disease in the United States

Parkinson’s disease prevalence worldwide more than 10 million people Estimated global population living with Parkinson’s disease

Annual new PD diagnoses U.S. approximately 60,000 Americans Estimated number of Americans diagnosed with Parkinson’s disease each year

Key Terms

composition of matter patent, Multiple System Atrophy, Fast Track Designation, Orphan Drug Designation, +2 more

6 terms

composition of matter patent regulatory

"USPTO has granted a new composition of matter patent for ATH434"

A composition of matter patent is a legal right that protects a specific chemical, molecule, material or formulated mixture—think of it as locking down a unique recipe for a substance. For investors it matters because the patent can give a company exclusive control to make, sell, or license that substance, creating a potential source of revenue and a competitive barrier similar to owning the only map to a valuable resource.

Multiple System Atrophy medical

"advances toward Phase 3 development in Multiple System Atrophy"

A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.

Fast Track Designation regulatory

"ATH434 has been granted Fast Track Designation by the U.S. Food and Drug Administration"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

Orphan Drug Designation regulatory

"Orphan Drug Designation by the FDA and the European Commission for the treatment of MSA"

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.

α-synuclein medical

"ATH434 has been shown to reduce α-synuclein pathology and preserve neuronal function"

A-synuclein is a small protein found in brain cells that can misfold and stick together, forming clumps that harm neurons—think of it like lint building up in a filter and blocking normal function. It matters to investors because these clumps are central to diseases such as Parkinson’s and related dementias, making a-synuclein a major focus for drug development and diagnostic tests; success or failure of therapies or tests targeting it can drive biotech valuations and regulatory decisions.

Orange Book regulatory

"expected to be listed in the FDA’s ... “Orange Book”), upon regulatory approval"

A publicly maintained FDA database that lists approved prescription drugs and notes which versions are considered interchangeable with brand-name products, along with key patent and exclusivity dates. Think of it as a product roster plus an expiration calendar: investors use it to see when a drug’s protection ends and generic competition can enter, which can directly affect a company’s sales, future revenue and stock value.

FAQ

What did Alterity Therapeutics (ATHE) announce in this Form 6-K?

Alterity Therapeutics announced that the USPTO granted a new composition of matter patent for ATH434, its lead neurodegeneration drug candidate, extending protection to at least 2045 and reinforcing its intellectual property position as it prepares for Phase 3 development in Multiple System Atrophy.

How does the new ATH434 patent affect Alterity Therapeutics (ATHE) commercial prospects?

The patent extends ATH434’s protection to at least 2045 and covers a crystalline mesylate form and treatment methods, which the company states enhances ATH434’s strategic value, supports potential partnerships, and lengthens the potential commercial life of the drug if it is ultimately approved.

Which diseases is Alterity’s (ATHE) ATH434 intended to treat?

ATH434 is designed to treat Multiple System Atrophy (MSA), Parkinson’s disease and related neurodegenerative disorders linked to iron dysregulation and protein aggregation, including α-synuclein pathology, with clinical development currently focused on MSA and potential future expansion into Parkinson’s disease.

What clinical data has Alterity Therapeutics (ATHE) reported for ATH434 so far?

Alterity reports that ATH434 showed clinically meaningful efficacy, biomarker-based target engagement, and a favorable safety profile in a randomized, double-blind, placebo-controlled Phase 2 MSA trial, with positive supporting data from a second open-label Phase 2 biomarker study in more advanced MSA patients.

What regulatory designations does ATH434 from Alterity Therapeutics (ATHE) hold?

ATH434 has received Fast Track Designation from the FDA and Orphan Drug Designation from both the FDA and the European Commission for Multiple System Atrophy, providing potential development, review, and market exclusivity benefits if the drug is eventually approved.

How common are Multiple System Atrophy and Parkinson’s disease targeted by ATH434?

Multiple System Atrophy affects up to 50,000 individuals in the U.S., while Parkinson’s disease affects nearly one million people in the U.S. and more than 10 million worldwide, with about 60,000 Americans diagnosed with Parkinson’s each year.

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Form 6-K: How Foreign Companies Report to the SEC →

Available on EDGAR 08/13/2026 - 06:06 AM Accepted by SEC EDGAR 08/13/2026 - 06:02 AM Learn about SEC filing dates

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 August 2026

Alterity Therapeutics Limited

(Name of Registrant)

Level 15, 500 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, 333-248980 and 333-228671) and our Registration Statements on Form F-3 (Files No. 333-274816, 333-251647, 333-231417 and 333-250076)

ALTERITY THERAPEUTICS LIMITED

(a development stage enterprise)

The following exhibits are submitted:

99.1 Granted New U.S. Composition of Matter Patent for ATH434

1

SIGNATURE

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
	By:	/s/ Julian Babarczy
		Julian Babarczy
		Chairman

Date: August 12, 2026

2

Exhibit 99.1

Alterity Therapeutics Announces Granting of New U.S. Composition of Matter Patent

for ATH434

– Newly granted patent extends protection for ATH434 to at least 2045,

significantly enhancing its strategic value and long-term commercial potential –

–  Strengthens ATH434’s intellectual property portfolio as it advances toward Phase 3 development in Multiple System Atrophy –

– Enables future development of ATH434 for Parkinson’s disease

and other major neurodegenerative disorders –

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 12 August 2026:  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 United States Patent and Trademark Office (USPTO) has granted a new composition of matter patent for ATH434, the Company’s lead clinical asset. ATH434 is an oral agent designed to treat the underlying pathology of neurodegenerative diseases such as Multiple System Atrophy (MSA), Parkinson’s disease and related disorders. The newly granted patent represents a significant intellectual property milestone for Alterity and strengthens ATH434’s long-term commercial potential as the Company prepares to initiate Phase 3 trial activities in MSA by year-end 2026.

The new patent provides composition-of-matter protection for a crystalline structure of the mesylate salt form of ATH434 as well as protection for methods for treating neurological conditions using it.  This form of ATH434 was used in the Company’s Phase 2 clinical trials in MSA and will be utilized in the planned Phase 3 study. The patent extends protection for ATH434 to at least 2045, and together with existing intellectual property (IP) and regulatory designations, provides multi-layered market protection. In addition to reinforcing Alterity’s position in MSA, the new patent enables future development opportunities for ATH434 in Parkinson’s disease and other neurodegenerative diseases where iron dysregulation and protein aggregation are implicated.

“With protection to at least 2045, this patent extends the commercial life and revenue potential for ATH434 in MSA, if approved, as we prepare to initiate Phase 3 trial activities by year-end 2026,” said David Stamler, M.D., Chief Executive Officer. “Importantly, Parkinson’s disease is now a viable target indication for ATH434, as our strengthened IP provides the protection needed to justify investment in this major neurodegenerative disorder. The granting of this new U.S. composition of matter patent reflects the deliberate execution of our IP strategy and is one of the most critical steps we have taken to protect the innovation behind ATH434.”

“Overall, this patent enhances the strategic value of ATH434, supporting potential partnerships and other opportunities to advance development. We remain dedicated to developing ATH434 as a disease modifying treatment for these debilitating conditions,” concluded Dr. Stamler.

New Composition of Matter Patent for ATH434

The USPTO granted the patent entitled "Crystalline Form, and Process for its Production" which covers the composition of matter of a crystalline form of ATH434 mesylate as well as methods for treating neurological conditions using it. The allowed claims protect the novel solid-state crystalline form of ATH434 mesylate and treatment methods, providing another layer of protection as a commercial asset for the treatment of MSA and additional neurodegenerative diseases.

The patent has an estimated expiration date of at least 2045 and is expected to be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (the “Orange Book”), upon regulatory approval of ATH434 for commercialization.

Composition of matter claims are widely recognized as one of the strongest forms of pharmaceutical patent protection.

About ATH434

Alterity’s lead candidate, ATH434, is an oral agent designed to reduce iron accumulation and inhibit abnormal protein aggregation associated with neurodegeneration. ATH434 has been shown to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models. With properties shared by endogenous iron chaperones, it has the potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). Positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated clinically meaningful efficacy, target engagement as indicated by 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 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 that causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic dysfunction affecting involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predispose patients to falls. A pathological hallmark of MSA is the accumulation of abnormal clumping of the protein α-synuclein within oligodendrocytes, the myelin-producing support cells of the central nervous system, along with progressive neuronal 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.¹

About Parkinson’s Disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder and causes unintended or uncontrollable movements of the body along with neuropsychiatric and other nonmotor features. The precise cause of PD is unknown, but some cases are hereditary while others are thought to occur from a combination of genetics and environmental factors that trigger the disease. In PD, brain cells become damaged or die in the substantia nigra, the part of the brain that produces dopamine – a chemical needed to produce smooth, purposeful movement. The cardinal symptoms of PD are tremors, rigidity, slowing of movements, and later in disease, impaired balance. Other symptoms may include difficulty swallowing, chewing, or speaking; emotional changes; urinary problems or constipation; dementia or other cognitive problems; fatigue; and problems sleeping.² Nearly one million people in the U.S. and more than 10 million people worldwide are living with PD. Approximately 60,000 Americans are diagnosed with PD each year.³

References

¹ Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)

² National Institute of Health: Neurological Disorders and Stroke, Parkinson's Disease Information Page;

³ Parkinson’s Foundation

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.

Authorisation & Additional information

This announcement was authorized by David Stamler, CEO 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.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 22.3 KB