Alterity Therapeutics Ltd SEC Filings

Alterity Therapeutics filed a Form 6-K to disclose the appointment of Daniel O. Claassen, M.D., M.S. as Chief Medical Advisor beginning in March 2026. Dr. Claassen is a tenured professor of neurology at Vanderbilt University Medical Center and an internationally recognized expert in neurodegenerative diseases, especially movement disorders and multiple system atrophy (MSA).

He previously served as coordinating investigator for Alterity’s Phase 2 study of its lead drug candidate ATH434 in MSA and has led numerous clinical trials across academia and industry. Alterity highlights that ATH434 showed clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial and positive data in an open-label Phase 2 study in advanced MSA, and notes it is preparing a Phase 3 pivotal trial.

Alterity Therapeutics reported a larger loss for the half-year ended 31 December 2025 as it advanced its lead drug ATH434 toward late-stage development. Revenue from ordinary activities was A$909,750, up 717%, mainly from higher interest income, while a R&D tax incentive contributed A$2,803,428 in other income.

The net loss after tax attributable to members widened 34% to A$9,615,849, driven by increased research and development expenses of A$7,842,289 and general and administration costs of A$5,116,261, including A$2,215,164 of share-based payments. Basic and diluted loss per share improved to 0.09 cents from 0.14 cents as the share count rose.

Alterity strengthened its balance sheet, raising approximately A$20 million in September 2025 and ending the period with cash and cash equivalents of A$49,200,547. Net tangible asset backing increased to 0.50 cents per share from 0.14 cents, and total equity rose to A$54,267,999. Operationally, the company highlighted positive Phase 2 data for ATH434 in Multiple System Atrophy, ongoing scientific engagement, and preparations for an End-of-Phase-2 FDA meeting targeted for mid-2026.

Alterity Therapeutics Limited reports its Q2 FY26 cash flow and a corporate update centered on lead candidate ATH434 for Multiple System Atrophy (MSA). The company highlights strengthened Phase 2 data, a Fast Track designation from the U.S. FDA, and active planning for an End-of-Phase 2 meeting targeted for mid-2026 to shape a pivotal Phase 3 trial.

New analyses of Phase 2 data showed an improved efficacy signal for the 75 mg dose on a modified UMSARS Part I endpoint and a beneficial effect on orthostatic hypotension symptoms. Alterity also points to a potential commercial opportunity of US$2.4 billion for ATH434 in MSA and is advancing partnering discussions with multiple pharmaceutical companies.

As of 31 December 2025, Alterity held A$49.2 million in cash and cash equivalents, with quarterly operating cash outflows of A$5.28 million, implying an estimated 9.3 quarters of funding. The company strengthened governance with a new Chair, added board representation for the CEO, and expanded its leadership team to support late-stage development and strategic partnering.

Alterity Therapeutics provides a shareholder update highlighting major progress with its lead drug candidate ATH434 for Multiple System Atrophy (MSA) and outlining priorities for 2026. In 2025 the company completed its Phase 2 program in MSA, reporting “resoundingly favourable” results, with ATH434 shown to be safe and well-tolerated and to provide strong signals of efficacy, including slowing disease progression and improving mobility and orthostatic hypotension, with no drug-related serious or severe adverse events compared with placebo. Alterity is now planning a pivotal Phase 3 program in MSA and expects to hold an End-of-Phase 2 meeting with the FDA in mid-2026 to finalize the Phase 3 trial design. The company also reports governance and leadership enhancements, including appointing Julian Babarczy as Chair of the Board and expanding its management team in investor relations and corporate strategy to support potential future commercialization and increased business development.

Alterity Therapeutics Limited has issued 18,000,000 new unlisted options under its employee incentive scheme. These options have an exercise price of AUD 0.008 and expire on 9 January 2031, and on exercise will convert into ordinary fully paid ATH shares.

The options form a new unquoted security class that is not intended to be quoted on ASX, and all options in this class rank equally from the issue date of 15 January 2026. The filing also notes that this report is incorporated by reference into Alterity’s existing Form S-8 and Form F-3 registration statements.

Alterity Therapeutics Limited has reported the grant of 43,500,000 unlisted options under its employee incentive scheme. These options have an exercise price of USD 0.0057 and expire on 13 January 2031, and are in a new unquoted class that will convert into ordinary fully paid ATH shares if exercised. None of the options were issued to key management personnel, and the issue was made under exception 13 in ASX Listing Rule 7.2, meaning separate security holder approval was not required. Following this grant, Alterity continues to have over 10.8 billion ordinary shares quoted on ASX along with several other series of quoted and unquoted options on issue.

Alterity Therapeutics is a late clinical stage biopharmaceutical company developing ATH434, an oral small molecule designed to chaperone excess labile iron in the brain, aiming to reduce α‑synuclein aggregation and oxidative injury in neurodegenerative diseases. The company reported positive Phase 2 results in multiple system atrophy (MSA), a rapidly progressive Parkinsonian disorder with no approved treatment, showing clinically meaningful benefits on the modified Unified MSA Rating Scale, global severity ratings, orthostatic hypotension symptoms and wearable movement metrics, with a favorable safety profile and MRI evidence of reduced brain iron. An open‑label study in more advanced MSA patients showed efficacy and biomarker effects consistent with the double‑blind trial. Independent commercial research estimated potential worldwide annual peak sales of USD $2.4 billion for ATH434 in MSA, and the company reported a cash balance of A$54.5 million as of 30 September as it prepares for a pivotal Phase 3 program.

Alterity Therapeutics Limited filed a Form 6-K furnishing an Appendix 3Y notice from the ASX that records a change in director interests for David Stamler. The filing shows that 91,392,720 unlisted options expiring on 06 January 2026 with an exercise price of $0.0320 expired and are now recorded as nil.

No ordinary shares or American Depositary Shares were acquired or disposed of, and the value/consideration for the expired options is listed as “NIL.” Stamler continues to hold fully paid ordinary shares, listed options with later expiries, further unlisted options, and 133,333 American Depositary Shares held indirectly through HSBC Custody Nominees. The Form 6-K is also incorporated by reference into several existing Form S-8 and Form F-3 registration statements.

Alterity Therapeutics Limited reports that 91,392,720 unquoted options with ASX code ATHAAD, exercisable at $0.032 and expiring on 6 January 2026, have lapsed without being exercised or converted. No consideration was paid in connection with this expiry.

Following this change, the company’s issued capital on ASX comprises 10,875,416,329 ordinary fully paid shares (ATH), along with quoted options ATHO (option expiring 31 August 2026) totaling 931,232,089 and ATHOA (option expiring 26 February 2027) totaling 1,222,300,911. Various classes of unquoted options remain on issue, while the ATHAAD class now has zero securities outstanding.