Core Insights - Alterity Therapeutics announced positive results from the ATH434-201 Phase 2 clinical trial for Multiple System Atrophy (MSA) at the MSA Research Symposium [1][2] - The trial demonstrated significant clinical efficacy of ATH434, with a 48% relative treatment effect at the 50 mg dose and a 30% effect at the 75 mg dose [3][5] - ATH434 is designed to inhibit the aggregation of pathological proteins and has shown potential in treating neurodegenerative diseases [4][8] Company Overview - Alterity Therapeutics is focused on developing disease-modifying therapies for neurodegenerative diseases, particularly Parkinson's disease and related disorders [8] - The company is based in Melbourne, Australia, and San Francisco, California, and is advancing its lead candidate, ATH434, through clinical trials [8] Clinical Trial Details - The ATH434-201 Phase 2 trial involved 77 patients and assessed the efficacy, safety, and pharmacokinetics of ATH434 over 12 months [5][6] - Key findings included a clinically significant reduction in disease severity on the modified UMSARS I scale and improvements in motor activities measured by wearable sensors [3][5] - ATH434 was well tolerated, with no serious adverse events reported, and showed trends in reducing iron accumulation in MSA-affected brain regions [3][4][6] Disease Context - Multiple System Atrophy (MSA) is a rare, rapidly progressive neurodegenerative disease affecting the autonomic nervous system and movement [7] - MSA currently has no approved treatments that can slow disease progression, highlighting the potential impact of successful therapies like ATH434 [7]

Core Insights - Alterity Therapeutics is advancing its lead drug candidate, ATH434, aimed at treating neurodegenerative diseases, specifically targeting Multiple System Atrophy (MSA) [1][4] - The last patient in the ATH434-202 Phase 2 trial has completed the study, with topline data expected to be reported in mid-2025 [1][2] Company Overview - Alterity Therapeutics is a clinical-stage biotechnology company focused on developing disease-modifying therapies for neurodegenerative diseases, particularly Parkinson's disease and related disorders [7] - The company is based in Melbourne, Australia, and San Francisco, California, and has a drug discovery platform aimed at creating treatments for neurological diseases [7] ATH434-202 Phase 2 Clinical Trial - The ATH434-202 trial is an open-label study involving 10 participants with advanced MSA, where participants received a 75 mg dose of ATH434 for 12 months [3] - The study aims to evaluate the effects of ATH434 on neuroimaging and protein biomarkers, alongside clinical measures, safety, and pharmacokinetics [3] - The primary objective is to assess the impact of ATH434 on brain volume in a more advanced patient population compared to previous trials [3] Drug Mechanism and Efficacy - ATH434 is designed to inhibit the aggregation of pathological proteins associated with neurodegeneration, specifically targeting α-synuclein pathology [4] - Preclinical studies have shown that ATH434 can reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain [4] - The drug has received Orphan Drug Designation for MSA treatment from the U.S. FDA and the European Commission [4] Disease Context - Multiple System Atrophy (MSA) is a rare, rapidly progressive neurodegenerative disease affecting at least 15,000 individuals in the U.S., characterized by autonomic dysfunction and impaired movement [5] - Currently, there are no approved drugs that can slow the progression of MSA, highlighting the potential significance of ATH434 in the treatment landscape [5]

[Appendix 4D: Half-Year Report Summary](index=4&type=section&id=Appendix%204D) [Results for Announcement to the Market](index=4&type=section&id=Results%20for%20announcement%20to%20the%20market) Alterity Therapeutics reported decreased revenue and increased net loss for H1 FY2025, with net tangible assets per share significantly declining Financial Performance Summary (vs. 31 Dec 2023) | Metric | Change | Value (A$) | | :--- | :--- | :--- | | Revenue from ordinary activities | Down 6.0% | 111,299 | | Net loss after tax | Up 10.2% | 7,173,335 | Net Tangible Assets per Security | Date | Cents per Share | | :--- | :--- | | 31 December 2024 | 0.14 | | 31 December 2023 | 0.62 | - The reported income of **$111,299** for the half-year was entirely from interest received on the Group's bank accounts[7](index=7&type=chunk) - No dividends have been paid or declared by the Group for the current or previous financial period[8](index=8&type=chunk) [Directors' Report](index=8&type=section&id=Directors'%20report) [Review of Operations](index=8&type=section&id=Review%20of%20Operations) The company achieved significant progress with positive ATH434-201 Phase 2 trial results for MSA, followed by a successful A$42 million capital raise [Lead Compound - ATH434](index=8&type=section&id=Lead%20Compound%20-%20ATH434) ATH434 is the company's lead oral agent, inhibiting pathological protein aggregation by redistributing iron, with potential for MSA and other neurodegenerative diseases - **ATH434** is an oral agent designed to inhibit pathological protein aggregation by redistributing excess iron in the brain, thereby rescuing neuronal function[23](index=23&type=chunk) - The compound has potential as a treatment for Multiple System Atrophy (MSA), Parkinson's disease, and Friedreich Ataxia[24](index=24&type=chunk)[25](index=25&type=chunk) [ATH434 Clinical Trials for Multiple System Atrophy (MSA)](index=9&type=section&id=ATH434%20Clinical%20Trials%20for%20Multiple%20System%20Atrophy%20(MSA)) The ATH434-201 Phase 2 trial showed a **48%** slowing of MSA progression, while the ATH434-202 trial also yielded positive interim data - The ATH434-201 Phase 2 trial in early-stage MSA demonstrated a clinically meaningful benefit, achieving statistical significance with a **48%** slowing of clinical progression on the UMSARS I rating scale at the **50** mg dose[18](index=18&type=chunk) - The ATH434-202 trial in more advanced MSA showed positive interim data, with **30%** of participants demonstrating stable or improved clinical outcomes and slower progression compared to a historical untreated group[34](index=34&type=chunk) - **ATH434** has received Orphan Drug Designation (ODD) for the treatment of MSA from both the U.S. FDA and the European Commission, which provides benefits like market exclusivity and fee reductions[26](index=26&type=chunk) [Other Research and Development Progress](index=10&type=section&id=Other%20Research%20and%20Development%20Progress) Pre-clinical data showed ATH434 improved motor performance in Parkinson's models, and the bioMUSE study is advancing MRI as an MSA biomarker - In a study on macaques with experimentally induced Parkinson's disease, **ATH434** treatment improved motor performance and was associated with reduced iron levels in the affected brain area[37](index=37&type=chunk) - A peer-reviewed publication in *Metallomics* characterized **ATH434** as an "iron chaperone" that targets the damaging, reactive form of iron[38](index=38&type=chunk) - The bioMUSE natural history study is utilizing advanced MRI and deep learning to track brain volume changes, establishing it as a potential biomarker for MSA progression[42](index=42&type=chunk)[43](index=43&type=chunk) [Corporate Activity and Subsequent Events](index=11&type=section&id=Corporate%20Activity%20and%20Subsequent%20Events) The company appointed a new Company Secretary and successfully raised approximately **A$42** million post-period to accelerate ATH434 development - Abby Macnish Niven was appointed as Company Secretary on November **18**, **2024**, following her earlier appointment as Chief Financial Officer[44](index=44&type=chunk) - Subsequent to the period end, in February **2025**, the company strengthened its balance sheet by raising approximately **A$42** million via an ATM facility and a two-tranche placement[46](index=46&type=chunk)[48](index=48&type=chunk) [Consolidated Financial Statements](index=14&type=section&id=Consolidated%20financial%20statements) [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=14&type=section&id=Consolidated%20statement%20of%20profit%20or%20loss%20and%20other%20comprehensive%20income) The Group reported a net loss of **A$7.17** million for H1 FY2025, driven by significant R&D and general/administration expenses Statement of Profit or Loss (Half-year ended 31 December) | Item | 2024 (A$) | 2023 (A$) | | :--- | :--- | :--- | | Interest income | 111,299 | 118,400 | | Other income (R&D tax incentive) | 1,605,925 | 1,900,724 | | General and administration expenses | (2,984,023) | (2,061,250) | | Research and development expenses | (5,717,901) | (6,361,034) | | **Loss for the period** | **(7,173,335)** | **(6,507,183)** | | **Basic loss per share (Cents)** | **(0.14)** | **(0.26)** | [Consolidated Statement of Financial Position](index=15&type=section&id=Consolidated%20statement%20of%20financial%20position) The Group's net assets decreased to **A$7.79** million as of December **31**, **2024**, primarily due to a reduction in cash and cash equivalents Statement of Financial Position (As at) | Item | 31 Dec 2024 (A$) | 30 Jun 2024 (A$) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | 4,536,559 | 12,638,885 | | Trade and other receivables | 5,684,107 | 4,041,675 | | **Total Assets** | **10,546,933** | **19,223,743** | | **Total Liabilities** | **2,760,926** | **5,425,686** | | **Net Assets** | **7,786,007** | **13,798,057** | | **Total Equity** | **7,786,007** | **13,798,057** | [Consolidated Statement of Changes in Equity](index=16&type=section&id=Consolidated%20statement%20of%20changes%20in%20equity) Total equity decreased by **A$6.01** million to **A$7.79** million, mainly due to the net loss, partially offset by share-based payments and new share issues Movements in Equity (Half-year ended 31 Dec 2024) | Item | Amount (A$) | | :--- | :--- | | Balance at 1 July 2024 | 13,798,057 | | Loss for the period | (7,173,335) | | Issue of ordinary shares | 398,645 | | Share-based payment expenses | 794,717 | | Transaction costs | (32,077) | | **Balance at 31 December 2024** | **7,786,007** | [Consolidated Statement of Cash Flows](index=17&type=section&id=Consolidated%20statement%20of%20cash%20flows) The Group experienced a net cash decrease of **A$8.06** million, primarily from **A$8.36** million in net cash used for operating activities Statement of Cash Flows (Half-year ended 31 December) | Item | 2024 (A$) | 2023 (A$) | | :--- | :--- | :--- | | Net cash (outflow) from operating activities | (8,359,622) | (4,494,940) | | Net cash (outflow) from investing activities | - | (5,722) | | Net cash inflow from financing activities | 298,319 | 1,050,347 | | **Net (decrease) in cash** | **(8,061,303)** | **(3,450,315)** | | Cash at beginning of period | 12,638,885 | 15,773,783 | | **Cash at end of period** | **4,536,559** | **12,320,426** | [Notes to the Consolidated Financial Statements](index=18&type=section&id=Notes%20to%20the%20consolidated%20financial%20statements) [Funding Position and Going Concern](index=27&type=section&id=Funding%20position%20of%20the%20Group) Despite a net loss and operating cash outflow, the company maintains a going concern basis, supported by a post-period **A$40** million capital raise - The Group incurred a recurring loss of **A$7,173,335** and an operating cash outflow of **A$8,359,622** for the half-year ended **31** December **2024**[107](index=107&type=chunk) - Cash and cash equivalents on hand as at **31** December **2024** was **$4,536,559**[108](index=108&type=chunk) - The financial statements are prepared on a going concern basis, justified by a subsequent capital raise of approximately **A$40** million. Of this, **A$12.8** million was received in February **2025**, with the remainder subject to shareholder approval[109](index=109&type=chunk)[110](index=110&type=chunk) [Financial Performance and Position Details](index=19&type=section&id=Financial%20Performance%20and%20Position%20Details) The Group's income is primarily from interest and R&D tax incentives, with major expenses in R&D and G&A, resulting in a basic loss per share of **(0.14)** **cents** Loss Per Share | Metric | 31 Dec 2024 (Cents) | 31 Dec 2023 (Cents) | | :--- | :--- | :--- | | Basic loss per share | (0.14) | (0.26) | | Diluted loss per share | (0.14) | (0.26) | Breakdown of Income (A$) | Source | 31 Dec 2024 | 31 Dec 2023 | | :--- | :--- | :--- | | Interest income | 111,299 | 118,400 | | R&D tax incentive | 1,605,925 | 1,900,724 | - The R&D tax incentive receivable was **A$5,625,211** as of Dec **31**, **2024**, representing the amount the Group expects to recover[80](index=80&type=chunk) [Equity and Share Capital](index=23&type=section&id=Equity%20and%20Share%20Capital) The company issued **75.2** million ordinary shares, raising **A$398,645**, while **1.94** billion options expired and **170** million new options were issued under ESOP Movements in Ordinary Shares (1 Jul 2024 - 31 Dec 2024) | Details | Number of Shares | Amount (A$) | | :--- | :--- | :--- | | Opening balance | 5,245,115,318 | 223,152,985 | | Shares issued during the year | 75,220,800 | 406,193 | | Transaction costs | - | (32,077) | | **Closing balance** | **5,320,336,118** | **223,527,101** | - On August **31**, **2024**, **1,935,759,704** free attaching short-dated options expired[90](index=90&type=chunk) - During the period, **170,000,000** unlisted options were issued under the Employee Stock Option Plan (ESOP)[89](index=89&type=chunk) [Events Occurring After the Reporting Period](index=25&type=section&id=Events%20occurring%20after%20the%20reporting%20period) Post-period, Alterity announced positive ATH434-201 Phase 2 trial results and secured **A$40** million in capital commitments to accelerate development - On January **30**, **2025**, the company announced positive topline results from its **ATH434-201** Phase **2** clinical trial, demonstrating a **48%** slowing of clinical progression on the UMSARS I scale[98](index=98&type=chunk) - On February **10**, **2025**, the company announced it had received binding commitments for a capital raising of **A$40** million via a two-tranche placement at **A$0.011** per share[100](index=100&type=chunk) - Tranche One of the placement was completed on February **17**, **2025**, raising **A$12.8** million. Tranche Two, to raise **A$27.2** million, is subject to shareholder approval expected in late March **2025**[100](index=100&type=chunk)[101](index=101&type=chunk) [Declarations and Reports](index=28&type=section&id=Declarations%20and%20Reports) [Directors' Declaration](index=28&type=section&id=Directors'%20declaration) The directors declare the financial statements provide a true and fair view and affirm the company's ability to meet its debts on a going concern basis - The directors affirm that the financial statements give a true and fair view of the consolidated entity's financial position and performance and are in accordance with the Corporations Act **2001**[111](index=111&type=chunk) - The directors state there are reasonable grounds to believe that Alterity Therapeutics Limited will be able to pay its debts as and when they become due and payable[111](index=111&type=chunk) [Independent Auditor's Review Report](index=30&type=section&id=Independent%20auditor's%20report%20to%20the%20members) PwC's review found no matters indicating non-compliance with accounting standards or the Corporations Act **2001** for the half-year financial report - The auditor, PricewaterhouseCoopers, concluded that based on their review, they have not become aware of any matter that makes them believe the financial report does not comply with the Corporations Act **2001**, including giving a true and fair view and complying with AASB **134**[117](index=117&type=chunk)[121](index=121&type=chunk) - The review was conducted in accordance with ASRE **2410**, which is substantially less in scope than an audit, and consequently, the auditor does not express an audit opinion[123](index=123&type=chunk)

6-K 1 ea0216061-6k_alterity.htm REPORT OF FOREIGN PRIVATE ISSUER SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-163 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FORM 6-K For the month of September 2024 Alterity Therapeutics Limited (Name of Registrant) Level 14, 350 Collins Street, Melbourne, Victoria 3000 Australia (Address of Principal Executive Office) Indicate by check mark whether the registrant files or will file annual reports un ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15 ...

Exhibit 99.1 | --- | --- | |--------|-------| | | | | ANNUAL | | A lterityTherapeuticsL im ited ACN080699065 Annualreport–June30,2024 CONTENTS CHAIRMAN'SLETTERi FORM20-F1 SHAREHOLDERINFORMATION83 CORPORATEDIRECTORY86 CHAIRMAN'S LETTER i Dear Shareholders, I am excited to present the Alterity Therapeutics'Annual Report as we made tremendous progress over the last year. MSA Program Hits Several Key Milestones We currently have three programs ongoing targeting the rare, parkinsonian disorder known as Multiple ...

- Late Breaking Abstract and Oral Presentation on ATH434-202 Interim Phase 2 Data - - Oral Presentation on ATH434-201 Phase 2 Baseline Characteristics - MELBOURNE, Australia and SAN FRANCISCO, Sept. 23, 2024 (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 announced that multiple oral and poster presentations will be presented at the Internationa ...

Highlights Positive interim data reported from ATH434-202 Phase 2 clinical trial showing improvement on the UMSARS Activities of Daily Living Scale and stable or improved neurological symptoms in some patientsData from the bioMUSE Natural History Study continues to characterize early stage MSA and inform Alterity's Phase 2 clinical trialsMultiple data presentations at the World Orphan Drug Congress and the American Academy of Neurology (AAN) Annual MeetingCash balance on 30 June 2024 of A$12.6M MELBOURNE, A ...

MELBOURNE, Australia and SAN FRANCISCO, June 12, 2024 (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 announced that David Stamler, M.D., Chief Executive Officer will present a company overview at the MST Access ‘Hidden Gems in Life Sciences’ webinar on Thursday, 13 June 2024 in Australia / Wednesday, 12 June 2024 in the United States. Details a ...

Core Insights - Alterity Therapeutics is hosting an investor webcast to discuss the bioMUSE Natural History Study results and their implications for the ATH434-202 Phase 2 clinical trial endpoints [1][2]. Group 1: Webcast Details - The webcast will feature CEO Dr. David Stamler and key opinion leader Dr. Daniel Claassen from Vanderbilt University [2]. - The event is scheduled for May 30, 2024, in Australia and May 29, 2024, in the United States, with specific times provided for both regions [2]. Group 2: Company Overview - Alterity Therapeutics is focused on developing treatments for neurodegenerative diseases, with its lead asset ATH434 aimed at treating Parkinsonian disorders [4]. - The company is currently conducting two Phase 2 clinical trials for ATH434 in Multiple System Atrophy [4]. - Alterity is based in Melbourne, Australia, and San Francisco, California, and has a drug discovery platform for neurological diseases [4].