– Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s Disease to be Presented at International Conference – – Baseline Biomarker Data to be Presented from Ongoing ATH434-201 Phase 2 Clinical Trial – MELBOURNE, Australia and SAN FRANCISCO, Feb. 20, 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 three posters f ...

- ATH434-201 Trial on Track to Complete in November 2024 – - Top-Line Data Expected in January 2025 - MELBOURNE, AUSTRALIA AND SAN FRANCISCO, Feb. 06, 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 an independent Data Monitoring Committee (DMC) has completed its second review of trial data and recommended the ATH434-201 Phas ...

Core Viewpoint - Alterity Therapeutics is actively engaging with investors and the public through a webinar to discuss its developments in neurodegenerative disease treatments, particularly focusing on its lead asset, ATH434 [1][2]. Group 1: Company Overview - Alterity Therapeutics is a clinical stage biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases [2]. - The company's lead asset, ATH434, has potential applications in treating various Parkinsonian disorders [2]. - Alterity operates from Melbourne, Australia, and San Francisco, California, USA [2]. Group 2: Event Participation - David Stamler, M.D., the CEO of Alterity, will participate in the ShareCafe Hidden Gems webinar on February 2, 2024, for Australian participants and February 1, 2024, for U.S. participants [1]. - The webinar is free to register, and an archived replay will be available after the event [1].

Core Insights - Alterity Therapeutics is focused on developing disease-modifying treatments for neurodegenerative diseases, particularly Multiple System Atrophy (MSA) and Parkinson's disease, with significant milestones achieved in 2023 and plans for 2024 [1][8]. Company Overview - Alterity Therapeutics is a clinical-stage biotechnology company based in Melbourne, Australia, and San Francisco, California, dedicated to treating neurodegenerative diseases [9]. Clinical Trials - The company is conducting two Phase 2 clinical trials: ATH434-201, which completed participant enrollment in November 2023 and will conclude in November 2024, and ATH434-202, which is assessing more advanced MSA patients and will provide preliminary data in the first half of 2024 [4][5]. - ATH434, the lead candidate, is an orally administered agent that redistributes excess iron in the brain, reduces alpha-synuclein protein, and rescues neuronal function, showing potential to treat both MSA and Parkinson's disease [3][8]. Regulatory Designation - ATH434 has received Orphan Drug Designation (ODD) from the U.S. FDA and the European Commission for the treatment of MSA, which provides benefits such as market exclusivity for 7-10 years, tax credits, and protocol assistance [3]. Research and Development - The bioMUSE Natural History study continues to provide valuable insights into MSA, aiding in the design of ongoing clinical trials and enhancing patient selection [6]. - Promising data from a Parkinson's disease primate model demonstrated that ATH434 can reduce symptoms, which supports the ongoing clinical trials [7]. Future Outlook - 2024 is expected to be pivotal for Alterity, with topline data from the ATH434-201 trial anticipated shortly after its completion in November 2024, and preliminary data from the ATH434-202 trial expected in the first half of the year [8].

Exhibit 99.1 Alterity Therapeutics Limited Appendix 4E Audited Financial Report For the year ended 30 June 2023 | --- | --- | |---------------------------------------------|-----------------------------------| | | | | Name of entity | Alterity Therapeutics Limited | | ABN or equivalent company reference | 37 080 699 065 | | Current reporting period | 30 June 2023 | | Corresponding reporting period | 30 June 2022 | Results for announcement to the market | --- | --- | --- | --- | --- | |---------------------- ...

Drug Development and Clinical Trials - Alterity's lead drug candidate, ATH434, is designed to block the accumulation of α-synuclein and has shown preclinical efficacy in reducing α-synuclein pathology and improving motor function[128]. - ATH434 has successfully completed Phase 1 clinical studies and is currently in two Phase 2 clinical trials for Multiple System Atrophy (MSA), with regulatory approvals in New Zealand, Italy, and the UK[147]. - In March 2023, Alterity announced a new Composition of Matter patent covering more than 100 novel compounds, with at least one showing efficacy in an animal model of dementia[140]. - The ongoing Phase 2 trial ATH434-201 aims to enroll approximately 60 patients with early-stage MSA, assessing treatment effects on imaging and protein biomarkers[177]. - ATH434 demonstrated neuroprotective effects in a genetic model of Parkinson's disease, preventing loss of smell in younger mice and motor impairment in older mice[186]. - In a study published in January 2022, ATH434 reduced toxic forms of α-synuclein and improved motor performance in a murine model of Multiple System Atrophy (MSA)[188]. - PBT2 demonstrated safety and tolerability in Phase 1 and Phase 2 trials, with 95% of participants completing the 52-week treatment period[158][159]. - The Phase 2 trial "Reach2HD" for Huntington disease demonstrated PBT2 as safe and well tolerated, achieving its primary objective[165]. - PBT2 has shown efficacy in preclinical studies for Huntington disease, leading to the recommendation for clinical trials[164]. - In the IMAGINE trial, PBT2 did not meet its primary endpoint for reducing beta-amyloid plaques, but showed a trend towards preserving hippocampal brain volume[159]. Research and Intellectual Property - The company has a diversified library of over 1000 validated compounds and continues to strengthen its intellectual property portfolio with new patents, including a US patent covering more than 80 novel compounds[140][138]. - The technology developed by Alterity is based on the interrelationship of metals and proteins, targeting neurodegenerative diseases such as Alzheimer's and Parkinson's[135]. - Alterity's research efforts have historically focused on neurological diseases, with a current emphasis on Parkinson's disease and related disorders, aiming to address underlying pathologies[133]. - The patent portfolio includes over 150 imidazo[l,5-a]pyridine compounds, with a patent granted in the US on July 1, 2021, with no prior art cited against the application[197]. - A European Patent for a related compound was granted on August 23, 2023, patent number 3938364[197]. - The company has filed a provisional application for an additional 80 novel compounds for treating neurodegenerative diseases, with a US patent granted on October 26, 2021[198]. Financial Performance and Funding - The company incurred an operating loss of A$13,806,515 for the year ended June 30, 2023, compared to A$12,847,061 in 2022, representing an increase of 7.4%[215]. - Research and development expenses decreased to A$13,198,583 for the year ended June 30, 2023, down A$1,547,193 or 10.5% from A$14,745,776 in 2022[222]. - General and administrative expenses decreased to A$5,056,571 for the year ended June 30, 2023, a reduction of A$457,345 or 8.3% from A$5,513,915 in 2022[222]. - Interest income increased significantly to A$16,436 for the year ended June 30, 2023, up A$13,932 or 556.4% from A$2,504 in 2022, due to higher cash balances and interest rates[220]. - The company recognized A$3,914,230 for the R&D Tax Incentive refundable cash offset for the year ended June 30, 2023, compared to A$4,669,405 in 2022[221]. - As of June 30, 2023, the company had A$15,773,783 in cash and cash equivalents, a decrease from A$34,806,799 as of June 30, 2022[232]. - The accumulated deficit totaled A$195,130,889 as of June 30, 2023[232]. - The company plans to raise new equity funding within six months of the financial year end to support its research and development programs[215]. - The company recorded A$3.9 million in other income related to the research and development tax incentive scheme for the financial year ended June 30, 2023[237]. - Operating losses were A$13.8 million and A$12.8 million for the years ended June 30, 2023 and 2022, respectively, with an operating cash outflow of A$20 million in 2023[238]. Corporate Structure and Governance - The company has two wholly-owned subsidiaries, Alterity Therapeutics Inc. and Alterity Therapeutics UK Limited, incorporated in the US and the UK respectively[206]. - The company has established valuable research collaborations with institutes in Australia and the U.S. to investigate various therapeutic indications[243]. - The company has established a Remuneration Committee comprised solely of independent directors to oversee executive compensation[307]. - The Audit Committee currently consists of two members, Messrs. Marks and Meltzer, both of whom meet the independence requirements[306]. - The company maintains a directors' and officers' liability insurance policy to cover certain liabilities incurred by its officers[313]. - The company has a staggered election process for its Board of Directors, requiring one-third of directors to retire and seek re-election at each annual general meeting[300]. Employee and Director Compensation - Total remuneration for directors in 2023 amounted to A$523,300, with Mr. Geoffrey Kempler receiving A$313,300, the highest among directors[276]. - Dr. David Stamler, a key management personnel, received total compensation of A$1,649,998, including a performance bonus of A$194,570[276]. - The aggregate amount available for non-executive directors' remuneration is A$1,250,000 per annum, as approved by shareholders[269]. - Total remuneration for directors and key management personnel amounted to A$2,690,011 for the fiscal year ended June 30, 2022[278]. - Long-term incentives (LTI) were provided in the form of share-based payments, while short-term incentives (STI) were provided as cash bonuses[282][281]. - The performance income for executives is based on a set monetary value or a portion of base salary, with no fixed proportion between incentive and non-incentive remuneration[279]. - As of June 30, 2023, the company had 11 employees, with 8 in research and development and 3 in management and administration[314]. - The total beneficial ownership of all directors and executive officers as a group is 86,999,032 ordinary shares, representing 2.65% of total ownership[317]. Market Position and Competition - There are currently no approved drugs for MSA, positioning ATH434 as a potential first-in-class treatment if approved[204]. - Competitors in the MSA treatment space include H. Lundbeck A/S and Takeda, both of which are developing drugs currently in Phase 2 studies[204]. - The pharmaceutical industry is highly competitive, with many competitors having greater resources and experience in clinical trials and regulatory approvals[203]. Shareholder Information - As of August 28, 2023, the total number of ordinary shares and unlisted options outstanding is 3,284,635,277, comprising 2,439,897,618 ordinary shares and 844,737,659 unlisted options[2]. - The company is authorized to issue up to an aggregate of 240,000,000 ordinary shares or ADSs under the Stock Option Plans, following shareholder approvals[321]. - The 2004 ASX Plan allows for the issuance of ordinary shares or options to purchase ordinary shares, promoting the interests of employees, directors, and consultants[322]. - The 2018 ADS Plan is designed for non-Australian based employees and allows for the issuance of incentive stock options and non-qualified stock options[325]. - The maximum fair market value of ADSs for incentive stock options exercisable in a calendar year is capped at U.S.$100,000[325]. - The vesting schedule for options under the 2004 ASX Plan typically spans four years, with 25% vesting at the end of each year[324].