SYP

- ATH434 shows promise as a disease-modifying therapy for MSA - - ATH434-202 Phase 2 interim data demonstrate stabilization of clinical symptoms and biomarkers in clinical responders - MELBOURNE, Australia and SAN FRANCISCO, Oct. 02, 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 were presented at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS). “We significantly raised the profile of Alterity and ATH434 at the MDS Congress with several data presentations, including a late breaking oral presentation on data from our ATH434-202 Phase 2 open-label clinical trial in Multiple System Atrophy (MSA),” said David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics. “At the Congress, we presented data from both of our Phase 2 clinical trials with ATH434, preclinical data on ATH434 in Parkinson’s disease, and findings from our bioMUSE natural history study that continues to advance our understanding of MSA. Taken together, the data demonstrate the potential for ATH434 to modify disease progression and reduce disability in individuals living with MSA.” Dr. Stamler continued, “In the open-label Phase 2 study, 30% of participants showed stable or improved clinical outcomes (clinical responders). In addition, the clinical responders demonstrated stability in objective biomarkers such as brain iron and a protein marker of nerve damage, when compared to non-responders. Taken together, these data suggest that ATH434 has potential as a disease modifying treatment.” “At the conference, we also presented baseline clinical and biomarker data from our ATH434-201 randomized, double-blind clinical trial. Based on the learnings from our bioMUSE natural history study, we employed strict selection criteria to confirm that participants were diagnosed with early-stage (clinically probable) MSA, giving us the best chance of success from the trial. Looking ahead, we expect to present the topline data from ATH434-201 in January 2025 and the 12-month data from ATH434-202 later in the year. We are grateful to the study participants and their families as well as the clinical sites for their dedication to make the Phase 2 trials successful,” concluded Dr. Stamler. Presentation Summaries Late-Breaking Oral Presentation and Poster on ATH434-202 Interim Data Title: Preliminary Efficacy and Safety of ATH434 in Multiple System AtrophyLead Author: Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical CenterFormat: Late Breaking Oral Platform Presentation and Poster SessionResults: The interim data suggest that ATH434 may have a disease-modifying effect in MSA, with 30% of participants showing stable or improved clinical outcomes (clinical responders). The average change in Unified MSA Rating Scale Part I (UMSARS I) scores over 6 months is smaller than typically observed in untreated MSA patients. At 6 months all participants exhibited brain volume declines consistent with MSA progression; however, the clinical responders maintained stable brain volumes at 12 months. Importantly, ATH434 was well tolerated with no drug-related serious adverse events, and most adverse events were mild to moderate, showing a favorable safety profile. Together, these early outcomes suggest that ATH434 could have a potential to modify disease progression. Neurofilament light chain (NfL) levels are a measure of neuronal injury and are often correlated with disease severity. In the Phase 2 trial, the clinical responders had stable or reduced NfL levels: at 6 months, the average increases in NfL were 2.7% in CSF and 4.5% in plasma, compared to 17.9% and 19.3% in Alterity’s bioMUSE natural history participants, respectively. In addition, clinical responders also showed stability in iron levels in the substantia nigra, putamen, and globus pallidus compared to non-responders with increased iron. The stabilization of iron content in these subcortical brain regions, combined with NfL biomarker data, indicates that ATH434 may slow neurodegeneration by modulating brain iron levels and reducing oxidative injury. Title: A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy Lead Author: David Stamler, M.D., Chief Executive Officer of Alterity TherapeuticsFormat: Oral Platform Presentation and Poster SessionResults: The oral presentation and poster describe the baseline characteristics for the 77 participants from Alterity’s ATH434-201 randomized, double-blind Phase 2 clinical trial, with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met strict selection criteria designed to confirm that participants had early-stage (clinically probable) MSA. The accuracy of diagnosing clinically probable MSA may be increased using a multimodal approach that includes neuroimaging biomarkers (increased iron content, reduced subcortical volumes) and fluid biomarkers such as NfL. ATH434 is a potential disease modifying therapy based on its ability to redistribute excess labile iron without impairing normal iron storage, inhibit α‐synuclein aggregation and reduce oxidative injury. Importantly, increased iron levels were evident in multiple subcortical brain regions, with increased levels being observed in the substantia nigra in nearly all subjects. Title: Association Between Clinical Progression in Multiple System Atrophy and Brain Volume Changes Evaluated via Deep Learning SegmentationLead Author: Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical CenterFormat: Poster SessionResults: The poster describes results from the “Biomarkers of progression in Multiple System Atrophy” (bioMUSE) natural history study designed to track the progression of individuals with MSA. For participants enrolled in bioMUSE, fluid and imaging biomarkers, along with clinical manifestations, were used to classify patients as MSA (n=10: 6 MSA-P, 4 MSA-C) or Parkinson’s Disease/Dementia with Lewy Bodies (n=5). Patients who tested negative for alpha-synuclein (n=2) were excluded from the analyses. In the trial, novel MRI imaging techniques and deep learning segmentation were used to assess brain volume across brain Regions of Interest (ROI) relevant to MSA. Structural MRI plays a critical role in both diagnosing MSA and monitoring disease progression. Subcortical brain volume shows potential as a biomarker for evaluating disease-modifying therapies. Over the course of one year, MRI with deep-learning segmentation revealed significant brain volume reduction in MSA ROIs whereas the PD patients showed no significant brain volume changes. In contrast, the MSA patients exhibited significant volume reductions in the cerebellum, globus pallidus, and brainstem. In addition, the MSA-P patients showed significant volume loss in the putamen. The results illustrate the correlation between the brain volume reduction and worsening clinical scores, as measured by the UMSARS, providing a visual representation of disease progression. Title: Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in a Parkinson's Disease Model in MacaquesLead Author: Margaret Bradbury, Vice President, Research and Nonclinical Development, Alterity TherapeuticsPresentation: Poster SessionResults: The presentation demonstrated that ATH434 treatment led to lower iron levels in the affected area of the brain, the substantia nigra, and improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. At week 12, all 5 ATH434-treated macaques had stable or improving scores from Baseline while two of three vehicle-treated macaques did not demonstrate improvement. The improved general behavior was well-correlated with reduced motor impairment. These favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway. These results support further investigation of ATH434 for the treatment of Parkinson’s disease. The poster presentations can be found on Alterity’s website here. About ATH434 Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA. ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission. About ATH434-202 Phase 2 Clinical Trial The ATH434-202 Phase 2 clinical trial is an open label study, entitled “A Biomarker Study of ATH434 in Participants with MSA.” The Biomarker trial enrolled 10 individuals with advanced MSA. ATH434-202 study participants will receive treatment with ATH434 for 12-months. The study will assess the effect of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. The selected biomarkers, including brain volume, iron and aggregating α-synuclein, are important contributors to MSA pathology and are appropriate targets to demonstrate drug activity. The primary objective of this study is to evaluate the impact of 12 months treatment with ATH434 on brain volume in a more advanced patient population than is being studied in Alterity’s randomized Phase 2 trial. Final, 12-month data from the ATH434-202 trial are expected in the first half of 2025. Additional information on the open label Phase 2 trial can be found at clinicaltrials.gov identifier: NCT05864365. About ATH434-201 Phase 2 Clinical Trial The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. Selected biomarkers, such as brain iron and aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors have also been employed to evaluate motor activities that are important to patients with MSA. The study enrolled 77 adults who were randomly assigned to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by clinicaltrials.gov identifier: NCT05109091. About bioMUSE Biomarkers of progression in Multiple System Atrophy (bioMUSE) is a natural history study that aims to track the progression of individuals with MSA, a parkinsonian disorder without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under the direction of Daniel Claassen, M.D., M.S., Professor of Neurology and Principal Investigator. Natural history studies are important for characterizing disease progression in selected patient populations. The study has provided rich data for optimizing the design of Alterity’s randomized ATH434-201 Phase 2 clinical trial and enrolled approximately 20 individuals with clinically probable or clinically established MSA. BioMUSE continues to provide vital information on early stage MSA patients, informs the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy, and delivers clinical data to characterize disease progression in a patient population that mirrors those currently enrolling in the Phase 2 clinical trial. 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 and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects at least 15,000 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 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Sources:1Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)2National Institute of Health: Neurological Disorders and Stroke, Parkinson's Disease Information Page;3Parkinson’s Foundation Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaHannah Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648 064 U.S.Remy Bernardaremy.bernarda@iradvisory.com +1 (415) 203-6386 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.

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, Australia and SAN FRANCISCO, July 31, 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 released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2024 (Q4 FY24). “We have made great strides over the last two months with the positive interim data readout from our ATH434-202 Phase 2 clinical trial and the important observations from our bioMUSE Natural History Study that continue to guide development of ATH434,” said David Stamler, M.D., Chief Executive Officer of Alterity. “I am very encouraged by the results from our 202 study in patients with advanced Multiple System Atrophy (MSA) where we saw favorable clinical and biomarker outcomes in some patients suggesting that ATH434 has the potential to modify the course of this devastating condition. We were also very pleased to see that the clinical responders had biomarker evidence of stable disease as this provides an objective indication of potential efficacy.” “Our bioMUSE study continues to provide valuable information to inform our patient selection criteria and choose endpoints for our Phase 2 clinical trials. This observational study has allowed us to monitor the progression of MSA in earlier stage patients and further characterize this devastating disease. Working with our colleagues at Vanderbilt University, we have employed novel MRI technology and machine learning to precisely analyze brain iron content and brain volumes in these patients over time. The results from the study have guided us to modify our endpoints in the ATH434-202 study. The data from our 202 and bioMUSE studies increases my overall confidence in the ATH434 development program,” concluded Dr. Stamler. Alterity’s cash position on 30 June 2024 was A$12.6M with operating cash outflows for the quarter of A$5.6M. In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees, remuneration and superannuation at commercial rates. Operational Activities ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA On 8 May 2024, Alterity announced that an independent Data Monitoring Committee (DMC) completed its third prespecified review of unblinded clinical trial data from the ATH434-201 Phase 2 study. The DMC expressed no concerns about safety and recommended that the study continue as planned without modification. This recommendation is an important milestone as participants are able to safely tolerate ATH434 as their time on study increases. In April 2024, important new data on ATH434 was presented at the World Orphan Drug Congress in a poster presentation, entitled, “Biophysical Characteristics of ATH434, a Unique Iron-Targeting Drug for Treating Friedreich’s Ataxia.” The study evaluated the ability of ATH434 to target the toxic form of iron that drives the pathology of Friedreich’s Ataxia, a rare neurodegenerative disease that affects young children to young adults. The investigation provides important insights into the mechanism of action of ATH434, namely that it selectively targets the labile iron implicated in the pathology of important neurodegenerative diseases. In this way, ATH434 behaves like a chaperone to redistribute iron within the body. In April 2024, a poster was presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, entitled, “A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy”. The poster described the baseline characteristics for the 65 evaluable participants from the ATH434-201 with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met strict selection criteria designed to confirm they had early-stage MSA. Overall, the participants had a mean duration of motor symptoms of two years. The data showed increased iron in areas of pathology and elevated plasma Neurofilament Light Chain (NfL) levels at baseline that correlated significantly with disease severity. The trial remains on track to complete in November 2024. The data from the trial will then be analyzed and the Company expects to report topline results by January 2025. ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in More Advanced MSA Subsequent to the quarter end, on 17 July 2024, Alterity reported positive interim data from the ATH434-202 trial in participants with advanced MSA. The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12 months. After 6 months of treatment, 43% of participants showed improvement on the UMSARS1, indicating reduced disability on activities of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms (clinical responders) as assessed by the global impression of change by both the treating physician and the patient. Importantly, the clinical responders on average had reduced accumulation of iron on MRI in the substantia nigra, putamen and globus pallidus and stable levels of NFL, a marker of axonal injury, when compared to participants who declined. bioMUSE Natural History Study On 30 May 2024 Alterity hosted a webinar to discuss data from the bioMUSE Natural History Study. The goal of the observational bioMUSE study is to optimize patient selection and choose endpoints for the Company’s Phase 2 clinical trials. This study enrolled 21 individuals who were observed for 12 months to characterize early-stage MSA in terms of various biomarkers. In particular, the focus is on brain iron, brain volume, and the pathology in glial support cells. Utilizing novel MRI technology, Alterity’s partners at Vanderbilt University have optimized specialized MRI methods, including machine learning (a form of artificial intelligence), to establish standardized methods to analyze brain iron and brain volumes with precision. Importantly, they developed a new, novel imaging biomarker to assess brain volume in MSA affected regions. The bioMUSE data showed a statistically significant increase in iron over 12 months in the substantia nigra, and statistically significant decreases in brain volume observed in affected regions at 12 months. Also at AAN, a poster was presented at the AAN 2024 Annual Meeting, entitled, “Neurofilament Light Chain and Clinical Progression in Early Multiple System Atrophy”. The poster described results from bioMUSE in which changes in clinical severity of 15 patients across a span of 12 months were compared with plasma biomarkers with a goal of establishing meaningful correlations. Importantly, the observational data suggest the fluid biomarker NfL may be used as a marker of disease severity in studies of MSA as it holds promise for measuring the extent of disease, tracking its progression, and forecasting the onset of clinical manifestations associated with MSA. ATH434 for the Treatment of Parkinson’s Disease A poster was also presented at AAN entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”. The presentation showed that ATH434 can reduce Parkinsonism in a higher order animal, the monkey, with symptoms that closely parallel human disease. Importantly, the improvements in motor skills and general functioning that parallel human parkinsonism were associated with reductions in abnormal iron in affected brain regions. These favorable parkinsonian outcomes observed in the ATH434-treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway. Taken together, the findings in this study increase the Company’s confidence in their approach in the ongoing Phase 2 program in MSA. 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaHannah Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648 064 U.S.Remy Bernardaremy.bernarda@iradvisory.com +1 (415) 203-6386 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.

Highlights ATH434-201 Phase 2 baseline data confirm approach to target biomarkers for slowing disease progressionPresented promising nonclinical data on ATH434 in a primate model of Parkinson’s diseaseRaised approximately A$5.25M to strengthen the balance sheetReceived an A$3.9M Research and Development Tax Incentive RefundCash balance on 31 March 2024 of A$18.3M MELBOURNE, Australia and SAN FRANCISCO, April 30, 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 released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 March 2024 (Q3 FY24). “We are excited about the advancement of all of our programs during the third quarter of our fiscal year as we progress towards clinical data readouts from our Phase 2 trials,” said, David Stamler, M.D., Chief Executive Officer of Alterity. “Collectively, the data we presented from our clinical trials in Multiple System Atrophy (MSA) and the primate model of Parkinson’s disease continue to validate our approach of using biomarkers to monitor disease progression. Overall, these data improve our ability to predict clinical outcomes and increase our confidence level in our ongoing Phase 2 clinical trials in MSA. We remain on track to report preliminary data from our ATH434-202 study in the second quarter of this year, and topline results in ATH434-201 by January 2025.” Alterity’s cash position on 31 March 2024 was A$18.3M with operating cash outflows for the quarter of A$2.6M. The company strengthened its balance sheet during the quarter by raising approximately A$5.25M. In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees, remuneration and superannuation at commercial rates. Operational Activities ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA On 6 February 2024, Alterity announced that an independent Data Monitoring Committee (DMC) completed its second prespecified review of unblinded clinical trial data from the ATH434-201 Phase 2 study. The DMC expressed no concerns about safety and recommended that the study continue as planned without modification. This recommendation is an important milestone as participants are able to safely tolerate ATH434 as their time on study increases. In April 2024, a poster was presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, entitled, “A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy”. The poster described the baseline characteristics for the 65 evaluable participants from the ATH434-201 with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met the strict criteria designed to confirm that participants were diagnosed with early-stage MSA and had a mean of two years of motor symptoms. The data showed increased iron in areas of pathology and elevated plasma Neurofilament Light Chain (NfL) levels at baseline that correlated significantly with disease severity. The trial remains on track to complete in November 2024. The data from the trial will then be analyzed and the Company expects to report topline results by January 2025. ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in More Advanced MSA The ATH434-202 trial continues to enroll participants with more advanced MSA than in the 201 trial. A key aim of the 202 study is to assess the efficacy of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. While the 202 trial is also treating participants for 12-months, it has an open label design that will allow Alterity to perform interim analyses of biomarker and clinical data while the study is ongoing, providing a potential early indication of efficacy. The Company expects to report preliminary six-month data from the initial patients enrolled in the ATH434-202 trial in the second quarter of 2024. ATH434 for the Treatment of Parkinson’s Disease A poster was also presented at AAN entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”. The presentation showed that ATH434 can reduce Parkinsonism in a higher order animal, the monkey, with symptoms that closely parallel human disease. Importantly, the improvements in motor skills and general functioning that parallel human parkinsonism were associated with reductions in abnormal iron in affected brain regions. These favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway. Taken together, the findings in this study increase the Company’s confidence in their approach in the ongoing Phase 2 program in MSA. bioMUSE Natural History Study The bioMUSE study continues to generate important data related to the understanding of MSA and its presentation as the disease progresses. The advancement of MSA is profoundly aggressive, highlighting the critical need for biomarkers to delineate its progression over time. Also at AAN, a poster was presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, entitled, “Neurofilament Light Chain and Clinical Progression in Early Multiple System Atrophy”. The poster described results from bioMUSE in which changes in clinical severity of 15 patients across a span of 12 months were compared with plasma biomarkers with a goal of establishing meaningful correlations. Importantly, the observational data suggest the fluid biomarker NfL may be a marker of disease modification in studies of MSA as it holds promise for measuring the extent of disease, tracking its progression, and forecasting the onset of clinical manifestations associated with MSA. 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’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: Australia Hannah Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648 064 U.S.Remy Bernarda remy.bernarda@iradvisory.com +1 (415) 203-6386 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.