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Highlights Aligned with the FDA in two Positive Type C meetings supporting key elements of the planned Phase 3 program for ATH434 in MSA Advancing ATH434 toward pivotal Phase 3 program; on track for End-of-Phase 2 FDA meeting mid-year 2026 Late breaking platform presentation at American Academy of Neurology annual meeting demonstrated consistent evidence of efficacy and reinforces ATH434's clinical profile Strengthened clinical leadership with appointment of Dr. Daniel Claassen as Chief Medical Advisor Enhanced Board of Directors with appointment of Ms. Ann Cunningham, bringing extensive global commercial and neurodegenerative disease expertise Hosted a virtual KOL event featuring leading experts to highlight clinical progress on MSA program and reinforce the scientific rationale for ATH434 Alterity continues to engage in discussions with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434 Cash balance of A$44.53 million at 31 March 2026 MELBOURNE, Australia and SAN FRANCISCO, April 30, 2026 (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 2026 (Q3 FY26). “We continue to build momentum across our ATH434 program in Multiple System Atrophy (MSA), including productive FDA engagement that supports our path toward Phase 3 initiation,” said, David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics. “Importantly, we reached agreement with the FDA on key elements of our pivotal development program related to clinical pharmacology, non-clinical development and CMC. Confirming alignment with the FDA in these areas provides an important foundation for our planned End-of-Phase 2 meeting that remains on track for midyear. In addition to our regulatory progress, we presented new analyses of our Phase 2 data that demonstrates consistent evidence of slowing disease progression, further strengthening the clinical profile of ATH434 and our overall confidence in the program.” Dr. Stamler, continued, “We are pleased to welcome Dr. Daniel Claassen to our management team and Ms. Ann Cunningham to our Board of Directors. Their collective e...

− Phase 2 Data Strengthened, Strong Cash Position, and Phase 3 Planning Well Advanced − Highlights Phase 2 data for ATH434 in Multiple System Atrophy (MSA) strengthened by additional analyses and multiple international scientific presentations during the quarter. Regulatory planning activities advancing toward a pivotal Phase 3 program, including preparation for FDA End-Of-Phase-2 meeting in mid-2026. Ongoing partnering and strategic discussions with pharmaceutical companies and corporate advisers to explore non-dilutive pathways to fund Phase 3 development. Board and executive leadership strengthened to support Alterity through its next stage of clinical development, partnering and commercial planning. Cash balance of A$49.2 million at 31 December 2025. MELBOURNE, Australia and SAN FRANCISCO, Jan. 30, 2026 (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 December 2025 (Q2 FY26). David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics, commented, “We continued to advance our Multiple System Atrophy (MSA) program on multiple fronts, including new analyses of the Phase 2 data that increase our overall confidence in ATH434’s potential as a disease-modifying therapy for this devastating disease. We also made significant strides in planning for a series of meetings with the U.S. FDA, culminating in a planned End-of-Phase 2 (EOP2) meeting in mid-2026.” Dr. Stamler continued, “During the quarter, we delivered several scientific presentations highlighting the Phase 2 data that support the potential commercial opportunity of US$2.4 billion for ATH434 in MSA. The growing body of data strengthen our conviction in ATH434 as a first-in-class disease-modifying therapy for MSA.” ATH434 Clinical and Regulatory Update Phase 2 Clinical Program & Regulatory Progress Alterity continued to build on the positive results from the ATH434-201 randomized, double-blind Phase 2 trial in MSA, while progressing regulatory planning activities to support advancement into late-stage development. During the quarter, the Company advanced its engagement strategy with the U.S. Food and Drug Administration (FDA)...

Highlights New analysis of ATH434-201 double blind trial strengthens efficacy signal at high dose level Positive data from ATH434-202 open-label trial demonstrates similar treatment effect in advanced MSA as observed in earlier stage patients in double-blind study Independent commercial assessment indicates USD $2.4 billion dollar potential worldwide peak sales opportunity in MSA for ATH434 Cash balance on 30 September 2025 of A$54.56M MELBOURNE, Australia and SAN FRANCISCO, Oct. 31, 2025 (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 September 2025 (Q1 FY26). “As we near the end of the calendar year, I am very proud of all we have accomplished in 2025, led by our compelling clinical results in Multiple System Atrophy (MSA), and I am excited about the prospect of delivering ATH434 to the MSA community,” said David Stamler, M.D., Chief Executive Officer of Alterity. Dr. Stamler continued, “During the recent quarter, we reported positive results from our trial in advanced MSA, published important neuroimaging findings from our natural history study, and completed our commercial assessment indicating a potential market opportunity of approximately USD$2.4 billion dollars. The totality of the data from our combined studies and interest from the medical and scientific community continues to give us great confidence in the potential of ATH434 as a first-in-class, disease-modifying therapy for MSA.” “We are actively engaging with the U.S. Food and Drug Administration (FDA) on ATH434 to conduct a series of meetings to discuss emerging nonclinical and chemistry and manufacturing data required for Phase 3 conduct. Reaching agreement on these elements with the FDA is critical for ensuring a productive End-of-Phase 2 meeting to enable us to initiate a Phase 3 trial in MSA,” concluded Dr. Stamler. Alterity’s cash position on 30 September 2025 was A$54.56M with operating cash outflows for the quarter of A$5.34M. In accordance with ASX Listing Rule 4.7C, payments of A$108k made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees...

Highlights Granted U.S. FDA Fast Track Designation for ATH434 to treat Multiple System Atrophy (MSA) Reported positive topline data from open-label Phase 2 clinical trial of ATH434 in MSA Presented additional analyses from the ATH434-201 trial demonstrating continued robust efficacy for the treatment of MSA Cash balance on 30 June 2025 of A$40.66M MELBOURNE, Australia and SAN FRANCISCO, July 30, 2025 (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 2025 (Q4 FY25). “U.S. FDA Fast Track designation for ATH434 in MSA was the highlight of the recent quarter that also featured additional positive clinical data from our Phase 2 double-blind trial,” said David Stamler, M.D., Chief Executive Officer of Alterity. “Receiving Fast Track Designation alongside the Orphan Drug Designation we have already received underscores the promise of this potentially disease modifying therapy to address the urgent needs of individuals with MSA. In addition, we presented additional efficacy data from the ATH434-201 double-blind trial at prominent medical meetings, including slowing of disease progression on the Unified MSA rating scale or UMSARS, improvement in key symptoms of MSA, and preserved activity in the outpatient setting.” “We were also very pleased to announce positive results from our ATH434-202 open-label Phase 2 clinical trial this week, in which ATH434 demonstrated a clinical benefit on the UMSARS and global assessments of neurological symptoms. Neuroimaging biomarkers showed target engagement and slowed brain atrophy in a manner consistent with the double-blind study findings. Importantly, ATH434 continues to demonstrate a favorable safety profile. These data reinforce our confidence in the MSA program as we prepare for interactions with the U.S. FDA,” concluded Dr. Stamler. Alterity’s cash position on 30 June 2025 was A$40.66M with operating cash outflows for the quarter of A$2.35M. In accordance with ASX Listing Rule 4.7C, payments of A$119k made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, consulting fees, remuneration and supe...

Highlights Reported positive topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) led by robust clinical efficacy Phase 2 data featured in an oral presentation at the American Academy of Neurology Annual Meeting ATH434-202 open-label trial in advanced MSA completed in March 2025 Cash balance on 31 March 2025 of A$17.96M with an additional A$27.1M raised subsequent to the end of the quarter MELBOURNE, Australia and SAN FRANCISCO, April 30, 2025 (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 2025 (Q3 FY25). David Stamler, M.D., Chief Executive Officer of Alterity, commented, “The third fiscal quarter of 2025 was one of our most successful periods to date for Alterity Therapeutics. The outstanding results from our ATH434 Phase 2 double-blind trial continue to demonstrate the tremendous potential for ATH434 as a disease modifying treatment for MSA and are resonating throughout the medical community. For individuals living with MSA, there is currently no approved therapy to help stabilize or improve their condition, and we believe that ATH434 may be able to change this paradigm.” “During the quarter we also completed our open-label Phase 2 trial in patients with more advanced MSA. Data from this study are expected mid-year and will provide insights on the effects of ATH434 treatment in a population that faces severe challenges due to the advanced stage of their illness. We look forward to engaging with the U.S. Food and Drug Administration and European regulatory authorities as we seek to advance the development of ATH434 for individuals living with MSA,” concluded Dr Stamler. Alterity’s cash position on 31 March 2025 was A$17.96M with operating cash outflows for the quarter of A$0.73M. In accordance with ASX Listing Rule 4.7C, payments of A$80K 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, Placebo Controlled Phase 2 Clinical Trial in...

MELBOURNE, Australia and SAN FRANCISCO, April 28, 2025 (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 presented the ATH434-201 Phase 2 clinical trial results at the annual MSA Research Symposium hosted by University College London, Institute of Neurology in partnership with the MSA Trust of the U.K. “We were honoured to be selected to present the recent data from our double-blind Phase 2 trial,” said, Dr. Stamler. “The Symposium brought together prominent clinicians and researchers from both Europe and the US along with industry scientists, all of whom are focused on increasing their understanding of MSA and advancing new therapies for this aggressive disorder. The strong clinical efficacy data and novel mechanism of ATH434 was well received by this esteemed group of clinicians and academics, as we collectively seek solutions to improve the lives of individuals living with MSA.” Presentation: A Randomized, Double Blind, Placebo Controlled Study of ATH434 in MSAThe oral presentation included data from Alterity’s ATH434-201 Phase 2 clinical trial. The clinical analysis included 71 patients who had at least one post-baseline assessment of the key clinical endpoint, the modified UMSARS1 I activities of daily living scale. On this endpoint, ATH434 demonstrated a clinically significant reduction in disease severity versus placebo, with a 48% relative treatment effect at the 50 mg dose (p=0.02)^ and a 30% relative treatment effect at the 75 mg dose (p=0.16) at 52 weeks. Additional efficacy assessments showed improvement consistent with the UMSARS I findings: the Clinical Global Impression of Severity Scale2 demonstrated improvement compared to placebo at both dose levels, with difference at 50 mg achieving nominal statistical significance (p=0.0088). On the Orthostatic Hypotension Symptom Assessment (a patient reported outcome), on average placebo patients worsened by approximately 6 points over 52 weeks whereas both ATH434 treatment groups improved over the same period (p=0.08 at 50 mg, p=0.14 at 75 mg). Increased activity in the outpatient setting was observed at both dose levels as compared to placebo with wearable sensors, with clinically...

MELBOURNE, Australia and SAN FRANCISCO, April 03, 2025 (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 oral presentation and a poster presentation related to Alterity’s clinical programs in Multiple System Atrophy (MSA) will be delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting taking place April 5 - 9, 2025 in San Diego, CA. David Stamler, M.D., Chief Executive Officer of Alterity, commented, “We are excited to present the positive topline data along with new analyses from our ATH434-201 clinical trial via an oral presentation at AAN, one of the premier global neurology meetings. In addition, data will be presented on the use of wearable sensor technology to assess patient outcomes, an important component of evaluating novel treatments for individuals with MSA.” 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 recently announced positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA. A second Phase 2 open-label 2 Biomarker trial in patients with more advanced MSA is ongoing. ATH434 has been granted Orphan Drug Designation for the treatment of MSA by the U.S. FDA and the European Commission. About ATH434-201 Phase 2 Clinical Trial The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of 12 months treatment with ATH434 in patients with MSA. The study evaluated the efficacy, safety and pharmacokinetics of ATH434 as well as the effect of ATH434 on neuroimaging and protein biomarkers. Wearable sensors were employed to evaluate motor activities outside of the cl...