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Alterity TherapeuticsDDocument history
Earnings documents stored for ATHE.
Investor releaseQuarter not tagged2026-07-30Alterity Therapeutics Releases Appendix 4C – Q4 FY26 Quarterly Cash Flow Report & Corporate Update
GlobeNewswire
Alterity Therapeutics Releases Appendix 4C – Q4 FY26 Quarterly Cash Flow Report & Corporate Update
Highlights FDA End-of-Phase 2 (EOP2) meeting minutes confirmed a registrational pathway for ATH434 in Multiple System Atrophy (MSA) FDA agreed that a single pivotal Phase 3 trial plus confirmatory evidence could support an approval of ATH434 for the treatment of MSA Pivotal Phase 3 trial activities on track to initiate by year-end 2026 Continued evaluation of strategic funding and partnering alternatives to support Phase 3 development and maximise long-term shareholder value Peer-reviewed publication in NeuroImage validated quantitative susceptibility mapping (QSM) of iron on MRI as a biomarker of MSA Strengthened the Board of Directors with the appointment of Ms Ann Cunningham A$3.98 million Australian R&D Tax Incentive refund received subsequent to quarter end, supporting continued development of Alterity’s clinical programs Cash balance of A$37.3 million as at 30 June 2026 MELBOURNE, Australia and SAN FRANCISCO, July 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 30 June 2026 (Q4 FY26). “This was a defining quarter for Alterity, highlighted by our positive End of Phase 2 meeting with the FDA that established a clear, efficient registrational pathway for ATH434,” said David Stamler, M.D., Chief Executive Officer. “With the Phase 3 design elements agreed upon, we are executing on our plans to initiate Phase 3 trial activities by year-end 2026.” Dr. Stamler continued, “The regulatory clarity we have now achieved, together with the growing body of clinical evidence supporting ATH434, puts us in a strong position as we prepare to initiate Phase 3 and continue strategic and other funding discussions aimed at maximising the long-term value of the program.” ATH434 Clinical and Regulatory Update Alterity achieved several key regulatory milestones during the quarter. The Company reached alignment with the U.S. Food and Drug Administration (FDA) at its End-of-Phase 2 (EOP2) meeting on the registrational pathway for a potential New Drug Application (NDA) for ATH434 in MSA. At the meeting, the FDA indicated that a single pivotal trial plus confirmatory evidence could provide the data necess…Read full documentShow less
Highlights FDA End-of-Phase 2 (EOP2) meeting minutes confirmed a registrational pathway for ATH434 in Multiple System Atrophy (MSA) FDA agreed that a single pivotal Phase 3 trial plus confirmatory evidence could support an approval of ATH434 for the treatment of MSA Pivotal Phase 3 trial activities on track to initiate by year-end 2026 Continued evaluation of strategic funding and partnering alternatives to support Phase 3 development and maximise long-term shareholder value Peer-reviewed publication in NeuroImage validated quantitative susceptibility mapping (QSM) of iron on MRI as a biomarker of MSA Strengthened the Board of Directors with the appointment of Ms Ann Cunningham A$3.98 million Australian R&D Tax Incentive refund received subsequent to quarter end, supporting continued development of Alterity’s clinical programs Cash balance of A$37.3 million as at 30 June 2026 MELBOURNE, Australia and SAN FRANCISCO, July 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 30 June 2026 (Q4 FY26). “This was a defining quarter for Alterity, highlighted by our positive End of Phase 2 meeting with the FDA that established a clear, efficient registrational pathway for ATH434,” said David Stamler, M.D., Chief Executive Officer. “With the Phase 3 design elements agreed upon, we are executing on our plans to initiate Phase 3 trial activities by year-end 2026.” Dr. Stamler continued, “The regulatory clarity we have now achieved, together with the growing body of clinical evidence supporting ATH434, puts us in a strong position as we prepare to initiate Phase 3 and continue strategic and other funding discussions aimed at maximising the long-term value of the program.” ATH434 Clinical and Regulatory Update Alterity achieved several key regulatory milestones during the quarter. The Company reached alignment with the U.S. Food and Drug Administration (FDA) at its End-of-Phase 2 (EOP2) meeting on the registrational pathway for a potential New Drug Application (NDA) for ATH434 in MSA. At the meeting, the FDA indicated that a single pivotal trial plus confirmatory evidence could provide the data necessary to support approval, with the Company anticipating that the data from its ATH434-201 Phase 2 clinical trial will provide the required confirmatory evidence. This outcome represents one of the most significant regulatory milestones achieved by the Company to date and de-risks the regulatory pathway toward potential approval of ATH434 in MSA. Successful completion of the planned Phase 3 program has the potential to support the first disease-modifying treatment approved for Multiple System Atrophy, a rare and rapidly progressive neurodegenerative disease with no approved therapy. Alignment was reached with the agency on several key elements of the proposed Phase 3 trial design, including the study population, treatment regimen and the use of the 11-item UMSARS Part I rating scale1 as the primary endpoint. Key secondary endpoints that assess key areas of impairment in MSA were agreed upon and the FDA also indicated that the anticipated size of the safety database at the conclusion of the Phase 3 trial was reasonable. The study is expected to enroll approximately 200 patients who will be randomized 1:1 to ATH434 50 mg or matching placebo treatment twice daily for 12 months. Alterity plans to offer an open-label extension to participants who complete the Phase 3 trial, both to continue their treatment and to enhance the safety database for ATH434. In April 2026, Alterity announced positive FDA feedback following a Type C meeting related to the chemistry, manufacturing and control (CMC) elements of the Phase 3 program. In preparation for Phase 3, Alterity has successfully manufactured the first registration batch of ATH434 for use in the pivotal trial. Scientific Engagement Alterity continues to actively engage with the global neurology community through multiple scientific presentations at leading international congresses. These presentations formed an important component of the Company’s strategy to disseminate clinical data, engage with key opinion leaders and specialists, and further interpret Phase 2 results for ATH434 in MSA. During the quarter, Alterity delivered the following presentations, which are available on the Publications and Presentations page of the Company’s website: April 2026 – American Academy of Neurology (AAN) Annual Meeting, Late-Breaking Science: An analysis using the newly described MSA Combined Outcome Assessment (MuSyCA)2 composite scale, which integrates items from UMSARS Parts I and II, showed ATH434 slowed functional decline versus placebo at Week 52, consistent with previously reported activity on the 11-item UMSARS Part I. May 2026 – Peer-reviewed publication in NeuroImage: A study drawing on the Company’s bioMUSE Natural History Study demonstrated that quantitative susceptibility mapping (QSM) of brain iron detects disease-specific accumulation in MSA, distinguishes MSA from Parkinson’s disease, and correlates with clinical severity in MSA. May 2026 – Three international scientific presentations at the International Society for Magnetic Resonance in Medicine (ISMRM), the Movement Disorder Society of Australia and New Zealand (MDSANZ) Scientific Meeting, and the MSA Symposium (University College London), presenting QSM imaging, CSF NfL3 covariate analyses and swallowing outcome data supporting ATH434’s mechanism as an iron chaperone. Also during the period, the Company hosted a virtual key opinion leader (KOL) event featuring Roy Freeman, M.D. (Harvard Medical School) and Daniel Claassen, M.D., M.S. (Vanderbilt University Medical Center), alongside CEO David Stamler, M.D., to discuss the unmet need and treatment landscape in MSA and the ATH434 development program. Strategic Partnering and Funding Alternatives Alterity continues to evaluate a range of strategic and funding alternatives to support the advancement of ATH434, including ongoing discussions with a number of pharmaceutical companies. The Company is progressing a structured evaluation process, with the assistance of external advisers, to assess these opportunities alongside other potential funding and development pathways. The Company remains focused on maintaining strategic flexibility while pursuing the pathway that best supports the advancement of ATH434 and maximises long-term shareholder value. Corporate and Financial Update Governance and Leadership In April 2026, the company announced the appointment of Ms Ann Cunningham to the Board of Directors as an independent Non-Executive Director. Ms Cunningham’s appointment adds global commercial and strategic expertise as the company transitions toward late-stage development in MSA. Share Consolidation Following shareholder approval at the Extraordinary General Meeting held on 29 May 2026, the Company completed a consolidation of its share capital on a 1-for-50 basis. Cash Position As of 30 June 2026, Alterity held cash and cash equivalents of A$37.3 million. Operating cash outflows for the quarter were A$7.72 million. Subsequent to quarter-end, on 9 July 2026, the Company received its research and development (R&D) tax refund for the 2025 financial year totaling A$3,982,992 (including A$43,117 of interest), under the Australian Government’s R&D Tax Incentive. In accordance with ASX Listing Rule 4.7C, payments of A$309k made to related parties and their associates during the quarter included non-executive directors’ fees, managing director salary, consulting fees, remuneration and superannuation at commercial rates. The full financial report can be found in the ASX filing here. 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 is focused on developing disease modifying therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. Alterity is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, the Company’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with MSA. Alterity has further reported positive data in its open label Phase 2 clinical trial in participants with advanced MSA. In addition, Alterity 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 website at https://alteritytx.com. References1 11-item UMSARS Part I (previously described as modified UMSARS I): Unified Multiple System Atrophy Rating Scale, 11-Items include: Orthostatic symptoms, Swallowing, Speech, Handwriting, Cutting food, Dressing, Hygiene, Walking, Falling, Urinary and Bowel function.2 For the MuSyCa MSA Combined Outcome assessment: UMSARS I items were swallowing, handwriting, utensils, dressing, hygiene, walking; UMSARS I items were speech, leg agility, arising from chair, body sway, gait 3 Neurofilament Light Chain measured in the cerebrospinal fluid (CSF) Authorisation & Additional informationThis announcement was authorized by the Board of Directors of Alterity Therapeutics Limited. Contacts: InvestorsElyse [email protected] Remy BernardaInvestor Relations Advisory [email protected] +1 (415) 203-6386 MediaMelissa TempraNWR [email protected] Casey McDonaldTiberend Strategic Advisors, [email protected] +1 (646) 577-8520 Forward Looking StatementsThis 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.
Investor releaseQuarter not tagged2026-04-30Alterity Therapeutics Releases Appendix 4C – Q3 FY26 Quarterly Cash Flow Report & Corporate Update
GlobeNewswire
Alterity Therapeutics Releases Appendix 4C – Q3 FY26 Quarterly Cash Flow Report & Corporate Update
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…Read full documentShow less
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 expertise strengthens our capabilities as we execute on our next phase of growth. We continue to engage with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434. Together, with our ongoing engagement with the investment and medical communities, we are well positioned to advance ATH434 and deliver on our mission to bring meaningful therapies to patients living with MSA.” ATH434 Clinical and Regulatory Update Regulatory Progress Alterity received significant endorsements from the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in MSA. In March 2026, Alterity received written feedback from a Type C meeting supporting its plans related to clinical pharmacology and non-clinical development elements of its development program. Subsequent to the end of the period, the company received written feedback from a Type C interaction with the FDA on the chemistry, manufacturing, and control (CMC) elements of the program. The Type C Meetings are part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. The planned End-of-Phase 2 meeting with the FDA remains on track for mid-year 2026. Clinical Program Subsequent to the end of the period, Alterity presented new data analyses from the ATH434-201 Phase 2 trial showing consistent evidence of clinical efficacy for ATH434 by slowing functional decline in patients with MSA. The presentation described an analysis from the ATH434-201 Phase 2 clinical trial in MSA utilizing a novel endpoint called the MSA Combined Outcome Assessment (MuSyCA). ATH434 slowed disease progression versus placebo on the MuSyCA assessment, with a treatment effect of −1.9 (75 mg dose) to −4.0 points (50 mg dose, p=0.034, relative treatment effect 41%) at Week 52. Beneficial effects were seen on both activities of daily living and neurological examination components, consistent with previously reported results on the established endpoint of UMSARS I1. The analyses were delivered as an oral presentation by Dr. Daniel Claassen at the American Academy of Neurology (AAN) Annual Meeting during a Late Breaking Science Session: “ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale.” Strategic Discussions Alterity continues to engage in discussions with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434. These discussions reflect ongoing interest in the program’s clinical profile, orphan disease status and late-stage development. Corporate and Financial Update Governance and Leadership In March 2026, Daniel O. Claassen, M.D., M.S., was appointed Chief Medical Advisor, bringing deep clinical and development expertise to Alterity. Dr. Claassen was the coordinating investigator for Alterity’s Phase 2 study in MSA and will be instrumental as the Company advances ATH434 into Phase 3. Dr. Claassen is a board-certified neurologist and internationally recognized expert in neurodegenerative diseases, with more than two decades of clinical and translational research in movement disorders and cognitive and behavioral neurology. Dr. Claassen is a sought-after investigator and collaborator in translational neuroscience and has served as principal investigator on numerous clinical trials, working across academic medical centers and industry partnerships to advance new therapies for neurodegenerative disorders. Subsequent to the end of the quarter, Alterity strengthened the composition of its Board of Directors by appointing Ms. Ann Cunningham to its Board as an independent Non-Executive Director. Ms. Cunningham brings more than 25 years of global pharmaceutical and biotechnology experience, with deep expertise in commercial strategy and leadership across neurodegenerative disease and psychiatry. She has held senior roles at leading global organisations including Eli Lilly and Company and Teva Pharmaceuticals, where she led multiple marketing and sales teams and was responsible for neurodegenerative and psychiatry portfolios. Investor Engagement The Company continues to actively engage the investment community with participation in the JP Morgan Healthcare Conference Week in the USA as well as the Bell Potter Healthcare Horizons Summit, the Emergence Life Science Investor Day, and the Impact Invest Summit in Australia. In April 2026, Alterity hosted a virtual key opinion leader (KOL) event featuring Roy Freeman, MD, Professor of Neurology at Harvard Medical School and Daniel Claassen, MD, MS. Dr. Freeman presented an overview of MSA and the need for new treatments and Dr. Claassen presented new analyses of the Phase 2 data demonstrating a mechanistic link between chaperoning, or redistributing, excess iron and slowing the progression of MSA. The webcast recording of the presentation is available by clicking here. Cash Position As of 31 March 2025, Alterity held cash and cash equivalents of A$44.53 million. Operating cash outflows for the quarter were A$4.73 million. The Company believes its strong cash position provides a solid runway to progress regulatory, clinical and commercial objectives while advancing partnering discussions from a position of financial strength. In accordance with ASX Listing Rule 4.7C, payments of A$406k made to related parties and their associates during the quarter included non-executive directors’ fees, managing director salary and bonus payments, consulting fees, remuneration and superannuation at commercial rates. 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 is focused on developing disease modifying therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. Alterity is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, the Company’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with MSA. Alterity has further reported positive data in its open label Phase 2 clinical trial in participants with advanced MSA. In addition, Alterity 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 website at https://alteritytx.com. 1 Unified MSA Rating Scale, Part I (historical review) assess activities of daily living. Domains assessed include speech, swallowing, handwriting, cutting food/handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function and bowel function. Authorisation & Additional information This announcement was authorized by the Board of Directors of Alterity Therapeutics Limited. Contacts: Investors Elyse Shapiro [email protected] Remy Bernarda Investor Relations Advisory Solutions [email protected] +1 (415) 203-6386 Media Casey McDonald Tiberend Strategic Advisors, Inc. [email protected] +1 (646) 577-8520 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.
Investor releaseQuarter not tagged2026-01-30Alterity Therapeutics: Appendix 4C – Q2 FY26 Quarterly Cash Flow Report & Corporate Update
GlobeNewswire
Alterity Therapeutics: Appendix 4C – Q2 FY26 Quarterly Cash Flow Report & Corporate Update
− 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)…Read full documentShow less
− 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), including preparation for regulatory interactions across clinical pharmacology and non-clinical topics and chemistry, manufacturing and controls (CMC). These activities are focused on preparation for a planned End-of-Phase-2 meeting with the FDA, targeted for mid-2026. The primary objective of this meeting is to align with the agency on the design and requirements of a pivotal Phase 3 clinical trial in MSA, including key elements such as endpoints, patient population and the overall development pathway. The Company remains confident in its ongoing engagement with the FDA and the clarity of the regulatory path toward Phase 3 development. In addition, Alterity also presented additional analyses from the ATH434-201 randomised, double-blind Phase 2 trial in MSA. A new analysis of modified UMSARS Part I1 data was presented at the International Congress of Parkinson’s Disease and Movement Disorders, incorporating baseline orthostatic2 blood pressure change as a covariate. In this analysis, the efficacy signal in the 75 mg dose group at 52 weeks strengthened from -2.4 to -2.8 points, improving the relative treatment effect from 30% to 35% versus placebo. Differences in baseline severity of orthostatic hypotension largely explained the differing responses observed between the 50 mg and 75 mg dose groups. ATH434 also demonstrated a beneficial effect on orthostatic hypotension symptoms, with placebo-treated participants worsening over 52 weeks while participants in both active treatment groups remained stable. ATH434 has been granted Fast Track designation by the FDA, reflecting the seriousness of MSA, the significant unmet medical need and the potential of ATH434 to address this need. This designation enables more frequent regulatory interactions and supports an efficient review process as Alterity advances ATH434 toward a pivotal Phase 3 program. Phase 3 Development Planning and Timeline Alterity also continued planning activities during the quarter to support the progression of ATH434 into a pivotal Phase 3 clinical program in MSA. The Company is focused on progressing the key elements required to initiate late-stage development, including clinical trial design, regulatory engagement, manufacturing and supply planning, and operational readiness. The timing and execution of Phase 3 will continue to be informed by regulatory guidance and operational considerations. Alterity’s strong balance sheet and active engagement with potential partners provide flexibility in determining the optimal pathway to advance ATH434 development. Scientific and Clinical Engagement During the quarter, Alterity actively engaged with the global neurology community through multiple scientific presentations at leading international congresses. These presentations formed an important component of the Company’s strategy to disseminate clinical data, engage with key opinion leaders and specialists, and further test and refine the interpretation of Phase 2 results for ATH434 in MSA. The medical and scientific meetings provide an opportunity for peer discussion of clinical, biomarker and imaging data from the ATH434-201 trial, contributing to a deeper understanding of treatment response, patient selection and disease characteristics. In addition, Alterity held a Clinical Advisory Board meeting in December 2025 comprising key opinion leaders in movement disorders and autonomic disorders. The meeting focused on a detailed review of data from the ATH434-201 Phase 2 study and provided expert input into the design and planning of the proposed Phase 3 clinical program. Insights from these scientific dialogues will further inform Phase 3 trial design considerations, including patient selection, endpoints and operational execution. During the quarter, Alterity delivered the following presentations on the ATH434-201 Phase 2 trial: October 2025 – International Congress of Parkinson’s Disease and Movement Disorders (MDS), Title of Oral Platform Presentation: “ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy” October 2025 – MDS, Title: “Relationship Between Alpha-Synuclein Aggregation Profiles, Imaging Biomarkers, and Disease Severity in a Phase 2 Study of ATH434 in MSA” October 2025 – MDS, Title: “Differences Between Clinical and Imaging Phenotypes in Phase 2 Study of ATH434 in Multiple System Atrophy” November 2025 – International Symposium on the Autonomic Nervous System, Title: “Efficacy of ATH434 in Multiple System Atrophy (MSA) is Affected by Baseline Disease Characteristics” Partnering and Strategic Discussions In parallel with advancing the ATH434 development program, Alterity broadened partnering discussions with a number of pharmaceutical companies. These discussions reflect growing industry interest in ATH434’s differentiated clinical profile, orphan disease status, and validated commercial potential. The Company is evaluating a range of strategic pathways to support the advancement of ATH434, including potential partnership structures, and is also in the process of engaging with external advisers to assist in assessing these options. These activities are occurring alongside ongoing regulatory and Phase 3 planning and are intended to preserve flexibility and maximising long-term shareholder value as the Company progresses toward Phase 3 development. Corporate and Financial Update Governance and Leadership During the quarter, Alterity strengthened its governance and leadership structure to support the Company’s transition into late-stage development and active partnering discussions. At the Company’s Annual General Meeting held in November 2025, Geoffrey Kempler retired as Non-Executive Chair and Director, Brian Meltzer retired as Non-Executive Director, and Julian Babarczy was appointed Chair of the Board. Mr Babarczy is an experienced company director and investor with over 20 years’ experience across Australia’s corporate and funds management sectors. He brings a strong track record in guiding emerging growth companies through periods of strategic transition, capital management and value realisation. In addition, Chief Executive Officer Dr David Stamler was appointed to the Board as Managing Director, further strengthening alignment between the Board and executive leadership. Dr Stamler brings deep clinical development and regulatory experience in neurology, including involvement in three FDA approvals in neurology, and continues to lead Alterity’s clinical, regulatory and strategic execution. The Company also expanded its leadership with the appointment of a Head of Investor Relations and Communications, a Head of Corporate Strategy and Operations, and a Head of Regulatory Affairs and Quality Assurance, reflecting an increased focus on institutional engagement, strategic partnering and operational execution. Together, these governance and leadership enhancements position Alterity strongly to execute its next phase of growth, including Phase 3 development planning, regulatory engagement and the pursuit of value-accretive partnering opportunities. Cash Position As of 31 December 2025, Alterity held cash and cash equivalents of A$49.2 million. Operating cash outflows for the quarter were A$5.28 million. The Company believes its strong cash position provides a solid runway to progress regulatory, clinical and commercial objectives while advancing partnering discussions from a position of financial strength. In accordance with ASX Listing Rule 4.7C, payments of A$705k made to related parties and their associates during the quarter included non-executive directors’ fees, managing director salary and bonus payments, consulting fees, remuneration and superannuation at commercial rates. Outlook Alterity enters the second half of FY26 with strong momentum, underpinned by: Robust and strengthened Phase 2 clinical data; A compelling, independently validated commercial opportunity for ATH434 in MSA; A strong balance sheet; and Meaningful engagement with potential strategic partners. The Company remains focused on advancing ATH434 toward a pivotal Phase 3 program, progressing regulatory alignment with the FDA, and pursuing partnering opportunities that maximise long-term value for shareholders while minimising dilution. 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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 recently reported positive data in its open label Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. References: 1 Unified MSA Rating Scale, Part I (historical review) assess activities of daily living. Domains assessed include speech, swallowing, handwriting, cutting food/handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function and bowel function. 2 Orthostatic hypotension is a form of low blood pressure that might cause dizziness, lightheadedness or fainting when rising from sitting or lying down. Source: Mayo Clinic. Authorisation & Additional information This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Contacts: Investors Tara Speranza Head of Investor Relations and Communications [email protected] Remy Bernarda Investor Relations Advisory Solutions [email protected] +1 (415) 203-6386 Media Casey McDonald Tiberend Strategic Advisors, Inc. [email protected] +1 (646) 577-8520 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.
Investor releaseQuarter not tagged2025-10-31Alterity Therapeutics: Appendix 4C – Q1 FY26 Quarterly Cash Flow Report
GlobeNewswire
Alterity Therapeutics: Appendix 4C – Q1 FY26 Quarterly Cash Flow Report
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…Read full documentShow less
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, remuneration and superannuation at commercial rates. Operational Highlights ATH434 Regulatory Update Alterity has continued to generate the required data and analyses that are needed to engage regulatory authorities about the path forward for ATH434. With respect to the U.S. Food and Drug Administration (FDA), this process necessitates a proactive, staged approach. The Fast Track Designation granted to ATH434 affords Alterity the opportunity to engage with the FDA in a series of Type C meetings related to the nonclinical and the chemistry, manufacturing, and controls (CMC) data necessary to support Phase 3. Following these meetings, an End-of-Phase 2 meeting will be held to align with the FDA on all elements of the Phase 3 program. Conducting these meetings in sequence allows Alterity to focus the End-of-Phase 2 meeting on the clinical development topics, including the Phase 3 protocol, and data requirements to commence the Phase 3 study. This series of meetings is expected to occur over the next several months with the End-of-Phase 2 meeting in mid-year 2026. ATH434–201: Randomized, Double-Blind, Placebo Controlled Phase 2 Clinical Trial in MSA Subsequent to the end of the quarter, Alterity presented a new analysis of the modified USMARS I1 data from the ATH434-201 trial at the International Congress of Parkinson’s Disease and Movement Disorders meeting. The analysis, which incorporated baseline orthostatic blood pressure change as a covariate, led to a strengthened efficacy signal in the 75 mg dose group at 52 weeks of −2.8 points, for a relative treatment effect of 35%. The baseline differences in the rate of severe orthostatic hypotension (OH)2 largely explains the different responses in 50 mg and 75 mg treatment groups. In addition, ATH434 demonstrated a beneficial effect on OH symptoms as assessed with the OH Symptom Assessment, a patient reported outcome. On this scale, placebo patients worsened on average by approximately 6 points over 52 weeks whereas the 50 mg and 75 mg groups were stable over the same period. Multiple presentations were delivered on the positive results from the ATH434-201 trial: September 2025 – American Neurological Association (ANA), Title: “ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy” October 2025 - International Congress of Parkinson’s Disease and Movement Disorders (MDS), Title of Oral Platform Presentation: “ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy” October 2025 – MDS, Title: “Relationship Between Alpha-Synuclein Aggregation Profiles, Imaging Biomarkers, and Disease Severity in a Phase 2 Study of ATH434 in MSA” October 2025 – MDS, Title: “Differences Between Clinical and Imaging Phenotypes in Phase 2 Study of ATH434 in Multiple System Atrophy” ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA In July 2025, Alterity announced positive data from the ATH434-202 open-label Phase 2 clinical trial in more advanced MSA than was studied in the double-blind Phase 2 trial. A key objective of the study was met as the 75 mg dose in this study demonstrating comparable efficacy to that observed in the ATH434-201 double-blind study, including the key efficacy endpoint of UMSARS I and preservation of brain volume. Importantly, biomarkers demonstrated target engagement and a safety profile that was comparable to prior studies. Overall, the Phase 2 studies confirmed ATH434’s favorable profile and provided further evidence that its mechanism of action has utility in addressing the underlying pathology of disease. bioMUSE Natural History Study In July 2025, the Company announced publication of a study in conjunction with researchers at Vanderbilt University Medical Center on an innovative neuroimaging measure developed in Alterity’s Biomarkers of Progression in Multiple System Atrophy (bioMUSE) Natural History Study. The publication, entitled “The MSA Atrophy Index (MSA-AI): An Imaging Marker for Diagnosis and Clinical Progression in Multiple System Atrophy”, was featured in the peer-reviewed journal Annals of Clinical and Translational Neurology. Development of the MSA Atrophy Index can enhance the understanding of MSA progression and provide support for using brain atrophy markers for diagnosis and evaluation of disease-modifying therapies. Corporate Activities Alterity continues to engage with the investment community with participation in the Bioshares Biotech Summit and Biotech Showcase events in Australia, as well as a panel presentation focused on neurodegenerative diseases at the Maxim Growth Summit Healthcare Day in the U.S. During the period, Alterity completed an independent commercial assessment of ATH434 in MSA that resulted in a potential worldwide peak sales opportunity of USD$2.4 billion dollars, if approved. Physicians surveyed noted the importance of inhibiting α‐synuclein aggregation to address the underlying pathology of disease as addressed by the targeted mechanism of action of ATH434. The key driver of physician interest in ATH434 was the Phase 2 data that demonstrated a slowing of disease progression and stabilization of orthostatic hypotension, leading more than 70% of the neurologists surveyed being “extremely likely” or “very likely” to prescribe ATH434. During the period, Alterity strengthened its balance sheet with a total of A$20M raised in gross proceeds from a strategic placement, led by high-quality healthcare-focused funds, to advance its programs. 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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 recently reported positive data in its open label Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. References: 1 Unified MSA Rating Scale, Part I (historical review) assess activities of daily living. Domains assessed include speech, swallowing, handwriting, cutting food/handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function and bowel function. 2 Orthostatic hypotension is a form of low blood pressure that might cause dizziness, lightheadedness or fainting when rising from sitting or lying down. Source: Mayo Clinic. Authorisation & Additional information This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Contacts: Investors Remy Bernarda Investor Relations Advisory Solutions [email protected] +1 (415) 203-6386 Media Casey McDonald Tiberend Strategic Advisors, Inc. [email protected] +1 (646) 577-8520 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.
Investor releaseQuarter not tagged2025-07-30Appendix 4C – Q4 FY25 Quarterly Cash Flow Report
GlobeNewswire
Appendix 4C – Q4 FY25 Quarterly Cash Flow Report
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…Read full documentShow less
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 superannuation at commercial rates. Operational Activities U.S. FDA Fast Track Designation for ATH434 In May 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ATH434 for the treatment of MSA. This designation is intended to accelerate the development and review of novel investigational products such as ATH434 and recognizes its potential as an innovative approach to address the high unmet need for treating MSA, a disease with no approved therapy. Fast Track designation for a drug candidate confers some or all of the following benefits: opportunities for more frequent and early communication with the FDA throughout the development process; rolling review for the future New Drug Application; and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. Fast Track eligibility requires demonstration of the potential for clinically meaningful benefits, which can include the mechanism of action, preclinical studies, or data from patient studies. Alterity’s previous interactions with the FDA indicated that the modified Unified Multiple System Atrophy Rating Scale Part I (UMSARS I)1 scale is considered a clinically meaningful endpoint for MSA. Alterity’s Fast Track application included top-line data from the ATH434-201 randomized, double-blind, placebo-controlled Phase 2 clinical trial which demonstrated efficacy on the modified UMSARS I in addition to preclinical data confirming that ATH434 is a moderate affinity iron chaperone and showed efficacy in animal models of MSA. ATH434–201: Randomized, Double-Blind, Placebo Controlled Phase 2 Clinical Trial in MSA In May 2025 additional analyses from the ATH434-201 trial were presented at the International MSA Congress. The presentation, entitled, “ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy”, evaluated the clinical analysis population (n=71) who had at least one post-baseline assessment of the key clinical endpoint, the modified UMSARS 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 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. Baseline differences in disease severity likely explain the different responses in 50 mg and 75 mg treatment groups. Increased activity in the outpatient setting, as measured by wearable movement sensors, was observed at both dose levels as compared to placebo utilized in the trial, with clinically meaningful improvements in step count, bouts of walking, total walking time, and total standing time. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious or severe adverse events attributed to ATH434. Regarding neuroimaging data in 61 participants, ATH434 demonstrated target engagement by stabilizing or reducing iron accumulation at both dose levels compared to placebo in MSA affected brain regions. In addition, ATH434 demonstrated trends in reducing brain atrophy at both dose levels compared to placebo. Overall, the study results support continued advancement of ATH434 for the treatment of MSA. During the period, multiple additional presentations were delivered on the positive results from the ATH434-201 trial: April 2025 – American Academy of Neurology (AAN), Title: “Topline Data from a Randomized, Double Blind, Placebo Controlled Phase 2 Study of ATH434 in Multiple System Atrophy” April 2025 – American Academy of Neurology (AAN), Title: “Association Between Wearable Sensor Data and Clinical Scores in Individuals with Early-stage Multiple System Atrophy” April 2025 – MSA Research Symposium, University College London, Title: “A Randomized, Double Blind, Placebo Controlled Study of ATH434 in MSA” ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA Subsequent to the period end, on 28 July 2025, Alterity announced positive positive topline data from the ATH434-202 open-label Phase 2 clinical trial in individuals with MSA. Ten (10) participants were enrolled and were treated with oral ATH434 75 mg twice daily for 12 months. The study assessed the safety and efficacy of ATH434 treatment on clinical and biomarker endpoints and evaluated a patient population with more advanced disease than was studied in the double-blind Phase 2 trial. The topline data showed that ATH434 conferred a clinical benefit on areas of impairment in MSA and stabilized key biomarkers that underpin the pathology of the disease. ATH434 demonstrated a benefit on the key clinical endpoint UMSARS I, which increased from baseline to 12 months by 3.5 (4.7) points. These study data compare favorably to historical data in a similar MSA population, where an increase of 6.5 (6.0) points over 12 months was observed.3 Regarding overall neurological symptoms, 30% (3/10) of participants stabilized or improved on both the Clinical Global Impression of Change (CGIC)4 and the Patient Global Impression of Change (PGIC)5 scales. On the important symptom of orthostatic hypotension6, low blood pressure symptoms stabilized on average in study participants over the treatment period. The aggregate data indicate that ATH434 has similar efficacy in this advanced MSA population as was observed in the earlier stage patients in the ATH434-201 trial. The key biomarker endpoint was defined as the change in brain volume from baseline to 12-months, as measured by the MSA Atrophy Index (MSA-AI)7. Neuroimaging outcomes indicate that ATH434 slowed brain atrophy in MSA affected areas when compared to placebo-treated participants in Study 201. Moreover, the effects on brain volume were comparable to those observed in participants in the 75 mg dose group in Study 201. In addition, ATH434 led to lower iron accumulation in the putamen and globus pallidus as compared to placebo treated patients in Study 201, providing further evidence of target engagement. On average, plasma and CSF Neurofilament Light Chain (NfL) levels were stable over the 12-month treatment period. ATH434 was well-tolerated with a favorable safety profile. No serious adverse events (SAEs) related to ATH434 were reported, and most adverse events were mild to moderate in severity. bioMUSE Natural History Study Subsequent to the period end, on 24 July 2025, the Company announced that an innovative neuroimaging measure developed in Alterity’s Biomarkers of Progression in Multiple System Atrophy (bioMUSE) Natural History Study was featured in the peer-reviewed journal Annals of Clinical and Translational Neurology. The publication, entitled “The MSA Atrophy Index (MSA-AI): An Imaging Marker for Diagnosis and Clinical Progression in Multiple System Atrophy,” describes how deep learning methods, a form of artificial intelligence, were used to precisely define the neuroanatomy of key brain regions along with development of a novel brain atrophy measure for tracking disease progression in MSA patients over one year. The results were then correlated with clinical measures of disease severity over the same timeframe. Development of the MSA Atrophy Index can enhance the understanding of MSA progression and provide support for using brain atrophy markers for the evaluation of disease-modifying therapies. These tools offer potential applications in diagnosis, staging, and monitoring of disease severity, contributing to more personalized care in MSA. In May 2025, additional presentations were delivered from bioMUSE at the at the International MSA Congress in May: MSA Atrophy Index (MSA-AI): A Quantitative Imaging Marker for Diagnosis and Monitoring of Multiple System Atrophy Cutaneous Phosphorylated Alpha-Synuclein Deposition Informs Autonomic Function in Individuals with Early-Stage Multiple System Atrophy Corporate Activities During the period, Alterity strengthened its balance sheet with a total of A$26.3M raised in gross proceeds upon completion of the second tranche of a two-tranche placement. During the period, Alterity also received a refund of A$3.98M from the Australian Taxation Office under the Australian Government’s Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the financial year ending 30 June 2024. 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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. References: 1Unified MSA Rating Scale, Part I (historical review) assess activities of daily living. Domains assessed include speech, swallowing, handwriting, cutting food/handling utensils, dressing, hygiene, walking, falling, orthostatic symptoms, urinary function, sexual function and bowel function. 2Clinical Global Impression of Severity: a clinician assessment of the total picture of the subject including the impact of the illness on function and level of distress 3 Wenning et al. The natural history of multiple system atrophy: a prospective European cohort study. Lancet Neurol 2013; 12: 264–74. 4 Clinical Global Impression of Change: a clinician assessment to evaluate overall neurological symptoms as compared to immediately before starting therapy. 5 Patient Global Impression of Change: a patient assessment to evaluate their overall neurological symptoms as compared to immediately before starting therapy. 6 Orthostatic hypotension is a form of low blood pressure that might cause dizziness, lightheadedness or fainting when rising from sitting or lying down. Source: Mayo Clinic. 7 Trujillo et al. The MSA Atrophy Index (MSA-AI): An Imaging Marker for Diagnosis and Clinical Progression in Multiple System Atrophy. Annals of Clinical and Translational Neurology 2025. ^All p-values are uncorrected Authorisation & Additional information This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: Australia Millie Macdonald Head of Investor Relations and Business Development [email protected] +61 3 9349 4906 Ana Luiza Harrop [email protected] +61 452 510 255 U.S. Remy Bernarda [email protected] +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.
Investor releaseQuarter not tagged2025-04-30Appendix 4C – Q3 FY25 Quarterly Cash Flow Report
GlobeNewswire
Appendix 4C – Q3 FY25 Quarterly Cash Flow Report
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…Read full documentShow less
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 MSA On 30 January 2025, Alterity announced the positive topline results led by robust clinical efficacy. Subsequent to the quarter end, on 10 April 2025, an oral presentation was delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting that provided additional data from the trial. Overall, the study results support continued advancement of ATH434 for the treatment of MSA. The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with MSA. In addition to evaluating the efficacy of ATH434 and its impact on biomarkers, wearable sensors were employed to evaluate outpatient activity levels relevant to patients with MSA. The study enrolled 77 individuals with MSA who were randomly assigned to receive one of two dose levels of ATH434 or placebo. Participants received treatment for 12 months. 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 as measured by wearable sensors, with clinically meaningful improvements in step count, bouts of walking, total walking time, and total standing time. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Regarding neuroimaging, ATH434 demonstrated target engagement by stabilizing or reducing iron at both dose levels compared to placebo in MSA affected brain regions. In addition, ATH434 demonstrated trends in reducing brain atrophy at both dose levels compared to placebo. Overall, the study results support continued advancement of ATH434 for the treatment of MSA. ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA On 27 March 2025, Alterity announced that the last patient in the ATH434-202 Phase 2 trial completed the study. The ATH434-202 is an open label study designed to evaluate the safety, efficacy and target engagement of ATH434 in participants with advanced MSA. The 202 study gives Alterity the opportunity to evaluate the effects of ATH434 treatment in an MSA population more advanced than individuals enrolled in the ATH434-201 study. These individuals face severe challenges due to the stage of their illness. The data from this study will help Alterity guide the MSA development program given the differences between the 202 study and the double-blind trial. Alterity expects to report topline data from this study in mid-year 2025. Corporate Activities During the period, Alterity strengthened its balance sheet with a total of approximately A$15.0M raised in gross proceeds through financing transactions. Subsequent to the end of the quarter, an additional A$27.1M was raised upon completion of the second tranche of the two-tranche placement. During the period, Alterity was also granted a settlement in relation to the refund of $1.65M from the Australian Taxation Office under the Australian Government’s Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the financial year ending 30 June 2020. The Company expects to use these funds to accelerate ATH434 regulatory and development activities and to continue research and discovery of novel compounds for additional indications such as Parkinson’s disease. 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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. References:1 UMSARS: Unified Multiple System Atrophy Rating Scale^ All p-values are uncorrected2 Clinical Global Impression of Severity: a clinician assessment of the total picture of the subject including the impact of the illness on function and level of distress Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: Australia Millie MacdonaldHead of Investor Relations and Business [email protected] +61 3 9349 4906 Ana Luiza [email protected]+61 452 510 255 U.S.Remy [email protected] +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.
Investor releaseQuarter not tagged2025-04-28Alterity Therapeutics Presents ATH434-201 Phase 2 Clinical Trial Results at European MSA Symposium
GlobeNewswire
Alterity Therapeutics Presents ATH434-201 Phase 2 Clinical Trial Results at European MSA Symposium
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…Read full documentShow less
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 meaningful improvements in step count, bouts of walking, total walking time, and total standing time. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Regarding neuroimaging, ATH434 demonstrated target engagement by stabilizing or reducing iron at both dose levels compared to placebo in MSA affected brain regions. In addition, ATH434 demonstrated trends in reducing brain atrophy at both dose levels compared to placebo. Overall, the study results support continued advancement of ATH434 for the treatment of 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 clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The topline data showed that ATH434 produced clinically and statistically significant improvement on the modified UMSARS Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. In addition to the robust efficacy demonstrated on the UMSARS Part I, trends in improved motor performance were observed on the Parkinson’s Plus rating scale and overall benefit was shown on the Clinical Global Impression of Severity at the 50 mg dose. Wearable sensor data indicated that both dose levels of ATH434 led to increased activity in an outpatient setting as compared to placebo. Biomarkers were used to evaluate potential drug effect and target engagement. Both dose levels reduced iron accumulation in MSA affected brain regions and trends in preservation of brain volume were observed relative to placebo. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091. 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.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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. References:1 UMSARS: Unified Multiple System Atrophy Rating Scale^ All p-values are uncorrected2 Clinical Global Impression of Severity: a clinician assessment of the total picture of the subject including the impact of the illness on function and level of distress3 Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov) Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaMillie MacdonaldHead of Investor Relations and Business [email protected] +61 468 304 742 Ana Luiza [email protected]+61 452 510 255 U.S.Remy [email protected] +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.
Investor releaseQuarter not tagged2025-04-03Alterity Therapeutics to Deliver an Oral Presentation of the Positive ATH434 Phase 2 Trial Results at the American Academy of Neurology Annual Meeting
GlobeNewswire
Alterity Therapeutics to Deliver an Oral Presentation of the Positive ATH434 Phase 2 Trial Results at the American Academy of Neurology Annual Meeting
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 c…Read full documentShow less
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 clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The topline data showed that ATH434 produced clinically and statistically significant improvement on the modified UMSARS Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. In addition to the robust efficacy demonstrated on the UMSARS Part I, trends in improved motor performance were observed on the Parkinson’s Plus rating scale and overall benefit was shown on the Clinical Global Impression of Severity at the 50 mg dose. Wearable sensor data indicated that both dose levels of ATH434 led to increased activity in an outpatient setting as compared to placebo. Biomarkers were used to evaluate potential drug effect and target engagement. Both dose levels reduced iron accumulation in MSA affected brain regions and trends in preservation of brain volume were observed relative to placebo. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091. 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 1Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov) 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 is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity 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 website at www.alteritytherapeutics.com. Authorisation & Additional informationThis announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: AustraliaAna Luiza [email protected]+61 452 510 255 U.S.Remy [email protected] +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.

