Appendix 4C – Q3 FY25 Quarterly Cash Flow Report
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 uncorrected
2 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 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 section21EoftheSecuritiesExchangeActof1934.TheCompanyhastriedtoidentifysuchforward-lookingstatementsbyuse 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 suchstatements.
Importantfactorsthatcouldcauseactualresultstodiffermateriallyfromthoseindicatedbysuchforward-lookingstatements aredescribedinthesectionstitled'RiskFactors'intheCompany'sfilingswiththeSEC,includingitsmostrecentAnnualReport onForm20-FaswellasreportsonForm6-K,including,butnotlimitedtothefollowing:statementsrelatingtotheCompany's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company'sdrugdevelopmentprogram,including,butnotlimitedto,ATH434,andanyotherstatementsthatarenothistorical facts.Suchstatementsinvolverisksanduncertainties,including,butnotlimitedto,thoserisksanduncertaintiesrelatingtothe difficultiesordelaysinfinancing,development,testing,regulatoryapproval,productionandmarketingoftheCompany'sdrug components,including,butnotlimitedto,ATH434,theabilityoftheCompanytoprocureadditionalfuturesourcesoffinancing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limitedto,ATH434,thatcouldslowor prevent productscomingtomarket,the uncertaintyof obtaining patent protectionfortheCompany's intellectualpropertyortradesecrets, 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 speaksonlyasofthedateonwhichitismade.Weundertakenoobligationtopubliclyupdateanyforward-lookingstatement, whetherwrittenororal,thatmaybemadefromtimetotime,whetherasaresultofnewinformation,futuredevelopmentsor otherwise.
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(Nasdaq: AGAE) is a global experiential entertainment company focused on providing a growing world of gamers and concertgoers with unique experiences through renowned assets, products and services. For more information, visit Forward Looking Statements This press release contains certain forward-looking statements under federal securities laws. Forward-looking statements may include our statements regarding our goals, beliefs, strategies, objectives, plans, including product and service developments, future financial conditions, results or projections or current expectations. In some cases, you can identify forward-looking statements by terminology such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'intend' or 'continue,' the negative of such terms, or other comparable terminology. Specific forward-looking statements include, but are not limited to, statements regarding our ability to execute on strategic and business plans and drive stockholder value, our projections on Allied Gaming's future financial performance and expense structure and our beliefs on the impact of Knighted director nominations and other actions of Knighted on the performance of the Company. These statements are subject to known and unknown risks, uncertainties, assumptions and other factors, many of which are outside our control, that may cause actual results to be materially different from those contemplated by the forward-looking statements. The inclusion of such information should not be regarded as a representation by us, or any person, that the objectives of Allied Gaming will be achieved. Important factors, among others, that may affect actual results or outcomes include: risks associated with our strategy, future direction or governance; the substantial uncertainties inherent in the acceptance of existing and future products and services; risks associated with our ability to retain key personnel; risks related to our common stock and the listing of our common stock on the Nasdaq Capital Market; risks associated with intellectual property; uncertainty around current and potential litigation and related legal expenses; and general economic, political and market conditions and events. You should consider the areas of risk described in connection with any forward-looking statements that may be made herein and other risk factors discussed from time to time in our filings with the U.S. Securities and Exchange Commission (the 'SEC'), including those factors discussed under the caption 'Risk Factors' in our most recent annual report on Form 10-K, filed with the SEC on June 9, 2025, as well as subsequent reports filed with the SEC. Readers are also urged to carefully review and consider the various disclosures we made in such Annual Report on Form 10-K and in subsequent reports with the SEC. We assume no obligation and do not intend to update these forward-looking statements, except as required by law, to reflect events or circumstances occurring after today's date.
