Appendix 4C – Q1 FY25 Quarterly Cash Flow Report
Alterity Therapeutics reported Q1 FY25 results with key developments in its ATH434 clinical trials. The company highlighted positive interim data from ATH434-202 Phase 2 trial in advanced MSA patients, suggesting potential disease-modifying effects. The ATH434-201 Phase 2 trial in early-stage MSA remains on track for topline data release in January 2025. Multiple data presentations were made at the International Congress of Parkinson's Disease and Movement Disorders®, showcasing ATH434's potential across various neurological conditions. The company appointed Abby Macnish Niven as CFO and reported a cash balance of A$9.28m as of September 30, 2024, with quarterly operating cash outflows of A$3.31M.
Alterity Therapeutics ha riportato i risultati del primo trimestre dell'anno fiscale 2025 con importanti sviluppi nei suoi studi clinici su ATH434. L'azienda ha evidenziato dati intermedi positivi dal trial di fase 2 ATH434-202 su pazienti con MSA avanzata, suggerendo potenziali effetti modificatori della malattia. Il trial di fase 2 ATH434-201 in pazienti con MSA in fase precoce rimane conforme al piano per il rilascio dei dati principali a gennaio 2025. Diversi dati sono stati presentati al Congresso Internazionale sulle Malattie di Parkinson e i Disturbi del Movimento®, evidenziando il potenziale di ATH434 in vari disturbi neurologici. L'azienda ha nominato Abby Macnish Niven come CFO e ha riportato un saldo di cassa di 9,28 milioni di dollari australiani al 30 settembre 2024, con deflussi di cassa operativi trimestrali di 3,31 milioni di dollari australiani.
Alterity Therapeutics informó los resultados del primer trimestre del año fiscal 2025 con desarrollos clave en sus ensayos clínicos de ATH434. La compañía destacó datos intermedios positivos del ensayo de fase 2 ATH434-202 en pacientes con MSA avanzada, sugiriendo posibles efectos modificadores de la enfermedad. El ensayo de fase 2 ATH434-201 en MSA en etapa temprana sigue en camino para la publicación de datos principales en enero de 2025. Se presentaron múltiples datos en el Congreso Internacional de Enfermedades de Parkinson y Trastornos del Movimiento®, mostrando el potencial de ATH434 en diversas condiciones neurológicas. La empresa nombró a Abby Macnish Niven como CFO y reportó un saldo de efectivo de A$9.28 millones al 30 de septiembre de 2024, con salidas de efectivo operativas trimestrales de A$3.31 millones.
Alterity Therapeutics는 FY25 1분기 실적과 ATH434 임상 시험의 주요 개발 사항을 보고했습니다. 이 회사는 진행성 MSA 환자를 대상으로 한 ATH434-202 2상 시험에서 긍정적인 중간 데이터를 강조하며 잠재적인 질병 변형 효과를 제시했습니다. 초기 단계 MSA에 대한 ATH434-201 2상 시험은 2025년 1월에 주요 데이터 발표를 위해 순조롭게 진행되고 있습니다. 여러 데이터 발표가 파킨슨병 및 운동장애 국제 회의®에서 이루어져, 다양한 신경학적 질환에서 ATH434의 잠재력을 보여주었습니다. 회사는 Abby Macnish Niven을 CFO로 임명했고, 2024년 9월 30일 기준으로 A$9.28백만의 현금 잔고를 보고하며 분기 운영 현금 유출이 A$3.31백만에 달했습니다.
Alterity Therapeutics a annoncé ses résultats du premier trimestre de l'exercice 2025, avec des développements clés dans ses essais cliniques ATH434. L'entreprise a mis en avant des données intermédiaires positives issues de l'essai de phase 2 ATH434-202 chez des patients atteints de MSA avancée, suggérant des effets potentiels modificateurs de la maladie. L'essai de phase 2 ATH434-201 chez des patients en début de MSA est toujours en bonne voie pour la publication des données principales en janvier 2025. Plusieurs présentations de données ont eu lieu lors du Congrès International sur la Maladie de Parkinson et les Troubles du Mouvement®, mettant en lumière le potentiel d'ATH434 dans diverses conditions neurologiques. L'entreprise a nommé Abby Macnish Niven au poste de CFO et a rapporté un solde de trésorerie de 9,28 millions AUD au 30 septembre 2024, avec des sorties de trésorerie opérationnelle trimestrielles de 3,31 millions AUD.
Alterity Therapeutics berichtete über die Ergebnisse des 1. Quartals des Geschäftsjahres 2025 und über wichtige Entwicklungen in seinen ATH434 klinischen Studien. Das Unternehmen hob positive Zwischenwerte aus der Phase-2-Studie ATH434-202 bei Patienten mit fortgeschrittener MSA hervor, was auf potenziell krankheitsmodifizierende Effekte hindeutet. Die Phase-2-Studie ATH434-201 bei Patienten mit MSA im Frühstadium ist planmäßig auf Kurs für die Veröffentlichung der Hauptdaten im Januar 2025. Mehrere Datenpräsentationen fanden auf dem International Congress of Parkinson's Disease and Movement Disorders® statt, die das Potenzial von ATH434 bei verschiedenen neurologischen Erkrankungen zeigen. Das Unternehmen ernannte Abby Macnish Niven zur CFO und berichtete von einem Kassenstand von 9,28 Millionen AUD zum 30. September 2024, mit vierteljährlichen Betriebskassenabflüssen von 3,31 Millionen AUD.
- Positive interim data from ATH434-202 trial showing 30% of participants had stable or improved clinical outcomes
- ATH434-201 Phase 2 trial on track for topline data release in January 2025
- Favorable safety profile with no drug-related serious adverse events in ATH434-202 trial
- Promising preclinical results in Parkinson's disease models
- Operating cash outflows of A$3.31M in Q1 FY25
- Brain volume declines observed in all participants at 6 months in ATH434-202 trial
Insights
Interim data from ATH434-202 trial shows promising disease-modifying potential in Multiple System Atrophy (MSA), with 30% of participants showing stable or improved clinical outcomes. The company's cash position of
Key clinical developments include stabilization of iron levels in brain regions and stable Neurofilament light chain levels in responders, indicating potential neuroprotective effects. The completion of patient enrollment (77 participants) in ATH434-201 Phase 2 trial strengthens near-term catalyst potential. Positive preclinical data in Parkinson's disease models expands potential market opportunities.
Highlights
- Topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial on track for release in January 2025
- Positive interim data reported from ATH434-202 Phase 2 clinical trial showing the potential for ATH434 to modify disease progression in Multiple System Atrophy
- Multiple data presentations at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS)
- Appointed Abby Macnish Niven as Chief Financial Officer
- Cash balance on 30 September 2024 of A
$9.28m
MELBOURNE, Australia and SAN FRANCISCO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2024 (Q1 FY25).
“We are excited about what this fiscal year has to offer as we started by reporting promising data from our Phase 2 clinical trial in participants with advanced multiple system atrophy (MSA),” said, David Stamler, M.D., Chief Executive Officer of Alterity. “The interim results from the ATH434-202 study suggest that ATH434 has potential to modify disease progression. Importantly, the stabilization of iron content in certain brain regions, combined with key biomarker data, indicates that ATH434 may slow neurodegeneration by modulating brain iron levels and reducing oxidative injury. These early data are an exciting indicator of what we might expect to see from our ATH434-201 trial in MSA patients with early-stage disease that is expected to read out in January 2025.”
“Last month, we delivered multiple presentations at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS), a prominent neurology meeting. At this event, we presented clinical and preclinical data demonstrating the potential of ATH434 in a variety of neurological conditions including early-stage MSA, advanced MSA, and Parkinson’s disease. We look forward to presenting additional data at medical meetings, and the topline results from both our ATH434-201 and ATH434-202 trials in calendar year 2025,” added, Dr. Stamler.
Alterity’s cash position on 30 September 2024 was A
In accordance with ASX Listing Rule 4.7C, payments of A
Operational Activities
ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA
On 17 July 2024, Alterity reported positive interim data from the ATH434-202 trial in participants with advanced MSA. The data were also presented in September 2024 as both a late-breaking oral presentation and poster session by Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center at the International Congress of Parkinson’s Disease and Movement Disorders® (MDS). The early outcomes reported from the interim analysis suggest that ATH434 has potential to modify disease progression.
The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12 months. ATH434 was well tolerated with no drug-related serious adverse events, and most adverse events were mild to moderate, showing a favorable safety profile.
The data suggest that ATH434 may have a disease-modifying effect in MSA, as
At 6 months all participants exhibited brain volume declines consistent with MSA progression; however, the clinical responders maintained stable brain volumes at 12 months. Importantly, the clinical responders on average showed stability in iron levels on MRI in the substantia nigra, putamen and globus pallidus, as well as stable levels of Neurofilament light chain (NfL), a marker of axonal injury, when compared to participants who declined. The stabilization of iron content in these subcortical brain regions, combined with NfL biomarker data, indicates that ATH434 may slow neurodegeneration by modulating brain iron levels and reducing oxidative injury.
The trial remains ongoing with Topline 12-month results expected in the first half of calendar year 2025.
ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA
In September 2024, Dr. Stamler delivered an Oral Platform presentation and poster session at MDS, entitled, “A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein Aggregation, for the Treatment of Multiple System Atrophy”. The oral presentation and poster described the baseline characteristics for the 77 participants from Alterity’s ATH434-201 randomized, double-blind Phase 2 clinical trial, with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met strict selection criteria designed to confirm they had early-stage (clinically probable) MSA.
The presentation further demonstrated that increased iron levels were evident in multiple subcortical brain regions, with increases being observed in the substantia nigra in nearly all subjects, and that ATH434 has potential to slow neurodegeneration based on its ability to redistribute this excess brain iron. Data were also presented indicating that plasma levels of neurofilament light chain, a marker of neuronal injury, were correlated with disease severity at baseline.
The trial remains on track to complete in November 2024. The data from the trial will then be analyzed and the Company expects to report topline results in January 2025.
bioMUSE Natural History Study
The Company’s “Biomarkers of progression in Multiple System Atrophy” (bioMUSE) natural history study continues to produce promising data to track the progression of individuals with MSA and characterize MSA in terms of various biomarkers. At the MDS meeting in September 2024, a poster featuring bioMUSE data was presented entitled, “Association Between Clinical Progression in Multiple System Atrophy and Brain Volume Changes Evaluated via Deep Learning Segmentation”. The poster described the novel MRI imaging techniques and deep learning segmentation that were used to assess brain volume in MSA brain regions of interest (ROI) in bioMUSE participants. Structural MRI plays a critical role in both diagnosing MSA and monitoring disease progression. Subcortical brain volume shows potential as a biomarker for evaluating disease-modifying therapies.
Over the course of one year, MRI with deep-learning segmentation revealed significant brain volume reduction in MSA ROIs whereas Parkinson’s disease patients showed no significant brain volume changes. In contrast, the MSA patients exhibited significant volume reductions in the cerebellum, globus pallidus, and brainstem. In addition, patients with the parkinsonian variant of MSA showed significant volume loss in the putamen. The results illustrate the correlation between the brain volume reduction and worsening clinical scores, as measured by the UMSARS, providing the basis for subcortical brain volume as a potential biomarker in treatment studies.
ATH434 for the Treatment of Parkinson’s Disease
In September 2024, a poster was presented at MDS entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”. The presentation demonstrated that ATH434 treatment led to lower iron levels in the affected area of the brain, the substantia nigra, and improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease.
At week 12, all 5 ATH434-treated macaques had stable or improving scores from Baseline while two of three vehicle-treated macaques did not demonstrate improvement. The improved general behavior was well-correlated with reduced motor impairment. These favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway. These results support further investigation of ATH434 for the treatment of Parkinson’s disease.
Corporate Activities
On September 30, 2024, Alterity announced Abby Macnish Niven as the Company’s Chief Financial Officer. Ms Macnish Niven consults for a range of listed and unlisted companies in governance, finance and corporate structure. She holds Bachelor of Commerce and Bachelor of Science degrees from University of Western Australia and is a Chartered Finance Analyst.
During the quarter, management participated in multiple investor activities including a webinar hosted by MST Financial, and a presentation hosted by ShareCafe.
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.
Investor and Media Contacts:
Australia
Ana Luiza Harrop
we-aualteritytherapeutics@we-worldwide.com
+61 452 510 255
U.S.
Remy Bernarda
remy.bernarda@iradvisory.com
+1 (415) 203-6386
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
FAQ
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