Appendix 4C – Q2 FY25 Quarterly Cash Flow Report
Alterity Therapeutics (NASDAQ: ATHE) has reported significant progress in Q2 FY25, particularly with its lead asset ATH434. The company completed its ATH434-201 Phase 2 clinical trial in early-stage Multiple System Atrophy (MSA) in November 2024, with topline data expected by early February 2025.
Positive interim data from the ATH434-202 Phase 2 trial in advanced MSA showed promising results, with 30% of participants demonstrating stable or improved clinical outcomes. The trial suggests potential disease-modifying effects, with stabilization of brain iron and volume after 12 months of treatment.
Multiple presentations and publications during the quarter highlighted ATH434's neuroprotective qualities and mechanism of action in treating various neurodegenerative conditions, including MSA, Parkinson's disease, and Friedreich's Ataxia. The company's cash position as of December 31, 2024, stood at A$4.54M, with quarterly operating cash outflows of A$5.06M.
Alterity Therapeutics (NASDAQ: ATHE) ha riportato progressi significativi nel secondo trimestre dell'anno fiscale 2025, in particolare con il suo principale asset ATH434. L'azienda ha completato il trial clinico di fase 2 ATH434-201 per l'Atrofia Sistemica Multipla (MSA) in fase iniziale a novembre 2024, con dati preliminari attesi per inizio febbraio 2025.
I dati intermedi positivi provenienti dal trial di fase 2 ATH434-202 per MSA avanzata hanno mostrato risultati promettenti, con il 30% dei partecipanti che ha dimostrato esiti clinici stabili o migliorati. Il trial suggerisce potenziali effetti modificatori della malattia, con stabilizzazione del ferro cerebrale e del volume dopo 12 mesi di trattamento.
Numerose presentazioni e pubblicazioni durante il trimestre hanno messo in evidenza le qualità neuroprotettive di ATH434 e il meccanismo d'azione nel trattamento di varie condizioni neurodegenerative, tra cui MSA, malattia di Parkinson e Atassia di Friedreich. La posizione di cassa dell'azienda al 31 dicembre 2024 ammontava a 4,54 milioni di dollari australiani, con flussi di cassa operativi trimestrali di 5,06 milioni di dollari australiani.
Alterity Therapeutics (NASDAQ: ATHE) ha reportado avances significativos en el segundo trimestre del año fiscal 2025, especialmente con su activo principal ATH434. La compañía completó su ensayo clínico de fase 2 ATH434-201 en la Atrofia Sistemica Múltiple (MSA) en fase temprana en noviembre de 2024, con datos preliminares esperados para principios de febrero de 2025.
Los datos intermedios positivos del ensayo de fase 2 ATH434-202 en MSA avanzada mostraron resultados prometedores, con un 30% de los participantes demostrando resultados clínicos estables o mejorados. El ensayo sugiere posibles efectos modificadores de la enfermedad, con estabilización del hierro cerebral y del volumen después de 12 meses de tratamiento.
Múltiples presentaciones y publicaciones durante el trimestre destacaron las cualidades neuroprotectoras de ATH434 y su mecanismo de acción en el tratamiento de diversas condiciones neurodegenerativas, incluyendo MSA, enfermedad de Parkinson y Ataxia de Friedreich. La posición de efectivo de la compañía al 31 de diciembre de 2024 era de 4,54 millones de dólares australianos, con flujos de efectivo operativos trimestrales de 5,06 millones de dólares australianos.
Alterity Therapeutics (NASDAQ: ATHE)는 2025 회계연도 2분기에 특히 주요 자산 ATH434와 관련하여 중요한 진전을 보고했습니다. 이 회사는 2024년 11월 초기 다계통 위축증(MSA) 대상의 ATH434-201 2상 임상 시험을 완료했으며, 기관 데이터는 2025년 2월 초에 예상됩니다.
고급 MSA에서의 ATH434-202 2상 시험의 긍정적인 중간 데이터는 참가자의 30%가 안정적이거나 개선된 임상 결과를 보여주어 유망한 결과를 나타냈습니다. 이 시험은 12개월 간의 치료 이후 뇌의 철분 및 부피가 안정화되는 등 잠재적인 질병 수정 효과를 시사합니다.
분기 동안 여러 발표 및 출판물은 MSA, 파킨슨병 및 프리드리히 운동 실조증을 포함한 다양한 신경퇴행성 질환 치료에서 ATH434의 신경 보호 특성과 작용 메커니즘을 강조했습니다. 2024년 12월 31일 기준 회사의 현금 유동성은 454만 호주 달러였으며, 분기 운영 현금 유출은 506만 호주 달러로 나타났습니다.
Alterity Therapeutics (NASDAQ: ATHE) a signalé des progrès significatifs au cours du deuxième trimestre de l'exercice 2025, en particulier avec son actif phare ATH434. L'entreprise a terminé son essai clinique de phase 2 ATH434-201 sur l'Atrophie Système Multiple (MSA) à un stade précoce en novembre 2024, avec des données préliminaires attendues pour début février 2025.
Les données intermédiaires positives de l'essai de phase 2 ATH434-202 sur la MSA avancée ont montré des résultats prometteurs, avec 30 % des participants démontrant des résultats cliniques stables ou améliorés. L'essai suggère des effets potentiels modificateurs de la maladie, avec une stabilisation du fer cérébral et du volume après 12 mois de traitement.
De nombreuses présentations et publications au cours du trimestre ont mis en lumière les qualités neuroprotectrices d'ATH434 et son mécanisme d'action dans le traitement de diverses conditions neurodégénératives, y compris la MSA, la maladie de Parkinson et l'Ataxie de Friedreich. La position de trésorerie de l'entreprise au 31 décembre 2024 s'élevait à 4,54 millions de dollars australiens, avec des sorties de trésorerie opérationnelles trimestrielles s'élevant à 5,06 millions de dollars australiens.
Alterity Therapeutics (NASDAQ: ATHE) hat im zweiten Quartal des Geschäftsjahres 2025 bedeutende Fortschritte gemeldet, insbesondere mit seinem Hauptprodukt ATH434. Das Unternehmen hat im November 2024 die Phase-2-Studie ATH434-201 zur früh einsetzenden Multiplen Systematrophie (MSA) abgeschlossen, wobei die ersten Daten Anfang Februar 2025 erwartet werden.
Positive Zwischenwerte aus der Phase-2-Studie ATH434-202 bei fortgeschrittener MSA zeigten vielversprechende Ergebnisse, wobei 30 % der Teilnehmer stabile oder verbesserte klinische Ergebnisse zeigten. Die Studie deutet auf potenzielle krankheitsmodifizierende Effekte hin, mit Stabilisierung von Hirneisen und -volumen nach 12 Monaten Behandlung.
Mehrere Präsentationen und Veröffentlichungen im Laufe des Quartals betonten die neuroprotektiven Eigenschaften von ATH434 sowie den Wirkmechanismus bei der Behandlung verschiedener neurodegenerativer Erkrankungen, einschließlich MSA, Parkinson-Krankheit und Friedrich-Ataxie. Zum 31. Dezember 2024 belief sich die Liquiditätsposition des Unternehmens auf 4,54 Millionen AUD, bei quartalsweisen operativen Mittelabflüssen von 5,06 Millionen AUD.
- Completion of ATH434-201 Phase 2 trial in early-stage MSA with topline results expected by February 2025
- Positive interim data from ATH434-202 trial showing 30% of participants with stable/improved outcomes
- Multiple successful data presentations demonstrating ATH434's potential as a disease-modifying treatment
- Significant cash burn with quarterly operating outflows of A$5.06M against A$4.54M cash balance
- cash runway based on current burn rate
Insights
The latest quarterly report reveals several critical developments for Alterity's lead compound ATH434, painting a compelling picture of its potential in treating neurodegenerative diseases. The completion of the ATH434-201 Phase 2 trial in early-stage MSA marks a significant milestone, with topline data expected in early February 2025 - a important catalyst for the company.
Particularly noteworthy is the interim data from the ATH434-202 trial, showing that 30% of participants demonstrated stable or improved clinical outcomes. This is remarkable for a progressive neurodegenerative condition like MSA, where any stabilization could be considered clinically meaningful. The biomarker data, including stable brain iron levels and brain volume in responders, provides objective evidence supporting ATH434's proposed mechanism of action.
The company's scientific foundation has been strengthened by multiple supporting studies, including:
- Publication in Metallomics validating ATH434's novel iron-targeting mechanism
- Preclinical data showing antioxidant and mitochondrial-protective properties
- Positive results in parkinsonian macaques demonstrating improved motor performance
However, investors should note the financial position carefully. With
The financial metrics warrant careful attention. With
The strategic sequencing of data releases is noteworthy:
- ATH434-201 topline results expected in early February 2025
- ATH434-202 12-month results anticipated in H1 2025
This creates multiple catalysts that could impact valuation and negotiating position for potential funding or partnerships. Positive results from ATH434-201 could strengthen the company's position for either equity financing or partnership discussions, while negative results could significantly complicate funding efforts. The current market cap of
Highlights
- Topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial on track for expected release by early February 2025
- ATH434-201 trial in early-stage MSA completed in November 2024
- Positive interim data presented at MDS from the ATH434-202 Phase 2 trial in advanced MSA
- Multiple data presentations and publications showing the potential for ATH434 to modify disease progression in neurodegenerative conditions
- Cash balance on 31 December 2024 of A
$4.54 m
MELBOURNE, Australia and SAN FRANCISCO, Jan. 24, 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 December 2024 (Q2 FY25).
“The second fiscal quarter of this year was extremely productive for Alterity and highlighted the tremendous potential of our lead asset, ATH434, as a promising therapy to treat a variety of neurodegenerative diseases,” said, David Stamler, M.D., Chief Executive Officer of Alterity. “Most significantly, we completed the ATH434-201 study, our 12-month, double-blind Phase 2 clinical trial of ATH434 in early-stage Multiple System Atrophy (MSA). Throughout the course of the trial, we have had tremendous interest from our clinical sites, doctors and patients around the globe as we seek a treatment to slow the progression of this devastating condition. The data analysis is being finalized, and we remain on track to report topline results in early February.”
“During the quarter, we delivered numerous posters, presentations and publications on the potential of ATH434 as a disease modifying treatment in a variety of indications including MSA, Parkinson’s disease, and Friedreich’s Ataxia. New, non-clinical data was presented that further describes the neuroprotective qualities and the mechanism of action of ATH434 including the importance of iron and iron-targeting agents like ATH434 to treat neurodegenerative diseases. Notably, positive clinical and biomarker interim results were presented from the ATH434-202 Phase 2 trial in advanced MSA, suggesting that ATH434 has the potential to modify disease progression. The topline 12-month results from the 202 trial are expected in the first half of calendar year 2025,” concluded Dr. Stamler.
Alterity’s cash position on 31 December 2024 was A
In accordance with ASX Listing Rule 4.7C, payments of A
Operational Activities
ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA
On 4 December 2024, Alterity reported the completion of the ATH434-201 study as the last patient finished all clinical evaluations. The completion of the trial represented a major accomplishment for Alterity in this rare neurodegenerative disease. With the achievement of this milestone, topline results remain on track to be reported by early February 2025.
In October 2024, Alterity announced Dr. Stamler delivered an Oral Platform presentation and poster session at the International Congress of Parkinson’s Disease and Movement Disorders® (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 MSA. The presentation characterized the distribution of iron in MSA affected brain areas and demonstrated that plasma levels of neurofilament light chain, a marker of neuronal injury, were correlated with disease severity at baseline.
ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in Advanced MSA
In October 2024, Alterity announced the presentation of positive interim data from the ATH434-202 trial as both a late-breaking oral presentation and poster session entitled, “Preliminary Efficacy and Safety of ATH434 in Multiple System Atrophy”, by Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center at the MDS meeting. The data suggest that ATH434 may have a disease-modifying effect in MSA, as
The trial remains ongoing with topline 12-month results expected in the first half of calendar year 2025.
bioMUSE Natural History Study
The Company’s “Biomarkers of progression in Multiple System Atrophy” (bioMUSE) natural history study has produced promising data to track the progression of individuals with MSA and characterize MSA in terms of various biomarkers.
In November 2024, data was presented at the 35th International Symposium on the Autonomic Nervous System that highlighted Alterity’s work to better understand not only how MSA initially presents, but also how it progresses over time. The platform presentation entitled, “The MSA Atrophy Index: A Marker of Clinical Progression in Multiple System Atrophy”, was presented by Paula Trujillo Diaz, PhD, Research Assistant Professor, Department of Neurology, Vanderbilt University Medical Center. The presentation described the use of state-of-the-art technology that goes beyond traditional MRI methods to track the change in volume in specific regions of the brain affected in patients with MSA. Importantly, it was observed that significant reductions in brain volume over 12 months correlated with clinical worsening of the disease. The results underscore the importance of utilizing advanced neuroimaging and analytical methods in evaluating MSA which Alterity has implemented in its Phase 2 clinical trials.
In October 2024, Alterity announced that a poster featuring bioMUSE data was presented at the MDS meeting 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. 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.
Peer-reviewed Publication Describing Novel Mechanism of Action for ATH434
In November 2024, the peer-reviewed journal, Metallomics, published data on the importance of iron and iron-targeting agents like ATH434 to treat neurodegenerative diseases. The publication, entitled, “ATH434, a promising iron-targeting compound for treating iron regulation disorders” was led by author Ashley Pall, Department of Pharmaceutical Sciences at Wayne State University. This publication demonstrates the novel way in which ATH434 targets the labile, or reactive, form of iron which can be so damaging to cells when in excess. The iron binding properties of ATH434 presented in the publication support the characterization of ATH434 as an iron chaperone. The publication describes how ATH434 targets the toxic form of iron that drives the pathology of a rare neurodegenerative disease known as Friedreich’s Ataxia. This toxic form of iron is also involved in the pathogenesis of Parkinson’s disease and MSA.
Non-Clinical Data Describing Neuroprotection of ATH434
In October 2024 promising new data related to ATH434 were presented at the Society for Neuroscience 2024 that further the understanding of ATH434’s potential as a disease modifying treatment for neurodegenerative diseases, including Parkinson’s disease and related disorders. The poster presentation entitled, “Potent Antioxidant and Mitochondrial-protectant Effects of ATH434, a Novel Inhibitor of α-Synuclein Aggregation with Moderate Iron-binding Affinity,” demonstrated that the neuroprotective and mitochondrial protectant properties of ATH434 include reducing lipid damage in two distinct and disease-relevant neuronal injury models. ATH434’s antioxidant properties were distinguished from those of another iron binding agent approved for treating iron overload. This is key as oxidative injury is an important contributor to the pathology of neurodegeneration. By addressing this injury in two different ways, both directly and by redistributing excess labile iron, ATH434 has excellent potential to treat this group of diseases. The ability of ATH434 to reduce damage to lipid membranes undergoing oxidative stress may augment its ability to slow disease progression. The study was run under the direction of Dr. Daniel J. Kosman, Distinguished Professor of Biochemistry at the State University of New York at Buffalo.
ATH434 for the Treatment of Parkinson’s Disease
Also announced in October 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
During the quarter, management participated in several investor activities and Alterity was featured in multiple media articles. The event webcasts and links to news coverage can be found on the Company’s website here.
On 22 November 2024, Alterity held its Annual General Meeting in Melbourne, Australia. The results, presentation, and Chairman’s Address can be found on the Company’s website 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’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
When will Alterity (ATHE) release topline data for the ATH434-201 Phase 2 trial?
What were the interim results of ATHE's ATH434-202 trial in advanced MSA?
What is Alterity's (ATHE) current cash position as of December 2024?
What conditions is Alterity's (ATHE) ATH434 being developed to treat?
When will ATHE release topline results for the ATH434-202 trial?
