Appendix 4C – Q2 FY24 Quarterly Cash Flow Report
- Completed enrollment in for ATH434-201 Phase 2 study
- Delivered promising data on ATH434 in Parkinson’s disease and on its novel mechanism of action
- Strengthened the balance sheet with successful A$4.8M financing
- Closed Securities Purchase Plan (SPP) on 25 January
- Cash balance on 31 December 2023 of A$12.3M
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 31 January 2024, Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 December 2023 (Q2 FY24).
“The second quarter of our fiscal year was extremely productive and provided great momentum to carry us into the 2024 calendar year,” said David Stamler, M.D., Chief Executive Officer of Alterity. “Completing enrolment in our ATH434-201 clinical trial in early-stage multiple system atrophy (MSA) was a major milestone as we look to change the treatment paradigm for individuals living with this rare and devastating disease. We expect to complete the 201 trial in November 2024 and report topline results in January 2025. For our ATH434-202 trial in more advanced MSA, we plan to report preliminary six-month data in the first half of 2024.”
Dr. Stamler, continued, “During the quarter, we also had several important data presentations related to ATH434 that validate the treatment approach in our ongoing clinical trials. Most notably, for the first time we demonstrated the efficacy of ATH434 in a primate model of Parkinson’s disease. ATH434 treatment improved both motor performance and general function in this higher order animal, and these benefits were associated with reductions in iron in affected brain regions. In a separate investigation, a new mechanism was described for ATH434 – direct antioxidant activity. By protecting vital mitochondrial function, we believe ATH434 has increased potential to slow disease progression.”
“During 2024, we will continue to reap benefits from our bioMUSE natural history study as we deepen our understanding of the biomarker evaluation of MSA. We are excited about the progress of all of our studies to date and look forward to the data readouts coming over the next year,” concluded Dr. Stamler.
Alterity’s cash position on 31 December 2023 was A$12.3M with operating cash outflows for the quarter of A$4.9M. The company strengthened its balance sheet through a Two Tranche placement raising approximately A$1.3M during the quarter from qualified institutional investors in Tranche One, with the balance of approximately A$3.5M from Tranche Two of the Placement raised in January 2024. In conjunction with this offering, a Security Purchase Plan (SPP) was approved by shareholders at the Extraordinary General Meeting held on 29 December 2023. The SPP results will be released this week and the Company is pleased to report that there was significant interest from current shareholders.
In accordance with ASX Listing Rule 4.7C, payments 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.
ATH434–201: Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA
On 8 November 2023, Alterity announced that enrollment was successfully completed in the ATH434-201 Phase 2 clinical trial. This randomized, double-blind, placebo-controlled study enrolled participants with early-stage multiple system atrophy (MSA) across the U.S., Europe, Australia and New Zealand. The ATH434-201 study is treating participants for 12 months and, therefore, the study will complete in November 2024. Once complete, the data from the trial will be analyzed and the Company expects to report topline results by January 2025.
ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial in More Advanced MSA
The ATH434-202 trial continues to enroll participants with more advanced MSA than in the 201 trial. A key aim of the 202 study is to assess the efficacy of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics. While the 202 trial is also treating participants for 12-months, it has an open label design that will allow Alterity to perform interim analyses of biomarker and clinical data while the study is ongoing, providing a potential early indication of efficacy. The Company expects to report preliminary six-month data from the initial patients enrolled in the ATH434-202 trial in the first half of 2024.
ATH434 for the Treatment of Parkinson’s Disease
On 4 December 2023, Alterity announced that promising new data on the effect of ATH434 in a Parkinson’s disease primate model was presented at the Future of Parkinson’s Disease Conference. The poster, entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques” demonstrated that ATH434 treatment improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. Importantly, the improvements in motor skills and general functioning in this higher order animal – the monkey – parallel human parkinsonism and were associated with reductions in iron in affected brain regions.
Novel Mechanisms for ATH434 as a Treatment for Neurodegenerative Diseases
On 16 November 2023, Alterity announced that promising new data related to ATH434 was presented at the Society for Neuroscience. The poster entitled, “Potent Antioxidant and Mitochondrial- protectant Effects of ATH434, a Novel Inhibitor of α-Synuclein Aggregation with Moderate Iron- binding Affinity,” demonstrated new data indicating that ATH434 can preserve mitochondrial function after oxidative injury and exert direct anti-oxidant activity independent of its iron binding properties. These features were not observed with another iron binding agent approved for treating iron overload that was also investigated. The demonstrated mitochondrial protection may reveal additional mechanisms that augment the ability of ATH434 to slow disease progression and underscores the potential of ATH434 as a treatment for neurodegenerative diseases.
bioMUSE Natural History Study
The bioMUSE study continues to generate invaluable data related to the understanding of MSA and its early presentation and demonstrates that Alterity is leading the way in biomarker evaluation of this
rare disease. On 27 November 2023, a data presentation entitled, “Relationship between N-acetylaspartate and neurofilament light chain in multiple system atrophy” was presented at the recent 34th International Symposium on the Autonomic Nervous System (AAS). In the study, the data provided evidence that N-acetylaspartate (NAA) correlates with levels of neurofilament light chain (NfL) in patients with early MSA. NfL is a widely used biomarker that is a measure of neuronal damage. The findings suggest that the NAA metabolite may be a useful biomarker for assessing disease severity and treatment response in MSA.
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. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. 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 authorised by David Stamler, CEO of Alterity Therapeutics Limited.