Full Press Release Details
Therapeutics Limited
ended 31 December 2024
| Name of entity: | Alterity Therapeutics Limited |
| ABN: | 37 080 699 065 |
| Half-year ended: | 31 December 2024 |
| Previous period: | 31 December 2023 |
for announcement to the market
| A$ | ||||||||||||
| Revenue from ordinary activities | Down | 6.0 | % | to | 111,299 | |||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Up | 10.2 | % | to | 7,173,335 | |||||||
| Net loss after tax for the period attributable to members | Up | 10.2 | % | to | 7,173,335 |
| Net tangible assets per security | ||||||||||||
| 31 December | 31 December | |||||||||||
| 2024 | 2023 | |||||||||||
| cents | cents | |||||||||||
| Net tangible asset backing (cents per share) | 0.14 | 0.62 |
Therapeutics Limited recorded income of $111,299 for the half-year ended 31 December 2024 (2023: $118,400) which is interest received
on the Group's bank accounts. Alterity Therapeutics Limited has incurred a loss of $7,173,335 for the half-year ended 31 December
2024 (2023: $6,507,183).
explanation of the key financial elements contributing to the revenue and result above can be found in the review of operations included
within the directors' report.
dividends have been paid or declared by the Group for the current financial period. No dividends were paid for the previous financial
in controlled entities
have been no changes in controlled entities during the period ended 31 December 2024.
information required by Listing Rule 4.2A
interim financial statements have been reviewed by the Group's independent auditor.
Therapeutics Limited
financial report for the
ended 31 December 2024
| Contents | Page | |
| Corporate directory | 1 | |
| Directors' report | 2 | |
| Consolidated statement of profit or loss and other comprehensive income | 8 | |
| Consolidated statement of financial position | 9 | |
| Consolidated statement of changes in equity | 10 | |
| Consolidated statement of cash flows | 11 | |
| Notes to the consolidated financial statements | 12 | |
| Directors' declaration | 21 | |
| Independent auditor's report to the members | 23 |
Therapeutics Limited
| Directors | Mr. Geoffrey Kempler | |
| Chairman | ||
| Mr. Brian Meltzer | ||
| Independent Non-Executive Director | ||
| Mr. Peter Marks | ||
| Independent Non-Executive Director | ||
| Mr. Lawrence Gozlan | ||
| Non-Executive Director | ||
| Secretary | Ms Abby Macnish Niven (from 18 November 2024) | |
| Mr Phillip Hains (to 17 November 2024) | ||
| Principal registered office in Australia | Level 14, 350 Collins Street | |
| Melbourne VIC 3000 | ||
| Australia | ||
| +61 3 9349 4906 | ||
| Share register | Automic Pty Ltd | |
| Level 5, 191 St Georges Terrace | ||
| Perth WA 6000 | ||
| 1300 288 664 (within Australia) & +61 2 9698 5414 (outside Australia) | ||
| Auditor | PricewaterhouseCoopers | |
| 2 Riverside Quay | ||
| Southbank Victoria 3006 | ||
| Solicitors | Quinert Rodda & Associates Pty Ltd | |
| Level 6/400 Collins St | ||
| Melbourne Victoria 3000 | ||
| Website | www.alteritytherapeutics.com |
Therapeutics Limited
directors present their report on the Consolidated Entity (referred to hereafter as the group) consisting of Alterity Therapeutics Limited
and the entities it controlled at the end of, or during, the half-year ended 31 December 2024.
following persons held office as directors of Alterity Therapeutics Limited during the whole of the half-year and up to the date of this
Yearly Review of Operations - 31 December 2024
the first half of FY25, Alterity delivered material progress on all aspects of its business.
notably, subsequent to the end of the period, in January 2025, Alterity announced positive topline results from its lead clinical development
program in early-stage Multiple System Atrophy (MSA). The ATH434-201 randomised, double-blind Phase 2 clinical trial demonstrated a clinically
meaningful benefit at both ATH434 doses studied, achieving statistical significance at the 50 mg dose, with 48% slowing of clinical progression
on the modified UMSARS Part I rating scale (UMSARS I) that assesses disability on activities of daily living affected in MSA. In addition,
ATH434 demonstrated a favourable safety profile and key MRI biomarker data showed target engagement with reduced iron accumulation in
MSA affected brain regions.
the first half of FY25, Alterity also reported positive interim data from the ATH434-202 trial in participants with MSA who had advanced
disease compared to study ATH434-201. The interim analysis showed a benefit on the UMSARS I compared to historical data with clinical
responders demonstrating target engagement on MRI.
data presentations were given at prominent medical meetings during the period featuring all of Alterity's clinical and research
programs in MSA, Parkinson's disease, and Friedreich Ataxia.
on the promising ATH-434-201 clinical results, Alterity successfully raised additional funding with new investors and current shareholders
to accelerate ATH434 regulatory and clinical development activities, business development activities, and to continue research and discovery
of novel compounds for major indications such as Parkinson's disease.
these advancements demonstrate Alterity's ability to deliver on its clinical pipeline and corporate objectives as it strives to
develop the first disease modifying treatment for neurodegenerative disease.
30 June 2024 Annual Report contains detailed background information relating to its operations, including its research and development
projects and collaboration partners, and should be read in conjunction with this report.
in Ongoing Clinical and Research Pipeline
internally, Alterity's lead compound ATH434 is an oral agent designed to inhibit the aggregation of pathological proteins implicated
in neurodegeneration. ATH434 acts by redistributing excess iron in the brain, reducing the toxic accumulation of the protein -synuclein,
and rescuing neuronal function. As an iron chaperone, ATH434 has the potential to address the underlying pathology of the disease and
preserve function in individuals with neurodegenerative diseases.
on accumulated pre-clinical data and an understanding of how Parkinsonian disorders develop and progress, the Company believes ATH434
has excellent potential to treat MSA, Parkinson's disease as well as Friedreich Ataxia.
Therapeutics Limited
Yearly Review of Operations - 31 December 2024 (continued)
on accumulated pre-clinical data and an understanding of how Parkinsonian disorders develop and progress, the Company believes ATH434
has excellent potential to treat MSA, Parkinson's disease as well as Friedreich Ataxia.
as a Potential Disease Modifying Treatment for Multiple System Atrophy (MSA)
made substantial progress in the first half of FY25 advancing its clinical and research programs in the rare, orphan indication of MSA.
ATH434 has been granted Orphan Drug Designation (ODD) for the treatment of MSA by the U.S. FDA and the European Commission. ODD comes
with many benefits including 7-10 years of market exclusivity, tax credits and fee reductions, as well as protocol assistance from each
is a rare neurodegenerative disease, related to Parkinson's disease, that progresses rapidly and causes profound disability. While
some of the symptoms of MSA can be treated with available medications, currently there are no drugs that can slow disease progression
and there is no cure. MSA is a Parkinsonian disorder characterised 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, all of which drastically impair quality of life.
pathological hallmark of MSA is accumulation of the protein -synuclein and neuron loss in multiple regions within the central
nervous system. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal
cord. Alterity's clinical trials are evaluating the efficacy, safety and pharmacokinetics of ATH434 in individuals with MSA. This
includes clinical endpoints that assess MSA symptoms and biomarkers that evaluate target engagement and drug activity. The selected biomarkers,
such as brain iron on MRI, reflect MSA pathology and are therefore appropriate targets to assess drug activity.
successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious
levels in animal models of MSA. Alterity has successfully completed its ATH434- 201 Phase 2 clinical trial and the ATH434-202 Phase 2
Randomised, Double-Blind, Placebo Controlled Phase 2 Clinical Trial in Early-State MSA
ATH434-201 Phase 2 clinical trial is a randomised, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage
MSA. In addition to evaluating biomarkers and clinical scores on the UMSARS scale, wearable sensors were also employed to evaluate motor
activities that are important to patients with MSA. The study enrolled 77 adults who were randomly assigned to receive one of two dose
levels of ATH434 or placebo. Participants received treatment for 12 months.
4 December 2024, Alterity reported the completion of the ATH434-201 study as the last patient finished all clinical evaluations leading
to the announcement of the topline results. The completion of the trial represented a major accomplishment for Alterity in this rare
neurodegenerative disease.
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 -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 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 characterised 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.
Open-label, Biomarker Phase 2 Clinical Trial in More Advanced MSA
ATH434-202 trial is evaluating participants with more advanced MSA as compared to the cohort from the 201 trial. While the 202 trial
is also treating participants for 12 months, it has an open label design that allowed Alterity to perform interim analyses of biomarker
and clinical data while the study is ongoing.
Therapeutics Limited
Yearly Review of Operations - 31 December 2024 (continued)
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" at the MDS meeting. The
data suggest that ATH434 may have a disease-modifying effect in MSA, as 30% of participants had stable or improved clinical outcomes
(clinical responders). Disease progression over 6 months was slower compared to a historical group of untreated MSA patients, as indicated
by the Unified MSA Rating Scale (UMSARS) Part I which assesses functional performance. The clinical responders had stable brain iron
and brain volume after 12 months treatment. The stabilisation of iron content in MSA affected brain regions, combined with stable levels