Full Press Release Details
Alterity Therapeutics Limited
Half-year ended 31 December 2023
| Name of entity: | Alterity Therapeutics Limited |
| ABN: | 37 080 699 065 |
| Half-year ended: | 31 December 2023 |
| Previous period: | 31 December 2022 |
Results for announcement to the market
| A$ | ||||||||||||
| Revenue from ordinary activities | Up | 940.5 | % | to | 118,400 | |||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Down | (19.0 | )% | to | 6,507,183 | |||||||
| Net loss after tax for the period attributable to members | Down | (19.0 | )% | to | 6,507,183 |
Net tangible assets per security
| 31 December | 31 December | |||||||
| 2023 | 2022 | |||||||
| cents | cents | |||||||
| Net tangible asset backing (cents per share) | 0.62 | 1.16 |
Explanation of results
Alterity Therapeutics Limited
recorded income of $118,400 for the half-year ended 31 December 2023 (2022: $11,379) which is interest received on the Group's
bank accounts. Alterity Therapeutics Limited has incurred a loss of $6,507,183 for the half-year ended 31 December 2023 (2022:
An 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.
No dividends have been paid or declared
by the Group for the current financial period. No dividends were paid for the previous financial period.
Changes in controlled entities
There have been no changes in controlled
entities during the period ended 31 December 2023.
Other information required by Listing
The interim financial statements have
been reviewed by the Group's independent auditor which includes a paragraph regarding a material uncertainty in relation to going concern.
Therapeutics Limited
financial report for the
ended 31 December 2023
| Page | ||
| Corporate directory | 1 | |
| Directors' report | 2 | |
| Consolidated statement of profit or loss and other comprehensive income | 7 | |
| Consolidated statement of financial position | 8 | |
| Consolidated statement of changes in equity | 9 | |
| Consolidated statement of cash flows | 10 | |
| Notes to the consolidated financial statements | 11 | |
| Directors' declaration | 20 | |
| Independent auditor's report to the members | 22 |
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 | Mr. Phillip Hains | |
| Principal registered office in Australia | Level 3, 62 Lygon Street | |
| Carlton Victoria 3053 | ||
| Australia | ||
| +61 3 9824 5254 | ||
| Share register | Computershare Investor Services Pty Ltd | |
| Yarra Falls, 452 Johnston Street | ||
| Abbotsford Victoria 3067 | ||
| 1300 85 05 05 (within Australia) & +61 3 9414 4000 | ||
| (overseas) | ||
| 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 |
Alterity Therapeutics Limited
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 2023.
The following persons held office as
directors of Alterity Therapeutics Limited during the whole of the half-year and up to the date of this report:
Mr. Geoffrey Kempler
Review of operations
of FY24, Alterity delivered material progress on all aspects of the business. Both of the Company's Phase 2 clinical trials advanced
on schedule with the ATH434-201 randomized, double-blind trial completing enrollment. Numerous data presentations were given at prominent
medical meetings during the period, highlighted by new, preclinical data on the potential efficacy of ATH434 in Parkinson's disease.
In addition, the Company successfully completed a financing round with new investors and current shareholders to continue this momentum
into the second half of FY24.
All 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
a rare neurodegenerative disease.
30 June 2023 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.
Development Pipeline
Lead Compound - ATH434
Discovered 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 Parkinson's disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA).
Based on accumulated
pre-clinical data and an understanding of how MSA develops and progresses, the Company believes ATH434 has excellent potential to treat
MSA as well as Parkinson's disease. ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and
achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials
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 agency.
Alterity Therapeutics Limited
Review of operations
- 31 December 2023 (continued)
for ATH434 as a Treatment for Neurodegenerative Diseases
Year, 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 -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.
Progress in Ongoing Clinical
and Research Pipeline in Multiple System Atrophy
Alterity made substantial
progress in the first half of FY24 advancing its clinical and research programs in the rare, orphan indication of multiple system atrophy
MSA is a rare neurodegenerative
disease, related to Parkinson's, 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 characterized 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.
hallmark of MSA is accumulation of the protein alpha-synuclein and neuron loss in multiple brain 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.
clinical trials are evaluating the effect of the ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement
and clinical endpoints that assess the key symptoms of MSA, in addition to assessing safety and pharmacokinetics. The selected biomarkers,
such as brain iron and aggregating -synuclein, are important contributors to MSA pathology and are therefore appropriate targets
to demonstrate drug activity. Wearable sensors are being used in the ATH434-201 study to evaluate motor activities important to individuals
with MSA in an outpatient setting.
Randomized, Double-Blind Phase 2 Clinical Trial in Early-State MSA
Alterity announced that enrollment was successfully completed in the ATH434-201 Phase 2 clinical trial. This is the Company's primary
clinical trial and is a randomized, double-blind, placebo-controlled study that enrolled participants with early-stage 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
important milestone was reached in the trial when the independent Data Monitoring Committee (DMC) for the trial recommended the Phase
2 study continue as planned. The DMC conducted a prespecified review of unblinded clinical data from an initial cohort of study participants.
The DMC expressed no concerns about safety and recommended that the study continue without modification. The plan for the DMC to review
initial safety data was cleared with the U.S. Food and Drug Administration.
On 6 February 2024, the DMC for the trial conducted its second prespecified review of unblinded clinical data from study participants.
The DMC again expressed no concerns about safety and recommended that the study continue without modification.
Alterity Therapeutics Limited
Review of operations - 31 December 2023 (continued)
Open-label, Biomarker Phase 2 Clinical Trial in More Advanced MSA
trial continues to evaluate participants with more advanced MSA when compared to the cohort from the 201 trial. While the 202 trial is