Highlights:

• Positive Guidance from European Medicines Agency for ATH434 Phase 2 Clinical Trial
• Publication in Movement Disorders demonstrates that ATH434 reduces α–synuclein related neurodegeneration in MSA animal model
• Presents to MST Access Australian Micro & Small Caps Conference
• Cash balance at 30 June 2021 of A$28M

MELBOURNE, Australia, July 30, 2021 /PRNewswire/ -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative conditions, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2021 (Q4 FY21).

The Company's cash position at 30 June 2021 of $28M was bolstered by the receipt of $17M in net proceeds from the use of the company's previously approved "At the Market" facility with shares issued in accordance with ASX Listing Rules 7.1 and 7.1A.

Operating cash outflows were A$4.9M, which was in line with company expectations and largely due to the preparation for the Phase 2 clinical trial for Alterity's lead drug candidate ATH434 in Multiple System Atrophy (MSA), a Parkinsonian disorder with no approved therapy.

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.

Operational Activities

Despite the prevailing impact of COVID-19 around the world, Alterity has continued to progress preparations for its Phase 2 Clinical Trial of ATH434 in MSA.

Significantly, Alterity announced in late June that it had received guidance from the European Medicines Agency (EMA) regarding key aspects of the Company's Phase 2 clinical trial for investigational drug ATH434 in the treatment of MSA. The EMA is the agency of the European Union responsible for the evaluation and supervision of medicinal products.

Given there is no approved treatment for MSA, the validation of the EMA providing their support to Alterity's intention to enroll early-stage MSA patients enhances the study's viability and design.

The EMA has also supported Alterity's intention to utilize biomarkers to enhance the diagnosis of these patients prior to enrolment. Improving diagnostic accuracy and targeting early-stage patients will enable Alterity to maximize the opportunity to demonstrate the disease modifying potential of ATH434.

In addition to preparation for the treatment study, which is on track to commence by end of this calendar year, the Company has made significant progress on its Natural History study in MSA being conducted at Vanderbilt University Medical Center.  The study, referred to as BioMUSE, has met its original enrollment goal and is in the process of being expanded to additional sites. Preliminary data has been highly informative regarding methods for biomarker assessment and patient characterization, all of which is expected to de-risk the Phase 2 study.

An independently conducted study was published demonstrating that ATH434 was neuroprotective in a widely accepted animal model of MSA, providing further support for Alterity's development strategy and validating the biologic target of ATH434. The publication in Movement Disorders, the official journal of the International Parkinson and Movement Disorder Society, demonstrated that ATH434 preserves neurons while reducing α–synuclein related pathology.

Outside of clinical development activities, Alterity's Chief Executive Officer, Dr David Stamler, presented a company overview at the MST Access Australian Micro & Small Caps Conference. The conference provided investors access to leaders across a broad range of ASX-listed micro and small-cap companies.

Commenting on the Quarter, Dr Stamler said: "The EMA support for our clinical development strategy in conjunction with the invaluable learnings from the Natural History study gives me great confidence that we are taking the right approach to finding a new treatment for MSA. Combined with the exciting new animal data demonstrating neuroprotection, we are eager to start our Phase 2 study by the end of this calendar year."  

END

Authorisation & Additional information

This announcement was authorised by David Stamler, CEO of Alterity Therapeutics Limited.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease with no approved therapy.  It is rapidly progressive and causes profound disability. MSA is a Parkinsonian disorder characterized by motor impairment typical of Parkinson's disease; autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control; and impaired balance and/or coordination that predisposes to falls. MSA affects approximately 15,000 patients in the U.S. A pathological hallmark of MSA is the accumulation of α-synuclein within oligodendroglia cells (glial cytoplasmic inclusions) and neuron loss in multiple brain regions.

About ATH434

ATH434 is the first of a new generation of small molecule drug candidates designed to inhibit the accumulation and aggregation of pathological proteins implicated in neurodegeneration. Alpha-synuclein is a neuronal protein that aggregates in neurons and is considered an important biologic target for treating these neurodegenerative diseases. ATH434 has been shown to reduce abnormal accumulation of α–synuclein protein in animal models of disease by restoring normal iron balance in the brain. As a result, it has the potential to treat various disorders including Multiple System Atrophy (MSA), Parkinson's Disease, and Dementia with Lewy Bodies (DLB). ATH434 has been granted Orphan designation for the treatment of MSA by the U.S. Food and Drug Administration and the European Union.

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 forms of Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical 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.^[1]

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, uncertainties relating to the impact of the novel coronavirus (COVID-19) pandemic on the company's business, operations and employees, 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 patent protection for the Company's intellectual property or trade secrets, including, but not limited to, the intellectual property relating to ATH434.

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.

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References

1. ^{^} www.alteritytherapeutics.com. (www.alteritytherapeutics.com)
2. ^{^} https://www.prnewswire.com/news-releases/appendix-4c--q4-fy21-quarterly-cash-flow-report-301345142.html (www.prnewswire.com)