Highlights:

• Michael J. Fox Foundation grants Alterity $US495K for Parkinson's disease research evaluation

• Strengthening profile at investment, scientific and clinical conferences

• Dr David Stamler appointed Chief Executive Officer

• Cash balance as at 31 March 2021 of A$32.8M

MELBOURNE, Australia, April 29, 2021 /PRNewswire/ -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company") releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 March 2021 (Q3 FY21).

The company's cash position was $32.8M with operational cash outflows of $5M, in line with company expectations and reflecting ongoing preparation for the Phase 2 clinical trial for Alterity's lead drug candidate ATH434 in Multiple System Atrophy (MSA) patients.

In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates are included at item 6.1 of the Appendix 4C incorporates directors' fees, consulting fees, remuneration and superannuation at commercial rates.

Operational Activities

During the quarter, Alterity continued to make important advances in its Phase 2 program.

Most of the company's efforts were focused on the bioMUSE Natural History study in MSA patients being conducted at Vanderbilt University Medical Center. This study will provide important information and insights to inform patient selection and design of the Phase 2 trial, which is scheduled to begin later this year.  The study has now recruited 80% of the original target population and the company is evaluating the feasibility to expand enrollment.

The Michael J. Fox Foundation awarded Alterity US$495,000 to evaluate the pharmacologic profile of ATH434 to determine the optimal dose of the drug in future Parkinson's disease clinical trials. It was the second grant the company has received from the Michael J. Fox Foundation for ATH434.

The profile of Alterity continues to strengthen with the company regularly invited to present at investor conferences and the leading clinical and scientific events around the world. In January and then again in March, Alterity CEO Dr David Stamler presented at life science and healthcare conferences hosted by HC Wainwright attended by institutional fund managers, HNW and other investors. Alterity also participated in the Biotech Showcase, a satellite event at the world's largest healthcare conference hosted by JP Morgan.

In February, the company presented at the 7th Annual International Congress of Multiple System Atrophy, the pre-eminent conference for scientists and clinicians focused on MSA. Alterity's presentation featured as part of the Congress' poster presentation and provided further data on ATH434. The new results included data on blood pressure following change in body position which demonstrated that ATH434 does not lower blood pressure when people move to the standing position. This is an important safety finding considering impaired maintenance of blood pressure is a key issue with MSA.

In January, Alterity announced the appointment of Dr David Stamler to the role of Chief Executive Officer.  Dr Stamler is based in San Francisco and joined the Company in June 2017 as Chief Medical Officer and Senior Vice President Clinical Development.  Mr. Geoffrey Kempler, who founded the company in November 1997, has stepped down from the role of CEO and continues as Non-Executive Chairman. 

Authorisation & Additional information

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

About Alterity Therapeutics Limited and ATH434

Alterity's lead candidate, ATH434, is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown to reduce abnormal accumulation of α-synuclein and tau proteins in animal models of disease by restoring normal iron balance in the brain. In this way, it has excellent potential to treat various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP). 

ATH434 has been granted Orphan designation for the treatment of MSA by the US FDA and the European Commission.

For further information please visit the Company's web site at www.alteritytherapeutics.com.

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.