Highlights:

• New details on ATH34 Phase 2 clinical trial released.
• Data from bioMUSE presented at International Parkinson and Movement Disorder Society Congress.
• Expanded intellectual property portfolio positions future opportunities.
• Cash balance as of 30 September 2021 of A$41.3M.
• Quarterly operating cash outflow of $4.9M as expected and in-line with clinical trial activity.

MELBOURNE, Australia, Oct. 29, 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 September 2021 (Q1 FY22).

The Company's cash position as of 30 September 2021 of $41.3M includes A$17.2M proceeds from the issue of shares via the approved ATM ("At the Market") facility in July 2021 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) and the bioMUSE (Biomarkers of Progression in Multiple Systems Atrophy) natural history.

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

During the quarter, the company progressed the Phase 2 development program for ATH434.  In September, data from the bioMUSE natural history study was presented at the International Parkinson and Movement Disorder Society Congress reporting that advanced MRI methods employed in the study, referred to as quantitative susceptibility mapping (QSM), demonstrated pathological iron accumulation in multiple areas of the brain in patients with early MSA. The study investigators, led by Dr. Daniel Claassen, Associate Professor of Neurology at Vanderbilt University Medical center, concluded that advanced MRI methods for measuring iron may improve patient selection in clinical trials of disease modifying therapy and has potential to serve as a biomarker for assessing treatment induced changes. 

Most recently, and after the reporting period, Alterity announced that bioMUSE has reached its original enrollment goal and will be expanded to a total of 20 patients with MSA. The study has proved to be invaluable in generating data to inform and de-risk the Phase 2 trial design, and it will continue to provide longitudinal biomarker and clinical data to characterize disease progression in a patient population that mirrors those to be enrolled in the Phase 2 study.

Alterity also announced the expansion of the clinical development program for ATH434. The planned Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers such as aggregating α-synuclein and excess iron, which are important contributors to MSA pathology. Several other biomarkers and clinical endpoints will permit comprehensive assessment of ATH434 efficacy along with characterization of its safety and pharmacokinetics.  Based on consultation with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and clinical experts in MSA, Alterity has established that patients will receive treatment for 12 months. The longer treatment duration will provide an improved opportunity to detect changes in biomarkers and clinical endpoints to optimize design of a definitive Phase 3 study.

During the period, significant progress was made on two important new patents that places Alterity in a commanding position with respect to its iron chaperone technology. These novel molecules are designed to redistribute the excess iron implicated in many neurodegenerative diseases.  In July, we announced that the United States Patent and Trademark Office (USPTO) granted US patent No. 10/941,143 relating to claims on a group of 150 novel compounds that act as iron chaperones. This was followed, in August, by a second composition of matter patent (No. 17/239,375) which was allowed by the USPTO securing exclusivity for a new group of iron chaperones and covers more than 80 novel compounds.

END

Authorisation & Additional information

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

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--q1-fy22-quarterly-cash-flow-report-301411733.html (www.prnewswire.com)