Appendix 4C - Q2 FY23 Quarterly Cash Flow Report

Highlights:

• Expanded participation in ATH434 Phase 2 clinical trial with sites opened for recruitment in Australia, the United States, and Italy
• Presented compelling bioMUSE data at two prestigious industry conferences
• Granted a 20-year patent for 100 new compounds targeting Parkinson's and Alzheimer's disease
• Cash balance on 31 December 2022 of A$25.3M

MELBOURNE, Australia and SAN FRANCISCO, Jan. 31, 2023 /PRNewswire/ -- Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31^st December 2022 (Q2 FY23).

In this quarter, Alterity continued to focus its efforts on running and expanding the Phase 2 clinical trial (the "Trial" or "Study") for its lead drug candidate ATH434 in Multiple System Atrophy (MSA), now enrolling patients across the globe. The Company's cash position on 31 December 2022 was A$25.3M with operating cash outflows of A$5.2M.

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.

David Stamler, M.D., Chief Executive Officer, Alterity, commented, "We are excited about the progress of our Phase 2 clinical trial which is now actively recruiting participants with early-stage MSA in three regions globally. We remain committed to bringing our potential disease modifying therapy to individuals living with this devastating condition. During the quarter, we also presented key bioMUSE data, grew our intellectual property portfolio, and published preclinical data giving us the opportunity to expand our pipeline into other neurodegenerative diseases."

Operational Activities

ATH434 Phase 2 Clinical Trial

During the second quarter of FY23, Alterity launched in its Phase 2 clinical trial of ATH434 in Sydney, Australia after successfully securing ethics approval from the Human Research Ethics Committee (HREC) at St. Vincent's Hospital, Melbourne.

After the quarter closed, in January 2023, the Company also announced further expansion of the trial with sites now open form enrollment in the United States and Italy. With these additions, the Company is now actively enrolling patients for the Study in three regions (Europe, Asia-Pacific, and North America), and five countries (New Zealand, Australia, United Kingdom, U.S., and Italy). Alterity's clinical team is providing ongoing support to the investigators at each site working toward the goal of recruiting 60 patients globally.

bioMUSE (Biomarkers of progression in Multiple System Atrophy)

The bioMUSE Natural History study continues to deliver valuable data to de-risk Alterity's Phase 2 trial by providing insight into the diagnosis and biomarkers of MSA to characterize disease progression.

In October, and in conjunction with collaborators at Vanderbilt University Medical Center, the Company gave a poster presentation at the 147th Annual Meeting of the American Neurological Association (ANA) on different methods of measuring the volume of brain structures affected in individuals with MSA, Parkinson's disease, and healthy controls. The poster, Deep Learning Segmentation Improves Precision of Volume Assessment of Subcortical Structures in early MSA, found meaningful differences in the accuracy of three different techniques for measuring the volume of subcortical brain structures on MRI scans of patients with MSA and Parkinson's disease.  The Deep Learning method provides the basis for measuring brain iron with high precision in the Phase 2 study.  

In November, Alterity also presented data from bioMUSE at the American Autonomic Society (AAS) 2022 Annual Conference. This poster, entitled Urinary Symptom Profile in Early Multiple System Atrophy, evaluated early stage MSA patients urinary symptoms with the Urinary Symptom Profile (USP). The study results indicate that the USP can be used for comprehensive evaluation of urinary complaints, a symptom which can have a profound negative impact on quality of life, in a group of patients similar to those being studied in the Phase 2 trial.

Publication

In October 2022, a preclinical investigation of ATH434 was published in the journal Neurotherapeutics and demonstrated efficacy in an animal model of Parkinson's disease. The publication, entitled, "ATH434 Rescues Pre–motor Hyposmia in a Mouse Model of Parkinsonism" assessed the impact of ATH434 on motor and non-motor manifestations in experimentally induced Parkinson's disease. The investigation showed that treatment with ATH434 prevented the development of motor impairment, which was associated with a reduction in iron levels and preservation of nerve cells in the brain region affected in Parkinson's. This study adds to the weight of evidence regarding ATH434 as a potential disease modifying therapy for Parkinsonian disorders.

Intellectual Property

Strengthening its IP portfolio, Alterity secured a new composition of matter patent from the United States Patent and Trademark Office (USPTO) in December. The patent, entitled, "Compounds for and methods of treating diseases", is based on a new scaffold that includes more than 100 novel compounds, at least one of which has demonstrated efficacy in an animal model of dementia.

The new patent covers iron chaperones, small molecules capable of binding and redistributing excess iron in the central nervous system, implicated in the pathology of many important neurodegenerative diseases, including Alzheimer's and Parkinson's diseases. Alterity will have 20 years of exclusivity for these compounds, expanding the company's intellectual property estate for treating major neurodegenerative diseases.

Corporate

Subsequent to the end of the quarter on 24 January 2023, Alterity received formal notification from The Nasdaq Stock Market LLC confirming that the Company had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule"), which requires that the Company's American Depositary Shares ("ADS") maintain a minimum bid price of at least US$1.00 per ADS, and that the matter is now closed.

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 Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds 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.

Authorization & Additional information

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

SOURCE Alterity Therapeutics Limited