Appendix 4C - Q1 FY23 Quarterly Cash Flow Report

Rhea-AI Summary

Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announces the dosing of the first patient in its Phase 2 clinical trial for ATH434, aimed at treating Multiple System Atrophy (MSA). The trial has expanded to Europe, Australia, and has received FDA approval to commence in the U.S. As of September 30, 2022, the company reported a cash balance of A$31.9M and an operating cash outflow of A$4.8M, driven by clinical advancement. The randomized trial is set to enroll around 60 patients over 12 months to evaluate efficacy endpoints, enhancing prospects for a future Phase 3 study.

Positive

• First patient dosed in Phase 2 clinical trial for ATH434.
• Phase 2 trial expanding to Europe, Australia, and U.S. with FDA approval.
• Cash balance of A$31.9M indicates strong financial standing for ongoing trials.

Negative

• Operating cash outflow increased to A$4.8M, potentially raising concerns over financial sustainability.

• First patient dosed in Phase 2 clinical trial for ATH434 in New Zealand, trial opens in Europe and Australia
• Approval of Investigational New Drug application by FDA to bring the Phase 2 clinical trial to the United States
• Data from bioMUSE study provides a quantitative measurement of MSA progression
• Cash balance on 30 September 2022 of A$31.9M

MELBOURNE, Australia and SAN FRANCISCO , Oct. 28, 2022 /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 30^th September 2022 (Q1 FY23).

The Company's cash position on 30 September 2022 was $31.9M with operating cash outflows of $4.8M, an increase on previous quarters due to the commencement of Alterity's Phase 2 clinical trial for lead drug candidate ATH434 for the treatment of Multiple System Atrophy (MSA), a rare Parkinsonian disorder with no approved therapy.

Chief Executive Officer David Stamler, M.D., said: "We are excited by the tremendous progress we made to advance our Phase 2 clinical trial over the last several months. We achieved a major milestone by dosing our first patient and the trial is now running in multiple countries. MSA is a devastating disease that currently has no cure, and our team is dedicated to supporting our research partners around the world as they recruit, screen, and enrol patients into the study, pursuing our goal of validating our treatment."

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

Alterity achieved significant milestones during the first quarter of 2023.

The first patient was dosed in New Zealand in the Company's Phase 2 clinical trial assessing ATH434 as a potentially disease modifying treatment for individuals with early-stage MSA. In addition, the first site in Europe was opened for enrolment in the United Kingdom. Subsequent to the closing of the quarter, Alterity also announced the opening of enrolment for the trial in Australia. Management continues to prioritise the expansion of the Phase 2 clinical trial into these and other countries.

In September 2022, the Company received approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to allow the evaluation of ATH434 in individuals with MSA in the United States. This follows receipt of approval from the Italian Medicines Agency, or Agenzia Italiana del Farmaco (AIFA) to expand recruitment and clinical sites into Italy.

The randomized, double-blind, placebo-controlled study will enrol approximately 60 adult patients who will receive two dose levels of ATH434 or placebo over a period of 12 months. Results will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.

Multiple data presentations were given in September and October from Alterity's bioMUSE Natural History Study that continue to inform the Phase 2 trial. At the International Congress of Parkinson's Disease and Movement Disorders, the poster, entitled "Wearable Sensors for Quantitative Motor Assessments in Multiple System Atrophy", correlated data from wearable sensors with clinical assessments of motor function. The study determined that wearable sensors provide a quantitative assessment of MSA progression that is not captured by neurological examination. At the American Neurological Association Annual Meeting, the poster, entitled "Deep Learning Segmentation Improves Precision of Volume Assessment of Subcortical Structures in early MSA," identified a method for measuring brain volume in MSA patients with improved precision, a finding that will increase the chance of demonstrating efficacy on biomarkers in Phase 2. 

Corporate activity

Alterity continues to raise awareness on its work in neurodegenerative diseases through media and investor engagement opportunities. Dr David Stamler presented at Switzer's Small & Micro Cap Virtual Conference and Alterity was featured in the Stockhead Investor Guide: Health & Biotech FY2023.

The Company also continues to support the MSA community and partnered with The Multiple System Atrophy Coalition to support the 2022 Patient & Family Conference in September.

In this quarter, Alterity received an extension of 180 calendar days until February 23, 2023 to regain compliance with Nasdaq's minimum bid price requirement. As previously reported, in February 2022 the Company received a deficiency letter from the Listing Qualifications Department of Nasdaq notifying that the bid price for the Company's American Depositary Shares ("ADSs") had closed below the minimum $US1.00 per share requirement for continued inclusion on the Nasdaq Global Market. Alterity continues to work towards regaining compliance with Nasdaq.

About ATH434

Alterity's lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA). ATH434 has 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 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European Commission. ATH434 is currently in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of ATH434 in patients with early-stage MSA.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by a combination of symptoms that affect both the autonomic nervous system and movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by motor impairment, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within the support cells of the central nervous system and neuron loss in multiple brain regions. MSA affects approximately 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.¹ 

¹ National Institute of Health: Neurological Disorders and Stroke, Multiple System Atrophy Fact Sheet

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 authorized by David Stamler, CEO of Alterity Therapeutics Limited.

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SOURCE Alterity Therapeutics

FAQ

What is the latest update on Alterity Therapeutics' clinical trial for ATH434?

Alterity Therapeutics has initiated its Phase 2 clinical trial for ATH434, with the first patient dosed in New Zealand and trials subsequently expanding to Europe, Australia, and the U.S.

How much cash does Alterity Therapeutics have as of September 30, 2022?

As of September 30, 2022, Alterity Therapeutics reported a cash balance of A$31.9 million.

What are the objectives of the Phase 2 clinical trial for ATH434?

The Phase 2 trial aims to assess the efficacy of ATH434 in treating Multiple System Atrophy, with about 60 patients enrolled over a 12-month period.

What were the operating cash outflows for Alterity Therapeutics in Q1 FY23?

Alterity Therapeutics reported operating cash outflows of A$4.8 million in Q1 FY23.

What is the significance of the FDA's approval for Alterity's IND application?

The FDA's approval allows Alterity to conduct its Phase 2 clinical trial for ATH434 in the United States, marking a crucial step in the drug's development.