Full Press Release Details
FY23 Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN
FRANCISCO, USA - 28 October 2022. 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 30th September 2022 (Q1
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.
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 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.
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 -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
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 -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
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.
Investor & Media Contacts:
Remy Bernarda remy.bernarda@iradvisory.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 obtaining patent protection for the
Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company's patent rights and
the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press release is