Highlights:
- Positive Guidance from European Medicines Agency for ATH434
Phase 2 Clinical Trial
- Publication in Movement Disorders demonstrates that
ATH434 reduces α–synuclein related neurodegeneration in MSA animal
model
- Presents to MST Access Australian Micro & Small Caps
Conference
- Cash balance at 30 June 2021 of
A$28M
MELBOURNE, Australia,
July 30, 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
June 2021 (Q4 FY21).
The Company's cash position at 30 June
2021 of $28M was bolstered by
the receipt of $17M in net proceeds
from the use of the company's previously approved "At the Market"
facility with shares 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), a Parkinsonian disorder with no
approved therapy.
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
Despite the prevailing impact of COVID-19 around the world,
Alterity has continued to progress preparations for its Phase 2
Clinical Trial of ATH434 in MSA.
Significantly, Alterity announced in late June that it had
received guidance from the European Medicines Agency (EMA)
regarding key aspects of the Company's Phase 2 clinical trial for
investigational drug ATH434 in the treatment of MSA. The EMA is the
agency of the European Union responsible for the evaluation and
supervision of medicinal products.
Given there is no approved treatment for MSA, the validation of
the EMA providing their support to Alterity's intention to enroll
early-stage MSA patients enhances the study's viability and
design.
The EMA has also supported Alterity's intention to utilize
biomarkers to enhance the diagnosis of these patients prior to
enrolment. Improving diagnostic accuracy and targeting early-stage
patients will enable Alterity to maximize the opportunity to
demonstrate the disease modifying potential of ATH434.
In addition to preparation for the treatment study, which is on
track to commence by end of this calendar year, the Company has
made significant progress on its Natural History study in MSA being
conducted at Vanderbilt University
Medical Center. The study, referred to as BioMUSE, has met
its original enrollment goal and is in the process of being
expanded to additional sites. Preliminary data has been highly
informative regarding methods for biomarker assessment and patient
characterization, all of which is expected to de-risk the Phase 2
study.
An independently conducted study was published demonstrating
that ATH434 was neuroprotective in a widely accepted animal model
of MSA, providing further support for Alterity's development
strategy and validating the biologic target of ATH434. The
publication in Movement Disorders, the official journal of
the International Parkinson and Movement Disorder Society,
demonstrated that ATH434 preserves neurons while reducing
α–synuclein related pathology.
Outside of clinical development activities, Alterity's Chief
Executive Officer, Dr David Stamler,
presented a company overview at the MST Access Australian Micro
& Small Caps Conference. The conference provided investors
access to leaders across a broad range of ASX-listed micro and
small-cap companies.
Commenting on the Quarter, Dr Stamler said: "The EMA support for
our clinical development strategy in conjunction with the
invaluable learnings from the Natural History study gives me great
confidence that we are taking the right approach to finding a new
treatment for MSA. Combined with the exciting new animal data
demonstrating neuroprotection, we are eager to start our Phase 2
study by the end of this calendar year."
END
Authorisation & Additional information
This announcement was authorised by David Stamler, CEO of Alterity Therapeutics
Limited.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare, neurodegenerative
disease with no approved therapy. It is rapidly
progressive and causes profound disability. MSA is a Parkinsonian
disorder characterized by motor impairment typical of Parkinson's
disease; autonomic instability that affects involuntary functions
such as blood pressure maintenance and bladder control; and
impaired balance and/or coordination that predisposes to falls. MSA
affects approximately 15,000 patients in the U.S. A pathological
hallmark of MSA is the accumulation of α-synuclein within
oligodendroglia cells (glial cytoplasmic inclusions) and neuron
loss in multiple brain regions.
About ATH434
ATH434 is the first of a new generation of small molecule drug
candidates designed to inhibit the accumulation and aggregation of
pathological proteins implicated in neurodegeneration.
Alpha-synuclein is a neuronal protein that aggregates in neurons
and is considered an important biologic target for treating these
neurodegenerative diseases. ATH434 has been shown to reduce
abnormal accumulation of α–synuclein protein in animal models of
disease by restoring normal iron balance in the brain. As a result,
it has the potential to treat various disorders including Multiple
System Atrophy (MSA), Parkinson's Disease, and Dementia with Lewy
Bodies (DLB). ATH434 has been granted Orphan designation for the
treatment of MSA by the U.S. Food and Drug Administration and the
European Union.
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.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/appendix-4c--q4-fy21-quarterly-cash-flow-report-301345142.html
SOURCE Alterity Therapeutics Limited