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 June 2023 (Q4 FY23).
“The last several months have been extremely
productive for Alterity as we hit several milestones and made
significant progress advancing ATH434,” said David Stamler, M.D.,
Chief Executive Officer, Alterity. “With the clearance by the Data
Monitoring Committee to continue the ATH434-201 trial as planned
and the enthusiasm for the trial from physicians around the world,
the trial remains on track to complete enrollment in the third
quarter of 2023 with top-line data expected by the end of
2024.”
Dr. Stamler, continued, “We also initiated a
second Phase 2 study, ATH434-202, in participants with more
advanced MSA. Importantly, this Biomarker study gives us the
opportunity to get an early indication of efficacy before the
ATH434-201 Phase 2 study reads out. Individuals with more advanced
MSA may also benefit from ATH434 and measuring key biomarkers will
permit us to evaluate drug activity in this population. The data
derived from the Biomarker study have the potential to accelerate
the overall development program.”
“An important element of our ATH434-201 trial is
the use of wearable sensors to determine the impact of ATH434 on
motor impairment and gait stability. During the quarter, data from
the bioMUSE natural history study reinforced this measure by
showing that wearable sensors can be used to assess disease
progression that may not be captured by neurological examination,”
concluded Dr. Stamler.
The Company’s cash position on 30 June 2023 was
A$15.8M with operating cash outflows for the quarter of
A$6.2M. The company anticipates the cash position will
be boosted in the coming weeks with the receipt of the A$4.7M
R&D Tax incentive for the 2022 fiscal year.
Operational Activities
ATH434-201 Phase 2 Clinical Trial
Subsequent to the quarter, on 26 July, Alterity
announced that the independent Data Monitoring Committee (DMC) for
the ATH434-201 Phase 2 study recommended the trial continue as
planned. The DMC conducted a prespecified review of unblinded
clinical data from an initial cohort of study participants. The DMC
expressed no concerns about safety and recommended that the study
continue without modification.
This randomized, double blind, placebo
controlled clinical trial continues to progress with participants
in both Australia and the United Kingdom now being treated. The
trial is enrolling participants with early stage MSA at over 15
sites in three regions – Australia/New Zealand, the United States,
and Europe. The trial is being well received by physicians across
the board with feedback positive as they implement Alterity’s state
of the art methods to diagnose and track the disease.
ATH434-202 Phase 2 Clinical Trial
Alterity initiated enrollment in a second Phase
2 trial of ATH434 during the quarter in participants with MSA. This
open label, single arm study, entitled “A Biomarker Study of ATH434
in participants with MSA” (ATH434-202), allows Alterity to evaluate
the effect of ATH434 on a MSA population more advanced than that
being investigated in the randomized study. The design of the
Biomarker study will allow the Company to perform interim analyses
of biomarker data during conduct, with potential to provide early
indications of efficacy before the randomized study reads out.
The key aim of the study is to assess the
efficacy of ATH434 on objective biomarkers that measure target
engagement and are relevant to the underlying pathology of disease.
Clinical measures important in MSA will also be assessed.
Promising wearable sensor data from the bioMUSE
Natural History Study
During the quarter, analysis from the Biomarkers
of Progression in Multiple System Atrophy (bioMUSE) natural history
study demonstrated that wearable sensors can quantify motor
impairment in individuals with MSA that is not captured by
neurological examination. This means that wearable sensors can be
used to assess disease progression and inform clinical trials.
These data were presented at the American Academy of Neurology
Annual Meeting. As a result of the study, Alterity has incorporated
wearable sensor data into its Phase 2 clinical trial for ATH434 as
one of its secondary endpoints to determine the effect of treatment
on gait parameters.
The ongoing bioMUSE study will continue to
provide vital information on early stage MSA, inform the selection
of biomarkers suitable to evaluate target engagement and
preliminary efficacy, and deliver clinical data to characterize
disease progression in a population that mirrors those being
studied in Alterity’s ATH434-201 trial.
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.
Authorisation & Additional informationThis
announcement was authorised by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
AustraliaHannah
Howlettwe-aualteritytherapeutics@we-worldwide.com+61 4 5064
8064
U.S.Remy Bernardaremy.bernarda@iradvisory.com
+1 (415) 203-6386
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,
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 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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