Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity”
or “the Company”), a biotechnology company dedicated to developing
disease modifying treatments for neurodegenerative diseases,
released its Appendix 4C Quarterly Cash Flow Report and update on
company activities for the quarter ending 31st March 2023 (Q3
FY23).
“We continue to make excellent progress with our
ATH434 Phase 2 clinical trial in participants with early‐stage
Multiple System Atrophy, a rapidly progressing Parkinsonian
disorder with no approved treatment,” said David Stamler, M.D.,
Chief Executive Officer, Alterity. “The Phase 2 trial is gaining
momentum with active recruitment in five countries, including the
United States. We were pleased that an independent study was
published providing further evidence that ATH434 has potential to
be neuroprotective in humans.”
The Company’s cash position on 31 March 2023 was A$21.9M with
operating cash outflows of A$4M.
Operational Activities
ATH434 Phase 2 Clinical Trial
During the quarter, Alterity's Phase 2 clinical trial of ATH434
for the treatment of participants with Multiple System Atrophy
(MSA) opened several new clinical trial sites. The trial is now
actively recruiting participants in three regions: Europe,
Asia‐Pacific and the U.S. as the Company looks to bring a potential
new treatment option to individuals living with MSA.
In the US, the Phase 2 clinical trial of ATH434 opened for
enrollment and enrolled the first participant at Vanderbilt
University Medical Center in Nashville, Tennessee. Vanderbilt
University has been an important partner for the clinical
development of ATH434 and initiating the trial in the U.S. is
a major milestone for Alterity.
Alterity also expanded enrollment in Europe with the dosing of
the first participant in Italy. In addition, Alterity received
regulatory authority in France and Austria to proceed with the
Phase 2 trial.
Publication
In an independent study published in the journal
Neurotherapeutics during the quarter, it was reported that ATH434
prevented the onset of motor and non‐motor symptoms in animals with
genetically induced Parkinson’s disease. The study found that
ATH434 prevented the development of motor impairment in older
animals that was associated with a reduction in iron levels and
preservation of neurons in the substantia nigra, the brain region
affected in Parkinson’s. The authors also demonstrated that ATH434
prevented an early non‐motor symptom (loss of smell) in younger
mice and rescued it in older mice. These data support other studies
indicating that ATH434 has a beneficial effect on the motor and
non‐motor symptoms in animal models of PD. The publication provides
further evidence that ATH434 has the potential to address the
underlying pathology of Parkinson’s disease and related disorders
such as MSA.
Intellectual Property
and Business
Development
Alterity was granted a new composition of matter patent,
entitled “Compounds for and methods of treating diseases” (No.
11,603,364). The patent covers more than 100 novel compounds with
an acyl hydrazone (AH) structure and provides 20 years of
exclusivity. The new patent is a testament to the ongoing success
of Alterity’s discovery team as they continue to generate novel
small molecules with potential to treat important neurodegenerative
diseases.
Alterity also entered into a Licensing Agreement for the new
patent and a sub‐licensing agreement for PBT2 to Professor Colin
Masters, M.D., A.O., to advance the compounds for the treatment of
Alzheimer’s and related diseases. Professor Masters is a preeminent
researcher in the field of Alzheimer’s disease whose work has
provided the foundation for recently approved disease modifying
treatments for Alzheimer’s disease. Under the license agreement,
Alterity grants the entire rights to the AH patents as well as an
exclusive worldwide license to develop and commercialise both AH
and PBT2 in Alzheimer’s disease. In exchange, Alterity is entitled
to future royalties of net sales from the assets.
Corporate
On 9 January 2023, the company effected a ratio change of its
American Depository Shares (ADSs) to Ordinary Shares from the
previous ratio of 1 ADS representing 60 Ordinary Shares to 1 ADS
representing 600 Ordinary Shares and has regained compliance with
NASDAQ’s minimum bid price requirement.
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.
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 informationThis
announcement was authorised by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media
Contacts:
AustraliaHannah Howlett
we‐aualteritytherapeutics@we‐worldwide.com+61 4 5064 8064
U.S.Remy Bernarda
remy.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,
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 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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