- Phase 2 clinical trial for ATH434 commences in New Zealand and patient enrolment begins
- Regulatory approval from the U.K. and Italian regulatory
agencies to proceed with the Phase 2 trial
- A$4.1 million R&D Tax
Incentive Scheme refund
- Cash balance on 30 June 2022 of
A$34.8M
MELBOURNE, Australia and SAN FRANCISCO, July 22,
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 30th June
2022 (Q4 FY22).
The Company's cash position at 30 June
2022 was $34.8M with gross
operating cash outflows of $4.4M,
which are aligned with Alterity's expectations as its progresses
and expands its Phase 2 clinical trial of lead drug candidate
ATH434 for the treatment of Multiple System Atrophy (MSA), a rare
Parkinsonian disorder with no approved therapy.
Strengthening its cash position during the quarter, Alterity
received a A$4.1 million refund from
the Australian Taxation Office under the Australian Government's
R&D Tax Incentive Scheme which will be used to further its
research and development activities.
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
In a milestone clinical achievement, Alterity commenced its
Phase 2 clinical trial for ATH434 during the quarter with the
dosing of the first patient at its first global site at
New Zealand's Brain Research
Institute (NZBRI).
The randomized, double-blind, placebo-controlled study will
enrol approximately 60 adult patients who will receive two dose
levels of ATH434 or the 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.
Initiation of the Phase 2 clinical trial is a significant
achievement for the Company and the industry as Alterity progresses
through its clinical pipeline aiming to bring the first known
therapy for MSA to market.
The Company also received regulatory approval from the Italian
Medicines Agency, or Agenzia Italiana del Farmaco (AIFA) to expand
recruitment and clinical sites into Italy. This follows receipt of approval from
the United Kingdom Medicines & Healthcare products Regulatory
Agency (MHRA). The company is working closely with clinical sites
in these countries to initiate patient recruitment.
Alterity also plans to further expand its Phase 2 trial
into other European countries, Australia, and the
United States and is exploring the addition of new drug
candidates that address neurodegenerative disorders to its growing
portfolio pipeline.
Corporate activity
Alterity continues to create awareness on the Company's work to
develop therapeutic solutions for neurodegenerative diseases.
Communication activities to investors, clinicians and patients
ramped up during the quarter with greater engagement of the media
to support awareness and recruitment of the Phase 2 clinical
trials.
As part of the Company's wider exposure strategy, Chief
Executive Officer David Stamler,
M.D., presented at three investor focused events. Dr. Stamler was
invited to participate in the Benchmark Company Healthcare House
Call Conference, having the opportunity to introduce Alterity to
Benchmark's clients in the US and beyond. He also presented at the
VirtualInvestorConferences.com Life Sciences Investor Forum and at
the Global Chinese Financial Forum (GCFF) Virtual Conference 2022 –
Investing in Healthcare Conference.
In further support for Alterity's profile with clinicians and
patient groups, a poster session was delivered on the Biomarkers of
progression in Multiple System Atrophy (bioMUSE) study at the
American Academy of Neurology (AAN) Annual Meeting in April.
Dr Stamler, CEO said: "We are delighted to see all the work we
put into the progress of our Phase 2 clinical study coming to
fruition with the start of recruitment in New Zealand. We are partnering with leading
research institutions, clinicians, and scientists from around the
globe to reach our goal of finding a treatment that can improve the
lives of patients with MSA, and potentially reversing the grim
outlook they face when receiving this diagnosis."
IP
In June, Alterity secured a patent (16/311,428) from the US
Patent and Trademark Office on the method of treating
immunoglobulin light chain amyloidosis, a rare blood disorder
caused by the overproduction of abnormal protein known as
amyloid.
About ATH434
Alterity's lead candidate, ATH434, is the first of a new
generation of small molecules 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.
In this way, 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 a
Phase 1 clinical trial demonstrating the agent is well tolerated,
orally bioavailable, and achieved brain levels comparable to
efficacious levels in animal models of MSA, with the objective of
restoring function in patients with MSA and other Parkinsonian
disorders. 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.
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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SOURCE Alterity Therapeutics