Highlights:
- Michael J. Fox Foundation grants Alterity $US495K for Parkinson's disease research
evaluation
- Strengthening profile at investment, scientific and clinical
conferences
- Dr David Stamler appointed Chief
Executive Officer
- Cash balance as at 31 March 2021
of A$32.8M
MELBOURNE, Australia,
April 29, 2021 /PRNewswire/ --
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity"
or "the Company") releases its Appendix 4C Quarterly Cash Flow
Report and update on company activities for the quarter ending
31 March 2021 (Q3 FY21).
The company's cash position was $32.8M with operational cash outflows of
$5M, in line with company
expectations and reflecting ongoing preparation for the Phase 2
clinical trial for Alterity's lead drug candidate ATH434 in
Multiple System Atrophy (MSA) patients.
In accordance with ASX Listing Rule 4.7C, payments made to
related parties and their associates are included at item 6.1 of
the Appendix 4C incorporates directors' fees, consulting fees,
remuneration and superannuation at commercial rates.
Operational Activities
During the quarter, Alterity continued to make important
advances in its Phase 2 program.
Most of the company's efforts were focused on the bioMUSE
Natural History study in MSA patients being conducted at
Vanderbilt University Medical Center.
This study will provide important information and insights to
inform patient selection and design of the Phase 2 trial, which is
scheduled to begin later this year. The study has now
recruited 80% of the original target population and the company is
evaluating the feasibility to expand enrollment.
The Michael J. Fox Foundation awarded Alterity US$495,000 to evaluate the pharmacologic profile
of ATH434 to determine the optimal dose of the drug in future
Parkinson's disease clinical trials. It was the second grant the
company has received from the Michael J. Fox Foundation for
ATH434.
The profile of Alterity continues to strengthen with the company
regularly invited to present at investor conferences and the
leading clinical and scientific events around the world. In January
and then again in March, Alterity CEO Dr David Stamler presented at life science and
healthcare conferences hosted by HC Wainwright attended by
institutional fund managers, HNW and other investors. Alterity also
participated in the Biotech Showcase, a satellite event at the
world's largest healthcare conference hosted by JP Morgan.
In February, the company presented at the 7th Annual
International Congress of Multiple System Atrophy, the pre-eminent
conference for scientists and clinicians focused on MSA. Alterity's
presentation featured as part of the Congress' poster presentation
and provided further data on ATH434. The new results included data
on blood pressure following change in body position which
demonstrated that ATH434 does not lower blood pressure when people
move to the standing position. This is an important safety finding
considering impaired maintenance of blood pressure is a key issue
with MSA.
In January, Alterity announced the appointment of Dr
David Stamler to the role of Chief
Executive Officer. Dr Stamler is based in San Francisco and joined the Company in
June 2017 as Chief Medical Officer
and Senior Vice President Clinical Development. Mr.
Geoffrey Kempler, who founded the
company in November 1997, has stepped
down from the role of CEO and continues as Non-Executive
Chairman.
Authorisation & Additional information
This announcement was authorised by David Stamler, CEO of Alterity Therapeutics
Limited.
About Alterity Therapeutics Limited and 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 to reduce abnormal accumulation of α-synuclein and
tau proteins in animal models of disease by restoring normal iron
balance in the brain. In this way, it has excellent potential to
treat various forms of atypical Parkinsonism such as Multiple
System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
ATH434 has been granted Orphan designation for the treatment of MSA
by the US FDA and the European Commission.
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.
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SOURCE Alterity Therapeutics Limited