Full Press Release Details
Appendix 4C - Q2 FY22
| NZ's regulator Medsafe authorizes Phase 2 clinical trial for ATH434; more jurisdictions to follow | ||
| New poster presentation and publications provide further evidence of potential of ATH434 to treat neurodegenerative diseases | ||
| New US composition of matter patent secures exclusivity for a new class of compounds targeting Parkinson's and Alzheimer's diseases | ||
| Active investor relations program in Australia and US | ||
| Cash balance on 31 December 2021 of A$37M |
AUSTRALIA AND SAN FRANCISCO, USA - 27 January 2022. 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 31st December 2021
cash position on 31 December 2021 was $37M with operating cash outflows of $4M. This was consistent 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
to identify new drug candidates to expand its portfolio and protect its therapeutic approach to address neurodegeneration.
On 14th December, Alterity announced
that the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) had authorized Alterity's Phase 2 clinical trial for
ATH434 in MSA to be recruited in that country. This is the first jurisdiction to authorize the trial with further countries to follow
this year. Alterity expects to launch the trial in the first quarter of 2022.
The Phase 2 clinical trial is a randomized,
double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434
treatment on imaging and protein biomarkers such as aggregating -synuclein and excess iron, which are important contributors to
MSA pathology. Clinical endpoints and other biomarkers will permit comprehensive assessment of ATH434 efficacy along with characterization
of safety and pharmacokinetics. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy
endpoints to optimize design of a definitive Phase 3 study.
Alterity gave a poster presentation at the American Autonomic Society 32nd Annual International Symposium. The poster,
entitled, "Cardiovascular safety and pharmacokinetics of ATH434, a novel small molecule inhibitor of -synuclein
aggregation, in adults and older adults", described results from the Company's Phase 1 clinical trial conducted in
healthy volunteers. In the Phase 1 trial, ATH434 was well tolerated in adult and 65-year-old volunteers and demonstrated no
cardiac adverse event signal and no clinically significant changes in blood pressure or heart rate at any dose. ATH434 also
demonstrated dose dependent pharmacokinetics (PK) after single and multiple oral doses and a half-life that supports twice-daily
Alterity's profile continues to
bolster with the publication of two preclinical studies demonstrating the potential of ATH434 to treat Parkinsonian disorders. Non-motor
symptoms are common in patients with Parkinsonian disorders, such as Parkinson's disease and MSA. Parkinson's disease patients
experience gastrointestinal complications, cognitive deficits, autonomic dysfunction, and mood disturbance and these non-motor manifestations
are an important source of morbidity and reduced quality of life. As published in the Journal of Parkinson's Disease, "ATH434
Reverses Colorectal Dysfunction in the A53T Mouse Model of Parkinson's Disease" presents results from a preclinical study
investigating the effect of ATH434 on gastrointestinal complications. Alterity also announced the publication in Plos One of an
in vitro study concluding that the novel mechanism of action of ATH434 provides a compelling case for its continued development as a therapeutic
agent in neurodegenerative diseases associated with iron accumulation.
increasing within the investment community in Australia and the US with Alterity's Chief Executive Officer, David Stamler, MD, presenting
at the MST Financial Lifesciences & Biotech Forum and the Benchmark Company Discovery One-On-One Investor Conference in 2021. Dr.
Stamler also presented at the at the H.C. Wainwright BIOCONNECT Virtual Conference during the annual JP Morgan Healthcare Conference in
Post the reporting period, the Company
announced the United States Patent and Trademark Office granted a composition of matter patent that was issued a Notice of Allowance in
August 2021. The patent covers more than 80 novel compounds and secures exclusivity for a new class of iron chaperones designed to redistribute
the excess iron implicated in many neurodegenerative diseases, including Parkinson's and Alzheimer's diseases.
"This past quarter has been highly
active as we move toward the initiation of our Phase 2 clinical trial for MSA with our profile significantly bolstered within the investment,
patient, clinical and research communities," said Dr Stamler. "It's an exciting time for our company, but more importantly
for clinicians and patients who understand intimately the devastation of the diseases we are targeting and understand the urgent need
to develop new treatments that address the underlying pathology of these diseases."
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 -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
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 -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.
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 authorised by David
Stamler, CEO of Alterity Therapeutics Limited.
Contact: Investor Relations
| Australia | US |
| Rebecca Wilson | Remy Bernarda |
| E: WE-AUAlterity@we-worldwide.com | E: remy.bernarda@iradvisory.com |
| Tp: +61 417 382 391 | Tp: +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 suchstatements.
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