Highlights:
- 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
MELBOURNE, Australia, Jan.
27, 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 31st December 2021 (Q2
FY22).
The Company's 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
Alterity continues 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
α-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.
In November, 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 α-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 dosing.
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.
Activity is also 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 January
2022.
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 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 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.
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.
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.
Appendix
4C
|
Quarterly cash
flow report for entities subject to Listing Rule
4.7B
|
|
Name of
entity
|
Alterity Therapeutics
Limited
|
|
ABN
|
Quarter ended
("current quarter")
|
37 080 699
065
|
31 December
21
|
|
Consolidated
statement of cash flows
|
Current
quarter
|
Year to date
(6
|
|
|
$A'000
|
months)
|
|
|
|
$A'000
|
1.
|
Cash flows from
operating activities
|
|
|
1.1
|
Receipts from
customers
|
-
|
-
|
1.2
|
Payments
for
|
|
|
|
(a) research and
development
|
(2,815)
|
(6,115)
|
|
(b) product
manufacturing and operating
|
-
|
-
|
costs
|
|
(c) advertising and
marketing
|
(110)
|
(191)
|
|
(d) leased
assets
|
-
|
-
|
|
(e) staff
costs
|
(873)
|
(1,676)
|
|
(f) administration and corporate
costs
|
(354)
|
(1,290)
|
1.3
|
Dividends received
(see note 3)
|
-
|
-
|
1.4
|
Interest
received
|
1
|
1
|
1.5
|
Interest and other
costs of finance paid
|
-
|
-
|
1.6
|
Income taxes
paid
|
-
|
-
|
1.7
|
Government grants and
tax incentives
|
103
|
329
|
1.8
|
Other (provide
details if material)
|
-
|
-
|
1.9
|
Net cash from /
(used in) operating activities
|
(4,048)
|
(8,942)
|
|
2.
|
Cash flows from
investing activities
|
|
|
2.1
|
Payments to acquire
or for:
|
|
|
|
(a)
entities
|
-
|
-
|
|
(b)
businesses
|
-
|
-
|
|
(c) property, plant
and equipment
|
-
|
-
|
|
(d)
investments
|
-
|
-
|
|
(e) intellectual
property
|
-
|
-
|
|
(f) other
non-current assets
|
-
|
-
|
|
|
|
|
|
Consolidated
statement of cash flows
|
Current
quarter
|
Year to date
(6
|
|
|
$A'000
|
months)
|
|
|
|
$A'000
|
2.2
|
Proceeds from
disposal of:
|
|
|
|
(a)
entities
|
-
|
-
|
|
(b)
businesses
|
-
|
-
|
|
(c) property, plant
and equipment
|
-
|
-
|
|
(d)
investments
|
-
|
-
|
|
(e) intellectual
property
|
-
|
-
|
|
(f) other
non-current assets
|
-
|
-
|
2.3
|
Cash flows from loans
to other entities
|
-
|
-
|
2.4
|
Dividends received
(see note 3)
|
-
|
-
|
2.5
|
Other (provide
details if material)
|
-
|
-
|
2.6
|
Net cash from /
(used in) investing
|
-
|
-
|
activities
|
|
|
3.
|
Cash flows from
financing activities
|
|
|
3.1
|
Proceeds from issues
of equity securities
|
|
|
(excluding
convertible debt securities)
|
-
|
17,176
|
3.2
|
Proceeds from issue
of convertible debt
|
-
|
-
|
securities
|
3.3
|
Proceeds from
exercise of options
|
-
|
-
|
3.4
|
Transaction costs
related to issues of
|
(23)
|
(587)
|
equity securities or
convertible debt
|
securities
|
3.5
|
Proceeds from
borrowings
|
-
|
-
|
3.6
|
Repayment of
borrowings
|
-
|
-
|
3.7
|
Transaction costs
related to loans and
|
-
|
-
|
borrowings
|
3.8
|
Dividends
paid
|
-
|
-
|
3.9
|
Other (provide
details if material)
|
-
|
-
|
3.1
|
Net cash from /
(used in) financing
|
(23)
|
16,589
|
activities
|
|
4.
|
Net increase /
(decrease) in cash and
|
|
|
cash equivalents
for the period
|
4.1
|
Cash and cash
equivalents at beginning of
|
|
|
period
|
41,335
|
28,116
|
4.2
|
Net cash from / (used
in) operating
|
(4,048)
|
(8,942)
|
activities (item 1.9
above)
|
4.3
|
Net cash from / (used
in) investing activities (item 2.6 above)
|
-
|
-
|
|
|
|
Consolidated
statement of cash flows
|
Current
quarter
|
Year to date
(6
|
|
|
$A'000
|
months)
|
|
|
|
$A'000
|
4.4
|
Net cash from / (used
in) financing activities
|
(23)
|
16,589
|
(item 3.10
above)
|
4.5
|
Effect of movement in
exchange rates on
|
(262)
|
1,239
|
cash held
|
4.6
|
Cash and cash
equivalents at end of
|
37,002
|
37,002
|
period
|
|
5.
|
Reconciliation of
cash and cash equivalents
|
Current
quarter
|
Previous
quarter
|
at the end of the
quarter (as shown in the
|
$A'000
|
$A'000
|
consolidated
statement of cash flows) to the
|
|
|
related items in the
accounts
|
|
|
5.1
|
Bank
balances
|
35,002
|
38,335
|
5.2
|
Call
deposits
|
2,000
|
3,000
|
5.3
|
Bank
overdrafts
|
-
|
-
|
5.4
|
Other (provide
details)
|
-
|
-
|
5.5
|
Cash and cash
equivalents at end of
|
37,002
|
41,335
|
quarter (should
equal item 4.6 above)
|
|
|
|
|
6.
|
Payments to
related parties of the entity and their
|
Current
quarter
|
associates
|
$A'000
|
6.1
|
Aggregate amount of
payments to related parties and their
|
166
|
associates included
in item 1
|
6.2
|
Aggregate amount of
payments to related parties and their
|
-
|
associates included
in item 2
|
Note: if any
amounts are shown in items 6.1 or 6.2, your quarterly activity
report must include a description of, and an
|
explanation for,
such payments.
|
|
The amount at 6.1
includes payment of director's fees and salaries and consulting
fees, excluding GST where applicable.
|
|
|
|
|
7.
|
Financing
facilities
|
Total
facility
|
Amount drawn
at
|
Note: the term
"facility' includes all forms of financing
|
amount at
quarter
|
quarter
end
|
arrangements
available to the entity.
|
end
|
$A'000
|
Add notes as
necessary for an understanding of the
|
$A'000
|
|
sources of finance
available to the entity.
|
|
|
7.1
|
Loan
facilities
|
-
|
-
|
7.2
|
Credit standby
arrangements
|
-
|
-
|
7.3
|
Other (please
specify)
|
-
|
-
|
7.4
|
Total financing
facilities
|
-
|
-
|
|
7.5
|
Unused financing
facilities available at quarter end
|
-
|
7.6
|
Include in the box
below a description of each facility above, including the lender,
interest
|
rate, maturity date
and whether it is secured or unsecured. If any additional
financing
|
facilities have been
entered into or are proposed to be entered into after quarter
end,
|
include a note
providing details of those facilities as well.
|
|
-
|
|
|
|
|
8.
|
Estimated cash
available for future operating activities
|
$A'000
|
8.1
|
Net cash from / (used
in) operating activities (item 1.9)
|
(4,048)
|
8.2
|
Cash and cash
equivalents at quarter end (item 4.6)
|
37,002
|
8.3
|
Unused finance
facilities available at quarter end (item 7.5)
|
-
|
8.4
|
Total available
funding (item 8.2 + item 8.3)
|
37,002
|
|
8.5
|
Estimated quarters
of funding available (item 8.4 divided by
item 8.1)
|
9.1
|
Note:
if the entity has reported positive net operating cash flows in
item 1.9, answer item 8.5 as "N/A". Otherwise, a
figure for the estimated quarters of funding available must be
included in item 8.5.
|
8.6
|
If item 8.5 is less
than 2 quarters, please provide answers to the following
questions:
|
|
8.6.1 Does the entity
expect that it will continue to have the current level of net
operating
cash flows for the time being and, if not, why not?
|
|
Answer:
N/A
|
8.6.2 Has the entity taken any steps, or does it propose to take
any steps, to raise further
cash to fund its operations and, if so, what are those steps and
how likely does it
believe that they will be successful?
|
|
Answer:
N/A
|
8.6.3 Does the entity expect to be able to continue its operations
and to meet its business
objectives and, if so, on what basis?
|
|
Answer:
N/A
|
Note: where item
8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and
8.6.3 above must be answered.
|
Compliance statement
- This statement has been prepared in accordance with accounting
standards and
policies which comply with Listing Rule 19.11A.
-
This statement gives a true and fair view of the matters disclosed.
Date:
27 January 2022
Authorised by: Phillip Hains
– Company Secretary
(Name of body or officer authorising release – see note 4)
Notes
- This quarterly cash flow report and the accompanying activity
report provide a basis for informing the market about
the entity's activities for the past quarter, how they have
been financed and the effect this has had on its cash position.
An entity that wishes to disclose additional information over
and above the minimum required under the Listing Rules
is encouraged to do so.
- If this quarterly cash flow report has been prepared in
accordance with Australian Accounting Standards, the
definitions in, and provisions of, AASB 107: Statement of
Cash Flows apply to this report. If this quarterly cash flow
report has been prepared in accordance with other accounting
standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
-
Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.
-
If this report has been authorised for release to the market by your board of directors, you can insert here: "By the board". If
it has been authorised for release to the market by a committee of
your board of directors, you can insert here: "By the [name
of board committee – eg Audit and Risk Committee]". If
it has been authorised for release to the market by
a disclosure committee, you can insert here: "By
the Disclosure Committee".
-
If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying
with recommendation 4.2 of the ASX Corporate Governance Council's
Corporate Governance Principles
and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records
of the entity have been properly maintained, that this report
complies with the appropriate accounting standards and gives a
true and fair view of the cash flows of the entity, and that their
opinion has been formed on the basis of
a sound system of risk management
and internal control which is
operating effectively.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/appendix-4c--q2-fy22-quarterly-cash-flow-report-301469401.html
SOURCE Alterity Therapeutics Limited