Anavex Life Sciences Reports Fiscal 2020 Year End Financial Results And Clinical Program Updates
December 28 2020 - 7:00AM
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative
and neurodevelopmental disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported financial results for its fiscal
year ended September 30, 2020.
Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex said: “Despite all of the new
challenges, 2020 was an extraordinary year for Anavex, with
significant progress across our portfolio, including our first
positive, placebo-controlled, U.S. ANAVEX®2-73 (blarcamesine) Rett
syndrome trial, a positive Parkinson’s disease dementia trial, and
further progress in Alzheimer’s disease. I want to thank the
patients, doctors, and the Anavex team who made all of this
progress possible. We look forward to building on this momentum
with key milestones expected from multiple programs, including data
on the ongoing late-stage Rett syndrome trials AVATAR and
EXCELLENCE, expanding the clinical biomarker-driven ANAVEX®2-73
rare disease program into additional late-stage studies with high
unmet medical need, completing the late stage ANAVEX®2-73 Phase
2b/3 Alzheimer’s disease trial, and advancing ANAVEX®2-73 into
clinical disease modifying testing in Parkinson’s disease.”
Key Clinical Updates:
- Plan to advance
the AVATAR adult Rett syndrome study into a pivotal Phase 2/3
clinical trial.
- Pipeline
expansion for ANAVEX®2-73 using gene biomarkers of response,
applying precision medicine for neurological disorders with unmet
medical need:
- Planned initiation of a pivotal
Phase 2/3 study in Fragile X Syndrome, the most frequent genetic
cause of autism spectrum disorder.
- Planned
initiation of a Phase 2/3 clinical trial for the treatment of a
new, rare-disease indication.
- Phase 2b/3
ANAVEX®2-73 Alzheimer’s disease (AD) study currently over 80%
enrolled with complete enrollment expected in early 2021.
- Planned
initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease
clinical study.
Recent Business Highlights:
- In December
2020, Anavex announced top-line results from a U.S. Phase 2
controlled trial of ANAVEX®2-73 in adult female patients with Rett
syndrome. Primary safety, pharmacokinetics and secondary efficacy
endpoints were met, with statistically significant and clinically
meaningful consistent improvements in Rett Syndrome Behaviour
Questionnaire (RSBQ) and Clinical Global Impression Improvement
(CGI-I) scores. Improvements in RSBQ Total scores were correlated
with decreases (improvements) in plasma glutamate. Based on the
results, Anavex is planning to meet with the FDA to discuss an
accelerated approval pathway.
- In November
2020, Anavex presented data at the 13th Clinical Trials on
Alzheimer’s Disease (CTAD) 2020 Conference, reporting top-line
results from the proof-of-concept Phase 2 placebo-controlled trial
with primary objectives of safety, tolerability, and efficacy in
cognition of ANAVEX®2-73 in patients in Parkinson’s disease
dementia (PDD) compared to placebo. Both primary objectives of the
study were met. The results show clinically meaningful,
dose-dependent, and statistically significant improvements in the
Cognitive Drug Research (CDR) computerized assessment system
analysis. The study confirmed the precision medicine approach of
targeting SIGMAR1 as a genetic biomarker in response to ANAVEX®2-73
supporting progression to further development in upcoming Phase 2/3
studies.
- In November
2020, Anavex received a Notice of Allowance from the United States
Patent and Trademark Office (USPTO) for its patent application
number 16/717,921 expected to remain in force at least until 2037,
expanding coverage of treatment methods using its lead drug
candidate, ANAVEX®2-73, as well as drug candidate ANAVEX®1-41 for
treating a range neurodevelopmental disorders including Rett
syndrome, autism spectrum disorder, Angelman syndrome, cerebral
palsy and multiple sclerosis, among other indications.
Financial Highlights:
- Cash and cash
equivalents of $47.6 million as of today and $29.2 million at
September 30, 2020, compared to $22.2 million at September 30,
2019.
- Net loss of
$26.3 million, or $0.45 per share for the year, compared to net
loss of $26.3 million, or $0.54 per share in fiscal 2019.
- Research and
development expenses of $25.2 million for the year, compared to
$22.3 million for fiscal 2019.
- General and
administrative expenses of $5.9 million for the year, compared to
$6.8 million for fiscal 2019.
The financial information for the fiscal year
ended September 30, 2020 should be read in conjunction with the
Company’s consolidated financial statements, which will appear on
EDGAR, www.sec.gov and will be available on the Anavex website at
www.anavex.com.
Conference Call / Webcast Information
The live webcast of the conference call can be accessed online
at https://wsw.com/webcast/cc/avxl16/1496358.
To join the conference call, live via telephone,
interested parties within the U.S. should dial, toll-free, 1 (866)
939-3921 and international callers should dial 1 (678) 302-3550.
Please use confirmation number 50061077, followed by the pound sign
(#).
A replay of the conference call will also be
available on www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental disorders including
Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other
central nervous system (CNS) diseases, pain and various types of
cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
recently completed successfully a Phase 2a clinical trials for
Alzheimer’s disease and a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 study in adult patients
with Rett syndrome. ANAVEX®2-73 is an orally available drug
candidate that restores cellular homeostasis by targeting sigma-1
and muscarinic receptors. Preclinical studies demonstrated its
potential to halt and/or reverse the course of Alzheimer’s disease.
ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic,
neuroprotective and anti-depressant properties in animal models,
indicating its potential to treat additional CNS disorders,
including epilepsy. The Michael J. Fox Foundation for Parkinson’s
Research previously awarded Anavex a research grant, which fully
funded a preclinical study to develop ANAVEX®2-73 for the treatment
of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and
muscarinic receptors, is a promising clinical stage drug candidate
demonstrating disease-modifying activity against the major
hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice,
including cognitive deficits, amyloid and tau pathologies. In
preclinical trials, ANAVEX®3-71 has shown beneficial effects on
mitochondrial dysfunction and neuroinflammation. Further
information is available at www.anavex.com. You can also connect
with the company on Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
|
|
|
ANAVEX LIFE
SCIENCES CORP. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
For the years ended
September 30, 2020 and 2019 |
|
Expressed in
US Dollars |
|
|
|
|
2020 |
|
|
2019 |
|
Operating Expenses |
|
|
General and
administrative |
$ |
5,856,609 |
|
$ |
6,846,599 |
|
Research and
development |
|
25,231,623 |
|
|
22,260,349 |
|
Total operating expenses |
|
(31,088,232 |
) |
|
(29,106,948 |
) |
|
|
|
Other income (expenses) |
|
|
Grant
income |
|
149,888 |
|
|
298,943 |
|
Research and
development incentive income |
|
4,375,025 |
|
|
2,465,691 |
|
Interest
income, net |
|
179,973 |
|
|
207,280 |
|
Gain on
settlement of accounts payable |
|
- |
|
|
115,758 |
|
Financing
related charges |
|
- |
|
|
(151,133 |
) |
Foreign
exchange gain (loss), net |
|
125,540 |
|
|
(42,389 |
) |
Total other income, net |
|
4,830,426 |
|
|
2,894,150 |
|
Net loss
before provision for income taxes |
|
(26,257,806 |
) |
|
(26,212,798 |
) |
Income tax
expense, current |
|
(22,664 |
) |
|
(82,181 |
) |
Net
loss and comprehensive loss |
$ |
(26,280,470 |
) |
$ |
(26,294,979 |
) |
|
|
|
Net loss per
share |
|
|
Basic and diluted |
$ |
(0.45 |
) |
$ |
(0.54 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
58,194,894 |
|
|
48,906,470 |
|
ANAVEX LIFE
SCIENCES CORP. |
CONSOLIDATED BALANCE
SHEETS |
As at September 30,
2020 and 2019 |
Expressed in
US Dollars |
|
|
|
|
2020 |
|
|
2019 |
|
ASSETS |
|
|
Current |
|
|
Cash and
cash equivalents |
$ |
29,249,018 |
|
$ |
22,185,630 |
|
Incentive
and tax receivables |
|
4,849,340 |
|
|
2,642,745 |
|
Prepaid
expenses and deposits |
|
443,839 |
|
|
500,998 |
|
Total Assets |
$ |
34,542,197 |
|
$ |
25,329,373 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities |
|
|
Accounts
payable |
$ |
3,989,054 |
|
$ |
3,523,332 |
|
Accrued
liabilities |
|
3,316,574 |
|
|
1,516,342 |
|
Total Liabilities |
|
7,305,628 |
|
|
5,039,674 |
|
Capital
Stock |
|
62,047 |
|
|
52,652 |
|
Additional
paid-in capital |
|
186,851,752 |
|
|
153,633,807 |
|
Accumulated
deficit |
|
(159,677,230 |
) |
|
(133,396,760 |
) |
Total Stockholders' Equity |
|
27,236,569 |
|
|
20,289,699 |
|
Total Liabilities and Stockholders' Equity |
$ |
34,542,197 |
|
$ |
25,329,373 |
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Clint
TomlinsonEmail: ir@anavex.com
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Sep 2023 to Sep 2024