Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Year End Financial Results
November 24 2021 - 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, 2021.
"Anavex concluded an exceptional fiscal year
2021 while continuing its momentum, highlighted by the efficient
execution and full enrollment of three Precision Medicine clinical
trials, including the Phase 2b/3 ANAVEX®2-73 clinical trial in
Alzheimer’s disease, the Phase 2/3 ANAVEX®2-73 clinical trial in
Rett syndrome as well as the Phase 1 of ANAVEX®3-71. As we look to
the remainder of 2021 and into 2022, I am very excited about the
Company’s potential as we continue to advance and expand our
Precision Medicine clinical programs," said Christopher U Missling,
PhD, President and Chief Executive Officer of Anavex. "As we look
ahead, we will continue to focus on driving meaningful growth
across our broad SIGMAR1 platform portfolio to deliver
transformational treatments for patients with both degenerative and
developmental neurological disorders around the world.”
Key Company Updates:
- Top-line results
from the second placebo-controlled AVATAR Phase 2/3
ANAVEX®2-73-RS-002 study for the treatment of adult patients with
Rett syndrome are expected around year end 2021.
- Top-line results
from the placebo-controlled Phase 1 ANAVEX®3-71-001 study
evaluating ANAVEX®3-71 in humans are expected around year end
2021.
- A scientific
presentation on ANAVEX®2-73 for the potential treatment of
amyotrophic lateral sclerosis (ALS) will be shared at the 4th
Annual ALS ONE Research Symposium, November 29th & 30th,
2021.
- Top-line results
from the placebo-controlled EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003
study for the treatment of pediatric patients with Rett syndrome
are expected 1H 2022.
- Top-line results
from the placebo-controlled Phase 2b/3 ANAVEX®2-73-AD-004 study for
the treatment of Alzheimer’s disease are expected 2H 2022.
- Pipeline
expansion for ANAVEX®2-73 using gene biomarkers of response,
applying precision medicine for neurological disorders with unmet
medical need are expected 1H 2022:
- Planned
initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease
clinical study.
- 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.
Recent Business Highlights:
- On October 13,
2021, Anavex announced that the Independent Data Safety Monitoring
Board (DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study
of its investigational compound ANAVEX®2-73 completed its recent
pre-planned review of the preliminary Phase 2b/3 study data. As
specified in the protocol, the DSMB reviewed the interim safety
data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical
study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE)
ANAVEX®2-73-AD-EP-004 ATTENTION-AD study. Upon review of the
interim safety data, the DSMB recommendation is to continue the
studies without modification.
- On August 26,
2021, Anavex announced that preclinical data of ANAVEX®2-73 in
Fragile X Syndrome was published in the peer-reviewed journal,
Scientific Reports. The study evaluated ANAVEX®2-73 in Fmr1
knockout (KO) mice, a validated animal model for the disease, which
resulted in the reversal of hyperactivity and restoration of
associative learning. Furthermore, ANAVEX®2-73 demonstrated dose
dependent SIGMAR1 receptor occupancy in a Positron Emission
Tomography (PET) study.
Financial Highlights:
- Cash and cash
equivalents of $152.1 million on September 30, 2021, an increase of
$122.9 million compared to $29.2 million from September 30,
2020.
- Net loss of
$37.9 million, or $0.54 per share for the year, compared to net
loss of $26.3 million, or $0.45 per share in fiscal 2020.
- Research and
development expenses of $33.0 million for the year, compared to
$25.2 million in fiscal 2020.
- General and
administrative expenses of $9.0 million for the year, compared to
$5.9 million in fiscal 2020.
The financial information for the year ended
September 30, 2021, 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.
Webcast / Conference Call Information:
The live webcast of the conference call can be accessed online
at https://wsw.com/webcast/cc/avxl20/1492110.
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 50258076, 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),
successfully completed a Phase 2a clinical trial for Alzheimer’s
disease and recently 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, Instagram 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 AND COMPREHENSIVE LOSS |
For the years ended
September 30, 2021 and 2020 |
|
Expressed in US Dollars |
|
|
|
|
2021 |
|
|
2020 |
|
Operating Expenses |
|
|
General and
administrative |
$ |
9,017,511 |
|
$ |
5,856,609 |
|
Research and
development |
|
32,983,674 |
|
|
25,231,623 |
|
Total operating expenses |
|
(42,001,185 |
) |
|
(31,088,232 |
) |
|
|
|
Other income (expenses) |
|
|
Grant
income |
|
54,100 |
|
|
149,888 |
|
Research and
development incentive income |
|
4,547,099 |
|
|
4,375,025 |
|
Interest
income, net |
|
26,261 |
|
|
179,973 |
|
Foreign
exchange gain (loss), net |
|
(267,344 |
) |
|
125,540 |
|
Total other income, net |
|
4,360,116 |
|
|
4,830,426 |
|
Net loss
before provision for income taxes |
|
(37,641,069 |
) |
|
(26,257,806 |
) |
Income tax
expense, current |
|
(267,565 |
) |
|
(22,664 |
) |
Net
loss and comprehensive loss |
$ |
(37,908,634 |
) |
$ |
(26,280,470 |
) |
|
|
|
Net loss per
share |
|
|
Basic and diluted |
$ |
(0.54 |
) |
$ |
(0.45 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
69,802,960 |
|
|
58,194,894 |
|
|
|
|
ANAVEX LIFE
SCIENCES CORP. |
CONSOLIDATED BALANCE
SHEETS |
As at September 30,
2021 and 2020 |
|
|
|
Expressed in US Dollars |
|
|
|
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
Current |
|
|
Cash and
cash equivalents |
$ |
152,107,745 |
|
$ |
29,249,018 |
|
Incentive
and tax receivables |
|
9,136,831 |
|
|
4,849,340 |
|
Prepaid
expenses and deposits |
|
355,549 |
|
|
443,839 |
|
Deferred
financing charges |
|
16,365 |
|
|
- |
|
Total Assets |
$ |
161,616,490 |
|
$ |
34,542,197 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
Current Liabilities |
|
|
Accounts
payable |
$ |
4,739,781 |
|
$ |
3,989,054 |
|
Accrued
liabilities |
|
5,614,774 |
|
|
3,316,574 |
|
Deferred
grant income |
|
443,831 |
|
|
- |
|
Total Liabilities |
|
10,798,386 |
|
|
7,305,628 |
|
Capital
Stock |
|
75,920 |
|
|
62,047 |
|
Additional
paid-in capital |
|
348,328,048 |
|
|
186,851,752 |
|
Accumulated
deficit |
|
(197,585,864 |
) |
|
(159,677,230 |
) |
Total Stockholders' Equity |
|
150,818,104 |
|
|
27,236,569 |
|
Total Liabilities and Stockholders' Equity |
$ |
161,616,490 |
|
$ |
34,542,197 |
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors:Andrew J.
BarwickiInvestor RelationsTel: 516-662-9461Email:
andrew@barwicki.com
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