Anavex Life Sciences Reports Fiscal 2022 Year End Financial Results and Provides Business Update
November 28 2022 - 07:00AM
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, 2022.
“This is an exciting time in neuroscience and
rare disease drug development and we remain on track for the
readout of the placebo-controlled ANAVEX®2-73 Phase 2b/3
Alzheimer’s disease clinical trial, a condition of significant
unmet need and economic burden for which there are only limited
approved pharmacological treatment options,” said Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
“Our recent progress highlights the potential of our clinical
Precision Medicine SIGMAR1 platform and portfolio, and we look
forward to sharing additional program and data updates.”
ANAVEX®2-73 Program and other Near-Term
Pipeline Data Updates:
- Late breaking
oral communication presentation of top line data of randomized,
double-blind, multicenter, placebo-controlled Phase 2b/3 study
ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease
at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD)
Congress 2022, December 1, 2022, at 4:30pm PT in San Francisco,
CA.
- Nearing the
enrollment completion of the randomized, placebo-controlled
EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of
pediatric patients with Rett syndrome.
- Guidance
received from the FDA confirms the Company’s strategy to advance
ANAVEX®2-73 for the treatment of Fragile X syndrome in a
double-blind, randomized, placebo-controlled Phase 2/3 development
program.
- Upcoming
Pipeline expansion of the ANAVEX platform using gene biomarkers of
response and applying precision medicine for treatment of
neurological disorders with high unmet medical need are expected:
- Meeting with FDA
to discuss ANAVEX®2-73 Parkinson’s disease program including
pivotal Phase 3 study.
- Planned
initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease
clinical study.
- Planned
initiation of a Phase 2/3 clinical trial for the treatment of a new
rare-disease indication.
- Planned
initiation of ANAVEX®3-71 Phase 2 clinical trial for
schizophrenia.
Recent Business Highlights:
- Anavex announced
a peer-reviewed publication in the journal of Science Translational
Medicine, titled “Widespread cell stress and mitochondrial
dysfunction occur in patients with early Alzheimer’s disease”,
which provided further scientific evidence of the relevance of
sigma-1 receptor (SIGMAR1) activation as a compensatory mechanism
to chronic CNS diseases.
- Anavex announced
that the United States Patent and Trademark Office (USPTO) issued
U.S. Patent No. 11,446,275 to Anavex, with claims to treatment
methods using its leading drug candidate, ANAVEX®2-73
(blarcamesine) and its analogs, for ameliorating biochemical and
functional abnormalities associated with methyl-CpG binding protein
2 defects (MeCP2 defects). Such defects encompass a range of
neurodevelopmental and neurological disorders, including but not
limited to, Rett syndrome, Angelman syndrome, Williams syndrome,
cerebral palsy, autism spectrum disorder, and multiple
sclerosis.
- Anavex announced
that the U.S. Food and Drug Administration (FDA) granted Orphan
Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the
treatment of Fragile X syndrome. Fragile X syndrome is the most
common form of inherited intellectual disability and the most
frequent single gene cause of autism spectrum disorder with an
estimated population of approximately 62,500 in the US and
1,088,500 worldwide.1
Financial Highlights:
- Cash and cash
equivalents of $149.2 million at September 30, 2022, compared to
$152.1 million at September 30, 2021.
- Net loss for the
fourth quarter of $14.3 million, or $0.18 per share, compared to a
net loss of $11.7 million, or $0.15 per share for the same period
in fiscal 2021.
- Net loss for the full fiscal year
ended September 30, 2022 of $48.0 million, or $0.62 per compared to
net loss of $37.9 million, or $0.54 per share for the full fiscal
2021 year.
- Research and
development expenses for the fourth quarter of $11.4 million
compared to $9.4 million for the same period in fiscal 2021.
- General and
administrative expenses of $3.9 million for fiscal 2022 compared to
$2.9 million for the comparable quarter of fiscal 2021.
The financial information for the fiscal year
ended September 30, 2022, 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:
Management will host a conference call today at 8:30 am ET. The
live webcast of the conference call will be available on Anavex’s
website at www.anavex.com.
The conference call can be also accessed by
dialing +1 929 205 6099 for participants in the U.S. using the
reference passcode 511901. A replay of the conference call will
also be available on Anavex’s website for up to 30 days.
Economic Burden of Alzheimer’s Disease2
Alzheimer’s disease is the most common cause of
dementia and the fifth leading cause of death in adults older than
65 years. The estimated total healthcare costs for the treatment of
Alzheimer disease in 2020 is estimated at $305 billion, with the
cost expected to increase to more than $1 trillion as the
population ages. Most of the direct costs of care for Alzheimer’s
disease are attributed to skilled nursing care, home healthcare,
and hospice care. Indirect costs of care, including quality of life
and informal caregiving, are likely underestimated and are
associated with significant negative societal and personal
burden.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of novel 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),
has successfully completed a Phase 2a clinical trial for
Alzheimer's disease, a Phase 2 proof-of-concept study in
Parkinson's disease dementia, and both a Phase 2 and a Phase 3
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 M1 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 |
(Unaudited -
Expressed in US Dollars) |
|
|
|
Three months ended
September 30, |
Years ended
September 30, |
|
|
|
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating Expenses |
|
|
|
|
|
General and
administrative |
|
$ |
3,902,508 |
|
$ |
2,878,983 |
|
$ |
13,070,068 |
|
$ |
9,017,511 |
|
Research and
development |
|
|
11,381,450 |
|
|
9,372,786 |
|
|
37,915,747 |
|
|
32,983,674 |
|
Total operating expenses |
|
|
15,283,958 |
|
|
12,251,769 |
|
|
50,985,815 |
|
|
42,001,185 |
|
Operating loss |
|
|
(15,283,958 |
) |
|
(12,251,769 |
) |
|
(50,985,815 |
) |
|
(42,001,185 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expenses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income |
|
|
- |
|
|
- |
|
|
- |
|
|
54,100 |
|
Research and
development incentive income |
|
|
994,336 |
|
|
953,243 |
|
|
3,323,011 |
|
|
4,547,099 |
|
Interest
income, net |
|
|
704,583 |
|
|
7,151 |
|
|
946,988 |
|
|
26,261 |
|
Foreign
exchange (loss) gain, net |
|
|
(495,070 |
) |
|
(284,535 |
) |
|
(903,611 |
) |
|
(267,344 |
) |
Total other income, net |
|
|
1,203,849 |
|
|
675,859 |
|
|
3,366,388 |
|
|
4,360,116 |
|
Net loss
before provision for income taxes |
|
|
(14,080,109 |
) |
|
(11,575,910 |
) |
|
(47,619,427 |
) |
|
(37,641,069 |
) |
Income tax
expense, current |
|
|
(210,291 |
) |
|
(142,296 |
) |
|
(358,492 |
) |
|
(267,565 |
) |
Net
loss and comprehensive loss |
|
$ |
(14,290,400 |
) |
$ |
(11,718,206 |
) |
$ |
(47,977,919 |
) |
$ |
(37,908,634 |
) |
|
|
|
|
|
|
Net loss per
share |
|
|
|
|
|
Basic and diluted |
|
$ |
(0.18 |
) |
$ |
(0.15 |
) |
$ |
(0.62 |
) |
$ |
(0.54 |
) |
|
|
|
|
|
|
Weighted
average number of shares outstanding |
|
|
|
|
|
|
|
Basic and diluted |
|
|
77,442,470 |
|
|
75,714,558 |
|
|
76,909,993 |
|
|
69,802,960 |
|
|
|
Anavex Life
Sciences Corp. |
|
Consolidated Balance
Sheets |
|
At September 30,
2022 and 2021 |
|
Expressed in
US Dollars |
|
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
Assets |
|
|
|
|
Current |
|
|
|
|
Cash and
cash equivalents |
|
$ |
149,157,861 |
|
$ |
152,107,745 |
|
|
Incentive
and tax receivables |
|
|
3,192,580 |
|
|
9,136,831 |
|
|
Prepaid
expenses and other current assets |
|
|
354,162 |
|
|
371,914 |
|
|
Total Assets |
|
$ |
152,704,603 |
|
$ |
161,616,490 |
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current Liabilities |
|
|
|
|
Accounts
payable |
|
$ |
3,824,777 |
|
$ |
4,739,781 |
|
|
Accrued
liabilities |
|
|
5,944,953 |
|
|
5,614,774 |
|
|
Deferred
grant income |
|
|
443,831 |
|
|
443,831 |
|
|
Total Liabilities |
|
|
10,213,561 |
|
|
10,798,386 |
|
|
Capital
Stock |
|
|
77,944 |
|
|
75,920 |
|
|
Additional
paid-in capital |
|
|
387,976,881 |
|
|
348,328,048 |
|
|
Accumulated
deficit |
|
|
(245,563,783 |
) |
|
(197,585,864 |
) |
|
Total Stockholders' Equity |
|
|
142,491,042 |
|
|
150,818,104 |
|
|
Total Liabilities and Stockholders' Equity |
|
$ |
152,704,603 |
|
$ |
161,616,490 |
|
|
|
|
|
|
|
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
____________________________1
https://fragilex.org/understanding-fragile-x/fragile-x-101/prevalence/2
W Wong Economic Burden of Alzheimer Disease and Managed Care
Considerations Am J Manag Care. 2020;26:S177-S183
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Feb 2024 to Mar 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Mar 2023 to Mar 2024