Anavex Life Sciences Provides Business Update and Reports Fiscal 2022 Third Quarter Financial Results
August 09 2022 - 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
quarter ended June 30, 2022.
“We are pleased with the progress of our
clinical Precision Medicine SIGMAR1 platform pipeline and 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.
“Subsequent data readouts, including the placebo-controlled Phase
2/3 Rett syndrome EXCELLENCE study, which completion is projected
by year end as well as initiation of biomarker-driven Precision
Medicine clinical studies are expected through the rest of the year
as planned.”
ANAVEX®2-73 Program and other Near-Term
Pipeline Data Updates:
- Last patient
last visit in the randomized, placebo-controlled Phase 2b/3 study
ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease
occurred at the end of June 2022 and top line results are expected
in the fall of 2022.
- Last patient
last visit of the 48-week open label extension of the Parkinson's
Disease Dementia Phase 2 study occurred this quarter and data
expected by end of 2022.
- 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 is expected by end of 2022.
- 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 2022:
- Meeting with FDA
for discussing 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 potentially
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.
- Planned
initiation of ANAVEX®3-71 Phase 2 clinical trials for
schizophrenia, frontotemporal dementia (FTD) and Alzheimer’s
disease indications.
Recent Business Highlights:
- Anavex presented
the first entire clinical human Alzheimer’s disease and Parkinson’s
disease gene pathway data from the ANAVEX®2-73-PDD-001 Parkinson’s
Disease Dementia (PDD) study at the Alzheimer’s Association
International Conference (AAIC), in San Diego, CA on July 31 –
August 4, 2022.
- Anavex presented
long-lasting effect of ANAVEX®3-71 preventing cognitive decline in
a transgenic rat model of Alzheimer’s disease at the Alzheimer’s
Association International Conference (AAIC), in San Diego, CA on
July 31 – August 4, 2022.
- Anavex announced
its very first scientific educational video news release of its
broad SIGMAR1 platform. The video, published on June 21, 2022
presented an overview of the Company’s biomarker driven precision
medicine approach and clinical development programs and was
presented by several members of the Anavex management team.
- Anavex announced
a peer-reviewed publication in American Journal of Medical Genetics
identifying a blood biomarker for assessing treatment effect of
ANAVEX®2-73 in Fragile X syndrome, which provided a strong
scientific support for the planned clinical trial of ANAVEX®2-73 in
Fragile X syndrome.
Financial Highlights:
- Cash and cash
equivalents of $153.2 million on June 30, 2022, compared to $152.1
million at fiscal year end September 30, 2021.
- Net loss of $12.4 million, or $0.16
per share for the quarter compared to net loss of $10.2 million, or
$0.14 per share for the comparable quarter of fiscal 2021.
- Research and development expenses of
$9.3 million compared to $9.0 million for the comparable quarter of
fiscal 2021.
- General and administrative expenses
of $3.2 million compared to $2.4 million for the comparable quarter
of fiscal 2021.
The financial information for the fiscal quarter
ended June 30, 2022, should be read in conjunction with the
Company’s interim condensed 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 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 911357. A replay of the conference call will
also be available on Anavex’s website for up to 30 days.
Economic Burden of Alzheimer’s Disease1
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 muscarinic M1 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. |
|
Interim Condensed
Consolidated Statements of Operations and Comprehensive Loss |
|
For the three months
ended June 30, 2022 and 2021 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2022 |
|
|
2021 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
3,185,451 |
|
$ |
2,434,127 |
|
|
Research and
development |
|
9,273,269 |
|
|
8,964,528 |
|
|
Total operating expenses |
|
(12,458,720 |
) |
|
(11,398,655 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
- |
|
|
43,280 |
|
|
Research and
development incentive income |
|
682,432 |
|
|
1,363,661 |
|
|
Interest
income, net |
|
229,917 |
|
|
11,453 |
|
|
Foreign
exchange (loss) gain, net |
|
(732,549 |
) |
|
(160,880 |
) |
|
Total other income, net |
|
179,800 |
|
|
1,257,514 |
|
|
Net loss
before provision for income taxes |
|
(12,278,920 |
) |
|
(10,141,141 |
) |
|
Income tax
expense, current |
|
(88,421 |
) |
|
(39,000 |
) |
|
Net
loss and comprehensive loss |
$ |
(12,367,341 |
) |
$ |
(10,180,141 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.16 |
) |
$ |
(0.14 |
) |
|
|
|
|
|
Weighted
average number of shares outstanding |
|
|
|
|
|
Basic and diluted |
|
77,442,236 |
|
|
70,589,651 |
|
|
|
|
|
|
|
|
|
|
Anavex Life
Sciences Corp. |
|
Interim Condensed
Consolidated Statements of Operations and Comprehensive Loss |
|
For the nine months
ended June 30, 2022 and 2021 |
|
(Unaudited) |
|
|
|
Expressed in
US Dollars |
|
|
|
|
|
2022 |
|
|
2021 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
9,167,560 |
|
$ |
6,138,528 |
|
|
Research and
development |
|
26,534,297 |
|
|
23,610,888 |
|
|
Total operating expenses |
|
(35,701,857 |
) |
|
(29,749,416 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
- |
|
|
54,100 |
|
|
Research and
development incentive income |
|
2,328,675 |
|
|
3,593,856 |
|
|
Interest
income, net |
|
242,405 |
|
|
19,110 |
|
|
Foreign
exchange (loss) gain, net |
|
(408,541 |
) |
|
17,191 |
|
|
Total other income, net |
|
2,162,539 |
|
|
3,684,257 |
|
|
Net loss
before provision for income taxes |
|
(33,539,318 |
) |
|
(26,065,159 |
) |
|
Income tax
expense, current |
|
(148,201 |
) |
|
(125,269 |
) |
|
Net
loss and comprehensive loss |
$ |
(33,687,519 |
) |
$ |
(26,190,428 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.44 |
) |
$ |
(0.39 |
) |
|
|
|
|
|
Weighted
average number of shares outstanding |
|
|
|
|
|
Basic and diluted |
|
76,561,940 |
|
|
67,810,774 |
|
|
|
|
|
|
|
|
Anavex Life
Sciences Corp. |
|
Interim Condensed
Consolidated Balance Sheets |
|
Unaudited |
|
Expressed in
US Dollars |
|
|
|
|
June 30, |
September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
Assets |
|
|
|
Current |
|
|
|
Cash and
cash equivalents |
$ |
153,199,352 |
|
$ |
152,107,745 |
|
|
Incentive
and tax receivables |
|
6,559,829 |
|
|
9,136,831 |
|
|
Prepaid
expenses and other current assets |
|
461,963 |
|
|
371,914 |
|
|
Total Assets |
$ |
160,221,144 |
|
$ |
161,616,490 |
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current Liabilities |
|
|
|
Accounts
payable |
$ |
3,126,892 |
|
$ |
4,739,781 |
|
|
Accrued
liabilities |
|
5,913,821 |
|
|
5,614,774 |
|
|
Deferred
grant income |
|
443,831 |
|
|
443,831 |
|
|
Total Liabilities |
|
9,484,544 |
|
|
10,798,386 |
|
|
Capital
Stock |
|
77,944 |
|
|
75,920 |
|
|
Additional
paid-in capital |
|
381,932,039 |
|
|
348,328,048 |
|
|
Accumulated
deficit |
|
(231,273,383 |
) |
|
(197,585,864 |
) |
|
Total Stockholders' Equity |
|
150,736,600 |
|
|
150,818,104 |
|
|
Total Liabilities and Stockholders' Equity |
$ |
160,221,144 |
|
$ |
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 Relations Tel: 516-662-9461 Email:
andrew@barwicki.com
______________________________________1 W Wong Economic Burden
of Alzheimer Disease and Managed Care Considerations Am J Manag
Care. 2020;26:S177-S183
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