Anavex Life Sciences Provides Business Update and Reports Fiscal 2022 Second Quarter Financial Results
May 10 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 March 31, 2022.
"We are pleased with the continued advancement
regarding our lead product candidate ANAVEX®2-73 in Alzheimer’s
disease and Rett syndrome as we maintain our attention on execution
across each of our clinical programs and overall business
operations," said Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex. "We are also looking forward to next
month’s R&D Day’s event, where we will present our broad
SIGMAR1 platform portfolio, which allows us to expand further
within the neurodegenerative and rare disease space. We remain on
track to deliver data readouts, as well as presentations at medical
meetings and initiating biomarker-driven precision medicine
clinical studies through the rest of the year as planned."
ANAVEX®2-73 Program and other Near-Term
Pipeline Data Updates:
- Top-line results
from the randomized, placebo-controlled Phase 2b/3 study
ANAVEX®2-73-AD-004 for the treatment of Alzheimer’s disease are
expected 2H 2022.
- Top-line results
from the randomized, placebo-controlled EXCELLENCE Phase 2/3 study
ANAVEX®2-73-RS-003 for the treatment of pediatric patients with
Rett syndrome are expected 2H 2022.
- ANAVEX will host
a R&D Day for investors and analysts on Tuesday, June 21, 2022.
Anavex’s R&D Day will include presentations from the Company’s
leadership team with a focus on the Company’s clinical development
pipeline. Additional details will follow closer to the event.
- Oral
presentation of ‘Effects of the Sigma-1 receptor agonist
blarcamesine (ANAVEX®2-73) in a murine model of fragile X syndrome:
Neurobehavioral phenotypes and receptor occupancy’ to be presented
at 18th NFXF International Fragile X Conference, July 14-17, 2022,
in San Diego, California.
- Pipeline
expansion of the ANAVEX platform using gene biomarkers of response,
applying precision medicine for neurological disorders with 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 FTD,
schizophrenias and Alzheimer’s disease indications.
Recent Business Highlights:
- Anavex presented
Phase 2 clinical biomarker data from the ANAVEX®2-73-PDD-001
Parkinson’s Disease Dementia (PDD) study at the AD/PDTM 2022
International Conference on Alzheimer’s & Parkinson’s Diseases
and related neurological disorders in Barcelona, Spain, March
15–20, 2022.
- Anavex announced
presentations of Psychometric Evaluation of the Rett Syndrome
Behaviour Questionnaire (RSBQ) and Burden of Illness (BOI) study in
Rett syndrome by the respective working groups, at the 2022
International Rett Syndrome Foundation (IRSF) Rett Syndrome
Scientific Meeting in Nashville, TN, April 26–27, 2022.
Financial Highlights:
- Continued fiscal
responsible management of cash utilization.
- Cash and cash
equivalents of $153.3 million on March 31, 2022, compared to $152.1
million at fiscal year end September 30, 2021.
- Net loss of $10.4 million, or $0.14
per share for the quarter compared to net loss of $8.1 million, or
$0.12 per share for the comparable quarter of fiscal 2021.
- Research and development expenses of
$8.6 million compared to $6.7 million for the comparable quarter of
fiscal 2021.
- General and administrative expenses
of $2.9 million compared to $2.2 million for the comparable quarter
of fiscal 2021.
The financial information for the fiscal quarter
ended March 31, 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.
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),
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 March 31, 2022 and 2021 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2022 |
|
|
2021 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
2,915,158 |
|
$ |
2,233,745 |
|
|
Research and
development |
|
8,604,589 |
|
|
6,720,841 |
|
|
Total operating expenses |
|
(11,519,747 |
) |
|
(8,954,586 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
- |
|
|
10,820 |
|
|
Research and
development incentive income |
|
835,513 |
|
|
960,879 |
|
|
Interest
income, net |
|
7,578 |
|
|
9,216 |
|
|
Foreign
exchange gain (loss), net |
|
268,645 |
|
|
(154,563 |
) |
|
Total other income, net |
|
1,111,736 |
|
|
826,352 |
|
|
Net loss
before provision for income taxes |
|
(10,408,011 |
) |
|
(8,128,234 |
) |
|
Income tax
expense, current |
|
(29,800 |
) |
|
(26,988 |
) |
|
Net
loss and comprehensive loss |
$ |
(10,437,811 |
) |
$ |
(8,155,222 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.14 |
) |
$ |
(0.12 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
76,248,603 |
|
|
68,594,867 |
|
|
|
|
|
|
Anavex Life
Sciences Corp. |
|
Interim Condensed
Consolidated Statements of Operations and Comprehensive Loss |
|
For the six months
ended March 31, 2022 and 2021 |
|
(Unaudited) |
|
|
|
Expressed in
US Dollars |
|
|
|
|
|
2022 |
|
|
2021 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
5,982,109 |
|
$ |
3,704,401 |
|
|
Research and
development |
|
17,261,028 |
|
|
14,646,360 |
|
|
Total operating expenses |
|
(23,243,137 |
) |
|
(18,350,761 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
- |
|
|
10,820 |
|
|
Research and
development incentive income |
|
1,646,243 |
|
|
2,230,195 |
|
|
Interest
income, net |
|
12,488 |
|
|
7,657 |
|
|
Foreign
exchange gain (loss), net |
|
324,008 |
|
|
178,071 |
|
|
Total other income, net |
|
1,982,739 |
|
|
2,426,743 |
|
|
Net loss
before provision for income taxes |
|
(21,260,398 |
) |
|
(15,924,018 |
) |
|
Income tax
expense, current |
|
(59,780 |
) |
|
(86,269 |
) |
|
Net
loss and comprehensive loss |
$ |
(21,320,178 |
) |
$ |
(16,010,287 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.28 |
) |
$ |
(0.24 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
76,121,792 |
|
|
66,421,380 |
|
|
|
|
|
|
Anavex Life
Sciences Corp. |
|
Interim Condensed
Consolidated Balance Sheets |
|
Unaudited |
|
Expressed in
US Dollars |
|
|
|
|
March 31, |
September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
Assets |
|
|
|
Current |
|
|
|
Cash and
cash equivalents |
$ |
153,342,556 |
|
$ |
152,107,745 |
|
|
Incentive
and tax receivables |
|
6,468,987 |
|
|
9,136,831 |
|
|
Prepaid
expenses and other current assets |
|
464,605 |
|
|
371,914 |
|
|
Total Assets |
$ |
160,276,148 |
|
$ |
161,616,490 |
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current Liabilities |
|
|
|
Accounts
payable |
$ |
2,631,888 |
|
$ |
4,739,781 |
|
|
Accrued
liabilities |
|
4,995,388 |
|
|
5,614,774 |
|
|
Deferred
grant income |
|
443,831 |
|
|
443,831 |
|
|
Total Liabilities |
|
8,071,107 |
|
|
10,798,386 |
|
|
Capital
Stock |
|
77,163 |
|
|
75,920 |
|
|
Additional
paid-in capital |
|
371,437,616 |
|
|
348,328,048 |
|
|
Share
proceeds receivable |
|
(403,696 |
) |
|
- |
|
|
Accumulated
deficit |
|
(218,906,042 |
) |
|
(197,585,864 |
) |
|
Total Stockholders' Equity |
|
152,205,041 |
|
|
150,818,104 |
|
|
Total Liabilities and Stockholders' Equity |
$ |
160,276,148 |
|
$ |
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
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