Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Third Quarter Financial Results
August 12 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
quarter ended June 30, 2021.
“We are pleased with the rigorous and efficient
execution of the confirmatory late-stage Precision Medicine
ANAVEX®2-73 Phase 2b/3 randomized, double-blind, placebo-controlled
clinical trial with a total of 509 patients with Alzheimer’s
disease and are excited to be able to provide top-line data by 2H
2022. The steadfast clinical trial execution capabilities of the
Anavex team also extend to the Precision Medicine ANAVEX®2-73 Phase
2/3 AVATAR clinical trial in patients with Rett syndrome, which
exceeded the enrollment target, and currently topline results from
this study are expected by 2H 2021,” said Christopher U Missling,
PhD, President and Chief Executive Officer of Anavex. “We are
excited about the potential of our SIGMAR1 platform, and we
continue working to advance new programs to the clinic, all with
the aim of meeting the unmet clinical needs of patients with both
degenerative and developmental neurological disorders around the
world.”
Recent Business Highlights:
- On May 25, 2021,
Anavex announced the appointment of Ms. Jiong Ma, PhD to its Board
of Directors. Ms. Ma is a Senior Board executive with over 25 years
of experience in investing, building, and scaling of companies with
a focus on innovative product launches in digital health,
technology, and new energy transition.
- On June 8, 2021,
Anavex announced that it exceeded its enrollment target for the
confirmatory late-stage ANAVEX®2-73 Phase 2b/3 randomized,
double-blind, placebo-controlled trial in Alzheimer’s disease. The
Company expects to announce topline results from this study by 2H
2022.
- On June 21,
2021, Anavex reported complete data from its ANAVEX®2-73 U.S. Rett
syndrome Phase 2 study. Predictive biomarker of response
established with SIGMAR1 mRNA expression correlates significantly
with responses in primary clinical efficacy endpoints from the U.S.
Phase 2 randomized, double-blind, placebo-controlled trial of
ANAVEX®2-73 in patients with Rett syndrome.
- On June 24,
2021, Anavex announced the closing of $50 million registered direct
offering to Deep Track Capital, an investment firm focused
exclusively on the life sciences industry.
- On June 28,
2021, Anavex reported complete data from its ANAVEX®2-73
Parkinson’s disease dementia (PDD) Phase 2 study. Predictive
biomarker of response established with SIGMAR1 mRNA expression
correlates significantly with responses in primary and secondary
clinical efficacy endpoints from the proof-of-concept randomized,
double-blind, placebo-controlled Phase 2 trial of 132 patients with
Parkinson’s disease dementia.
- Further clinical
milestones are provided in Anavex Life Sciences’ latest corporate
presentation, available on www.anavex.com.
Financial Highlights:
- Cash and cash
equivalents of $157.6 million on June 30, 2021, an increase of over
$128 million compared to $29.2 million from September 30,
2020.
- Net loss of
$10.2 million, or $0.14 per share for the quarter, compared to net
loss of $6.5 million, or $0.11 per share in comparative quarter of
fiscal 2020.
- Research and
development expenses of $9.0 million for the quarter, compared to
$6.7 million for comparable quarter of fiscal 2020.
- General and
administrative expenses of $2.4 million for the quarter, compared
to $1.4 million for comparable quarter of fiscal 2020.
The financial information for the fiscal quarter
ended June 30, 2021, 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 can be accessed online
at https://wsw.com/webcast/cc/avxl19/1500606.
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 50210582, 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. |
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
For the three months
ended June 30, 2021 and 2020 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
2,434,127 |
|
$ |
1,381,477 |
|
|
Research and
development |
|
8,964,528 |
|
|
6,725,002 |
|
|
Total operating expenses |
|
(11,398,655 |
) |
|
(8,106,479 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
43,280 |
|
|
- |
|
|
Research and
development incentive income |
|
1,363,661 |
|
|
1,319,913 |
|
|
Interest
income, net |
|
11,453 |
|
|
56,096 |
|
|
Foreign
exchange gain (loss), net |
|
(160,880 |
) |
|
248,665 |
|
|
Total other income, net |
|
1,257,514 |
|
|
1,624,674 |
|
|
Net loss
before provision for income taxes |
|
(10,141,141 |
) |
|
(6,481,805 |
) |
|
Income tax
expense, current |
|
(39,000 |
) |
|
(4,817 |
) |
|
Net
loss and comprehensive loss |
$ |
(10,180,141 |
) |
$ |
(6,486,622 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.14 |
) |
$ |
(0.11 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
70,589,561 |
|
|
59,105,399 |
|
|
|
|
|
|
ANAVEX LIFE
SCIENCES CORP. |
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
For the nine months
ended June 30, 2021 and 2020 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
6,138,528 |
|
$ |
4,453,654 |
|
|
Research and
development |
|
23,610,888 |
|
|
19,126,717 |
|
|
Total operating expenses |
|
(29,749,416 |
) |
|
(23,580,371 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
54,100 |
|
|
149,888 |
|
|
Research and
development incentive income |
|
3,593,856 |
|
|
2,980,456 |
|
|
Interest
income, net |
|
19,110 |
|
|
172,996 |
|
|
Foreign
exchange gain (loss), net |
|
17,191 |
|
|
(24,182 |
) |
|
Total other income, net |
|
3,684,257 |
|
|
3,279,158 |
|
|
Net loss
before provision for income taxes |
|
(26,065,159 |
) |
|
(20,301,213 |
) |
|
Income tax
expense, current |
|
(125,269 |
) |
|
(14,031 |
) |
|
Net
loss and comprehensive loss |
$ |
(26,190,428 |
) |
$ |
(20,315,244 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.39 |
) |
$ |
(0.35 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
67,810,774 |
|
|
57,401,387 |
|
|
|
|
|
|
ANAVEX LIFE
SCIENCES CORP. |
|
INTERIM CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
As at June 30, 2021
and September 30, 2020 |
|
Expressed in
US Dollars |
|
|
|
|
June 30, 2021 |
September 30, 2020 |
|
ASSETS |
(Unaudited) |
|
|
Current |
|
|
|
Cash and cash equivalents |
$ |
157,560,045 |
|
$ |
29,249,018 |
|
|
Incentive
and tax receivables |
|
8,601,258 |
|
|
4,849,340 |
|
|
Prepaid
expenses and deposits |
|
258,198 |
|
|
443,839 |
|
|
Total Assets |
$ |
166,419,501 |
|
$ |
34,542,197 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities |
|
|
|
Accounts
payable |
$ |
4,176,707 |
|
$ |
3,989,054 |
|
|
Accrued
liabilities |
|
4,653,234 |
|
|
3,316,574 |
|
|
Deferred
grant income |
|
443,831 |
|
|
- |
|
|
Total Liabilities |
|
9,273,772 |
|
|
7,305,628 |
|
|
Capital
Stock |
|
75,151 |
|
|
62,047 |
|
|
Additional
paid-in capital |
|
342,938,236 |
|
|
186,851,752 |
|
|
Accumulated
deficit |
|
(185,867,658 |
) |
|
(159,677,230 |
) |
|
Total Stockholders' Equity |
|
157,145,729 |
|
|
27,236,569 |
|
|
Total Liabilities and Stockholders' Equity |
$ |
166,419,501 |
|
$ |
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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