Anavex Life Sciences Provides Business Update and Reports Fiscal 2022 First Quarter Financial Results
February 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 December 31, 2021.
“The first quarter marked significant progress
across our portfolio, highlighted by the positive top-line results
of the randomized, placebo-controlled AVATAR Phase 3 study
(ANAVEX®2-73-RS-002) for the treatment of adult patients with Rett
syndrome and the positive top-line results from the
placebo-controlled Phase 1 study of ANAVEX®3-71, which is in
development for the treatment of neurodegenerative diseases
including Frontotemporal Dementia (FTD). The clinical trial
data-driven evidence of efficacy and safety of our broad SIGMAR1
platform portfolio allows us to plan to expand further within the
rare disease space including implementing expanded access for adult
patients with Rett syndrome, an underserved population,” said
Christopher U. Missling, PhD, President and Chief Executive Officer
of Anavex. “At the same time, we are advancing both ANAVEX®2-73 and
ANAVEX®3-71 in the planned studies with the goal to 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:
- Anavex reported positive top-line results from the second
randomized, placebo-controlled AVATAR Phase 3 study
(ANAVEX®2-73-RS-002) for the treatment of adult patients with Rett
syndrome. The study met its primary and secondary efficacy and
safety endpoints, with consistent and clinically meaningful
improvements in all efficacy measures.
- Anavex reported positive top-line results from the
placebo-controlled Phase 1 clinical trial (ANAVEX®3-71-001) in
development for the treatment of neurodegenerative diseases
including Frontotemporal Dementia (FTD), for which ANAVEX®3-71 has
been granted Orphan Drug Designation (ODD) by the FDA. The study
reached primary and secondary safety endpoints.
- 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. The
extended enrollment duration is triggered by Country and local
Government requirements for full COVID-19 vaccination among
children prior to joining the pediatric EXCELLENCE trial.
- Top-line results from the placebo-controlled Phase 2b/3 study
ANAVEX®2-73-AD-004 for the treatment of Alzheimer’s disease is
expected 2H 2022.
- Pipeline expansion of the ANAVEX platform pipeline using gene
biomarkers of response, applying precision medicine for
neurological disorders with unmet medical need are expected 2022:
- 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.
Financial Highlights:
- Cash and cash equivalents of $151.1 million on December 31,
2021, compared to $152.1 million on September 30, 2021.
- Net loss of $10.9 million, or $0.14 per share for the quarter,
inclusive of non-cash compensation charges of $3.9 million,
compared to net loss of $7.9 million, or $0.12 per share, inclusive
of non-cash compensation charges of $0.9 million for the comparable
quarter of fiscal 2021.
- Research and development expenses of $8.7 million, inclusive of
non-cash compensation charges of $2.2 million for the quarter,
compared to $7.9 million, inclusive of non-cash compensation
charges of $0.5 million for the comparable quarter of fiscal
2021.
- General and administrative expenses of $3.1 million, inclusive
of non-cash compensation charges of $1.7 million for the quarter,
compared to $1.5 million, inclusive of non-cash compensation
charges of $0.4 million for the comparable quarter of fiscal
2021.
The financial information for the fiscal quarter
ended December 31, 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 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),
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 and Comprehensive Loss |
For the three months
ended December 31, 2021 and 2020 |
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
2021 |
|
|
2020 |
|
Operating Expenses |
|
|
General and
administrative |
$ |
3,066,951 |
|
$ |
1,470,656 |
|
Research and
development |
|
8,656,439 |
|
|
7,925,519 |
|
Total operating expenses |
|
(11,723,390 |
) |
|
(9,396,175 |
) |
|
|
|
Other income (expenses) |
|
|
Research and
development incentive income |
|
810,730 |
|
|
1,269,316 |
|
Interest
income (expense), net |
|
4,910 |
|
|
(1,559 |
) |
Foreign
exchange gain, net |
|
55,363 |
|
|
332,634 |
|
Total other income, net |
|
871,003 |
|
|
1,600,391 |
|
Net loss
before provision for income taxes |
|
(10,852,387 |
) |
|
(7,795,784 |
) |
Income tax
expense, current |
|
(29,980 |
) |
|
(59,281 |
) |
Net
loss and comprehensive loss |
$ |
(10,882,367 |
) |
$ |
(7,855,065 |
) |
|
|
|
Net loss per
share |
|
|
Basic and diluted |
$ |
(0.14 |
) |
$ |
(0.12 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
75,997,738 |
|
|
64,295,143 |
|
|
|
|
Anavex Life
Sciences Corp. |
Interim Condensed
Consolidated Balance Sheets |
|
|
|
Expressed in
US Dollars |
|
|
|
December 31, |
September 30, |
|
|
2021 |
|
|
2021 |
|
Assets |
(Unaudited) |
|
Current |
|
|
Cash and
cash equivalents |
$ |
151,146,355 |
|
$ |
152,107,745 |
|
Incentive
and tax receivables |
|
5,372,153 |
|
|
9,136,831 |
|
Prepaid
expenses and other current assets |
|
377,860 |
|
|
371,914 |
|
Total Assets |
$ |
156,896,368 |
|
$ |
161,616,490 |
|
|
|
|
Liabilities and stockholders’ equity |
|
|
Current Liabilities |
|
|
Accounts
payable |
$ |
4,634,791 |
|
$ |
4,739,781 |
|
Accrued
liabilities |
|
5,450,040 |
|
|
5,614,774 |
|
Deferred
grant income |
|
443,831 |
|
|
443,831 |
|
Total Liabilities |
|
10,528,662 |
|
|
10,798,386 |
|
Capital
Stock |
|
76,156 |
|
|
75,920 |
|
Additional
paid-in capital |
|
354,759,781 |
|
|
348,328,048 |
|
Accumulated
deficit |
|
(208,468,231 |
) |
|
(197,585,864 |
) |
Total Stockholders’ Equity |
|
146,367,706 |
|
|
150,818,104 |
|
Total Liabilities and Stockholders’ Equity |
$ |
156,896,368 |
|
$ |
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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