Anavex Life Sciences Reports Fiscal 2023 First Quarter Financial Results
February 07 2023 - 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, 2022.
“Alzheimer’s disease represents a growing burden
to healthcare systems and societies worldwide. This disease is
often multifactorial and complex in nature, and we believe that our
precision medicine platform and novel central nervous system
mechanism improve the chance of clinical success. We are pleased by
the results of the placebo-controlled Phase 2b/3 Alzheimer’s
disease trial which data suggest that ANAVEX®2-73 (blarcamesine),
an orally available, small-molecule activator of the upstream
sigma-1 receptor (SIGMAR1), is pivotal to restoring neural cell
homeostasis and promoting neuroplasticity and might be at the
forefront of biomarker-guided pathway-based targeted precision
medicine drug development,” said Christopher U Missling, PhD,
President and Chief Executive Officer of Anavex. “We look forward
to presenting the complete dataset of the study as well as other
long-term study data of the other programs, including Parkinson’s
disease dementia and Rett syndrome. With a deep portfolio of
promising therapies, we believe that Anavex remains well positioned
to address the urgent needs of patients affected by
neurodegenerative and rare neurodevelopmental diseases.”
Key Near Term Pipeline
Updates:
-
Alzheimer’s disease: Full data ANAVEX®2-73-AD-004:
Potentially pivotal Phase 2b/3 clinical trial
-
Parkinson’s disease dementia: Data of 48-week OLE
Phase 2 study
-
Parkinson’s disease: Initiation of ANAVEX®2-73
imaging-focused clinical trial
- Fragile
X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3
clinical trial
-
Schizophrenia: Initiation of ANAVEX®3-71 Phase 2
clinical trial
- New Rare
disease: Initiation of potentially pivotal ANAVEX®2-73
Phase 2/3 clinical trial
- Publications:
Several clinical publications involving ANAVEX®2-73, ANAVEX®3-71
and Rett syndrome Burden of Illness study
Recent Business Highlights:
- On February 2nd,
2023, the Company announced completion of enrollment of the
randomized, placebo-controlled EXCELLENCE Phase 2/3 study
ANAVEX®2-73-RS-003 for the treatment of pediatric patients with
Rett syndrome. Company expects to announce topline results from
this study in the second half of 2023.
- On January 12th,
2023, Anavex presented at the 41st Annual J.P. Morgan Healthcare
Conference, in San Francisco, CA.
- On December
14th, 2022, Anavex strengthened its Scientific Advisory Board with
the appointment of Prof. Dr. Timo Grimmer, MD. Prof. Dr. Grimmer
served as National Coordinating Investigator for the ANAVEX®2-73
Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial.
- On December 1st,
2022, the Company announced, in a late breaking oral presentation
at the Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022,
the top line data of its randomized, double-blind, multicenter,
placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the
treatment of early Alzheimer’s disease. The trial met both its
co-primary and key secondary endpoints, showing statistically
significant and clinically meaningful improvement in cognition and
function as measured by ADAS-Cog, ADCS-ADL, and CDR-SB,
respectively.
Financial Highlights:
- Cash and cash
equivalents of $143.6 million at December 31, 2022 compared to
$149.2 million at year end September 30, 2022.
- General and
administrative expenses for the quarter of $3.3 million compared to
$3.1 million for the comparable quarter of fiscal 2022.
- Research and
development expenses for the quarter of $12.1 million compared to
$8.7 million for the comparable quarter of fiscal 2022.
- Net loss for the
quarter of $13.0 million, inclusive of $5.3 million in non-cash
items, or $0.17 per share, compared to a net loss of $10.9 million,
or $0.14 per share for the comparable quarter of fiscal 2022.
The financial information for the quarter ended
December 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:
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 1-305-224-1968 for participants in the U.S. using the
Meeting ID# 891 9995 1143 and reference passcode 511901. 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 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 and recently a Phase 2b/3
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. |
Interim Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited - Expressed in US Dollars) |
|
|
Three months ended December 31, |
|
|
2022 |
|
|
2021 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
3,317,036 |
|
$ |
3,066,951 |
|
Research and development |
|
12,066,919 |
|
|
8,656,439 |
|
Total operating
expenses |
|
15,383,955 |
|
|
11,723,390 |
|
Operating
loss |
|
(15,383,955 |
) |
|
(11,723,390 |
) |
|
|
|
Other
income |
|
|
Grant income |
|
25,000 |
|
|
- |
|
Research and development
incentive income |
|
733,590 |
|
|
810,730 |
|
Interest income, net |
|
1,267,618 |
|
|
4,910 |
|
Foreign exchange gain,
net |
|
365,983 |
|
|
55,363 |
|
Total other income,
net |
|
2,392,191 |
|
|
871,003 |
|
Net loss before provision for
income taxes |
|
(12,991,764 |
) |
|
(10,852,387 |
) |
Income tax recovery (expense),
current |
|
20,046 |
|
|
(29,980 |
) |
Net loss and
comprehensive loss |
$ |
(12,971,718 |
) |
$ |
(10,882,367 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.17 |
) |
$ |
(0.14 |
) |
|
|
|
Weighted average number of
shares outstanding |
|
|
Basic and diluted |
|
77,977,112 |
|
|
75,997,738 |
|
Anavex Life Sciences Corp. |
Interim Condensed Consolidated Balance Sheets |
At December 31, 2022 and September 30, 2022 |
(Unaudited) |
Expressed in US Dollars |
|
|
|
December 31,2022 |
September 30, 2022 |
Assets |
|
|
Current |
|
|
Cash and cash equivalents |
$ |
143,621,848 |
|
$ |
149,157,861 |
|
Incentive and tax
receivables |
|
4,094,431 |
|
|
3,192,580 |
|
Prepaid expenses and other
current assets |
|
655,643 |
|
|
354,162 |
|
Total
Assets |
$ |
148,371,922 |
|
$ |
152,704,603 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
Current
Liabilities |
|
|
Accounts payable |
$ |
5,288,261 |
|
$ |
3,824,777 |
|
Accrued liabilities |
|
7,042,822 |
|
|
5,944,953 |
|
Deferred grant income |
|
916,763 |
|
|
443,831 |
|
Total
Liabilities |
|
13,247,846 |
|
|
10,213,561 |
|
Capital Stock |
|
78,033 |
|
|
77,944 |
|
Additional paid-in
capital |
|
393,581,544 |
|
|
387,976,881 |
|
Accumulated deficit |
|
(258,535,501 |
) |
|
(245,563,783 |
) |
Total Stockholders'
Equity |
|
135,124,076 |
|
|
142,491,042 |
|
Total Liabilities and
Stockholders' Equity |
$ |
148,371,922 |
|
$ |
152,704,603 |
|
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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