Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results
May 09 2023 - 6:30AM
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, 2023.
“Recent positive clinical study results and FDA
approvals through the Accelerated Approval Pathway are positive for
the Alzheimer’s disease community, especially for the patients,
families and caregivers who fight everyday against this devastating
disease. We look forward to presenting the complete dataset of the
Phase 2b/3 Alzheimer’s disease trial of ANAVEX®2-73 (blarcamesine),
an orally available, small-molecule activator of the upstream
sigma-1 receptor (SIGMAR1), involved in restoring neural cell
homeostasis and promoting neuroplasticity, which might be at the
forefront of patient-centric, next-generation biomarker-guided
precision medicine Alzheimer’s disease treatments. With newly
available preliminary efficacy results of surrogate biomarkers, we
consider initiating discussions with regulatory agencies for
Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine),” said
Christopher U Missling, PhD, President and Chief Executive Officer
of Anavex. "We also look forward to making meaningful advances in
our neurodevelopmental and other neurodegenerative precision
medicine portfolio this year with the expected topline data from
the potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE
pediatric clinical trial in the second half of 2023. Additionally,
we continue to focus on initiating our pivotal study of ANAVEX®2-73
(blarcamesine) in patients with Parkinson’s disease, the second
largest neurodegenerative disease after Alzheimer’s disease.”
Key Near Term Pipeline
Updates:
-
Alzheimer’s disease: Full data ANAVEX®2-73-AD-004,
including newly available preliminary results of surrogate
biomarkers of pivotal Phase 2b/3 clinical trial. The Company
intends to discuss these findings with regulatory authorities in
the context of the ongoing clinical development of ANAVEX®2-73 in
this indication, with the goal of providing a much-needed treatment
to the millions of patients living with Alzheimer’s disease with a
convenient once-daily oral treatment. The Company plans to proceed
in parallel with the initiation of a confirmatory Alzheimer’s
disease study.
- Rett
syndrome: Top-line data of potentially pivotal
ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial.
Company expects to announce topline results from this study in the
second half of 2023.
-
Parkinson’s disease: Initiation of ANAVEX®2-73
pivotal clinical trial.
-
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 May 2nd,
2023, the Company participated in a fireside chat at the
H.C.Wainright BioConnect Investor Conference at NASDAQ World
Headquarters in New York.
- On May 1st,
2023, the Company announced that it was granted a new U.S. Patent
No. 11,622,955 entitled “SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD
PRESSURE THERAPY,” from the United States Patent and Trademark
Office (USPTO), expanding Anavex’s coverage of treatment methods
for ANAVEX®2-73 (blarcamesine), to the treatment of systolic
hypertension, or lowering systolic blood pressure.
- On April 17th,
2023, the Company presented at the 22nd Annual Needham Virtual
Healthcare Conference 2023.
- On March 30th,
2023, the Company reported the preliminary 48-week open label
extension Parkinson’s disease dementia ANAVEX2-73-PDD-EP-001 Phase
2 clinical trial data, which demonstrated longitudinal beneficial
effects of ANAVEX®2-73 on the prespecified primary and secondary
objectives, as well as planned primary and key secondary endpoints
which will be utilized in a forthcoming pivotal study of
ANAVEX®2-73 in Parkinson’s disease.
- On March 9th,
2023, Anavex announced the appointment of Kun Jin, PhD, as Vice
President, Head of Biostatistics. Dr. Jin will draw on his
extensive experience, including recently as the Statistical Team
Leader at the U.S. Food and Drug Administration (FDA).
Financial Highlights:
- Cash and cash
equivalents of $153.5 million at March 31, 2023 compared to $149.2
million at year end September 30, 2022.
- General and
administrative expenses for the quarter of $2.9 million compared to
$2.9 million for the comparable quarter of fiscal 2022.
- Research and
development expenses for the quarter of $11.3 million compared to
$8.6 million for the comparable quarter of fiscal 2022.
- Net loss for the
quarter of $13.1 million, inclusive of $4.8 million in non-cash
items, or $0.17 per share, compared to a net loss of $10.4 million,
inclusive of $4.4 million in non-cash items, or $0.14 per share for
the comparable quarter of fiscal 2022.
The financial information for the quarter ended
March 31, 2023, 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 on Tuesday May 9, 2023,
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 1 929 205 6099 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 March 31, |
|
|
|
|
|
2023 |
|
|
2022 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
2,882,568 |
|
$ |
2,915,158 |
|
Research and development |
|
11,306,591 |
|
|
8,604,589 |
|
Total operating
expenses |
|
14,189,159 |
|
|
11,519,747 |
|
Operating
loss |
|
(14,189,159 |
) |
|
(11,519,747 |
) |
|
|
|
Other
income |
|
|
Research and development
incentive income |
|
749,681 |
|
|
835,513 |
|
Interest income, net |
|
1,465,221 |
|
|
7,578 |
|
Other financing expense |
|
(964,344 |
) |
|
- |
|
Foreign exchange (loss) gain,
net |
|
(118,678 |
) |
|
268,645 |
|
Total other income,
net |
|
1,131,880 |
|
|
1,111,736 |
|
Net loss before provision for
income taxes |
|
(13,057,279 |
) |
|
(10,408,011 |
) |
Income tax expense,
current |
|
(50,000 |
) |
|
(29,800 |
) |
Net loss and
comprehensive loss |
$ |
(13,107,279 |
) |
$ |
(10,437,811 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.17 |
) |
$ |
(0.14 |
) |
|
|
|
Weighted average number of
shares outstanding |
|
|
Basic and diluted |
|
78,304,363 |
|
|
76,248,603 |
|
|
Anavex Life Sciences Corp. |
Interim Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited - Expressed in US Dollars) |
|
|
Six months ended March 31, |
|
|
|
|
|
2023 |
|
|
2022 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
6,199,604 |
|
$ |
5,982,109 |
|
Research and development |
|
23,373,510 |
|
|
17,261,028 |
|
Total operating
expenses |
|
29,573,114 |
|
|
23,243,137 |
|
Operating
loss |
|
(29,573,114 |
) |
|
(23,243,137 |
) |
|
|
|
Other
income |
|
|
Grant income |
|
25,000 |
|
|
- |
|
Research and development
incentive income |
|
1,483,271 |
|
|
1,646,243 |
|
Interest income, net |
|
2,732,839 |
|
|
12,488 |
|
Other financing expense |
|
(964,344 |
) |
|
- |
|
Foreign exchange gain,
net |
|
247,305 |
|
|
324,008 |
|
Total other income,
net |
|
3,524,071 |
|
|
1,982,739 |
|
Net loss before provision for
income taxes |
|
(26,049,043 |
) |
|
(21,260,398 |
) |
Income tax expense,
current |
|
(29,954 |
) |
|
(59,780 |
) |
Net loss and
comprehensive loss |
$ |
(26,078,997 |
) |
$ |
(21,320,178 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.33 |
) |
$ |
(0.28 |
) |
|
|
|
Weighted average number of
shares outstanding |
|
|
Basic and diluted |
|
78,138,940 |
|
|
76,121,792 |
|
|
Anavex Life Sciences Corp. |
Interim Condensed Consolidated Balance Sheets |
At March 31, 2023 and September 30, 2022 |
(Unaudited – Expressed in US Dollars) |
|
|
|
|
March 31, 2023 |
September 30,2022 |
Assets |
|
|
Current |
|
|
Cash and cash equivalents |
$ |
153,466,962 |
|
$ |
149,157,861 |
|
Incentive and tax
receivables |
|
4,737,661 |
|
|
3,192,580 |
|
Prepaid expenses and other
current assets |
|
981,774 |
|
|
354,162 |
|
Total
Assets |
$ |
159,186,397 |
|
$ |
152,704,603 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
Current
Liabilities |
|
|
Accounts payable |
$ |
6,281,742 |
|
$ |
3,824,777 |
|
Accrued liabilities |
|
6,822,838 |
|
|
5,944,953 |
|
Deferred grant income |
|
916,763 |
|
|
443,831 |
|
Total
Liabilities |
|
14,021,343 |
|
|
10,213,561 |
|
Capital Stock |
|
80,236 |
|
|
77,944 |
|
Additional paid-in
capital |
|
416,727,598 |
|
|
387,976,881 |
|
Accumulated deficit |
|
(271,642,780 |
) |
|
(245,563,783 |
) |
Total Stockholders'
Equity |
|
145,165,054 |
|
|
142,491,042 |
|
Total Liabilities and Stockholders' Equity |
$ |
159,186,397 |
|
$ |
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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