Anavex Life Sciences Reports Fiscal 2023 Year End Financial Results and Provides Business Update
November 27 2023 - 8:00AM
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
year ended September 30, 2023.
“We are very excited to be entering a new phase
of the Company’s history. For the first time we initiated the
process of submitting a Marketing Authorisation application to the
European Medicines Agency (EMA) for blarcamesine related to the
treatment of Alzheimer’s disease. Relatedly, we are starting to
explore possible commercial activities and examining innovative
strategies to effectively engage patients, providers and payers,”
said Christopher U Missling, PhD, President and Chief Executive
Officer of Anavex. “There is a high demand from Alzheimer’s disease
patients and families for easy access and scalable treatment
options. We are striving to work towards presenting a drug that
will potentially improve patients' lives with our precision
medicine oral blarcamesine, which is intended to reduce the need
for complex procedures for the treatment of people with Alzheimer’s
disease.”
Key Pipeline Updates:
-
Alzheimer’s disease: Full data from the
blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical
trial will be published in an upcoming peer-reviewed journal. The
Company has initiated the process for submitting a Marketing
Authorisation application to the European Medicines Agency (EMA)
under the Centralised Procedure. The Marketing Authorisation would
allow direct market access throughout the European Union for oral
blarcamesine for the treatment of Alzheimer’s disease. There are an
estimated 7 million people in Europe with Alzheimer’s disease, a
number expected to double by 2030, according to the European Brain
Council.1
-
Alzheimer’s disease: Ongoing ATTENTION-AD
open-label extension 96-week trial.
- Rett
syndrome: On track for top-line data of potentially
pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical
trial.
-
Parkinson’s disease: Initiation of ANAVEX®2-73
imaging-focused trial and Phase 2b/3 6 months trial.
-
Schizophrenia: Initiation of ANAVEX®3-71 Phase 2
clinical trial.
- Fragile
X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3
clinical trial.
- New Rare
disease: Initiation of potentially pivotal ANAVEX®2-73
Phase 2/3 clinical trial.
- Publications:
Continued clinical publications involving ANAVEX®2-73 and
ANAVEX®3-71.
1
https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
Recent Business Highlights:
- On November 22,
2023, the Company announced that the United States Patent and
Trademark Office (USPTO) granted U.S. Patent No. 11,813,242
entitled “A2-73 AS A THERAPEUTIC FOR INSOMNIA, ANXIETY, AND
AGITATION”. This patent expands Anavex’s existing patent coverage
of blarcamesine (ANAVEX®2-73), including U.S. Patent No. 11,337,953
to cover Anavex’s leading drug candidate, blarcamesine
(ANAVEX®2-73), ANAVEX®1-41 and ANAVEX®19-144, for treating
insomnia, anxiety or agitation.
- On November 20,
2023, the Company announced the initiation of the process for
submitting a Marketing Authorisation application under the
Centralised Procedure. The Marketing Authorisation would allow
direct market access throughout the European Union for oral
blarcamesine (ANAVEX®2-73) for the treatment of Alzheimer’s
disease.
- On November 6,
2023, the Company announced the appointment of David Goldberger,
RPh, MLS as Senior Vice President Regulatory Affairs. Mr.
Goldberger brings over 40 years of pharmacy practice and
pharmaceutical industry experience to the Company.
- On October 25,
2023, the Company announced a new peer-reviewed publication in the
journal Neurobiology of Aging, titled “Early treatment with an M1
and sigma-1 receptor agonist prevents cognitive decline in a
transgenic rat model displaying Alzheimer-like amyloid pathology”,
featuring the orally available small molecule ANAVEX®3-71 (AF710B).
This preclinical study describes the potential disease-modifying
properties of ANAVEX®3-71 on Alzheimer’s disease pathology as a
possible drug candidate for a once daily oral preventive strategy
for Alzheimer’s disease.
- On September 14,
2023, the Company announced that the Phase 2b/3 clinical trial to
treat Alzheimer’s disease with blarcamesine (ANAVEX®2-73)
demonstrated a statistically significant slowing in cognitive
decline associated with Alzheimer's disease. The clinical effect
was complemented by two independent biomarkers: A significant
reduction in pathological amyloid beta levels in plasma, as well as
a significant slowing in the rate of pathological brain volume
loss.
- On September 12,
2023, the Company announced the appointment of Prof. Dr. Marwan N
Sabbagh, MD as Chairman of the Scientific Advisory Board. Dr.
Sabbagh is a behavioral neurologist in the Alzheimer’s and Memory
Disorders Program at Barrow Neurological Institute and is also a
professor and the Vice Chair of Research in the Institute’s
Department of Neurology. He is board certified in neurology by the
American Board of Psychiatry and Neurology and is a fellow of the
American Academy of Neurology. Dr. Sabbagh is also a prolific
author who has written and edited books on Alzheimer’s disease and
has contributed to hundreds of medical and scientific
articles.
Financial Highlights:
- Cash and cash
equivalents of $151.0 million at September 30, 2023 compared to
$149.2 million at September 30, 2022.
- General and
administrative expenses for the fourth quarter of $2.6 million
compared to $3.9 million for the comparable fourth quarter of
fiscal 2022.
- Research and
development expenses for the fourth quarter of $10.0 million
compared to $11.4 million for the comparable fourth quarter of
fiscal 2022.
- Net loss for the
fourth quarter of $10.1 million, inclusive of $3.2 million in
non-cash items, or $0.12 per share, compared to a net loss of $14.3
million, inclusive of $6.0 million in non-cash items, or $0.18 per
share for the comparable fourth quarter of fiscal 2022.
The financial information for the fiscal year
ended September 30, 2023, should be read in conjunction with the
Company’s 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
Meeting ID# 860 5505 7787 and reference passcode 146807. 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 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
StatementsStatements 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. |
Consolidated Statements of Operations and Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
|
Three months ended September 30, |
|
|
2023 |
|
|
2022 |
|
Operating Expenses |
|
|
General and administrative |
$ |
2,592 |
|
$ |
3,903 |
|
Research and development |
|
10,061 |
|
|
11,381 |
|
Total operating expenses |
|
12,653 |
|
|
15,284 |
|
Operating loss |
|
(12,653 |
) |
|
(15,284 |
) |
|
|
|
Other income |
|
|
Research and development incentive income |
|
670 |
|
|
994 |
|
Interest income, net |
|
1,958 |
|
|
705 |
|
Foreign exchange loss, net |
|
(186 |
) |
|
(495 |
) |
Total other income, net |
|
2,442 |
|
|
1,204 |
|
Net loss before provision for income taxes |
|
(10,211 |
) |
|
(14,080 |
) |
Income tax recovery (expense), current |
|
64 |
|
|
(210 |
) |
Net loss and comprehensive loss |
$ |
(10,147 |
) |
$ |
(14,290 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.12 |
) |
$ |
(0.18 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
81,973,250 |
|
|
77,442,470 |
|
|
|
|
|
|
|
|
Anavex Life Sciences Corp. |
Consolidated Statements of Operations and Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
|
Year ended September 30, |
|
|
2023 |
|
|
2022 |
|
Operating Expenses |
|
|
General and administrative |
$ |
12,039 |
|
$ |
13,070 |
|
Research and development |
|
43,717 |
|
|
37,916 |
|
Total operating expenses |
|
55,756 |
|
|
50,986 |
|
Operating loss |
|
(55,756 |
) |
|
(50,986 |
) |
|
|
|
Other income |
|
|
Grant income |
|
25 |
|
|
- |
|
Research and development incentive income |
|
2,718 |
|
|
3,323 |
|
Interest income, net |
|
6,519 |
|
|
947 |
|
Other financing expense |
|
(964 |
) |
|
- |
|
Foreign exchange loss, net |
|
(40 |
) |
|
(904 |
) |
Total other income, net |
|
8,258 |
|
|
3,366 |
|
Net loss before provision for income taxes |
|
(47,498 |
) |
|
(47,620 |
) |
Income tax expense, current |
|
(7 |
) |
|
(358 |
) |
Net loss and comprehensive loss |
$ |
(47,505 |
) |
$ |
(47,978 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.60 |
) |
$ |
(0.62 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
79,787,596 |
|
|
76,909,993 |
|
|
|
|
|
|
|
|
Anavex Life Sciences Corp. |
Consolidated Balance Sheets |
(in thousands, except share and per share amounts) |
|
|
|
|
September 30, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
Current |
|
|
Cash and cash equivalents |
$ |
151,024 |
|
$ |
149,158 |
|
Incentive and tax receivables |
|
2,709 |
|
|
3,193 |
|
Prepaid expenses and other current assets |
|
653 |
|
|
354 |
|
Total Assets |
$ |
154,386 |
|
$ |
152,705 |
|
|
|
|
Liabilities and stockholders' equity |
|
|
Current Liabilities |
|
|
Accounts payable |
$ |
4,322 |
|
$ |
3,825 |
|
Accrued liabilities |
|
7,295 |
|
|
5,945 |
|
Deferred grant income |
|
917 |
|
|
444 |
|
Total Liabilities |
|
12,534 |
|
|
10,214 |
|
Capital Stock |
|
82 |
|
|
78 |
|
Additional paid-in capital |
|
434,839 |
|
|
387,977 |
|
Accumulated deficit |
|
(293,069 |
) |
|
(245,564 |
) |
Total Stockholders' Equity |
|
141,852 |
|
|
142,491 |
|
Total Liabilities and Stockholders' Equity |
$ |
154,386 |
|
$ |
152,705 |
|
|
|
|
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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