Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update
2024年8月6日 - 8:30PM
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of Alzheimer's
disease, Parkinson's disease, schizophrenia, neurodevelopmental,
neurodegenerative, and rare diseases, including Rett syndrome, and
other central nervous system (CNS) diseases, today reported
financial results for its fiscal quarter ended June 30, 2024.
“We continue to meaningfully advance our
differentiated precision medicine clinical program, highlighted by
the recent presentation of comprehensive results from the Phase
2b/3 clinical trial of blarcamesine (ANAVEX®2-73), which were
presented at the Alzheimer’s Association International Conference
(AAIC), showing that oral, once daily blarcamesine significantly
slowed clinical decline for early Alzheimer's disease patients with
good comparative safety profile and no associated neuroimaging
adverse events. We are also pleased to report that the clinical
team continues to beat the planned timelines in the ongoing
ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71 in schizophrenia
patients,” said Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex. “Additionally, we remain dedicated to
developing medicines for individuals suffering from brain disorders
within neurodegenerative and neurodevelopmental disorders, which
could further expand our differentiated precision medicine platform
to deliver scalable treatment options coupled with convenient oral
dosing.”
Key Pipeline Updates:
- Alzheimer’s disease:
- Full data from the blarcamesine in
Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial
will be published in an upcoming peer-reviewed journal. The
initiated process for submitting a Marketing Authorisation
application (MAA) to the European Medicines Agency (EMA) under the
Centralised Procedure is underway, with full regulatory submission
of blarcamesine expected in Q4 2024. 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
- Analysis of RNA sequencing
(RNA-seq), which would reveal which genes are actively transcribed
(expressed) in Alzheimer’s patients in comparison between placebo
and blarcamesine of the placebo-controlled Phase 2b/3 blarcamesine
trial in early Alzheimer’s disease. This data might have relevant
value since it may provide insight into Alzheimer’s disease
pathology and how cells function in presence of placebo or in
presence of blarcamesine, respectively. Interim data expected in
the second half of 2024.
- Completed last patient last visit
in the ATTENTION-AD open-label extension 96-week trial. Interim
data expected in the second half of 2024.
- AAIC 2024 meeting resulted in
constructive feedback received coupled with enthusiasm around our
Alzheimer’s disease program strengthened by the recent addition of
an experienced clinical team, which support Anavex future plans.
Educational reach out to continue towards MAA submission and
beyond.
- Schizophrenia: The
placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical trial of
ANAVEX®3-71 for the treatment of schizophrenia has completed dosing
of the first cohort and is nearing the completion of enrollment of
the second cohort of schizophrenia patients in Part A of the
trial.
- Parkinson’s
disease: Initiation of ANAVEX®2-73 Phase 2b/3 >6-month
trial, including biomarkers, which we believe may be key to
understanding drug effects on Parkinson’s disease pathophysiology
and account for the recently changing context in the field of
Parkinson’s disease is expected in the second half of 2024.
- Rett syndrome: An
educational presentation was provided at the 2024 IRSF Rett
Syndrome Scientific Meeting, June 18 – June 19, 2024, which
demonstrated the commitment of Anavex to the Rett syndrome
community through direct engagement with patients and families.
Positive and supportive feedback was received from families and
investigators about the continued Anavex Rett syndrome
program.
- Fragile X: New
disease-specific, translatable, and objective biomarker data
generated with ANAVEX®2-73, supporting the initiation of the
ANAVEX®2-73 Phase 2/3 clinical trial was presented at the 19th NFXF
International Fragile X Conference. Meeting with NFXF leadership
team strengthened Anavex’s relationship with community coupled with
increased awareness of Anavex’s Fragile X syndrome (FXS) program by
engaging with patients and families in attendance.
- New Rare disease:
Initiation of ANAVEX®2-73 Phase 2/3 clinical trial.
- Medical Affairs:
Building Medical Affairs capabilities to expand education and
physician support activities to ensure optimal medical impact
including continued clinical publications involving ANAVEX®2-73 and
ANAVEX®3-71.
Recent Business Highlights:
- On May 22, 2024, Anavex announced
new additions to its leadership team with the appointment of Juan
Carlos Lopez-Talavera, MD, PhD as Senior Vice President, Head of
Research and Development, Terrie Kellmeyer, PhD as Senior Vice
President of Clinical Development, and Jeffrey Edwards, PhD as Vice
President of Clinical Pharmacology and Science, all with a track
record of successfully bringing drugs to market.
- On July 28, 2024, comprehensive
results from the Phase 2b/3 clinical trial of ANAVEX®2-73
(blarcamesine) were presented at the Alzheimer’s Association
Conference (AAIC), showing that oral, once daily blarcamesine
significantly slowed clinical decline for early Alzheimer's disease
patients with good comparative safety profile and no associated
neuroimaging adverse events. The clinical benefit of blarcamesine
was consistently observed for both 30 mg and 50 mg treatment
groups, and the results demonstrated benefits of blarcamesine on
both cognitive and functional parameters (ADAS-Cog13, CDR-SB,
CGI-I), as well as amyloid-beta and brain volume, two underlying
pathological hallmarks of Alzheimer’s disease.
- On July 30, 2024, Anavex reported
positive preclinical results in biomarkers that are directly
translatable to humans for individuals with FXS for ANAVEX®2-73
(blarcamesine), in a disease model of Fragile X syndrome (FXS). The
findings presented at the 19th NFXF International Fragile X
Conference reports positive results for electroencephalogram (EEG)
biomarkers that are directly translatable to humans and present in
both individuals with FXS and animal models of FXS.
Financial Highlights:
- Cash and cash equivalents of $138.8
million at June 30, 2024 compared to $151.0 million at fiscal
yearend September 30, 2023. The Company anticipates at the current
cash utilization rate a runway of approximately 4 years.
- General and administrative expenses
for the quarter of $2.9 million compared to $3.2 million for the
comparable quarter of fiscal 2023.
- Research and development expenses
for the quarter of $11.9 million compared to $10.3 million for the
comparable quarter of fiscal 2023.
- Net loss for the quarter of $12.2
million, or $0.14 per share, compared to a net loss of $11.3
million, or $0.14 per share for the comparable quarter of fiscal
2023.
The financial information for the fiscal quarter
ended June 30, 2024, should be read in conjunction with the
Company’s condensed consolidated interim 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# 821 9280 7728 and reference passcode 121725. 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, neurodevelopmental, and neuropsychiatric
disorders, including Alzheimer's disease, Parkinson's disease,
schizophrenia, 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 and one Phase 2/3 study in pediatric
patients with Rett syndrome. ANAVEX®2-73 is an orally available
drug candidate designed to restore cellular homeostasis by
targeting SIGMAR1 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. We believe that ANAVEX®3-71,
which targets SIGMAR1 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.
____________________1
https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
|
Anavex Life Sciences Corp. |
Condensed Consolidated Interim Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
|
Three months ended June 30, |
|
2024 |
2023 |
Operating Expenses |
|
|
General and administrative |
$ |
2,859 |
|
$ |
3,248 |
|
Research and development |
|
11,870 |
|
|
10,283 |
|
Total operating expenses |
|
14,729 |
|
|
13,531 |
|
Operating loss |
|
(14,729 |
) |
|
(13,531 |
) |
|
|
|
Other income |
|
|
Research and development incentive income |
|
526 |
|
|
565 |
|
Interest income, net |
|
1,796 |
|
|
1,828 |
|
Foreign exchange gain (loss) |
|
67 |
|
|
(101 |
) |
Gain on settlement of accounts payable |
|
59 |
|
|
- |
|
Total other income, net |
|
2,448 |
|
|
2,292 |
|
Net loss before provision for income taxes |
|
(12,281 |
) |
|
(11,239 |
) |
Income tax recovery (expense), current |
|
67 |
|
|
(41 |
) |
Net loss and comprehensive loss |
$ |
(12,214 |
) |
$ |
(11,280 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.14 |
) |
$ |
(0.14 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
84,535,328 |
|
|
80,875,235 |
|
|
|
|
|
|
|
|
Anavex Life Sciences Corp. |
Condensed Consolidated Interim Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
|
Nine months ended June 30, |
|
2024 |
2023 |
Operating Expenses |
|
|
General and administrative |
$ |
8,258 |
|
$ |
9,447 |
|
Research and development |
|
30,283 |
|
|
33,657 |
|
Total operating expenses |
|
38,541 |
|
|
43,104 |
|
Operating loss |
|
(38,541 |
) |
|
(43,104 |
) |
|
|
|
Other income |
|
|
Grant income |
|
- |
|
|
25 |
|
Research and development incentive income |
|
1,591 |
|
|
2,048 |
|
Interest income, net |
|
5,561 |
|
|
4,561 |
|
Other financing expense |
|
- |
|
|
(964 |
) |
Foreign exchange gain (loss) |
|
72 |
|
|
146 |
|
Gain on settlement of accounts payable |
|
59 |
|
|
- |
|
Total other income, net |
|
7,283 |
|
|
5,816 |
|
Net loss before provision for income taxes |
|
(31,258 |
) |
|
(37,288 |
) |
Income tax expense, current |
|
(124 |
) |
|
(71 |
) |
Net loss and comprehensive loss |
$ |
(31,382 |
) |
$ |
(37,359 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.38 |
) |
$ |
(0.47 |
) |
|
|
|
Weighted average number of shares outstanding |
|
Basic and diluted |
|
83,022,330 |
|
|
79,051,038 |
|
|
|
|
|
|
|
|
|
|
Anavex Life Sciences Corp. |
Condensed Consolidated Interim Balance Sheets |
(in thousands, except share and per share amounts) |
|
|
|
|
|
|
June 30, |
September 30, |
|
2024 |
2023 |
Assets |
|
|
|
|
Current |
|
|
|
|
Cash and cash equivalents |
$ |
138,756 |
|
$ |
151,024 |
|
Incentive and tax
receivables |
1,720 |
|
2,709 |
|
Prepaid expenses and other
current assets |
1,059 |
|
653 |
|
Total
Assets |
$ |
141,535 |
|
$ |
154,386 |
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
Current
Liabilities |
|
|
|
|
Accounts payable |
$ |
3,503 |
|
$ |
4,322 |
|
Accrued liabilities |
7,334 |
|
7,295 |
|
Deferred grant income |
917 |
|
917 |
|
Total
Liabilities |
11,754 |
|
12,534 |
|
Capital Stock |
85 |
|
82 |
|
Additional paid-in
capital |
454,236 |
|
434,839 |
|
Share proceeds receivable |
(89 |
) |
- |
|
Accumulated deficit |
(324,451 |
) |
(293,069 |
) |
Total Stockholders'
Equity |
129,781 |
|
141,852 |
|
Total Liabilities and
Stockholders' Equity |
$ |
141,535 |
|
$ |
154,386 |
|
|
|
|
|
|
For Further Information: Anavex
Life Sciences Corp. Research & Business Development Toll-free:
1-844-689-3939 Email: info@anavex.com
Investors: Andrew J. Barwicki
Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com
Anavex Life Sciences (NASDAQ:AVXL)
過去 株価チャート
から 8 2024 まで 9 2024
Anavex Life Sciences (NASDAQ:AVXL)
過去 株価チャート
から 9 2023 まで 9 2024