Anavex Life Sciences Reports Fiscal 2023 Third Quarter Financial Results
August 08 2023 - 7:30AM
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 June 30, 2023.
“We are very excited to be entering an important
phase of the Company, with several key data readouts based on
innovative science at Anavex with 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,” said Christopher U Missling, PhD,
President and Chief Executive Officer of Anavex. “We remain focused
on execution as we prepare for a pivotal year ahead of us
potentially involving a digital ‘Healthcare Sales Marketing’ pharma
platform and also making meaningful advances in our other
neurodevelopmental and neurodegenerative precision medicine
portfolio, including schizophrenia and Parkinson’s disease.”
Key Near Term Pipeline
Updates:
- 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.
-
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. Company expects to announce
data 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 August 7,
2023, the Company announced a peer-reviewed publication in Clinical
Pharmacology in Drug Development, findings from the ANAVEX®3-71
first-in-human study which achieved its cardiovascular safety
objectives. The publication is entitled, ‘Concentration-QTc
Relationship from a Single Ascending Dose Study of ANAVEX3-71, a
Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor
Agonist in Development for the Treatment of Frontotemporal
Dementia, Schizophrenia, and Alzheimer's Disease’.
- On June 28,
2023, the Company announced that long-term clinical study results
from the U.S. ANAVEX®2-73-RS-001 clinical trial demonstrate
disease-modifying effect of ANAVEX®2-73 (blarcamesine) for adult
patients with Rett syndrome.
- On June 27,
2023, the Company announced a strategic partnership with Partex
N.V. Group, the first Data-to-Drugs digital pharma platform in
which Partex will implement AI-based ‘Healthcare Sales Marketing’
in preparation for Anavex’s late-stage drug pipeline.
- On June 12,
2023, the Company announced the publication of a relevant new
peer-reviewed study in the American Journal on Intellectual and
Developmental Disabilities, entitled ‘Rett Syndrome Behaviour
Questionnaire in Children and Adults With Rett Syndrome:
Psychometric Characterization and Revised Factor Structure.’ In the
EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 Rett syndrome pediatric
clinical trial, the characterized Rett Syndrome Behaviour
Questionnaire (RBSQ), together with the Clinical Global Impression
Improvement Scale (CGI-I), represent the co-primary efficacy
endpoints of the study.
- On June 6, 2023,
the Company announced completion of dosing of all participants of
the placebo-controlled EXCELLENCE Phase 2/3 clinical trial
ANAVEX®2-73-RS-003 in pediatric patients with Rett syndrome.
- On June 1, 2023,
the Company announced that it was awarded a new U.S. Patent No.
11,661,405 entitled “CRYSTAL FORMS OF
TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE
HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR
PHARMACEUTICAL COMPOSITIONS” from the United States Patent and
Trademark Office (USPTO), expanding Anavex’s patent coverage of
certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions,
processes of preparation, and uses thereof.
Financial Highlights:
- Cash and cash
equivalents of $154.8 million at June 30, 2023 compared to $149.2
million at fiscal year end September 30, 2022.
- General and
administrative expenses for the quarter of $3.2 million compared to
$3.2 million for the comparable quarter of fiscal 2022.
- Research and
development expenses for the quarter of $10.3 million compared to
$9.3 million for the comparable quarter of fiscal 2022.
- Net loss for the
quarter of $11.3 million, inclusive of $3.9 million in non-cash
items, or $0.14 per share, compared to a net loss of $12.4 million,
inclusive of $4.0 million in non-cash items, or $0.16 per share for
the comparable quarter of fiscal 2022.
The financial information for the quarter ended
June 30, 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:
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 June 30, |
|
|
|
|
|
2023 |
|
|
2022 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
3,247,843 |
|
$ |
3,185,451 |
|
Research and development |
|
10,282,854 |
|
|
9,273,269 |
|
Total operating
expenses |
|
13,530,697 |
|
|
12,458,720 |
|
Operating
loss |
|
(13,530,697 |
) |
|
(12,458,720 |
) |
|
|
|
Other
income |
|
|
Research and development
incentive income |
|
564,842 |
|
|
682,432 |
|
Interest income, net |
|
1,827,945 |
|
|
229,917 |
|
Foreign exchange loss,
net |
|
(101,066 |
) |
|
(732,549 |
) |
Total other income,
net |
|
2,291,721 |
|
|
179,800 |
|
Net loss before provision for
income taxes |
|
(11,238,976 |
) |
|
(12,278,920 |
) |
Income tax expense,
current |
|
(41,000 |
) |
|
(88,421 |
) |
Net loss and
comprehensive loss |
$ |
(11,279,976 |
) |
$ |
(12,367,341 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.14 |
) |
$ |
(0.16 |
) |
|
|
|
Weighted average number of
shares outstanding |
|
|
Basic and diluted |
|
80,875,235 |
|
|
77,442,236 |
|
Anavex Life Sciences Corp. |
Interim Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited - Expressed in US Dollars) |
|
|
Nine months ended June 30, |
|
|
|
|
|
2023 |
|
|
2022 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
9,447,447 |
|
$ |
9,167,560 |
|
Research and development |
|
33,656,364 |
|
|
26,534,297 |
|
Total operating
expenses |
|
43,103,811 |
|
|
35,701,857 |
|
Operating
loss |
|
(43,103,811 |
) |
|
(35,701,857 |
) |
|
|
|
Other
income |
|
|
Grant income |
|
25,000 |
|
|
- |
|
Research and development
incentive income |
|
2,048,113 |
|
|
2,328,675 |
|
Interest income, net |
|
4,560,784 |
|
|
242,405 |
|
Other financing expense |
|
(964,344 |
) |
|
- |
|
Foreign exchange gain (loss),
net |
|
146,239 |
|
|
(408,541 |
) |
Total other income,
net |
|
5,815,792 |
|
|
2,162,539 |
|
Net loss before provision for
income taxes |
|
(37,288,019 |
) |
|
(33,539,318 |
) |
Income tax expense,
current |
|
(70,954 |
) |
|
(148,201 |
) |
Net loss and
comprehensive loss |
$ |
(37,358,973 |
) |
$ |
(33,687,519 |
) |
|
|
|
Net loss per share |
|
|
Basic and diluted |
$ |
(0.47 |
) |
$ |
(0.44 |
) |
|
|
|
Weighted average number of
shares outstanding |
|
|
Basic and diluted |
|
79,051,038 |
|
|
76,561,940 |
|
Anavex Life Sciences Corp. |
Interim Condensed Consolidated Balance Sheets |
At June 30, 2023 and September 30, 2022 |
(Unaudited – Expressed in US Dollars) |
|
|
|
|
June 30, 2023 |
September 30,2022 |
Assets |
|
|
Current |
|
|
Cash and cash equivalents |
$ |
154,817,164 |
|
$ |
149,157,861 |
|
Incentive and tax
receivables |
|
2,165,127 |
|
|
3,192,580 |
|
Prepaid expenses and other
current assets |
|
827,572 |
|
|
354,162 |
|
Total
Assets |
$ |
157,809,863 |
|
$ |
152,704,603 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
Current
Liabilities |
|
|
Accounts payable |
$ |
4,152,846 |
|
$ |
3,824,777 |
|
Accrued liabilities |
|
5,985,658 |
|
|
5,944,953 |
|
Deferred grant income |
|
916,763 |
|
|
443,831 |
|
Total
Liabilities |
|
11,055,267 |
|
|
10,213,561 |
|
Capital Stock |
|
81,391 |
|
|
77,944 |
|
Additional paid-in
capital |
|
429,595,961 |
|
|
387,976,881 |
|
Accumulated deficit |
|
(282,922,756 |
) |
|
(245,563,783 |
) |
Total Stockholders'
Equity |
|
146,754,596 |
|
|
142,491,042 |
|
Total Liabilities and Stockholders' Equity |
$ |
157,809,863 |
|
$ |
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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