Anavex Life Sciences Reports Fiscal 2021 Second Quarter Financial Results And Business Outlook
May 13 2021 - 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 March 31, 2021.
"Positive momentum continues to build this
quarter and affirms the strength of our pipeline and execution
capabilities," said Christopher U Missling, PhD, President and
Chief Executive Officer of Anavex. "For our lead drug candidate,
ANAVEX®2-73 in Alzheimer’s disease, we are close to complete
enrollment for our Phase 2b/3 study, and we expect a very data-rich
current quarter with data readouts from multiple clinical trials
and the remainder of 2021 to be a catalyst-rich year for Anavex.
This is an exciting time for Anavex and I look forward to advancing
our impressive pipeline of mid- and late-stage clinical trials with
a commitment to bringing innovative therapies to patients in need
around the globe.”
Anavex Life Sciences’ Business and Near-Term Clinical
Outlook:
ANAVEX®2-73 Program and other Near-Term
Pipeline Data Updates:
- Complete data
ANAVEX®2-73 U.S. Rett syndrome Phase 2 study.
- Complete data
ANAVEX®2-73 Parkinson’s disease dementia (PDD) Phase 2 study.
- Top-line data
AVATAR: Potentially pivotal Phase 2/3 ANAVEX®2-73 adult Rett
syndrome clinical trial.
- Top-line data
Phase 1 ANAVEX®3-71 clinical trial.
- Complete
enrollment of Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease clinical
trial.
Recent Business Highlights:
- In March 2021,
Anavex announced that the Independent Data Safety Monitoring Board
(DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study of
its investigational compound ANAVEX®2-73 (blarcamesine) has
completed its recent pre-planned review of the preliminary Phase
2b/3 study data. As specified in the protocol, the DSMB reviewed
the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s
disease clinical study ANAVEX®2-73-AD-004 and its Open Label
Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study. Upon
review of the interim safety data, the DSMB made the following
recommendation: The DSMB recommendation is to continue the studies
without modification.
- In April 2021,
Anavex announced that the Independent Data Safety Monitoring Board
(DSMB) for the Company’s ongoing clinical trial program, including
the late-stage AVATAR (ANAVEX®2-73-RS-002), EXCELLENCE
(ANAVEX®2-73-RS-003) and the U.S. Rett syndrome extension study
(ANAVEX®2-73-RS-EP-001) of its investigational compound ANAVEX®2-73
(blarcamesine) has completed its recent pre-planned review of the
respective interim safety data for these three separate clinical
studies. Upon review of the interim safety data, the DSMB made the
following recommendation for each of the three studies: The DSMB
recommendation is to continue the studies without
modification.
- In March 2021,
Anavex announced that ANAVEX®2-73 (blarcamesine) is featured in a
recent peer-reviewed publication in the journal of
Neuropharmacology, titled “Future avenues for Alzheimer’s disease
detection and therapy: liquid biopsy, intracellular signaling
modulation, systems pharmacology drug discovery” from the series of
the special issue on ‘The Quest for Disease-Modifying Therapies for
Neurodegenerative Disorders’.
- In May 2021,
Anavex announced the appointment of former FDA officer as Senior
Vice President for Nonclinical Development.
- Further clinical
milestones are provided in Anavex Life Sciences’ latest corporate
presentation, available on www.anavex.com.
Financial Highlights:
- Continued fiscal
responsible management of cash utilization.
- Cash and cash
equivalents at March 31, 2021 of approximately $75.9 million,
sufficient cash runway for up to three (3) years.
- Net loss of $8.2
million, or $0.12 per share for the quarter, compared to net loss
of $7.2 million, or $0.12 per share in comparative quarter of
fiscal 2020.
- Research and
development expenses of $6.7 million for the quarter, compared to
$6.1 million for comparable quarter of fiscal 2020.
- General and
administrative expenses were $2.2 million for the quarter, as
compared to $1.7 million for the prior year period.
The financial information for the fiscal quarter
ended March 31, 2021 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.
Conference Call / Webcast Information:
The live webcast of the conference call can be accessed online
at https://wsw.com/webcast/cc/avxl18/1499544.
To join the conference call, live via telephone,
interested parties within the U.S. should dial, toll-free, 1 (866)
866-1333 and international callers should dial 1 (404) 260-1421.
Please use confirmation number 50162864, followed by the pound sign
(#).
A replay of the conference call will also be
available on www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of 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, pain and various types of
cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
successfully completed a Phase 2a clinical trial for Alzheimer’s
disease and recently a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 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
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 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 |
|
For the three months
ended March 31, 2021 and 2020 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
2,233,745 |
|
$ |
1,720,142 |
|
|
Research and
development |
|
6,720,841 |
|
|
6,053,047 |
|
|
Total operating expenses |
|
(8,954,586 |
) |
|
(7,773,189 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
10,820 |
|
|
74,944 |
|
|
Research and
development incentive income |
|
960,879 |
|
|
717,328 |
|
|
Interest
income, net |
|
9,216 |
|
|
70,180 |
|
|
Foreign
exchange gain (loss), net |
|
(154,563 |
) |
|
(325,960 |
) |
|
Total other income, net |
|
826,352 |
|
|
536,492 |
|
|
Net loss
before provision for income taxes |
|
(8,128,234 |
) |
|
(7,236,697 |
) |
|
Income tax
expense, current |
|
(26,988 |
) |
|
- |
|
|
Net
loss and comprehensive loss |
$ |
(8,155,222 |
) |
$ |
(7,236,697 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.12 |
) |
$ |
(0.12 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
68,594,867 |
|
|
58,353,954 |
|
|
ANAVEX LIFE
SCIENCES CORP. |
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
For the six months
ended March 31, 2021 and 2020 |
|
(Unaudited) |
|
Expressed in
US Dollars |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
3,704,401 |
|
$ |
3,072,176 |
|
|
Research and
development |
|
14,646,360 |
|
|
12,401,715 |
|
|
Total operating expenses |
|
(18,350,761 |
) |
|
(15,473,891 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant
income |
|
10,820 |
|
|
149,888 |
|
|
Research and
development incentive income |
|
2,230,195 |
|
|
1,660,543 |
|
|
Interest
income, net |
|
7,657 |
|
|
116,900 |
|
|
Foreign
exchange gain (loss), net |
|
178,071 |
|
|
(272,848 |
) |
|
Total other income, net |
|
2,426,743 |
|
|
1,654,483 |
|
|
Net loss
before provision for income taxes |
|
(15,924,018 |
) |
|
(13,819,408 |
) |
|
Income tax
expense, current |
|
(86,269 |
) |
|
(9,214 |
) |
|
Net
loss and comprehensive loss |
$ |
(16,010,287 |
) |
$ |
(13,828,622 |
) |
|
|
|
|
|
Net loss per
share |
|
|
|
Basic and diluted |
$ |
(0.24 |
) |
$ |
(0.24 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
66,421,380 |
|
|
56,544,037 |
|
|
ANAVEX LIFE
SCIENCES CORP. |
|
INTERIM CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
As at March 31, 2021
and September 30, 2020 |
|
Expressed in
US Dollars |
|
|
|
|
March 31, 2021 |
September 30, 2020 |
|
ASSETS |
(Unaudited) |
|
|
Current |
|
|
|
Cash and
cash equivalents |
$ |
75,859,339 |
|
$ |
29,249,018 |
|
|
Incentive
and tax receivables |
|
7,328,090 |
|
|
4,849,340 |
|
|
Prepaid
expenses and deposits |
|
386,809 |
|
|
443,839 |
|
|
Total Assets |
$ |
83,574,238 |
|
$ |
34,542,197 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities |
|
|
|
Accounts
payable |
$ |
3,658,052 |
|
$ |
3,989,054 |
|
|
Accrued
liabilities |
|
3,618,779 |
|
|
3,316,574 |
|
|
Deferred
grant income |
|
487,111 |
|
|
- |
|
|
Total Liabilities |
|
7,763,942 |
|
|
7,305,628 |
|
|
Capital
Stock |
|
70,032 |
|
|
62,047 |
|
|
Additional
paid-in capital |
|
251,427,781 |
|
|
186,851,752 |
|
|
Accumulated
deficit |
|
(175,687,517 |
) |
|
(159,677,230 |
) |
|
Total Stockholders' Equity |
|
75,810,296 |
|
|
27,236,569 |
|
|
Total Liabilities and Stockholders' Equity |
$ |
83,574,238 |
|
$ |
34,542,197 |
|
|
|
|
|
|
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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