Anavex Life Sciences Reports Fiscal Year 2019 Financial Results And Provides Clinical Study Updates
December 16 2019 - 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
year ended September 30, 2019.
“Anavex continues to make steady progress
towards reaching several important milestones and is poised for an
exciting 2020,” said Christopher U Missling, PhD, President and
Chief Executive Officer of Anavex. “Bringing novel biomarker-driven
CNS precision medicine therapies to patients with devastating rare
diseases, as well as the largest unmet medical need of the aging
population, Alzheimer’s and Parkinson disease has been the key
vision for the development of ANAVEX®2-73 (blarcamesine) with
multiple data read outs.”
ANAVEX®2-73 (blarcamesine) Program
Update:
- The U.S. Food and Drug
Administration (FDA) granted the Rare Pediatric Disease (RPD)
designation for ANAVEX®2-73 (blarcamesine) for the treatment of
Rett syndrome. The RPD designation provides the opportunity for the
award of a pediatric review voucher at the time of marketing
approval.
- To offer all participants access to
ANAVEX®2-73 (blarcamesine) after completion of the ANAVEX®2-73
(blarcamesine) U.S. Phase 2 Rett syndrome study1 and the AVATAR
Rett syndrome study2, 12-week and 48-week open-label extension
studies, respectively were initiated. Currently 90% and 100% of
eligible participants have continued into the corresponding
extension studies.
- The international EXCELLENCE Rett
syndrome study of ANAVEX®2-73 (blarcamesine) in pediatric patients
was approved by the Australian Human Research Ethics Committee and
is scheduled to initiate early 2020.
- Anavex Life Sciences presented data
at the 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019
Conference reporting baseline-matched Real-World external control
data of Alzheimer’s Disease Neuroimaging Initiative (ADNI) with
ANAVEX®2-73 (blarcamesine) Phase 2a clinical data, demonstrating a
significantly lower cognitive decline of the sufficiently dosed
ANAVEX®2-73 (blarcamesine) Phase 2a study cohort compared to the
ADNI control cohort at the interim 2-Year (104-Week) timepoint.
Separately, abundance of Lachnospiraceae and Enterobacteriaceae
families were identified as potential biomarkers of response from
the 2-Year study interim clinical data analysis of
ANAVEX®2-73 (blarcamesine).
- Enrollment for the Phase 2b/3
ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study3 is
nearly 50% recruited. To offer all participants of the study access
to ANAVEX®2-73 (blarcamesine) a voluntary 96-week open-label
extension (ATTENTION-AD OLE study) was initiated and currently 95%
of eligible participants have opted into the extension study.
- Enrollment for the Phase 2
ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD)
study4 is expected to be completed by the end of December 2019 with
top-line data expected mid-2020. To offer all participants of the
study access to ANAVEX®2-73 (blarcamesine), a voluntary 48-week
open-label extension, including microbiome assessment, was
initiated and currently 100% of eligible participants have opted
into the extension study.
Financial Highlights:
- Cash and cash equivalents of $22.2
million at September 30, 2019, compared to $22.9 million at
September 30, 2018.
- Operating expenses for fiscal 2019
of $29.1 million compared to $19.3 million for fiscal 2018.
Research and development expenses increased as we continue to
advance our clinical studies for ANAVEX®2-73 (blarcamesine).
- Net loss of $26.3 million, or $0.54
per share, compared to a net loss of $17.3 million, or $0.39 per
share for fiscal 2018.
The financial information for the fiscal year
ended September 30, 2019 should be read in conjunction with the
Company’s consolidated interim financial statements, which will
appear on EDGAR and will be available on the Anavex website at
www.anavex.com.
Conference Call / Webcast Information
Anavex will host a conference call and webcast today at 4:30
p.m. ET.
The live webcast of the conference call can be
accessed online at http://www.wsw.com/webcast/cc/avxl11.
To join the conference call, live via telephone,
interested parties within the U.S. should dial, toll-free, 1 (866)
939-3921 and international callers should dial 1 (678) 302-3550.
Please use confirmation number 49249215, followed by the pound sign
(#).
A replay of the conference call will also be
available on www.anavex.com approximately one hour after the
call.
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),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s
disease. ANAVEX®3-71, which targets sigma-1 and muscarinic
receptors, is a promising preclinical 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. |
|
CONSOLIDATED BALANCE
SHEETS |
|
As at September 30,
2019 and 2018 |
|
Expressed in US Dollars |
|
|
|
|
|
2019 |
|
|
2018 |
|
|
ASSETS |
|
|
|
Current |
|
|
|
Cash and
cash equivalents |
$ |
22,185,630 |
|
$ |
22,930,638 |
|
|
Incentives
and taxes receivable |
|
2,642,745 |
|
|
1,870,357 |
|
|
Prepaid
expenses and deposits |
|
500,998 |
|
|
1,251,798 |
|
|
Total
current assets |
|
25,329,373 |
|
|
26,052,793 |
|
|
Deferred
costs |
|
- |
|
|
101,133 |
|
|
Deposits |
|
- |
|
|
52,396 |
|
|
Total assets |
$ |
25,329,373 |
|
$ |
26,206,322 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current |
|
|
|
Accounts
payable |
$ |
3,523,332 |
|
$ |
2,955,293 |
|
|
Accrued
liabilities |
|
1,516,342 |
|
|
929,333 |
|
|
Total liabilities |
|
5,039,674 |
|
|
3,884,626 |
|
|
Common
stock |
|
52,652 |
|
|
45,935 |
|
|
Additional
paid-in capital |
|
153,633,807 |
|
|
129,377,542 |
|
|
Accumulated
deficit |
|
(133,396,760 |
) |
|
(107,101,781 |
) |
|
Total stockholders' equity |
|
20,289,699 |
|
|
22,321,696 |
|
|
Total liabilities and stockholders' equity |
$ |
25,329,373 |
|
$ |
26,206,322 |
|
|
|
|
|
|
ANAVEX LIFE
SCIENCES CORP. |
|
CONSOLIDATED
STATEMENT OF OPERATIONS |
|
Years ended
September 30, 2019 and 2018 |
|
|
|
Expressed in US Dollars |
|
|
|
|
|
2019 |
|
|
2018 |
|
|
Operating Expenses |
|
|
|
General and
administrative |
$ |
6,846,599 |
|
$ |
5,989,170 |
|
|
Research and
development |
|
22,260,349 |
|
|
13,344,421 |
|
|
Total operating expenses |
|
29,106,948 |
|
|
19,333,591 |
|
|
|
|
|
|
Other income |
|
|
|
Grant
income |
|
298,943 |
|
|
149,055 |
|
|
Research and
development incentive income |
|
2,465,691 |
|
|
1,830,186 |
|
|
Interest
income, net |
|
207,280 |
|
|
255,092 |
|
|
Gain on
settlement of accounts payable |
|
115,758 |
|
|
- |
|
|
Financing
related charges |
|
(151,133 |
) |
|
(30,943 |
) |
|
Foreign
exchange gain (loss) |
|
(42,389 |
) |
|
(49,789 |
) |
|
Total other income |
|
2,894,150 |
|
|
2,153,601 |
|
|
Net loss
before income taxes |
|
(26,212,798 |
) |
|
(17,179,990 |
) |
|
Income tax
expense - current |
|
(82,181 |
) |
|
(72,746 |
) |
|
Net
loss |
$ |
(26,294,979 |
) |
$ |
(17,252,736 |
) |
|
|
|
|
|
Net loss per
Share |
|
|
|
Basic and Diluted |
$ |
(0.54 |
) |
$ |
(0.39 |
) |
|
|
|
|
|
Weighted Average Number of Shares Outstanding |
|
|
Basic and Diluted |
|
48,906,470 |
|
|
44,655,725 |
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Email:
ir@anavex.com
1 ClinicalTrials.gov Identifier: NCT037589242 ClinicalTrials.gov
Identifier: NCT039414443 ClinicalTrials.gov Identifier:
NCT037907094 ClinicalTrials.gov Identifier: NCT03774459
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