Anavex Life Sciences Reports Fiscal Second Quarter 2018 Financial Results
May 10 2018 - 6:00AM
Conference Call and Webcast Today at 4:30 p.m.
ET
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 diseases including
Alzheimer’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported financial results for the second
fiscal quarter ended March 31, 2018.
Clinical Update:
- The Phase 2a Alzheimer’s extension study ANAVEX®2-73-003 has
been approved by the Ethics Committee in Australia to continue for
a further 104 weeks, i.e. additional two (2) years per request by
patients, their caregivers and physicians. The ANAVEX®2-73-003
extension study was the continuation of the 57-week ANAVEX®2-73-002
study and is designed to allow participants who complete the first
104 week extension to continue taking ANAVEX®2-73 for an additional
104 weeks, providing an opportunity to gather extended five (5)
years of cumulative safety and tolerability data for orally daily
dosed ANAVEX®2-73. The further extension is in addition and
independent of the Company’s planned larger Phase 2/3
double-blinded, placebo-controlled study of ANAVEX®2-73 in
Alzheimer’s disease.
Financial Highlights:
- Cash and equivalents of $25.7 million at March 31, 2018,
compared to $27.4 million at September 30, 2017.
- Cash used to fund operations in the second fiscal quarter was
$2.8 million, compared to $0.7 million for the comparative quarter
last year. This is in line with the Company’s cash utilization
guidance.
- Operating expenses in the second fiscal quarter of $4.7 million
compared to $3.6 million for the comparative quarter last year.
This increase was a result of increased spending on research and
development, related to clinical trial preparatory activities.
- Net loss for the second fiscal quarter of $4.8 million, or
$0.11 per share, compared to a net loss of $1.5 million, or $0.04
per share for the comparative quarter.
“We are looking forward, focusing on executing
clinical trials using the inclusion of advanced genomic biomarkers
into late-stage CNS precision medicine trials, including our Rett
syndrome, Alzheimer’s disease and Parkinson’s disease dementia
trials – all indications with high unmet need,” said, Christopher
U. Missling, PhD, President and Chief Executive Officer of
Anavex.
Recent Corporate Highlights:
- April 17, 2018 – Anavex announced that the Company had
submitted to regulatory authorities in Europe a Phase 2 Parkinson’s
disease dementia study and, pending approval, the Company plans to
initiate this clinical trial in calendar H2 2018.
- March 7, 2018 – Anavex announced new data for ANAVEX®2-73 in a
genetic mouse model of Tuberous Sclerosis Complex (TSC), a rare
genetic disorder characterized by the growth of numerous benign
tumors in many parts of the body with a high incidence of seizures.
The new preclinical data demonstrate that treatment with
ANAVEX®2-73 significantly increases survival and reduces
seizures.
- March 5, 2018 –Stephan Toutain, MS, MBA joined Anavex as Senior
Vice President Operations and Claus van der Velden, PhD was
appointed to the Board of Directors.
The financial information for fiscal quarter
ended March 31, 2018, should be read in conjunction with the
Company’s condensed 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 at 4:30 p.m. ET today, May
10, 2018.
The live webcast of the conference call can be accessed online
at http://www.wsw.com/webcast/cc/avxl5. To listen to the live call
by phone, 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 46931087. A replay
of the call will be available approximately one hour after the end
of the call at 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 diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX®2-73, recently completed a successful Phase 2a clinical
trial for Alzheimer’s disease. 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 to develop
ANAVEX®2-73 for the treatment of Parkinson’s disease. The grant
fully funded a preclinical study, which could justify moving
ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71,
which targets sigma-1 and M1 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 neuroinflammation and mitochondrial
dysfunction. 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. |
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS |
|
|
|
|
March 31, |
September 30, |
ASSETS |
2018 |
2017 |
Current |
|
|
Cash and
cash equivalents |
$ |
25,656,584 |
|
$ |
27,440,257 |
|
Sales
tax recoverable |
|
5,011 |
|
|
9,748 |
|
Prepaid
expenses and deposits |
|
150,660 |
|
|
335,928 |
|
Total current
assets |
|
25,812,255 |
|
|
27,785,933 |
|
Deposits |
|
52,396 |
|
|
52,396 |
|
Deferred financing
charges |
|
30,943 |
|
|
- |
|
Total
assets |
$ |
25,895,594 |
|
$ |
27,838,329 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current |
|
|
Accounts
payable and accrued liabilities |
$ |
3,416,737 |
|
$ |
3,584,334 |
|
Total
liabilities |
|
3,416,737 |
|
|
3,584,334 |
|
Common stock |
|
44,575 |
|
|
43,332 |
|
Additional paid-in
capital |
|
122,724,029 |
|
|
115,689,221 |
|
Accumulated
deficit |
|
(100,289,747 |
) |
|
(91,478,558 |
) |
Total
stockholders' equity |
|
22,478,857 |
|
|
24,253,995 |
|
Total
liabilities and stockholders' equity |
$ |
25,895,594 |
|
$ |
27,838,329 |
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
THREE MONTHS ENDED MARCH 31, 2018 AND 2017 |
(Unaudited) |
|
|
|
|
2018 |
2017 |
Operating
Expenses |
|
|
General and
administrative |
$ |
1,489,450 |
|
$ |
1,116,014 |
|
Research and
development |
|
3,245,023 |
|
|
2,492,933 |
|
Total operating expenses |
|
4,734,473 |
|
|
3,608,947 |
|
|
|
|
Operating
Loss |
|
(4,734,473 |
) |
|
(3,608,947 |
) |
Other
income |
|
|
Grant income |
|
- |
|
|
16,684 |
|
Research and
development incentive income |
|
- |
|
|
2,022,902 |
|
Interest income,
net |
|
28,647 |
|
|
18,147 |
|
Foreign exchange gain
(loss) |
|
(18,337 |
) |
|
11,722 |
|
Total other income |
|
10,310 |
|
|
2,069,455 |
|
Net loss before income
taxes |
|
(4,724,163 |
) |
|
(1,539,492 |
) |
Income tax expense -
current |
|
(27,861 |
) |
|
(9,595 |
) |
Net
loss |
$ |
(4,752,024 |
) |
$ |
(1,549,087 |
) |
|
|
|
Net loss per Share |
|
|
Basic and
Diluted |
$ |
(0.11 |
) |
$ |
(0.04 |
) |
|
|
|
Weighted
Average Number of Shares Outstanding |
|
Basic and
Diluted |
|
44,545,523 |
|
|
41,159,707 |
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
SIX MONTHS ENDED MARCH 31, 2018 AND 2017 |
(Unaudited) |
|
|
|
|
2018 |
2017 |
Operating
Expenses |
|
|
General and
administrative |
$ |
2,887,253 |
|
$ |
2,242,198 |
|
Research and
development |
|
5,939,335 |
|
|
4,535,423 |
|
Total operating expenses |
|
8,826,588 |
|
|
6,777,621 |
|
|
|
|
Operating
Loss |
|
(8,826,588 |
) |
|
(6,777,621 |
) |
Other income
(expenses) |
|
|
Grant income |
|
- |
|
|
51,970 |
|
Research and
development incentive income |
|
- |
|
|
2,022,902 |
|
Interest income,
net |
|
59,023 |
|
|
21,802 |
|
Foreign exchange gain
(loss) |
|
(6,358 |
) |
|
25,804 |
|
Total other income |
|
52,665 |
|
|
2,122,478 |
|
Net loss before income
taxes |
|
(8,773,923 |
) |
|
(4,655,143 |
) |
Income tax expense -
current |
|
(37,266 |
) |
|
(40,603 |
) |
Net
loss |
$ |
(8,811,189 |
) |
$ |
(4,695,746 |
) |
|
|
|
Net loss per Share |
|
|
Basic and
Diluted |
$ |
(0.20 |
) |
$ |
(0.12 |
) |
|
|
|
Weighted
Average Number of Shares Outstanding |
|
Basic and
Diluted |
|
44,210,591 |
|
|
39,761,612 |
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Meggie
PurcellSolebury Troutmpurcell@soleburytrout.com
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