Anavex Life Sciences Reports Fiscal Third Quarter 2018 Financial Results
August 09 2018 - 7:00AM
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 its third
fiscal quarter ended June 30, 2018.
Financial Highlights:
- Cash and equivalents of $25.8 million at June 30, 2018,
compared to $27.4 million at September 30, 2017.
- Cash used to fund operations in the third fiscal quarter was
$2.1 million, which is net of grant and research and development
incentive income of $1.7 million, compared to $3.0 million for the
comparative quarter last year. This is in line with the Company’s
cash utilization guidance.
- Operating expenses in the third fiscal quarter of $4.6 million
compared to $3.7 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, as
well as an expanded scientific team.
- Net loss for the third fiscal quarter of $2.8 million, or $0.06
per share, compared to a net loss of $3.6 million, or $0.04 per
share for the comparative quarter.
“In order to identify the key biomarkers for the
design of our late-stage CNS precision medicine trials, we have
taken a data driven, hypothesis free approach to the systematic
analysis of our ongoing Phase 2a trial in Alzheimer’s disease.
Using the Artificial Intelligence (AI) technology KEM, the relation
between all parameters, both clinical and genomic, and their impact
on outcome was ranked in an unbiased mode,” said Christopher U
Missling, PhD President and Chief Executive Officer of Anavex. “We
believe this unbiased and systematic approach to identifying our
biomarkers is likely to increase the chance of success in our
follow-up, genomic marker driven late-stage CNS precision medicine
trials in Parkinson’s disease dementia, Alzheimer’s disease and
Rett
syndrome.”
Recent Corporate Highlights:
- July 25, 2018 – Anavex reported the results of an entire genome
DNA and RNA evaluation of study participants in a 57-week Phase 2a
Alzheimer’s disease study investigating ANAVEX®2-73, a selective
sigma-1 receptor agonist, resulting in the analysis of 33,311 genes
and 860 pathways. Additionally, direct target occupancy of
ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron
emissions tomography (PET) scanning was presented.
- July 9, 2018 – Anavex announced that it had received approval
from the Spanish Agency for Medicinal Products and Medical Devices
(AEMPS) to initiate its Phase 2, double-blind, placebo-controlled
14-week trial of the safety and efficacy of ANAVEX®2-73 for the
treatment of Parkinson’s disease dementia (PDD).
- July 3, 2018 – Anavex announced that the Company had received
approval by the Australian Human Research Ethics Committee to
initiate its Phase 2b/3 double-blind, randomized,
placebo-controlled, 48-week safety and efficacy trial of
ANAVEX®2-73 for the treatment of Alzheimer’s disease.
The financial information for fiscal quarter
ended June 30, 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, August
9, 2018.
The live webcast of the conference call can be
accessed online at http://www.wsw.com/webcast/cc/avxl6/. 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
47394949. 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, 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 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 |
|
|
|
|
|
|
|
|
June 30, |
September 30, |
|
|
ASSETS |
|
2018 |
|
|
2017 |
|
|
|
Current |
|
|
|
|
Cash and
cash equivalents |
$ |
25,827,592 |
|
$ |
27,440,257 |
|
|
|
Sales
tax recoverable |
|
6,145 |
|
|
9,748 |
|
|
|
Prepaid
expenses and deposits |
|
858,560 |
|
|
335,928 |
|
|
|
Deferred financing
charges |
|
50,000 |
|
|
- |
|
|
|
Total current
assets |
|
26,742,297 |
|
|
27,785,933 |
|
|
|
Deposits |
|
52,396 |
|
|
52,396 |
|
|
|
Total
assets |
$ |
26,794,693 |
|
$ |
27,838,329 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
3,209,070 |
|
$ |
3,584,334 |
|
|
|
Total
liabilities |
|
3,209,070 |
|
|
3,584,334 |
|
|
|
Common stock |
|
45,315 |
|
|
43,332 |
|
|
|
Additional paid-in
capital |
|
126,679,219 |
|
|
115,689,221 |
|
|
|
Accumulated
deficit |
|
(103,138,911 |
) |
|
(91,478,558 |
) |
|
|
Total
stockholders' equity |
|
23,585,623 |
|
|
24,253,995 |
|
|
|
Total
liabilities and stockholders' equity |
$ |
26,794,693 |
|
$ |
27,838,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF
OPERATIONS |
|
|
THREE MONTHS ENDED JUNE 30, 2018 AND 2017 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
2018 |
|
|
2017 |
|
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
1,620,379 |
|
$ |
1,405,026 |
|
|
|
Research and
development |
|
2,997,634 |
|
|
2,300,277 |
|
|
|
Total operating expenses |
|
4,618,013 |
|
|
3,705,303 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(4,618,013 |
) |
|
(3,705,303 |
) |
|
|
Other
income |
|
|
|
|
Grant income |
|
74,528 |
|
|
69,146 |
|
|
|
Research and
development incentive income |
|
1,629,513 |
|
|
- |
|
|
|
Interest income,
net |
|
112,226 |
|
|
26,677 |
|
|
|
Gain on settlement of
accounts payable |
|
- |
|
|
75,204 |
|
|
|
Financing related
charges |
|
(30,943 |
) |
|
|
|
Foreign exchange gain
(loss) |
|
(16,475 |
) |
|
(65,932 |
) |
|
|
Total other income |
|
1,768,849 |
|
|
105,095 |
|
|
|
Net loss before income
taxes |
|
(2,849,164 |
) |
|
(3,600,208 |
) |
|
|
Income tax expense -
current |
|
- |
|
|
(9,877 |
) |
|
|
Net
loss |
$ |
(2,849,164 |
) |
$ |
(3,610,085 |
) |
|
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and
Diluted |
$ |
(0.06 |
) |
$ |
(0.09 |
) |
|
|
|
|
|
|
|
Weighted
Average Number of Shares Outstanding |
|
|
|
Basic and Diluted |
|
45,212,074 |
|
|
41,509,225 |
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF
OPERATIONS |
|
NINE MONTHS ENDED JUNE 30, 2018 AND 2017 |
|
(Unaudited) |
|
|
|
|
|
|
|
2018 |
|
|
2017 |
|
|
Operating
Expenses |
|
|
|
General and
administrative |
$ |
4,507,632 |
|
$ |
3,647,224 |
|
|
Research and
development |
|
8,936,969 |
|
|
6,835,700 |
|
|
Total operating expenses |
|
13,444,601 |
|
|
10,482,924 |
|
|
|
|
|
|
Operating
Loss |
|
(13,444,601 |
) |
|
(10,482,924 |
) |
|
Other income
(expenses) |
|
|
|
Grant income |
|
74,528 |
|
|
121,116 |
|
|
Research and
development incentive income |
|
1,629,513 |
|
|
2,022,902 |
|
|
Interest income,
net |
|
171,249 |
|
|
48,479 |
|
|
Gain on settlement of
accounts payable |
|
- |
|
|
75,204 |
|
|
Financing related
charges |
|
(30,943 |
) |
|
- |
|
|
Foreign exchange gain
(loss) |
|
(22,833 |
) |
|
(40,128 |
) |
|
Total other income |
|
1,821,514 |
|
|
2,227,573 |
|
|
Net loss before income
taxes |
|
(11,623,087 |
) |
|
(8,255,351 |
) |
|
Income tax expense -
current |
|
(37,266 |
) |
|
(50,480 |
) |
|
Net
loss |
$ |
(11,660,353 |
) |
$ |
(8,305,831 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
Basic and
Diluted |
$ |
(0.26 |
) |
$ |
(0.21 |
) |
|
|
|
|
|
Weighted
Average Number of Shares Outstanding |
|
|
Basic and Diluted |
|
44,365,683 |
|
|
40,344,149 |
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors:Scott GordonCore
IRscottg@coreir.com
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