Anavex Reports Fiscal Second Quarter 2017 Financial Results
May 10 2017 - 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 diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer, today reported financial results
for the fiscal quarter ended March 31, 2017.
Financial Highlights:
- Cash and equivalents of $23.4 million at March 31, 2017,
compared to $9.2 million at September 30, 2016.
- During the first six months of fiscal year 2017, Anavex used
$3.9 million in cash to fund operations, after receipt of $2.1
million in research and development incentive income.
- Operating expenses of approximately $3.6 million compared to
approximately $2.2 million for the comparative quarter. This
increase was a result of increased spending on research and
development and clinical preparatory activities.
- Net loss for the quarter of approximately $1.5 million, or
$0.04 per share, compared to a net loss of approximately $2.0
million, or $0.06 per share for the comparative quarter.
“We are continuing 2017 with a stronger balance
sheet than the previous quarter and a strengthened corporate team,”
said Christopher U. Missling, PhD, President and Chief Executive
Officer of Anavex. “We are on track to initiate placebo-controlled
efficacy and safety trials this year in Alzheimer’s and Parkinson’s
disease as well as Rett syndrome, for which ANAVEX 2-73 was granted
Orphan Drug Designation (ODD) by the U.S. Food and Drug
Administration (FDA).”
Corporate Highlights
- May 1, 2017 – Anavex announced the appointment of Emmanuel O.
Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs.
Dr. Fadiran has 24 years of regulatory experience within the U.S.
Food and Drug Administration (FDA), having held leadership
positions at the FDA’s Center for Drug Evaluation and Research
(CDER).
- April 3, 2017 – Anavex announced the presentation of new
mechanism of action data related to ANAVEX compounds targeting the
sigma-1 receptor at the 13th International Conference on
Alzheimer’s and Parkinson’s Diseases (AD/PD 2017).- Preclinical
data was presented indicating that in addition to reducing
oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41
demonstrate protective effects of the mitochondrial enzyme
complexes I and IV during pathological conditions, which, if
impaired, are believed to play a role in the pathogenesis of
neurodegenerative and neurodevelopmental diseases.- Additional data
was presented for ANAVEX 3-71 indicating that during pathological
conditions, ANAVEX 3-71 demonstrated the formation of new synapses
between neurons (synaptogenesis) without causing an abnormal
increase in the number of astrocytes. In neurodegenerative
diseases such as Alzheimer’s and Parkinson’s, synaptogenesis is
believed to be impaired.
- February 13, 2017 – Anavex announced the appointment of Peter
Donhauser, D.O. to its Board of Directors. Mr. Donhauser has
more than 20 years of expertise in clinical research followed by
practicing osteopathic medicine with an integrated medical approach
in private practice since 2000.
The financial information for the three and six
months ended March 31, 2017 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.
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 successfully a 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. It has also exhibited anticonvulsant, anti-amnesic,
neuroprotective and anti-depressant properties in animal models,
indicating its potential to treat additional CNS disorders,
including epilepsy and others. The Michael J. Fox Foundation for
Parkinson’s Research has awarded Anavex a research grant to develop
ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund
a preclinical study, which could justify moving ANAVEX 2-73 into a
Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting
sigma-1 and M1 muscarinic receptors, is a promising preclinical
drug candidate demonstrating disease modifications against the
major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid and tau pathologies, and also with
beneficial effects on neuroinflammation and mitochondrial
dysfunctions. Further information is available at www.anavex.com
and 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 |
(Unaudited) |
|
|
|
|
|
|
|
March 31, |
September 30, |
ASSETS |
|
2017 |
|
|
2016 |
|
Current |
|
|
Cash |
$ |
23,351,567 |
|
$ |
9,186,814 |
|
Sales Tax
Recoverable |
|
60,636 |
|
|
79,347 |
|
Prepaid expenses and
deposits |
|
141,989 |
|
|
180,124 |
|
Total current
assets |
|
23,554,192 |
|
|
9,446,285 |
|
Deposits |
|
52,396 |
|
|
52,396 |
|
Total
assets |
$ |
23,606,588 |
|
$ |
9,498,681 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
Current |
|
|
Accounts payable and
accrued liabilities |
$ |
2,033,692 |
|
$ |
3,119,993 |
|
Deferred grant
income |
|
86,205 |
|
|
70,532 |
|
Total
liabilities |
|
2,119,897 |
|
|
3,190,525 |
|
Common stock |
|
41,377 |
|
|
36,169 |
|
Additional paid-in
capital |
|
104,159,213 |
|
|
84,290,140 |
|
Accumulated
deficit |
|
(82,713,899 |
) |
|
(78,018,153 |
) |
Total
stockholders' equity |
|
21,486,691 |
|
|
6,308,156 |
|
Total
liabilities and stockholders' equity |
$ |
23,606,588 |
|
$ |
9,498,681 |
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
THREE MONTHS ENDED MARCH 31, 2017 AND 2016 |
(Unaudited) |
|
|
|
|
|
2017 |
|
|
2016 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
1,116,014 |
|
$ |
1,089,641 |
|
Research and
development |
|
2,492,933 |
|
|
1,090,527 |
|
Total operating
expenses |
|
3,608,947 |
|
|
2,180,168 |
|
|
|
|
Operating
Loss |
|
(3,608,947 |
) |
|
(2,180,168 |
) |
Other income
(expenses) |
|
|
Grant income |
|
16,684 |
|
|
26,879 |
|
Research and
development incentive income |
|
2,022,902 |
|
|
- |
|
Interest income,
net |
|
18,147 |
|
|
2,064 |
|
Financing related
charges and adjustments |
|
- |
|
|
151,330 |
|
Foreign exchange gain
(loss) |
|
11,722 |
|
|
(30,906 |
) |
Total other
income (expenses) |
|
2,069,455 |
|
|
149,367 |
|
Net loss before income
taxes |
|
(1,539,492 |
) |
|
(2,030,801 |
) |
Income tax expense -
current |
|
(9,595 |
) |
|
- |
|
Net
loss |
$ |
(1,549,087 |
) |
$ |
(2,030,801 |
) |
|
|
|
Net loss per Share |
|
|
Basic |
$ |
(0.04 |
) |
$ |
(0.06 |
) |
Diluted |
$ |
(0.04 |
) |
$ |
(0.06 |
) |
|
|
|
Weighted
Average Number of Shares Outstanding |
|
Basic |
|
41,159,707 |
|
|
35,214,793 |
|
Diluted |
|
41,159,707 |
|
|
35,214,793 |
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
SIX MONTHS ENDED MARCH 31, 2017 AND 2016 |
(Unaudited) |
|
|
|
|
|
2017 |
|
|
2016 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
2,242,198 |
|
$ |
3,982,746 |
|
Research and
development |
|
4,535,423 |
|
|
2,729,856 |
|
Total operating
expenses |
|
6,777,621 |
|
|
6,712,602 |
|
|
|
|
Operating
Loss |
|
(6,777,621 |
) |
|
(6,712,602 |
) |
Other income
(expenses) |
|
|
Grant income |
|
51,970 |
|
|
65,934 |
|
Research and
development incentive income |
|
2,022,902 |
|
|
571,093 |
|
Interest income,
net |
|
21,802 |
|
|
4,206 |
|
Financing related
charges and adjustments |
|
- |
|
|
150,235 |
|
Foreign exchange gain
(loss) |
|
25,804 |
|
|
(46,561 |
) |
Total other
income |
|
2,122,478 |
|
|
744,907 |
|
Net loss before income
taxes |
|
(4,655,143 |
) |
|
(5,967,695 |
) |
Income tax expense -
current |
|
(40,603 |
) |
|
(17,615 |
) |
Net
loss |
$ |
(4,695,746 |
) |
$ |
(5,985,310 |
) |
|
|
|
Net loss per Share |
|
|
Basic |
$ |
(0.12 |
) |
$ |
(0.17 |
) |
Diluted |
$ |
(0.12 |
) |
$ |
(0.17 |
) |
|
|
|
Weighted
Average Number of Shares Outstanding |
|
Basic |
|
39,761,612 |
|
|
34,589,957 |
|
Diluted |
|
39,761,612 |
|
|
34,589,957 |
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
203-258-0159
dennisdobsonjr@dobsonmediagroup.com
Social Media:
Bill Douglass
Gotham Communications
646-504-0890
bill@gothamcomm.com
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