Anavex Life Sciences Reports Fiscal 2016 Financial Results - Conference Call and Webcast Today at 4:30 p.m. ET to Discuss Fin...
December 12 2016 - 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 its fiscal year ended September 30, 2016.
Highlights:
- Cash and cash equivalents of $17.3 million as of December 12,
2016, and $9.2 million at September 30, 2016, compared to $15.3
million at September 30, 2015.
- During fiscal year 2016, Anavex used $9.2 million in cash to
fund operations, which was within the Company’s spending plan
guidance.
- Operating expenses for the year ended September 30, 2016, were
$15.6 million, which included $5.1 million non-cash charges,
compared to $7.1 million for the comparable period in fiscal year
2015. The increase was primarily attributable to ongoing clinical
trial activities, preclinical work, and expansion of the Company’s
team.
- Net loss for fiscal year 2016 was $14.7 million, or $0.42 per
share, compared to a net loss of $12.1 million, or $0.65 per share,
for the 2015 fiscal year.
- “9-Months and 12-Months Safety and Exploratory Efficacy Data of
ANAVEX 2-73 in a Phase 2a Study in Mild-to-Moderate Alzheimer’s
Disease Patients” was presented at the 9th annual Clinical Trials
on Alzheimer's Disease (CTAD) 2016 conference in San Diego, CA. The
presentation by Associate Professor Stephen Macfarlane, FRANZCP, is
available in the publications section of the Anavex website.
“We are entering into 2017 with a stronger balance sheet and a
strengthened corporate and scientific advisory team coupled with
recently reported encouraging 57-week safety and tolerability data
for ANAVEX 2-73, which restores cellular homeostasis, in a Phase 2a
clinical trial in Alzheimer’s disease,” said Christopher U.
Missling, PhD, President and Chief Executive Officer of Anavex. “We
are now analyzing the significant correlations observed between
cognition, function and behavior in combination with PK/PD modeling
of the population as well as of each individual patient in order to
derive the optimal parameters for the subsequent planned
placebo-controlled efficacy trials. We believe this coherent
approach should reduce future clinical development risk.”
Dr. Missling continued, “Given the strengthened financial
resources and scientific validation, in 2017, we are able to
prepare for a Phase 2/3, placebo-controlled trial in Alzheimer’s
disease as well as a Phase 2, placebo-controlled trial in Rett
syndrome, for which the U.S. Food and Drug Administration (FDA)
granted Orphan Drug Designation (ODD) for ANAVEX 2-73 and a Phase
2, placebo-controlled trial in Parkinson’s disease.”
Recent Corporate Highlights
- December 1, 2016 - Christopher U. Missling, PhD, President and
Chief Executive Officer of Anavex participated on a panel at the
Fourth Annual Mental Health Parity and Addiction Equity Act
(MHPAEA) Business Roundtable. The panel focused on implementation
of the MHPAEA of 2008.
- November 30, 2016 – Anavex announced addition of three
prominent researchers in Parkinson’s and other CNS diseases to the
company’s Scientific Advisory Board. The new SAB members include
Tanya Simuni, M.D., Professor of Neurology and Director,
Parkinson's Disease and Movement Disorders Program at Northwestern
University, Chicago, Illinois; Daniel Weintraub, M.D., Professor of
Psychiatry at University of Pennsylvania, Philadelphia,
Pennsylvania; and Kalpana M. Merchant, Ph.D., Adjunct Professor of
Neurology at Northwestern University Feinberg School of Medicine
and Adjunct Professor of Biology at Purdue University, Portland,
Oregon.
- November 14, 2016 – Anavex reported preclinical efficacy data
for the treatment of neuropathic pain and visceral pain with ANAVEX
1066. Data was presented in a poster titled “Mixed sigma-1 /
sigma-2 ligands as analgesics: studies with ANAVEX 1066 in animal
models of neuropathic pain and visceral pain” at the annual meeting
of the Society for Neuroscience 2016.
- October 5, 2016 – Anavex entered into a collaboration with
Ariana Pharma to use Ariana’s proprietary KEM® (Knowledge,
Extraction, Management) patient stratification technology. KEM® is
a comprehensive and FDA-tested clinical data analysis system that
enables full exploitation of complex datasets including of smaller
numbers of patients.
- September 28, 2016 – Anavex entered into a material transfer
agreement with Biogen under which Biogen will test Anavex’s lead
drug candidate, ANAVEX 2-73, in an oligodendrocyte precursor cell
(OPC) differentiation assay. A satisfactory result from the OPC
assay study may lead to an in vivo remyelination study using a
chemical demyelination model.
- September 22, 2016 – Anavex presented preclinical data
demonstrating that ANAVEX 2-73 restores function in a classic
animal model of Parkinson’s disease. Significant improvements were
seen on all measures: behavioral, histopathological and
neuroinflammatory endpoints.
- July 24 and 27, 2016 – Anavex presented positive safety and
efficacy data through 31 weeks from the ongoing ANAVEX 2-73 Phase
2a study in mild-to-moderate Alzheimer’s patients at the
Alzheimer’s Association International Conference (AAIC)® 2016.
Financial information for the fiscal year ended September 30,
2016 should be read in conjunction with the Company’s audited
consolidated financial statements, which will appear on EDGAR and
will be available on the Anavex website at www.anavex.com.
Conference Call / Webcast Information
To join the conference call, dial the toll-free number: (866)
939-3921. Please use confirmation number 43930140, followed by the
pound sign (#). The live webcast of the conference call can be
accessed online at http://wsw.com/webcast/cc/avxl. Investors may
also listen to an archived version of the webcast 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 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, is currently
in 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 and
successfully completed Phase 1 with a clean safety profile.
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.
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.
TABLES FOLLOW
ANAVEX LIFE SCIENCES CORP. |
|
CONSOLIDATED BALANCE SHEETS |
|
AS AT SEPTEMBER 30, 2016 AND 2015 |
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
Current |
|
|
|
|
|
Cash |
|
$ |
9,186,814 |
|
|
$ |
15,290,976 |
|
|
Sales
Tax Recoverable |
|
|
79,347 |
|
|
|
76,840 |
|
|
Prepaid
expenses and deposits |
|
|
180,124 |
|
|
|
100,845 |
|
|
Total current
assets |
|
|
9,446,285 |
|
|
|
15,468,661 |
|
|
Deposits |
|
|
52,396 |
|
|
|
- |
|
|
Equipment |
|
|
- |
|
|
|
1,252 |
|
|
Total
assets |
|
$ |
9,498,681 |
|
|
$ |
15,469,913 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current |
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
3,119,993 |
|
|
$ |
2,503,726 |
|
|
Deferred
grant income |
|
|
70,532 |
|
|
|
71,614 |
|
|
Promissory notes payable |
|
|
- |
|
|
|
85,238 |
|
|
Total current
liabilities |
|
|
3,190,525 |
|
|
|
2,660,578 |
|
|
Senior
Convertible Debentures |
|
|
- |
|
|
|
332 |
|
|
Total
liabilities |
|
|
3,190,525 |
|
|
|
2,660,910 |
|
|
Common
stock |
|
|
36,169 |
|
|
|
32,044 |
|
|
Additional paid-in
capital |
|
|
84,290,140 |
|
|
|
74,060,999 |
|
|
Common stock to be
issued |
|
|
- |
|
|
|
1,997,415 |
|
|
Accumulated
deficit |
|
|
(78,018,153 |
) |
|
|
(63,281,455 |
) |
|
Total
stockholders' equity |
|
|
6,308,156 |
|
|
|
12,809,003 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
9,498,681 |
|
|
$ |
15,469,913 |
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
TWELVE MONTHS ENDED SEPTEMBER 30, 2016, 2015 AND
2014 |
|
|
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
General and
administrative |
$ |
8,334,740 |
|
|
$ |
4,836,978 |
|
|
$ |
2,236,580 |
|
Research and
development |
|
7,254,303 |
|
|
|
2,271,736 |
|
|
|
732,395 |
|
Total
operating expenses |
|
15,589,043 |
|
|
|
7,108,714 |
|
|
|
2,968,975 |
|
|
|
|
|
|
|
OPERATING LOSS |
|
(15,589,043 |
) |
|
|
(7,108,714 |
) |
|
|
(2,968,975 |
) |
|
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
|
|
Grant income |
|
712,288 |
|
|
|
- |
|
|
|
- |
|
Interest income
(expense), net |
|
11,322 |
|
|
|
(71,825 |
) |
|
|
(7,089 |
) |
Other income |
|
212,607 |
|
|
|
- |
|
|
|
199,655 |
|
Financing related
charges and adjustments |
|
(5,812 |
) |
|
|
(4,998,145 |
) |
|
|
(8,624,986 |
) |
Foreign exchange
loss |
|
(48,445 |
) |
|
|
70,554 |
|
|
|
33,042 |
|
Total
other income (expenses) |
|
881,960 |
|
|
|
(4,999,416 |
) |
|
|
(8,399,378 |
) |
|
|
|
|
|
|
Net loss before income
taxes |
|
(14,707,083 |
) |
|
|
(12,108,130 |
) |
|
|
(11,368,353 |
) |
Income tax expense -
current |
|
(29,615 |
) |
|
|
- |
|
|
|
- |
|
Income tax benefit -
deferred |
|
- |
|
|
|
- |
|
|
|
1,400,000 |
|
|
|
|
|
|
|
NET LOSS |
$ |
(14,736,698 |
) |
|
$ |
(12,108,130 |
) |
|
$ |
(9,968,353 |
) |
|
|
|
|
|
|
NET LOSS PER COMMON
SHARE |
|
|
|
|
|
BASIC |
$ |
(0.42 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.02 |
) |
DILUTED |
$ |
(0.42 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER
OF SHARES OUTSTANDING |
|
|
|
|
|
|
|
BASIC |
|
35,153,426 |
|
|
|
18,584,820 |
|
|
|
9,804,539 |
|
DILUTED |
|
35,153,426 |
|
|
|
18,584,820 |
|
|
|
9,804,539 |
|
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
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