Anavex Life Sciences Provides Clinical Programs Update and Reports Fiscal First Quarter 2018 Financial Results
February 07 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 three
months ended December 31, 2017.
The Company also provided an update on its most
advanced clinical programs for ANAVEX®2-73 for the treatment of
Alzheimer’s disease, Rett syndrome, and Parkinson’s disease.
ANAVEX®2-73 Programs
Update:
The Company has completed both RNA and whole
exome DNA genome sequencing from ANAVEX®2-73-treated patients
utilizing Illumina HiSeq 2500 Next Generation Sequencing (NGS)
technology. The analysis of this data has characterized several
genomic alterations in well-characterized targets that have the
potential to be used as biomarkers, which the Company plans to use
to identify optimal patients in forthcoming clinical trials. This
novel, precision-medicine approach will enable enriched clinical
trial populations, more robust regulatory submissions and better
characterized clinical trial designs. Full details of the genomic
sequencing analysis have been submitted for presentation at an
upcoming scientific meeting.
In consideration of the new genomic results, the
investigational new drug application (IND) filing for ANAVEX®2-73
for the treatment of Rett syndrome will be updated and submitted
during the current quarter to include this data. The FDA previously
granted ANAVEX®2-73 orphan drug designation for the treatment of
Rett syndrome. Start-up activities with clinical trial sites are
underway to be prepared to dose the first patient following FDA
approval of the updated IND.
Additionally, with the availability of this new
genome sequencing information, the Company plans to submit an IND
to the FDA within the first half of this year for the planned
Alzheimer’s Phase 2/3 study. The randomized, double-blind,
placebo-controlled study will evaluate the safety, tolerability and
efficacy of ANAVEX®2-73 in Alzheimer’s disease patients and will be
conducted in both Australia and North America. The Company is
planning to use a similar process and trial design for the
Parkinson’s disease Phase 2 study, for which the clinical site
validation has been completed.
“We believe Anavex is pioneering the inclusion
of advanced genomic biomarkers into late-stage CNS precision
medicine trials, including our Rett syndrome, Alzheimer’s disease
and Parkinson’s disease trials. It was a strategic decision to
start the new clinical trials after genetic data were collected and
analyzed. We are expecting to leverage these important findings to
more precisely target patients based on specific genomic profiles
that may be highly responsive to ANAVEX®2-73,” said Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
“This should allow us to improve upon existing trial designs and
expedite other aspects of our clinical development program.”
Financial Highlights:
- Cash and equivalents of $28.0 million at December 31, 2017,
compared to $27.4 million at September 30, 2017.
- Cash utilized in operations was $3.6 million for the first
quarter of fiscal 2018, compared to $3.2 million for the
comparative quarter in fiscal 2017.
- Operating expenses of $4.1 million for the first quarter of
fiscal 2018 compared to $3.2 million for the comparative quarter in
fiscal 2017. The increase in operating expenses is primarily
attributable to an increase in research and development activities
due to a ramp up of expenses incurred in preparation for upcoming
clinical trials.
- Net loss for the first quarter of fiscal 2018 of $4.1 million,
or $0.09 per share, compared to a net loss of $3.1 million, or
$0.08 per share for the comparative quarter in fiscal 2017.
Recent Corporate Highlights:
- January 16, 2018 – Anavex reported that the peer-reviewed
scientific journal The Journal of Clinical Hypertension
published a post-hoc analysis of blood pressure data collected
during the Phase 2a study in mild-to-moderate Alzheimer’s disease
patients demonstrating that ANAVEX®2-73 seems to normalize systolic
blood pressure (SBP) in a patient population with risk for
hypertension.
The financial information for three months ended
December 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.
Conference Call / Webcast Information
Anavex will host a conference call at 4:30 p.m. ET today,
February 7, 2018.
The live webcast of the conference call can be
accessed online at http://wsw.com/webcast/cc/avxl4. 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 46430090. 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 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. 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. The grant fully funds 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.
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 |
|
|
|
|
|
|
|
|
December 31, |
September 30, |
|
|
ASSETS |
|
2017 |
|
|
2017 |
|
|
|
Current |
|
|
|
|
Cash and
cash equivalents |
$ |
28,048,644 |
|
$ |
27,440,257 |
|
|
|
Sales
tax recoverable |
|
7,377 |
|
|
9,748 |
|
|
|
Prepaid
expenses and deposits |
|
235,390 |
|
|
335,928 |
|
|
|
Total current
assets |
|
28,291,411 |
|
|
27,785,933 |
|
|
|
Deposits |
|
52,396 |
|
|
52,396 |
|
|
|
Total
assets |
$ |
28,343,807 |
|
$ |
27,838,329 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
2,798,472 |
|
$ |
3,584,334 |
|
|
|
Total
liabilities |
|
2,798,472 |
|
|
3,584,334 |
|
|
|
Common stock |
|
44,423 |
|
|
43,332 |
|
|
|
Additional paid-in
capital |
|
121,038,635 |
|
|
115,689,221 |
|
|
|
Accumulated
deficit |
|
(95,537,723 |
) |
|
(91,478,558 |
) |
|
|
Total
stockholders' equity |
|
25,545,335 |
|
|
24,253,995 |
|
|
|
Total
liabilities and stockholders' equity |
$ |
28,343,807 |
|
$ |
27,838,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF
OPERATIONS |
|
|
THREE MONTHS ENDED DECEMBER 31, 2017 AND 2016 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
1,397,803 |
|
$ |
1,126,184 |
|
|
|
Research and
development |
|
2,694,312 |
|
|
2,042,490 |
|
|
|
Total operating expenses |
|
4,092,115 |
|
|
3,168,674 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(4,092,115 |
) |
|
(3,168,674 |
) |
|
|
Other
income |
|
|
|
|
Grant income |
|
- |
|
|
35,286 |
|
|
|
Interest income,
net |
|
30,376 |
|
|
3,655 |
|
|
|
Foreign exchange
gain |
|
11,979 |
|
|
14,082 |
|
|
|
Total other income |
|
42,355 |
|
|
53,023 |
|
|
|
Net loss before income
taxes |
|
(4,049,760 |
) |
|
(3,115,651 |
) |
|
|
Income tax expense -
current |
|
(9,405 |
) |
|
(31,008 |
) |
|
|
Net
loss |
$ |
(4,059,165 |
) |
$ |
(3,146,659 |
) |
|
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and
Diluted |
$ |
(0.09 |
) |
$ |
(0.08 |
) |
|
|
|
|
|
|
|
Weighted
Average Number of Shares Outstanding |
|
|
|
Basic and
Diluted |
|
43,882,939 |
|
|
38,393,910 |
|
|
|
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Clayton
RobertsonThe Trout GroupTel: (646) 378-2900Email:
crobertson@troutgroup.com
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