Anavex Life Sciences Reports Fiscal 2019 First Quarter Financial Results And Provides Clinical Study Updates
February 07 2019 - 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,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported financial results for its fiscal
2019 first quarter.
“We are very pleased with the pace of enrollment
for the novel genomic marker driven later-stage CNS precision
medicine clinical studies in Parkinson’s disease dementia and
Alzheimer’s disease. We are looking forward to continuous updates
on enrollment for these studies as we advance into 2019,” said
Christopher U Missling, PhD, President and Chief Executive Officer
of Anavex.
ANAVEX®2-73 Program Update:
- Since enrollment started on October 30, 2018 for the Phase 2
ANAVEX®2-73 Parkinson’s disease dementia (PDD) study1, over
one-third of the total patient enrollment target has been achieved
to date.
- Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease
(AD) study2 is proceeding as planned with over 80 patients screened
to date.
- Successfully submitted Phase 2 ANAVEX®2-73 Rett syndrome (RTT)
study3 to respective United States Institutional Review Boards
(IRB) of the first three clinical trial sites.
1 ClinicalTrials.gov Identifier: NCT037744592 ClinicalTrials.gov
Identifier: NCT037907093 ClinicalTrials.gov Identifier:
NCT03758924
Financial Highlights:
- Cash and equivalents of $20.7 million at December 31, 2018,
compared to $22.9 million at September 30, 2018.
- Cash used to fund operations for first quarter fiscal 2019 was
$4.2 million, compared to $3.6 million for the comparative first
quarter in fiscal 2018.
- Operating expenses for first quarter fiscal 2019 of $7.5
million compared to $4.1 million for the comparative fiscal
quarter. Research and development expenses increased as a result of
expenses incurred in connection with the advancement of clinical
studies for ANAVEX®2-73, and non-recurring expenses of
approximately $1.0 million associated with large-scale
manufacturing of ANAVEX®2-73 in quantities reserved for potential
future commercial use.
- Net loss for the quarter of $7.3 million, or $0.16 per share,
compared to a net loss of $4.1 million, or $0.09 per share for the
first quarter of fiscal 2018. The fiscal quarter in 2019 contains
non-cash expenses of approximately $2.1 million and non-recurring
expenses of approximately $1.0 million.
Recent Corporate Highlights:
- January 2, 2019 – Anavex announced the appointment of Walter E.
Kaufmann, MD as Chief Medical Officer (CMO). Dr. Kaufmann’s
clinical focus is on developing novel therapies for genetic
disorders associated with intellectual disability. A major focus of
Dr. Kaufmann’s research has been Rett syndrome, a field where he
has published extensively on neurobiology and clinical
aspects.
The financial information for the fiscal quarter
ended December 31, 2018 should be read in conjunction with the
Company’s consolidated financial statements, which will appear on
EDGAR and will be available on the Anavex website at
www.anavex.com.
Conference Call / Webcast Information
The live webcast of the conference call can be
accessed online at http://www.wsw.com/webcast/cc/avxl8.
To join the conference call live via telephone,
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 48199094, followed by the pound sign
(#).
A replay of the conference call will also be
available on www.anavex.com approximately one hour after the
call.
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, Parkinson’s disease, Rett syndrome and 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 |
Unaudited |
|
|
|
Expressed in US
Dollars |
December 31, |
September 30, |
ASSETS |
2018 |
2018 |
Current |
|
|
Cash and cash
equivalents |
$ |
20,715,169 |
|
$ |
22,930,638 |
|
Sales
tax recoverable |
|
30,372 |
|
|
40,171 |
|
Prepaid
expenses and deposits |
|
1,155,958 |
|
|
1,251,798 |
|
Deferred
financing charges |
|
151,133 |
|
|
101,133 |
|
Deposits |
|
43,047 |
|
|
- |
|
Total
current assets |
|
22,095,679 |
|
|
24,323,740 |
|
Deposits |
|
- |
|
|
52,396 |
|
Total
assets |
$ |
22,095,679 |
|
$ |
24,376,136 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current |
|
|
Accounts
payable and accrued liabilities |
$ |
4,875,895 |
|
$ |
3,884,626 |
|
Total
liabilities |
|
4,875,895 |
|
|
3,884,626 |
|
Common stock |
|
46,888 |
|
|
45,935 |
|
Additional paid-in
capital |
|
133,438,276 |
|
|
129,377,542 |
|
Accumulated
deficit |
|
(116,265,380 |
) |
|
(108,931,967 |
) |
Total
stockholders' equity |
|
17,219,784 |
|
|
20,491,510 |
|
Total
liabilities and stockholders' equity |
$ |
22,095,679 |
|
$ |
24,376,136 |
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF
OPERATIONS |
THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 |
(Unaudited) |
|
|
|
|
|
2018 |
|
|
2017 |
|
Operating
Expenses |
|
|
General and
administrative |
$ |
1,761,307 |
|
$ |
1,397,803 |
|
Research and
development |
|
5,712,210 |
|
|
2,694,312 |
|
Total operating expenses |
|
7,473,517 |
|
|
4,092,115 |
|
|
|
|
Operating
Loss |
|
(7,473,517 |
) |
|
(4,092,115 |
) |
Other
income |
|
|
Grant income |
|
74,528 |
|
|
- |
|
Interest income,
net |
|
78,800 |
|
|
30,376 |
|
Foreign exchange gain
(loss) |
|
(4,507 |
) |
|
11,979 |
|
Total other income |
|
148,821 |
|
|
42,355 |
|
Net loss before income
taxes |
|
(7,324,696 |
) |
|
(4,049,760 |
) |
Income tax expense -
current |
|
(8,717 |
) |
|
(9,405 |
) |
Net
loss |
$ |
(7,333,413 |
) |
$ |
(4,059,165 |
) |
|
|
|
Net loss per Share |
|
|
Basic and
Diluted |
$ |
(0.16 |
) |
$ |
(0.09 |
) |
|
|
|
Weighted
Average Number of Shares Outstanding |
|
Basic and Diluted |
|
46,327,482 |
|
|
43,882,939 |
|
|
|
|
|
|
|
|
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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