Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates
August 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 disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported financial results for its fiscal
2019 third quarter.
“We remain focused on our core strategic goal of
bringing novel biomarker driven CNS precision medicine therapies to
patients with devastating rare diseases, as well as the largest
unmet medical need of aging population, Alzheimer’s and Parkinson
disease, as quickly as possible. We are very pleased with the
execution of advancing our pipeline and look forward to providing
updates on four clinical programs by year end,” said, Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 (blarcamesine) Program
Update:
- Enrollments for the U.S. Phase 2 Rett syndrome study1 and the
AVATAR Rett syndrome study2 of ANAVEX®2-73 (blarcamesine) are
advancing with high priority.
- The independent Data Safety Monitoring Board (DSMB) for the
U.S. Phase 2 Rett syndrome study of ANAVEX®2-73 (blarcamesine)
completed its recent pre-planned review of the preliminary Phase 2
efficacy and safety data. Upon review of the most recent data, the
DSMB made the recommendation to continue the study without
modification.
- The enrollment of the Phase 2 ANAVEX®2-73 (blarcamesine)
Parkinson’s disease dementia (PDD) study3 is proceeding well and is
getting closer to reach completion. At the request of investigators
in order to offer all participants of the clinical study access to
ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is
in preparation including microbiome assessment.
- Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine)
Alzheimer’s disease (AD) study4 is proceeding as scheduled. At the
request of investigators in order to offer all participants of the
clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary
extension of this study is planned.
- A recent peer-reviewed scientific publication titled, Neuronal
Sigma-1 receptors: signaling functions and protective roles in
neurodegenerative diseases, details the mechanism of action of
Sigma-1 receptors (S1R) and references ANAVEX®2-73 among the
relevant S1R ligands. The paper summarizes: “In conclusion, S1R is
incredibly versatile in its ability to foster neuronal homeostasis
in the context of several neurodegenerative disorders.”5
Financial Highlights:
- Cash and cash equivalents of $21.2 million at June 30, 2019,
compared to $22.9 million at September 30, 2018.
- Existing cash and cash equivalents, along with existing
financial commitments from third parties, are sufficient to meet
cash utilization for in excess of two years.
- Operating expenses for third quarter fiscal 2019 of $7.1
million compared to $4.6 million for the comparative fiscal
quarter. Research and development expenses have increased in the
current fiscal year as a result of expenses incurred in connection
with the advancement of clinical studies for ANAVEX®2-73
(blarcamesine).
- Net loss for the quarter of $7.1 million, or $0.14 per share,
compared to a net loss of $2.8 million, or $0.06 per share for the
third quarter of fiscal 2018.
The financial information for the fiscal quarter
ended June 30, 2019 should be read in conjunction with the
Company’s 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
The live webcast of the conference call can be
accessed online at http://www.wsw.com/webcast/cc/avxl10.
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 48906457, 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 disorders 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 (blarcamesine),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) 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 |
|
|
|
|
June 30, 2019 |
September 30, 2018 |
|
ASSETS |
|
|
|
Current |
|
|
|
Cash and cash equivalents |
$ |
21,249,206 |
|
$ |
22,930,638 |
|
|
Sales tax recoverable |
|
93,314 |
|
|
40,171 |
|
|
Prepaid expenses and
deposits |
|
459,618 |
|
|
1,251,798 |
|
|
Deposits |
|
15,000 |
|
|
- |
|
|
Total current assets |
|
21,817,138 |
|
|
24,222,607 |
|
|
Deferred costs |
|
151,133 |
|
|
101,133 |
|
|
Deposits |
|
- |
|
|
52,396 |
|
|
Total
assets |
$ |
21,968,271 |
|
$ |
24,376,136 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current |
|
|
|
Accounts payable and accrued
liabilities |
$ |
4,336,607 |
|
$ |
3,884,626 |
|
|
Total
liabilities |
|
4,336,607 |
|
|
3,884,626 |
|
|
Common stock |
|
51,511 |
|
|
45,935 |
|
|
Accumulated deficit |
|
(131,347,535 |
) |
|
(108,931,967 |
) |
|
Total stockholders'
equity |
|
17,631,664 |
|
|
20,491,510 |
|
|
Total liabilities and stockholders' equity |
$ |
21,968,271 |
|
$ |
24,376,136 |
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS |
|
|
THREE MONTHS ENDED JUNE 30, 2019 AND 2018 |
|
|
(Unaudited) |
|
|
Expressed in US Dollars |
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
1,388,729 |
|
$ |
1,620,379 |
|
|
|
Research and development |
|
5,758,446 |
|
|
2,997,634 |
|
|
|
Total operating
expenses |
|
7,147,175 |
|
|
4,618,013 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(7,147,175 |
) |
|
(4,618,013 |
) |
|
|
Other
income |
|
|
|
|
Grant income |
|
74,944 |
|
|
74,528 |
|
|
|
Research and development
incentive income |
|
- |
|
|
1,629,513 |
|
|
|
Interest income, net |
|
34,838 |
|
|
112,226 |
|
|
|
Gain on settlement of accounts
payable |
|
36,978 |
|
|
- |
|
|
|
Financing related charges |
|
- |
|
|
(30,943 |
) |
|
|
Foreign exchange gain
(loss) |
|
(54,546 |
) |
|
(16,475 |
) |
|
|
Total other
income |
|
92,214 |
|
|
1,768,849 |
|
|
|
Net loss before income
taxes |
|
(7,054,961 |
) |
|
(2,849,164 |
) |
|
|
Income tax expense -
current |
|
(19,300 |
) |
|
- |
|
|
|
Net loss |
$ |
(7,074,261 |
) |
$ |
(2,849,164 |
) |
|
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.14 |
) |
$ |
(0.06 |
) |
|
|
|
|
|
|
|
Weighted Average
Number of Shares Outstanding |
|
|
|
Basic and Diluted |
|
49,622,465 |
|
|
45,212,074 |
|
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS |
|
NINE MONTHS ENDED JUNE 30, 2019 AND 2018 |
|
(Unaudited) |
|
Expressed in US Dollars |
|
|
|
|
|
2019 |
|
|
2018 |
|
|
Operating
Expenses |
|
|
|
General and
administrative |
$ |
5,211,287 |
|
$ |
4,507,632 |
|
|
Research and development |
|
17,549,442 |
|
|
8,936,969 |
|
|
Total operating
expenses |
|
22,760,729 |
|
|
13,444,601 |
|
|
|
|
|
|
Operating
Loss |
|
(22,760,729 |
) |
|
(13,444,601 |
) |
|
Other
income |
|
|
|
Grant income |
|
223,999 |
|
|
74,528 |
|
|
Research and development
incentive income |
|
- |
|
|
1,629,513 |
|
|
Interest income, net |
|
165,103 |
|
|
171,249 |
|
|
Gain on settlement of accounts
payable |
|
36,978 |
|
|
- |
|
|
Financing related charges |
|
- |
|
|
(30,943 |
) |
|
Foreign exchange gain
(loss) |
|
(4,854 |
) |
|
(22,833 |
) |
|
Total other
income |
|
421,226 |
|
|
1,821,514 |
|
|
Net loss before income
taxes |
|
(22,339,503 |
) |
|
(11,623,087 |
) |
|
Income tax expense -
current |
|
(76,065 |
) |
|
(37,266 |
) |
|
Net loss |
$ |
(22,415,568 |
) |
$ |
(11,660,353 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
Basic and Diluted |
$ |
(0.47 |
) |
$ |
(0.26 |
) |
|
|
|
|
|
Weighted Average
Number of Shares Outstanding |
|
|
Basic and Diluted |
|
47,691,921 |
|
|
44,365,683 |
|
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Email:
ir@anavex.com
1 ClinicalTrials.gov Identifier: NCT03758924 2
ClinicalTrials.gov Identifier: NCT03941444 3
ClinicalTrials.gov Identifier: NCT03774459 4
ClinicalTrials.gov Identifier: NCT03790709 5
www.frontiersin.org/articles/10.3389/fnins.2019.00862/abstract
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