Anavex Life Sciences Reports Fiscal 2019 Second Quarter Financial Results and Provides Clinical Study Updates
May 08 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 second quarter.
“We are very pleased with the progress we made
related to enrollment for the novel genomic marker driven CNS
precision medicine clinical studies in Parkinson’s disease dementia
and Alzheimer’s disease and initiating a second Rett syndrome
study,” said, Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex.
ANAVEX®2-73 Program Update:
- 70% of the total patient enrollment target has been achieved to
date for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD)
study1.
- Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease
(AD) study2 is proceeding as planned with over 20% patients
enrolled to date.
- 40% of the total patient enrollment target has been achieved to
date for the Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study3.
- Anavex received approval by the Australian Human Research
Ethics Committee to initiate an approximately 30 patient Phase 2
double-blind, randomized, placebo-controlled, study of ANAVEX®2-73
for the treatment of Rett syndrome, called AVATAR study4. The
AVATAR study is scheduled to initiate this quarter.
Financial Highlights:
- Cash and equivalents of $19.5 million at March 31, 2019,
compared to $22.9 million at September 30, 2018.
- Cash used to fund operations for second quarter fiscal 2019 was
$4.3 million, compared to $2.8 million for the comparative second
quarter in fiscal 2018.
- Operating expenses for second quarter fiscal 2019 of $8.1
million compared to $4.7 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.
- Net loss for the quarter of $8.0 million, or $0.17 per share,
compared to a net loss of $4.8 million, or $0.11 per share for the
second quarter of fiscal 2018. The fiscal quarter in 2019 contains
non-cash expenses of approximately $1.9 million.
The financial information for the fiscal quarter
ended March 31, 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/avxl9.
To join the conference call live via telephone,
interested parties within the U.S. should dial, toll-free,
1-866-866-1333 and international callers should dial
1-404-260-1421. Please use confirmation number 48595200, 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 |
March 31 |
September 30, |
|
ASSETS |
|
2019 |
|
|
2018 |
|
|
Current |
|
|
|
Cash and cash equivalents |
$ |
19,457,845 |
|
$ |
22,930,638 |
|
|
Sales tax recoverable |
|
76,160 |
|
|
40,171 |
|
|
Prepaid expenses and deposits |
|
849,642 |
|
|
1,251,798 |
|
|
Deferred financing charges |
|
151,133 |
|
|
101,133 |
|
|
Deposits |
|
15,000 |
|
|
- |
|
|
Total current assets |
|
20,549,780 |
|
|
24,323,740 |
|
|
Deposits |
|
- |
|
|
52,396 |
|
|
Total
assets |
$ |
20,549,780 |
|
$ |
24,376,136 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current |
|
|
|
Accounts payable and accrued liabilities |
$ |
6,370,604 |
|
$ |
3,884,626 |
|
|
Total
liabilities |
|
6,370,604 |
|
|
3,884,626 |
|
|
Common stock |
|
48,175 |
|
|
45,935 |
|
|
Additional paid-in
capital |
|
138,696,975 |
|
|
129,377,542 |
|
|
Subscriptions receivable |
|
(292,700 |
) |
|
- |
|
|
Accumulated deficit |
|
(124,273,274 |
) |
|
(108,931,967 |
) |
|
Total stockholders'
equity |
|
14,179,176 |
|
|
20,491,510 |
|
|
Total liabilities and
stockholders' equity |
$ |
20,549,780 |
|
$ |
24,376,136 |
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS |
|
|
THREE MONTHS ENDED MARCH 31, 2019 AND 2018 |
|
|
(Unaudited) |
|
|
Expressed in US Dollars |
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
2,061,251 |
|
$ |
1,489,450 |
|
|
|
Research and development |
|
6,078,786 |
|
|
3,245,023 |
|
|
|
Total operating expenses |
|
8,140,037 |
|
|
4,734,473 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(8,140,037 |
) |
|
(4,734,473 |
) |
|
|
Other
income |
|
|
|
|
Grant income |
|
74,527 |
|
|
- |
|
|
|
Interest income, net |
|
51,465 |
|
|
28,647 |
|
|
|
Foreign exchange gain
(loss) |
|
54,199 |
|
|
(18,337 |
) |
|
|
Total other income |
|
180,191 |
|
|
10,310 |
|
|
|
Net loss before income
taxes |
|
(7,959,846 |
) |
|
(4,724,163 |
) |
|
|
Income tax expense -
current |
|
(48,048 |
) |
|
(27,861 |
) |
|
|
Net loss |
$ |
(8,007,894 |
) |
$ |
(4,752,024 |
) |
|
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.17 |
) |
$ |
(0.11 |
) |
|
|
|
|
|
|
|
Weighted Average
Number of Shares Outstanding |
|
|
|
Basic and Diluted |
|
47,134,686 |
|
|
44,545,523 |
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
|
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS |
|
|
SIX MONTHS ENDED MARCH 31, 2019 AND 2018 |
|
|
(Unaudited) |
|
|
Expressed in US Dollars |
|
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
3,822,559 |
|
$ |
2,887,253 |
|
|
|
Research and development |
|
11,790,996 |
|
|
5,939,335 |
|
|
|
Total operating expenses |
|
15,613,555 |
|
|
8,826,588 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(15,613,555 |
) |
|
(8,826,588 |
) |
|
|
Other
income |
|
|
|
|
Grant income |
|
149,055 |
|
|
- |
|
|
|
Interest income, net |
|
130,265 |
|
|
59,023 |
|
|
|
Foreign exchange gain
(loss) |
|
49,693 |
|
|
(6,358 |
) |
|
|
Total other income |
|
329,013 |
|
|
52,665 |
|
|
|
Net loss before income
taxes |
|
(15,284,542 |
) |
|
(8,773,923 |
) |
|
|
Income tax expense -
current |
|
(56,765 |
) |
|
(37,266 |
) |
|
|
Net loss |
$ |
(15,341,307 |
) |
$ |
(8,811,189 |
) |
|
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.33 |
) |
$ |
(0.20 |
) |
|
|
|
|
|
|
|
Weighted Average
Number of Shares Outstanding |
|
|
|
Basic and Diluted |
|
46,726,649 |
|
|
44,210,591 |
|
|
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: NCT03774459
2 ClinicalTrials.gov Identifier: NCT03790709
3 ClinicalTrials.gov Identifier: NCT03758924
4 ANAVEX®2-73 assessment of safety and efficacy in Rett syndrome
patients
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