Anavex Life Sciences Reports Fiscal 2020 First Quarter Financial Results and Provides Clinical Study Updates
February 06 2020 - 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
2020 first quarter.
“We are excited about the progress across our
pipeline, including the receipt of Fast Track designation for the
ANAVEX®2-73 (blarcamesine) clinical development program from the
U.S. Food and Drug Administration (FDA) for the treatment of Rett
syndrome,” commented Christopher U Missling, PhD, President and
Chief Executive Officer of Anavex. “Our clinical Rett syndrome
programs are on track with continued enrollment. While our
enrollment and early data have been exciting, we are humbled by the
needs of the rare disease and Alzheimer’s and Parkinson’s disease
communities with whom we engage. They impress a sense of urgency on
our work to deliver a new paradigm that underscores the need for
new treatment options for patients and their families.”
Program Updates and
Milestones:
- On February 3, 2020, we announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for the
ANAVEX®2-73 (blarcamesine) clinical development program for the
treatment of Rett syndrome.
- We announced January 8, 2020 that the United States Patent and
Trademark Office (USPTO) granted U.S. Patent No. 10,507,196 to
support Anavex’s leading drug candidate, ANAVEX®2-73 (blarcamesine)
for the treatment of neurodevelopmental disorders including Rett
syndrome, and multiple sclerosis. This patent is expected to remain
in force at least until 2037, not including any patent term
extensions.
- On January 27, 2020, we announced that we have met our
enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study1
in Parkinson’s Disease Dementia (PDD). The study enrolled
over 120 patients at 20 sites across Spain and 3 sites in
Australia. We expect to announce topline results from this study by
mid-2020.
- Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine)
Alzheimer’s disease (AD) study2 is 50% complete. Recruitment is
expected to accelerate given the anticipated international
expansion of the study, which will increase the total number of
sites from 15 to approximately 45 in 2020.
- ANAVEX®3-71 successfully completed IND-enabling toxicology
studies and drug product manufacturing. ANAVEX®3-71 previously
received Orphan Drug Designation from the U.S. FDA for
Frontotemporal dementia (FTD). Initiation of the first Phase 1
clinical trial of ANAVEX®3-71 is expected in 2020. ANAVEX®3-71 has
demonstrated disease-modifying activity against the major hallmarks
of Alzheimer’s disease in transgenic (3xTg-AD) mice, including
cognitive deficits, inflammation, amyloid and tau pathologies.
Financial Highlights:
- Cash and cash equivalents of $27.5 million at December 31,
2019, compared to $22.2 million at September 30, 2019.
- Anavex reported a net loss of $6.6 million, or $0.12 per share
for the first quarter of 2020, compared to a net loss of $6.9
million, or $0.15 per share in the comparable first quarter 2019.
This decrease was due to increased research and development
incentive income.
- Research and development expenses were $6.3 million for the
first quarter of 2020 as compared to $5.7 million for the
comparable period in 2019. This increase was driven by increased
program development activities related to the advancement of the
Company’s pipeline.
- General and administrative expenses were $1.4 million for the
first quarter of 2020 as compared to $1.8 million for the
comparable period in 2019. This decrease was primarily due to lower
non-cash stock-based compensation.
The financial information for the fiscal quarter
ended December 31, 2019 should be read in conjunction with the
Company’s consolidated interim financial statements, which will
appear on EDGAR, www.sec.gov and will be available on the Anavex
website at www.anavex.com.
Conference Call / Webcast
Information
Anavex will host a conference call and webcast
today at 4:30 p.m. ET.
The live webcast of the conference call may be
accessed online at http://www.wsw.com/webcast/cc/avxl12.
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 49361235, followed by the pound sign
(#).
A replay of the conference call will also be
available 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 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 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 mitochondrial
dysfunction and neuroinflammation.
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 |
As at December 31, 2019 and September 30, 2019 |
Expressed in US Dollars |
|
|
|
|
|
December 31, |
September 30, |
|
2019 |
2019 |
ASSETS |
|
|
|
|
Current |
|
|
|
|
Cash and cash equivalents |
$ |
27,458,423 |
|
$ |
22,185,630 |
|
Incentives and taxes receivable |
3,730,672 |
|
2,642,745 |
|
Prepaid expenses and deposits |
234,972 |
|
500,998 |
|
Total
assets |
$ |
31,424,067 |
|
$ |
25,329,373 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current |
|
|
|
|
Accounts payable |
$ |
3,127,498 |
|
$ |
3,523,332 |
|
Accrued liabilities |
2,336,419 |
|
1,516,342 |
|
Total
liabilities |
5,463,917 |
|
5,039,674 |
|
Common stock |
57,082 |
|
52,652 |
|
Additional paid-in
capital |
165,891,753 |
|
153,633,807 |
|
Accumulated deficit |
(139,988,685 |
) |
(133,396,760 |
) |
Total stockholders'
equity |
25,960,150 |
|
20,289,699 |
|
Total liabilities and stockholders' equity |
$ |
31,424,067 |
|
$ |
25,329,373 |
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS |
THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018 |
(Unaudited) |
Expressed in US Dollars |
|
|
|
|
|
2019 |
2018 |
Operating
Expenses |
|
|
|
|
General and administrative |
$ |
1,352,035 |
|
$ |
1,761,307 |
|
Research and development |
6,348,668 |
|
5,712,210 |
|
Total operating expenses |
7,700,703 |
|
7,473,517 |
|
|
|
|
|
|
Operating
Loss |
(7,700,703 |
) |
(7,473,517 |
) |
Other
income |
|
|
|
|
Grant income |
74,944 |
|
74,528 |
|
Research and development
incentive income |
943,215 |
|
413,682 |
|
Interest income, net |
46,720 |
|
78,800 |
|
Foreign exchange gain
(loss) |
53,113 |
|
(4,507 |
) |
Total other income |
1,117,992 |
|
562,503 |
|
Net loss before income
taxes |
(6,582,711 |
) |
(6,911,014 |
) |
Income tax expense -
current |
(9,214 |
) |
(8,717 |
) |
Net loss |
$ |
(6,591,925 |
) |
$ |
(6,919,731 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.12 |
) |
$ |
(0.15 |
) |
|
|
|
|
|
Weighted Average Number of
Shares Outstanding |
|
|
|
|
Basic and Diluted |
54,773,685 |
|
46,327,482 |
|
|
|
|
|
|
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: NCT037744592
ClinicalTrials.gov Identifier: NCT03790709
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