Anavex Life Sciences Reports Fiscal 2020 Third Quarter Financial Results And Provides Business Updates
August 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 third quarter.
“It is an accomplishment having three ongoing
clinical studies in Rett syndrome in progress with ANAVEX®2-73
(blarcamesine) and we expect respective clinical trial results to
be reported as we progress,” said Christopher U Missling, PhD,
President and Chief Executive Officer of Anavex. “It is important
to point out that all clinical studies with ANAVEX®2-73
(blarcamesine), including the ongoing Alzheimer’s disease Phase
2b/3 trial and Parkinson’s disease dementia Phase 2 study, which
read out is upcoming, includes the entire genome and exome
sequencing, opens the possibility of using big data-driven unbiased
genome-wide patient analysis, hence, maintaining the focus on
Precision Medicine for neurological disorders.”
Program Updates:
- Yesterday Anavex announced it has received compassionate use
Special Access Scheme (SAS) approval for Alzheimer’s disease
patients continued treatment with ANAVEX®2-73 (blarcamesine) by the
Australian Government Department of Health - Therapeutic Goods
Administration (TGA).
- In June 2020, Anavex announced it has received Clinical Trial
Authorization (CTA) from the Medicines and Healthcare products
Regulatory Agency (MHRA) in the United Kingdom (UK) as well as a
‘No Objection Letter’ from Health Canada to expand the footprint of
the international Phase 2b/3 double-blind, randomized,
placebo-controlled safety and efficacy trial (Study
ANAVEX®2-73-AD-004) of ANAVEX2-73 (blarcamesine) for the treatment
of early Alzheimer’s disease into the UK and Canada,
respectively.
- In June 2020, Anavex announced it exceeded by 50% its
enrollment target for the ANAVEX®2-73 (blarcamesine) U.S. Phase 2
study in Rett syndrome. The Company expects to announce topline
results from this study in calendar Q4 2020.
- In July 2020, Anavex announced that the first pediatric patient
was dosed in the Phase 2/3 ANAVEX®2-73-RS-003 EXCELLENCE clinical
trial for the treatment of Rett syndrome with ANAVEX®2-73
(blarcamesine).
- In July 2020, Anavex announced the enrollment of the first
participant in a Phase 1 clinical trial of ANAVEX®3-71 (AF710B), an
orally-administered small molecule targeting sigma-1 and M1
muscarinic receptors that is designed to be beneficial for
neurodegenerative diseases, with topline data anticipated in the
first half of 2021.
Financial Highlights:
- Cash and cash equivalents of $27.6 million at June 30, 2020,
compared to $22.2 million at fiscal year ended September 30,
2019.
- Research and development expenses of $6.7 million for the
quarter, compared to $5.8 million in the comparable quarter in
2019.
- General and administrative expenses of $1.4 million for the
quarter as well as for the comparable quarter in 2019.
- Net loss of $6.5 million, or $0.11 per share for the quarter,
compared to net loss of $6.5 million, or $0.13 per share in the
comparable quarter of 2019.
The financial information for the fiscal quarter
ended June 30, 2020 should be read in conjunction with the
Company’s interim condensed consolidated 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 11:00
a.m. ET.
The live webcast of the conference call can be
accessed online at https://wsw.com/webcast/cc/avxl14.
To join the conference call, live via telephone,
interested parties within the U.S. should dial, toll-free, 1 (866)
901-2585 and international callers should dial 1 (404) 835-7099.
Please use confirmation number 49865428, 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 clinical 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. |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS |
As at June 30, 2020 and September 30, 2019 |
Expressed in US Dollars |
|
|
|
June 30, 2020 |
September 30,2019 |
|
(Unaudited) |
|
ASSETS |
|
|
Current |
|
|
Cash and cash equivalents |
$ |
27,619,145 |
$ |
22,185,630 |
Incentive and taxe receivables |
3,547,972 |
2,642,745 |
Prepaid expenses and deposits |
438,631 |
500,998 |
Deferred costs |
24,508 |
- |
Total
assets |
$ |
31,630,256 |
$ |
25,329,373 |
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current |
|
|
Accounts payable |
$ |
3,980,204 |
$ |
3,523,332 |
Accrued liabilities |
2,968,994 |
1,516,342 |
Total
liabilities |
6,949,198 |
5,039,674 |
Common stock |
60,083 |
52,652 |
Additional paid-in
capital |
178,332,979 |
153,633,807 |
Accumulated deficit |
(153,712,004) |
(133,396,760) |
Total stockholders'
equity |
24,681,058 |
20,289,699 |
Total liabilities and stockholders' equity |
$ |
31,630,256 |
$ |
25,329,373 |
ANAVEX LIFE SCIENCES CORP. |
INTERIM CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS |
THREE MONTHS ENDED JUNE 30, 2020 and 2019 |
(Unaudited) |
Expressed in US Dollars |
|
|
|
|
|
2020 |
|
2019 |
|
Operating
Expenses |
|
|
|
|
General and administrative |
$ |
1,381,477 |
|
$ |
1,388,729 |
|
Research and development |
6,725,002 |
|
5,758,446 |
|
Total operating expenses |
8,106,479 |
|
7,147,175 |
|
|
|
|
|
|
Operating
Loss |
(8,106,479 |
) |
(7,147,175 |
) |
Other
income |
|
|
|
|
Grant income |
- |
|
74,944 |
|
Research and development
incentive income |
1,319,913 |
|
552,335 |
|
Interest income, net |
56,096 |
|
34,838 |
|
Gain on settlement of accounts
payable |
- |
|
36,978 |
|
Foreign exchange gain (loss),
net |
248,665 |
|
(54,546 |
) |
Total other income |
1,624,674 |
|
644,549 |
|
Net loss before income
taxes |
(6,481,805 |
) |
(6,502,626 |
) |
Income tax expense,
current |
(4,817 |
) |
(19,300 |
) |
Net loss |
$ |
(6,486,622 |
) |
$ |
(6,521,926 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.11 |
) |
$ |
(0.13 |
) |
|
|
|
|
|
Weighted Average Number of
Shares Outstanding |
|
|
|
|
Basic and Diluted |
59,105,399 |
|
49,622,465 |
|
ANAVEX LIFE SCIENCES CORP. |
INTERIM CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS |
NINE MONTHS ENDED JUNE 30, 2020 AND 2019 |
(Unaudited) |
Expressed in US Dollars |
|
|
|
|
|
2020 |
|
2019 |
|
Operating
Expenses |
|
|
|
|
General and administrative |
$ |
4,453,654 |
|
$ |
5,211,287 |
|
Research and development |
19,126,717 |
|
17,549,442 |
|
Total operating expenses |
23,580,371 |
|
22,760,729 |
|
|
|
|
|
|
Other
income |
|
|
|
|
Grant income |
149,888 |
|
223,999 |
|
Research and development
incentive income |
2,980,456 |
|
1,727,007 |
|
Interest income, net |
172,996 |
|
165,103 |
|
Gain on settlement of accounts
payable |
- |
|
36,978 |
|
Foreign exchange gain (loss),
net |
|
(24,182 |
) |
|
(4,854 |
) |
Total other income |
3,279,158 |
|
2,148,233 |
|
Net loss before income
taxes |
|
(20,301,213 |
) |
|
(20,612,496 |
) |
Income tax expense,
current |
|
(14,031 |
) |
|
(76,065 |
) |
Net loss |
$ |
(20,315,244 |
) |
$ |
(20,688,561 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and Diluted |
$ |
(0.35 |
) |
$ |
(0.43 |
) |
|
|
|
|
|
Weighted Average Number of
Shares Outstanding |
|
|
|
|
Basic and Diluted |
57,401,387 |
|
47,691,921 |
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free:
1-844-689-3939Email: info@anavex.com
Investors & Media:Email:
ir@anavex.com
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