Anavex Reports Fiscal Third Quarter 2017 Financial Results
August 07 2017 - 07:00AM
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, other central nervous system (CNS) diseases,
pain and various types of cancer, today reported financial results
for the fiscal quarter ended June 30, 2017.
Financial Highlights:
- Cash and equivalents of $24.8 million at June 30, 2017,
compared to $9.2 million at September 30, 2016.
- Cash used to fund operations was $3.0 million, compared to $2.2
million for the comparative quarter last year. This is in line with
the Company’s cash utilization guidance.
- Operating expenses of $3.7 million compared to $2.3 million for
the comparative quarter last year. This increase was a result of
increased spending on research and development, including clinical
trial preparatory activities.
- Net loss for the quarter of $3.6 million, or $0.09 per share,
compared to a net loss of $2.2 million, or $0.06 per share, for the
comparative quarter.
“We are entering the second half of 2017 with
our strongest balance sheet to date, which allows the Company to
execute the Phase 2 clinical trial in Rett syndrome, for which
ANAVEX™ 2-73 has been granted Orphan Drug Designation by the FDA,
as well as the Phase 2/3 clinical trial in Alzheimer’s disease and
the Phase 2 clinical trial in Parkinson’s disease,” said
Christopher U. Missling, PhD, President and Chief Executive Officer
of Anavex Life Sciences. “We look forward to initiating these
placebo-controlled clinical trials. The respective trial designs
are based on broad genomic and biomarker characterization,
pharmacokinetic and pharmacodynamic modeling including data from
patients in previous ANAVEX™ 2-73 trials, as well as preclinical
translational science. To our knowledge, this is the first use of
this approach in the design of clinical trials for Alzheimer’s
disease, Parkinson’s disease and Rett syndrome, and marks a shift
towards advancing implementation of precision medicine for these
and other neurodegenerative and neurodevelopmental diseases."
Corporate Highlights:
• July 20, 2017 – Anavex further strengthened its
Scientific Advisory Board with the appointment of Andrew J. Cole,
M.D., F.R.C.P.(C.) Dr. Cole is Director of the MGH Epilepsy
Service, Chief of the Division of Clinical Neurophysiology and
Epilepsy and Professor of Neurology at Harvard Medical School.
• May 22, 2017 – Anavex announced new preclinical data for
ANAVEXTM 2-73 in the rare diseases Angelman syndrome, Fragile X
syndrome and Rett syndrome.
- In a study sponsored by the Foundation for Angelman Syndrome,
ANAVEXTM 2-73 was assessed in a mouse model for the development of
audiogenic seizures. The results indicated that ANAVEX™ 2-73
administration significantly reduced audiogenic-induced
seizures.
- In a study sponsored by FRAXA Research Foundation, data
demonstrated that ANAVEXTM 2-73 restored hippocampal brain-derived
neurotrophic factor (BDNF) expression to normal levels. BDNF
under-expression has been observed in many neurodevelopmental and
neurodegenerative pathologies. BDNF signaling promotes maturation
of both excitatory and inhibitory synapses. ANAVEXTM 2-73
normalization of BDNF expression could be a contributing factor for
the positive data observed in both neurodevelopmental and
neurodegenerative disorders.
- In an experiment sponsored by Rettsyndrome.org, ANAVEXTM 2-73
was evaluated in automatic visual response and respiration tests in
seven-month old mice, an age at which advanced pathology is
evident. Vehicle-treated MECP2 mice demonstrated fewer automatic
visual responses than wild-type mice. Treatment with ANAVEXTM 2-73
significantly increased the automatic visual response in the MECP2
Rett syndrome disease mouse.
Planned Objectives:
- Report PK/PD data from Alzheimer’s Phase 2a clinical
trial.
- Initiate Phase 2 clinical trial in Rett syndrome (12-week,
randomized, double-blind, placebo-controlled).
- Initiate Phase 2 clinical trial in Parkinson’s disease
(12-week, randomized, double-blind, placebo-controlled).
- Initiate Phase 2/3 clinical trial in Alzheimer’s disease
(6/12-month, randomized, double-blind, placebo-controlled).
- Potential for several clinical read-outs in 2018.
- Complement current pipeline through in-licensing –
ongoing.
The financial information for the three and nine
months ended June 30, 2017, should be read in conjunction with the
Company’s condensed consolidated interim financial statements,
which will appear on EDGAR and will be available on the Anavex
website at 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 diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEXTM 2-73, recently completed successfully a Phase 2a clinical
trial for Alzheimer’s disease. ANAVEXTM 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. It has also exhibited anticonvulsant, anti-amnesic,
neuroprotective and anti-depressant properties in animal models,
indicating its potential to treat additional CNS disorders,
including epilepsy and others. The Michael J. Fox Foundation for
Parkinson’s Research has awarded Anavex a research grant to develop
ANAVEXTM 2-73 for the treatment of Parkinson’s disease to fully
fund a preclinical study, which could justify moving ANAVEXTM 2-73
into a Parkinson’s disease clinical trial. ANAVEX 3-71, also
targeting sigma-1 and M1 muscarinic receptors, is a promising
preclinical drug candidate demonstrating disease modifications
against the major Alzheimer’s hallmarks in transgenic (3xTg-AD)
mice, including cognitive deficits, amyloid and tau pathologies,
and also with beneficial effects on neuroinflammation and
mitochondrial dysfunctions. 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. |
|
|
CONSOLIDATED BALANCE SHEETS |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
September 30, |
|
|
ASSETS |
|
2017 |
|
|
2016 |
|
|
|
Current |
|
|
|
|
Cash |
$ |
24,793,424 |
|
$ |
9,186,814 |
|
|
|
Sales
Tax Recoverable |
|
8,216 |
|
|
79,347 |
|
|
|
Prepaid
expenses and deposits |
|
52,694 |
|
|
180,124 |
|
|
|
Total current
assets |
|
24,854,334 |
|
|
9,446,285 |
|
|
|
Deposits |
|
52,396 |
|
|
52,396 |
|
|
|
Total
assets |
$ |
24,906,730 |
|
$ |
9,498,681 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
1,435,498 |
|
$ |
3,119,993 |
|
|
|
Deferred
grant income |
|
19,073 |
|
|
70,532 |
|
|
|
Total
liabilities |
|
1,454,571 |
|
|
3,190,525 |
|
|
|
Common
stock |
|
42,173 |
|
|
36,169 |
|
|
|
Additional paid-in
capital |
|
109,733,970 |
|
|
84,290,140 |
|
|
|
Accumulated
deficit |
|
(86,323,984 |
) |
|
(78,018,153 |
) |
|
|
Total
stockholders' equity |
|
23,452,159 |
|
|
6,308,156 |
|
|
|
Total
liabilities and stockholders' equity |
$ |
24,906,730 |
|
$ |
9,498,681 |
|
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
|
THREE MONTHS ENDED JUNE 30, 2017 AND 2016 |
|
(Unaudited) |
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
Operating
Expenses |
|
|
|
General and
administrative |
$ |
1,405,026 |
|
$ |
1,134,845 |
|
|
Research and
development |
|
2,300,277 |
|
|
1,158,820 |
|
|
Total operating expenses |
|
3,705,303 |
|
|
2,293,665 |
|
|
|
|
|
|
Operating
Loss |
|
(3,705,303 |
) |
|
(2,293,665 |
) |
|
Other income
(expenses) |
|
|
|
Grant income |
|
69,146 |
|
|
47,767 |
|
|
Gain on settlement of
accounts payable |
|
75,204 |
|
|
- |
|
|
Interest income,
net |
|
26,677 |
|
|
2,626 |
|
|
Financing related
charges and adjustments |
|
|
(8 |
) |
|
Foreign exchange gain
(loss) |
|
(65,932 |
) |
|
8,924 |
|
|
Total other income (expenses) |
|
105,095 |
|
|
59,309 |
|
|
Net loss before income
taxes |
|
(3,600,208 |
) |
|
(2,234,356 |
) |
|
Income tax expense -
current |
|
(9,877 |
) |
|
(6,000 |
) |
|
Net
loss |
$ |
(3,610,085 |
) |
$ |
(2,240,356 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
Basic and
Diluted |
$ |
(0.09 |
) |
$ |
(0.06 |
) |
|
|
|
|
|
Weighted
Average Number of Shares Outstanding |
|
|
Basic and
Diluted |
|
41,509,225 |
|
|
35,709,686 |
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS |
|
NINE MONTHS ENDED JUNE 30, 2017 AND 2016 |
|
(Unaudited) |
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
Operating
Expenses |
|
|
|
General and
administrative |
$ |
3,647,224 |
|
$ |
5,117,591 |
|
|
Research and
development |
|
6,835,700 |
|
|
3,888,676 |
|
|
Total operating expenses |
|
10,482,924 |
|
|
9,006,267 |
|
|
|
|
|
|
Operating
Loss |
|
(10,482,924 |
) |
|
(9,006,267 |
) |
|
Other income
(expenses) |
|
|
|
Grant income |
|
121,116 |
|
|
113,701 |
|
|
Research and
development incentive income |
|
2,022,902 |
|
|
571,093 |
|
|
Gain on settlement of
accounts payable |
|
75,204 |
|
|
151,402 |
|
|
Interest income,
net |
|
48,479 |
|
|
6,832 |
|
|
Financing related
charges and adjustments |
|
- |
|
|
(1,175 |
) |
|
Foreign exchange gain
(loss) |
|
(40,128 |
) |
|
(37,637 |
) |
|
Total other
income |
|
2,227,573 |
|
|
804,216 |
|
|
Net loss before income
taxes |
|
(8,255,351 |
) |
|
(8,202,051 |
) |
|
Income tax expense -
current |
|
(50,480 |
) |
|
(23,615 |
) |
|
Net
loss |
$ |
(8,305,831 |
) |
$ |
(8,225,666 |
) |
|
|
|
|
|
Net loss per Share |
|
|
|
Basic and
Diluted |
$ |
(0.21 |
) |
$ |
(0.24 |
) |
|
|
|
|
|
Weighted
Average Number of Shares Outstanding |
|
|
Basic and
Diluted |
|
40,344,149 |
|
|
34,961,838 |
|
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
203-258-0159
dennisdobsonjr@dobsonmediagroup.com
Social Media:
Bill Douglass
Gotham Communications, LLC
646-504-0890
bill@gothamcomm.com
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