Anavex Life Sciences Reports Fiscal 2017 Financial Results And Provides Update On Therapeutic Programs
December 11 2017 - 7:00AM
Conference Call and Webcast Today at 4:30 p.m.
ET
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 year ended September 30, 2017.
The Company also provided an update on its most
advanced programs for ANAVEX®2-73 for the treatment of Rett
syndrome (RTT), a severe neurological disorder caused by mutations
in the X-linked gene MECP2 (methyl-CpG-binding protein 2),
Alzheimer’s disease and Parkinson’s disease.
“We are entering fiscal 2018 with our strongest
balance sheet to date, which allows the Company to carry out
planned clinical studies for ANAVEX®2-73. This year has been an
extraordinarily productive period for Anavex, with advanced
preparation underway for studies in Rett syndrome, Alzheimer’s
disease and Parkinson’s disease – all indications with high unmet
need,” said, Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex. “The upcoming year will be focused on
deploying key programs through clinical trials, with the
anticipation of a number of data readouts in 2018.”
ANAVEX®2-73 Program
Update:
- The Company filed an IND for ANAVEX®2-73 in Rett syndrome, for
which the Company received orphan drug designation by the FDA, and
is expecting feedback from the FDA to finalize the clinical trial
protocol for this study. As start-up activities with clinical trial
sites have been underway, the Company anticipates dosing the first
patient in due course following FDA approval of the IND.
- With the integration of genome sequencing information from
ANAVEX®2-73-treated patients, the Company is now able to enhance
the planned Alzheimer’s Phase 2/3 study. It is expected that
incorporating this novel precision medicine approach as well as
including comprehensive fluid-based biomarkers and multimodal
neuroimaging, will enable a more robust regulatory submission,
anticipated within the upcoming quarter. The randomized,
double-blind, placebo-controlled study will be aimed at evaluating
the safety, tolerability and efficacy of ANAVEX®2-73 in Alzheimer’s
disease patients and will be conducted in both Australia and North
America. Further details of the study will be shared in upcoming
announcements.
- Due the strength of the preclinical Parkinson’s disease data on
ANAVEX®2-73 from a collaboration with Michael J. Fox Foundation,
Anavex plans to file an upcoming clinical trial application (CTA)
with European regulatory authorities to conduct a Phase 2 trial for
ANAVEX®2-73 in Parkinson’s disease patients.
Financial Highlights:
- Cash and equivalents of $27.4 million at September 30, 2017,
compared to $9.2 million at September 30, 2016.
- Cash used to fund operations was $9.0 million for the 2017
fiscal year, compared to $9.2 million for the comparative 2016
fiscal year. This is in line with the Company’s cash utilization
guidance, after adjusting for tax incentive income of $2.0
million.
- Operating expenses of $15.7 million for the 2017 fiscal year
compared to $15.6 million for the comparative 2016 fiscal year. The
results included a 47% increase in research and development
expenditures over the comparative year. The increase was
associated with expenditures incurred in preparation of our planned
clinical studies, and an increase in preclinical activities for
ANAVEX®3-71 and ANAVEX®1066.
- Net loss for the 2017 fiscal year of $13.5 million, or $0.33
per share, compared to a net loss of $14.7 million, or $0.42 per
share for the comparative 2016 fiscal year.
Corporate Highlights:
- November 4, 2017 – Anavex presented pharmacokinetic (PK) and
pharmacodynamic (PD) data for ANAVEX®2-73 in a late-breaking oral
presentation at the 2017 Clinical Trials on Alzheimer’s Disease
(CTAD) Meeting. Data presented included new results from the Phase
2a study and data from the first year of the Phase 2a long-term
extension study. Data from patients with the highest
ANAVEX®2-73 concentrations pointed towards the continued ability of
the compound to stop the decline in the exploratory secondary
endpoints cognition (MMSE) and function (ADCS-ADL). In addition,
ANAVEX®2-73 continued to demonstrate favorable safety and
tolerability through 109 weeks.
- October 12, 2017 – Anavex announced PK and PD data for
ANAVEX®2-73 from its positive Phase 2a study in mild-to-moderate
Alzheimer’s disease patients, which demonstrated a clear
concentration-effect relationship between ANAVEX®2-73 and study
measurements. The Company is identifying the best responders to
ANAVEX®2-73 by using Ariana Pharma’s KEM® advanced Artificial
Intelligence technology. These data provide support to proceed with
the clinical development of ANAVEX2-73 for Alzheimer’s disease
using a precision medicine paradigm, including DNA whole exome
sequencing, RNA expression and gut microbiome
characterization.
- October 30, 2017 – Anavex announced additional data for
ANAVEX®2-73 in a model for experimental parkinsonism at The Michael
J. Fox Foundation’s Parkinson’s Disease Therapeutics Conference.
These results support the notion that ANAVEX®2-73 is a promising
clinical candidate for Parkinson’s disease.
- October 27, 2017 – Anavex announced additional preclinical data
related to multiple sclerosis (MS) in which ANAVEX®2-73
demonstrated the potential to protect and repair myelin-forming
cells at the 7th ECTRIMS-ACTRIMS Meeting MSPARIS2017.
The financial information for year ended
September 30, 2017, should be read in conjunction with the
Company’s consolidated financial statements, which will appear on
EDGAR and will be available on the Anavex website at
www.anavex.com.
Conference Call / Webcast Information
Anavex will host a conference call at 4:30 p.m. ET today,
December 11, 2017.The live webcast of the conference call can be
accessed online at http://wsw.com/webcast/cc/avxl3.To join the
conference call live via telephone, dial the toll-free number:
1-(866) 939-3921 or 1-(678) 302-3550 from outside the United
States. Please use confirmation number 46142537, 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 diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX®2-73, recently completed a successful a 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 has awarded Anavex a research grant to develop ANAVEX®2-73
for the treatment of Parkinson’s disease. The grant fully funds a
preclinical study, which could justify moving ANAVEX®2-73 into a
Parkinson’s disease clinical trial. ANAVEX®3-71, 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 |
|
|
|
|
|
|
|
ASSETS |
|
2017 |
|
|
2016 |
|
|
|
Current |
|
|
|
|
Cash and
cash equivalents |
$ |
27,440,257 |
|
$ |
9,186,814 |
|
|
|
Sales
tax recoverable |
|
9,748 |
|
|
79,347 |
|
|
|
Prepaid
expenses and deposits |
|
335,928 |
|
|
180,124 |
|
|
|
Total current
assets |
|
27,785,933 |
|
|
9,446,285 |
|
|
|
Deposits |
|
52,396 |
|
|
52,396 |
|
|
|
Total
assets |
$ |
27,838,329 |
|
$ |
9,498,681 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
3,584,334 |
|
$ |
3,119,993 |
|
|
|
Deferred
grant income |
|
- |
|
|
70,532 |
|
|
|
Total
liabilities |
|
3,584,334 |
|
|
3,190,525 |
|
|
|
Common
stock |
|
43,332 |
|
|
36,169 |
|
|
|
Additional paid-in
capital |
|
115,689,221 |
|
|
84,290,140 |
|
|
|
Accumulated
deficit |
|
(91,478,558 |
) |
|
(78,018,153 |
) |
|
|
Total
stockholders' equity |
|
24,253,995 |
|
|
6,308,156 |
|
|
|
Total
liabilities and stockholders' equity |
$ |
27,838,329 |
|
$ |
9,498,681 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
YEARS ENDED SEPTEMBER 30, 2017, 2016, AND 2015 |
|
|
|
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
2015 |
|
|
Operating
Expenses |
|
|
|
|
General and
administrative |
$ |
5,008,275 |
|
$ |
8,334,740 |
|
$ |
4,836,978 |
|
|
Research and
development |
|
10,672,086 |
|
|
7,254,303 |
|
|
2,271,736 |
|
|
Total operating expenses |
|
15,680,361 |
|
|
15,589,043 |
|
|
7,108,714 |
|
|
|
|
|
|
|
Operating
Loss |
|
(15,680,361 |
) |
|
(15,589,043 |
) |
|
(7,108,714 |
) |
|
Other income
(expenses) |
|
|
|
|
Grant income |
|
140,942 |
|
|
141,195 |
|
|
- |
|
|
Research and
development incentive income |
|
2,022,902 |
|
|
571,093 |
|
|
- |
|
|
Interest income,
net |
|
88,098 |
|
|
11,322 |
|
|
(71,825 |
) |
|
Gain on settlement of
accounts payable |
|
75,204 |
|
|
151,402 |
|
|
- |
|
|
Gain on settlement of
debt |
|
- |
|
|
61,205 |
|
|
- |
|
|
Financing related
charges and adjustments |
|
- |
|
|
(5,812 |
) |
|
(4,998,145 |
) |
|
Foreign exchange gain
(loss) |
|
(47,583 |
) |
|
(48,445 |
) |
|
70,554 |
|
|
Total other
income |
|
2,279,563 |
|
|
881,960 |
|
|
(4,999,416 |
) |
|
Net loss before income
taxes |
|
(13,400,798 |
) |
|
(14,707,083 |
) |
|
(12,108,130 |
) |
|
Income tax expense -
current |
|
(59,607 |
) |
|
(29,615 |
) |
|
- |
|
|
Net
loss |
$ |
(13,460,405 |
) |
$ |
(14,736,698 |
) |
$ |
(12,108,130 |
) |
|
|
|
|
|
|
Net loss per Share |
|
|
|
|
Basic and
Diluted |
$ |
(0.33 |
) |
$ |
(0.42 |
) |
$ |
(0.65 |
) |
|
|
|
|
|
|
Weighted Average Number
of Shares Outstanding |
|
|
|
|
Basic and
Diluted |
|
40,841,033 |
|
|
35,153,426 |
|
|
18,584,820 |
|
|
|
|
|
|
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors & Media:Clayton
RobertsonThe Trout Group Tel: (646) 378-2900Email:
crobertson@troutgroup.com
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Apr 2023 to Apr 2024