Anavex Life Sciences Reports Fiscal 2021 First Quarter Financial Results And Business Outlook
February 11 2021 - 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
quarter ended December 31, 2020.
“We are thrilled to begin the new year with this
business outlook, which adds to the breadth of strong clinical data
we’ve reported across our precision medicine pipeline using orally
once daily ANAVEX®2-73 (blarcamesine) for Rett syndrome,
Parkinson’s disease dementia and Alzheimer’s disease,” said
Christopher U Missling, PhD, President and Chief Executive Officer
of Anavex. “We look forward to providing on a timely basis in 2021
multiple clinical data read-outs from these clinical programs. The
converging biomarker-driven clinical data is giving us added
confidence in our efforts to meet our goal of potentially bringing
new therapeutic interventions to patients.”
Anavex Life Sciences’ product portfolio includes
small molecule drug lead candidate ANAVEX®2-73 for the treatment of
Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
ANAVEX®2-73 activates the sigma-1 receptor
(SIGMAR1). Data suggests that activation of SIGMAR1 results in the
restoration of complete housekeeping function within the body and
is pivotal to restoring neural cell homeostasis and promoting
neuroplasticity.1
Anavex Life Sciences’ 2021 Business and
Clinical Outlook:
Underlying cause of Alzheimer's disease and
therapeutic intervention:
- Researchers at the University of
California San Diego have identified the underlying cause of
Alzheimer's disease in neurons. They discovered that changes in the
structure of chromatin are responsible.2 Sigma-1 Receptor
(SIGMAR1), the direct target which gets activated with ANAVEX®2-73
demonstrated to restore chromatin structures.3
- ANAVEX®2-73 linked to the
prevention and treatment of age-associated diseases through
induction of the autophagy “cellular recycling” process and
enhanced protein clearance in cells.4
- ANAVEX®2-73 is currently in a Phase
2b/3 Alzheimer's disease clinical trial utilizing differentiated
patient selection criteria and study is presently over 86%
recruited.5
ANAVEX®2-73 program for Rett syndrome and other
pipeline updates:
- Potential accelerated approval
strategy planning underway as Phase 2 U.S. Rett syndrome trial
clinical data showed positive clinical activity and safety data
with progress within ongoing Phase 2/3 AVATAR adult Rett syndrome
and Phase 2/3 EXCELLENCE pediatric Rett syndrome studies.
- U.S. Food and Drug Administration
(FDA) approved extension of ANAVEX®2-73 U.S. Rett syndrome Phase 2
open-label extension study from 12 weeks to 36 weeks.
- Anavex received compassionate use
Special Access Scheme (SAS) approval in Australia for Rett syndrome
patients to continue treatment with ANAVEX®2-73 after completing
the Phase 2/3 AVATAR adult Rett syndrome clinical extension
study.
- Anavex has sufficient ANAVEX®2-73
available to support all ongoing and planned clinical trials and
first-year commercial launch needs for the Rett syndrome
program.
- ANAVEX®2-73 drug substance and oral
solution exhibit excellent chemical stability based upon 3 years of
stability data in both cases.
- New clinical pipeline compound
ANAVEX®3-71 Phase 1 study is on track: Independent Data Safety
Monitoring Board (DSMB) for the Company’s Phase 1 study of its new
investigational compound ANAVEX®3-71, also a small molecule
activating SIGMAR1, has completed its recent pre-planned review of
the preliminary Phase 1 safety data. The DSMB recommendation is to
continue the study without modification.6
- Anavex is pioneering the approach
of big data in clinical trials to leverage the relevance of
phenotypic and genotypic precision medicine analyses of Whole Exome
Sequencing (WES) and gene expression (RNAseq) data in drug
development and in particular the potential to identify patients’
genetic variants and gene expression changes that may predict
increased chances of success of Alzheimer’s disease, Parkinson’s
disease and Rett syndrome treatments.
- Further clinical milestones are
provided in Anavex Life Sciences’ latest corporate presentation,
available on www.anavex.com.
Recent Business Highlights:
- In January 2021, Anavex announced
that it has been awarded a research grant of $995,862.51 from the
Michael J. Fox Foundation for Parkinson’s Research (MJFF) to
develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s
disease. The award will explore utilization of PET imaging
biomarkers to enable measurement of target engagement and pathway
activation of the sigma-1 receptor (SIGMAR1) with clinically
relevant doses in people with Parkinson’s disease.
Financial Highlights:
- On February 11, 2021, cash and cash
equivalents of approximately $75 million, sufficient cash runway
for up to three (3) years.
- Cash and cash equivalents of $47.4
million as of December 31, 2020, compared to $29.2 million at
September 30, 2020.
- Net loss of $7.9 million, or $0.12
per share for the quarter, compared to net loss of $6.6 million, or
$0.12 per share in comparative quarter of fiscal 2020.
- Research and development expenses
of $7.9 million for the quarter, compared to $6.3 million for
comparable quarter of fiscal 2020.
The financial information for the fiscal quarter
ended December 31, 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:
The live webcast of the conference call can be
accessed online at https://wsw.com/webcast/cc/avxl17/1498482.
To join the conference call, live via telephone,
interested parties within the U.S. should dial, toll-free, 1 (866)
451-7964 and international callers should dial 1 (847) 944-7134.
Please use confirmation number 50097999, followed by the pound sign
(#).
A replay of the conference call will also be
available on www.anavex.com.
1 Advances in Experimental Medicine and Biology
Volume 964 (2017) Sigma Receptors: Their Role in Disease and as
Therapeutic Targets.2
https://medicalxpress.com/news/2020-11-neurons-identity-hallmark-alzheimer-disease.html;
Caldwell et al., Dedifferentiation and neuronal repression define
familial Alzheimer's disease. Sci Adv. 2020 Nov 13;6(46).3 Couly et
al., Knocking Out Sigma-1 Receptors Reveals Diverse Health
Problems. Cell Mol Neurobiol (2020); Lee et al., Sigma-1 receptor
chaperones rescue nucleocytoplasmic transport deficit seen in
cellular and Drosophila ALS/FTD models. Nat Commun. 2020 Nov
4;11(1):5580.4 Christ et al., Sigma-1 Receptor Activation Induces
Autophagy and Increases Proteostasis Capacity In Vitro and In Vivo.
Cells. 2019; 8(3):211.5 ClinicalTrials.gov Identifier: NCT037907096
ClinicalTrials.gov Identifier: NCT04442945
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 successfully a Phase 2a clinical trials for
Alzheimer’s disease and a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 study in adult patients
with Rett syndrome. 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
muscarinic receptors, is a promising clinical stage 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 STATEMENTS OF OPERATIONS |
|
For the three months ended December 31, 2020 and 2019 |
|
(Unaudited) |
|
Expressed in US Dollars |
|
|
|
|
|
2020 |
|
|
2019 |
|
|
Operating Expenses |
|
|
|
General and administrative |
$ |
1,470,656 |
|
$ |
1,352,035 |
|
|
Research and development |
|
7,925,519 |
|
|
6,348,668 |
|
|
Total operating expenses |
|
(9,396,175 |
) |
|
(7,700,703 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
Grant income |
|
- |
|
|
74,944 |
|
|
Research and development incentive income |
|
1,269,316 |
|
|
943,215 |
|
|
Interest (expense) income, net |
|
(1,559 |
) |
|
46,720 |
|
|
Foreign exchange gain, net |
|
332,634 |
|
|
53,113 |
|
|
Total other income, net |
|
1,600,391 |
|
|
1,117,992 |
|
|
Net loss before provision for income taxes |
|
(7,795,784 |
) |
|
(6,582,711 |
) |
|
Income tax expense, current |
|
(59,281 |
) |
|
(9,214 |
) |
|
Net loss and comprehensive loss |
$ |
(7,855,065 |
) |
$ |
(6,591,925 |
) |
|
|
|
|
|
Net loss per share |
|
|
|
Basic and diluted |
$ |
(0.12 |
) |
$ |
(0.12 |
) |
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
Basic and diluted |
|
64,295,143 |
|
|
54,773,685 |
|
|
|
|
|
|
|
|
|
|
ANAVEX LIFE SCIENCES CORP. |
|
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS |
|
As at December 31, 2020 and September 30, 2020 |
|
Expressed in US Dollars |
|
|
|
|
December 31, 2020 |
September 30, 2020 |
|
ASSETS |
(Unaudited) |
|
|
Current |
|
|
|
Cash and cash equivalents |
$ |
47,357,599 |
|
$ |
29,249,018 |
|
|
Incentive and tax receivables |
|
6,577,807 |
|
|
4,849,340 |
|
|
Prepaid expenses and deposits |
|
398,840 |
|
|
443,839 |
|
|
Total Assets |
$ |
54,334,246 |
|
$ |
34,542,197 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities |
|
|
|
Accounts payable |
$ |
4,216,948 |
|
$ |
3,989,054 |
|
|
Accrued liabilities |
|
3,816,521 |
|
|
3,316,574 |
|
|
Total Liabilities |
|
8,033,469 |
|
|
7,305,628 |
|
|
Capital Stock |
|
66,964 |
|
|
62,047 |
|
|
Additional paid-in capital |
|
213,766,108 |
|
|
186,851,752 |
|
|
Accumulated deficit |
|
(167,532,295 |
) |
|
(159,677,230 |
) |
|
Total Stockholders' Equity |
|
46,300,777 |
|
|
27,236,569 |
|
|
Total Liabilities and Stockholders' Equity |
$ |
54,334,246 |
|
$ |
34,542,197 |
|
|
|
|
|
|
For Further Information:
Anavex Life Sciences Corp. Research &
Business Development Toll-free: 1-844-689-3939 Email:
info@anavex.com
Investors: Andrew J. Barwicki
Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.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