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UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May
9, 2024
ANAVEX
LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
Nevada |
001-37606 |
98-0608404 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
630 5th Avenue, 20th Floor, New York, NY USA
10111
(Address of principal executive offices) (Zip Code)
1-844-689-3939
Registrant’s telephone number, including area
code
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
☐ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of
the Act:
Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on which
Registered |
Common Stock, par value $0.001 per share |
|
AVXL |
|
Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 9, 2024, Anavex Life Sciences
Corp. (the “Company”) issued a press release reporting financial results for its fiscal quarter ended March 31, 2024
(the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report and is incorporated
herein by reference.
The information furnished pursuant
to Item 2.02 of this Current Report, including Exhibit 99.1 attached hereto, shall not be considered “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933,
as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filing that such information is to be considered
“filed” or incorporated by reference therein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
ANAVEX LIFE SCIENCES CORP. |
|
|
|
/s/ Christopher Missling |
|
Name: |
Christopher Missling, PhD |
|
Title: |
Chief Executive Officer |
|
|
Date: May 9, 2024 |
|
EXHIBIT 99.1
Anavex Life Sciences Reports
Fiscal 2024 Second Quarter Financial Results and
Provides Business Update
Company to host a webcast
today at 8:30 a.m. Eastern Time
NEW YORK – May 9, 2024 – Anavex
Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental and neuropsychiatric disorders including Alzheimer’s
disease, Parkinson’s disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today reported financial
results for its fiscal quarter ended March 31, 2024.
“We are encouraged by the very recently issued
FDA guidance for Early Alzheimer’s disease, which states that one cognitive measurement alone, like ADAS-Cog13, could
be a sufficient primary endpoint for early Alzheimer’s disease.[1] We appreciate this new guidance and believe this
opens another possible pathway for us to move forward in parallel to the initiated process of Marketing Authorisation application to
the European Medicines Agency (EMA) for blarcamesine related to the treatment of Alzheimer’s disease, which is underway. We are
also pleased to report that the first cohort of schizophrenia patients in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71
has been fully enrolled,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Moreover, we
remain committed to the development of our programs within neurodegenerative, neurodevelopmental disorders, which could further expand
our portfolio of transformative investigational therapies and utilizing
our differentiated precision medicine platform to deliver easy access and scalable treatment options for brain disorders.”
Key
Pipeline Updates:
| ● | Full
data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical
trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting
a Marketing Authorisation application to the European Medicines Agency (EMA) under the Centralised
Procedure is underway. The Marketing Authorisation would allow direct market access throughout
the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
There are an estimated 7 million people in Europe with Alzheimer’s disease, a number
expected to double by 2030, according to the European Brain Council.[2] |
| ● | Analysis
of RNA sequencing (RNA-seq) of the placebo-controlled Phase 2b/3 blarcamesine trial
in early Alzheimer’s disease is underway. Interim data expected by mid 2024. |
| ● | Ongoing
ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half
of 2024. |
[1]
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-alzheimers-disease-developing-drugs-treatment
[2] https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
| ● | Schizophrenia:
The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical study of ANAVEX®3-71
for the treatment of schizophrenia is well underway with the first cohort of schizophrenia
patients fully enrolled. |
| ● | Parkinson’s
disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 month trial
is expected in the second half of 2024. |
| ● | Rett
syndrome: Continued positive Real World Evidence (RWE) feedback from Rett syndrome patients
and caregivers from the ongoing open-label extension trial and Compassionate Use Program
for patients who participated in the Phase 2/3 EXCELLENCE trial encourages us to continue
our partnership with the Rett syndrome community and to proceed with
a Phase 3 12-week efficacy study. An educational presentation will be provided at the 2024
IRSF Rett Syndrome Scientific Meeting, taking place June 18 – June 19, 2024. ANAVEX®2-73
had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan
Drug designation from the FDA for the treatment of Rett syndrome. |
| ● | Fragile
X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73,
supporting the initiation of the potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial
will be presented at the 19th National Fragile X Foundation Conference, taking
place July 25 – July 28, 2024. |
| ● | New
Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial. |
| ● | Publications:
Continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71. |
Recent
Business Highlights:
| ● | On
March 18, 2024, the Company announced that the first patient in its U.S. FDA cleared placebo-controlled
Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia had been screened,
ahead of schedule. |
| ● | On
January 24, 2024, the Company announced a peer-reviewed publication in Clinical Pharmacology
in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved
its safety objectives. The publication is entitled, ‘Population-Based Characterization
of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric
M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia,
and Alzheimer Disease’.[3] The publication reports pharmacokinetic (PK)
dose proportionality of ANAVEX®3-71 in humans and food had no effect on the PK of ANAVEX®3-71.
This data also expands the safety objectives met in this first-in-human study of ANAVEX®3-71,
further supporting its drug development program. |
| ● | On
January 8, 2024, the Company announced that the United States Patent and Trademark Office
(USPTO) granted U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY”
from the United States Patent and Trademark Office (USPTO) for its patent application number
17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73
(blarcamesine) therapy to ameliorate various conditions associated with loss-of-function
mutations of the gene encoding methyl-CpG binding protein (MeCP2). |
[3] Fadiran EO, Hammond E, Tran J, Missling
CU, Ette E. Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric
M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease. Clin
Pharmacol Drug Dev. 2024;13(1):21-31. doi:10.1002/cpdd.1323
Financial Highlights:
| ● | Cash
and cash equivalents of $139.4 million at March 31, 2024 compared to $151.0 million at fiscal
yearend September 30, 2023. The Company anticipates at the current cash utilization rate
a runway of approximately 4 years. |
| ● | General
and administrative expenses for the quarter of $2.8 million compared to $2.9 million for
the comparable quarter of fiscal 2023. |
| ● | Research
and development expenses for the quarter of $9.7 million compared to $11.3 million for the
comparable quarter of fiscal 2023. |
| ● | Net
loss for the quarter of $10.5 million, or $0.13 per share, compared to a net loss of $13.1
million, or $0.17 per share for the comparable quarter of fiscal 2023. |
The
financial information for the fiscal quarter ended March 31, 2024, should be read in conjunction with the Company’s condensed consolidated
interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
Webcast
/ Conference Call Information:
The live webcast of the conference
call will be available on Anavex’s website at www.anavex.com.
The conference call can be also accessed by dialing
1 929 205 6099 for participants in
the U.S. using the Meeting ID# 815 2682 8440 and reference passcode 121725. A replay of the conference call will also be available
on Anavex’s website for up to 30 days.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly
traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental,
and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia and other
central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study
in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 in pediatric patients
with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting SIGMAR1 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.
We believe that ANAVEX®3-71,
which targets SIGMAR1 and M1 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, Instagram, 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 Statements of Operations and Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
| |
Three months ended March 31, |
| |
2024 | |
2023 |
Operating Expenses | |
| | | |
| | |
General and administrative | |
$ | 2,790 | | |
$ | 2,883 | |
Research and development | |
| 9,729 | | |
| 11,307 | |
Total operating expenses | |
| 12,519 | | |
| 14,190 | |
Operating loss | |
| (12,519 | ) | |
| (14,190 | ) |
| |
| | | |
| | |
Other income | |
| | | |
| | |
Research and development incentive income | |
| 472 | | |
| 750 | |
Interest income, net | |
| 1,756 | | |
| 1,465 | |
Other financing expense | |
| — | | |
| (964 | ) |
Foreign exchange gain (loss), net | |
| (150 | ) | |
| (118 | ) |
Total other income, net | |
| 2,078 | | |
| 1,133 | |
Net loss before provision for income taxes | |
| (10,441 | ) | |
| (13,057 | ) |
Income tax expense, current | |
| (105 | ) | |
| (50 | ) |
Net loss and comprehensive loss | |
$ | (10,546 | ) | |
$ | (13,107 | ) |
| |
| | | |
| | |
Net loss per share | |
| | | |
| | |
Basic and diluted | |
$ | (0.13 | ) | |
$ | (0.17 | ) |
| |
| | | |
| | |
Weighted average number of shares outstanding | |
| | | |
| | |
Basic and diluted | |
| 82,464,226 | | |
| 78,304,363 | |
Anavex Life Sciences Corp. |
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss |
(in thousands, except share and per share amounts) |
|
| |
Six months ended March 31, |
| |
2024 | |
2023 |
Operating Expenses | |
| | | |
| | |
General and administrative | |
$ | 5,399 | | |
$ | 6,200 | |
Research and development | |
| 18,413 | | |
| 23,373 | |
Total operating expenses | |
| 23,812 | | |
| 29,573 | |
Operating loss | |
| (23,812 | ) | |
| (29,573 | ) |
| |
| | | |
| | |
Other income | |
| | | |
| | |
Grant income | |
| — | | |
| 25 | |
Research and development incentive income | |
| 1,064 | | |
| 1,483 | |
Interest income, net | |
| 3,764 | | |
| 2,733 | |
Other financing expense | |
| — | | |
| (964 | ) |
Foreign exchange gain (loss), net | |
| 7 | | |
| 247 | |
Total other income, net | |
| 4,835 | | |
| 3,524 | |
Net loss before provision for income taxes | |
| (18,977 | ) | |
| (26,049 | ) |
Income tax expense, current | |
| (191 | ) | |
| (30 | ) |
Net loss and comprehensive loss | |
$ | (19,168 | ) | |
$ | (26,079 | ) |
| |
| | | |
| | |
Net loss per share | |
| | | |
| | |
Basic and diluted | |
$ | (0.23 | ) | |
$ | (0.33 | ) |
| |
| | | |
| | |
Weighted average number of shares outstanding | |
| | | |
| | |
Basic and diluted | |
| 82,269,965 | | |
| 78,138,940 | |
Anavex Life Sciences Corp. |
Condensed Consolidated Interim Balance Sheets |
(in thousands, except share and per share amounts) |
| |
|
| |
March 31, | |
September 30, |
| |
2024 | |
2023 |
Assets | |
| | | |
| | |
Current | |
| | | |
| | |
Cash and cash equivalents | |
$ | 139,386 | | |
$ | 151,024 | |
Incentive and tax receivables | |
| 3,785 | | |
| 2,709 | |
Prepaid expenses and other current assets | |
| 1,345 | | |
| 653 | |
Total Assets | |
$ | 144,516 | | |
$ | 154,386 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable | |
$ | 3,726 | | |
$ | 4,322 | |
Accrued liabilities | |
| 4,915 | | |
| 7,295 | |
Deferred grant income | |
| 917 | | |
| 917 | |
Total Liabilities | |
| 9,558 | | |
| 12,534 | |
Capital Stock | |
| 84 | | |
| 82 | |
Additional paid-in capital | |
| 447,345 | | |
| 434,839 | |
Share proceeds receivable | |
| (234 | ) | |
| — | |
Accumulated deficit | |
| (312,237 | ) | |
| (293,069 | ) |
Total Stockholders’ Equity | |
| 134,958 | | |
| 141,852 | |
Total Liabilities and Stockholders’ Equity | |
$ | 144,516 | | |
$ | 154,386 | |
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
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Anavex Life Sciences (NASDAQ:AVXL)
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From Jul 2024 to Aug 2024
Anavex Life Sciences (NASDAQ:AVXL)
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From Aug 2023 to Aug 2024