SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
of Report (Date of earliest event reported): October 15,
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
or other jurisdiction
51 West 52nd Street, 7th Floor, New York, NY USA 10019
(Address of principal executive offices) (Zip Code)
telephone number, including area code
(Former name or former address, if changed since last
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.
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))
registered pursuant to Section 12(b) of the Act:
of each class
of each exchange on which
Stock, $0.001 par value
Nasdaq Stock Market LLC
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17
growth company ☐
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. ☐
Regulation FD Disclosure.
October 15, 2020, Anavex Life Sciences Corp. (the “Company”) issued
a press release announcing positive results from proof of concept
controlled Phase 2 Clinical Trial Evaluating ANAVEX®2-73
(blarcamesine) in Parkinson’s Disease Dementia. A copy of the press
release is furnished as Exhibit 99.1 to this Current
information furnished pursuant to Item 7.01 of this Current Report,
including Exhibit 99.1 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 8.01 Other Events.
On October 15, 2020, the Company announced results from the proof
of concept Phase 2 controlled trial evaluating the safety,
tolerability, and efficacy of ANAVEX®2-73 (blarcamesine) in
patients with Parkinson’s disease dementia (PDD).
The study found that ANAVEX®2-73 (blarcamesine) was safe and
well tolerated in oral doses up to 50 mg once daily. The results
show clinically meaningful, dose-dependent, and statistically
significant improvements in the Cognitive Drug Research (CDR)
computerized assessment system analysis. The study confirmed the
precision medicine approach of targeting SIGMAR1 as a genetic
biomarker of response to ANAVEX®2-73 (blarcamesine).
The ANAVEX®2-73-PDD-001 study was an international, double-blind,
multicenter, placebo-controlled Phase 2 clinical study and
randomized 132 patients with PDD equally to target doses of 30mg,
50mg ANAVEX®2-73 (blarcamesine) or placebo, respectively. In
addition to safety and cognitive efficacy, sleep function was
assessed during the study at week 8 and week 14.
ANAVEX®2-73-PDD-001 study results will be submitted for
presentation at a medical conference and for publication in a
peer-reviewed medical journal. Anavex is planning a pivotal trial
of ANAVEX®2-73 (blarcamesine) in Parkinson’s disease
dementia after submitting the results of the study to the FDA to
obtain regulatory guidance.
After completing the trial, participants were able to enroll in a
voluntary 48-week open-label extension study,
ANAVEX®2-73-PDD-EP-001, which continues to assess safety, long term
efficacy and changes in gut microbiota.
ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule
activator of the sigma-1 receptor, which has been shown to be
pivotal to restoring neural cell homeostasis and promoting
Statements in this Current Report on Form 8-K that are not strictly
historical in nature are forward-looking statements. These
statements include, but are not limited to, statements relating to
the implications of clinical data, any subsequent presentation
related thereto and any future studies. 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.
9.01 Financial Statements and Exhibits.
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.
LIFE SCIENCES CORP.
Christopher Missling, PhD
Chief Executive Officer
October 15, 2020
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