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): March 27,
2020
Edesa Biotech,
Inc.
(Exact Name of
Registrant as Specified in its Charter)
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British Columbia, Canada
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001-37619
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N/A
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(State or Other
Jurisdiction
of
Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification
No.)
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100 Spy Court
Markham, Ontario, Canada L3R 5H6
(Address of Principal Executive
Offices)
(289)
800-9600
Registrant’s telephone
number, including area code
N/A
(Former name or former
address, if changed since last report)
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:
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Title of each
class
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Trading
Symbol(s)
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Name of exchange
on which registered
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Common Shares
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EDSA
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The Nasdaq Stock Market
LLC
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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. ☒
Ongoing Phase 2b
Clinical Study of EB01 in Allergic Contact
Dermatitis
Edesa Biotech, Inc. (the
“Company”) reports that it will file a protocol
amendment with the U.S. Food and Drug Administration for its
ongoing Phase 2b clinical study in allergic contact dermatitis (the
“Study”). The amendment provides for, among other
changes, a reduction in the number of in-person office visits,
allowances for remote telehealth appointments and other procedural
updates to simplify enrollment and patient
care.
The proposed changes to the
protocol, which the Company expects to be implemented in the coming
weeks subject to the approval of the Study’s institutional
review (ethics) board, are designed, in part, to respond to and
mitigate the impacts of the COVID-19 pandemic on investigational
centers. These impacts include governmental orders to restrict
travel and practice social distancing, as well as governmental and
institutional directives to devote critical healthcare resources to
the COVID-19 pandemic.
As of March 27, 2020, the Company
reports that five of its investigational sites have temporarily
paused new patient randomization in the Study, either voluntarily,
out of an abundance of caution for patient and staff safety, or at
the direction of local governments or institutions. At this time,
the remaining five investigational sites are continuing enrollment
and/or care for subjects already enrolled. The Company is in the
process of identifying and screening additional investigational
sites to either replace or supplement current sites. Investigators
have not experienced any interruption in clinical trial supply of
drug product for the Study as a result of the COVID-19 pandemic. At
this time, it is unclear if the temporary pausing of enrollment at
certain investigational sites, or mitigations being implemented by
the Company to simplify enrollment and patient care, will
materially impact the timeline for completing the
Study.
Supplemental
Risk Factor
The Company is supplementing the
risk factors set forth under "Item 1A. Risk Factors" in the
Company's Annual Report on Form 10-K for the nine-month period
ended September 30, 2019 with the additional risk factor set forth
below. This supplemental risk factor should be read in conjunction
with the additional risk factors set forth in the Annual
Report.
Public health threats could have an adverse effect on our
operations and financial results.
Public health threats could
adversely affect our ongoing or planned research and development
activities. In particular, a novel strain of coronavirus,
SARS-CoV-2 (which causes the disease now called COVID-19), was
reported to have surfaced in Wuhan, China in December 2019, and has
since spread globally, including to every state in the United
States. On March 11, 2020, the World Health Organization declared
COVID-19 a pandemic, and on March 13, 2020, the United States
declared a national emergency with respect to COVID-19. The
outbreak of COVID-19 has severely impacted global economic activity
and caused significant volatility and negative pressure in
financial markets. The global impact of the outbreak has been
rapidly evolving and many countries, including the United States,
have reacted by instituting quarantines, mandating business and
school closures and restricting travel. As a result, the COVID-19
pandemic is negatively impacting almost every industry directly or
indirectly. We cannot presently predict the scope and severity of
any potential business shutdowns or disruptions, but if we or any
of the third parties with whom we engage, including the suppliers,
clinical trial sites, regulators and other third parties with whom
we conduct business, were to experience shutdowns or other business
disruptions, our ability to conduct our business in the manner and
on the timelines presently planned could be materially and
negatively impacted. Global epidemics, such as the coronavirus,
could also negatively affect site activation, as well as
recruitment and retention, at sites in a region or city whose
health care system becomes overwhelmed due to the illness, which
could have a material adverse effect on our business and our
results of operation and financial condition.
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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.
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Edesa Biotech,
Inc.
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Date: March 27,
2020
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By:
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/s/ Michael
Brooks
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Name:
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Michael Brooks,
PhD
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Title:
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President
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