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): February 16,
2021
Edesa Biotech, Inc.
(Exact Name of Registrant as Specified in its Charter)
|
British Columbia, Canada
|
001-37619
|
N/A
|
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
|
|
|
|
|
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:
|
Title
of each class
|
Trading
Symbol(s)
|
Name of
exchange on which registered
|
|
Common
Shares
|
EDSA
|
The
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
February 16, 2021, Edesa Biotech, Inc. (the “Company”)
issued a press release announcing its financial results for the
three-month period ended December 31, 2020 (the “Earnings
Release”). The full text of the Earnings Release is attached
hereto as Exhibit 99.1. The information furnished herein and
therein shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”) or otherwise subject to the liabilities
of that Section, or incorporated by reference in any filing under
the Exchange Act or the Securities Act of 1933, as amended, except
as shall be expressly set forth by specific reference in such a
filing.
|
|
Item 9.01
|
Financial Statements and Exhibits.
|
(d) Exhibits
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
Press
release issued by Edesa Biotech, Inc. dated February 16,
2021.
|
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.
|
|
Edesa
Biotech, Inc.
|
|
|
|
|
|
|
Date:
February 16, 2021
|
By:
|
/s/
Kathi Niffenegger
|
|
|
Name:
|
Kathi
Niffenegger
|
|
|
Title:
|
Chief
Financial Officer
|
Exhibit
99.1
Edesa Biotech Reports Fiscal First Quarter 2021
Results
TORONTO,
ON / ACCESSWIRE / February 16, 2021 / Edesa Biotech, Inc.
(Nasdaq: EDSA), a clinical-stage biopharmaceutical company focused
on inflammatory and immune-related diseases, today reported
financial results for the three months ended December 31, 2020 and
provided an update on its business.
Earlier
this month, the company announced that it has been awarded a C$14
million reimbursement grant from the Canadian government. The funds
will support the Phase 2 portion of an ongoing Phase 2/Phase 3
clinical study of Edesa’s investigational drug, EB05, as a
treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a
life-threatening form of respiratory failure, and the leading cause
of death among COVID-19 patients. Should the antibody treatment
demonstrate promising results at the Phase 2 readout, the company
plans to continue with a pivotal Phase 3 study and enter
negotiations for additional government funding. Last month, the
company announced that it received approval from the U.S. Food and
Drug Administration and Health Canada to add a sub-study to the
ARDS trial. The sub-study will evaluate the drug as a potential
rescue therapy for critically severe COVID-19 cases.
“We
initiated our ARDS study in the midst of an unprecedented
resurgence of SARS-CoV-2 infections and are working closely with
our hospital partners to help meet the urgent medical needs of
COVID-19 patients. The federal funding will allow us to move ahead
much more quickly than we could do otherwise,” said Dr. Par
Nijhawan, Chief Executive Officer of Edesa. “Based on current
enrollment trends, we are looking forward to the first interim
analysis in the near term and moving another step closer to
providing a new, effective treatment option for COVID-19
patients.”
In
addition to its ARDS clinical program, during the first fiscal
quarter, the company also reported ongoing progress in a Phase 2b
study of its non-steroidal anti-inflammatory drug candidate in
chronic allergic contact dermatitis. More than 50% of the patients
planned for the first cohort had been randomized and
dosed.
Edesa’s
Chief Financial Officer Kathi Niffenegger reported that the
company’s expenditures during the first fiscal quarter were
in line with management’s expectations and reflected the
company’s plans to advance both its ARDS and dermatitis
studies concurrently. "The change in our research and development
expenses over the comparable period reflect the priority we have
placed in rapidly getting our monoclonal antibody candidate in the
hands of frontline physicians, and expanding our international
Phase 2/3 study to multiple jurisdictions," said Ms.
Niffenegger.
Financial Results for the Three Months Ended December 31,
2020
There were no revenues for the three months ended December 31, 2020
compared to $0.11 million for the three months ended December 31,
2019, reflecting the winddown and discontinuation of sales of
product inventory obtained in the reverse acquisition.
Total operating expenses increased by $1.40 million to $2.61
million for the three months ended December 31, 2020 compared to
$1.21 million for the same period last year:
●
There
were no cost of sales for the three months ended December 31, 2020
as a result of the winddown and discontinuation of sales of product
inventory obtained in the reverse acquisition. For the same period
last year, cost of sales was less than $0.01 million.
●
Research
and development expenses increased by $0.85 million to $1.38
million for the three months ended December 31, 2020 compared to
$0.53 million for the same period last year primarily due to
increased external research expenses related to the company’s
ongoing clinical studies and an increase in non-cash share-based
compensation. Higher salary and related personnel expenses and
patent fees also contributed to the increase.
●
General
and administrative expenses increased by $0.55 million to $1.23
million for the three months ended December 31, 2020 compared to
$0.68 million for the same period last year primarily as a result
of an increase in non-cash share-based compensation. Higher salary
and related personnel expenses, and legal and other professional
services also contributed to the increase.
For the three months ended December 31, 2020, Edesa reported a net
loss of $2.64 million, or $0.26 per common share, compared to a net
loss of $1.09 million, or $0.15 per common share, for the three
months ended December 31, 2019.
Working Capital
At December 31, 2020, Edesa had working capital of $6.76 million.
Cash and cash equivalents totaled $6.31 million. From January 1 to
February 12, 2021, the company received combined net proceeds of
$3.13 million from the issuance of common shares under an equity
distribution agreement with RBC Capital Markets and exercises of
common share purchase warrants and share options.
Calendar
Edesa management plans to participate in the H.C. Wainwright Annual
Global Life Sciences Conference scheduled for March 9-10, 2021.
Investors interested in meetings with management can schedule
one-on-one teleconference and video meetings through the conference
website or by contacting Edesa at investors@edesabiotech.com.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq:
EDSA) is a clinical-stage biopharmaceutical company focused on
developing innovative treatments for inflammatory and
immune-related diseases with clear unmet medical needs. The
company’s two lead product candidates, EB05 and EB01, are in
later stage clinical studies. EB05 is a monoclonal antibody therapy
that we are developing as a treatment for Acute Respiratory
Distress Syndrome (ARDS). ARDS is a life-threatening form of
respiratory failure, and the leading cause of death among COVID-19
patients. Edesa is also developing an sPLA2 inhibitor, designated
as EB01, as a topical treatment for chronic allergic contact
dermatitis (ACD), a common, potentially debilitating condition and
occupational illness. EB01 employs a novel, non-steroidal mechanism
of action and in two clinical studies has demonstrated
statistically significant improvement of multiple symptoms in ACD
patients. The company is based in Markham, Ontario, Canada, with a
U.S. subsidiary located in Southern California. Sign up for
news
alerts.
Edesa Forward-Looking Statements
This press release may contain forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements may be identified by the use of
words such as "anticipate," "believe," "plan," "estimate,"
"expect," "intend," "may," "will," "would," "could," "should,"
"might," "potential," or "continue" and variations or similar
expressions, including statements related to: upcoming milestones
in the company’s clinical studies, including enrollment
milestones and interim readouts for its COVID-19 and dermatitis
studies. Readers should not unduly rely on these forward-looking
statements, which are not a guarantee of future performance. There
can be no assurance that forward-looking statements will prove to
be accurate, as all such forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause
actual results or future events to differ materially from the
forward-looking statements. Such risks include: the ability of
Edesa to obtain regulatory approval for or successfully
commercialize any of its product candidates, the risk that access
to sufficient capital to fund Edesa’s operations may not be
available or may be available on terms that are not commercially
favorable to Edesa, the risk that Edesa’s product candidates
may not be effective against the diseases tested in its clinical
trials, the risk that Edesa fails to comply with the terms of
license agreements with third parties and as a result loses the
right to use key intellectual property in its business,
Edesa’s ability to protect its intellectual property, the
timing and success of submission, acceptance and approval of
regulatory filings, and the impacts of public health crises, such
as COVID-19. Many of these factors that will determine actual
results are beyond the company's ability to control or predict. For
a discussion of further risks and uncertainties related to Edesa's
business, please refer to Edesa’s public company reports
filed with the U.S. Securities and Exchange Commission and the
British Columbia Securities Commission. All forward-looking
statements are made as of the date hereof and are subject to
change. Except as required by law, Edesa assumes no obligation to
update such statements.
Contact
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com
|
Condensed Interim Consolidated Statements of
Operations
|
||
|
(Unaudited)
|
||
|
|
|
|
|
|
Three Months Ended
|
|
|
|
December 31,
2020
|
December 31,
2019
|
|
|
|
|
|
Total Revenues
|
$-
|
$107,800
|
|
|
|
|
|
Expenses:
|
|
|
|
Cost
of sales
|
-
|
3,778
|
|
Research
and development
|
1,379,654
|
527,998
|
|
General
and administrative
|
1,234,148
|
681,706
|
|
|
|
|
|
|
2,613,802
|
1,213,482
|
|
|
|
|
|
Loss from operations
|
(2,613,802)
|
(1,105,682)
|
|
|
|
|
|
Other income (loss)
|
(23,810)
|
12,149
|
|
Income tax expense
|
-
|
800
|
|
|
|
|
|
Net loss
|
(2,637,612)
|
(1,094,333)
|
|
|
|
|
|
Exchange
differences on translation
|
103,427
|
18,114
|
|
|
|
|
|
Net comprehensive loss
|
$(2,534,185)
|
$(1,076,219)
|
|
|
|
|
|
Weighted
average number of common shares
|
10,277,750
|
7,504,468
|
|
|
|
|
|
Loss per common share - basic and diluted
|
$(0.26)
|
$(0.15)
|
|
|
|
|
|
Condensed Interim Consolidated Balance Sheets
|
||
|
(Unaudited)
|
||
|
|
|
|
|
|
December 31,
2020
|
September 30, 2020
|
|
|
|
|
|
Assets:
|
|
|
|
Cash
and cash equivalents
|
$6,305,293
|
$7,213,695
|
|
Other
current assets
|
1,362,032
|
890,323
|
|
Property
and equipment, net
|
14,788
|
14,815
|
|
Intangible
asset, net
|
2,458,243
|
2,483,536
|
|
Operating
lease right-of-use assets
|
150,413
|
160,006
|
|
|
|
|
|
Total Assets
|
$10,290,769
|
$10,762,375
|
|
|
|
|
|
Liabilities, shareholders' equity and temporary
equity:
|
|
|
|
Current
liabilities
|
$906,327
|
$1,529,857
|
|
Noncurrent
liabilities
|
127,005
|
124,388
|
|
Temporary
equity
|
1,372,213
|
2,476,955
|
|
Shareholders'
equity
|
7,885,224
|
6,631,175
|
|
|
|
|
|
Total liabilities, shareholders' equity and temporary
equity
|
$10,290,769
|
$10,762,375
|
|
|
|
|
|
Condensed Interim Consolidated Statements of Cash
Flows
|
||
|
(Unaudited)
|
||
|
|
|
|
|
|
Three Months Ended
|
|
|
|
December 31,
2020
|
December 31,
2019
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
Net
loss
|
$(2,637,612)
|
$(1,094,333)
|
|
Adjustments
for non-cash items
|
751,752
|
11,178
|
|
Change
in working capital items
|
(1,124,669)
|
293,443
|
|
|
|
|
|
Net cash used in operating activities
|
(3,010,529)
|
(789,712)
|
|
|
|
|
|
Net cash used in investing activities
|
(1,135)
|
(477,293)
|
|
|
|
|
|
Net cash provided by financing activities
|
1,994,972
|
45,000
|
|
|
|
|
|
Effect
of exchange rate changes on cash and cash equivalents
|
108,290
|
18,472
|
|
|
|
|
|
Increase
in cash and cash equivalents during the period
|
(908,402)
|
(1,203,533)
|
|
Cash
and cash equivalents, beginning of period
|
7,213,695
|
5,030,583
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
$6,305,293
|
$3,827,050
|
|
|
|
|