EDSA 8-K
Edesa Biotech, Inc. (EDSA)
8-K
2020-12-07
For: 2020-12-07
View Original
Added on
April 09, 2026
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): December 7,
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
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(Address
of Principal Executive Offices)
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(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. ☒
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Item 2.02
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Results of Operations and Financial Condition.
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On
December 7, 2020, Edesa Biotech, Inc. (the “Company”)
issued a press release announcing its financial results for the
fiscal year ended September 30, 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.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit No.
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Description
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Press
release issued by Edesa Biotech, Inc. dated December 7,
2020.
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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:
December 7, 2020
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By:
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/s/
Kathi Niffenegger
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Name:
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Kathi
Niffenegger
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Title:
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Chief
Financial Officer
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Exhibit 99.1
Edesa Biotech Reports Fiscal Year 2020 Results
TORONTO,
ON / ACCESSWIRE / December 7, 2020 / Edesa Biotech, Inc.
(Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today
reported financial results for the fiscal year ended September 30,
2020 and provided an update on its business.
During
the fiscal year, Edesa added two Phase 2-ready biologics to its
development pipeline, with a focus on COVID-19 and other strategic
indications. Last month, the company initiated a Phase 2/Phase 3
study of the most advanced one of these acquired monoclonal
antibodies in hospitalized COVID-19 patients, and is currently
enrolling subjects in the U.S. and Canada. In response to the
pandemic, Edesa also took actions to facilitate enrollment for an
ongoing Phase 2b clinical study of its EB01 drug candidate in
chronic allergic contact dermatitis patients, and recently
announced that that the project had reached an enrollment
milestone.
“While
2020 brought unexpected challenges, it also brought opportunities
for Edesa to demonstrate the flexibility and breadth of our
clinical development strategy. In a matter of months, we achieved
new regulatory approvals in two jurisdictions and launched a Phase
2/3 study of a potential best-in-class anti-TLR4 antibody treatment
for Acute Respiratory Distress Syndrome – the leading cause
of death in COVID-19 patients,” said Dr. Par Nijhawan, Chief
Executive Officer of Edesa. "Our team continues to operate at a
high level and we are looking forward to building on our momentum,
achieving our near-term milestones and, ultimately, building value
for shareholders.”
Chief
Financial Officer Kathi Niffenegger reported that Edesa’s
year-end results reflect the company’s increased clinical
activities and growth-related expenditures, which included COVID-19
study preparations, fill-finish expenses for its EB05 drug product,
increased staffing and enrollment-based expenses for the
company’s ongoing dermatitis study. “Our fiscal year
results demonstrate the efficiency of our business model and the
disciplined approach we are taking to deploying our working capital
to studies with near-term inflection points,” she
said.
Ms.
Niffenegger reported that cash and cash equivalents totaled
approximately $7.2 million at September 30, 2020. In addition, she
noted that subsequent to end of the fiscal year, Edesa received
cash proceeds of approximately $2.0 million as a result of warrant
exercises and issuances of common shares under the company’s
at-the-market equity distribution program.
Financial Results for the Fiscal Year Ended September 30,
2020*
Total revenues for fiscal year 2020 were $0.33 million compared to
$0.41 million for the nine-month period ended September 30, 2019,
reflecting a reduction in sales of product inventory obtained in
the June 2019 reverse acquisition. The company expects such product
sales to continue to decline as a result of the discontinuation of
legacy operations.
Total operating expenses increased by $3.49 million to $6.73
million for fiscal year 2020 compared to $3.24 million for the
nine-month period ended September 30, 2019:
●
Cost
of sales was $0.02 million for fiscal year 2020 compared to $0.10
million for the nine-month period ended September 30, 2019,
reflecting a reduction in sales of product inventory obtained in
the reverse acquisition.
●
Research
and development expenses were $3.33 million for the year ended
September 30, 2020, reflecting increased external research expenses
related to the clinical study of the company’s EB01 drug
candidate and increased activities and preparations related to the
company’s Phase 2/3 clinical study of EB05 as a potential
treatment for hospitalized COVID-19 patients, as well as increased
salary and related personnel expenses. Research and development
expenses were $1.10 million for the nine-month period ended
September 30, 2019.
●
General
and administrative expenses were $3.38 million for the year ended
September 30, 2020, reflecting increased salary and related
personnel expenses, and increased public company expenses. General
and administrative expenses were $2.05 million for the nine-month
period ended September 30, 2019.
For the fiscal year ended September 30, 2020, Edesa reported a net
loss of $6.36 million, or $0.74 per common share, compared to a net
loss of $2.78 million, or $0.55 per common share, for the
nine-month period ended September 30, 2019.
* As a result of the acquisition accounting for the business
combination completed on June 7, 2019, and the subsequent change in
year end of the company's subsidiary Edesa Biotech Research, Inc.,
the comparative year-end data represent the twelve month period
ended September 30, 2020 and the nine-months ended September 30,
2019, which should be taken into account when reviewing comparative
results. Financial results for any periods ended prior to June 7,
2019 reflect the financials of the company’s subsidiary Edesa
Biotech Research, Inc. on a standalone basis.
Working Capital
At
September 30, 2020, Edesa had working capital of $6.57 million.
Cash and cash equivalents totaled $7.21 million. From October 1 to
December 2, 2020, the exercise of common share purchase warrants
resulted in cash proceeds to the company of approximately $1.0
million. During this same period, the company also received cash
proceeds of approximately $1.0 million from the issuance of common
shares under an equity distribution agreement with RBC Capital
Markets, LLC.
Calendar
From
January 11-14, 2021, Edesa is scheduled to participate in the H.C.
Wainwright Bioconnect Conference. Investors and biopharma
executives interested in meetings with management can schedule
one-on-one teleconference and video meetings through the conference
website or by contacting Edesa at
[email protected].
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) in COVID-19 patients. 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 and the expectation that
legacy product sales will continue to decline. 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.
Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
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Consolidated
Statements of Operations
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Year
Ended
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Nine-MonthPeriod
Ended
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September 30,
2020
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September 30,
2019
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Total Revenues
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$328,801
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$410,870
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Expenses:
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Cost
of sales
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17,601
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101,286
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Research
and development
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3,329,451
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1,096,426
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General
and administrative
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3,382,591
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2,045,296
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6,729,643
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3,243,008
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Loss from operations
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(6,400,842)
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(2,832,138)
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Other income
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37,412
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55,404
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Income tax expense
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800
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-
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Net loss
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(6,364,230)
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(2,776,734)
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Exchange
differences on translation
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54,870
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87,899
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Net comprehensive loss
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$(6,309,360)
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$(2,688,835)
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Weighted
average number of common shares outstanding
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8,607,161
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5,036,331
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Loss per common share - basic and diluted
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$(0.74)
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$(0.55)
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Consolidated
Balance Sheets
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September
30,
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September
30,
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2020
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2019
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Assets:
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Cash and cash
equivalents
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$7,213,695
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$5,030,583
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Other current
assets
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890,323
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614,123
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Intangible assets,
net
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2,483,536
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-
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Operating lease
right-of-use assets
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160,006
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-
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Property and
equipment, net
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14,815
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73,058
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Total
Assets
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$10,762,375
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$5,717,764
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Liabilities,
shareholders' equity and temporary equity:
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Current
liabilities
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$1,529,857
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$461,634
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Noncurrent
liabilities
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124,388
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-
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Temporary
equity
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2,476,955
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-
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Shareholders'
equity
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6,631,175
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5,256,130
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Total
liabilities, shareholders' equity and temporary equity
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$10,762,375
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$5,717,764
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Consolidated
Statements of Cash Flows
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Year
Ended
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Nine-MonthPeriod
Ended
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September 30,
2020
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September 30,
2019
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Cash flows from operating activities:
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Net
loss
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$(6,364,230)
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$(2,776,734)
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Adjustments
for non-cash items
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655,922
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39,853
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Change
in working capital items
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721,968
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(2,108,906)
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Net cash used in operating activities
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(4,986,340)
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(4,845,787)
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Net cash provided by investing activities
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19,073
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6,417,968
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Net cash provided by financing activities
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7,092,749
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-
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Effect
of exchange rate changes on cash and cash equivalents
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57,630
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91,304
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Net
change in cash and cash equivalents
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2,183,112
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1,663,485
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Cash
and cash equivalents, beginning of period
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5,030,583
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3,367,098
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Cash and cash equivalents, end of period
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$7,213,695
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$5,030,583
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