Full Press Release Details
Edesa Biotech Reports Fiscal Year 2020 Results
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.
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
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
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
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,
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
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:
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.
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
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.
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
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
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