Full Press Release Details
Edesa Biotech Reports Fiscal 3rd Quarter 2021 Financial
ON / ACCESSWIRE / August 13, 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 and nine months ended June 30, 2021
and provided an update on its business.
the quarter, the company achieved key interim milestones for both
of its lead product candidates, EB05 and EB01. Independent
monitoring boards assessed blinded interim treatment data and based
on their positive findings recommended that the two development
programs advance to the final stages of enrollment. Edesa expects
the end of Phase 2 (interim) analysis of a Phase 2/3 study of EB05
as a single-dose treatment for hospitalized COVID-19 patients will
be completed as early as the current quarter. The company plans to
provide more detailed clinical updates as they become available. In
parallel, the company has begun patient randomizations for the
final part of a Phase 2b clinical study evaluating EB01 as a
monotherapy for chronic Allergic Contact Dermatitis. Edesa recently
added new investigational sites and expanded recruitment beyond the
pleased to have these two key programs advancing side by side
toward data readouts and value inflection opportunities. EB05 and
EB01 each represent novel anti-inflammatory technologies with the
potential to provide transformational therapies for a broad range
of inflammatory and autoimmune conditions," said Par Nijhawan, MD,
Chief Executive Officer of Edesa Biotech. "We look forward to
maintaining the momentum we achieved year to date, and announcing
our end of Phase 2 results of our EB05 program as soon as
Chief Financial Officer Kathi Niffenegger reported that
expenditures for the fiscal third quarter were in line with
management's expectations and driven primarily by incremental
clinical study expenses related to patient enrollment, expanded
operations and drug product-related costs. "Our R&D
expenditures for the three-month and nine-month periods have
largely tracked the accelerated progress of our clinical studies as
well as preparations related to commercial-scale manufacturing of
our product candidates, she said.
nine-month period ended June 30, 2021, Ms. Niffenegger reported
that the company recorded reimbursements of approximately $8.5
million under a C$14 million reimbursement grant from the Canadian
Government, including $1.3 million for the fiscal third quarter. At
June 30, 2021, Edesa had working capital of $13.35 million,
including cash and cash equivalents of $8.05 million.
Financial Results for the Three Months Ended June 30,
There were no revenues for the three months ended June 30, 2021
compared to $0.11 million for the three months ended June 30, 2020,
reflecting the winddown and discontinuation of sales of product
inventory from legacy operations.
Total operating expenses increased by $4.19 million to $6.07
million for the three months ended June 30, 2021 compared to $1.88
million for the same period last year:
and development expenses increased by $3.32 million to $4.46
million for the three months ended June 30, 2021 compared to $1.14
million for the same period last year primarily due to increased
external research expenses related to recruitment and enrollment in
the company's ongoing clinical studies, increased
investigational drug product expenses and an increase in
non cash share- based compensation. Higher salary and
related personnel expenses and patent fees also contributed to the
and administrative expenses increased by $0.88 million to $1.61
million for the three months ended June 30, 2021 compared to $0.73
million for the same period last year primarily as a result of
higher salary and related personnel expenses, non cash share
-based compensation and increased headcount. Higher legal and other
professional services also contributed to the
Total other income increased by $1.31 million to $1.31 million for
the three months ended June 30, 2021 compared to less than $0.01
million for the same period last year primarily due to increased
grant income under the company's federal reimbursement grant
with the Canadian government's Strategic Innovation
For the three months ended June 30, 2021, Edesa reported a net loss
of $4.76 million, or $0.36 per common share, compared to a net loss
of $1.77 million, or $0.20 per common share, for the three months
ended June 30, 2020.
Financial Results for the Nine Months Ended June 30,
There were no revenues for the nine months ended June 30, 2021
compared to $0.33 million for the nine months ended June 30, 2020,
reflecting the winddown and discontinuation of sales of product
inventory from legacy operations.
Total operating expenses increased by $13.48 million to $18.20
million for the nine months ended June 30, 2021 compared to $4.72
million for the same period last year:
and development expenses increased by $11.65 million to $13.82
million for the nine months ended June 30, 2021 compared to $2.17
million for the same period last year primarily due to milestone
payments related to advancement of the company's EB05
clinical program, increased external research expenses related to
accelerated activity in the company's ongoing clinical
studies, increased investigational drug product expenses and an
increase in non cash share- based compensation. Higher
salary and related personnel expenses and patent fees also
contributed to the increase.
and administrative expenses increased by $1.85 million to $4.38
million for the nine months ended June 30, 2021 compared to $2.53
million for the same period last year primarily as a result of
higher salary and related personnel expenses, non cash
share- based compensation and increased headcount. Higher
legal and other professional services also contributed to the
Total other income increased by $8.50 million to $8.54 million for
the nine months ended June 30, 2021 compared to $0.04 million for
the same period last year primarily due to increased grant income