Full Press Release Details
Edesa Biotech Reports Fiscal 2nd Quarter 2021 Results
ON / ACCESSWIRE / May 14, 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 six months ended March 31, 2021
and provided an update on its business.
company reported that it has enrolled more than 285 patients in an
ongoing Phase 2/3 clinical study of its investigational drug, EB05,
as a single-dose treatment for hospitalized COVID-19 patients with
or at risk of developing Acute Respiratory Distress Syndrome
(ARDS). ARDS is the leading cause of death in COVID-19 patients.
The study is being funded in part by a C$14 million reimbursement
grant from the Canadian Government. In addition, Edesa completed
enrollment of the first cohort of a Phase 2b clinical study
evaluating another drug candidate, EB01, as a monotherapy for
chronic Allergic Contact Dermatitis. The company is currently
performing a blinded interim analysis on EB01. Edesa recently
expanded its global rights to the technology that forms the basis
of EB01 for all fields of use in humans and animals. During the
second fiscal quarter, Edesa raised net cash proceeds of
approximately $12.1 million from equity financings and
warrant/option exercises.
achieved another quarter of positive momentum, highlighted by key
enrollment milestones in two separate clinical programs, the award
of a C$14 million competitive grant announced by the Prime Minister
of Canada, and the completion of an over-subscribed equity
offering. While the results of our clinical studies will be
data-driven, and are subject to regulatory review, we are already
preparing to be in position to rapidly advance these studies should
the interim results be positive and get these promising treatments
in the hands of physicians. With these projects and initiatives in
mind, we believe 2021 could be a transformative year for the
company, said Dr. Par Nijhawan, Chief Executive Officer of
Chief Financial Officer Kathi Niffenegger reported that working
capital was significantly bolstered by the federal reimbursement
grant and equity financings. At March
31, 2021, Edesa had working capital of $16.80 million. Cash and
cash equivalents totaled $10.97 million. Research and development
expenditures have largely tracked the company's accelerated
We have recorded cash reimbursements of approximately $7.2
million under our federal grant. This has allowed us to advance our
ARDS project more quickly and significantly offset development
costs, said Ms. Niffenegger.
added, In the second fiscal quarter, research and
development expenditures have been driven by the achievement of
development milestones and drug product costs, and have generally
shifted earlier than originally estimated due to the rapid pace of
enrollment and related activities in our two ongoing clinical
trials. Overall project expenditures have been in line with
management's expectations.
Financial Results for the Three Months Ended March 31,
There were no revenues for the three months ended March 31, 2021
compared to $0.11 million for the three months ended March 31,
2020, reflecting the winddown and discontinuation of sales of
product inventory from legacy operations.
Total operating expenses increased by $7.88 million to $9.51
million for the three months ended March 31, 2021 compared to $1.63
million for the same period last year:
and development expenses increased by $7.48 million to $7.98
million for the three months ended March 31, 2021 compared to $0.50
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 ongoing clinical studies, increased
investigational drug product expenses and an increase in non-cash
share-based compensation. Higher salary and related personnel
expenses, increased employee headcount and patent fees also
contributed to the increase.
and administrative expenses increased by $0.43 million to $1.54
million for the three months ended March 31, 2021 compared to $1.11
million for the same period last year primarily as a result of
higher salary and related personnel expenses. Higher legal and
other professional services also contributed to the
Total other income increased by $7.22 million to $7.25 million for
the three months ended March 31, 2021 compared to $0.03 million for
the same period last year primarily due to increased grant income
related to the initiation of reimbursements under the
company's federal grant with the Canadian government's
Strategic Innovation Fund.
For the three months ended March 31, 2021, Edesa reported a net
loss of $2.26 million, or $0.19 per common share, compared to a net
loss of $1.49 million, or $0.17 per common share, for the three
months ended March 31, 2020.
Financial Results for the Six Months Ended March 31,
There were no revenues for the six months ended March 31, 2021
compared to $0.22 million for the six months ended March 31,2020,
reflecting the winddown and discontinuation of sales of product
inventory from legacy operations.
Total operating expenses increased by $9.28 million to $12.12
million for the six months ended March 31, 2021 compared to $2.84
million for the same period last year:
and development expenses increased by $8.32 million to $9.35
million for the six months ended March 31, 2021 compared to $1.03
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 ongoing clinical studies, increased
investigational drug product expenses and an increase in non-cash
share-based compensation. Higher salary and related personnel
expenses, increased employee headcount and patent fees also