Full Press Release Details
Edesa Biotech Reports Fiscal First Quarter 2021
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.
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.
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
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
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.
Financial Results for the Three Months Ended December 31,
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:
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.
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.
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.
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.
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