Full Press Release Details
Edesa Biotech Reports Fiscal 3rd Quarter 2020 Results
ON / ACCESSWIRE / August 12, 2020 / Edesa Biotech, Inc.
(Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today
reported financial results for the three and nine months ended June
30, 2020 and provided an update on its business.
the quarter, Edesa received Canadian regulatory approval to begin a
Phase 2/Phase 3 clinical study of its biologic drug candidate,
EB05, as a potential treatment for hospitalized COVID-19 patients.
Based on previous clinical data and the drug's mechanism of
action, the company believes that EB05 could regulate the
overactive immune response associated with Acute Respiratory
Distress Syndrome (ARDS) the leading cause of death in
COVID-19 patients. In July, Edesa filed an investigational new drug
(IND) application with the Food and Drug Administration to expand
the company's planned clinical study to U.S. hospitals. Edesa
also reported that protocol amendments to facilitate enrollment for
its ongoing Phase 2b clinical study in allergic contact dermatitis
have been implemented at the majority of the company's
investigational centers.
the quarter, we continued the dosing of subjects in our dermatitis
study, while simultaneously preparing for the launch of a Phase 2/3
study of our first biologic candidate a novel monoclonal
antibody targeting TLR4, said Dr. Par Nijhawan, Chief
Executive Officer of Edesa. The lack of effective therapies
for ARDS has been made even more devastating by the COVID-19
pandemic, which can cause severe acute respiratory failure in up to
40% of hospitalized COVID-19 patients and up to 85% of patients
admitted to the ICU. Dr. Nijhawan said that, subject to
funding and IND approval, the company is presently on track to be
ready to initiate patient enrollment ahead of the anticipated
resurgence of SARS-CoV-2 infections this fall/winter.
Chief Financial Officer Kathi Niffenegger reported that
expenditures during the quarter reflected increased activities and
preparations related to the planned COVID-19 study as well as trial
expenses for the company's ongoing dermatitis study. She also
noted that subsequent to the quarter end the company has received
cash proceeds of approximately $2.42 million as a result of
exercises of common share purchase warrants.
have built flexibility into our business planning processes, and
have prioritized working capital for our clinical projects based on
their feasibility amid the pandemic, the nearness of their
inflection points and their ability to address significant unmet
medical needs, said Ms. Niffenegger.
Financial Results for the Three Months Ended June 30,
Total revenues for the three months ended June 30, 2020 were $0.11
million, reflecting sale of product inventory obtained in the
reverse acquisition completed in June 2019. There were no
significant revenues for the three months ended June 30,
Total operating expenses increased by $0.56 million to $1.88
million for the three months ended June 30, 2020 compared to $1.32
million for the same period last year:
of sales and services was less than $0.01 million for the three
months ended June 30, 2020, reflecting the sales of product
inventory obtained in the reverse acquisition. There were no
product sales in the same period last year.
and development expenses increased by $0.64 million to $1.14
million for the three months ended June 30, 2020 compared to $0.50
million for the same period last year. The increase was primarily
due to increased external research expenses related to the clinical
study of the company's EB01 drug candidate, and increased
activities and preparations related to the planned Phase 2/Phase 3
clinical study of EB05 as a potential treatment for hospitalized
and administrative expenses decreased by $0.09 million to $0.73
million for the three months ended June 30, 2020 compared to $0.82
million for the same period last year primarily due to a decrease
in legal fees, which was partially offset by increased salary and
related personnel expenses and higher public company
For the three months ended June 30, 2020, Edesa reported a net loss
of $1.77 million, or $0.20 per basic share, compared to a net loss
of $1.29 million, or $0.30 per basic share, for the three months
ended June 30, 2019.
Financial Results for the Nine Months Ended June 30,
Total revenues for the nine months ended June 30, 2020 were $0.33
million, reflecting sale of product inventory obtained in the
reverse acquisition completed in June 2019. There were no
significant revenues for the nine months ended June 30,
Total operating expenses increased by $2.45 million to $4.72
million for the nine months ended June 30, 2020 compared to $2.27
million for the same period last year:
of sales and services was $0.02 million for the nine months ended
June 30, 2020, reflecting the sales of product inventory obtained
in the reverse acquisition. There were no product sales in the same
and development expenses increased by $1.30 million to $2.17
million for the nine months ended June 30, 2020 compared to $0.87
million for the same period last year. The increase was primarily
due to increased external research expenses related to the clinical
study of the company's EB01 drug candidate, and increased
activities and preparations related to the planned Phase 2/Phase 3
clinical study of EB05 as a potential treatment for hospitalized
COVID-19 patients, as well as increased salary and related
and administrative expenses increased by $1.13 million to $2.53
million for the nine months ended June 30, 2020 compared to $1.40
million for the same period last year. The increase was primarily
due to increased salary and related personnel expenses, increased
legal and professional fees, and higher public company
For the nine months ended June 30, 2020, Edesa reported a net loss
of $4.35 million, or $0.52 per basic share, compared to a net loss
of $2.19 million, or $0.61 per basic share, for the nine months
ended June 30, 2019.
* Financial results for any periods ended prior to June 7, 2019