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May 14, 2021, 8:01 a.m. EDT

Edesa Biotech Reports Fiscal 2nd Quarter 2021 Results

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May 14, 2021 (ACCESSWIRE via COMTEX) -- TORONTO, ON / ACCESSWIRE / May 14, 2021 / Edesa Biotech, Inc. /zigman2/quotes/200172674/composite EDSA -1.80% , 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.

The 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.

"We 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 Edesa Biotech.

Edesa's 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 clinical progress.

"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.

She 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, 2021

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:

  • Research 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.

  • General 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 increase.

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, 2021

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:

  • Research 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 contributed to the increase.

  • General and administrative expenses increased by $0.97 million to $2.77 million for the six months ended March 31, 2021 compared to $1.80 million for the same period last year primarily as a result of higher salary and related personnel expenses, and non-cash share-based compensation. Higher legal and other professional services also contributed to the increase.

/zigman2/quotes/200172674/composite
US : U.S.: Nasdaq
$ 6.54
-0.12 -1.80%
Volume: 124,486
Nov. 26, 2021 1:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$86.95 million
Rev. per Employee
$27,400
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