Feb 14, 2022 (ACCESSWIRE via COMTEX) -- TORONTO, ON / ACCESSWIRE / February 14, 2022 / Edesa Biotech, Inc. /zigman2/quotes/200172674/composite EDSA -1.88% , a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three months ended December 31, 2021 and provided an update on its business.
During the quarter, Health Canada approved the Phase 3 design of a Phase 2/3 clinical study evaluating the company's monoclonal antibody, designated EB05, as a rescue therapy for critically ill patients with a life-threatening form of respiratory failure known as ARDS. The authorization follows Phase 2 results that demonstrated a significant reduction in mortality among critically ill Covid-19 patients treated with EB05.
Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the promising EB05 results provide an opportunity for the company to play a significant role in building a lasting solution to the pandemic, as Covid becomes endemic and governments focus more on treatments for those who become hospitalized.
"Our expectation is that Covid-19 cases are going to continue to drive ARDS-related ICU admissions well beyond historical levels for the foreseeable future. There's a significant and urgent unmet medical need for critical care treatments and we believe that EB05 could become an important part of reducing mortality and improving ICU capacity. If these two challenges can be managed, it helps provide the world with a way forward to live with Covid," he said.
The company also reported that its Phase 2b clinical study in chronic Allergic Contact Dermatitis (ACD) reached an enrollment milestone during the quarter, and that enrollment in the study has returned to a pre-pandemic pace in recent months. Recruitment also continues for the EB05 study. The company plans to provide more detailed clinical updates for these development programs as they become available. "In the coming quarters we look forward to completing recruitment and presenting topline results for these lead product candidates," said Dr. Nijhawan.
Edesa's Chief Financial Officer Kathi Niffenegger said that the fiscal first quarter reflected increased development and regulatory activities for the company's ongoing clinical programs. Results continued to benefit from reimbursements under the company's government grant.
"Our fiscal first quarter results demonstrated the disciplined approach we are taking to deploying our working capital and the flexibility management has to align the timing of scale-up expenditures with clinical advancements and other important value inflection points," said Ms. Niffenegger.
Financial Results for the Three Months Ended December 31, 2021
Total operating expenses increased by $2.55 million to $5.16 million for the three months ended December 31, 2021 compared to $2.61 million for the same period last year:
Research and development expenses increased by $2.57 million to $3.95 million for the three months ended December 31, 2021 compared to $1.38 million for the same period last year primarily due to increased external research expenses related to the company's ongoing clinical studies, increased investigational drug product expenses, higher salary and related personnel expenses due to increased headcount and higher patent fees, which were partially offset by a decrease in noncash share-based compensation.
General and administrative expenses decreased by $0.02 million to $1.21 million for the three months ended December 31, 2021 compared to $1.23 million for the same period last year primarily as a result of decreased noncash share-based compensation, which was partially offset by higher insurance, and legal and other professional service fees.
Total other income (loss) increased by $0.80 million to an overall gain of $0.78 million for the three months ended December 31, 2021 compared to an overall loss of $0.02 million for the prior year primarily due to increased grant income under the company's federal reimbursement grant with the Canadian government's Strategic Innovation Fund.
For the quarter ended December 31, 2021, Edesa reported a net loss of $4.38 million, or $0.33 per common share, compared to a net loss of $2.64 million, or $0.26 per common share, for the quarter ended December 31, 2020.
At December 31, 2021, Edesa had working capital of $8.14 million. Cash and cash equivalents totaled $5.88 million. Subsequent to the end of the fiscal first quarter, the company received gross proceeds of approximately $1.19 million from the issuance of common shares under an equity distribution agreement with RBC Capital Markets.
Edesa management plans to participate in the BIO Europe Spring 2022 virtual conference scheduled for March 28-31, 2022. Members of the investment or biopharma community who are interested in meeting with management can schedule one-on-one calls through the conference website or by contacting Edesa at email@example.com .
About Edesa Biotech, Inc.