Business
Edesa Biotech Reports Fiscal Year 2022 Results
TORONTO, ON / ACCESSWIRE / December 16, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"TORONTO, ON / ACCESSWIRE / December 16, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the fiscal year ended September 30, 2022 and provided an update on its business.During the fiscal year, Edesa reported positive final results from the Phase 2 part of a Phase 2/3 study of its monoclonal antibody in Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS). Among the results, critically ill patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. The company has submitted a Phase 2 Clinical Study Report to the U.S. Food and Drug Administration as part of the review of Edesa's Phase 3 clinical protocol design and statistical plan. In the fourth quarter, the company also completed enrollment in its Phase 2b dermatology study, and expects to report topline data in the next four weeks.\"We believe the significant strides we made in 2022 have positioned us for continued and accelerated progress,\" said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. \"With two late-stage studies, a growing development pipeline, large addressable markets and interest from potential partners, we are excited about the opportunities we are bringing into the new year.\"Edesa's Chief Financial Officer Kathi Niffenegger reported that operational expenses for fiscal 2022 decreased by more than 20% over the previous year, benefitting from the completion of clinical activities related to the company's Phase 2b dermatitis study and the flexibility of Edesa's business model to manage working capital. \"Our full fiscal year results reflect the trend demonstrated in the past three quarters of reduced operating expenses and prudent management of working capital,\" she said.Edesa reported that near-term operational objectives include, among others, completing the FDA review of the company's Phase 3 protocol design for EB05; fully enrolling the Phase 3 study of EB05; reporting Phase 2b results for EB01; completing a Phase 2 investigational new drug application in the U.S. for systemic sclerosis; and submitting a clinical trial application for vitiligo in Canada.Financial Results for the Fiscal Year Ended September 30, 2022Tota...