Business
Edesa Biotech Reports Fiscal 1st Quarter 2023 Results
TORONTO, ON / ACCESSWIRE / February 10, 2023 / 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 / February 10, 2023 / 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, 2022 and provided an update on its business.During the fiscal first quarter, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Edesa's drug candidate, EB05, which the company is developing for Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure. Approval of the company's application follows favorable Phase 2 results and provides increased access to agency staff as well as potential pathways for accelerated regulatory approval. Last month, the company also reported preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of its drug candidate, EB01, as a monotherapy for chronic moderate-to-severe Allergic Contact Dermatitis (ACD). Among the results, 1.0% EB01 cream demonstrated statistically significant improvement over placebo for both the primary efficacy endpoint and a key secondary endpoint. Most recently, the company announced that Canadian regulators authorized a Phase 2 clinical study of Edesa's EB06 monoclonal antibody candidate as a treatment for vitiligo, an autoimmune disease that causes loss of skin color in patches.\"We are pleased to start off the year with three major pieces of good news,\" said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. \"Overall, this was a strong quarter across our operations, and we look forward to building on this momentum, including making use of our expanded access under Fast Track and advancing our strategic discussions with potential commercialization and licensing partners. We see significant opportunities for our late-stage ARDS, ACD and vitiligo assets, and look forward to sharing our clinical and operational progress, including important upcoming regulatory milestones.\"Edesa's Chief Financial Officer Kathi Niffenegger reported that fiscal first quarter operating expenditures declined by more than 50% compared the same period last year, and that the company continued to demonstrate its ability to effectively manage working capital and operational priorities.\"Fiscal first quarter results reflect the flexibility of Edesa's busine...