Business
Edesa Biotech Reports Fiscal 2nd Quarter 2023 Results
TORONTO, ON / ACCESSWIRE / May 11, 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 / May 11, 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 and six months ended March 31, 2023 and provided an update on its business.During the fiscal second quarter, the company achieved two regulatory milestones, including an agreement with the U.S. Food and Drug Administration on the primary endpoint of a pivotal Phase 3 study of Edesa's ARDS (acute respiratory distress syndrome) drug candidate EB05 (paridiprubart) in critical-care patients hospitalized with SARS-CoV2 infections, and an authorization by Canadian regulators for a Phase 2 clinical study of Edesa's EB06 monoclonal antibody candidate as a treatment for vitiligo. In addition, the company reported favorable preliminary, topline results from a Phase 2b clinical study of Edesa's drug candidate EB01 as a monotherapy for moderate-to-severe chronic allergic contact dermatitis (ACD).\"These regulatory and clinical milestones represent a key part of our growth strategy, and we are excited about the opportunities we have to expand our business development discussions for these innovative assets,\" said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. \"As part of our development and go-to-market planning, we are also exploring broader potential use of our lead biologic, paridiprubart, as treatment for general ARDS and other conditions that involve dysregulated innate immune responses, such as systemic sclerosis.\"Dr. Nijhawan reported that the company plans to file an investigational new drug application (IND) in the U.S. for a future Phase 2 study of EB07 (paridiprubart) in systemic sclerosis (scleroderma), a chronic fibrotic disease of the skin and internal organs that primarily impacts women. Additional objectives include the completion of the company's ongoing Phase 2/3 study of EB05 (paridiprubart), and completing the full analysis of the results from the company's ACD study.Edesa's Chief Financial Officer Kathi Niffenegger reported that operating expenditures for the three and six month periods ended March 31, 2023 declined by 47% and 51%, respectively. \"Second quarter and first half expenditures were in line with our expectations and reflected, in part, a disciplined approach toward working capi...