Edesa Biotech, Inc. Common Shares - EDSA STOCK NEWS

Edesa Biotech (NASDAQ:EDSA) has received Health Canada approval to proceed with a Phase 3 clinical trial of its monoclonal antibody candidate EB05. This trial aims to assess EB05 as a rescue therapy for critically ill patients suffering from Acute Respiratory Distress Syndrome (ARDS), particularly in the context of COVID-19. Previous Phase 2 results indicated a significant 68.5% reduction in mortality risk for patients treated with EB05. The Phase 3 study will involve approximately 315 subjects, with a primary focus on 28-day mortality rates and additional secondary outcomes.

Edesa Biotech (NASDAQ:EDSA) reported fiscal year results for 2021, highlighting significant advancements in clinical trials for its lead products, EB05 and EB01. The Phase 2 studies for both candidates showed promising interim results, particularly for EB05, which was unblinded early due to efficacy. The company received $10.34 million in grant income, contributing positively to its finances despite a net loss of $13.34 million. Total operating expenses rose to $23.68 million, primarily due to clinical program costs. Edesa ended the fiscal year with $10.63 million in working capital.

Edesa Biotech, Inc. (NASDAQ:EDSA) has completed over 75% enrollment for its Phase 2b study of the EB01 cream for chronic allergic contact dermatitis, involving approximately 170 subjects. The company is also initiating a dose-ranging study for an additional 40 participants. A voluntary open-label extension allows placebo patients access to EB01 post-study. Interim results showed promising efficacy, with a 1.7-fold difference in primary endpoints and no serious adverse events reported. EB01 aims to provide a non-steroidal treatment alternative for ACD, addressing a significant unmet medical need.

Edesa Biotech (NASDAQ:EDSA) has received approval from Polish regulators to expand its clinical trial for EB05, a monoclonal antibody candidate for treating hospitalized COVID-19 patients. This follows promising Phase 2 results, showing a 68.5% reduction in mortality risk among critically ill patients. The ongoing Phase 2/3 trial is also recruiting in the U.S., Canada, and Colombia, particularly focusing on patients needing advanced respiratory support. The company aims to update its Phase 3 protocol and explore expedited regulatory paths in multiple jurisdictions.

Edesa Biotech (NASDAQ:EDSA) announced promising results from its Phase 2 study of monoclonal antibody EB05 for hospitalized COVID-19 patients. The Data and Safety Monitoring Board revealed a 68.5% decrease in mortality risk for critically ill patients treated with EB05 compared to placebo. Additional efficacy signals were found, including an 8.2% mortality rate for patients on supplemental oxygen in the EB05 group. The company plans to focus on this critically ill population in Phase 3 and may expedite regulatory filings due to the significant clinical outcomes observed.

Edesa Biotech (NASDAQ:EDSA) announced promising results from the Phase 2 segment of its ongoing Phase 2/3 study for EB05, a monoclonal antibody aimed at treating hospitalized COVID-19 patients. An independent Data Safety Monitoring Board noted a significant efficacy signal, leading to the study's unblinding. Critically ill patients showed a 68.5% reduction in 28-day mortality with EB05 treatment compared to standard care. The DSMB recommended continuing to the Phase 3 study, which is set to focus on segments with the strongest efficacy signals.

Edesa Biotech (NASDAQ:EDSA) will be presenting at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Dr. Par Nijhawan, CEO, will discuss the company's corporate strategy and business overview. An on-demand presentation will be available starting September 13, 2021, at 7:00 am ET. Attendees can also schedule one-on-one meetings with company management. Edesa is focused on developing treatments for inflammatory and immune-related diseases, with products in clinical stages for conditions like ARDS and chronic allergic contact dermatitis.

Edesa Biotech (NASDAQ:EDSA) announced significant progress in its Phase 2/3 clinical study for a monoclonal antibody (EB05) targeting hospitalized COVID-19 patients. As of August 25, 2021, over 525 patients have been enrolled, with an upcoming blinded interim analysis expected soon, covering approximately 316 subjects. The Delta variant has accelerated patient enrollment, particularly in regions heavily impacted by the virus. Funded partly by a C$14 million grant from the Canadian Government, Edesa has established 46 clinical sites across Canada, Colombia, and the U.S. for this crucial therapeutic development.

Edesa Biotech (NASDAQ:EDSA) reported its financial results for Q3 and the nine months ending June 30, 2021. The company achieved key milestones in clinical programs EB05 and EB01, with recommendations to advance both to final enrollment stages. R&D expenditures increased to $4.46 million, reflecting enhanced clinical study activities. Edesa recorded no revenues for the quarter, leading to a net loss of $4.76 million ($0.36 per share). For the nine-month period, total operating expenses rose to $18.20 million amid no revenues, resulting in a net loss of $9.66 million ($0.83 per share).