Edesa Biotech, Inc. Common Shares - EDSA STOCK NEWS

Edesa Biotech (Nasdaq: EDSA) has initiated enrollment for a second cohort in the Phase 3 study of its monoclonal antibody EB05, targeting Covid-19-induced Acute Respiratory Distress Syndrome (ARDS). This cohort includes hospitalized patients on invasive mechanical ventilation. The aim is to utilize EB05 earlier to reduce ICU stays and mortality. Recruitment is ongoing for approximately 500 subjects, with primary endpoints focusing on ventilator-free days and mortality rates at 28 and 60 days. Regulatory approval has been secured in Canada, Colombia, and Poland, with discussions ongoing in the U.S.

Edesa Biotech (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced that CEO Par Nijhawan, MD, will present virtually at the H.C. Wainwright Global Investment Conference from May 23-26, 2022. An on-demand presentation will be available from May 24 at 7:00 am ET on the Edesa website. Additionally, senior management will hold one-on-one meetings with attendees. Edesa is developing lead candidates EB05 and EB01 for ARDS and chronic allergic contact dermatitis, respectively.

Edesa Biotech (NASDAQ:EDSA) reported financial results for the first half of 2022, highlighting a net loss of $8.95 million, or $0.66 per share, an increase from a loss of $4.90 million in 2021. Operating expenses decreased to $9.74 million, attributed to lower R&D costs which fell to $6.99 million. The Phase 3 study for its Covid-19 treatment is underway, with over 25% of subjects randomized, and its dermatology study is 75% enrolled. The company raised approximately $11.6 million to strengthen its balance sheet, facilitating clinical advancements.

Edesa Biotech (NASDAQ:EDSA) announced that enrollment for its Phase 2b study of EB01, an anti-inflammatory drug for chronic allergic contact dermatitis, is progressing ahead of schedule. The company aims to complete enrollment of 210 subjects by Q4 2022, with topline data expected in Q1 2023. Positive interim data and strong interest in the drug’s novel mechanism are driving recruitment. EB01, a non-steroidal compound, targets inflammatory mechanisms potentially providing an effective alternative to steroids, addressing a significant unmet medical need among ACD patients.

Edesa Biotech, Inc. (NASDAQ:EDSA) has appointed Jennifer M. Chao to its Board of Directors, marking a significant move as the company approaches key milestones in its clinical programs. With over 25 years in biotech finance and corporate strategy, Chao is expected to provide valuable insights. She previously served in executive roles at major firms and is currently a board member at Endo International plc and Cardiol Therapeutics Inc. Edesa continues to focus on developing therapies for inflammatory and immune-related diseases, notably EB05 for Acute Respiratory Distress Syndrome and EB01 for allergic contact dermatitis.

Edesa Biotech (NASDAQ:EDSA) closed a registered direct offering of 2,739,727 common shares at $3.65 each, generating approximately $10 million in gross proceeds. The offering included warrants for the purchase of an equal number of shares at an exercise price of $3.52, valid for five and a half years. The funds will be used for working capital and corporate purposes. The company, focused on inflammatory and immune-related diseases, has two lead candidates in clinical trials: EB05 for Acute Respiratory Distress Syndrome and EB01 for chronic allergic contact dermatitis.

Edesa Biotech (NASDAQ:EDSA) announced a definitive agreement for a registered direct offering of 2,739,727 common shares at $3.65 each, estimated to raise $10 million before fees. The offering is expected to close around March 24, 2022. Concurrently, the company will issue warrants for an equal number of shares at an exercise price of $3.52, valid for five and a half years. Proceeds will be allocated for working capital and general corporate purposes, furthering Edesa's focus on innovative treatments for inflammatory diseases.

Edesa Biotech (NASDAQ:EDSA) announced a Phase 3 enrollment milestone for its monoclonal antibody candidate, EB05, targeting critically ill Covid-19 patients. Over 25% of subjects have been randomized, following positive Phase 2 results showing a 68.5% reduction in mortality risk. The study aims to confirm the efficacy and safety of EB05, especially for patients on ECMO and IMV+. The primary endpoint is 28-day mortality among approximately 315 patients, with additional metrics like ventilator-free days assessed. The company is also in discussions with the FDA regarding protocol amendments.

Edesa Biotech (NASDAQ:EDSA) announced its financial results for Q1 2022, reporting a net loss of $4.38 million, or $0.33 per share, up from a net loss of $2.64 million in the previous year. Operating expenses rose by $2.55 million to $5.16 million, mainly due to increased R&D costs linked to ongoing clinical studies. Health Canada approved the Phase 3 design for its EB05 clinical trial targeting ARDS in COVID-19 patients, following promising Phase 2 results. Edesa also achieved a recruitment milestone in its Phase 2b study for Allergic Contact Dermatitis.