Edesa Biotech Inc - EDSA STOCK NEWS

Edesa Biotech (NASDAQ:EDSA) has secured approval from Colombia's Ministry of Health to expand its clinical trial for the investigational drug EB05 in hospitalized COVID-19 patients. The trial, already underway in the U.S. and Canada, aims to evaluate EB05's efficacy in modulating immune response associated with Acute Respiratory Distress Syndrome (ARDS). About 316 patients will be enrolled across various sites in Colombia, with results expected to facilitate a subsequent Phase 3 study. This initiative demonstrates Edesa's commitment to address significant unmet needs in COVID-19 treatment.

Edesa Biotech, Inc. (NASDAQ:EDSA) reflected on a challenging yet productive 2020 in a letter to shareholders from CEO Par Nijhawan. Despite the global pandemic, the company made strides in expanding its development pipeline, acquiring global rights to key monoclonal antibody candidates. Regulatory approvals were obtained for clinical studies targeting COVID-19, and the Phase 2/3 study for EB05 was launched. Edesa also reported encouraging patient recruitment for its Allergic Contact Dermatitis study. The company is focused on efficiently utilizing its capital and prioritizing projects that meet significant medical needs.

Edesa Biotech (NASDAQ:EDSA) reported its fiscal year 2020 financial results, highlighting key developments in its clinical pipeline. The company added two Phase 2-ready biologics focused on COVID-19 and initiated a Phase 2/Phase 3 study for an anti-TLR4 antibody treatment. Financial results showed total revenues of $0.33 million, down from $0.41 million in the previous period, while net loss increased to $6.36 million. Cash and cash equivalents were approximately $7.2 million as of September 30, 2020. Edesa anticipates future growth driven by ongoing clinical studies.

Edesa Biotech, Inc. (NASDAQ:EDSA) has enrolled its first patient in a Phase 2/Phase 3 clinical trial for its investigational drug, EB05, aimed at treating hospitalized COVID-19 patients. EB05 is designed to moderate the immune response associated with Acute Respiratory Distress Syndrome (ARDS), which affects 20%-42% of hospitalized COVID-19 patients. The trial plans to include around 316 patients across approximately 40 hospitals. If successful, EB05 could provide crucial treatment options for severe cases of COVID-19.

Edesa Biotech, Inc. (NASDAQ:EDSA) will present at the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020, at 12:30 pm ET. Dr. Par Nijhawan, CEO, will lead the presentation, with senior management available for one-on-one meetings. Interested investors can reach out for appointments. Edesa focuses on innovative treatments for inflammatory and immune-related diseases, with lead candidates including EB05 for Acute Respiratory Distress Syndrome in COVID-19 patients and EB01 for chronic allergic contact dermatitis.

Edesa Biotech (NASDAQ:EDSA) has surpassed 50% patient enrollment for the Phase 2b clinical study of its drug candidate, EB01, targeting chronic allergic contact dermatitis. This study evaluates EB01's safety and efficacy in 46 subjects. Previous trials have shown statistically significant symptom improvement. CEO Dr. Par Nijhawan expressed optimism about the recruitment rate during the pandemic and plans for a blinded interim analysis post-first cohort. The annual economic impact of contact dermatitis in the U.S. is estimated at $2 billion, with over 2.5 million people affected.

Edesa Biotech (NASDAQ:EDSA) has received FDA clearance to commence the Phase 2 portion of its Phase 2/3 clinical study for EB05, an investigational drug targeting hospitalized COVID-19 patients. The study aims to evaluate the efficacy and safety of EB05 in adults at risk of developing Acute Respiratory Distress Syndrome (ARDS). With the goal of reducing ICU admissions and mortality, Edesa is initiating site processes in U.S. hospitals. The Phase 2/3 study is randomized and double-blind, with hopes to progress to a pivotal Phase 3 trial based on Phase 2 results.

Pardeep Nijhawan announced an increase in his beneficial ownership of Edesa Biotech by over 2% from previous holdings. This change was prompted by a private share transfer and an earlier acquisition of shares, raising his total ownership to approximately 34.01% of the issued Common Shares. The new holdings include 3,257,157 Common Shares, 48,480 Options, and 11,570 Warrants. Dr. Nijhawan acquired these shares for investment purposes and will continue to monitor the company’s performance and may adjust his holdings in the future.

Edesa Biotech reported Q3 financial results for the period ending June 30, 2020. The company received Canadian approval for a Phase 2/3 clinical study of EB05, targeting COVID-19 related ARDS. Edesa's revenues were $0.11 million, attributed to past product sales, while net loss increased to $1.77 million or $0.20 per share. Operating expenses rose by $0.56 million to $1.88 million, primarily due to research activities. For the nine months, total revenue was $0.33 million with a net loss of $4.35 million. Working capital stood at $5.24 million, bolstered by recent warrant exercises bringing in $2.42 million.