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Edesa Biotech, Inc. (NASDAQ: EDSA) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for inflammatory and immune-related diseases. Founded in 2015, Edesa is focused on dermatological and anorectal conditions, particularly those with limited treatment options. The company's experienced team has licensed global rights to several clinical-stage assets targeting these conditions.
Edesa operates in a single segment: the research, development, manufacturing, and commercialization of pharmaceutical products. Its leading product candidates include EB01, a non-steroidal, anti-inflammatory treatment for chronic Allergic Contact Dermatitis (ACD), and EB05, a monoclonal antibody therapy for hospitalized COVID-19 patients. The company's focus on alternatives to topical steroids, which often have side effects, positions it uniquely in the dermatology market.
In the latest developments, Edesa announced its intention to effect a one-for-seven reverse share split of its common shares, which began trading on a post-reverse split basis on October 11, 2023. Additionally, the company secured a commitment of up to C$23 million from the Government of Canada for a pivotal Phase 3 clinical study of EB05. This support underscores the potential of Edesa's therapies to modulate the body's immune response in critical conditions like Acute Respiratory Distress Syndrome (ARDS).
Another significant milestone was the favorable final results from a Phase 2b study of EB01, demonstrating its efficacy in treating moderate-to-severe chronic ACD. The company also received Health Canada approval to harmonize clinical trial designs in the U.S. and Canada for its ongoing Phase 3 study of EB05. Further, a $10 million revolving credit facility agreement with the company's CEO enhances its financial flexibility for future developments.
Edesa's pipeline includes candidates like EB06, for the treatment of vitiligo, and plans to file an investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis. The company's ongoing efforts in research and strategic partnerships continue to pave the way for innovative solutions in the biopharmaceutical landscape.
Edesa Biotech (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, will partake in the BTIG Biotechnology Conference in New York on August 8-9, 2022. This hybrid event allows for both virtual and in-person attendance. Interested parties can connect with Edesa through BTIG representatives or via email at investors@edesabiotech.com. Edesa is advancing two critical product candidates, EB05, targeting Acute Respiratory Distress Syndrome, and EB01, for chronic allergic contact dermatitis.
Edesa Biotech, focusing on inflammatory and immune-related diseases, will present at the 2nd Annual ARDS Drug Development Summit on July 14, 2022, in Boston. CEO Par Nijhawan is set to discuss the EB05 drug candidate, a potential treatment for Acute Respiratory Distress Syndrome (ARDS), highlighting its Phase 2/3 clinical trial design influenced by Covid-19. Edesa's EB05 has shown a promising 68.5% reduction in mortality among critically ill Covid-19 patients. Additionally, the press release provides insights into the company's clinical programs for EB01 and their ongoing studies.
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.
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