Edesa Initiates Phase 2 Study for EB06 Dermatology Drug
During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa's dermatology drug candidate, EB06, in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that recruitment will begin by midyear 2026, subject to the completion of clinical-grade drug manufacturing and regulatory approvals. In its respiratory program, Edesa reported that a Phase 3 study of its monoclonal antibody, paridiprubart, met primary and secondary endpoints with statistical significance. Edesa is currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions. "Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs." Edesa's Chief Financial Officer Peter Weiler reported that financial results for the fiscal year reflected a ramp up in activities for the company's vitiligo program as well as the completion and close-out of the Phase 3 clinical study of paridiprubart. "This year, we strengthened our balance sheet and extended our Canadian government funding agreement to support manufacturing and development for our respiratory program. Looking ahead, our priorities include executing the Phase 2 vitiligo study, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline," he said.
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Edesa Biotech Reports GAAP EPS of -$1.27, Exceeding Estimates by $0.51
Earnings Performance: Edesa Biotech reported a fiscal year GAAP EPS of -$1.27, which exceeded expectations by $0.51.
Financial Position: As of September 30, 2025, the company had cash and cash equivalents totaling $10.8 million and working capital of $10.4 million.
Recent Funding: Following the fiscal year end, Edesa Biotech secured $3.4 million in net proceeds from common shares sold under an at-the-market offering program.
Company Presentation: Edesa Biotech presented at the LSX Investival Showcase Europe 2025, highlighting its ongoing developments and financial status.
Edesa Biotech Reveals Schedule for Upcoming Conferences
Upcoming Conferences: Edesa Biotech, Inc. will participate in BIO-Europe in Vienna from November 3-5, 2025, and the LSX Investival Showcase Europe in London on November 17, 2025.
Company Focus: Edesa is a clinical-stage biopharmaceutical company developing treatments for immuno-inflammatory diseases, with a pipeline that includes therapies for Medical Dermatology and Respiratory conditions.
Key Products: The company is advancing EB06 for vitiligo and EB01 for Allergic Contact Dermatitis, while its respiratory candidate, paridiprubart, is aimed at treating Acute Respiratory Distress Syndrome and is being evaluated in a U.S. government-funded study.
Forward-Looking Statements: The press release includes forward-looking statements regarding Edesa's future performance, emphasizing the risks and uncertainties that could affect the company's ability to achieve its goals.
Edesa Biotech Announces Encouraging Phase 3 Outcomes for Paridiprubart in ARDS
Positive Phase 3 Study Results: Edesa Biotech reported that its drug candidate paridiprubart significantly reduced 28-day mortality in patients with Acute Respiratory Distress Syndrome (ARDS) during a Phase 3 study.
Comparison with Placebo: Patients receiving paridiprubart plus standard of care had a 39% risk of death, compared to 52% for those on placebo, indicating a 13% absolute improvement in survival and a 25% relative risk reduction.
Ongoing Research: Paridiprubart is also being tested in the U.S. government's Just Breathe study, which focuses on novel therapeutics for hospitalized adult ARDS patients.
Disclaimer: The views expressed in the report are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
Edesa Biotech Posts Narrower Loss in Q3
Earnings Report: Edesa Biotech reported a GAAP EPS loss of $(0.25) for Q3 FY2025, better than the expected $(0.26), with no revenue recognized due to its clinical-stage status and stable operating expenses of $1.9 million.
Clinical Development Focus: The company is prioritizing the development of EB06, an experimental treatment for vitiligo, while managing operational costs and leveraging government funding for ongoing clinical trials, particularly for its EB05 program.
HC Wainwright & Co. Assumes Edesa Biotech at Buy, Announces Price Target of $5
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, providing real-time intelligence to help them succeed in the stock market.
Community and Exclusivity: Joining Benzinga Pro connects users with over 10,000 serious traders and grants access to exclusive stories and insights from Benzinga reporters.
Edesa Biotech to Participate in Bloom Burton Healthcare Investor Conference
Edesa Biotech Conference Participation: Edesa Biotech, a clinical-stage biopharmaceutical company, will present at the 2024 Bloom Burton & Co. Healthcare Investor Conference in Toronto on May 5, 2025, and invites attendees to connect through the conference portal or directly via email.
Company Overview and Pipeline: Edesa is focused on developing treatments for immuno-inflammatory diseases, with key products including EB06 for vitiligo, EB01 for Allergic Contact Dermatitis, and EB05 for Acute Respiratory Distress Syndrome, alongside plans for further studies in pulmonary fibrosis.
Edesa Biotech Reports GAAP EPS of -$1.27, Exceeding Estimates by $0.51
Earnings Performance: Edesa Biotech reported a fiscal year GAAP EPS of -$1.27, which exceeded expectations by $0.51.
Financial Position: As of September 30, 2025, the company had cash and cash equivalents totaling $10.8 million and working capital of $10.4 million.
Recent Funding: Following the fiscal year end, Edesa Biotech secured $3.4 million in net proceeds from common shares sold under an at-the-market offering program.
Company Presentation: Edesa Biotech presented at the LSX Investival Showcase Europe 2025, highlighting its ongoing developments and financial status.
Edesa Biotech Reveals Schedule for Upcoming Conferences
Upcoming Conferences: Edesa Biotech, Inc. will participate in BIO-Europe in Vienna from November 3-5, 2025, and the LSX Investival Showcase Europe in London on November 17, 2025.
Company Focus: Edesa is a clinical-stage biopharmaceutical company developing treatments for immuno-inflammatory diseases, with a pipeline that includes therapies for Medical Dermatology and Respiratory conditions.
Key Products: The company is advancing EB06 for vitiligo and EB01 for Allergic Contact Dermatitis, while its respiratory candidate, paridiprubart, is aimed at treating Acute Respiratory Distress Syndrome and is being evaluated in a U.S. government-funded study.
Forward-Looking Statements: The press release includes forward-looking statements regarding Edesa's future performance, emphasizing the risks and uncertainties that could affect the company's ability to achieve its goals.
Edesa Biotech Announces Encouraging Phase 3 Outcomes for Paridiprubart in ARDS
Positive Phase 3 Study Results: Edesa Biotech reported that its drug candidate paridiprubart significantly reduced 28-day mortality in patients with Acute Respiratory Distress Syndrome (ARDS) during a Phase 3 study.
Comparison with Placebo: Patients receiving paridiprubart plus standard of care had a 39% risk of death, compared to 52% for those on placebo, indicating a 13% absolute improvement in survival and a 25% relative risk reduction.
Ongoing Research: Paridiprubart is also being tested in the U.S. government's Just Breathe study, which focuses on novel therapeutics for hospitalized adult ARDS patients.
Disclaimer: The views expressed in the report are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
Edesa Biotech Posts Narrower Loss in Q3
Earnings Report: Edesa Biotech reported a GAAP EPS loss of $(0.25) for Q3 FY2025, better than the expected $(0.26), with no revenue recognized due to its clinical-stage status and stable operating expenses of $1.9 million.
Clinical Development Focus: The company is prioritizing the development of EB06, an experimental treatment for vitiligo, while managing operational costs and leveraging government funding for ongoing clinical trials, particularly for its EB05 program.
HC Wainwright & Co. Assumes Edesa Biotech at Buy, Announces Price Target of $5
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, providing real-time intelligence to help them succeed in the stock market.
Community and Exclusivity: Joining Benzinga Pro connects users with over 10,000 serious traders and grants access to exclusive stories and insights from Benzinga reporters.
Edesa Biotech to Participate in Bloom Burton Healthcare Investor Conference
Edesa Biotech Conference Participation: Edesa Biotech, a clinical-stage biopharmaceutical company, will present at the 2024 Bloom Burton & Co. Healthcare Investor Conference in Toronto on May 5, 2025, and invites attendees to connect through the conference portal or directly via email.
Company Overview and Pipeline: Edesa is focused on developing treatments for immuno-inflammatory diseases, with key products including EB06 for vitiligo, EB01 for Allergic Contact Dermatitis, and EB05 for Acute Respiratory Distress Syndrome, alongside plans for further studies in pulmonary fibrosis.
