Edesa Biotech(EDSA) - 2025 Q3 - Quarterly Results

Company Overview and Business Update This section provides an introduction to Edesa Biotech, a clinical-stage biopharmaceutical company, and updates on its business and pipeline development Company Introduction Edesa Biotech, a clinical-stage biopharmaceutical company focused on immuno-inflammatory diseases, reported its financial results for the three and nine months ended June 30, 2025, and provided a business update - Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases[2] Business Highlights and Pipeline Update Edesa advanced manufacturing activities for its drug candidate EB06 to support a Phase 2 study for moderate-to-severe nonsegmental vitiligo, with FDA IND submission anticipated by the end of calendar 2025 - Advanced manufacturing activities for EB06 (an anti-CXCL10 monoclonal antibody) support U.S. regulatory approval of a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients[3] - Anticipates submitting EB06 drug manufacturing data to the U.S. FDA for its IND application by the end of calendar 2025[3] - Increased expenditures for the EB06 program were offset by decreased EB05 expenses, benefiting from the fully funded U.S. government 'Just Breathe' study for ARDS[4] Financial Performance Summary This section summarizes Edesa Biotech's financial results for the three and nine months ended June 30, 2025, detailing operating expenses, other income, and net loss Three Months Ended June 30, 2025 For the three months ended June 30, 2025, total operating expenses remained consistent at $1.9 million, while net loss was $1.7 million, or $0.25 per common share Financial Highlights (Three Months Ended June 30) | Metric | Q3 2025 | Q3 2024 | | :----- | :------ | :------ | | Total Operating Expenses | $1.9 million | $1.9 million | | Total Other Income | $154,000 | $264,000 | | Net Loss | $1.7 million | $1.7 million | | Loss per Common Share | $0.25 | $0.52 | - Total other income decreased by $110,000, primarily due to reduced Canadian government funding and lower interest income[6] Nine Months Ended June 30, 2025 For the nine months ended June 30, 2025, total operating expenses decreased by $0.6 million to $5.4 million, resulting in an improved net loss of $5.0 million Financial Highlights (Nine Months Ended June 30) | Metric | YTD 2025 | YTD 2024 | | :----- | :------- | :------- | | Total Operating Expenses | $5.4 million | $6.0 million | | Research and Development Expenses | $2.4 million | $2.8 million | | General and Administrative Expenses | $3.0 million | $3.2 million | | Total Other Income | $0.5 million | $0.8 million | | Net Loss | $5.0 million | $5.2 million | | Loss per Common Share | $0.95 | $1.64 | - Research and development expenses decreased by $0.4 million to $2.4 million, driven by lower EB05 external research expenses, partially offset by increased EB06 costs[8][15] - General and administrative expenses decreased by $0.2 million to $3.0 million, primarily due to reduced professional service fees and noncash share-based compensation[8][15] Financial Statements This section presents the unaudited condensed interim consolidated statements of operations, financial position, and cash flows for Edesa Biotech Condensed Interim Consolidated Statements of Operations This section presents the unaudited condensed interim consolidated statements of operations, detailing revenues, expenses, and net loss for the three and nine months ended June 30, 2025, and 2024 Condensed Interim Consolidated Statements of Operations | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Research and development | $939,067 | $897,305 | $2,443,191 | $2,778,100 | | General and administrative | $964,676 | $1,035,140 | $2,998,127 | $3,232,248 | | Loss from operations | $(1,903,743) | $(1,932,445) | $(5,441,318) | $(6,010,348) | | Reimbursement grant income | $183,281 | $236,226 | $536,744 | $661,062 | | Other income (loss) | $(29,002) | $28,007 | $(51,791) | $142,092 | | Net loss | $(1,749,464) | $(1,668,212) | $(4,957,165) | $(5,207,994) | | Loss per common share - basic and diluted | $(0.25) | $(0.52) | $(0.95) | $(1.64) | Condensed Interim Consolidated Statements of Financial Position This section provides the unaudited condensed interim consolidated balance sheet, outlining the company's assets, liabilities, and shareholders' equity as of June 30, 2025, and September 30, 2024 Condensed Interim Consolidated Statements of Financial Position | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------------- | :-------------- | :----------------- | | Cash and cash equivalents | $12,361,690 | $1,037,320 | | Total Assets | $14,804,800 | $3,813,982 | | Current liabilities | $672,674 | $1,832,827 | | Shareholders' equity | $14,132,126 | $1,981,155 | | Total liabilities and shareholders' equity | $14,804,800 | $3,813,982 | Condensed Interim Consolidated Statements of Cash Flows This section presents the unaudited condensed interim consolidated statements of cash flows for the nine months ended June 30, 2025, and 2024, detailing cash movements from operating, financing, and the effect of exchange rate changes Condensed Interim Consolidated Statements of Cash Flows | Metric | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(5,601,268) | $(3,923,166) | | Net cash provided by financing activities | $16,844,415 | $623,466 | | Net change in cash and cash equivalents | $11,324,370 | $(3,320,513) | | Cash and cash equivalents, end of period | $12,361,690 | $2,040,884 | Additional Information This section provides supplementary details on Edesa Biotech's working capital, upcoming investor conferences, company overview, and forward-looking statements Working Capital As of June 30, 2025, Edesa Biotech reported $12.4 million in cash and cash equivalents and $12.1 million in working capital Working Capital as of June 30, 2025 | Metric | Amount | | :----- | :----- | | Cash and cash equivalents | $12.4 million | | Working capital | $12.1 million | Investor Calendar Edesa management is scheduled to participate in two investor conferences in August and September 2025: the Canaccord Genuity 45th Annual Growth Conference and the H.C. Wainwright 27th Annual Global Investment Conference - Edesa management will participate in the Canaccord Genuity 45th Annual Growth Conference (August 12-13, 2025) and the H.C. Wainwright 27th Annual Global Investment Conference (September 8-10, 2025)[12] About Edesa Biotech, Inc. Edesa Biotech, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases - Edesa Biotech, Inc. is a clinical-stage biopharmaceutical company developing innovative treatments for inflammatory and immune-related diseases[13] - The clinical pipeline focuses on Medical Dermatology (EB06 for vitiligo, EB01 for chronic Allergic Contact Dermatitis) and Respiratory (EB05 for Acute Respiratory Distress Syndrome)[13] - The EB05 program is evaluated in a U.S. government-funded platform study and has received two funding awards from the Government of Canada[13] Forward-Looking Statements This section contains forward-looking statements regarding Edesa's business plans, including EB06 development and regulatory submission, and highlights various risks and uncertainties - Forward-looking statements are identified by words such as 'anticipate,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'will,' 'would,' 'could,' 'should,' 'might,' 'potential,' or 'continue'[14] - Forward-looking statements include plans to channel operational efforts into regulatory preparation and drug manufacturing of EB06, aiming for rapid clinical testing and FDA IND submission by end of calendar 2025[14] - Risks include obtaining regulatory approval, access to sufficient capital, product efficacy, compliance with license agreements, intellectual property protection, and public health crisis impacts[16]