Edesa Biotech(EDSA) - 2025 Q2 - Quarterly Results

Executive Summary Edesa Biotech reported Q2 FY2025 results, highlighting a strategic pivot towards its vitiligo drug candidate EB06, supported by a recent $15 million equity financing. The company is advancing regulatory and manufacturing activities for a U.S. Phase 2 study for EB06 Company Highlights & Strategic Focus Edesa Biotech reported Q2 FY2025 results, highlighting a strategic pivot towards its vitiligo drug candidate EB06, supported by a recent $15 million equity financing. The company is advancing regulatory and manufacturing activities for a U.S. Phase 2 study for EB06 - Completed a $15 million equity financing from healthcare-focused institutional investors, existing shareholders, and insiders to support the development of the company's vitiligo drug candidate EB06[3] - Financial results for the quarter reflected a pivot in operational activity to the company's vitiligo development program (EB06) from its respiratory program[5] - Initiated outreach to potential investigators and manufacturing-related activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients[3] Business Update Edesa is actively advancing its EB06 vitiligo program while managing other pipeline assets, including EB05 for ARDS and EB01 for ACD Vitiligo Program (EB06) Development Edesa is actively advancing its EB06 vitiligo program, with manufacturing and regulatory preparations underway for a U.S. Phase 2 study. The company anticipates submitting manufacturing data to the FDA in H2 2025, with topline results potentially available 12-18 months post-regulatory clearance - Initial steps in the manufacturing of the biological drug EB06 are ongoing, with anticipation of submitting drug manufacturing data to the U.S. FDA for its investigational new drug (IND) application in the second half of calendar 2025[4][7] - Topline results for the planned Phase 2 study could be available within 12 to 18 months following regulatory clearance by the FDA. The planned Phase 2 study is already approved in Canada[7] - Increased expenditures for the EB06 program reflect the deployment of additional resources to manufacturing and preparatory regulatory activities to speed the launch of the upcoming vitiligo study[5][6] Other Pipeline Programs While focusing on EB06, Edesa continues to benefit from a fully funded government study for its respiratory drug EB05 (paridiprubart) for ARDS, which offset some EB06 expenses. The company also has EB01 for Allergic Contact Dermatitis and is preparing an IND for EB07 (paridiprubart) for pulmonary fibrosis - Decreased expenses for the EB05 drug candidate as the company benefits from a fully funded government study investigating Edesa's respiratory drug as a treatment for Acute Respiratory Distress Syndrome (ARDS)[5] - Medical dermatology assets include EB01 (1.0% daniluromer cream), a Phase 3-ready asset for moderate-to-severe chronic Allergic Contact Dermatitis (ACD)[15] - Preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis[15] Financial Performance Edesa reported reduced net losses for both the three and six months ended March 31, 2025, driven by decreased operating expenses Three Months Ended March 31, 2025 For Q2 FY2025, Edesa reported a reduced net loss of $1.6 million, or $0.30 per share, compared to $1.9 million, or $0.58 per share, in the prior year. This improvement was driven by a decrease in total operating expenses, primarily R&D, despite a decline in other income | Metric | Q2 FY2025 (3 months) | Q2 FY2024 (3 months) | Change | | :----------------------- | :------------------- | :------------------- | :----- | | Net Loss | $(1.6) million | $(1.9) million | $(0.3) million decrease | | Loss per Common Share | $(0.30) | $(0.58) | $(0.28) decrease | | Total Operating Expenses | $1.6 million | $2.2 million | $(0.6) million decrease | | Research & Development | $0.5 million | $1.2 million | $(0.7) million decrease | | General & Administrative | $1.2 million | $1.0 million | $0.2 million increase | | Total Other Income | $49,000 | $360,000 | $(311,000) decrease | - Research and development expenses decreased primarily due to decreased external research expenses related to manufacturing the company's investigational drug, paridiprubart, partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study[10] - Total other income decreased primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income[8] Six Months Ended March 31, 2025 For the six-month period, Edesa's net loss decreased to $3.2 million, or $0.74 per share, from $3.5 million, or $1.12 per share, in the prior year. This was driven by a reduction in total operating expenses, including R&D and G&A, despite a decline in other income | Metric | H1 FY2025 (6 months) | H1 FY2024 (6 months) | Change | | :----------------------- | :------------------- | :------------------- | :----- | | Net Loss | $(3.2) million | $(3.5) million | $(0.3) million decrease | | Loss per Common Share | $(0.74) | $(1.12) | $(0.38) decrease | | Total Operating Expenses | $3.5 million | $4.1 million | $(0.6) million decrease | | Research & Development | $1.5 million | $1.9 million | $(0.4) million decrease | | General & Administrative | $2.0 million | $2.2 million | $(0.2) million decrease | | Total Other Income | $331,000 | $539,000 | $(208,000) decrease | - Research and development expenses decreased primarily due to decreased external research expenses related to manufacturing paridiprubart, partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study[17] - General and administrative expenses decreased primarily due to a decrease in noncash share-based compensation and professional service fees, partially offset by an increase in salaries and related costs[17] Financial Position & Liquidity Edesa's financial position improved significantly with increased cash and working capital due to recent equity financing Working Capital As of March 31, 2025, Edesa reported a significant increase in cash and cash equivalents to $13.9 million and working capital of $13.5 million, largely due to the recent equity financing | Metric | March 31, 2025 | | :-------------------- | :------------- | | Cash and Cash Equivalents | $13.9 million | | Working Capital | $13.5 million | Corporate Information Edesa Biotech is a clinical-stage biopharmaceutical company focused on immuno-inflammatory diseases, with upcoming event participation and forward-looking statements Upcoming Events Edesa plans to participate in the BIO International Convention in Boston from June 16-19, 2025, offering opportunities for meetings with company representatives - Edesa plans to participate in the BIO International Convention being held June 16-19, 2025, in Boston, Mass[14] About Edesa Biotech Edesa Biotech is a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, with a pipeline in Medical Dermatology (EB06 for vitiligo, EB01 for ACD) and Respiratory (EB05 for ARDS, EB07 for pulmonary fibrosis) - Edesa Biotech, Inc. is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases[15] - Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology (EB06 for vitiligo, EB01 for Allergic Contact Dermatitis) and Respiratory (EB05 for Acute Respiratory Distress Syndrome, EB07 for pulmonary fibrosis)[15] Forward-Looking Statements The report contains forward-looking statements regarding future performance, clinical trials, regulatory approvals, and financial resources, which are subject to various risks and uncertainties that could cause actual results to differ materially - This press release may contain forward-looking statements regarding plans for regulatory approval, potential of drug candidates, changes in treatment paradigms, resource deployment, and timing of clinical studies[16][18] - Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause actual results or future events to differ materially, including the ability to obtain regulatory approval, access to capital, product effectiveness, and intellectual property protection[18] Condensed Interim Consolidated Financial Statements The report includes unaudited condensed interim consolidated financial statements, detailing operations, balance sheets, and cash flows Statements of Operations The unaudited condensed interim consolidated statements of operations provide detailed financial results for the three and six months ended March 31, 2025 and 2024, showing key expense categories, net loss, and loss per common share | Metric | 3 Months Ended Mar 31, 2025 | 3 Months Ended Mar 31, 2024 | 6 Months Ended Mar 31, 2025 | 6 Months Ended Mar 31, 2024 | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $484,306 | $1,176,337 | $1,504,124 | $1,880,795 | | General and administrative | $1,154,580 | $1,044,137 | $2,033,451 | $2,197,108 | | Loss from operations | $(1,638,886) | $(2,220,474) | $(3,537,575) | $(4,077,903) | | Reimbursement grant income | $52,268 | $304,002 | $353,463 | $424,836 | | Net loss | $(1,590,448) | $(1,861,331) | $(3,207,701) | $(3,539,782) | | Loss per common share | $(0.30) | $(0.58) | $(0.74) | $(1.12) | Balance Sheets The unaudited condensed interim consolidated balance sheets present the company's financial position as of March 31, 2025, and September 30, 2024, showing a significant increase in cash and shareholders' equity | Metric | March 31, 2025 | September 30, 2024 | | :-------------------------- | :-------------------------- | :-------------------------- | | Cash and cash equivalents | $13,896,650 | $1,037,320 | | Total Assets | $16,454,299 | $3,813,982 | | Current liabilities | $914,701 | $1,832,827 | | Shareholders' equity | $15,539,598 | $1,981,155 | | Total liabilities and shareholders' equity | $16,454,299 | $3,813,982 | Statements of Cash Flows The unaudited condensed interim consolidated statements of cash flows detail the cash movements for the six months ended March 31, 2025, and 2024, highlighting significant cash provided by financing activities in the current period | Metric | 6 Months Ended Mar 31, 2025 | 6 Months Ended Mar 31, 2024 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(3,900,501) | $(3,066,687) | | Net cash provided by financing activities | $16,844,415 | $517,441 | | Net change in cash and cash equivalents | $12,859,330 | $(2,561,766) | | Cash and cash equivalents, beginning of period | $1,037,320 | $5,361,397 |