Edesa Biotech(EDSA) - 2024 Q2 - Quarterly Results

Edesa Biotech Fiscal Q2 2024 Results Business Update and Strategic Outlook Edesa Biotech advances its clinical pipeline, including Phase 3 ARDS study with C$23M funding, and dermatology assets - Expanded site selection for the Phase 3 study of its ARDS drug candidate, EB05 (paridiprubart), backed by up to C$23 million from the Canadian government[3] - The company plans to evaluate EB05 in a broader ARDS population and file an IND for a Phase 2 study in pulmonary fibrosis, positioning the anti-TLR4 technology for both acute and chronic conditions[3][4] - For its dermatology portfolio, Edesa plans to seek U.S. regulatory approval for a Phase 2 study of its anti-CXCL10 antibody for vitiligo and seek strategic partners to develop or monetize its EB01 asset for dermatitis[4] - Management believes government funding provides a strong position to manage the Phase 3 ARDS study while opportunistically advancing its vitiligo and pulmonary fibrosis programs[6] Financial Performance Edesa Biotech reported improved Q2 and H1 fiscal 2024 results, with reduced net loss from lower expenses and higher grant income Three Months Ended March 31, 2024 Q2 2024 net loss narrowed to $1.9 million from $2.3 million, driven by lower operating expenses and higher grant income Q2 Fiscal 2024 vs. Q2 Fiscal 2023 Financial Highlights | Metric | Three Months Ended Mar 31, 2024 (USD) | Three Months Ended Mar 31, 2023 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $2.2 million | $2.4 million | -$0.2 million | | Total Other Income | $360,000 | $77,000 | +$283,000 | | Net Loss | $1.9 million | $2.3 million | -$0.4 million | | Loss Per Common Share | $0.58 | $0.82 | -$0.24 | - Research and development (R&D) expenses decreased by $0.3 million, primarily due to lower external research costs for the completed dermatitis study[8] - General and administrative (G&A) expenses increased by $0.1 million, mainly due to higher fees for professional services[8] Six Months Ended March 31, 2024 Net loss for the six months ended March 31, 2024, decreased to $3.5 million from $4.7 million, due to lower expenses and higher government reimbursement Six Months Fiscal 2024 vs. Six Months Fiscal 2023 Financial Highlights | Metric | Six Months Ended Mar 31, 2024 (USD) | Six Months Ended Mar 31, 2023 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $4.1 million | $4.8 million | -$0.7 million | | Total Other Income | $0.5 million | $0.1 million | +$0.4 million | | Net Loss | $3.5 million | $4.7 million | -$1.2 million | | Loss Per Common Share | $1.12 | $1.70 | -$0.58 | - R&D expenses for the six-month period decreased by $0.9 million, while G&A expenses increased by $0.2 million[15] Financial Position and Cash Flow As of March 31, 2024, Edesa held $2.8 million in cash and $2.1 million in working capital, with $3.1 million net cash used in operations Key Financial Position Data (as of March 31, 2024) | Metric | Amount (USD) | | :--- | :--- | | Cash and Cash Equivalents | $2.8 million | | Working Capital | $2.1 million | - Subsequent to the quarter end, the company received $0.7 million in reimbursement funding from the Canadian government's Strategic Innovation Fund[11] - Net cash used in operating activities for the six months ended March 31, 2024, was $3,066,687[22] Corporate Information Edesa Biotech is a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, with key pipeline assets EB05, EB06, and EB01 - Edesa's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody being evaluated in a Phase 3 study for Acute Respiratory Distress Syndrome (ARDS)[13] - The company's pipeline also includes EB06 for vitiligo and EB01 for chronic Allergic Contact Dermatitis (ACD)[13] - Management plans to attend the RBC Capital Markets Global Healthcare Conference (May 14-15, 2024) and the BIO International Convention (June 5-8, 2024)[12] Condensed Financial Statements This section presents unaudited condensed interim consolidated financial statements, including Statements of Operations, Balance Sheets, and Cash Flows Condensed Interim Consolidated Statements of Operations The statement details expenses and income, showing a net loss of $1,861,331 for Q2 and $3,539,782 for H1 2024 Condensed Interim Consolidated Statements of Operations (Unaudited) | | Three Months Ended March 31, (USD) | Six Months Ended March 31, (USD) | | :--- | :--- | :--- | | | 2024 | 2023 | 2024 | 2023 | | Expenses: | | | | | | Research and development | $1,176,337 | $1,458,190 | $1,880,795 | $2,815,528 | | General and administrative | $1,044,137 | $952,391 | $2,197,108 | $1,973,358 | | Loss from operations | ($2,220,474) | ($2,410,581) | ($4,077,903) | ($4,788,886) | | Other Income (Loss): | | | | | | Reimbursement grant income | $304,002 | - | $424,836 | - | | Other income (loss) | $55,941 | $77,032 | $114,085 | $120,520 | | Net loss | ($1,861,331) | ($2,334,349) | ($3,539,782) | ($4,669,166) | | Loss per common share | ($0.58) | ($0.82) | ($1.12) | ($1.70) | Condensed Interim Consolidated Balance Sheets As of March 31, 2024, total assets were $6,475,056 and shareholders' equity $4,324,333, a decrease from September 30, 2023 Condensed Interim Consolidated Balance Sheets (Unaudited) | | March 31, 2024 (USD) | September 30, 2023 (USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $2,799,631 | $5,361,397 | | Other current assets | $1,442,587 | $1,075,455 | | Non-current assets | $2,232,838 | $2,453,585 | | Total Assets | $6,475,056 | $8,890,437 | | Liabilities and Shareholders' Equity | | | | Current liabilities | $2,150,723 | $1,821,864 | | Non-current liabilities | - | $19,773 | | Shareholders' equity | $4,324,333 | $7,048,800 | | Total liabilities and shareholders' equity | $6,475,056 | $8,890,437 | Condensed Interim Consolidated Statements of Cash Flows Net cash used in operating activities for the six months ended March 31, 2024, was $3,066,687, with an ending cash balance of $2,799,631 Condensed Interim Consolidated Statements of Cash Flows (Unaudited) | | Six Months Ended March 31, (USD) | | :--- | :--- | :--- | | | 2024 | 2023 | | Net cash used in operating activities | ($3,066,687) | ($3,363,240) | | Net cash provided by financing activities | $517,441 | $3,676,415 | | Net change in cash and cash equivalents | ($2,561,766) | $380,333 | | Cash and cash equivalents, beginning of period | $5,361,397 | $7,090,919 | | Cash and cash equivalents, end of period | $2,799,631 | $7,471,252 |