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Milestone Pharmaceuticals(MIST) - 2025 Q1 - Quarterly Results

Q1 2025 Financial Results and Corporate Update Milestone Pharmaceuticals reported increased Q1 2025 net loss and no revenue, prioritizing FDA's CARDAMYST CRL resolution and pausing other clinical programs Program and Regulatory Updates Milestone focuses on resolving FDA's CARDAMYST CRL for PSVT, securing a new patent, and pausing the AFib-RVR study - Received a Complete Response Letter (CRL) from the FDA for CARDAMYST™ for PSVT, citing two key Chemistry, Manufacturing and Controls (CMC) issues4 - The CRL issues include a request for additional information on nitrosamine impurities and a required re-inspection of a third-party manufacturing facility4 - The company requested a Type A meeting with the FDA to discuss and resolve the CRL issues23 - A new U.S. patent (No. 12,257,224) was issued, potentially extending CARDAMYST intellectual property protection until July 20424 - The Phase 3 study for etripamil in AFib-RVR is paused to prioritize resources for resolving the PSVT indication CRL5 First Quarter 2025 Financial Results Milestone Pharmaceuticals reported no Q1 2025 revenue, a $20.8 million net loss, and decreased cash due to higher operating expenses Q1 2025 Financial Highlights (in millions of US dollars) | Financial Metric | Q1 2025 (millions USD) | Q1 2024 (millions USD) | | :--- | :--- | :--- | | Revenue | $0.0 | $0.0 | | R&D Expense | $5.0 | $3.6 | | G&A Expense | $5.2 | $4.0 | | Commercial Expense | $10.4 | $2.9 | | Net Loss | $20.8 | $10.4 | | Cash, Cash Equivalents, and Short-term Investments | $56.0 | N/A | - The increase in commercial expense resulted from additional personnel, professional costs, and operational expenses for CARDAMYST launch preparation8 - Due to the CRL, the company temporarily paused the ramping of operational expenditures related to the launch8 Financial Statements The company's financial statements show a decrease in total assets, an increase in liabilities, and a doubled net loss for Q1 2025 Condensed Consolidated Balance Sheets As of March 31, 2025, total assets decreased to $61.9 million, liabilities increased, resulting in a $6.1 million shareholders' deficit Condensed Consolidated Balance Sheets (Unaudited, in thousands of US dollars) | | March 31, 2025 (thousands USD) | December 31, 2024 (thousands USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $45,085 | $25,314 | | Short-term investments | $10,873 | $44,381 | | Total current assets | $60,475 | $73,926 | | Total assets | $61,885 | $75,499 | | Liabilities & Equity | | | | Total current liabilities | $12,963 | $8,126 | | Senior secured convertible notes | $54,287 | $53,352 | | Total liabilities | $68,008 | $62,352 | | Total shareholders' (deficit) equity | ($6,123) | $13,147 | Condensed Consolidated Statements of Loss For Q1 2025, Milestone reported no revenue, with loss from operations doubling to $20.5 million and a net loss of $20.8 million Condensed Consolidated Statements of Loss (Unaudited, in thousands of US dollars, except per share data) | | Three months ended March 31, 2025 (thousands USD) | Three months ended March 31, 2024 (thousands USD) | | :--- | :--- | :--- | | Revenue | $— | $— | | Research and development | $4,978 | $3,639 | | General and administrative | $5,167 | $3,953 | | Commercial | $10,378 | $2,884 | | Loss from operations | ($20,523) | ($10,476) | | Net loss | ($20,761) | ($10,354) | | Net loss per share, basic and diluted | ($0.31) | ($0.21) | About Etripamil Etripamil is Milestone's lead investigational calcium channel blocker nasal spray for self-administration in PSVT and AFib-RVR About Etripamil Etripamil is Milestone's investigational calcium channel blocker nasal spray for self-administration in PSVT and AFib-RVR - Etripamil is a novel calcium channel blocker nasal spray developed for patient self-administration10 - It is being developed for paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular rate (AFib-RVR)10 - The therapy aims to provide on-demand care and patient self-management, potentially bypassing immediate medical oversight10