Milestone Pharmaceuticals(MIST) - 2025 Q2 - Quarterly Results

Executive Summary and Recent Highlights Milestone Pharmaceuticals reported Q2 2025 financial results, including FDA acceptance of its CARDAMYST™ CRL response and a new PDUFA date - Milestone Pharmaceuticals reported Q2 2025 financial results and provided updates, including the FDA's acceptance of its CRL response for CARDAMYST™ (etripamil) Nasal Spray, setting a new PDUFA target date of December 13, 2025[1] - The company strengthened its balance sheet through a public equity offering in July, raising up to $170 million gross proceeds if all warrants are exercised, and extended a $75 million royalty purchase agreement payment from RTW through the end of 2025[1][2] - CEO Joe Oliveto emphasized the team's focus on the potential approval and rapid commercialization of CARDAMYST for PSVT patients[2] Program and Regulatory Updates Etripamil for PSVT The FDA accepted Milestone's response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray, assigning a new PDUFA target date of December 13, 2025, leading the company to restart targeted pre-launch activities - FDA accepted the Company's response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray[3] - A new Prescription Drug User Fee Act (PDUFA) target date of December 13, 2025, has been set[3] - Milestone has restarted targeted pre-launch activities for CARDAMYST, maintaining its launch infrastructure[3] Etripamil for AFib-RVR Milestone has finalized the Phase 3 study protocol for etripamil in AFib-RVR with FDA concurrence but has paused enrollment to prioritize resources for the anticipated launch of etripamil in PSVT - Phase 3 study protocol of etripamil in AFib-RVR finalized following FDA review and concurrence[3] - Initiation of enrollment in the AFib-RVR study has been paused to prioritize resources for the expected launch of etripamil in PSVT[3] Corporate and Financial Updates Corporate Developments Milestone completed a public equity offering in July 2025, raising significant gross and net proceeds, and extended its royalty purchase agreement with RTW to December 31, 2025, to support the commercial launch of CARDAMYST Public Equity Offering Proceeds (July 2025) | Metric | Amount (Millions USD) | | :-------------------------------- | :-------------------- | | Total Gross Proceeds (if all warrants exercised) | Up to 170 | | Immediate Net Proceeds | Approximately 48.7 | - The proceeds from the public offering are intended to fund the continued development and commercial launch of CARDAMYST in PSVT, as well as for working capital and general corporate purposes[6] - Milestone extended the marketing approval deadline in its $75 million Royalty Purchase Agreement with RTW from September 30, 2025, to December 31, 2025[6] Financial Performance Overview Milestone reported no revenue for Q2 2025, an increase in R&D and commercial expenses due to launch preparations, a decrease in G&A expenses, and a higher net loss compared to the prior year Cash Position and Liquidity As of June 30, 2025, Milestone's cash, cash equivalents, and short-term investments totaled $43.4 million, a decrease from December 31, 2024, but significantly bolstered by $48.7 million in net proceeds from a subsequent public offering Cash, Cash Equivalents, and Short-term Investments | Period | Amount (Millions USD) | | :----------------------- | :-------------------- | | June 30, 2025 | $43.4 | | December 31, 2024 | $69.7 | | Change | ($26.3) | - Subsequent to the quarter end, the company raised approximately $48.7 million in net proceeds from a public offering[6] Operating Expenses Research and development expenses increased due to higher consulting costs, while general and administrative expenses decreased primarily due to lower legal and personnel fees. Commercial expenses significantly rose in preparation for CARDAMYST's launch Research and Development Expense | Period | 2025 (Millions USD) | 2024 (Millions USD) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :----------- | | Q2 | $3.7 | $2.8 | +$0.9 | | Six Months Ended June 30 | $8.6 | $6.5 | +$2.1 | - The increase in R&D expense was primarily due to higher consulting and outside service costs, partially offset by lower personnel-related costs[6] General and Administrative Expense | Period | 2025 (Millions USD) | 2024 (Millions USD) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :----------- | | Q2 | $3.8 | $5.0 | -$1.2 | | Six Months Ended June 30 | $8.9 | $9.0 | -$0.1 | - The decrease in G&A expense was primarily due to a decrease in legal fees, professional fees, and personnel costs[6] Commercial Expense | Period | 2025 (Millions USD) | 2024 (Millions USD) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :----------- | | Q2 | $5.1 | $1.8 | +$3.3 | | Six Months Ended June 30 | $15.5 | $4.7 | +$10.8 | - Increases in commercial expense were a result of additional personnel costs, professional costs, and other operational expenses related to preparation for the launch of CARDAMYST[10] Net Loss Milestone's net loss increased for both the second quarter and the six months ended June 30, 2025, compared to the prior year periods Net Loss and Comprehensive Loss | Period | 2025 (Millions USD) | 2024 (Millions USD) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :----------- | | Q2 | ($13.0) | ($9.4) | ($3.6) | | Six Months Ended June 30 | ($33.7) | ($19.7) | ($14.0) | Net Loss Per Share (Basic and Diluted) | Period | 2025 (USD) | 2024 (USD) | Change (YoY) | | :----------------------- | :--------- | :--------- | :----------- | | Q2 | ($0.20) | ($0.14) | ($0.06) | | Six Months Ended June 30 | ($0.51) | ($0.34) | ($0.17) | About Etripamil Etripamil is Milestone's lead investigational product, a novel calcium channel blocker nasal spray for PSVT and AFib-RVR, designed for self-administration - Etripamil is Milestone's lead investigational product, a novel calcium channel blocker nasal spray for PSVT and AFib-RVR[8] - It is designed as a self-administered rapid response therapy for patients, bypassing the need for immediate medical oversight[8] - CARDAMYST™ is the conditionally approved brand name for etripamil nasal spray, supported by a robust clinical trial program including a completed Phase 3 for PSVT and Phase 2 for AFib-RVR[8] About Milestone Pharmaceuticals Milestone Pharmaceuticals is a biopharmaceutical company focused on developing innovative cardiovascular solutions, empowering patients with self-management - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing innovative cardiovascular solutions[9] - The company aims to provide new treatment approaches that empower patients with an active role in self-managing their care[9] - Etripamil, a novel calcium channel blocker nasal spray, is its lead investigational product for self-administration to treat symptomatic episodic attacks of PSVT and AFib-RVR[9] Condensed Consolidated Financial Statements Condensed Consolidated Balance Sheets The unaudited condensed consolidated balance sheets present the company's financial position as of June 30, 2025, compared to December 31, 2024, showing changes in assets, liabilities, and shareholders' equity Condensed Consolidated Balance Sheets (Unaudited) | | June 30, 2025 (in thousands of US dollars) | December 31, 2024 (in thousands of US dollars) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Assets | | | | Cash and cash equivalents | $42,499 | $25,314 | | Short-term investments | $918 | $44,381 | | Total current assets | $46,168 | $73,926 | | Total assets | $47,417 | $75,499 | | Liabilities | | | | Total current liabilities | $9,283 | $8,126 | | Senior secured convertible notes | $55,238 | $53,352 | | Total liabilities | $65,162 | $62,352 | | Shareholders' (Deficit) Equity | | | | Accumulated deficit | ($401,272) | ($367,545) | | Total shareholders' (deficit) equity | ($17,745) | $13,147 | Condensed Consolidated Statements of Loss The unaudited condensed consolidated statements of loss detail the company's financial performance for the three and six months ended June 30, 2025, and 2024, highlighting operating expenses, net loss, and net loss per share Condensed Consolidated Statements of Loss (Unaudited) | | Three months ended June 30, 2025 (in thousands of US dollars) | Three months ended June 30, 2024 (in thousands of US dollars) | Six months ended June 30, 2025 (in thousands of US dollars) | Six months ended June 30, 2024 (in thousands of US dollars) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Revenue | $— | $— | $— | $— | | Research and development, net of tax credits | $3,669 | $2,815 | $8,647 | $6,454 | | General and administrative | $3,759 | $5,046 | $8,926 | $8,999 | | Commercial | $5,103 | $1,801 | $15,481 | $4,685 | | Loss from operations | ($12,531) | ($9,662) | ($33,054) | ($20,138) | | Net loss and comprehensive loss | ($12,966) | ($9,363) | ($33,727) | ($19,717) | | Net loss per share, basic and diluted | ($0.20) | ($0.14) | ($0.51) | ($0.34) | Forward-Looking Statements This section outlines forward-looking statements based on expectations and assumptions, subject to risks that may cause actual results to differ materially - This press release contains forward-looking statements regarding future events, conditions, or circumstances, identified by words such as 'potential,' 'expect,' and 'will'[11] - These statements are based on Milestone's expectations and assumptions and involve risks and uncertainties, meaning actual results may differ materially[11] - Important factors that could cause differences include FDA approval outcomes, timing of clinical trials, market conditions, and the sufficiency of capital resources, as detailed in SEC filings[11] Contact Information Provides contact details for investor relations inquiries - For investor relations inquiries, contact Kevin Gardner at kgardner@lifesciadvisors.com[12]