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Milestone Pharmaceuticals (MIST) investor relations material
Milestone Pharmaceuticals Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Focused on developing and commercializing etripamil (CARDAMYST), a nasal spray for PSVT and AFib-RVR, with a PDUFA target date of December 13, 2025, and rapid launch plans upon potential FDA approval.
Strengthened commercialization capabilities and increased pre-launch activities for CARDAMYST.
Received a Complete Response Letter (CRL) from the FDA in March 2025 for CARDAMYST; response accepted with new PDUFA date.
Preparing for a Phase 3 program in AFib-RVR and pursuing a supplemental NDA pathway.
Financial highlights
Net loss for Q3 2025 was $11.9 million, up from $9.4 million in Q3 2024; nine-month net loss was $45.6 million, up from $29.2 million year-over-year.
No revenue recorded for Q3 2025 or Q3 2024.
Cash, cash equivalents, and short-term investments totaled $82.6 million as of September 30, 2025, up from $69.7 million at December 31, 2024.
Operating expenses for Q3 2025 were $11.8 million, a 23% increase year-over-year; commercial expenses rose 142% to $4.6 million.
Accumulated deficit reached $413.2 million as of September 30, 2025.
Outlook and guidance
Sufficient liquidity to fund operations for at least the next 12 months.
Plans to launch CARDAMYST quickly following potential FDA approval, with commercial expenses expected to rise upon approval and product launch.
Proceeds from recent equity offering and amended royalty purchase agreement expected to fund commercial launch and continued development.
Anticipates $75 million royalty payment upon FDA approval.
Anticipates continued operating losses and increased expenses as development and commercialization efforts progress.
Commercial spend ramp-up for CARDAMYST launch
What is the expected cash runway post-FDA approval?
AFib-RVR Phase 3 study initiation timeline
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Next Milestone Pharmaceuticals earnings date
Q4 202520 Mar, 2026
Next Milestone Pharmaceuticals earnings date
Q4 202520 Mar, 2026
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Frequently asked questions
Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing cardiovascular therapies. The company specializes in the research and development of treatments for episodic cardiovascular conditions, aiming to provide rapid and effective symptom relief. Its lead drug candidates target conditions such as paroxysmal supraventricular tachycardia (PSVT) and other heart-related disorders. The company is headquartered in Montreal, Canada, and its shares are listed on the NASDAQ.
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