Milestone Pharmaceuticals Reports $11.9M Net Loss in Q3 2025, Prepares for Etripamil Launch

Milestone Pharmaceuticals Inc. reported its financial results for the third quarter of 2025, revealing a net loss of $11.9 million, compared to a loss of $9.4 million in the same period last year, marking a 26.3% increase in losses. For the nine months ending September 30, 2025, the company recorded a net loss of $45.6 million, a significant rise of 56.6% from the $29.2 million loss reported for the same period in 2024. The company has not generated any revenue during these periods, as it awaits regulatory approval for its lead product candidate, etripamil, a nasal spray treatment for paroxysmal supraventricular tachycardia (PSVT).

Operating expenses for the third quarter totaled $11.8 million, a 23% increase from $9.6 million in the prior year. The rise in expenses was primarily driven by a substantial increase in commercial expenses, which surged by 142.1% to $4.6 million, reflecting preparations for the potential launch of etripamil. Research and development expenses remained relatively stable at $3.9 million, while general and administrative costs decreased by 12.8% to $3.3 million. For the nine-month period, total operating expenses reached $44.9 million, up 50.9% from $29.8 million in 2024, largely due to increased commercial activities.

Milestone's cash and cash equivalents, along with short-term investments, totaled $82.6 million as of September 30, 2025, providing a liquidity cushion as the company continues to navigate its clinical development and regulatory processes. The company has an accumulated deficit of $413.2 million, reflecting its ongoing investment in research and development without any revenue generation to date. The company anticipates that its existing cash resources will be sufficient to fund operations for at least the next 12 months.

Strategically, Milestone is focused on advancing etripamil through the regulatory process. Following a Complete Response Letter (CRL) from the FDA in March 2025, the company submitted a response in June, which was accepted, with a new Prescription Drug User Fee Act (PDUFA) target date set for December 13, 2025. The company is also preparing to initiate a Phase 3 clinical trial for etripamil in the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR), leveraging data from previous studies to support its application.

Looking ahead, Milestone expects to continue incurring significant losses as it invests in the development and commercialization of etripamil. The company plans to establish a sales and marketing infrastructure to support the launch of etripamil, contingent upon receiving FDA approval. The ongoing development of etripamil and potential future product candidates will require substantial capital, and the company may seek additional funding through equity or debt financing to support its operational needs.