Milestone Pharmaceuticals Reports $12.97 Million Net Loss in Q2 2025

Milestone Pharmaceuticals Inc. reported its financial results for the second quarter of 2025, revealing a net loss of $12.97 million, a 38.5% increase from the $9.36 million loss recorded in the same period of 2024. For the first half of 2025, the company experienced a net loss of $33.73 million, compared to a loss of $19.72 million in the first half of 2024. The company did not generate any revenue during the reported periods, maintaining a consistent trend from the previous year. Operating expenses for the second quarter totaled $12.53 million, up 29.7% from $9.66 million in the prior year, driven primarily by increased commercial expenses related to preparations for the potential launch of its lead product candidate, etripamil.

Research and development expenses rose significantly, with a 30.3% increase in the second quarter to $3.67 million, and a 34% increase for the first half to $8.65 million. The increase was attributed to higher consulting and external service costs, although these were partially offset by lower personnel-related expenses. General and administrative expenses decreased by 25.5% in the second quarter to $3.76 million, reflecting reduced legal and professional fees. Commercial expenses surged by 183.3% in the second quarter to $5.10 million, and by 230.4% in the first half to $15.48 million, as the company ramped up its operational activities in anticipation of the product launch.

As of June 30, 2025, Milestone reported total assets of $47.42 million, down from $75.50 million at the end of 2024. The company’s cash and cash equivalents increased to $42.50 million from $25.31 million, bolstered by a public offering completed in July 2025, which raised approximately $48.7 million. The company’s accumulated deficit reached $401.27 million, reflecting ongoing operational losses since its inception. The total liabilities stood at $65.16 million, up from $62.35 million at the end of 2024, primarily due to increased accounts payable and accrued liabilities.

Milestone is focused on advancing etripamil, a rapid-onset nasal spray designed for the treatment of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular rate (AFib-RVR). The company received a Complete Response Letter (CRL) from the FDA in March 2025 regarding its New Drug Application (NDA) for etripamil, citing Chemistry, Manufacturing, and Controls (CMC) issues. In response, Milestone submitted additional information to the FDA, which has set a new target action date of December 13, 2025, for the NDA review. The company is also preparing for a Phase 3 clinical trial for etripamil in AFib-RVR, although enrollment is currently on hold pending the resolution of the CRL.

Looking ahead, Milestone anticipates continued operating losses as it invests in the development and commercialization of etripamil. The company plans to utilize its existing cash reserves and proceeds from recent financing activities to support its operations for at least the next 12 months. The management remains optimistic about the potential market for etripamil, estimating a significant addressable market for both PSVT and AFib-RVR, and is focused on optimizing its launch strategy in anticipation of FDA approval.