Milestone Pharmaceuticals Reports $20.8 Million Net Loss in Q1 2025, No Revenue Generated

Milestone Pharmaceuticals Inc. reported a net loss of $20.8 million for the first quarter of 2025, a significant increase from the $10.4 million loss recorded in the same period of 2024. The company did not generate any revenue during this quarter, consistent with the previous year. Operating expenses surged to $20.5 million, up 95.9% from $10.5 million in the prior year, driven primarily by a 259.9% increase in commercial expenses, which rose to $10.4 million as the company prepared for the potential launch of its lead product, etripamil, a nasal spray for treating paroxysmal supraventricular tachycardia (PSVT).

The increase in operating expenses was also attributed to higher research and development costs, which rose by 36.8% to $5.0 million, largely due to increased consulting fees related to drug manufacturing and regulatory activities. General and administrative expenses increased by 30.7% to $5.2 million, reflecting higher outside service costs. The company’s accumulated deficit reached $388.3 million as of March 31, 2025, compared to $367.5 million at the end of 2024.

Milestone's financial position showed a cash and cash equivalents balance of $45.1 million, alongside $10.9 million in short-term investments, totaling $56.0 million in liquid assets. This represents a significant increase from the $25.3 million in cash and cash equivalents reported at the end of 2024. The company has indicated that it expects to have sufficient capital to fund its operations for at least the next 12 months, despite the ongoing losses.

Strategically, Milestone is focused on advancing etripamil through regulatory processes. In March 2025, the company received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for etripamil, citing Chemistry, Manufacturing, and Controls (CMC) issues that need to be addressed. The company plans to request a Type A meeting with the FDA to discuss the CRL and is preparing to respond to the agency's requests. Additionally, Milestone is exploring opportunities for geographic expansion and potential collaborations to enhance its product pipeline.

Looking ahead, Milestone anticipates continued investment in research and development, particularly for etripamil and its other cardiovascular indications. The company is also preparing for the commercialization of etripamil, contingent upon receiving FDA approval. The management has expressed confidence in the product's potential to address significant unmet needs in the treatment of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR), with a target market that could encompass millions of patients in the U.S.