Milestone Pharmaceuticals Inc. reported a net loss of $41.5 million for the fiscal year ending December 31, 2024, a decrease from a net loss of $59.7 million in the previous year. The company did not generate any revenue in 2024, compared to $1 million in 2023, which was attributed to a milestone payment from a collaboration agreement with Corxel Pharmaceuticals. Total operating expenses decreased by 32.2% to $42.1 million, primarily due to a significant reduction in research and development costs, which fell by 53.8% to $14.4 million as the company completed its Phase 3 clinical trials for its lead product candidate, etripamil.
Milestone is focused on the development of etripamil, a nasal spray treatment for paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular rate (AFib-RVR). The company is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for etripamil, with a Prescription Drug User Fee Act (PDUFA) goal date set for March 27, 2025. In addition to its ongoing efforts in the U.S., Milestone is also pursuing regulatory approval for etripamil in China through its partnership with Corxel.
Operationally, Milestone has made significant strides in its clinical development programs. The company completed the NODE-303 Phase 3 study, which demonstrated that etripamil effectively restored sinus rhythm in patients experiencing PSVT. The results indicated a median time-to-conversion of 17 minutes, with a conversion rate of 60% within 30 minutes of administration. Furthermore, the company presented positive Phase 2 data for etripamil in treating AFib-RVR, which supports its potential for self-administration in non-medical settings.
As of December 31, 2024, Milestone had cash and cash equivalents of $25.3 million and short-term investments of $44.4 million, providing a total liquidity of $69.7 million. The company anticipates that its existing cash resources will be sufficient to fund operations for at least the next 12 months. However, it acknowledges the need for additional funding to support ongoing clinical trials and potential commercialization efforts. The company has also entered into a Royalty Purchase Agreement with RTW Investments, which could provide a contingent source of funding upon FDA approval of etripamil. Looking ahead, Milestone aims to expand its product pipeline and establish commercialization capabilities, contingent on successful regulatory outcomes.
About Milestone Pharmaceuticals Inc.
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