Milestone Pharmaceuticals Q1 2024 Financial Results and Updates

Milestone Pharmaceuticals Inc. has reported its financial results for the first quarter ending March 31, 2024, alongside updates on its regulatory and corporate activities. The company is progressing toward potential FDA approval of CARDAMYST™ (etripamil) nasal spray by the first half of 2025, aimed at treating patients with paroxysmal supraventricular tachycardia (PSVT). Milestone's President and CEO, Joseph Oliveto, stated the company's focus on working with the FDA and preparing for the drug's commercial launch in the U.S. The company's cash position, bolstered by a potential future synthetic royalty payment, is expected to support the launch.

For PSVT, Milestone resubmitted a New Drug Application (NDA) for etripamil after a Type A meeting with the FDA in February 2024. The resubmission addressed issues raised in a Refusal to File letter, including restructured data sets to better capture adverse events in the Phase 3 trial. The company anticipates a standard review period for the NDA. New clinical data presented at The American College of Cardiology Scientific Sessions and published in the Journal of the American College of Cardiology demonstrated the effectiveness of etripamil in converting PSVT, with a high rate of symptom relief within 60 minutes of self-administration.

In addition, Milestone is advancing its dialogue with the FDA to finalize the Phase 3 protocol for etripamil in treating atrial fibrillation with a rapid ventricular rate (AFib-RVR). The FDA has reiterated its guidance on a single-study, supplemental NDA pathway and has concurred on key elements of the Phase 3 study design, including patient population and endpoints. Further discussions with the FDA are planned for the second half of 2024 to finalize the study protocol.

In corporate developments, Milestone completed a public offering of common shares and pre-funded warrants in March 2024, raising approximately $32.2 million. The proceeds are earmarked for the continued development and commercialization of etripamil for PSVT and AFib-RVR, as well as for general corporate purposes.

Financially, as of March 31, 2024, Milestone reported cash, cash equivalents, and short-term investments totaling $89.5 million, up from $66.0 million as of December 31, 2023. The company had no revenue for the first quarter of 2024, compared to $1.0 million in the same period the previous year. Research and development expenses decreased to $3.6 million, down from $10.3 million, primarily due to the completion of Phase 3 clinical studies for PSVT in 2023. General and administrative expenses saw a slight increase to $4.0 million, and commercial expenses rose to $2.9 million.

Net loss for the first quarter of 2024 was $10.4 million, compared to $15.0 million in the prior year period. The company's cash conservation measures, aligned with the revised NDA timeline, were mostly completed during the first quarter.

PSVT is an arrhythmia characterized by sudden rapid heartbeats, leading to symptoms such as severe palpitations, shortness of breath, and dizziness. The condition impacts approximately two million people in the U.S., often requiring emergency care due to the lack of effective treatment options. AFib-RVR, another arrhythmia affecting about five million Americans, also requires urgent medical attention, with many patients seeking emergency department care for symptom relief.

Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker nasal spray designed for self-administration to treat symptomatic episodes of PSVT and AFib-RVR. The product aims to offer patients a rapid response therapy, potentially reducing the need for immediate medical supervision and providing greater control over their condition.

Milestone Pharmaceuticals continues to focus on developing innovative cardiovascular solutions to improve patient outcomes and experiences, with etripamil at the forefront of their efforts to address unmet medical needs in arrhythmia management.