Milestone Pharmaceuticals Q2 2024 Financial Results and Updates

Milestone Pharmaceuticals Inc. recently announced its financial results for the second quarter ending June 30, 2024, and shared updates on regulatory and corporate developments. The key highlight of these updates includes the acceptance of the New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target date slated for March 2025. This acceptance allows Milestone Pharmaceuticals to prepare for the potential market launch of the product in 2025.

Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, expressed optimism about the progress, particularly noting the interest from cardiology experts in their Phase 3 study for atrial fibrillation with rapid ventricular rate (AFib-RVR), scheduled to begin in the first half of 2025.

Program Developments

CARDAMYST for Paroxysmal Supraventricular Tachycardia (PSVT)

The FDA's acceptance of the NDA for CARDAMYST is a significant milestone. Milestone Pharmaceuticals hosted a Key Opinion Leader (KOL) webinar titled “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting.” The webinar, which featured cardiologists Dr. George Mark and Dr. Vivek Sailam, discussed the burden of PSVT on patients, current treatment options, unmet needs, and future expectations for treatment landscapes. A replay of the webinar is available on the company's website.

Etripamil for Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR)

Planning for the Phase 3 pivotal trial of etripamil in AFib-RVR is underway, with guidance from the FDA received in the first quarter of 2024. Milestone Pharmaceuticals is collaborating with experts to finalize the trial design, which will involve a self-administered, repeat-dose regimen of 70 mg etripamil nasal spray, similar to the regimen used in the RAPID trial for PSVT. Enrollment for this study is expected to begin in the first half of 2025.

During the second quarter, data from previous studies on etripamil were presented at several conferences, including ISPOR 2024, the Stanford BioDesign Arrhythmia Technologies Retreat, and the Heart Rhythm Society meeting. These presentations highlighted the potential of etripamil to reduce emergency department visits for patients who can self-treat PSVT episodes and provided rationale for the company's Phase 3 program for AFib-RVR.

Corporate Updates

In July, Milestone Pharmaceuticals appointed Stuart Duty and Andrew Saik as independent directors to its board. Mr. Duty brings over 30 years of experience in investment banking and biotechnology, while Mr. Saik has over 25 years of experience in accounting and finance, including leading capital structure transformations.

Financial Highlights for Q2 2024

As of June 30, 2024, Milestone Pharmaceuticals had cash, cash equivalents, and short-term investments totaling $83.3 million, compared to $66.0 million as of December 31, 2023. Research and development expenses for the second quarter of 2024 were $2.8 million, a significant decrease from $8.6 million in the same period in 2023. This reduction was attributed to lower clinical development costs and personnel-related costs following the completion of Phase 3 studies.

General and administrative expenses for the second quarter of 2024 were $5.0 million, compared to $4.4 million in the same period in 2023. The increase was primarily due to higher legal and professional fees, offset by a decrease in personnel costs. Commercial expenses for the second quarter of 2024 were $1.8 million, down from $3.4 million in the same period in 2023, due to reduced personnel and operational costs.

The net loss for the second quarter of 2024 was $9.4 million, compared to $16.0 million in the prior year period. For the six months ending June 30, 2024, the net loss was $19.7 million, down from $31.0 million in the prior year period.

About PSVT and AFib-RVR

Paroxysmal Supraventricular Tachycardia (PSVT) affects around two million people in the U.S. and is characterized by sudden, rapid heartbeats that can significantly impact a patient's quality of life. Current treatment options are limited, often necessitating emergency department visits or invasive procedures.

Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) affects millions of Americans and is expected to increase in prevalence. AFib-RVR can lead to symptoms severe enough to require emergency care. Milestone Pharmaceuticals' research indicates a substantial potential market for etripamil in treating AFib-RVR.

About Milestone Pharmaceuticals and Etripamil

Milestone Pharmaceuticals Inc. is a biopharmaceutical company specializing in cardiovascular solutions. Its lead investigational product, etripamil, is a nasal spray designed for self-administration to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Etripamil aims to provide patients with a rapid response treatment that can be self-administered, potentially reducing the need for immediate medical oversight and emergency department visits.

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