Milestone Pharmaceuticals Showcases Growth Despite Regulatory Hurdles

Milestone Pharmaceuticals Reports Strong Financial Results

MONTREAL and CHARLOTTE, N.C. — Milestone Pharmaceuticals Inc. (NASDAQ: MIST) has shared its financial performance for the first quarter of 2025, highlighting progress despite encountering regulatory hurdles. The company is actively addressing issues raised by the U.S. Food and Drug Administration (FDA) on their breakthrough treatment CARDAMYST for paroxysmal supraventricular tachycardia (PSVT).

Addressing Regulatory Challenges

Joe Oliveto, President and CEO of Milestone Pharmaceuticals, stated that the primary focus is to engage meaningfully with the FDA to tackle the Chemistry, Manufacturing, and Controls (CMC) issues discussed in the Complete Response Letter (CRL) received in March.

CRL Overview

The CRL indicated two key issues that need to be resolved before proceeding further: the agency requested more data regarding nitrosamine impurities and a new inspection of a manufacturing facility that is critical for the approval of CARDAMYST. The company is encouraged by the dialogue and is preparing for a Type A meeting with the FDA to discuss the required measures rigorously.

First Quarter Highlights

Milestone's financial performance for the period ended March 31, 2025, included cash and cash equivalents on hand amounting to $56.0 million. This figure reflects a reduction from the previous quarter, which reported $69.7 million. Notably, the company reported no revenue in the first quarter of 2025 or 2024, indicating that they are still in the pre-commercialization stage for CARDAMYST.

Research and Development Investment

Research and development expenses rose to $5.0 million, up from $3.6 million year-on-year, primarily driven by increased consulting expenses related to regulatory processes. Meanwhile, general and administrative expenses also escalated to $5.2 million, correlated with the company's preparations for the anticipated launch of CARDAMYST.

Innovation and Market Engagement

The patent landscape for Milestone has strengthened, with a new Method of Use patent for etripamil nasal spray granted by the U.S. Patent and Trademark Office (USPTO). This patent extends intellectual property protection until 2042, providing vital security for the company as it moves toward commercialization.

Market Survey Insights

Recently, Milestone's CARDAMYST gained recognition in an independent survey of Managed Care professionals, where it was seen as the top candidate among new drugs poised to significantly enhance patient outcomes. This suggests strong market interest and potential for adoption, pending regulatory approval.

Future Directions

Milestone Pharmaceuticals is not only focused on PSVT treatments but is also developing etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR). The Phase 3 protocol for AFib-RVR has been finalized, but enrollment is currently paused to allocate resources towards resolving the pressing issues raised by the FDA.

Vision for Patients

Etripamil is designed as a novel self-administered nasal spray, aimed at providing a convenient treatment option for patients experiencing symptomatic episodes of PSVT and AFib-RVR. If successful in clinical trials, this innovation could transform on-demand care and allow patients a higher degree of autonomy in managing their health.

Financial Snapshot

The net loss for the first quarter was reported at $20.8 million, a substantial increase from $10.4 million in the prior year. This reflects the continued investments in research, development, and operational preparedness as the company positions itself for a future launch of its groundbreaking products. As they move forward, investor confidence remains crucial and existing resources will be strategically utilized.

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. is dedicated to improving lives through innovative cardiovascular solutions. Their commitment to enhancing the patient experience drives the development of etripamil—a product designed to empower patients by enabling self-management of their symptoms without immediate medical oversight.

Frequently Asked Questions

1. What financial results did Milestone Pharmaceuticals report for Q1 2025?

Milestone reported a cash balance of $56.0 million and a net loss of $20.8 million for the first quarter of 2025.

2. What issues did the FDA identify for CARDAMYST?

The FDA raised concerns about nitrosamine impurities and required a new facility inspection before approving CARDAMYST.

3. How has Milestone's patent protection changed?

Milestone received a new patent for etripamil, extending its IP protection until July 2042.

4. What innovative solution is Milestone developing?

Milestone is developing etripamil, a self-administered nasal spray treatment for PSVT and AFib-RVR.

5. What steps is Milestone taking to resolve FDA concerns?

Milestone has submitted a meeting request to the FDA to discuss the CRL issues and outline their plans for resolution.

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