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Jun 30, 2024
Milestone Pharmaceuticals Q2 2024 Earnings Report
Reported financial results for the second quarter ended June 30, 2024 and provided a regulatory and corporate update.
Key Takeaways
Milestone Pharmaceuticals' NDA for CARDAMYST™ in PSVT was accepted by the FDA in Q2 2024, with a PDUFA date in March 2025. The company's cash of $83.3 million as of June 30, 2024, is expected to fund operations into 2026. Stuart Duty and Andrew Saik were appointed as independent board directors.
FDA accepted the New Drug Application (NDA) for CARDAMYST™.
Commercial team is advancing preparations for potential approval and launch in 2025.
Phase 3 AFib-RVR study is planned to commence in the first half of 2025.
Cash of $83.3 million as of June 30, 2024 is expected to fund operations into 2026.
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
This press release contains forward-looking statements regarding expected cash runway into 2026, the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA, including the timing of the FDA’s review of the NDA, the potential of etripamil, the timing of the launch of etripamil, and the timing, design and outcomes of clinical trials, including the Phase 3 study in AFib-RVR.
Positive Outlook
- Future interactions with the FDA will have satisfactory outcomes.
- NDA for etripamil will be approved by the FDA.
- Etripamil has the potential to help patients living with serious heart arrythmias.
- Etripamil has the potential to reduce ED visits for patients who are able to self-treat their PSVT episodes.
- Clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications
Challenges Ahead
- Future interactions with the FDA will not have satisfactory outcomes.
- The FDA may require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful.
- Uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials
- Risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data.
- General economic, political, and market conditions