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Jun 30, 2022
Milestone Pharmaceuticals Q2 2022 Earnings Report
Milestone Pharmaceuticals reported financial results for the second quarter ended June 30, 2022, and provided a clinical and corporate update.
Key Takeaways
Milestone Pharmaceuticals reported on their Phase 3 PSVT clinical program, highlighting the crossing of the 180th event in the RAPID trial. They are focusing on data cleaning and analysis and anticipate reporting top line data in the middle of the second half of the year. A Phase 3 PSVT study was initiated in China.
Phase 3 RAPID study reached the target of 180 confirmed PSVT events treated with double-blind study medication required to initiate primary efficacy analysis.
Topline data readout for RAPID study remains on track for mid-second half 2022.
Phase 3 PSVT study initiated in China
Etripamil is in Phase 3 clinical-stage program for the treatment of paroxysmal supraventricular tachycardia (PSVT) and in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
This press release contains forward-looking statements regarding the potential of etripamil, the design, progress, timing, scope and results of the RAPID and ReVeRA trials, Milestone’s ability to execute on the remainder of the PSVT program, the timing of release of unblind RAPID results and topline data, Milestone’s ongoing plans to study etripamil in atrial fibrillation patients, the sufficiency of Milestone’s current cash resources, and estimates about the addressable market and commercial potential for treatments of atrial fibrillation with rapid ventricular rate.
Positive Outlook
- Potential of etripamil to serve as a promising therapy for PSVT patients
- Design, progress, timing, scope and results of the RAPID and ReVeRA trials
- Milestone’s ability to execute on the remainder of the PSVT program
- Timing of release of unblind RAPID results and topline data
- Milestone’s ongoing plans to study etripamil in atrial fibrillation patients
Challenges Ahead
- Risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process
- Uncertainties related to the timing of initiation, enrollment, completion and evaluation of clinical trials
- Risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data
- Whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications
- Risks related to pandemics and public health emergencies, including those related to the ongoing COVID-19 pandemic, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital.