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Mar 31, 2023
Milestone Pharmaceuticals Q1 2023 Earnings Report
Milestone Pharmaceuticals reported financial results for the first quarter ended March 31, 2023, and provided a clinical and corporate update.
Key Takeaways
Milestone Pharmaceuticals is on track for NDA submission for etripamil in Q3 2023. They are expanding market preparation activities and assessing etripamil's potential in AFib-RVR patients, with Phase 2 ReVeRA topline data expected in 2H 2023. Cash resources are expected to fund operations into mid-2025.
NDA submission for etripamil in patients with PSVT is currently on track for 3Q23.
Company to host virtual KOL event focused on etripamil for the potential treatment of AFib-RVR on Monday, May 22, 2023.
Topline data from Phase 2 ReVeRA study evaluating etripamil in patients with AFib-RVR expected in 2H, 2023.
Cash resources as of March 31, 2023, together with strategic March 2023 financing, are expected to fund operations into mid-2025.
Milestone Pharmaceuticals
Milestone Pharmaceuticals
Forward Guidance
Milestone Pharmaceuticals is focused on the development and commercialization of innovative cardiovascular medicines. The company's lead product candidate, etripamil, has completed Phase 3 trials for PSVT and is in a Phase 2 trial for AFib-RVR. Milestone expects to submit an NDA for etripamil in Q3 2023 and anticipates topline data from the Phase 2 ReVeRA study in 2H 2023.
Positive Outlook
- Potential of etripamil to serve as a promising therapy for PSVT patients.
- Timing of the NDA submission for etripamil nasal spray.
- Potential for clinical trial data from the Phase 2 ReVeRA program later this year.
- Ability to fund operations into the middle of 2025.
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, evaluation and results of our 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.
- Sufficiency of Milestone's capital resources and its ability to raise additional capital in the current economic climate.