Overview

• US biotech reported Q1 adjusted EPS beat analyst expectations

• Q1 net loss slightly missed analyst expectations

• R&D expenses fell due to timing of manufacturing batches; G&A rose on launch preparation

Outlook

• Dyne expects to submit BLA for z-rostudirsen in DMD in Q2 2026

• Company targets potential U.S. launch of z-rostudirsen in Q1 2027, pending approval

• Dyne expects to complete enrollment in z-basivarsen ACHIEVE trial in Q2 2026

Result Drivers

• R&D EXPENSES - Decrease in R&D expenses was primarily due to timing of manufacturing batches for z-rostudirsen and z-basivarsen

• G&A EXPENSES - Increase in G&A expenses was primarily due to higher costs in preparation for the potential launch of z-rostudirsen

Company press release: ID:nGNX6cZhdV

Key Details

*Applies to a deviation of less than 1%; not applicable for per-share numbers.

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