Dyne Therapeutics (DYN) Q4 2025 earnings summary

Executive summary

• Positive topline results from Phase 1/2 DELIVER trial for z-rostudirsen in DMD, showing significant improvement in muscle dystrophin expression and functional endpoints at six months.

• Enrollment in the registrational expansion cohort of the ACHIEVE trial for z-basivarsen in DM1 expected to complete in Q2 2026, with Phase 3 trial design to be presented at MDA conference.

• Advancing four additional DMD candidates targeting exons 53, 45, 44, and 55 into IND-enabling studies.

• Year-end cash position of $1.1 billion, with cash runway expected into Q1 2028.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $1.1 billion as of December 31, 2025.

• R&D expenses were $95.4M for Q4 2025 (up from $81.8M in Q4 2024) and $398.3M for FY 2025 (up from $281.4M in FY 2024).

• G&A expenses were $20.7M for Q4 2025 (up from $15.3M in Q4 2024) and $69.9M for FY 2025 (up from $62.5M in FY 2024).

• Net loss for Q4 2025 was $112.0M ($0.76/share) vs. $89.5M ($0.88/share) in Q4 2024; FY 2025 net loss was $446.2M ($3.47/share) vs. $317.4M ($3.37/share) in FY 2024.

Outlook and guidance

• BLA submission for U.S. Accelerated Approval of z-rostudirsen planned for Q2 2026, with potential U.S. launch in Q1 2027 pending FDA Priority Review.

• Global confirmatory Phase 3 trial for z-rostudirsen to begin in Q2 2026; FDA alignment on trial design achieved.

• Enrollment for z-basivarsen ACHIEVE REC to complete in Q2 2026; data expected Q1 2027 to support BLA submission in early Q3 2027 and potential U.S. launch in Q1 2028.

• Cash runway reaffirmed into Q1 2028.