Dyne Therapeutics (DYN) investor relations material

Executive summary

• Clinical-stage programs span DMD, DM1, FSHD and Pompe; no product revenue to date, with potential z-rostudirsen launch in Q1 2027 and z-basivarsen launch in H1 2028, subject to approval and data.

• September 30, 2026 cash, cash equivalents and marketable securities totaled $1.134B, expected to fund operations, debt service and capital expenditures into Q2 2028.

Financial highlights

• Q3 2026 operating expenses were $197.1M vs. $113.9M YoY; operating loss was $197.1M and net loss was $193.6M vs. $108.0M.

• Q3 R&D was $161.7M vs. $97.2M, driven by z-rostudirsen manufacturing and higher Phase 3 trial costs; G&A was $35.3M vs. $16.7M, reflecting launch preparation and higher headcount.

• 9M 2026 operating expenses were $504.0M vs. $352.1M YoY; net loss was $493.0M vs. $334.3M, and basic/diluted loss per share was $2.89 vs. $2.74.

• No product revenue generated; 9M operating cash use was $452.7M vs. $291.4M YoY.

Outlook and guidance

• Cash runway expected into Q2 2028; estimate excludes potential additional Hercules loan tranches and product sales revenue, and depends on assumptions that may prove incorrect.

• FY 2026 manufacturing costs projected at 55–65% of total R&D expense and clinical trial costs at 10–20%; manufacturing costs expected to increase progressively each quarter.

• Potential z-rostudirsen U.S. launch in Q1 2027, following priority review and a January 21, 2027 FDA action date; timing assumes approval on schedule.

• ACHIEVE REC data planned for Q1 2027 to support a potential z-basivarsen BLA submission in Q3 2027; potential H1 2028 U.S. launch depends on favorable data, priority review and timely approval.