Dyne Therapeutics (DYN) investor relations material

Executive summary

• Focused on developing therapies for genetically driven neuromuscular diseases using the FORCE platform, with lead programs in Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral dystrophy (FSHD), and Pompe disease.

• Completed positive pre-BLA meeting with FDA for z-rostudirsen in exon 51 DMD; BLA submission on track for Q2 2026 and potential launch in Q1 2027.

• No commercial products or revenue; all programs are in preclinical or clinical development, with first potential product launch not expected until 2027.

• Net loss for Q1 2026 was $120.9 million, reflecting increased R&D and G&A expenses as clinical and preclinical activities ramp up.

• Cash, cash equivalents, and marketable securities totaled $972.2 million as of March 31, 2026, expected to fund operations into Q1 2028.

Financial highlights

• Q1 2026 net loss: $120.9 million, compared to $115.4 million in Q1 2025.

• Research and development expenses: $100.9 million (down from $106.4 million in Q1 2025), with increased costs for DMD offset by lower DM1 manufacturing activity.

• General and administrative expenses: $24.4 million (up from $15.9 million in Q1 2025), driven by increased headcount and launch preparation costs.

• Interest income: $8.8 million; interest expense: $4.2 million (reflecting new debt facility).

• Cash used in operations: $144.9 million in Q1 2026.

Outlook and guidance

• Cash runway expected into Q1 2028, not including potential additional debt tranches or future product revenue.

• First product launch (z-rostudirsen for DMD) targeted for Q1 2027, pending FDA approval; DM1 program (z-basivarsen) potential launch in Q1 2028.

• Anticipates increased expenses as clinical programs advance and manufacturing scales up.

• Data from ACHIEVE cohort expected in Q1 2027 to support BLA for z-basivarsen.