Dyne Therapeutics (DYN) investor relations material

Executive summary

• Advanced clinical programs in neuromuscular diseases, including key candidates in Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral dystrophy (FSHD), and Pompe disease.

• BLA for z-rostudirsen in exon 51 DMD accepted by FDA with Priority Review; PDUFA date set for January 21, 2027.

• Enrollment completed for Phase 1/2 ACHIEVE trial of z-basivarsen in DM1; topline data expected Q1 2027.

• IND cleared for DYNE-302 in FSHD; Phase 1 trial to begin.

• Completed a $405 million public offering in July 2026, strengthening liquidity.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $898.5 million as of June 30, 2026, excluding July 2026 offering proceeds.

• Net loss was $178.6 million for Q2 2026, compared to $110.9 million in Q2 2025; net loss for the first half of 2026 was $299.4 million, up from $226.2 million year-over-year.

• Research and development expenses rose to $152.2 million in Q2 2026 (up $52.9 million year-over-year), driven by increased clinical and manufacturing activity.

• General and administrative expenses increased to $29.5 million in Q2 2026 (up $12.9 million year-over-year), reflecting higher headcount and launch preparation costs.

• Completed public offering in July 2026 raised estimated net proceeds of $405 million.

Outlook and guidance

• Cash runway, including July 2026 offering, expected to fund operations into Q2 2028.

• No product revenue expected until at least 2027, pending regulatory approvals.

• Potential U.S. launch of z-rostudirsen in Q1 2027, pending FDA approval.

• Topline data for z-basivarsen expected Q1 2027; potential BLA submission for Accelerated Approval in Q3 2027.

• Anticipates increased expenses as clinical programs advance and commercial infrastructure is built.