Dyne Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $1.134 billion as of September 30, 2026, up from $1.111 billion as of December 31, 2025.
• The company expects its cash position to fund operations into the second quarter of 2028.
• Research and development (R&D) expenses were $161.7 million for the three months ended September 30, 2026, compared to $97.2 million for the same period in 2025.
• General and administrative (G&A) expenses were $35.3 million for the three months ended September 30, 2026, compared to $16.7 million for the same period in 2025.
• Net loss for the three months ended September 30, 2026, was $193.6 million ($1.06 per share), compared to a net loss of $108.0 million ($0.76 per share) in 2025.
• Total operating expenses were $197.1 million for the three months ended September 30, 2026, compared to $113.9 million in 2025.
• Other income, net, was $3.5 million for the three months ended September 30, 2026, compared to $5.9 million in 2025.
• Weighted average common shares outstanding were 181.8 million for the three months ended September 30, 2026, compared to 141.8 million in 2025.
• Total assets were $1.235 billion as of September 30, 2026, compared to $1.187 billion as of December 31, 2025.
• Total liabilities were $303.9 million as of September 30, 2026, compared to $214.8 million as of December 31, 2025.

Guidance and Future Outlook:

• Dyne expects a potential U.S. launch of z-rostudirsen in Q1 2027, assuming FDA approval is received on the anticipated timeline.
• Topline data from the ACHIEVE registrational expansion cohort (REC) for z-basivarsen is planned for Q1 2027.
• The company intends to submit a BLA for z-basivarsen for U.S. Accelerated Approval in Q3 2027, pending REC data.
• Dyne expects a potential U.S. launch of z-basivarsen in the first half of 2028, assuming FDA Priority Review and approval are received on the anticipated timeline.
• The confirmatory Phase 3 FORZETTO trial for z-rostudirsen is intended to support conversion of Accelerated Approval to traditional approval in the U.S. and support ex-U.S. marketing applications.
• The confirmatory Phase 3 HARMONIA trial for z-basivarsen is intended to support conversion of Accelerated Approval to traditional approval in the U.S. and support ex-U.S. marketing applications.

Business Segments and Product Lines:

• z-rostudirsen (DMD): The Biologics License Application (BLA) is under priority review by the FDA with a PDUFA target action date of January 21, 2027. The company is advancing four additional investigational therapies (DYNE-244, DYNE-245, DYNE-253, and DYNE-255) for DMD amenable to skipping exons 44, 45, 53, or 55.
• z-basivarsen (DM1): Additional one-year clinical data from the Phase 1/2 ACHIEVE trial presented at WMS and AANEM showed functional improvement versus baseline, placebo, and a matched natural history cohort across multiple measures at 12 months. The HARMONIA trial is the only Phase 3 clinical trial in DM1 currently enrolling participants.
• Other Programs: Preclinical data presented at NMSG supports the development of four investigational therapies for DMD. The company is also advancing preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Market and Competitive Landscape:

• Dyne is advancing HARMONIA, described as the only Phase 3 clinical trial in DM1 currently enrolling participants.
• The company aims to expand its reach to over one-third of individuals living with Duchenne muscular dystrophy through its four preclinical DMD programs targeting exon skipping.

Risks and Challenges:

• The press release includes standard forward-looking statement disclaimers regarding uncertainties inherent in product development, clinical trial initiation and completion, patient enrollment, and the predictive nature of preclinical and clinical data.
• Risks include uncertainties regarding FDA and other regulatory authorities' interpretation of data, acceptance of clinical programs, and the timing of regulatory approvals.
• There is a risk that cash resources may not be sufficient to fund foreseeable and unforeseeable operating expenses, debt service obligations, and capital expenditure requirements.
• Actual results may differ materially from plans due to factors such as the outcome of interactions with regulatory authorities and the availability of expedited approval pathways.

Management Commentary and Tone:

• John Cox, President and CEO, stated the company is investing across multiple programs to unlock the full value of its FORCE platform in preparation for potential commercialization.
• Management highlighted preparations for the potential U.S. launch of z-rostudirsen and the expectation of topline data from the ACHIEVE REC in Q1 2027.
• The tone reflects confidence in the pipeline's potential to deliver functional improvement, citing the advancement of multiple programs and the unique position of the HARMONIA trial.

Other Key Points:

• The increase in R&D expenses was primarily driven by increased manufacturing activity for z-rostudirsen and higher clinical trial costs for the FORZETTO and HARMONIA Phase 3 trials.
• The increase in G&A expenses was primarily due to preparation for the potential launch of z-rostudirsen, including an increase in headcount.
• Dyne Therapeutics is a clinical-stage company focused on genetically driven neuromuscular diseases, targeting muscle and the central nervous system.
• The company trades on Nasdaq under the ticker symbol DYN.