10-Q · May 11, 2026
Dyne Therapeutics reported a net loss of approximately $120.9 million for Q1 2026, slightly increasing from a loss of $115.4 million in Q1 2025, amid continued development efforts in their clinical programs. Key focus…
Earnings analysis · 10-Q
DYN earnings analysis
Filed July 29, 2026 · Our reading of the company's report
The latest report
Dyne remains pre-revenue, with Q2 2026 net loss widening to $178.6 million from $110.9 million a year earlier as R&D spending rose to $152.2 million to support DMD and DM1 registrational programs. The operating picture…
Read full summary
Dyne remains pre-revenue, with Q2 2026 net loss widening to $178.6 million from $110.9 million a year earlier as R&D spending rose to $152.2 million to support DMD and DM1 registrational programs. The operating picture is cash-intensive—six-month operating cash use reached $275.2 million—but $898.5 million of June liquidity plus approximately $405.0 million of July equity proceeds is expected to fund operations into Q2 2028. The key near-term value driver is the priority-review z-rostudirsen BLA, with a January 21, 2027 PDUFA date and a potential Q1 2027 launch if approved.
How we read each report
Our analysis across the last few reports.
Our model's reading of each filing, not the share price or the market's reaction. Annual and quarterly reports each occupy one position.
What stood out
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Z-rostudirsen BLA has Jan. 2027 action date
The company reported no revenue, consistent with its clinical-stage status, but the FDA accepted the z-rostudirsen BLA with priority review and assigned a January 21, 2027 PDUFA target action date. Management continues to expect a potential U.S. launch in Q1 2027, subject to approval.
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Loss and operating spend accelerated
Q2 net loss widened 61.1% year over year to $178.6 million from $110.9 million, while operating expenses rose 56.9% to $181.7 million. Sequentially, Q2 net loss increased 47.8% from the implied Q1 2026 loss of $120.9 million.
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DMD and DM1 investment rose sharply
DMD program R&D expense rose $22.8 million year over year to $52.3 million in Q2, driven by manufacturing and the Phase 3 FORZETTO trial. DM1 program R&D increased $14.3 million to $49.0 million as ACHIEVE enrollment completed and HARMONIA enrollment expanded.
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Liquidity runway extends into Q2 2028
Cash, cash equivalents and marketable securities were $898.5 million at June 30, 2026; the July equity offering subsequently added estimated net proceeds of approximately $405.0 million. Management states this liquidity funds operating expenses, debt service and capex into Q2 2028.
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Operating cash burn increased; capex remains low
Six-month operating cash use increased 37.2% to $275.2 million from $200.6 million. Capex was modest at $1.7 million, or approximately 0.6% of operating cash use, during the first six months of 2026; free cash flow was not explicitly reported.
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Multiple late-stage and pipeline milestones
Pipeline execution advanced: the Phase 3 FORZETTO trial began in May 2026, HARMONIA began dosing in July 2026, and the FDA cleared the DYNE-302 FSHD IND in July 2026. The ACHIEVE registrational expansion cohort completed enrollment of 71 participants, with data planned for Q1 2027.
What to watch
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Growing cash burn despite extended runway
Losses and cash use are rising: the six-month net loss increased to $299.4 million from $226.2 million, while operating cash use was $275.2 million. Although management projects runway into Q2 2028, it warns that capital could be exhausted sooner and additional financing may be required.
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Equity dilution and conditional debt capacity
Financing and leverage have increased. The company issued 21,045,000 shares in July 2026 for estimated net proceeds of $405.0 million, while term-loan principal was $200.0 million at June 30, 2026; remaining loan availability is contingent on milestones or lender discretion.
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New tariff and supply-chain policy exposure
The filing adds heightened trade-policy exposure: a 100% Section 232 tariff on covered patented pharmaceuticals, biologics and ingredients is scheduled to apply from September 29, 2026 for companies without qualifying exemptions. The company also cites a June 2026 designation of one CDMO under the BIOSECURE Act framework, though it does not currently expect an impact.
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Large manufacturing commitments raise execution risk
Manufacturing commitments are substantial and potentially non-cancelable: one CMO arrangement has $99.7 million committed through June 2028 and another has $59.8 million committed through December 2027. Manufacturing is projected to represent 55-65% of full-year 2026 R&D expense.
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Registrational trials still carry high execution risk
Clinical and regulatory risk remains central despite expedited designations. FORZETTO plans to enroll approximately 90 participants and HARMONIA approximately 150 participants, while the company has never completed clinical development of a product candidate or generated product revenue.
Management's outlook
No numeric revenue or EPS guidance was provided. Management expects no product-sales revenue until at least 2027, if at all; it expects available cash plus approximately $405.0 million of July offering proceeds to fund operations into Q2 2028. For full-year 2026, manufacturing costs are projected at 55-65% of R&D expense and clinical-trial costs at 10-20%.
Earlier filings 4
10-K · March 2, 2026
Dyne is a clinical‑stage, pre‑revenue biotech building a modular FORCE TfR1 delivery platform and advancing co‑lead registrational programs in DMD (z‑rostudirsen) and DM1 (z‑basivarsen). The 10‑K outlines clear…
10-Q · November 5, 2025
Dyne remains pre-revenue and cash consumptive but materially strengthened liquidity in 2025 Q3 after equity raises and a new debt facility. Q3 net loss was $108.0M (‑$0.76 per share), slightly improved versus Q2 2025…
10-Q · July 28, 2025
Dyne remains a pre-revenue, clinical‑stage company with rising R&D spend and larger quarterly losses; Q2 net loss widened to $(110,857) (net loss per share $(0.97)) versus $(65,102) ($(0.70)) year‑ago. The company…
This is our reading of a public filing, not the filing itself. Analysis can contain errors; check the source document for full context.