Cambridge biotech tracker · Waltham
Dyne Therapeutics
Listed on Nasdaq as DYN, filed under SEC industry code 2834 (pharmaceutical preparations). Fiscal year ends in December. Numbers below are from the company’s own SEC filings through Q3 '26.
- Cash & investments
- $1.13B
- Q3 '26 · Sep 30, 2026
- Burn per quarter
- $141M
- avg. operating cash flow, 4 qtrs
- Runway
- 2.0 yrs
- 24 to 36 months
- Net loss
- $194M
- Q3 '26
- R&D expense
- $162M
- 82% of opex
- Raised, last 4 qtrs
- +$914M
- net financing cash flow
- FDA decision
- Nov 2026
- FDA decision · cash past the catalyst
Cash & investments
Quarter-end balance
Operating cash flow
Per quarter; below zero is burn
R&D expense
Per quarter
Two views of the runway
Compare across the clusterThe outside view
2.0 years
Cash at Q3 '26 divided by the average burn of the last four quarters, $47.0M a month.
Management’s own date
Into Q2 2028
Apr–Jun 2028
Guidance counts money received after quarter end, so it is not converted into a burn rate.
“We believe that our cash, cash equivalents and marketable securities as of September 30, 2026 will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into the second quarter of 2028.”
Cash against the calendar
What the runway has to reach.
Nov 22, 2026
FDA target action date (PDUFA)
Disclosed in the 10-Q filed Nov 5, 2026Does the cash reach it?
Cash past the catalyst
- Runway
- 2.0 years
- Time to the date
- 2 weeks
It is about 2 weeks out. At the current burn there is roughly 24 months of cash left on the far side of it, which is enough room to raise on the result rather than ahead of it.
Catalysts ahead
- Nov 2026FDA decisionFDA target action date (PDUFA)
- Jan 2027FDA decisionFDA target action date (PDUFA)
- Jul 2028Phase 3Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
- Jul 2029Phase 1/2Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1
- Dec 2030Phase 3Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)
- Sep 2031Phase 1/2Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
FDA decision dates disclosed in filings
“…Inc. (INS1201) are gene therapy programs in Phase 1 development. Capricor Therapeutics BLA for its cell therapy deramiocel is currently under FDA review with a PDUFA date of November 22, 2026. Precision Biosciences has initiated a Phase 1/2 trial for its PBGENE-DMD gene editing therapy for patients whose mutations are contained between ex…”
“…d Recent Business Highlights - Biologics License Application (BLA) for z-rostudirsen in exon 51 Duchenne muscular dystrophy (DMD) under priority review by FDA; PDUFA target action date of January 21, 2027 - - Additional one-year clinical data from Phase 1/2 ACHIEVE trial of z-basivarsen for myotonic dystrophy type 1 (DM1) presented at WMS…”
Pulled from the company’s own filing text. An approval decision is a financing event as much as a clinical one, since the commercial build-out has to be funded months before any revenue from it arrives.
Pipeline
4 active trials, through phase 3.
Phase 3 · 2Phase 1/2 · 2
Interventional studies where this company is the lead sponsor, from ClinicalTrials.gov. Primary completion is when the last patient is measured on the primary endpoint, which is when the data exists rather than when it is announced. Extension, rollover and healthy-volunteer studies are listed but marked as non-catalysts, because they finish long after the result that mattered. Sponsors revise these dates as enrollment moves, so an estimate is a plan rather than a promise.
The controller’s read
What the filings say.
Generated from the numbers above using the same questions I ask when I open a client’s books: how long the cash lasts, what is driving the gap between loss and burn, and where the accounting judgment sits.
Get this read on your companyThe cash clears the next catalyst
The next dated event is a FDA target action date in Nov 2026, about 2 weeks out. That leaves roughly 24 months of cash afterwards, which is the position you want: the raise can be negotiated on the data instead of on the calendar.
About 2.0 years of runway
Cash and investments of $1.13B at Q3 '26 against an average operating cash burn of $141M per quarter over the last four reported quarters runs out around September 2028. More than two years of runway means the finance conversation is about deployment, not survival.
Cash position up $492M since Q4 '24
Net financing inflows of $914M over the last four quarters, from equity, debt, or ATM sales, more than covered operating burn. The balance is the number the board watches; the trend is the number the auditors watch.
R&D is 82% of operating expenses
$162M of R&D against $197M of total operating expenses in Q3 '26, with G&A at $35.3M. For a clinical-stage company, the accounting questions live inside that R&D line: CRO and CMC accruals, milestone recognition, and what gets capitalized versus expensed under ASC 730.
$200M of long-term debt or convertible notes
Debt in a pre-revenue biotech usually comes with liquidity covenants and, for convertibles, embedded features that need ASC 815 and ASC 470 analysis each quarter.
Accumulated deficit of $1.89B
Total losses since inception. It is also roughly the size of the net operating loss carryforward the tax provision has to track, subject to Section 382 limits after each ownership change.
Quarterly detail, eight quarters
| Quarter | Cash & inv. | Op. cash flow | Net income | R&D | G&A | Revenue | Stock comp | Financing |
|---|---|---|---|---|---|---|---|---|
| Q4 '24 · Dec 31, 24 | $642M | −$84.3M | $228M | $81.8M | $15.3M | — | $10.5M | $3.6M |
| Q1 '25 · Mar 31, 25 | $677M | −$106M | −$115M | $106M | $15.9M | — | $13.0M | $141M |
| Q2 '25 · Jun 30, 25 | $684M | −$94.7M | −$111M | $99.2M | $16.6M | — | $10.5M | $101M |
| Q3 '25 · Sep 30, 25 | $792M | −$90.8M | −$108M | $97.2M | $16.7M | — | $11.1M | $217M |
| Q4 '25 · Dec 31, 25 | $1.11B | −$112M | $334M | $95.4M | $20.7M | — | $11.2M | $431M |
| Q1 '26 · Mar 31, 26 | $972M | −$145M | −$121M | $101M | $24.4M | — | $13.1M | $7.1M |
| Q2 '26 · Jun 30, 26 | $898M | −$130M | −$179M | $152M | $29.5M | — | $15.0M | $58.1M |
| Q3 '26 · Sep 30, 26 | $1.13B | −$177M | −$194M | $162M | $35.3M | — | $16.2M | $418M |
Source: SEC EDGAR XBRL company facts, latest filed value for each period. Fourth quarters are derived from annual less nine-month figures; quarterly cash flows are derived from year-to-date amounts. Not investment advice. If a figure disagrees with the filing, the filing is right.