Second quarter 2026
Filed Aug 4, 2026Spyre Therapeutics reported second quarter 2026 results, highlighted positive SPY001 and SPY002 Phase 2 induction data, completed enrollment in all SKYWAY sub-studies, and reported cash runway into the second half of 2029.
The company reported positive Phase 2 induction data for SPY001 and SPY002, completed enrollment across the three SKYWAY sub-studies, and held $1,145.3 million in cash, cash equivalents, and marketable securities. The period also included a $36.2 million net loss and $69.9 million of net cash used in operating activities.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Cash, cash equivalents, and marketable securitiesGAAP | $1,145.3 million | – | – |
| Net proceeds from public offering of common stockGAAP | $435.2 million | – | – |
| Net cash used in operating activitiesGAAP | $69.9 million | – | – |
| Research and development expensesGAAP | $65.5 million | – | – |
| General and administrative expensesGAAP | $16.1 million | – | – |
| Gain on sale of in-process research and development assetGAAP | $40.0 million | – | – |
| Other incomeGAAP | $5.4 million | – | – |
| Net lossGAAP | $36.2 million | – | – |
| SPY001 reduction in Robart’s Histopathology Index scoreother | 9.2 points | – | – |
| SPY002 reduction in Robart’s Histopathology Index scoreother | 10.7 points | – | – |
| SPY001 clinical remission rateother | 40% | – | – |
| SPY001 endoscopic improvement rateother | 51% | – | – |
| SPY002 clinical remission rateother | 33% | – | – |
| SPY002 endoscopic improvement rateother | 42% | – | – |
| SPY001 and SPY002 change in modified Mayo Score from baseline at Week 12other | -3.7 | – | – |
2026 outlook
- NoteRemain on track for 6 proof-of-concept Phase 2 readouts in 2026.
- NoteTopline data expected for SPY003 in September 2026.
- NoteTopline proof-of-concept data are expected in September 2026 for the RA sub-study.
- NoteTopline proof-of-concept data are expected in the fourth quarter of 2026 for the PsA sub-study.
- NoteTopline proof-of-concept data are expected in the fourth quarter of 2026 for the axSpA sub-study.
- NoteInduction data expected in 2027 for Part B of the SKYLINE trial.
- NoteExpected runway into the second half of 2029.
What drove it
- R&D expenses increased primarily due to higher manufacturing and clinical trial expenses, as well as higher headcount costs.
- G&A expenses increased primarily due to higher headcount costs.
- The Company recognized a gain of $40.0 million for an achieved milestone related to Immedica’s sale of a priority review voucher.
- SPY001 and SPY002 achieved their respective primary endpoints and were well-tolerated with a safety profile consistent with in-class comparators.
- All three SKYWAY sub-studies completed enrollment on or ahead of schedule.
Concerns
- Spyre remained a clinical-stage biotechnology company and reported a net loss of $36.2 million.
- Net cash used in operating activities was $69.9 million for the second quarter of 2026.
- R&D expenses totaled $65.5 million, with higher manufacturing, clinical trial, and headcount costs.
- The pivotal upcoming program milestones remain clinical data readouts, including the RA sub-study, SPY003, PsA, and axSpA results.
What to watch
- SPY072 RA sub-study topline proof-of-concept data expected in September 2026.
- SPY003 Part A topline data from SKYLINE expected in September 2026.
- SPY072 PsA and axSpA sub-study topline proof-of-concept data expected in the fourth quarter of 2026.
- SKYLINE Part B enrollment progress and induction data expected in 2027.
- Execution toward 6 proof-of-concept Phase 2 readouts in 2026.
Balance sheet and cash flow
- Cash, cash equivalents, and marketable securities of $1,145.3 million as of June 30, 2026.
- In April 2026, the Company raised $435.2 million in net proceeds from a public offering of common stock.
- Net cash used in operating activities was $69.9 million for the second quarter of 2026.
- Expected runway into the second half of 2029.
Analysis
Spyre’s second quarter update centered on clinical execution rather than commercial revenue. The company reported positive topline induction data from Part A of the SKYLINE Phase 2 trial for SPY001 and SPY002 in ulcerative colitis. Both agents achieved their respective primary endpoints, with reductions in the Robart’s Histopathology Index score of 9.2 points for SPY001 and 10.7 points for SPY002. Reported clinical remission and endoscopic improvement rates were 40% and 51%, respectively, for SPY001, and 33% and 42%, respectively, for SPY002.
The development cadence advanced during the quarter. Enrollment for Part A of SKYLINE has completed, SPY003 Part A data are expected in September 2026, and the company is enrolling monotherapies and combinations in Part B. All three SKYWAY sub-studies in RA, PsA, and axSpA completed enrollment on or ahead of schedule. The next scheduled data events are the RA sub-study and SPY003 in September 2026, followed by PsA and axSpA results in the fourth quarter of 2026.
Operating spending rose as the clinical pipeline advanced. R&D expenses totaled $65.5 million for the second quarter of 2026 versus $40.1 million for the second quarter of 2025, driven primarily by higher manufacturing and clinical trial expenses and higher headcount costs. G&A expenses totaled $16.1 million versus $11.8 million, primarily due to higher headcount costs. Net cash used in operating activities was $69.9 million, while net loss totaled $36.2 million compared with $36.7 million in the second quarter of 2025.
The reported net loss included a $40.0 million gain tied to an achieved milestone from the 2023 sale of global rights to pegzilarginase, specifically Immedica’s sale of a priority review voucher. Other income totaled $5.4 million compared with $5.2 million in the prior-year quarter. The company also raised $435.2 million in net proceeds from a public offering of common stock in April 2026.
Liquidity is the principal financial support for the planned clinical catalyst schedule. Spyre ended June 30, 2026 with $1,145.3 million of cash, cash equivalents, and marketable securities and stated that it expects runway into the second half of 2029. The filing provided no revenue, margin, EPS, or conventional financial outlook, so the near-term read is driven by the pending proof-of-concept clinical data and continued spending required to advance the SKYLINE and SKYWAY programs.
Management, verbatim
Following encouraging Phase 2 results from both SPY001 and SPY002, as well as competitor results validating the promise of combination therapy, the case for our approach in IBD has strengthened considerably. We believe our three investigational combinations have the potential to deliver efficacy, safety, and convenience beyond what is achievable with today’s therapies.
Cameron Turtle, DPhil, Chief Executive Officer of Spyre
Beyond IBD, we are approaching a pivotal milestone with placebo-controlled Phase 2 proof-of-concept data for SPY072, an anti-TL1A monotherapy, in rheumatoid arthritis expected next month, representing a key opportunity to demonstrate the broader utility of this mechanism. If successful, we look forward to initiating pivotal development of SPY072 next year, while also exploring combination approaches outside IBD.
Cameron Turtle, DPhil, Chief Executive Officer of Spyre
Not in the filing
stated, not guessed- Revenue and revenue comparisons were not reported.
- Segment revenue and segment revenue comparisons were not reported.
- Gross profit, gross margin, and gross-margin guidance were not reported.
- Operating income or loss and operating-margin figures were not reported.
- Earnings per share, diluted share count, and non-GAAP financial measures were not reported.
- Free cash flow was not reported.
- Debt was not reported.
- Share repurchases and dividends were not reported.
- Prior-quarter comparisons for reported financial metrics were not reported.
- Financial revenue, operating-expense, gross-margin, and tax-rate guidance were not reported.
- A previous outlook section was not provided.
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.