SYRE

EX-99.1

2 spyre-20260930xexx991pd.htm

EX-99.1

Document

Exhibit 99.1

Spyre Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Announced positive topline induction data for SPY003 from Part A of the Phase 2 SKYLINE trial (“SKYLINE”), completing proof-of-concept for all three monotherapies in inflammatory bowel disease (“IBD”). SKYLINE Part B is enrolling ahead of schedule, enabling the Company to increase enrollment and provide topline induction results for three potential best-in-indication combinations, which are expected in Q3 2027

Reported positive topline results for SPY072 in rheumatoid arthritis (“RA”) sub-study of the Phase 2 SKYWAY basket trial (“SKYWAY”), though with a magnitude of benefit insufficient to prioritize advancement. SPY072 was well-tolerated but did not meet its primary endpoint in the psoriatic arthritis (“PsA”) or axial spondyloarthritis (“axSpA”) SKYWAY sub-studies. SPY072 will not be advanced in rheumatic disease

Initiated a new Phase 2 trial (“SKYLIGHT”) designed to provide clinical proof-of-concept for dual TL1A and

IL-17A/F inhibition in hidradenitis suppurativa (“HS”). Raised over $400 million in gross proceeds from an underwritten public offering in October to fund a pivotal program in HS with SPY072, our potential best-in-class TL1A monotherapy

$1.5 billion in pro forma cash, cash equivalents, and marketable securities as of September 30, 2026, with expected runway into the second half of 2029

Waltham, Mass, November 3, 2026 (GLOBE NEWSWIRE) - Spyre Therapeutics, Inc. (“Spyre” or the “Company”) (NASDAQ:SYRE), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients, today announced its third quarter 2026 financial results and provided program and corporate updates.

“We are increasingly well-positioned to deliver on our ambition of elevating the standard of care across immunology. In IBD, our three compelling Phase 2 monotherapy readouts and a growing body of supportive clinical evidence strengthen our conviction that our combination products have the potential to transform the treatment paradigm. The combination portion of our SKYLINE trial is enrolling faster than expected enabling an increased enrollment target, and we plan to deliver topline data in Q3 2027 with the potential for efficacy, safety, and convenience that meaningfully surpasses today's standard of care,” said Cameron Turtle, DPhil, Chief Executive Officer of Spyre. “Beyond IBD, we were thrilled to see excellent external proof-of-concept data for TL1A in hidradenitis suppurativa, supporting the expansion of our pipeline to include a pivotal monotherapy program as well as a combination study with the current standard of care, IL17-A/F. Collectively, we believe the breadth of our pipeline, strength of our clinical data, and continued execution position Spyre to potentially deliver meaningful advances for patients across multiple large markets and substantial long-term value for shareholders.”

Development Pipeline Overview and Update

The Company is committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. The Company’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, IL-23 and IL-17A/F (each as

defined below), as well as rational combination programs, in large therapeutic areas of focus, each with high unmet need.

•In Gastroenterology, the Company is advancing three potential first- and best-in-class combination programs in inflammatory bowel disease (“IBD”). IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: ulcerative colitis (“UC”) and Crohn's disease (“CD”). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD and the global market is forecasted to exceed $40 billion by 2030.

•In Dermatology, the Company is advancing a potential first- and best-in-class anti-TL1A + IL-17A/F combination program in hidradenitis suppurativa (“HS”). Additionally, the Company plans to advance a potential best-in-class anti-TL1A monotherapy agent into pivotal studies for HS in 2027. HS is a chronic inflammatory skin condition characterized by recurrent, painful nodules and abscesses, primarily in areas such as the underarms and groin. The disease can progress to draining tunnels and permanent scarring, substantially impacting patients’ quality of life. It is estimated that the disease affects approximately 3.0 million patients in the United States, with the global market forecasted to exceed $10 billion by 2035.

The Company has three ongoing Phase 2 clinical trials with meaningful proof-of-concept data readouts in 20

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