Spyre Therapeutics Announces Positive Phase 1 Results and Pipeline Updates in Q2 2025

August 5, 2025 — Spyre Therapeutics Inc. (NASDAQ:SYRE) reported positive interim Phase 1 results for two next-generation TL1A antibodies, demonstrating tolerability and pharmacokinetic profiles supporting quarterly or biannual dosing, alongside full TL1A engagement through 20 weeks of follow-up.

The company initiated the Phase 2 SKYLINE-UC platform study, evaluating optimized monotherapies and combinations in ulcerative colitis (UC), and is on track to start the Phase 2 SKYWAY-RD basket study in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) in Q3 2025.

Interim Phase 1 data for SPY003 is expected in Q4 2025, with nine proof-of-concept readouts planned across IBD and rheumatic diseases in 2026 & 2027. As of June 30, 2025, Spyre holds $526.6 million in cash, expected to last into the second half of 2028.

Cameron Turtle, DPhil, CEO of Spyre, noted the launch of the SKYLINE-UC and upcoming SKYWAY-RD trials as key to identifying indication-leading profiles. Spyre aims to generate nine proof-of-concept readouts in IBD and rheumatic conditions over the next two years.

Second Quarter 2025 Financial Results:

Cash Position: As of June 30, 2025, Spyre had cash, cash equivalents, and marketable securities of $526.6 million. Net cash used in operating activities was $46.6 million for the second quarter of 2025.

Research and Development (R&D) expenses: R&D expenses totaled $40.1 million for the second quarter of 2025 and $32.6 million for the second quarter of 2024. The increase was primarily driven by higher clinical trial expenses and increased compensation costs, offset partially by lower early-stage R&D activities.

General and Administrative (G&A) expenses: G&A expenses totaled $11.8 million for the second quarter of 2025 and $11.5 million for the second quarter of 2024.

Gain on Sale of In-Process Research and Development Asset: During the second quarter of 2025, the Company recognized a gain of $10.0 million for achieved milestones related to the 2023 sale of the global rights of the legacy Aeglea asset pegzilarginase to Immedica, driven by a favorable reimbursement decision for pegzilarginase in Europe.

Other income: Other income totaled $5.2 million for the second quarter of 2025 and $5.3 million for the second quarter of 2024.

Net Loss: Net loss totaled $36.7 million and $38.8 million for the second quarters of 2025 and 2024, respectively, which includes non-cash stock-based compensation expense of $9.4 million and $8.7 million for the second quarters of 2025 and 2024, respectively.

Media Contact:
Josie Butler, 1AB
josie@1abmedia.com

Investor Contact:
Eric McIntyre
eric.mcintyre@spyre.com

Source: Spyre Therapeutics, Inc.

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