On track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials Part A readouts from SKYLINE platform trial in ulcerative colitis ("UC") expected to begin in the second quarter, with enrollment continuing ahead of schedule Enrollment on track in Phase 2 SKYWAY basket trial evaluating TL1A inhibition in rheumatoid arthritis ("RA"), psoriatic arthritis ("PsA"), and axial spondyloarthritis ("axSpA"), with fourth quarter readouts expected in each sub-study Strengthened the balance ...

Core Insights - Spyre Therapeutics is set to deliver six proof-of-concept readouts in 2026 from its SKYLINE and SKYWAY trials, focusing on inflammatory bowel disease and rheumatic diseases [2][3] - The company has appointed Kate Tansey Chevlen as Chief Commercial Officer, bringing extensive experience from Amgen to enhance its commercial strategy [2][7][8] Group 1: Trial Updates - The SKYLINE platform trial for ulcerative colitis is progressing faster than anticipated, with SPY001 enrollment completed ahead of schedule and Part A readouts expected to begin in Q2 2026 [1][4] - The SKYWAY basket trial is on track, with enrollment ongoing across rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, with all readouts anticipated in Q4 2026 [1][5] Group 2: Financial Position - As of September 30, 2025, Spyre Therapeutics reported a strong balance sheet with pro forma cash, cash equivalents, and marketable securities totaling $783 million, providing a cash runway into the second half of 2028 [2][9] Group 3: Leadership and Strategy - The appointment of Kate Tansey Chevlen as CCO is expected to significantly contribute to the company's Phase 3 strategy and product uptake, leveraging her nearly two decades of experience in biopharma [3][8] - The company aims to redefine the standard of care for inflammatory bowel disease and rheumatic diseases with its innovative long-acting antibodies and combinations [2][10]

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for SPY003, a next-generation anti-IL-23 antibody, indicating a well-tolerated profile and an approximately 85-day half-life, supporting quarterly or biannual maintenance dosing [1] - The company initiated the Phase 2 SKYWAY basket study for SPY072, focusing on TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis [1] - Spyre is on track for six proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials [1] - The company strengthened its balance sheet with $316 million in gross proceeds from a public offering, resulting in $783 million in pro forma cash as of September 30, 2025, with a projected runway into the second half of 2028 [1][13] Company Overview - Spyre Therapeutics is a clinical-stage biotechnology company focused on long-acting antibodies and antibody combinations aimed at redefining the standard of care for inflammatory bowel disease and rheumatic diseases [1][16] - The company’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, with a market potential exceeding $60 billion in annual revenue across its indications [2][3] Development Pipeline - The company is advancing multiple investigational antibodies, including SPY001, SPY002, SPY003, and SPY072, targeting validated mechanisms for the treatment of inflammatory bowel disease and rheumatic diseases [4][10][11] - SPY001 targets α4β7 and is designed for infrequent subcutaneous maintenance dosing, while SPY002 and SPY072 are anti-TL1A monoclonal antibodies also engineered for extended half-lives [5][6][7] - The SKYLINE Phase 2 platform trial includes SPY001, SPY002, and SPY003, with Part A focusing on safety and preliminary efficacy, and Part B planned for randomized assessments [10] Financial Performance - As of September 30, 2025, Spyre reported cash, cash equivalents, and marketable securities totaling $486.2 million, with pro forma cash reflecting $782.7 million after a recent public offering [13] - Research and development expenses for Q3 2025 were $45.2 million, slightly higher than $44.7 million in Q3 2024, driven by increased clinical trial costs [14] - The net loss for Q3 2025 was $11.2 million, a significant improvement from a net loss of $69.0 million in Q3 2024 [15][27]