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Spyre Therapeutics (SYRE) investor relations material

Spyre Therapeutics Stifel Virtual Immunology and Inflammation Forum summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Stifel Virtual Immunology and Inflammation Forum summary15 Sep, 2025

Strategic focus and clinical development

  • Targeting unmet needs in autoimmune diseases with two ongoing phase II trials, focusing on IBD and rheumatic diseases.

  • Utilizing co-formulated combinations of optimized antibodies against α4β7, TL1A, and IL-23 p19 to address multiple disease pathways.

  • Announced first dosing of anti-TL1A antibody in three rheumatic diseases, aiming for quarterly or twice-annual dosing.

  • Expecting nine proof-of-concept placebo-controlled readouts over the next two years, covering indications with over $60 billion in annual revenue.

  • Aggressive capital formation has secured funding for all planned readouts and operations into the second half of 2028.

Rationale for combination therapies and competitive landscape

  • Combination therapies in IBD are seen as the most promising way to break the efficacy ceiling, supported by studies like J&J's VEGA and AFFINITY.

  • VEGA showed nearly double the remission rate with combination therapy versus monotherapy in ulcerative colitis.

  • Co-formulation of antibodies is preferred over bispecifics due to lower immunogenicity risk, better target engagement, and flexible dosing ratios.

  • Small molecule orals are unlikely to match the efficacy of biologics or optimized antibody combinations.

  • The market favors long-acting injectables over daily orals if efficacy is similar.

Study design and upcoming milestones

  • SKYLINE platform study investigates three monotherapies and their combinations, with open-label Part A and placebo-controlled Part B.

  • Part A aims for early proof of concept, with results expected in 2026; Part B will provide six readouts in 2027.

  • Subcutaneous and IV dosing strategies are tailored to optimize induction and maintenance, especially for anti-IL-23 P19 antibody.

  • Open-label data will focus on objective disease improvement measures like endoscopy and histology.

  • Six readouts from both IBD and rheumatic disease studies are expected next year, with additional industry readouts anticipated.

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Frequently asked questions

Spyre Therapeutics Inc., previously known as Aeglea BioTherapeutics, is a clinical-stage biotechnology company. It specializes in developing therapeutics for inflammatory bowel disease (IBD), which includes conditions like ulcerative colitis and Crohn's disease. The company's focus is on creating novel and proprietary monoclonal antibody product candidates designed to address unmet needs in IBD care. The company is headquartered in Waltham, Massachusetts, and its shares are listed on the NASDAQ.

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