Spyre Therapeutics (SYRE) investor relations material

Strategic focus and pipeline overview

• Aims to elevate care in autoimmune diseases, starting with IBD and expanding into rheumatology and dermatology, using optimized biologic antibodies and innovative pairwise combinations.

• Combines three leading biologic targets (alpha-4 beta-7, TL1A, IL-23) in co-formulations, with potential for additive efficacy and improved dosing convenience.

• Expanded strategy to include dermatology and hidradenitis suppurativa (HS), leveraging learnings from IBD.

Clinical development and study design

• SKYLINE platform study evaluates monotherapies and all pairwise combinations in IBD, with a global, near-phase III scale trial across almost 300 sites.

• Monotherapy arms completed enrollment; combination arms underway, with a single comprehensive readout expected next year.

• Data cadence includes induction and maintenance results, with maintenance data typically nine months after induction.

Data insights and forward-looking plans

• Long-acting TL1A and IL-23 antibodies match in-class efficacy with less frequent dosing; alpha-4 beta-7 may show greater efficacy at higher doses.

• Combination therapies aim to outperform current standards by at least 10 percentage points in clinical remission, guiding phase III advancement decisions.

• Efficacy is the primary criterion for advancing combinations, with safety and convenience also considered.