Lyra Therapeutics (LYRA) Corporate Presentation summary

Company overview and market opportunity

• Late-stage biotech developing long-acting, bioabsorbable sinonasal drug implants for chronic rhinosinusitis (CRS), targeting both polyp and non-polyp patients.

• Lead product LYR-210 delivers 6 months of continuous anti-inflammatory therapy with a single administration.

• Over 500 CRS patients treated in six clinical trials; robust safety and efficacy data.

• CRS affects ~12% of the US population, with ~50% failing medical therapy; multi-billion dollar market opportunity.

• CRS market remains underpenetrated, with nearly 80% of patients not served by current treatments.

Product and technology

• LYR-210 is a proprietary, bioabsorbable, drug-eluting implant designed for office-based, single-use nasal administration.

• Provides 6 months of local, continuous mometasone furoate therapy; engineered for shape memory and optimal drug release.

• LYR-220, a larger dimension implant, is designed for patients with enlarged anatomy but its development is currently paused.

• Only product candidate designed to provide 6 months of CRS therapy with a single treatment.

• Robust patent portfolio with potential coverage to 2042.

Clinical development and trial results

• ENLIGHTEN 2 Phase 3 trial met its primary endpoint, showing statistically significant improvement in 3CS at Week 24 for CRS without nasal polyps.

• Key secondary endpoints (3CS and SNOT-22) also met in the full study population; improvements observed as early as Week 4 and sustained through Week 24.

• Well-tolerated safety profile with no treatment-related serious adverse events; most frequent adverse events included epistaxis and upper respiratory tract infection.

• Pooled analysis of ENLIGHTEN 1 and 2 in patients with grade 1 nasal polyps showed consistent, positive trends in symptomatic and objective endpoints.

• No difference in corticosteroid use for any reason; lower endoscopic sinus surgery rates in the LYR-210 group.