Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (September 2025)
20 slides from Lyra Therapeutics's investor presentation, September 2025
Slide 1: Investor Presentation
Investor Presentation September 2025
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify f
Slide 3: Company Overview
Company Overview Late-stage biotechnology company developing long-acting, bioabsorbable, anti-inflammatory sinonasal drug implants for the treatment of chronic rhinosinusitis (CRS) • Innovative, proprietary sinonasal drug implant ‒ Designed to deliver 6 months of continuous anti-inflammatory therapy
Slide 4: Chronic Rhinosinusitis (CRS): An Unrecognized Epidemic
Chronic Rhinosinusitis (CRS): An “Unrecognized Epidemic”(1) Significant market opportunity in both polyp and non-polyp CRS populations CRS in the United States Annually ~8M ~4M ~$60B CRS patients Annual CRS patients failing medical healthcare treated(2) management(3) expenditure(4) CRS Cardinal Symp
Slide 5: Annual Incidence of CRS in the U.S. Represents Large Unmet Need
Annual Incidence of CRS in the U.S. Represents Large Unmet Need Both polyp and non-polyp CRS includes ~4M eligible patients for Lyra products; current focus on non-polyp patients, which represents 70% of the market CRS with Polyps CRS without Polyps (~30%)(1) (~70%)(1) ~2.4M CRS patients treated(2)
Slide 6: CRS is a Large, Underserved Market
CRS is a Large, Underserved Market Despite the introduction of biologics for severe polyp patients, the CRS market remains highly underpenetrated with the vast majority of patients not served by current treatments Market Size Current Standard of Care & Key Limitations Medical Management Non-Polyp Ma
Slide 7: A Novel Drug-Eluting Implant to Deliver 6 Months of Continuous Therapy
A Novel Drug-Eluting Implant to Deliver 6 Months of Continuous Therapy Polymer-Drug Complex Designed to deliver 6 months of continuous, local drug therapy with a single placement Engineered Elastomeric Matrix Shape memory intended to keep implant in place Bioabsorbable Mesh Scaffold Designed to maxi
Slide 8: Strong Clinical Progress in CRS without Nasal Polyps – One Successful Phase 3 Study Completed
Strong Clinical Progress in CRS without Nasal Polyps – One Successful Phase 3 Study Completed • ENLIGHTEN 2 study met its primary endpoint ‒ Statistically significant improvement over sham in 3CS at Week 24 in the primary population of CRS patients without nasal polyps, with improvement observed as
Slide 9: Significant Experience in CRS without Nasal Polyps, with ~300 Patients Treated in ENLIGHTEN Program
Significant Experience in CRS without Nasal Polyps, with ~300 Patients Treated in ENLIGHTEN Program ENLIGHTEN 2 met its primary endpoint ENLIGHTEN Program Design ENLIGHTEN 1(4) Criteria Daily Saline Irrigation END OF STUDY • Two Phase 3 studies of ~180 subjects each, including ~30 polyp RANDOMIZATIO
Slide 10: ENLIGHTEN 1 and 2: Patient Demographics & Baseline Characteristics
ENLIGHTEN 1 and 2: Patient Demographics & Baseline Characteristics ENLIGHTEN 1 enrolled nearly double the proportion of patients with perennial allergic rhinitis (PAR) than ENLIGHTEN 2. A statistically significant interaction of PAR by Treatment was detected (p=0.039), implying PAR as a confounder i
Slide 11: ENLIGHTEN 2: Most Frequent Adverse Events (≥5% of patients)
ENLIGHTEN 2: Most Frequent Adverse Events (≥5% of patients) Favorable safety profile with no product-related serious adverse events ENLIGHTEN 1 ENLIGHTEN 2 Safety Analysis Set Preferred Term1 LYR-210 Sham LYR-210 Sham (n=124) (n=66) (n=112) (n=60) Any adverse event 95 (76.6%) 41 (62.1%) 67 (60.4%) 2
Slide 12: ENLIGHTEN 2 Trial Met Primary Endpoint
ENLIGHTEN 2 Trial Met Primary Endpoint Statistically significant improvement in 3CS at 24 weeks, with consistent improvement over Sham control starting as early as Week 8 Composite of the 3 Cardinal Symptoms in Non-Polyp Patients * Represents p-value < 0.05. * Statistically significant 12
Slide 13: ENLIGHTEN 2 Trial Met Key Secondary Endpoints
ENLIGHTEN 2 Trial Met Key Secondary Endpoints Data represent ~40% improvement in 3CS and SNOT-22 scores relative to baseline in ITT population Key Secondary Endpoints Change in 3CS at Week 24 Change in SNOT-22 at Week 24 Change in % Ethmoid All Patients All Patients Opacification (CT) 0 LS Mean CFBL
Slide 14: ENLIGHTEN 2: Proportion of Patients Recommended for Rescue Surgery
ENLIGHTEN 2: Proportion of Patients Recommended for Rescue Surgery Treatment with LYR-210 reduced the need for sinus surgery by 60% compared to Sham Rescue Sinus Surgery 10% % Patients Recommended for 8% Rescue Surgery 6% 60% less 4% 2% 0% LYR-210 Sham 14
Slide 15: ENLIGHTEN 2: Patient Global Impression of Change (PGIC) in Non-Polyp Patients
ENLIGHTEN 2: Patient Global Impression of Change (PGIC) in Non-Polyp Patients(1) Patients treated with LYR-210 were over 3-fold more likely than Sham-treated to experience a change of “very much better” or “much better” PGIC at Week 24 50% Odds Ratio 3.33 Better or Much Better Change % Patients with
Slide 16: Clarity on Path to NDA Submission for CRS without Nasal Polyps
Clarity on Path to NDA Submission for CRS without Nasal Polyps Met with FDA in September 2025 on NDA requirements for CRS without nasal polyps* • As expected, an additional clinical study is required to demonstrate substantial evidence of effectiveness in CRS without nasal polyps • FDA has agreed to
Slide 17: Large Treatment Effect Observed in Patients with Higher CT Opacification
Large Treatment Effect Observed in Patients with Higher CT Opacification In patient population with greater than 25% CT opacification, treatment effect relative to Sham of 2.5 points in 3CS score All CRS without Nasal Polyps with Ethmoid Opacification >25% ENLIGHTEN 2 All EU Patients, ENLIGHTEN 1 &
Slide 18: Targeted Go-to-Market Strategy
Targeted Go-to-Market Strategy Significant market opportunity with targeted focus on ENTs specializing in sinus procedures ~4M of Eligible Polyp and Non-Polyp Patients Targeted Patient and Physician Base Annual Incidence of CRS in the U.S. Highly Accessible Patients CRS with Polyps (~30%)(1) CRS wit
Slide 19: Key Milestones
Key Milestones May 2024: Data readout from ENLIGHTEN 1 Q4 2024: Extension study data from ENLIGHTEN 1 2H 2024: Complete enrollment in ENLIGHTEN 2 2Q 2025: Data readout from ENLIGHTEN 2 2H 2025: Clarity from FDA on NDA strategy for CRS without Nasal Polyps Est. 1H 2026: Initiation of pivotal phase 3
Slide 20: Lyra Therapeutics
LI“YRA THERAPEUTICS
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