Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (June 2025)
26 slides from Lyra Therapeutics's investor presentation, Jun 9, 2025
Slide 1: Corporate Presentation June 2025
Corporate Presentation June 2025 Exhibit 99.1
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,” “would,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to i
Slide 3: Company Overview
(1) Summary Health Statistics Tables for U.S. Adults: National Health Interview Survey, 2018, Tables A-2b, A-2c; (2) Baguley et al. Int Forum Allergy Rhinol, 2014;4(7):525-3; (3) Subject to additional financing Company Overview Innovative, proprietary sinonasal drug implant Designed to deliver 6 mon
Slide 4: Chronic Rhinosinusitis (CRS): An Unrecognized Epidemic
Chronic Rhinosinusitis (CRS): An “Unrecognized Epidemic”(1) CRS Cardinal Symptoms(1) Nasal obstruction and congestion Facial pain and pressure Nasal discharge Reduced sense of smell (1) Tan BK et al. Am J Respir Crit Care Med, 2013;188(11):1275–7; (2) Jang et al. Otolaryngol Head Neck Surg, 2018; (3
Slide 5: Annual Incidence of CRS in the U.S.
Note: Clinical development for LYR-220 is currently paused. (1) Biomedical Insights Market Sizing Assessment 2020; (2) Jang et al. Otolaryngol Head Neck Surg, 2018; (3) Baguley et al. Int Forum Allergy Rhinol, 2014;4(7):525-32; (4) OM1 Real World Data Cloud (OM1, Inc, Boston, MA, US), 2015 – 4/2019.
Slide 6: CRS is a Large, Underserved Market
Despite the introduction of biologics for severe polyp patients, the CRS market remains highly underpenetrated with nearly 80% of patients not served by current treatments CRS is a Large, Underserved Market (1) Sinuva approved 12/2017. Estimated patients based on Intersect 2022 guidance of <$10M in
Slide 7: Lyra's Proprietary Drug-Eluting Implant
Lyra’s Proprietary Drug-Eluting Implant Engineered Elastomeric Matrix Shape memory intended to keep implant in place Polymer-Drug Complex Designed to deliver 6 months of continuous, local drug therapy with a single placement Bioabsorbable Mesh Scaffold Designed to maximize surface area for drug rele
Slide 8: Program Design – LYR-210 Phase 3 Program
ENLIGHTEN Program Design – LYR-210 Phase 3 Program (1) 35 and 29 patients with grade 1 nasal polyps enrolled in ENLIGHTEN 1 and ENLIGHTEN 2, respectively; study population represents 95% of CRS patients; (2) Three Cardinal Symptom Score is as a composite of nasal blockage/obstruction, facial pain/pr
Slide 9: ENLIGHTEN 2 study met its primary endpoint
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 early as Week 8 Key secondary endpoints of change in 3CS and SNOT-22 in the full study population
Slide 10: ENLIGHTEN 2: Patient Demographics & Baseline Characteristics
ENLIGHTEN 2: Patient Demographics & Baseline Characteristics CONFIDENTIAL ITT Analysis Set LYR-210 (n=111) Sham (n=61) Age in years (mean, SD) 50 (15.5) 49 (12.99) Sex (n, %) Male Female 65 ( 58.6) 46 ( 41.4) 31 ( 50.8) 30 ( 49.2) Race (n, %) White Black or African American 94 ( 84.7) 9 ( 8.1) 51 (
Slide 11: ENLIGHTEN 2: Most Frequent Adverse Events
ENLIGHTEN 2: Most Frequent Adverse Events (≥5% of patients) Safety Analysis Set (Preferred Term) LYR-210 (n=111) n (%) Sham (n=61) n (%) Any treatment-emergent adverse events (TEAEs) 67 (60.4%) 27 (44.3%) Epistaxis 18 (16.2%) 1 (1.6%) Upper respiratory tract infection 10 (9.0%) 5 (8.2%) Chronic sinu
Slide 12: ENLIGHTEN 2: Change from Baseline in 3CS (Primary Endpoint)
ENLIGHTEN 2: Change from Baseline in 3CS at Week 24 (Primary Endpoint in Patients Without Nasal Polyps) Statistically significant improvement in 3CS at 24 weeks, with consistent improvement over sham control starting as early as Week 8 * Statistically significant 3CS – Non-Polyp Patients CONFIDENTIA
Slide 13: ENLIGHTEN 2: Change from Baseline in 3CS, Full Population
ENLIGHTEN 2: Change from Baseline in 3CS at Week 24 for Full Population (1st Key Secondary Endpoint)(1) Statistically significant improvement in 3CS at 24 weeks, with robust improvement over sham control starting at Week 12 (1) Key secondary endpoint population is the intent-to-treat (ITT) analysis
Slide 14: ENLIGHTEN 2: Change from Baseline in SNOT-22
ENLIGHTEN 2: Change from Baseline in SNOT-22 at Week 24 (2nd Key Secondary Endpoint)(1) Statistically significant improvement in clinically-validated SNOT-22 score at 24 weeks, with robust improvement over sham control starting at Week 4 (1) Key secondary endpoint population is the intent-to-treat (
Slide 15: ENLIGHTEN 2: Change in % Ethmoid Opacification
ENLIGHTEN 2: Change in % Ethmoid Opacification at Week 20 (3rd Key Secondary Endpoint)(1) N=172 Numerical improvement in % ethmoid opacification by CT (1) Key secondary endpoint population is the intent-to-treat (ITT) analysis set (patients with or without Nasal Polyps). % Ethmoid Opacification – Al
Slide 16: Pooled ENLIGHTEN 1 and 2: Rescue Treatment Use
ENLIGHTEN 1 and 2: Rescue Treatment Use (4th Key Secondary Endpoint)(1) Pooled ENLIGHTEN 1 and ENLIGHTEN 2 Full Population LYR-210 n (%) Sham n (%) Systemic Corticosteroid (SCS) for any reason/ ESS, n (%) 24 (10.2%) 14 (11.0%) SCS for any reason, n (%) 22 (9.4%) 12 (9.4%) Endoscopic Sinonasal Surger
Slide 17: Next Steps Towards NDA Approval in CRS without Nasal Polyps
We intend to advocate for NDA submission based on totality of ENLIGHTEN data Next Steps Towards NDA Approval in CRS without Nasal Polyps If required, design additional Phase 3 trial Hold FDA meeting to align on strategy Complete CMC package at Waltham manufacturing facility
Slide 18: Pooled ENLIGHTEN 1 & 2: 3CS in European Non-Polyp Patients
Pooled ENLIGHTEN 1 & 2 Data: CFBL in 3CS in European, Non-Polyp Patients with Ethmoid Opacification by CT >25% Demonstrates Robust Improvement (p = 0.0017) N=38 CONFIDENTIAL With a potential “ENLIGHTEN 3” study, if required by FDA, we would intend to target a similar patient population with 1) >25%
Slide 19: Pooled CRS with Nasal Polyps: Change in 3CS Score
ENLIGHTEN 1 and 2 Pooled CRS with Nasal Polyps: Change from Baseline in 3CS Score at Week 24 CONFIDENTIAL Consistent, positive trend starting in Week 4 and further improvement at Weeks 20 and 24 with small sample size (n=64) Analysis population is the pooled intent-to-treat (ITT) analysis set with n
Slide 20: Pooled CRS with Nasal Polyps: Change in SNOT-22 Score
ENLIGHTEN 1 and 2 Pooled CRS with Nasal Polyps: Change from Baseline in SNOT-22 Score at Week 24 CONFIDENTIAL * Consistent, positive trend in SNOT-22 score starting in Week 4 and throughout Week 24 SNOT-22 - All Nasal Polyp Patients Analysis population is the pooled intent-to-treat (ITT) analysis se
Slide 21: Pooled CRS with Nasal Polyps: Nasal Congestion Score
ENLIGHTEN 1 and 2 Pooled CRS with Nasal Polyps: CFBL in Nasal Congestion Score (NCS) at Week 24 (for Subjects with Baseline NCS ≥2) CONFIDENTIAL Consistent, positive trend of improvement in nasal congestion score starting in Week 4 and throughout Week 24 NCS - Moderate to Severe NCS at Baseline Anal
Slide 22: Pooled CRS with Nasal Polyps: Ethmoid Opacification and NPS
ENLIGHTEN 1 and 2 Pooled CRS with Nasal Polyps: Change from Baseline in % Ethmoid Opacification (CT) at Week 20 and NPS at Week 24 CONFIDENTIAL Objective measures of % Ethmoid Opacification and NPS saw Sham group worsen while LYR-210 group improved on average in small polyps (grade 1) Analysis popul
Slide 23: Planned Phase 3 Clinical Trial for CRS with Nasal Polyps
Planned Phase 3 Clinical Trial for CRS with Nasal Polyps(1) Received FDA feedback in December 2024 on study design for CRS with nasal polyps Safety dataset would be sufficient along with data from ENLIGHTEN and LANTERN, subject to no further additional safety concerns being identified Lyra believes
Slide 24: Targeted Go-to-Market Strategy
Targeted Go-to-Market Strategy Specialist Physicians 1,800 ENTs manage ~80% of CRS volume(6) 1,800 10,000 ENTs Significant market opportunity with targeted focus on ENTs specializing in sinus procedures Highly Accessible Patients 1.4M failed CRS patients actively seek care from ENT annually(5) 4M Fa
Slide 25: 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 Est. 1H 2026: Initiate Phase 3 Trial in CRS with Nasal Polyps(1) Est. 2H 2025: FDA meeting to align on strategy for
Slide 26: Slide 26
Lyra Therapeutics — Investor Presentation (June 2025) on 6ix