Lyra Therapeutics, Inc. · OTC:LYRA

Lyra Therapeutics — Investor Presentation (August 2025)

21 slides from Lyra Therapeutics's investor presentation, Aug 12, 2025

  1. Slide 1: Investor Presentation August 2025

    Investor Presentation August 2025

  2. 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

  3. 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 Company Overview Innovative, proprietary sinonasal drug implant Designed to deliver 6 months of continuous anti-inflammatory t

  4. 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

  5. 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.

  6. Slide 6: 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 CRS is a Large, Underserved Market (1) Sinuva approved 12/2017. Estimated patients based on Intersect 2022 guidance of <$

  7. 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

  8. 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

  9. 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

  10. 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 (

  11. 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

  12. Slide 12: ENLIGHTEN 2: Change from Baseline in 3CS at Week 24 (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

  13. Slide 13: ENLIGHTEN 2: Change from Baseline in 3CS for 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

  14. Slide 14: ENLIGHTEN 2: Change from Baseline in SNOT-22 at Week 24

    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 (

  15. Slide 15: ENLIGHTEN 2: Change in % Ethmoid Opacification at Week 20

    -2.15 p=0.1809 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 Opa

  16. 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

  17. 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

  18. Slide 18: Pooled ENLIGHTEN Data: 3CS in European Non-Polyp Patients with Ethmoid Opacification

    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) -2.48 p=0.0017* N=38 CONFIDENTIAL Potential “ENLIGHTEN 3” study, if required by FDA, would intend to target similar patient population with 1) >

  19. Slide 19: 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

  20. Slide 20: 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. 2H 2025: FDA meeting to align on strategy for CRS without Nasal Polyps

  21. Slide 21: Slide 21

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