Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (January 2025)
22 slides from Lyra Therapeutics's investor presentation, Jan 10, 2025
Slide 1: Corporate Presentation January 2025
Corporate Presentation January 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,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify f
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 Bioabsorbable sinonasal implant designed to deliver 6 months of continuous anti-inflammatory
Slide 4: Chronic Rhinosinusitis (CRS): An "Unrecognized Epidemic"
Chronic Rhinosinusitis (CRS): An “Unrecognized Epidemic”1 CRS Cardinal Symptoms1 Nasal obstruction and congestion Facial pain and pressure Nasal discharge Reduced sense of smell CRS in the United States Annually CRS patients treated2 CRS patients failing medical management3 ~8M ~4M CRS patients curr
Slide 5: Lyra's Proprietary Drug-Eluting Implant
Lyra’s Proprietary Drug-Eluting Implant Engineered Elastomeric Matrix Shape memory keeps implant in place Polymer-Drug Complex Designed to deliver 6 months of continuous, local drug therapy with a single placement Bioabsorbable Mesh Scaffold Maximizes surface area for drug release while maintaining
Slide 6: Designed to be the New Standard of Care for CRS
FDA-approved steroid: Mometasone furoate Designed to provide continuous anti-inflammatory therapy Straightforward, office-based procedure with topical anesthesia Administered nasally via a single-use applicator Two product candidates are designed to address the diverse anatomy of both pre and post s
Slide 7: Summary of Clinical Studies
Summary of Clinical Studies Candidate Phase 1 Phase 2 Phase 3 Status LYR-210 (Small diameter) Complete Complete Complete Complete Ongoing Planned LYR-2202 (Large diameter) Complete ENLIGHTEN 1 Study for CRS (n=190) BEACON Phase 2 Study (n=48) ENLIGHTEN 2 Study for CRS (n=180) Pivotal Study for CRS w
Slide 8: ENLIGHTEN Program Design
ENLIGHTEN Program Design LYR-210 Ongoing Phase 3 Program ENLIGHTEN 13 Daily Saline Irrigation Sham Control Sham Control (n=60) LYR-210 7500 ug (n=120) LYR-210 7500 ug SCREENING RANDOMIZATION Treatment Stage 24 weeks Safety Extension Stage 28 weeks Screening & Run-in 1:1 END OF STUDY 1) Up to 30 pati
Slide 9: ENLIGHTEN 1 Treatment Stage Results
Primary endpoint of Change from Baseline (CFBL) in 3CS Score at Week 24 in Patients without Nasal Polyps was not met In the primary efficacy analysis, treatment with LYR-210 resulted in a mean (standard deviation; SD) improvement in the 3CS score of 2.13 (2.17) points, compared to 2.06 (2.14) points
Slide 10: Nasal congestion scores improved in polyp patients
Nasal congestion scores improved in polyp patients with at least moderate nasal congestion at baseline ENLIGHTEN 1 Polyp Cohort: Nasal Congestion Score at 24 Weeks -0.73 p=0.0216 Change in Nasal Congestion Score for Patients with Congestion Score ≥ 2 @ Baseline1,2 N=30 1) Data represent least square
Slide 11: Reduction in Polyp Size in ENLIGHTEN 1 polyp cohort
Reduction in Polyp Size at week 24 in the nasal polyp cohort in ENLIGHTEN 1 despite inclusion of patients with only small polyps1 ENLIGHTEN 1 Polyp Cohort: Evaluation of Polyp Size CFBL = Change from baseline ENLIGHTEN 1 included Grade 1 nasal polyps. Polyp scores were determined post-hoc by an inde
Slide 12: Visual improvement in nasal polyps and mucosa after LYR-210 treatment
Visual improvement in nasal polyps and mucosa after LYR-210 treatment ENLIGHTEN 1 Polyp Cohort: In-Office Endoscopic Evaluation Day 1 (before LYR-210 treatment) Polypoid tissue Week 24 (after LYR-210 treatment) Polypoid tissue greatly diminished
Slide 13: ENLIGHTEN 1: Extension Stage
ENLIGHTEN 1: Extension Stage (Week 24 through Week 52) Daily Saline Irrigation Sham Procedure Control LYR-210 (7500 mcg) SCREENING RANDOMIZATION END OF STUDY RANDOMIZED TREATMENT Treatment Stage (24 weeks) Screening & 2-4 weeks Run-in Run-in Safety Extension Stage (28 weeks) 2:1 randomization LYR-21
Slide 14: Sham patients crossed over to LYR-210 exhibited improvement
Sham patients that crossed over to LYR-210 treatment exhibited improvement in both their symptoms and polyp size Extension Stage Polyp Cohort: Sham Polyp Patients Crossing Over to LYR-210 Week 52 -3.4 (Additive improvement w/ LYR-210) Week 48 -1.0 (Additive improvement w/ LYR-210) N=7; Post-hoc anal
Slide 15: LYR-210 polyp patients crossed over to Sham demonstrated durable response
LYR-210 polyp patients that crossed over to Sham demonstrated a durable response out to one year Extension Stage Polyp Cohort: LYR-210 Polyp Patients Crossing Over to Sham N=8; Post-hoc analysis; nasal polyp score assessed using standard polyp grading scale
Slide 16: Annual Incidence of CRS With Polyps in the U.S.
Annual Incidence of CRS With Polyps in the U.S. Polyp patients treated2 Polyp patients failing medical management3 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 D
Slide 17: Planned Phase 3 Clinical Trial for CRS with Nasal Polyps
Planned Phase 3 Clinical Trial for CRS with Nasal Polyps1 Potential pivotal study of ~200 subjects Adult CRS patients with nasal polyps, with or without prior ethmoid sinus surgery and who have failed medical management2 Co-primary endpoints3 Change from baseline in Nasal Congestion Score (NCS) at W
Slide 18: ENLIGHTEN 1 Outcomes in Non-polyp Patients
Although non-polyp patients showed a 2-point improvement from baseline in 3CS, a separation from the sham control group was not seen Treatment effect observed in European cohort, but not in the US cohort Blinded post-hoc analysis demonstrated a signal in non-polyp CRS patients with endoscopic eviden
Slide 19: Annual Incidence of CRS Without Polyps in the U.S.
CRS patients treated2 CRS patients failing medical management3 Note: Clinical development for LYR-00 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
Slide 20: Key Milestones
Key Milestones May 2024: Topline data from ENLIGHTEN 1 Q4 2024: Extension study data from ENLIGHTEN 1 2H 2024: Complete enrollment in ENLIGHTEN 2 2Q 2025: Topline data from ENLIGHTEN 2 Est. 2H 2025: Initiate Polyp Pivotal Trial1 1) Subject to additional financing.
Slide 21: Financial Profile
Financial Profile Cash, cash equivalents and short-term investments of $51.6 million as of September 30, 2024 65.5 million common shares outstanding as of September 30, 2024
Slide 22: Slide 22
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