Slide 1: BEACON Study Topline Results
BEACON Study Topline Results LYR-220-2021-001 A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy https://clinicaltrials.gov
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including state
Slide 3: LYR-210 and LYR-220 are Designed to Address the Full Spectrum of CRS Patients
LYR-210 and LYR-220 are Designed to Address the Full Spectrum of CRS Patients Topline results now available for the LYR-220 Phase 2 BEACON study Candidate CRS Patient Type Phase 2 Phase 3 Chronic Rhinosinusitis LYR-210 Patients with Surgically-Naïve Anatomy Long-acting Mometasone Furoate ENLIGHTEN P
Slide 4: LYR-220 for CRS Patients who have Undergone Prior Sinus Surgery but have Persistent Symptoms
LYR-220 for CRS Patients who have Undergone Prior Sinus Surgery but have Persistent Symptoms • LYR-220 is an enlarged version of LYR-210 to accommodate post-surgical anatomy • LYR-220 is designed to provide 24 weeks of mometasone furoate therapy directly to the site of disease • LYR-220 dosage of mo
Slide 5: LYR-220 is being Developed to Address a Significant Proportion of the CRS Population
LYR-220 is being Developed to Address a Significant Proportion of the CRS Population CRS in the United States Annually ~8M CRS patients treated2 Current Treatments: ~4M CRS patients failing medical management3 • Medical Management ‒ Saline rinses, topical nasal steroids, ~1.4M CRS patients currently
Slide 6: BEACON Study Design
BEACON: Phase 2 Clinical Study of LYR-220 • CRS patients who have had a prior bilateral BEACON Study Design ethmoidectomy Daily Saline Irrigation • Randomized, blinded, sham-controlled proof of END OF STUDY concept study to assess safety and efficacy of SCREENING RANDOMIZATION 42 patients randomized
Slide 7: BEACON: Patient Demographics and Baseline Characteristics
BEACON: Patient Demographics and Baseline Characteristics LYR-220 Sham Total (n=21) (n=21) (n=42) Age in years (mean, SD) 48 (12.51) 55 (11.29) 51 (12.35) Sex (n, %) Male 7 ( 33.3) 10 ( 47.6) 17 ( 40.5) Female 14 ( 66.7) 11 ( 52.4) 25 ( 59.5) Race (n, %) White 20 ( 95.2) 18 ( 85.7) 38 ( 90.5) Black
Slide 8: Statistically Significant Improvement in 3CS Composite Score
BEACON Efficacy Results: Statistically Significant Improvement in 3CS Composite Score Week 4 Week 24 LS Mean Change from Baseline in 3CS 0 -0.26 -0.5 -0.94 -1 -1.50 p=0.020 -0.87 p=0.037 -1.5 -1.81 -1.76 -2 -2.5 LYR-220 SHAM Error bars represent standard error 8
Slide 9: Statistically Significant Improvements in Individual CS at Week 24
BEACON Efficacy Results: Statistically Significant Improvements in Individual CS at Week 24 Nasal Blockage Facial Pain/Pressure Nasal Discharge 0.2 LS Mean Change from Baseline at Week 24 0.06 0 -0.07 -0.2 -0.24 -0.52 p=0.023 -0.51 p=0.019 -0.4 -0.46 -0.49 -0.58 p=0.048 -0.6 -0.73 -0.8 -1 LYR-220 SH
Slide 10: Statistically Significant Improvement in SNOT-22 Score
BEACON Efficacy Results: Statistically Significant Improvement in SNOT-22 Score Week 4 Week 24 5 LS Mean Change from Baseline in SNOT-22 0.5 0.5 0 -4.2 -5 -16.8 p=0.007 -10 -12.7 p=0.012 -15 -16.9 -16.3 -20 -25 LYR-220 SHAM Error bars represent standard error 10
Slide 11: Early and Sustained Improvement in SNOT-22 Score
BEACON Efficacy Results: Early and Sustained Improvement in SNOT-22 Score Change from baseline in SNOT-22 total score LS Mean (±SE) Change from Baseline in SNOT-22 5 LYR-220 SHAM 0 -5 -10 -15 * -20 * * * * * * -25 0 4 8 12 16 20 24 Weeks * p <0.05 11
Slide 12: BEACON Study Summary
BEACON Study Summary No SAEs and statistically significant, clinically relevant improvements in key efficacy endpoints • No serious adverse events observed. Most commonly observed adverse events included sinusitis, nasopharyngitis, bronchitis, and COVID-19 • Statistically significant improvement in
Slide 13: Lyra Therapeutics
LO“YRA THERAPEUTICS