Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (January 2024)
23 slides from Lyra Therapeutics's investor presentation, Jan 8, 2024
Slide 1: Corporate Presentation January 2024
Corporate Presentation January 2024 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; Bioresorbable nasal implant designed to deliver 6 months of continuous anti-inflammatory therapy to the site of disease Indicat
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 Biocompatible Mesh Scaffold Maximizes surface area for drug release while maintaining
Slide 6: Lyra's "Family" of CRS Product Candidates
Lyra’s “Family” of CRS Product Candidates Larger dimension for patients with enlarged anatomy due to previous ethmoid sinus surgery Smaller dimension for patients with narrow anatomy (includes surgery naïve patients) LYR-210 and LYR-220 are designed to address the full spectrum of CRS patients where
Slide 7: LYR-210 and LYR-220 designed to address the full spectrum of CRS patients
LYR-210 and LYR-220 are designed to address the full spectrum of CRS patients where ENTs select size based on patient anatomy Lyra Pipeline Candidate CRS Patient Type Phase 2 Phase 3 LYR-210 Long-acting Mometasone Furoate LYR-220 Long-acting Mometasone Furoate ENLIGHTEN Phase 3 Program Chronic Rhino
Slide 8: LYR-210 and LYR-220 Designed to be the New Standard of Care for CRS
FDA-approved API/steroid: Mometasone furoate Designed to provide continuous anti-inflammatory therapy Straightforward, office-based procedure with topical anesthesia Administered nasally via a single-use applicator Designed to be replaced every 6 months Only product candidate designed to provide 6 m
Slide 9: LANTERN Study Design
LANTERN Study Design LYR-210 Phase 2 Clinical Trial in CRS Patients LANTERN Daily Saline Irrigation Sham Control (n=23) LYR-210 2500 μg (n=23) SCREENING RANDOMIZATION END OF STUDY LYR-210 7500 μg (n=21) Primary Study Phase 24 weeks Extension Phase 24 weeks Screening & Run-in Safety Follow-up Functio
Slide 10: LANTERN Efficacy Results: Improvement in SNOT-22 Score
LANTERN Efficacy Results Rapid and Durable Improvement in SNOT-22 Score over 24 Weeks1 1) Cervin A, et al. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum AllergyRhinol. 2021;1-13; 2) SinoNasal Outcome Test i
Slide 11: LANTERN Efficacy Results: Three Cardinal Symptoms of CRS
LANTERN Efficacy Results Improvement Across Three Cardinal Symptoms of CRS1 Change in Three Cardinal Symptoms of CRS at Week 24 0.57 p=0.005 0.52 p=0.007 0.60 p=0.007 SHAM CONTROL Error bars represent standard error 1) Cervin A, et al. Long-acting implantable corticosteroid matrix for chronic rhinos
Slide 12: LANTERN Efficacy Results: 3CS Score at Week 24
LANTERN Efficacy Results Robust Effect in 3 Cardinal Symptom (3CS) Score at Week 241 1) Cervin A, et al. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum AllergyRhinol. 2021;1-13; 2) Mean change from baseline
Slide 13: ENLIGHTEN Program Design
ENLIGHTEN Program Design LYR-210 Ongoing Pivotal Phase 3 Program ENLIGHTEN I4 Daily Saline Irrigation Sham Control Sham Control (n=60) LYR-210 7500 ug (n=120) LYR-210 7500 ug SCREENING RANDOMIZATION Primary Study Phase 24 weeks Extension Phase 28 weeks Screening & Run-in 1:1 END OF STUDY 1) Up to 30
Slide 14: BEACON Study Design
BEACON Study Design LYR-220 Phase 2 Clinical Study Randomized, blinded, sham-controlled proof of concept study to assess safety and efficacy1 Adult CRS patients who have had a prior bilateral FESS and failed medical management Primary endpoint – safety Product-related serious adverse events Key effi
Slide 15: BEACON Efficacy Results: 3CS Score at Weeks 4 and 24
BEACON Efficacy Results Robust Effect in 3 Cardinal Symptoms (3CS) Score - Weeks 4 and 241 -0.87 p=0.037 -1.50 p=0.020 Change from Baseline (CFBL) Change in Composite of 3CS Score2,3 SHAM CONTROL Error bars represent standard error 1) Data on file as of January 5, 2024; 2) Mean change from baseline
Slide 16: BEACON Efficacy Results: Three Cardinal Symptoms of CRS
BEACON Efficacy Results Improvement Across Three Cardinal Symptoms of CRS1 -0.49 p=0.048 -0.52 p=0.023 -0.51 p=0.019 Change from Baseline (CFBL) Change in Three Cardinal Symptoms of CRS at Week 242,3 SHAM CONTROL 1) Data on file as of January 5, 2024; 2) Mean change from baseline (CFBL) in the 7-day
Slide 17: BEACON Efficacy Results: Improvement in Loss of Smell
BEACON Efficacy Results Improvement in Loss of Smell1 Change from Baseline (CFBL) * * * * * Statistically significant (0.87-point) improvement over control at week 24 (p=0.026) * p <0.05 1) Data on file as of January 5, 2024. (n=14) (n=11)
Slide 18: BEACON Efficacy Results: SNOT-22 Score over 28 Weeks
BEACON Efficacy Results Rapid and Durable Improvement in SNOT-22 Score over 28 Weeks1 * p <0.05 * * * * * * * Change in SNOT-22 Total Score2,3 Weeks Change from Baseline (CFBL) Achieved 17-point improvement over control (1.9x the MCID4) as early as two weeks and through 28 weeks SHAM CONTROL Error b
Slide 19: Product Candidates Expected To Align With Current ENT Practices
LYRA Product Candidates, if Approved, are Expected To Align With Current ENT Practices Office-based procedure that ENTs are accustomed to performing Treatment option for patients who are unwilling to undergo surgery, allowing ENTs to serve more patients in their care Expected to fit into ENT practic
Slide 20: Targeted Go-to-Market Strategy
Targeted Go-to-Market Strategy Anticipate 20-40 sales reps & 3-5 medical science liaisons Specialty Field Force Targeted Patient & Physician Base 2,500 ENTs perform ~90% of CRS procedures2 2,500 Specialist Physicians 1.4M failed CRS patients actively seek care from ENT annually1 4M Failed Patients 1
Slide 21: Anticipated Milestones
Anticipated Milestones LYR-210: ENLIGHTEN Phase 3 Program LYR-220: BEACON Phase 2 Program Mid-2023: Complete enrollment in ENLIGHTEN I Q2 2024: Topline pivotal data from ENLIGHTEN I 2H 2024: Extension study data from ENLIGHTEN I 2H 2024: Complete enrollment in ENLIGHTEN II Early 2023: Complete enrol
Slide 22: Financial Profile
Financial Profile Cash, cash equivalents and short-term investments of $102.6 million as of September 30, 2023 On October 2, 2023, the Company sold an aggregate of 3,017,568 shares of common stock under the ATM Sales Agreement, at a weighted average price of $3.71 per share, which generated net proc
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