Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (August 2024)
25 slides from Lyra Therapeutics's investor presentation, Aug 14, 2024
Slide 1: Corporate Presentation August 2024
Corporate Presentation August 2024
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; Bioabsorbable sinonasal implant designed to deliver 6 months of continuous anti-inflammatory therapy Indication: Chronic rhinos
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: 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 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 1 Trial Chronic Rhinosinusiti
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: SNOT-22 Score over 24 Weeks
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: Cardinal Symptom (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: 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 (polyp and non-polyp) who have had a prior bilateral FESS and failed medical management Primary endpoint – safety – Product-related serious
Slide 14: BEACON Efficacy Results: 3CS Score Weeks 4 and 24
BEACON Efficacy Results Robust Effect in 3 Cardinal Symptoms (3CS) Score - Weeks 4 and 241 Change in Composite of 3CS Score2,3 Error bars represent standard error 1) Data on file as of January 5, 2024; 2) Mean change from baseline (CFBL) in the 7-day average score in the 3CS composite score of nasal
Slide 15: BEACON Efficacy Results: Three Cardinal Symptoms of CRS
BEACON Efficacy Results Improvement Across Three Cardinal Symptoms of CRS1 Change in Three Cardinal Symptoms of CRS at Week 242,3 1) Data on file as of January 5, 2024; 2) Mean change from baseline (CFBL) in the 7-day average score in each individual CS of nasal blockage/obstruction, facial pain/pre
Slide 16: 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 17: 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 18: ENLIGHTEN Program Design
ENLIGHTEN Program Design LYR-210 Ongoing Pivotal Phase 3 Program ENLIGHTEN 14 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 19: ENLIGHTEN 1 primary readout and sub-group analyses
Primary readout as of May 6, 2024 and sub-group analyses as of August 14, 2024 – 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) i
Slide 20: ENLIGHTEN 1: 3 Cardinal Symptoms in Polyp Patients at Week 24
-2.25 p=0.0058 Improvement observed in the three cardinal symptoms in polyp subgroup, and to a greater extent in those with at least moderate nasal congestion at baseline ENLIGHTEN 1: 3 Cardinal Symptoms in Polyp Patients at Week 24 CONFIDENTIAL Change in Composite of 3CS Score - All Polyp Patients1
Slide 21: ENLIGHTEN 1: Nasal Congestion Score in Polyp Patients at Week 24
-0.73 p=0.0216 Nasal congestion scores improved in polyp patients with at least moderate nasal congestion at baseline ENLIGHTEN 1: Nasal Congestion Score in Polyp Patients at Week 24 CONFIDENTIAL Change in Nasal Congestion Score – All Polyp Patients1 Change in Nasal Congestion Score – Patients ≥ 2 @
Slide 22: LYR-210, if Advanced, Would Be Positioned To Align With Current ENT Practices
LYR-210, if Advanced, Would Be Positioned 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 practice reimbur
Slide 23: Anticipated Milestones
Anticipated Milestones LYR-210: ENLIGHTEN Phase 3 Program May 2024: Topline data from ENLIGHTEN 1 Q4 2024: Extension study data from ENLIGHTEN 1 2H 2024: Complete enrollment in ENLIGHTEN 2 1H 2025: Topline data from ENLIGHTEN 1
Slide 24: Financial Profile
Financial Profile Cash, cash equivalents and short-term investments of $67.5 million as of June 30, 2024 65.5 million common shares outstanding as of August 1, 2024
Slide 25: Slide 25
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