Lyra Therapeutics, Inc. · OTC:LYRA
Lyra Therapeutics — Investor Presentation (March 2023)
20 slides from Lyra Therapeutics's investor presentation, Mar 29, 2023
Slide 1: Investor Presentation March 2023
Investor Presentation March 2023
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: Company overview
Proprietary drug-eluting implantable matrix designed to provide 6 months of continuous anti-inflammatory therapy Indication: Chronic rhinosinusitis (CRS), which affects 14M patients (US) and for which there is no approved therapeutic treatment Pivotal Phase 3 trials ongoing for lead candidate LYR-21
Slide 4: Lyra's proprietary drug-eluting matrix design
Lyra’s proprietary drug-eluting matrix design Middle Turbinate Middle Meatus BIOCOMPATIBLE MESH SCAFFOLD Maximizes surface area for drug release while maintaining underlying tissue function ENGINEERED ELASTOMERIC MATRIX Dynamically adapts to target anatomy VERSATILE POLYMER-DRUG COMPLEX Continuous d
Slide 5: Lyra's proprietary drug-eluting matrix design (cont.)
Lyra’s proprietary drug-eluting matrix design (cont.) Designed to deliver six months or more of continuous, local drug therapy with a single administration Shape memory keeps matrix in place Sustained targeted drug therapy
Slide 6: CRS development pipeline
CRS development pipeline Candidate CRS Patient Type Phase 2 Phase 3 LYR-210 Long-acting Mometasone Furoate LYR-220 Long-acting Mometasone Furoate LYR-210 and LYR-220: Designed to address the full spectrum of CRS patients ENLIGHTEN Phase 3 Program Chronic Rhinosinusitis Patients with Surgically-Naïve
Slide 7: What is chronic rhinosinusitis (CRS)?
What is chronic rhinosinusitis (CRS)? United States Chronic rhinosinusitis: The “Unrecognized Epidemic”1 ~14M CRS Patients2 CRS Patients Treated by Physicians Annually3 CRS Patients Fail Medical Management Annually4 ~8M ~4M CRS Cardinal Symptoms1 Nasal obstruction and congestion Facial pain and pres
Slide 8: Developing solutions for the full range of CRS patients who have failed medical management
Developing solutions for the full range of CRS patients who have failed medical management LYR-210 Designed to treat CRS patients with surgically naïve anatomy LYR-220 Designed to treat CRS patients with post-surgical anatomy ~4M Failed Patients Annually 60% 40% 2.4M 1.6M Patients with polyps Biolog
Slide 9: LYR-210: Designed to be the gold standard of CRS therapy
LYR-210: Designed to be the gold standard of CRS therapy Designed to provide continuous anti-inflammatory therapy Administered nasally via a single-use applicator Brief, office-based procedure with topical anesthesia Designed to enhance patient comfort and avoid painful surgery Designed to be replac
Slide 10: LANTERN: Phase 2 Clinical Trial of LYR-210 in CRS Patients
Study design: Multicenter, randomized, blinded, controlled, dose-ranging trial Adult patients with CRS who failed previous medical management and have not undergone FESS Primary endpoint: Change from baseline in 4 cardinal symptoms composite score (4CS) at Week 4 Secondary endpoints included SNOT-22
Slide 11: LYR-210: LANTERN Phase 2 study results
LYR-210 achieved rapid and durable improvement in SNOT-22 score over 24 weeks Half of treated patients (7,500 mg) experienced a durable response six months post-LYR-210 removal as measured by 4CS5 scores from Week 24 No treatment-related SAEs observed LYR-210: LANTERN Phase 2 study1 results 1) Cervi
Slide 12: Improvement across three cardinal symptoms of CRS
Improvement across three cardinal symptoms of CRS LANTERN Phase 2 Results: Change from Baseline at 24 Weeks (0-3 point scale) Source: Cervin A, et al. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum AllergyRh
Slide 13: Robust effect in composite 3CS at Week 24
Source: Cervin A, et al. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase2 randomized controlled study. Int Forum AllergyRhinol. 2021;1-13. 1) Mean change from baseline (CFBL) in the 7-day average score in the 3CS composite score (nasal blockage, fac
Slide 14: LYR-210 ENLIGHTEN Phase 3 program
2 studies of ~180 CRS patients each, without nasal polyps or with grade 1 nasal polyps, who have failed medical management3 Primary Endpoint: Change from baseline in 3CS Score at Week 24 in patients without nasal polyps Key Secondary Endpoints include individual cardinal symptoms, SNOT-22, CT sinus
Slide 15: LYR-220 BEACON Phase 2 trial
Conducted in CRS patients who have had a prior bilateral ethmoidectomy Part 1 – open label, to assess 2 LYR-220 matrix designs, including feasibility and optimization of placement in 6 patients Part 2 – randomized, patient-blinded, sham-controlled to assess safety, tolerability, PK, and efficacy of
Slide 16: Lyra products expected to align with current ENT practices
LYRA products, if approved, are expected to align with current ENT practices Office-based procedure that ENTs are accustomed to performing Potential path for patients who are unwilling to undergo surgery Possible alternative before systemic interventions (e.g., biologics) Expected to fit well into E
Slide 17: Efficient go-to-market strategy
Efficient go-to-market strategy 20-40 sales reps 3-5 medical science liaisons Specialty Field Force Targeted Patient & Physician Base 1,800 ENTs perform ~80% of CRS procedures2 1,800 Specialist Physicians 1.4M failed CRS patients actively seek care from ENT annually1 4M Failed Patients 1.4M Highly A
Slide 18: Anticipated milestones
Anticipated milestones LYR-210: ENLIGHTEN Phase 3 Program LYR-220: BEACON Phase 2 Program Mid-2023: Complete enrollment in ENLIGHTEN I Mid-2024: Topline pivotal data from ENLIGHTEN I 2H 2024: Complete enrollment in ENLIGHTEN II Early 2023: Complete enrollment Q4 2023: Topline data
Slide 19: Financial profile
Cash and short-term investments of $97.9 million as of December 31, 2022 31,829,774 common shares outstanding as of March 1, 2023 Trades on NASDAQ under the ticker symbol “LYRA” Financial profile
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