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Jun 30, 2024
Lyra Q2 2024 Earnings Report
Lyra Therapeutics reported financial results for the second quarter ended June 30, 2024 and provided a corporate update.
Key Takeaways
Lyra Therapeutics reported its Q2 2024 financial results, highlighting ongoing Phase 3 trials for LYR-210 and cost-cutting measures, including a workforce reduction. Further analysis of the ENLIGHTEN 1 data revealed that LYR-210 demonstrated improvement over control in symptomatic endpoints in the CRS patient cohort with nasal polyps.
Lyra is focusing on the ENLIGHTEN 1 Phase 3 extension study with results expected in Q4 2024 and the ENLIGHTEN 2 pivotal Phase 3 trial in CRS patients with results expected in 1H 2025.
Further analysis of the ENLIGHTEN 1 data has revealed that LYR-210 demonstrated improvement over control in symptomatic endpoints in the CRS patient cohort with nasal polyps.
Cost-cutting measures were implemented to preserve capital, including a reduction in force of approximately 75% of its workforce and pausing development efforts for LYR-220.
Cash, cash equivalents and short-term investments as of June 30, 2024 were $67.5 million, which is expected to fund operations into the first quarter of 2026.
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CapyFin.com Forward Guidance
Lyra Therapeutics is primarily focused on the ongoing ENLIGHTEN Phase 3 trials and expects results from the ENLIGHTEN 1 extension study in Q4 2024 and ENLIGHTEN 2 pivotal trial in 1H 2025. The company anticipates its cash, cash equivalents and short-term investment balance is sufficient to fund operating expenses and capital expenditures into the first quarter of 2026.
Positive Outlook
- Results from the ENLIGHTEN 1 52-week extension study are expected in Q4 2024.
- Topline results from ENLIGHTEN 2 are expected in the first half of 2025.
- Enrollment in ENLIGHTEN 2, the second pivotal Phase 3 trial of LYR-210 in CRS, is ongoing; enrollment completion is expected in the second half of 2024.
- Further analysis of the ENLIGHTEN 1 data shows that LYR-210 demonstrated a positive effect compared to sham control in 3CS and nasal congestion scores at 24 weeks in the CRS patient subgroup with nasal polyps.
- Based on our current business plan, we anticipate that our cash, cash equivalents and short-term investment balance is sufficient to fund our operating expenses and capital expenditures into the first quarter of 2026.
Challenges Ahead
- The ENLIGHTEN 1 Phase 3 trial did not meet its primary endpoint of statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS at 24 weeks.
- Lyra announced cost-cutting measures to preserve capital, including a reduction in force of approximately 75% of its workforce.
- Lyra stopped manufacturing and commercialization efforts and is seeking to sublease its three leaseholds to significantly reduce the Company’s operating costs.
- Lyra paused development efforts for LYR‑220 in an effort to focus on the ongoing ENLIGHTEN Phase 3 program evaluating LYR-210.
- Net loss for the second quarter 2024 was $48.1 million compared to $15.6 million for the same period in 2023.