Lyra Therapeutics (LYRA) investor relations material

Executive summary

• Positive Phase 3 ENLIGHTEN 2 trial results for LYR-210 in chronic rhinosinusitis (CRS), meeting primary and key secondary endpoints, with no product-related serious adverse events reported; results presented at a major medical conference in October 2025.

• ENLIGHTEN 1 trial failed to meet its primary endpoint in May 2024, leading to a 75% workforce reduction, pausing of LYR-220 development, and cost-saving measures.

• Company is preparing a new confirmatory Phase 3 trial for LYR-210, aiming for NDA submission, contingent on securing additional funding.

Financial highlights

• Cash and cash equivalents were $22.1 million as of September 30, 2025, down from $40.6 million at year-end 2024.

• Net loss for the nine months ended September 30, 2025 was $22.0 million, a significant improvement from $82.5 million in the prior year period, primarily due to reduced R&D and G&A expenses.

• Operating expenses for the nine months ended September 30, 2025 were $24.3 million, down from $86.3 million year-over-year.

• Net loss for Q3 2025 was $6.0 million, compared to $11.9 million for Q3 2024.

• Research and development expenses decreased by $1.9 million year-over-year to $4.0 million for Q3 2025.

Outlook and guidance

• Existing cash is expected to fund operations into Q3 2026, excluding costs for the planned third Phase 3 trial, which will require additional financing.

• Management has concluded there is substantial doubt about the ability to continue as a going concern without new funding.

• Strategic options, including partnerships or transactions, are being evaluated to maximize shareholder value.

• Plans to conduct an additional Phase 3 trial to support NDA submission for LYR-210.