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Sep 30, 2023

Lyra Q3 2023 Earnings Report

Reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Takeaways

Lyra Therapeutics reported its Q3 2023 financial results, highlighting positive data from the BEACON Phase 2 clinical trial of LYR-220 and the completion of enrollment in the ENLIGHTEN I pivotal Phase 3 trial of LYR-210. The company's cash, cash equivalents, and short-term investments totaled $102.6 million as of September 30, 2023, expected to fund operations into the first quarter of 2025.

Additional Phase 2 BEACON trial CT scan data demonstrated statistically significant improvement in sinus opacification with LYR-220.

Emerging data further support the previously reported positive BEACON topline results demonstrating CRS symptom improvement.

ENLIGHTEN I pivotal Phase 3 trial of LYR-210 in CRS patients who have not had ethmoid sinus surgery is fully enrolled; topline results expected in 1H 2024.

Cash, cash equivalents and short-term investments as of September 30, 2023 were $102.6 million, sufficient to fund operations into the first quarter of 2025.

Total Revenue
$544K
Previous year: $359K
+51.5%
EPS
-$0.27
Previous year: -$0.4
-32.5%
Gross Profit
-$11.8M
Previous year: $359K
-3393.6%
Cash and Equivalents
$24.9M
Previous year: $110M
-77.3%
Free Cash Flow
-$14.3M
Previous year: -$10.9M
+31.1%
Total Assets
$121M
Previous year: $119M
+0.9%

Lyra

Lyra

Forward Guidance

Lyra Therapeutics anticipates topline data from the ENLIGHTEN I clinical trial in the first half of 2024 and expects enrollment completion for the ENLIGHTEN II trial in the second half of 2024. The company's cash is expected to fund operations into the first quarter of 2025.

Positive Outlook

  • Anticipate topline data from the ENLIGHTEN I clinical trial in the first half of 2024.
  • Expect enrollment completion for the ENLIGHTEN II trial in the second half of 2024.
  • Cash balance is expected to fund operations into the first quarter of 2025.
  • Positive data from BEACON Phase 2 clinical trial supports further development of LYR-220.
  • LYR-220 demonstrated statistically significant improvement in sinus opacification.

Challenges Ahead

  • Incurred significant losses since inception and expects to incur additional losses for the foreseeable future.
  • Need for additional funding, which may not be available.
  • Limited operating history.
  • Product candidates are in various stages of development and may not be successful.
  • Clinical trials are expensive and time-consuming, and their outcomes are uncertain.