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Dec 31, 2021

Lyra Q4 2021 Earnings Report

Lyra Therapeutics reported financial results for the fourth quarter and full year 2021, highlighting clinical developments for LYR-210 and LYR-220, and appointed Harlan W. Waksal, MD, as Executive Chairman.

Key Takeaways

Lyra Therapeutics reported a net loss of $13.6 million for the fourth quarter of 2021. The company's cash and cash equivalents were $45.7 million as of December 31, 2021. Key milestones included the initiation of the Phase 3 ENLIGHTEN I clinical trial for LYR-210 and the Phase 2 BEACON trial for LYR-220.

Initiated pivotal Phase 3 ENLIGHTEN program for surgically naïve chronic rhinosinusitis patients.

Initiated BEACON Phase 2 trial for LYR-220 in chronic rhinosinusitis patients with post-surgical anatomy.

Appointed Harlan W. Waksal, MD, as Executive Chairman.

Cash and cash equivalents totaled $45.7 million as of December 31, 2021.

Total Revenue
$271K
EPS
-$1.05
Previous year: -$0.46
+128.3%
Gross Profit
$257K
Cash and Equivalents
$45.7M
Previous year: $74.6M
-38.7%
Free Cash Flow
-$12.4M
Total Assets
$54.9M
Previous year: $80.8M
-32.1%

Lyra

Lyra

Forward Guidance

Lyra Therapeutics anticipates several key milestones in 2022, including the first patient dosed in the ENLIGHTEN II Phase 3 study for LYR-210 in mid-year, presentations of new LYR-210 data at COSM, and topline results from Part 1 of the Phase 2 BEACON study for LYR-220 around year end.

Positive Outlook

  • First patient dosed (FPI) in the ENLIGHTEN II Phase 3 study for LYR-210 is anticipated in mid-year 2022.
  • Two presentations of new LYR-210 data at COSM to be held April 27–May 1.
  • Screening is ongoing, and the FPI in the Part 1/non-randomized portion of the Phase 2 BEACON study for LYR-220 is anticipated in the first half of 2022.
  • FPI in the Part 2/randomized portion of the Phase 2 BEACON study is anticipated in the first half of the year.
  • Enrollment completion in the Phase 2 BEACON study is anticipated around year end.

Challenges Ahead

  • The company has incurred significant losses since inception and expects to incur losses for the foreseeable future.
  • The company's need for additional funding, which may not be available.
  • The company's limited operating history.
  • The fact that the company has no approved products.
  • The fact that the company's product candidates are in various stages of development.