Loading...
•
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.
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.