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Mar 31, 2021
Lyra Q1 2021 Earnings Report
Lyra Therapeutics reported financial results for the first quarter of 2021 and provided a corporate update.
Key Takeaways
Lyra Therapeutics reported a net loss of $7.8 million for the first quarter of 2021, with cash and cash equivalents totaling $66.1 million as of March 31, 2021. The company presented positive data from its LANTERN Phase 2 study of LYR-210 and appointed Robert Kern, MD, as Chief Medical Officer.
Presented positive full data set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual Event, demonstrating effectiveness in both non-polyp and polyp patients.
Commenced first manufacturing lot at CMO to support the IND supplement and the commencement of Phase 3 clinical trial for LYR-210 around the end of the year.
Appointed Robert Kern, MD, as Chief Medical Officer.
Management believes Lyra has sufficient cash to fund the company through planned operations into 2023.
Lyra
Lyra
Forward Guidance
Lyra Therapeutics anticipates sharing results from its PK study of LYR-210 in the second quarter, along with feedback from its End-of Phase-2 meeting with the FDA around mid-year. Subject to FDA guidance, the company plans to initiate a Phase 2 trial for LYR-220 in the second half of 2021 and a Phase 3 trial of LYR-210 around the end of the year. Management believes Lyra has sufficient cash to fund the company through planned operations into 2023.
Positive Outlook
- Presenting results from PK study of LYR-210 in Q2 2021.
- Sharing feedback from End-of Phase-2 meeting with the FDA around mid-year.
- Planning to initiate a Phase 2 trial for LYR-220 in the second half of 2021.
- Planning to initiate a Phase 3 trial of LYR-210 around the end of the year.
- Sufficient cash to fund operations into 2023.
Challenges Ahead
- Uncertainty regarding FDA guidance affecting trial plans.
- Clinical trials are expensive and time-consuming
- Reliance on third parties for manufacturing and clinical trials.
- Potential adverse impacts from the COVID-19 pandemic.
- Risk of failure to obtain and maintain intellectual property rights.