WATERTOWN -
Corporate Update & Anticipated Milestones for 2021
LYR-210: Announced Positive Topline Results for the company's LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its LANTERN Phase 2 study of LYR-210 for the treatment of Chronic Rhinosinusitis (CRS), including: 7500 mcg dose achieved statistically significant improvement in a composite score of the 4 Cardinal Symptoms of CRS at weeks 16, 20 & 24 compared to control.
7500 mcg achieved statistically significant improvement in SNOT-22 at weeks 8, 16, 20 & 24 compared to control.
LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing.
Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward to a pivotal Phase 3 trial using the 7500 mcg dose.
LYR-210: End of Phase 2 Meeting with FDA Expected Mid 2021. The company anticipates meeting with the FDA mid-2021 to discuss the results from the LANTERN Phase 2 trial, and intends to initiate a pivotal Phase 3 trial at the end of 2021.
LYR-210: Results From PK (pharmacokinetic) Study Expected 2Q 2021.
LYR-220: Initiation of Phase 2 Study in 2H 2021. Lyra anticipates initiating a Phase 2 study for LYR-220 in the late second half of 2021. The company believes the LANTERN study validates its XTreo platform and also plans to utilize the 7500 mcg for LYR-220.
Cash runway into 2023. Lyra maintains a strong balance sheet and reaffirms its previously announced guidance of having sufficient cash to fund operations into 2023. Cash and equivalents as of
'Having recently announced positive topline results from our LANTERN Phase 2 study of LYR-210, we enter 2021 planning and preparing for our pivotal trial, as we seek to continue development of this innovative product candidate and to ultimately bring it to millions of underserved CRS patients,' said Maria Palasis, Ph.D., CEO of
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the company's lead product candidate LYR-210, the presentation of top-line results relating to the Company's Phase 2 LANTERN clinical trial for LYR-210, the Company's plans to initiate a pivotal Phase 3 study for LYR-210 at the end of 2021, the Company's anticipated announcement and use of data from its ongoing PK study, the Company's initiation of a Phase 2 study for LYR-220, and its cash guidance. These and other important factors discussed under the caption 'Risk Factors' in the company's Quarterly Report on Form 10-Q filed with the
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