Lyra Therapeutics Provides Corporate Update and Anticipated Milestones for 2021

Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today provided a corporate update and anticipated milestones for 2021.

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. Lyra Therapeutics expects to announce data from its ongoing PK study, which has completed enrollment at 24 patients in the U.S., in the second quarter. The company expects to use the data from this study to support LYR-210’s path to regulatory approval through a 505(b)(2) New Drug Application.
• 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 31 December 2020 was $74.6 million, which exceeds prior guidance of $67-70 million.

“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 Lyra Therapeutics. “In addition, Lyra intends to initiate a Phase 2 trial for LYR-220 and to explore the further opportunities we believe exist for our now validated XTreo platform.”