Lyra Therapeutics, Inc. Q1 FY2021 earnings call

• Lyra's goal is to transform ENT treatment by providing solutions for chronic rhinosinusitis (CRS) patients. • Presented full data from LANTERN Phase 2 study of LYR-210 at Combined Otolaryngology Spring Meetings. • Appointed Dr. Robert Kern as Chief Medical Officer. • Progress in tech transfer to contract manufacturer, with manufacturing equipment and infrastructure completed. • Upcoming sharing of feedback from end of Phase 2 meeting with FDA for LYR-210 and topline results from pharmacokinetic clinical study. • Plan to initiate Phase 2 trial for LYR-220 in second half of year and Phase 3 trial for LYR-210 around year end. • LYR-210 showed 100% of non-polyp and polyp patients achieved minimal clinically important difference in SNOT-22 score at week 24, improved objective imaging endpoint, and reduced rescue treatment need.

• Lyra believes it has sufficient cash to fund planned operations into 2023. • Anticipate sharing top line results of pharmacokinetic clinical study of LYR-210 this fall. • Plan to initiate Phase 2 trial for LYR-220 in second half of 2021 and Phase 3 trial for LYR-210 around year end.

• Forward-looking statements involve significant risks and uncertainties, including factors in risk factors and Form 10-Q that could cause actual results to differ from expectations.

Q: Curious about the time point for potential Phase 3 trial and choosing the time point.

A: Maria Palasis mentioned looking at SNOT-22 results and three cardinal symptoms, with later time points like 24 weeks showing statistically significant improvement.

Q: Status of manufacturing capabilities for Phase 3 trial and commercial readiness.

A: Technology transfer is on track, working with contract manufacturer, and automation is key for commercial readiness.

Q: Key agenda points for FDA meeting, study size, and inclusion criteria.

A: Maria Palasis discussed primary endpoint as composite of cardinal symptoms, time point up to 24 weeks, study size of approximately 350 patients, and high dose of 7,500 micrograms.

Q: Learnings from US experience in PK study and transfer to Phase III study, final design of LYR-220, and financial guidance.

A: Rob Kern mentioned ease of recruitment and acceptance in US for PK study; Maria Palasis said LYR-220 design is finalized at 7,500 microgram dose; Don Elsey discussed financial guidance includes planned operations like Phase 3 trials.