Lyra Therapeutics, Inc. Q2 FY2021 earnings call

• Second quarter was exciting with release of LANTERN Phase 2 full data set, successful End-of-Phase 2 meeting with FDA for lead program, licensing agreement in Greater China and other Asian markets with LianBio, and positive top-line results from PK study for LYR-210. • Proprietary XTreo technology platform is key, with product candidates targeting disease sites for chronic illness management. • LYR-210 Phase 3 and LYR-220 Phase 2 clinical programs set to advance around end of 2021. • Chronic rhinosinusitis is an underserved market, and LYR-210 and 220 aim to transform the treatment landscape. • Financials: ended Q2 with $69 million in cash and cash equivalents, total operating expenses $11.1 million in Q2, net loss $11.1 million. • Upcoming events: August 31 event on CRS treatment landscape, and abstracts accepted for American Otolaryngology society meeting. • Publications accepted in leading journals for LANTERN study and preclinical research on LYR-210.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Plan to initiate Phase 3 for LYR-210 and Phase 2 for LYR-220 around end of 2021. • Expect data from LYR-220 trials towards end of 2022 and readout from LYR-210 trials in 2023. • Confident in bringing LYR-210 to Asia through partnership with LianBio.

• Forward-looking statements involve significant risks and uncertainties, including those described in risk factors and Form 10-Q.

Q: Could you provide more color on Lyra-220 study size, endpoints?

A: LYR-220 study estimates ~60 patients, will evaluate safety, pharmacokinetics, CRS symptoms via SNOT-22 score and cardinal symptoms, with three arms including control.

Q: Thoughts on M&A in the sector and implications for Lyra?

A: Medtronic acquiring Intersect ENT is good news, Lyra's products are uniquely differentiated and can leverage Medtronic's work.

Q: Comment on how LYR-210 is differentiated from biologics?

A: Biologics are for small market of patients who failed surgery with extensive polyps, have systemic side effects, while LYR-210 is for larger market, simple office procedure, avoids systemic side effects.

Q: Inclusion/exclusion criteria difference between Phase 3 and Phase 2 for LYR-210?

A: Phase 3 will mirror Phase 2 but primary endpoint is composite of three cardinal symptoms, and will use CT instead of MRI.

Q: Color on LianBio milestone payments?

A: Milestone payments are regulatory, clinical, and commercial in US and Asia, no further specifics given.

Q: Breakdown of R&D spend and G&A?

A: No granular breakdown of R&D spend between tech transfer and clinical operations given; G&A not necessarily a new run rate, some episodic factors drove Q2 higher.