LYRA

• Clinical progress: Generated data strengthening LYR-210's profile, announced positive LANTERN and PK study results, both presented at ARS; Phase 3 ENLIGHTEN for LYR-210 and Phase 2 BEACON for LYR-220 to initiate around year end.
• Corporate news: Jason Cavalier appointed CFO in September, bringing investment banking experience; Focus on CRS market with large underserved patient population, Lyra's mission to provide first treatment for CRS patients using XTreo platform.
• Product details: LYR-210 for surgically naive CRS patients post topical steroid failure, LYR-220 for postsurgical CRS patients; Both are small shape memory implants placed via ENT office endoscopy.

• Phase 3 ENLIGHTEN program for LYR-210 and Phase 2 BEACON program for LYR-220 to initiate around year end.
• Expect enrollment in Phase 3 ENLIGHTEN over 12 months and Phase 2 BEACON starting this month with enrollment through 2022.
• Lyra has sufficient cash to fund operations through 2022.

On the clinical front, Lyra continued to make progress with the lead candidate LYR-210. New positive data from the Phase 2 LANTERN post-treatment evaluation showed continued safety and durable response six months post removal, and the 56-day pharmacokinetic study validated LYR-210's steady drug release. On the corporate front, Jason Cavalier was appointed as Chief Financial Officer in September. There are no specific absolute financial figures for product segments in terms of revenue contribution as the focus is on clinical and corporate developments related to CRS treatments leveraging the XTreo platform technology.

• Factors causing results to differ from forward-looking statements described in the company's Form 10-Q filed on November 9, 2021; Undue reliance on forward-looking statements should be avoided.

Q: Update on manufacturing capacity and second sourcing?

A: Maria Palasis said they are in good shape with current manufacturing for clinical studies, will scale up with contract manufacturer and will have additional backup sources for manufacturing in the future.

Q: What stood out in Phase 2 data for winning the Clinical Science Maurice Cottle Award?

A: Robert Kern stated the magnitude of response with single administration, robust statistics, and dose response were key factors; Maria Palasis added the dose response seen in the study was validating.

Q: Update on LianBio development plan?

A: Corinne Noyes said LianBio is on track to participate in Phase 3 studies and submit/commercialize shortly after the U.S.

Q: Trajectory of R&D going forward?

A: Jason Cavalier said there would be a slight uptick in R&D due to manufacturing and clinical expenses for ongoing trials.

Q: Enrollment timeline for Phase 3 and Phase 2 studies?

A: Maria Palasis said Phase 3 enrollment expected over 12 months, Phase 2 LYR-220 study initiating this month with enrollment through 2022.

Q: LianBio milestone payments and Phase 2 220 open label data?

A: Jason Cavalier said specifics on LianBio milestones not disclosed; Maria Palasis said open label data from Phase 2 220 study expected in second half of 2022