WATERTOWN - 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.'

About Lyra Therapeutics

Lyra Therapeutics, Inc. is 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. The company's lead product candidate, LYR-210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines for sustained periods with a single administration.

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 SEC on November 10, 2020 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

Contact:

Laurence Watts

Tel: 619-916-7620

Email: laurence@gilmartinir.com

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