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LYRA THERAPEUTICS Lyra Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Accomplishments August 9 , 2021 - Successful EOP2 FDA meeting for LYR - 210 in CRS ; Phase 3 program on track to begin around year - end 2021 - - Licensing agreement with LianBio for LYR - 210 in Greater China and other Asian markets - - Positive topline results of LYR - 210 PK study support 505 ( b ) ( 2 ) NDA pathway - WATERTOWN , Mass . , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) Lyra Therapeutics , Inc. ( Nasdaq : LYRA ) , a clinical - stage therapeutics company leveraging its proprietary XTreoTM platform to enable precise , sustained , and local delivery of medications to the ear , nose and throat ( ENT ) passages and other diseased tissues , today reported financial results for the quarter ended June 30 , 2021 , and highlighted recent accomplishments . Recent Company Highlights • In June , Lyra announced the positive outcome of its End - of - Phase 2 meeting with the U.S. Food and Drug Administration ( FDA ) for LYR - 210 for the Treatment of Chronic Rhinosinusitis ( CRS ) . Lyra and the FDA established key elements of the Phase 3 program to support a 505 ( b ) ( 2 ) new drug application , including the single primary endpoint , which will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS . • Lyra announced a strategic partnership and exclusive license agreement with LianBio to develop and commercialize LYR - 210 in Greater China and other Asian markets . Lyra received an upfront payment of $ 12 million and is eligible to receive up to $ 135 million in future payments based upon development , regulatory and commercialization milestones , as well as low double - digit royalties on net sales of LYR - 210 in the licensed territories . • The Company announced positive topline results of a pharmacokinetic ( PK ) study of LYR - 210 in patients with CRS . The data were supportive of LYR - 210's safety profile and provide a PK bridge to the established safety of mometasone furoate for a 505 ( b ) ( 2 ) pathway for New Drug Approval ( NDA ) submission . " Following our successful End - of - Phase 2 meeting with the FDA , we believe that we have a clear path forward to advance LYR - 210 into Phase 3 clinical development for the treatment of Chronic Rhinosinusitis , which we expect to begin around year - end , " said Maria Palasis , PhD , President and Chief Executive Officer of Lyra Therapeutics . " Our second CRS product , LYR - 220 for post - surgical CRS patients , is also advancing and remains on track to enter Phase 2 later this year . We believe LYR - 210 and LYR - 220 will disrupt the current CRS treatment landscape by providing a new pharmacologic solution for the full spectrum of the 4 million U.S. CRS patients who fail medical management each year . " Second Quarter 2021 Financial Highlights • Cash and cash equivalents as of June 30 , 2021 were $ 69.0 million , compared with $ 74.6 million at December 31 , 2020 . The Company expects its cash balance to be sufficient to fund its planned operations into 2023 . • Research and development expenses for the quarter ended June 30 , 2021 were $ 7.5 million compared to $ 2.1 million for the same period in 2020 . • General and administrative expenses for the second quarter 2021 were $ 3.6 million compared to $ 2.4 million for the same period in 2020 . • Total operating expenses for the quarter ended June 30 , 2021 were $ 11.1 million compared to $ 4.5 million for the same period in 2020 . • Net loss for the second quarter was $ 11.0 million compared to $ 4.5 million for the same period in 2020 . Conference Call and Webcast Details LYRA will host a conference call and live webcast today at 4:30 p.m. ET . To access the live call by phone , dial ( 833 ) 519-1249 ( domestic ) or ( 914 ) 800-3822 ( international ) and use the conference ID : 6997916. To access the live webcast of the call , please visit the Investor Relations section of the Lyra Therapeutics website at https://investors.lyratherapeutics.com/ . The recorded webcast will be available for replay for approximately 30 days following the call . About Lyra Therapeutics Lyra Therapeutics , Inc. is a clinical - stage therapeutics company leveraging its proprietary XTreoTM platform to enable precise , sustained , local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches . Lyra's XTreoTM platform is comprised of a biocompatible mesh scaffold , an engineered elastomeric matrix and a versatile polymer - drug complex . The company's current pipeline of therapeutics target tissues deep in the ear , nose and throat passages and are designed to deliver continuous drug therapy for months following a single non - invasive , in - office administration . Lyra's lead product candidate , LYR - 210 , is in late - stage clinical development for the treatment of chronic rhinosinusitis and is designed