Earnings release
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LYRA THERAPEUTICS Lyra Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update May 11 , 2021 - Presented positive full data from LANTERN Phase 2 study of LYR - 210 at COSM - Appointed Robert Kern , MD , as Chief Medical Officer - - Conference call and webcast today at 4:30 p.m. ET - WATERTOWN , Mass .-- ( BUSINESS WIRE ) -- May 11 , 2021-- 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 reported financial results for the quarter ended March 31 , 2021 and provided a corporate update . Key First Quarter 2021 and Subsequent Highlights • Presented positive full data set from LANTERN Phase 2 Study of LYR - 210 at COSM 2021 Virtual Event . In April , the company presented the positive full data set from its LANTERN Phase 2 study of LYR - 210 for the treatment of chronic rhinosinusitis ( CRS ) at the COSM 2021 Virtual Event . The new data demonstrated that LYR - 210 is effective in both non - polyp and polyp patients in a clinical trial with 100 % of patients in both groups achieving SNOT - 22 MCID at week 24 at 7500 µg . Further , LYR - 210 decreased ethmoid opacification at week 24 as well as reduced patient need for rescue medication . Previously , Lyra announced positive topline from the data in December 2020. We expect that the results from Lyra's LANTERN Phase 2 Study will be used to design a Phase 3 pivotal trial , subject to an End - of - Phase 2 meeting with the FDA in the second quarter 2021 . • Tech transfer to Contract Manufacturing Organization ( CMO ) on Track . The company commenced our first manufacturing lot at our CMO to support the IND supplement and the commencement of our phase 3 clinical trial for LYR - 210 around the end of the year . • Appointed Robert Kern , MD , as Chief Medical Officer . In February , the company appointed Dr. Robert Kern as Chief Medical Officer . Dr. Kern is a highly regarded clinician and researcher in the field of sinonasal disorders . With more than 30 years of experience in the ENT medical field and currently serving as the George A. Sisson Professor and Chair , Department of Otolaryngology - Head and Neck Surgery at Northwestern University Feinberg School of Medicine . Dr. Kern is expected to be a valuable asset to the company as clinical trials progress for LYR - 210 and LYR - 220 . " We were thrilled to present the full data set from our LANTERN Phase 2 Study of LYR - 210 at the virtual COSM event , and to share data that we believe demonstrates how effective our product candidate is at treating chronic rhinosinusitis . Dr. Cervin did a wonderful job detailing the symptom improvements observed in both polyp and non - polyp patients , as well as revealing evidence of disease modification through patient's improved bilateral ethmoid Zinreich scores , " said Maria Palasis , Ph.D. , President and Chief Executive Officer of Lyra Therapeutics . " Additionally , we announced a separate analysis of the LANTERN study that showed statistically significant improvement in a composite of three cardinal symptoms , which includes nasal blockage , nasal discharge and facial pain , that we believe could inform our design for a pivotal Phase 3 study . " Dr. Palasis continued : " Turning to the near term , we intend to share results from our PK study of LYR - 210 in the second quarter , and to share feedback from our End - of Phase - 2 meeting with the FDA around mid - year . Subject to guidance from the FDA , we then plan to initiate a Phase 2 trial for LYR - 220 in the second half of 2021 , and a Phase 3 trial of LYR - 210 around the end of the year . " Financial Highlights Cash and cash equivalents as of March 31 , 2021 were $ 66.1 million , compared with $ 74.6 million at December 31 , 2020 . Research and development expenses for the quarter ended March 31 , 2021 were $ 4.8 million compared to $ 3.0 million for the same period in 2020 . General and administrative expenses for the first quarter 2021 were $ 3.1 million compared to $ 1.3 million for the same period in 2020 . Total operating expenses for the quarter ended March 31 , 2021 were $ 7.8 million compared to $ 4.2 million for the same period in 2020 . Net loss for the first quarter was $ 7.8 million compared to $ 4.2 million for the same period in 2020 . In terms of financial guidance for 2021 , management believes Lyra has sufficient cash to fund the company through planned operations into 2023 . Conference Call Individuals interested in listening to the conference call may do so by dialing ( 833 ) 519-1249 for domestic callers , or ( 914 ) 800-3822 for international callers , and using the conference ID : 3067707 ; or from the webcast link in the investor relations section of the company's website at : www.lyratherapeutics.com . The recorded webcast will be available for replay for approximately 30 days following the call . About Lyra Therapeutics