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Lyra Therapeutics, Inc. (Nasdaq: LYRA) is a clinical-stage therapeutics company focused on advancing and commercializing innovative drug and delivery solutions specifically designed for ear, nose, and throat diseases. Founded in 2005 and headquartered in Watertown, Massachusetts, Lyra Therapeutics leverages its proprietary XTreo™ technology platform to deliver sustained medication directly to the targeted tissue via a single administration.
The company's primary product candidates, LYR-210 and LYR-220, are bioresorbable polymeric matrices targeting the treatment of chronic rhinosinusitis (CRS). These candidates are formulated to provide up to six months of continuous drug therapy through a non-invasive, in-office procedure. LYR-210 is intended for patients who have not undergone sinus surgery, while LYR-220 is designed for those who have had prior ethmoid sinus surgery.
Recent advancements include the BEACON Phase 2 clinical trial of LYR-220, which demonstrated significant improvement in CRS patients post-surgery, and the ongoing ENLIGHTEN Phase 3 clinical trials of LYR-210, targeting patients who have not had surgery. Lyra's financial condition remains robust, with cash and short-term investments totaling $102.6 million as of September 30, 2023, expected to support operations into the first quarter of 2025.
Lyra Therapeutics continues to innovate within the CRS treatment landscape, aiming to address the unmet medical needs of the estimated four million CRS patients in the United States who fail to respond to existing treatments annually. The company remains committed to advancing its product portfolio and achieving regulatory milestones to bring these therapies to market.
Lyra Therapeutics (LYRA) announced significant advancements in its XTreo™ technology platform, demonstrating effective dosing of anti-inflammatory medication for Chronic Rhinosinusitis (CRS). The preclinical study published in the American Journal of Rhinology & Allergy confirmed that LYR-210, utilizing XTreo™, surpassed traditional intranasal corticosteroid sprays in targeting and sustaining drug release. With LYR-210 now entering Phase 3 studies, the company aims to address the needs of the 14 million CRS patients in the U.S., specifically those who failed conventional treatments.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) announced that its President and CEO, Maria Palasis, Ph.D., will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 a.m. ET. The presentation will be available for on-demand viewing, and a webcast can be accessed in the Investor Relations section of Lyra's website. Lyra is focused on local drug delivery in ENT treatments, with its lead product candidate, LYR-210, entering Phase 3 for chronic rhinosinusitis, and LYR-220 entering Phase 2. Both candidates aim for up to six months of therapy from a single treatment.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) will host a Chronic Rhinosinusitis (CRS) Key Opinion Leader Event on August 31, 2021, from 3:00 p.m. to 4:30 p.m. ET. Dr. Robert Kern will moderate a discussion featuring experts Dr. Amber Luong and Dr. Brent Senior. The company is advancing its LYR-210 and LYR-220 candidates for CRS, targeting four million U.S. patients annually. Phase 3 trials for LYR-210 and Phase 2 for LYR-220 are expected to commence by the end of 2021. A live webcast will be available on their Investor Relations website.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) reported significant advancements during its second quarter of 2021. The company successfully completed an End-of-Phase 2 meeting with the FDA for LYR-210, aiming to initiate a Phase 3 program by year-end 2021. A licensing deal with LianBio for LYR-210 in Greater China has been established, including an upfront payment of $12 million and up to $135 million in milestone payments. Financially, the company reported a net loss of $11 million, and cash reserves stood at $69 million, sufficient to fund operations into 2023.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) will report its second quarter 2021 financial results on August 9, 2021, post-market. The company will host a conference call at 4:30 p.m. ET to discuss the results and provide updates. Lyra is focused on precise, sustained medication delivery in ENT passages through its XTreo™ platform. Its lead product candidate, LYR-210, is under late-stage development for chronic rhinosinusitis, designed to deliver anti-inflammatory therapy for up to six months. Investors can access the call via phone or live webcast.
Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company, announced that Maria Palasis, Ph.D., President and CEO, will present at the William Blair Biotech Focus Conference on July 15, 2021, at 10:00 a.m. ET. The discussion will focus on Lyra's proprietary XTreo™ platform, designed for local drug delivery to ENT passages. Lyra’s lead product candidate, LYR-210, aims to treat chronic rhinosinusitis, offering up to six months of therapy from a single administration. A live webcast will be available on the company’s Investor Relations website.
Lyra Therapeutics announced positive topline results from its pharmacokinetic study of LYR-210, a novel treatment for chronic rhinosinusitis (CRS). The study, involving 24 patients over 56 days, confirmed LYR-210's safety and established a pharmacokinetic profile supporting a 505(b)(2) New Drug Application pathway. Both dosage groups (2500 µg and 7500 µg) showed well-tolerated results, with plasma concentrations significantly below established safety thresholds. The company anticipates initiating a Phase 3 clinical program by year-end, underscoring LYR-210's potential as a non-invasive treatment option for CRS patients.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) announced a successful End-of-Phase 2 meeting with the FDA regarding LYR-210 for chronic rhinosinusitis (CRS). The upcoming Phase 3 program will include 350 subjects across two trials, aiming to demonstrate improvement in CRS symptoms at week 24. Encouragingly, previous trials indicated significant symptom reduction. The FDA's approval of the 505(b)(2) application pathway allows for an efficient study design, potentially incorporating Asian patients, and suggests a clear path forward for LYR-210’s clinical development.
Lyra Therapeutics (LYRA) has entered a strategic partnership with LianBio to develop and commercialize LYR-210, an anti-inflammatory drug for chronic rhinosinusitis (CRS), across Greater China, South Korea, Singapore, and Thailand. Lyra will receive an upfront payment of $12 million and could earn up to $135 million based on future milestones. The agreement allows LianBio to license LYR-210 and potentially LYR-220 in the region. This collaboration aims to address the significant unmet medical need for CRS patients, with an estimated 88 million adult CRS patients in China.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) announced that its President and CEO, Maria Palasis, Ph.D., will participate in a fireside chat at the William Blair 41st Annual Growth Stock Conference on June 3, 2021, at 11:30 am EDT. Investors can access a live audio webcast from the company's website, with a replay available for 30 days. Lyra focuses on drug delivery solutions for ENT diseases, with its lead candidate, LYR-210, targeting chronic rhinosinusitis. The company also develops LYR-220 for post-surgery CRS patients, leveraging its XTreo™ platform.
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