Lyra Health, Inc.

-- Topline Results Expected Q2 2025 -- WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to the sinonasal passages for the treatment of CRS. Topline results from ENLIGHTEN 2 are expected in Q2 2025. “We are pleased to have fully enrolled the second of our two pivotal trials of LYR-210 in CRS patients, and our team is moving forward expeditiously to report the results in Q2 of next year,” said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. “We thank the participants and the investigators in the ENLIGHTEN studies who have enabled the evaluation of our technology that could potentially benefit patients with CRS.” About the ENLIGHTEN Pivotal Program The ENLIGHTEN program consists of two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each ENLIGHTEN trial has enrolled approximately 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control for 24 weeks. About LYR-210 LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioresorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 is being evaluated in the ENLIGHTEN pivotal Phase 3 clinical program. About Lyra TherapeuticsLyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with standard anatomy, primarily patients who have not undergone ethmoid sinus surgery. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn. Forward-Looking StatementsThis 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 whether LYR-210 could potentially benefit patients with CRS, the completion of the Company’s ENLIGHTEN 2 Phase 3 clinical trial, and the timing of the release of topline data from the ENLIGHTEN 2 Phase 3 clinical trial. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. 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 August 14, 2024 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.

WATERTOWN, Mass., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the Company will present results from the Phase 3 ENLIGHTEN 1 study for LYR-210, the company’s lead product candidate for CRS, at the 70th Annual Meeting of the American Rhinologic Society (ARS), taking place September 27-28 in Miami. The Company will also present additional results from the Phase 2 BEACON study for LYR-220 in adult patients with CRS who have had prior ethmoid sinus surgery at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), taking place September 28 - October 1 in Miami. A poster presentation on LYR-210 will be featured at the ARS Annual Meeting and an oral presentation on LYR-220 will be featured at the AAO-HNS Annual Meeting. Presentation Details: Poster PresentationAmerican Rhinologic Society (ARS) 2024 Annual Meeting Title: Efficacy and safety of LYR-210 for CRS from the pivotal Phase 3 ENLIGHTEN 1 trialPresenting Author: Vineeta Belanger, PhD, Lyra TherapeuticsDate and Time: Poster Session, Friday, September 27th at 1:00-8:00 p.m. ET Scientific Oral PresentationAmerican Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) 2024 Annual Meeting Title: LYR-220 24-Week Steroid-Eluting Sinus Insert Improves Smell and Sleep in Patients with Chronic RhinosinusitisPresenting Author: Zachary M. Soler, MD, MSc, Medical University of South Carolina, Charleston, SCDate and Time: Sunday, September 29th at 1:06 p.m. ETSession: Rhinology/Allergy (1:00 – 2:00 p.m. ET) About Lyra Therapeutics Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with standard anatomy, primarily patients who have not undergone ethmoid sinus surgery. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn. 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 date, time and details of the presentations at ARS and AAO-HNS. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. 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 August 14, 2024 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 Information:Jason Cavalier, Chief Financial Officer 917.584.7668 jcavalier@lyratx.com Media Contact:Kathryn Morris, The Yates Network LLC 914.204.6412kathryn@theyatesnetwork.com

BURLINGAME, Calif.--( BUSINESS WIRE )--Lyra Health, the leading provider of innovative Workforce Mental Health solutions for employers and health plans , and Hazelden Betty Ford Foundation , the nation's leading nonprofit provider of comprehensive addiction and mental health care today announced their collaboration to deliver the highest quality, specialized care for individuals and families battling with substance use disorder. Accessing high-quality mental health and substance use treatment can be complicated and overwhelming. Often, programs aren’t accepting new patients or are out of network and prohibitively expensive. As part of Lyra’s Complex Care program, Lyra and Hazelden Betty Ford Foundation are working together to help employers, families, and individuals more easily get connected to the right care for their needs. “Our Complex Care program is anchored to four key pillars: a specialized network of facility partners, dedicated multidisciplinary team of experts, comprehensive assessment and triage process, and true end-to-end support,” said Dr. Smita Das, Vice President of Psychiatry and Complex Care, Lyra Health. “We are incredibly proud to work with Hazelden Betty Ford Foundation to ensure that we deliver a highly coordinated level of care and family support to help individuals achieve their long-term substance use recovery goals.” “As the nation’s leader and most trusted source of high-quality care, successful outcomes and comprehensive behavioral health capabilities, Hazelden Betty Ford is grateful to work with a strong, like-minded collaborator like Lyra Health to extend their continuum and ultimately reach more people in the workplace,” said Bob Poznanovich, Hazelden Betty Ford’s chief business growth officer. ”Lyra is the first collaborator to fully leverage our new navigation model to maximize support and coordination of care for patients and their families and create a more tightly integrated continuum. We’re excited to be working together.” Hazelden Betty Ford provides treatment for adults, teens, and children identified for treatment, - and critical guidance and skill-building for caregivers throughout the entire care journey. Together, Lyra and Hazelden Betty Ford provide: Timely access to high-quality care: For an individual or family member seeking treatment, a dedicated Complex Care Specialist is assigned to ensure a continuum of seamless step-up and step-down care. Lyra’s dedicated program for substance use disorder and recovery supports all outpatient care and offers highly specialized therapy, medication management and confidential group sessions to support long term recovery. For more acute needs, Hazelden Betty Ford provides inpatient rehabilitation programs. Patients will receive streamlined intake and admission at any of Hazelden Betty Ford’s facilities located throughout the U.S. Dedicated multidisciplinary oversight team to manage care transitions between providers: Lyra Renew recovery support providers, the Complex Care team, and Hazelden Betty Ford work together to plan effortless transitions for patients who are moving from one level of care to another. This team works closely with the individual and their family to minimize wait or red tape. Support for the whole family: Caregivers play a critical support role in the long-term success of substance use recovery. Fast access to provider support, educational information, and tools to address the needs of the whole family are available throughout the outpatient and inpatient experience. To learn more about Lyra and Hazelden Betty Ford’s collaboration, join us for a special LinkedIn Live on October 1, 2024 at 11:00 AM PDT / 1:00 pm CDT. About Lyra Health Lyra Health is the leading provider of Workforce Mental Health benefits, available to more than 17 million people globally. Lyra is transforming access to life-changing mental health care using AI-powered provider matching, personalized support, and a digital platform to deliver evidence-based support for individuals and teams. Lyra quickly connects members to the largest dedicated global network of evidenced-based mental health providers and well-being tools, to address every mental health need and deliver outstanding positive outcomes that are equitable across diverse racial and ethnic groups. Peer-reviewed published research confirms Lyra’s transformative care model helps people recover twice as fast , and delivers a 26% average annual reduction in overall health care claims costs. For more information about Lyra Health’s Workforce Mental Health benefits for employers, visit lyrahealth.com . About the Hazelden Betty Ford Foundation The Hazelden Betty Ford Foundation is a force of healing and hope for individuals, families and communities affected by addiction to alcohol and other drugs. As the nation's leading nonprofit provider of comprehensive inpatient and outpatient addiction and mental health care for adults and youth, the Foundation has treatment centers and telehealth services nationwide as well as a network of collaborators throughout health care. Through charitable support and a commitment to innovation, the Foundation is able to continually enhance care, research, programs and services, and help more people. With a legacy that began in 1949 and includes the 1982 founding of the Betty Ford Center, the Foundation today is committed to diversity, equity and inclusion in its services and throughout the organization, which also encompasses a graduate school of addiction studies, a publishing division, an addiction research center, recovery advocacy and thought leadership, professional and medical education programs, school-based prevention resources and a specialized program for children who grow up in families with addiction. Learn more at HazeldenBettyFord.org . In addition to its award-winning adult treatment centers, located in multiple states, Hazelden Betty Ford has a nationally renowned Center for Teens, Young Adults and Families in Minnesota.