Mometasone Furoate

Company continues to focus on upcoming results from ENLIGHTEN 2 pivotal Phase 3 trial in CRS patients expected in 2Q 2025 Company reports topline safety results from ENLIGHTEN 1 Phase 3 extension study indicating no product-related serious adverse events and general consistency with the primary treatment phase WATERTOWN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the third quarter ended September 30, 2024 and provided a corporate update. “We look forward to key milestones in the coming months from the two ongoing ENLIGHTEN Phase 3 trials that will provide us with a more complete data set and greater insight into determining a potential pathway to approval for LYR-210 in CRS patients with and without nasal polyps. The topline 52-week safety data from the ENLIGHTEN 1 safety extension study was in-line with the primary treatment phase, with no product-related serious adverse events, including for those patients that received a repeat dose, resulting in a 12-month treatment period. We are anticipating additional data from the ENLIGHTEN 1 safety extension study in the coming months, which will be presented at an upcoming medical conference, as well as topline results from the ENLIGHTEN 2 pivotal trial expected in Q2 2025,” said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. Dr. Palasis continued, “We eagerly await the upcoming data readouts, and they will guide us in making data-driven evaluations as we determine the potential path for LYR-210 to add value for CRS patients, investors and other stakeholders.” 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. Topline Results from the ENLIGHTEN 1 52-week extension study Today, Lyra reported topline 52-week safety data from the ENLIGHTEN 1 safety extension study: Safety data for LYR-210 was generally consistent with the 24-week primary treatment phase, including for those patients that received a repeat dosing, resulting in a 12-month treatment period.LYR-210 was generally well tolerated, with no product-related serious adverse events. The most commonly reported adverse events in the study population were chronic sinusitis, nasal odor, epistaxis, sinusitis, and nasopharyngitis. Clinical Program Highlights Enrollment in ENLIGHTEN 2 completed In October 2024, Lyra 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, was fully enrolled, achieving the expected enrollment timeframe of second half of 2024. Milestones for Ongoing ENLIGHTEN Pivotal Program of LYR-210 in CRS Topline results from ENLIGHTEN 2 are expected in Q2 2025. Third Quarter 2024 Financial Highlights Cash, cash equivalents and short-term investments as of September 30, 2024 were $51.6 million, compared with $67.5 million at June 30, 2024. Based on our current business plan, we anticipate that our cash, cash equivalents and short-term investment balance is sufficient to fund our operating expenses and capital expenditures into the first quarter of 2026. Research and development expenses for the quarter ended September 30, 2024 were $5.9 million compared to $12.4 million for the same period in 2023, representing a decrease of $6.5 million. The decrease in research and development expenses for the three months ended September 30, 2024 was primarily attributable to a $3.8 million decrease in clinical related costs as we completed both the BEACON trial for LYR-220 and the primary study phase of the ENLIGHTEN 1 trial for LYR-210, a decrease of $2.5 million in employee related costs primarily driven by the reduction in force which occurred in May 2024, a decrease in professional and consulting costs of $0.4 million and a decrease in product development and manufacturing costs of $0.4 million. This decrease in costs was partially offset by an increase in allocated costs and depreciation of $0.6 million. General and administrative expenses for the quarter ended September 30, 2024 were $3.9 million compared to $5.0 million for the same period in 2023, representing a decrease of $1.1 million. The decrease in general and administrative expenses for the three months ended September 30, 2024 was primarily driven by a decrease in professional and consulting fees of $1.0 million as we scaled back activities subsequent to announcing in May 2024 that the ENLIGHTEN 1 trial did not meet its primary endpoint, in addition to a decrease in employee related costs of $0.5 million primarily due to the reduction in force which occurred in May 2024. These cost decreases were partially offset by an increase in allocation and support costs of $0.4 million primarily due to the increased rent and facilities expenses for the Company’s three leased facilities for the three months ended September 30, 2024 compared to the three months ended September 30, 2023. Net loss for the quarter ended September 30, 2024 was $11.9 million compared to $15.7 million for the same period in 2023. LYRA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Collaboration revenue $195 $544 $1,325 $1,412 Operating expenses: Research and development 5,902 12,368 37,404 35,763 General and administrative 3,931 5,003 14,888 14,700 Impairment of property and equipment — — 1,883 1,592 Impairment of right-of-use assets — — 22,836 — Restructuring and other related charges 2,804 — 9,254 — Total operating expenses 12,637 17,371 86,265 52,055 Loss from operations (12,442) (16,827) (84,940) (50,643)Other income: Interest income 576 1,192 2,517 3,161 Total other income 576 1,192 2,517 3,161 Loss before income tax expense (11,866) (15,635) (82,423) (47,482)Income tax expense (7) (16) (33) (42)Net loss (11,873) (15,651) (82,456) (47,524)Other comprehensive loss: Unrealized holding gain (loss) on short-term investments, net of tax 24 20 (13) (17)Comprehensive loss $(11,849) $(15,631) $(82,469) $(47,541)Net loss per share attributable to common stockholders— basic and diluted $(0.18) $(0.27) $(1.27) $(1.04)Weighted-average common shares outstanding— basic and diluted 65,456,735 56,953,685 64,981,219 45,894,643 LYRA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except share data) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $23,800 $22,353 Short-term investments 27,826 80,400 Prepaid expenses and other current assets 2,818 2,068 Total current assets 54,444 104,821 Property and equipment, net 1,613 2,043 Operating lease right-of-use assets 20,707 33,233 Restricted cash 1,992 1,392 Other assets — 1,111 Total assets $78,756 $142,600 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $2,292 $3,131 Restructuring liability 4,855 — Accrued expenses and other current liabilities 3,197 9,374 Operating lease liabilities 4,003 5,434 Deferred revenue 607 1,658 Total current liabilities 14,954 19,597 Operating lease liabilities, net of current portion 31,321 21,447 Deferred revenue, net of current portion 11,862 12,136 Total liabilities 58,137 53,180 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2024 and December 31, 2023; 65,456,735 and 57,214,550 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 65 57 Additional paid-in capital 414,345 400,685 Accumulated other comprehensive income, net of tax 20 33 Accumulated deficit (393,811) (311,355)Total stockholders’ equity 20,619 89,420 Total liabilities and stockholders’ equity $78,756 $142,600 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 and without nasal polyps. 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 November 12, 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.

对于慢性鼻窦炎的治疗，其常见药物治疗和手术治疗，在药物治疗无效后，功能性内镜鼻窦手术（FESS）是首选的外科治疗手段。但术后患者仍需要用药辅助治疗，帮助恢复。常见的术后鼻喷激素疗效未知，结合术后冲洗，用药率更拿捏不准，难以阻止较多并发症的出现，且易复发。 FESS初期并发症发生率为4%左右，严重手术并发症发率为0.31%~1.91%。常见的手术并发症就有术腔粘连，窦口狭窄/闭锁，息肉复发等。每年约有1/5的患者进行二次手术。 合肥启灏医疗科技有限公司（下称“启灏医疗”）自主研发的灏畅®全降解鼻窦药物支架能够在患者接受FESS手术治疗后，将药物精准到达靶位，持续一段时间的精确释放，降低术后并发症的发生，提高、延长治疗的有效性。该产品于2024年10月17日获国家药品监督管理局医疗器械批准上市（国械注准20243132055）。 10月31日（星期四）19:30，动脉新品鉴第107期，邀请到中山大学附属第一医院耳鼻咽喉科鼻科副主任&副主任医师赖银妍、河北医科大学第二医院耳鼻咽喉二科主任医师蔡丽、启灏医疗高级产品经理陈媛，带来启灏医疗旗下全新产品“灏畅®全降解鼻窦药物支架系统”，“灏畅®可降解膨胀止血绵”、“美合钉®全降解鼻中隔软骨固定系统”的产品介绍与创新性分享。 新品名称 ● 灏畅®全降解鼻窦药物支架系统 新品亮点 一、全降解鼻窦药物支架系统由全降解鼻窦支架（丙交酯-乙交酯共聚物）、药物涂层（糠酸莫米松）、输送系统和压握组件组成。 二、采用全新配比的平台材料，材料降解性能与支撑性能符合临床需求，可以提供大于28天的有效支撑。 三、载体的选择与载体配比完美结合，共同控制支架上药物的释放率及释放速率，保证28天内药物持续有效释放，持续发挥药物作用。 四、平台材料与载体完美结合，使药物释放与支撑性能及降解情况之间完美配合，支架降解维持在28天有效支撑的同时，药物得以有效充分释放，且药物利用率高；更为便捷、安全的支架输送装置。 五、补充说明： ① 载药：650μg 糠酸莫米松，强效的皮质类固醇，能够减少炎症、纤维蛋白沉积和肉芽组织形成，药物释放周期约 30 天。 ② 设计突破：对药物支架的压握盒进行了优化，在避免直接用手接触药物支架进行压缩的同时，还能避免压缩时支架被弹飞。 ③ 降解周期：经临床观察，4周以后开始降解，降解周期有个体化差异。 扫描海报二维码，添加小助手预约直播 嘉宾介绍 赖银妍|中山大学附属第一医院耳鼻咽喉科鼻科副主任&副主任医师 医学博士，鼻科副主任，副主任医师，硕士研究生导师 广东省精准医学应用学会过敏性疾病分会 副主任委员及秘书长 广东省医师协会变态反应分会 委员 广东省医师协会 委员广东省医学会 委员 广东省健康管理学会耳鼻咽喉头颈外科学专业委员会 常委 广东省第三届耳鼻咽喉头颈外科用药专委会 常委 中华医学会《世界耳鼻咽喉头颈外科杂志（英文）》第二届编委会 通讯编委 蔡丽|河北医科大学第二医院耳鼻咽喉二科主任医师 长期专注于耳鼻咽喉科鼻科学、鼻眼相关及鼻颅底相关领域方面的手术，拥有多年耳鼻喉科疾病诊治经验，具有北京同仁医院、上海复旦大学眼耳鼻喉医院鼻内镜手术专项培训经历。擅长功能性鼻内镜全组鼻窦开放手术、鼻中隔矫正术、经鼻鼻腔鼻窦良性及恶性肿瘤切除术、尖牙窝及泪前隐窝入路行上颌窦病变切除术、高选择性鼻后神经切断术以及鼻颅底及鼻眼相关手术等； 擅长慢性鼻－鼻窦炎、变应性鼻炎、真菌性鼻-鼻窦炎及耳鼻咽喉科常见病及多发病的诊治。承担河北省卫生厅课题多项，获河北省卫生厅医学科技二等奖2项，发表著作2篇，核心论文10余篇。  中华医学会会员，石家庄市退伍军人伤残认定专家组成员，中国中西医结合耳鼻咽喉科专业委员会鼻－鼻窦炎专家委员会委员，中国中西医结合耳鼻咽喉科专业委员会嗓音专家委员会委员，河北省健康教育与康复学会耳鼻咽喉头颈外科专委会常委，河北中西医结合耳鼻咽喉科专业委员会委员，河北省省级突发事件医疗应急专家库成员，2023年被审选为河北省卫生系列高级评委库入库人选。 陈媛|启灏医疗高级产品经理 临床医学硕士研究生，耳鼻咽喉头颈外科专业 主办方介绍 关于启灏医疗 启灏医疗总部位于合肥高新区启灏医疗产业园，是一家集研发、生产和销售的高新技术创新企业，与中科院兰州化学物理研究所共同建立了中科启灏生物医用材料技术联合实验室，具备高端研发和生产能力。 启灏医疗专注于耳鼻咽喉头颈外科(ENT)微创高端植入领域，秉承“创新、高效、专业、诚信”的理念，以多元创新为引领企业发展的第一动力，为临床提供丰富的产品与手术方案。 目前拥有多项国内自主研发的专利技术，其中创新产品“可降解膨胀止血绵”更是打破了进口技术壁垒，填补了国产领域技术的空白；“全降解鼻窦药物支架”已上市，实现便利给药，精准用药，原位降解的临床效果；颠覆传统缝合方式的美合钉®已经获批国家创新医疗器械，迈出鼻中隔成形术后固定新手段的历史一步；“泪点塞”产品获安徽省科技创新攻坚计划，探索鼻眼相关领域，直击广大干眼症患者需求。 启灏医疗未来还将陆续推出更多创新产品，致力为国内医疗行业突破技术旧难题，提供更优化治疗新思路。 关于动脉新品鉴 「动脉新品鉴」是助力医疗企业创新产品发布的直播栏目，栏目的宗旨是：助力每一个医疗创新产品里程碑发布。如果有企业有创新医疗产品或重大里程发布的计划，想参与动脉新品鉴栏目，请添加小助手咨询。 直播通道 方式一：小程序观看直播 扫描下方二维码联系小助手预约直播（如已添加过，请主动询问小助手） 方式二：上动脉网APP观看直播，幸运大奖等你拿 扫描下方二维码，下载动脉网APP报名观看直播 联系小助手发送直播截图，参与抽奖即有机会获取【动脉橙产业智库15天试用会员】 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。 动脉网，未来医疗服务平台