Core Viewpoint - Lyra Therapeutics is implementing significant workforce reductions and cost-cutting measures to extend its cash runway and focus on ongoing clinical trials for its product LYR-210, a treatment for chronic rhinosinusitis (CRS) [1][3][4]. Group 1: Workforce and Cost-Cutting Measures - The company is laying off approximately 75% of its workforce, affecting 87 employees, and has halted manufacturing and commercialization efforts [1][3]. - Lyra Therapeutics is seeking to sublease its facilities to significantly reduce operating costs and has paused efforts for another product candidate, LYR-220 [3][4]. - These measures are expected to extend the company's cash runway into 2026, with approximately $87.1 million in cash, cash equivalents, and short-term investments as of March 31, 2024 [3]. Group 2: Clinical Trials Focus - Lyra is concentrating on two ongoing ENLIGHTEN Phase 3 trials for LYR-210, which is a bioabsorbable sinonasal implant for CRS treatment [2][5]. - The ENLIGHTEN 1 trial did not meet its 24-week primary endpoint, and the company is analyzing this data to inform the completion of the 52-week extension phase, with results expected in Q4 2024 [2][5]. - The ENLIGHTEN program includes two randomized, blinded, sham-controlled trials designed to evaluate the efficacy and safety of LYR-210 in 180 CRS patients who have failed medical management [5][6]. Group 3: Product Information - LYR-210 is designed to deliver six months of continuous anti-inflammatory medication (7500µg mometasone furoate) to treat CRS, which affects up to four million patients annually in the U.S. [7][9]. - The product is intended for patients who have not undergone ethmoid sinus surgery, while LYR-220 is designed for those with enlarged nasal cavities due to previous surgeries [9].

WATERTOWN, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) ("Lyra" or the "Company"), today announced that it is advancing its goal to preserve capital by implementing a layoff of approximately 75% of its workforce, in addition to other cost-cutting measures. In the near term, Lyra Therapeutics will focus on the two ongoing ENLIGHTEN Phase 3 trials evaluating LYR- 210, a bioabsorbable sinonasal implant for the treatment of chronic rhinosinusitis (CRS). Lyra continues to analyz ...

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.44 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -34.62%. A quarter ago, it was expected that this company would post a loss of $0.33 per share when it actually produced a loss of $0.22, delivering a surprise of 33.33%.Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39273 Lyra Therapeutics, Inc. | Large accelerated filer | ☐ | Accelerated filer | ☐ | | - ...

Lyra Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update WATERTOWN, Mass., April 30, 2024 -- 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 first quarter ended March 31, 2024 and provided a corporate update. "With results imminent for our ENLIGHTEN 1 pivotal Ph ...

WATERTOWN, Mass., April 26, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (NASDAQ:LYRA) (the "Company" or "Lyra"), a clinical-stage biotech developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today announced that it has granted non-qualified stock options to purchase a total of 78,400 shares of Lyra Therapeutics common stock to 16 new non-executive employees as an inducement material to their acceptance of employment with Lyra Therapeutics. The ...

Product Development and Clinical Trials - LYR-210 and LYR-220 are designed to provide six months of continuous anti-inflammatory drug therapy for chronic rhinosinusitis (CRS) patients with a single administration[1]. - LYR-210 is currently undergoing a pivotal Phase 3 clinical trial called the ENLIGHTEN program, while LYR-220 has recently completed a Phase 2 clinical trial called BEACON[22][23]. - The Phase 3 ENLIGHTEN I trial, initiated in February 2022, involves approximately 180 adult CRS patients with a 2:1 randomization to receive LYR-210 (7,500 µg) or sham procedure[39]. - Enrollment for the ENLIGHTEN I trial was completed in September 2023, marking a significant milestone in the clinical development of LYR-210[39]. - The Phase 3 ENLIGHTEN II trial, initiated in September 2022, is ongoing and also targets approximately 180 adult CRS patients[40]. - The primary endpoint for both ENLIGHTEN I and ENLIGHTEN II trials is the change from baseline in the composite score of 3 cardinal symptoms at week 24[41]. - The Phase 2 trial reported that approximately 50% of patients experienced a durable response post-removal of LYR-210, with no worsening of 4CS scores from the Week 24 baseline[51]. - The Phase 2 LANTERN trial, LYR-210 at the 7,500 µg dose showed statistically significant improvement in 4CSS at week 16 (-1.47, p=0.021), week 20 (-1.61, p=0.012), and week 24 (-1.64, p=0.016)[47]. - In the Phase 2 trial, LYR-210 demonstrated a clinically relevant improvement in SNOT-22 scores within 2 weeks of treatment[38]. - In the Phase 2 BEACON trial for LYR-220, statistically significant improvement in the composite of the 3 cardinal symptoms of CRS was observed at week 24 (-1.50; p=0.02) and as early as week 4 (-0.87; p=0.037)[64]. - LYR-220 demonstrated a statistically significant improvement in SNOT-22 score at week 24 (-16.8; p=0.007) and sustained improvements throughout the study[65]. Market Potential and Patient Demographics - Approximately 14 million people in the United States are affected by CRS, with an estimated 4 million failing medical management annually[26]. - The estimated prevalence of sinusitis, including CRS, is approximately 30 million people in the U.S., making it the fifth most common condition in adults under 65[26]. - The company estimates that 40% of CRS patients have had prior surgery, representing a significant addressable market for LYR-220[59]. - LYR-210 is designed for patients who have not undergone ethmoid sinus surgery, while LYR-220 targets those who have had such surgery and still require treatment[22][23]. Technology and Drug Delivery - The technology behind LYR-210 and LYR-220 allows for localized delivery of mometasone furoate (MF), minimizing systemic side effects associated with oral steroids[29]. - The proprietary drug delivery technology allows for sustained delivery of medications for six months from a single administration, targeting deep tissues in the ENT passages[70]. - LYR-210 is designed to be administered in a simple, in-office procedure, enhancing convenience for both patients and physicians[32]. - LYR-210 achieved a significant improvement in SNOT-22 scores, with an average change from baseline of -20.5 points at week 24 (p < 0.0001) and -20.0 points at week 25 (p < 0.0001) in the Phase 1 trial[37]. Financial Overview and Funding - The company incurred operating losses of approximately $62.7 million and $55.3 million for the fiscal years ended December 31, 2023, and December 31, 2022, respectively[149]. - The company has not commercialized any products and has never generated revenue from product sales[149]. - The company expects to continue incurring significant additional operating losses for the foreseeable future as it advances product candidates through pre-clinical and clinical development[150]. - The company has a limited operating history and a history of escalating operating losses, making it difficult to evaluate future viability[146]. - The company is dependent on securing additional financing to avoid delays or reductions in research and development programs[154]. - Future funding requirements will depend on various factors, including clinical trial results and regulatory approval timelines[157]. Regulatory Environment - The company must submit a New Drug Application (NDA) to the FDA demonstrating that product candidates are safe and effective for their intended use[150]. - The FDA has a goal of 10 months to review and act on a standard NDA and 6 months for a priority NDA, which significantly impacts the timeline for product approval[104]. - The FDA may require a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of a drug outweigh its risks[106]. - The FDA strictly regulates marketing and promotion of approved drugs, allowing promotion only for approved indications[129]. - The regulatory approval process is lengthy and costly, typically taking many years and requiring substantial resources for research and testing[214]. - The company is subject to extensive regulation by the FDA, requiring substantial time and financial resources for compliance throughout the product development process[96]. Manufacturing and Supply Chain - The company is currently improving manufacturing capabilities and increasing capacity to support larger scale clinical studies and commercialization, with a new lease executed in May 2022 for manufacturing and office space in Waltham, Massachusetts[90]. - The company has transitioned most of its clinical manufacturing from a contract manufacturing organization (CMO) to an in-house facility to produce LYR-210 and LYR-220, with plans to scale up manufacturing capabilities in a new facility in Waltham, Massachusetts[188]. - The company relies on single source suppliers for some components, which may impact the ability to supply products and develop candidates if not managed effectively[89]. - The company plans to enter into manufacturing, supply, and quality agreements with single source suppliers to ensure compliance with regulatory requirements[89]. Competitive Landscape - Key competitive factors for LYR-210 and LYR-220 include efficacy, safety, tolerability, reliability, convenience of administration, price, and reimbursement[87]. - The company faces significant competition in securing collaborations for the development and commercialization of its drug candidates, which may impact its market potential[176]. - The company may not successfully identify and commercialize additional product candidates, which could adversely affect its business strategy and financial position[177]. - The company has not conducted head-to-head trials comparing LYR-210 to other treatments, which could impact its market adoption if results are unfavorable[195]. Challenges and Risks - The company may face challenges in obtaining marketing approvals in international jurisdictions, which could limit its ability to market products globally[174]. - The company has faced challenges in patient enrollment for clinical trials, which could adversely affect the completion of these trials and subsequent regulatory approvals[219]. - The COVID-19 pandemic has caused delays in clinical trials and regulatory inspections, which may continue to affect the approval process[218]. - The company may incur additional operating expenses due to delays in pre-clinical studies or clinical trials, which can arise from various factors including regulatory disagreements and recruitment challenges[181]. - The company has experienced setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, which could delay or prevent regulatory approval[194].

Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update -- Data from ENLIGHTEN I Pivotal Phase 3 Trial of LYR-210 in Chronic Rhinosinusitis (CRS) Anticipated Q2 2024 -- WATERTOWN, Mass., March 21, 2024 -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) ("Lyra" or the "Company"), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ 480 Arsenal Way Watertown, MA 02472 (I.R.S. Employer Identification No.) (Address of principal executive offices) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) Delaware 84-1700838 (State or other jurisdiction of incorporation or organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ...