Lyra Therapeutics(US:LYRA)2025-11-12 21:09Financial Performance - Collaboration revenue for the three months ended September 30, 2025, was $25 thousand, a decrease of 87.4% compared to $195 thousand for the same period in 2024[22]. - Total operating expenses for the nine months ended September 30, 2025, were $24,295 thousand, down 71.8% from $86,265 thousand in the same period of 2024[22]. - Net loss for the three months ended September 30, 2025, was $5,984 thousand, compared to a net loss of $11,873 thousand for the same period in 2024, indicating a 49.6% improvement[22]. - For the nine months ended September 30, 2025, the company reported a net loss of $21.97 million, a decrease from a net loss of $82.46 million in the same period of 2024[29]. - Net loss for Q3 2025 was $5,984,000, compared to a net loss of $11,873,000 in Q3 2024, representing a 49.6% improvement[72]. - Net loss for the nine months ended September 30, 2025, was $21,968, a reduction of 25.5% compared to a net loss of $82,456 in 2024[201]. Cash and Assets - Total current assets decreased from $43,025 thousand as of December 31, 2024, to $23,019 thousand as of September 30, 2025, representing a decline of 46.4%[21]. - Cash and cash equivalents decreased from $40,577 thousand as of December 31, 2024, to $22,055 thousand as of September 30, 2025, a reduction of 45.4%[21]. - As of September 30, 2025, the company had approximately $22.1 million in cash and cash equivalents, with an accumulated deficit of approximately $426.8 million[37]. - As of September 30, 2025, the company reported cash and cash equivalents of $22.1 million, down from $40.6 million as of December 31, 2024, indicating a decrease of approximately 45%[55]. - The company reported a net loss of $426.8 million from inception to September 30, 2025, with cash and cash equivalents of approximately $22.1 million[148]. Liabilities and Deficits - The accumulated deficit increased from $(404,790) thousand as of December 31, 2024, to $(426,758) thousand as of September 30, 2025, reflecting a worsening of 5.4%[21]. - Total liabilities decreased from $54,752 thousand as of December 31, 2024, to $48,037 thousand as of September 30, 2025, a decline of 12.2%[21]. - The company’s restructuring liability balance as of September 30, 2025, was $3.06 million, reflecting ongoing adjustments from severance and retention costs[63]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $4,047 thousand, down 31.4% from $5,902 thousand in the same period of 2024[22]. - The company expects research and development expenses to decrease due to a 75% workforce layoff in May 2024 and the completion of the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210[180]. - The primary product candidate, LYR-210, is designed to deliver six months of continuous anti-inflammatory drug therapy for chronic rhinosinusitis (CRS)[130]. - The Phase 3 ENLIGHTEN 2 trial for LYR-210 met its primary endpoint, showing statistically significant improvement in CRS symptoms at 24 weeks[131]. - Following the announcement that the Phase 3 ENLIGHTEN 1 trial did not meet its primary endpoint, the company reduced its workforce by approximately 75%, impacting 87 employees[133]. Financing Activities - The company raised $5.0 million in gross proceeds from financing activities in June 2025, contributing to a total of $429.8 million raised since inception[38]. - The company raised $44.0 million in gross proceeds from the 2023 Purchase Agreement, with net proceeds of $46.5 million after deducting issuance costs[88]. - The company received approximately $100.5 million in gross proceeds from the April 2022 Financing, with net proceeds of approximately $96.3 million after costs[91]. - The company generated $26.7 million in proceeds from the sale of 414,196 shares under its effective shelf registration statement as of September 30, 2025[74]. - The company has $50.2 million still available for future sale under the Amended Sales Agreement with Cantor Fitzgerald[85]. Stock and Equity - A reverse stock split of 1-for-50 was executed on May 27, 2025, to comply with Nasdaq's minimum bid price requirement[45]. - Following the reverse stock split, the company maintained a minimum bid price of $1.00 per share for over 10 consecutive business days, regaining compliance with Nasdaq on June 13, 2025[160]. - The company reported a basic net loss per share attributable to common stockholders, with potentially dilutive securities totaling 1,146,311 common stock equivalent shares excluded from the diluted net loss per share calculation[58]. - As of September 30, 2025, the company has reserved 1,380,577 shares of common stock for future issuances, including 1,142,231 stock warrants[93]. Impairments and Charges - The company recorded an impairment charge of $1.9 million for property and equipment due to the failure of the Phase 3 ENLIGHTEN 1 trial, which was included in the consolidated statements of operations for the year ended December 31, 2024[65]. - The company recognized an impairment charge of $22.8 million for right-of-use assets related to the same trial failure, recorded in the three months ended September 30, 2024[66]. - The company reported a loss of $1.6 million on impairment of long-lived assets due to a legal proceeding with a former CMO[124]. Collaboration and Licensing - The company recognized $5.1 million in collaboration revenue from the LianBio License Agreement, with no revenue from product sales expected in the foreseeable future[164]. - The company is eligible for up to $135.0 million in future milestone payments from LianBio based on the achievement of specified development, regulatory, and commercialization milestones[167]. - The future of the collaboration with LianBio is uncertain due to LianBio's strategic review and wind down of operations, which may impact the company's business and financial condition[173]. - The upfront payment under the LianBio License Agreement was $12.0 million, with $8.4 million allocated to the Combined Performance Obligation[103]. Operational Adjustments - The company is currently in the process of subleasing two of its three leased properties to reduce operating expenses[40]. - The company has paused commercialization efforts for its product candidates LYR-210 and LYR-220 following the failure of the Phase 3 ENLIGHTEN 1 trial[35]. - The company plans to finance its operations through a combination of equity or debt financings, collaboration agreements, and licensing arrangements, as it continues to incur operating losses[41]. - The company plans to conduct an additional confirmatory clinical trial for LYR-210 based on FDA requirements, while focusing on cash preservation and potential lease negotiations[163].