Lyra Therapeutics(LYRA) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Update Lyra Therapeutics reported Q2 2025 results, highlighting positive LYR-210 Phase 3 data and extended cash runway Overview Lyra Therapeutics reported Q2 2025 results, emphasizing positive LYR-210 Phase 3 data, driving manufacturing and regulatory strategy - Positive ENLIGHTEN 2 Phase 3 results for LYR-210 are propelling business activities in manufacturing, regulatory strategy, and clinical dataset analysis[2] - Financing announced in June 2025 extends the company's cash runway into the third quarter of 2026[2] - The company is optimizing its regulatory strategy and resuming manufacturing activities to advance LYR-210 as a six-month treatment option for chronic rhinosinusitis (CRS)[3] Recent Business Highlights Lyra Therapeutics completed a $5.0 million offering in June 2025, extending cash runway into Q3 2026, re-engaged FDA for NDA, and resumed manufacturing Financing Details (June 2025) | Metric | Amount | | :-------------------------------- | :------------- | | Gross proceeds from offering | ~$5.0 million | | Potential additional proceeds (warrant exercise) | ~$9.8 million | | Expected cash runway extension | Into 3Q 2026 | - Lyra has reengaged with the U.S. Food and Drug Administration (FDA) and is preparing for a Type C meeting in the second half of 2025 to align on a path forward for an NDA submission for LYR-210[4] - The company has resumed in-house chemistry, manufacturing and controls (CMC) activities to prepare for manufacturing LYR-210 for potential future clinical trials and regulatory compliance[4] Clinical Development Update This section provides an update on the clinical development of LYR-210, focusing on the ENLIGHTEN Phase 3 program results ENLIGHTEN Phase 3 Program Results The ENLIGHTEN program evaluated LYR-210 for chronic rhinosinusitis (CRS), with ENLIGHTEN 2 achieving primary and key secondary endpoints, demonstrating statistically significant improvement in cardinal CRS symptoms and SNOT-22 scores, particularly in patients without nasal polyps, while ENLIGHTEN 1 did not meet its endpoints - The ENLIGHTEN 2 Phase 3 trial met its primary endpoint, showing statistically significant improvement in a composite of the three cardinal symptoms (3CS) of CRS at week 24 (-1.13; p=0.0078) in patients without nasal polyps[10] - ENLIGHTEN 2 also met key secondary endpoints, including 3CS at 24 weeks in the full population (-0.90; p=0.0209) and clinically-validated SNOT-22 score at 24 weeks (-8.7; p=0.0101)[10] - In contrast, the ENLIGHTEN 1 trial did not meet its primary or secondary endpoints, as previously reported in May 2024[6] - LYR-210 was generally well tolerated in ENLIGHTEN 2, with no product-related serious adverse events[10] Financial Review This section provides a review of Lyra Therapeutics' financial performance, including key highlights for the second quarter of 2025 Second Quarter 2025 Financial Highlights Lyra Therapeutics reported a significant reduction in net loss for Q2 2025 to $7.4 million, driven by decreases in R&D and G&A expenses, and no significant impairment or restructuring charges, with cash and cash equivalents at $29.8 million and recent financing extending the cash runway into Q3 2026 Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | | :---------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $29.8 million | $40.6 million | Net Loss (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :------- | :---------- | :---------- | :---------- | | Net loss | $(7.4) million | $(48.1) million | $(40.7) million | Research and Development Expenses (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :---------------------- | :--------- | :---------- | :---------- | | R&D expenses | $5.1 million | $13.3 million | $(8.2) million | - The decrease in R&D expenses was primarily due to a $3.7 million decrease in clinical related costs (ENLIGHTEN 1 completion), a $1.4 million decrease in employee-related costs, and a $1.3 million decrease in product development and manufacturing costs[9] General and Administrative Expenses (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :---------------------- | :--------- | :--------- | :---------- | | G&A expenses | $3.5 million | $5.1 million | $(1.6) million | - The decrease in G&A expenses was primarily driven by a $0.7 million decrease in professional, consulting, and public company fees and a $0.9 million decrease in employee-related costs[12] - No impairment costs related to property and equipment or right-of-use assets were incurred in Q2 2025, compared to $1.9 million and $22.8 million, respectively, in Q2 2024[13] - Restructuring charges decreased significantly to $0.4 million in Q2 2025 from $6.5 million in Q2 2024[14] - Lyra implemented a 1-for-50 reverse stock split on May 27, 2025, and subsequently regained compliance with Nasdaq's minimum bid price requirement on June 13, 2025[10] Financial Statements This section presents the detailed consolidated financial statements of Lyra Therapeutics Consolidated Statements of Operations and Comprehensive Loss This section presents the detailed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, reflecting collaboration revenue, operating expenses, loss from operations, other income, net loss, and net loss per share Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Collaboration revenue | $183 | $598 | $366 | $1,130 | | Research and development | $5,110 | $13,264 | $9,986 | $31,502 | | General and administrative | $3,501 | $5,139 | $6,764 | $10,957 | | Impairment of property and equipment | $— | $1,883 | $— | $1,883 | | Impairment of right-of-use assets | $— | $22,836 | $— | $22,836 | | Restructuring and other related charges | $398 | $6,450 | $1,283 | $6,450 | | Total operating expenses | $9,009 | $49,572 | $18,033 | $73,628 | | Loss from operations | $(8,826) | $(48,974) | $(17,667) | $(72,498) | | Net loss | $(7,437) | $(48,131) | $(15,984) | $(70,583) | | Net loss per share (basic and diluted) | $(5.51) | $(36.76) | $(12.00) | $(54.51) | | Weighted-average common shares outstanding | 1,348,630 | 1,309,193 | 1,331,985 | 1,294,790 | Consolidated Balance Sheets This section provides the consolidated balance sheets for Lyra Therapeutics as of June 30, 2025, and December 31, 2024, detailing the company's assets, liabilities, and stockholders' equity Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Assets: | | | | Cash and cash equivalents | $29,784 | $40,577 | | Total current assets | $31,063 | $43,025 | | Total assets | $52,573 | $66,346 | | Liabilities: | | | | Total current liabilities | $11,163 | $12,631 | | Total liabilities | $50,951 | $54,752 | | Stockholders' Equity: | | | | Total stockholders' equity