分组1 - Lyra Therapeutics reported a quarterly loss of $5.51 per share, which was better than the Zacks Consensus Estimate of a loss of $5.79, and an improvement from a loss of $14.5 per share a year ago, resulting in an earnings surprise of +4.84% [1] - The company posted revenues of $0.18 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 26.21%, although this was a decline from year-ago revenues of $0.6 million [2] - Lyra Therapeutics shares have declined approximately 35.4% year-to-date, contrasting with the S&P 500's gain of 8.4% [3] 分组2 - The earnings outlook for Lyra Therapeutics is mixed, with the current consensus EPS estimate for the upcoming quarter at -$6.52 on revenues of $0.15 million, and -$2.02 on revenues of $0.45 million for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the top 35% of over 250 Zacks industries, suggesting that companies in the top half tend to outperform those in the bottom half by more than 2 to 1 [8]

FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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. (Exact Name of Registrant as Specified in its Charter) Delaw ...

Exhibit 99.1 Lyra Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update – Positive ENLIGHTEN 2 Phase 3 results announced in June 2025 propel business activities in manufacturing, regulatory strategy and ENLIGHTEN clinical dataset analysis to advance path forward for LYR-210 for treatment of chronic rhinosinusitis (CRS) – – Financing announced in June 2025 extends cash runway into 3Q 2026 – WATERTOWN, Mass., August 12, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasda ...

Core Points - Lyra Therapeutics, Inc. has announced a definitive agreement for a registered direct offering of 423,372 shares of common stock and concurrent private placement of warrants to purchase up to 846,744 shares of common stock, with a combined effective purchase price of $11.81 per share [1][3] - The gross proceeds from the offering are expected to be approximately $5.0 million, with potential additional proceeds of approximately $9.8 million if the private placement warrants are fully exercised [3][4] - The company intends to use the net proceeds for working capital and other general corporate purposes, including clinical development and pre-commercialization expenses for LYR-210 [3] Offering Details - The offering is expected to close on or about June 27, 2025, subject to customary closing conditions [3] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The securities offered in the registered direct offering are being made pursuant to a shelf registration statement previously filed with the SEC [5] Private Placement Warrants - The private placement warrants have an exercise price of $11.56 per share and will expire twenty-four months after the effective date of the resale registration statement [1] - The private placement warrants were offered in a private placement under Section 4(a)(2) of the Securities Act and have not been registered under the Act [6]

Company Overview - Lyra Therapeutics (NASDAQ: LYRA) is focused on developing corticosteroid-eluting implants specifically for the treatment of chronic rhinosinusitis [1] - The company is working on two main products: LYR-210 for patients without prior surgery and LYR-220 for patients who have undergone prior ethmoid sinus surgery [1] Product Details - The implants are designed to be a single therapy that can be easily placed in an ENT's office, enhancing convenience for both patients and healthcare providers [1]

Core Viewpoint - Lyra Therapeutics, Inc. (LYRA) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - For Lyra Therapeutics, the recent increase in earnings estimates suggests an improvement in the company's underlying business, likely leading to a rise in stock price [5][10]. Earnings Estimate Revisions - Over the past three months, the Zacks Consensus Estimate for Lyra Therapeutics has increased by 58.6%, with expectations of earnings at -$12.01 per share for the fiscal year ending December 2025, indicating no year-over-year change [8][10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a "Strong Buy" or "Buy" rating, highlighting their potential for market-beating returns [9][10].

Core Insights - Lyra Therapeutics (LYRA) shares surged 355.5% in one week following positive results from the late-stage study of LYR-210 for chronic rhinosinusitis (CRS) [2][6] - LYR-210 is a bioabsorbable nasal implant that provides six months of continuous anti-inflammatory medication [2] Study Results - The phase III ENLIGHTEN 2 study met its primary endpoint, showing significant improvement in the three cardinal symptoms of CRS at week 24 in patients without nasal polyps [3] - Key secondary endpoints were also achieved, with significant improvements in symptom scores and the Sino-Nasal Outcome Test (SNOT-22) at week 24, with symptom relief observed as early as week 4 [4][6] - LYR-210 demonstrated a safety profile comparable to sham control, with most adverse events being mild to moderate [5] Future Plans - Following the success of the ENLIGHTEN 2 study, Lyra plans to discuss the data with the FDA and may seek approval for LYR-210 in CRS patients without nasal polyps [10] - Encouraging findings from the combined analysis of ENLIGHTEN 1 and ENLIGHTEN 2 support further development of LYR-210 for patients with nasal polyps [12] Market Performance - Year-to-date, LYRA shares have increased by 121.1%, significantly outperforming the industry growth of 9.9% [5]

ENLIGHTEN 2 Study Results - The ENLIGHTEN 2 study met its primary endpoint, demonstrating a statistically significant improvement over sham in 3CS at Week 24 in CRS patients without nasal polyps[42] - Key secondary endpoints of change in 3CS and SNOT-22 in the full study population were also met, showing statistically significant results at Week 24[42] - The study showed a numerical improvement in the key secondary endpoint of change in % ethmoid opacification (CT)[42] - The trial demonstrated a favorable safety profile with no product-related serious adverse events reported[42] Patient Demographics & Adverse Events - In the LYR-210 group (n=111), 60.4% of patients experienced any treatment-emergent adverse events (TEAEs), compared to 44.3% in the Sham group (n=61)[27] - Epistaxis was more frequent in the LYR-210 group (16.2%) compared to the Sham group (1.6%)[27] Market Opportunity & Product Design - Approximately 8 million people in the United States have CRS with nasal polyps, and around 4 million have CRS without nasal polyps[9] - The annual healthcare expenditure for CRS in the United States is approximately $60 billion[9] - Lyra's product is designed to deliver 6 months of continuous, local drug therapy with a single placement[13,17] Pooled Analysis - In the pooled ENLIGHTEN 1 and ENLIGHTEN 2 patients with grade 1 nasal polyps, there was a consistent, positive trend in symptomatic endpoints starting in Week 4 and throughout Week 24[42]

Core Insights - Lyra Therapeutics' shares experienced a significant surge of 550% in pre-market trading following positive results from its drug trials [1] - The stock price increased from $4.93 to over $32, despite being down more than 50% year-to-date [1] Drug Trial Results - The drug candidate LYR-210 showed statistically significant results in treating chronic rhinosinusitis (CRS) in adults [3] - The ENLIGHTEN 2 trial met its primary endpoint, showing marked improvement in three core CRS symptoms: nasal obstruction, discharge, and facial pain at 24 weeks [4] - Key secondary endpoints were also achieved, with a 22.4-point reduction in the SNOT-22 score, indicating a significant improvement in symptom severity [5] - LYR-210 was well-tolerated, with a safety profile comparable to the control group [5] Regulatory Plans - The company plans to align with the FDA for a New Drug Application (NDA) submission for patients without nasal polyps [6] Financial Performance - In Q1 2025, Lyra reported revenue of $0.18 million, missing consensus estimates by nearly 24% [7] - This revenue figure is a decline from $0.53 million in the same quarter last year, and the company has only beaten revenue expectations once in the past four quarters [8] Market Sentiment - Despite the positive trial results and stock surge, Wall Street analysts remain cautious, with all three covering analysts maintaining a 'Hold' rating and a 12-month price target of $2.00, indicating a potential 59% downside from Friday's close [8]

Summary of Lyra Therapeutics Conference Call on ENLIGHTEN Two Phase Three Trial Results Company Overview - **Company**: Lyra Therapeutics (LYRA) - **Focus**: Development of LYR210 for the treatment of chronic rhinosinusitis (CRS) Industry Context - **Industry**: Biopharmaceuticals, specifically targeting chronic rhinosinusitis - **Market Opportunity**: Approximately 8 million patients treated annually in the US, with 50% failing current therapies, representing a significant market opportunity of around $60 billion in annual healthcare expenditures related to CRS [7][6] Core Findings from the ENLIGHTEN Two Trial - **Positive Results**: The ENLIGHTEN Two trial demonstrated statistically significant improvements in the primary endpoint (change from baseline in the three cardinal symptoms or 3CS) and key secondary endpoints (SNOT22 score) at 24 weeks [20][21] - **Patient Demographics**: The trial included approximately 180 CRS patients who had failed medical management, with 55% from North America and 45% from Europe [12] - **Safety Profile**: The trial reported a favorable safety profile with no serious adverse events related to the product or procedure [13][21] Detailed Trial Results - **Primary Endpoint**: At week 24, LYR210 showed a 1.13 improvement over sham control in 3CS, with a p-value of 0.00078 [14] - **Key Secondary Endpoints**: - SNOT22 score improvement of 8.7 over sham, with a p-value of 0.0101, exceeding the minimal clinically important difference of 8.9 points [16] - Numerical improvement in percent ethmoid opacification by CT, showing a 2.2 point improvement over sham [17] - **Subgroup Analysis**: Consistent positive trends were observed in patients with grade one nasal polyps, mirroring results in non-polyp patients [19] Future Plans and Regulatory Strategy - **FDA Engagement**: Lyra plans to meet with the FDA in the second half of 2025 to discuss the regulatory strategy for LYR210, including potential NDA submissions [21][35] - **Next Steps**: Initiation of a Phase III trial for patients with nasal polyps is planned for the first half of 2026, pending additional financing [21] - **Funding Needs**: Estimated cost for a potential new trial (ENLIGHTEN Three) is around $20 million, with current cash reserves of $32 million expected to last until early next year [46] Additional Insights - **Comparison with Previous Trials**: Differences in results between ENLIGHTEN One and Two were attributed to variations in patient populations and site characteristics, with a noted higher sham effect in US patients during ENLIGHTEN One [27][28] - **Market Strategy**: The company aims to leverage existing data on approved steroid treatments to support its NDA filing, emphasizing the strong safety and efficacy profile of LYR210 [41][42] Conclusion - **Overall Sentiment**: The results from the ENLIGHTEN Two trial are viewed positively, reinforcing the potential of LYR210 as a new standard of care for CRS patients who have not responded to existing treatments [21][20]