Financial Performance - As of December 31, 2024, cash and cash equivalents were $40.6 million, down from $51.6 million at September 30, 2024, with sufficient funds projected to cover operating expenses into Q1 2026[11] - Research and development expenses for the full year 2024 were $43.8 million, a decrease of 8.5% from $48.0 million in 2023, primarily due to reduced clinical costs[12] - General and administrative expenses for the full year 2024 were $18.5 million, down from $19.1 million in 2023, reflecting a decrease in professional and consulting fees[13] - The net loss for the full year 2024 was $93.4 million, compared to a net loss of $62.7 million in 2023, indicating a significant increase in losses year-over-year[14] - The total operating expenses for the full year 2024 were $97.9 million, an increase from $68.7 million in 2023, driven by various impairment and restructuring charges[15] - The company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future[20] Clinical Trials and Product Development - The ENLIGHTEN 2 Phase 3 trial results for LYR-210 are expected in Q2 2025, which will provide critical data on its efficacy in chronic rhinosinusitis patients[4] - The ENLIGHTEN program includes two pivotal Phase 3 trials, with approximately 180 CRS patients enrolled in each trial, randomized 2:1 to receive either LYR-210 or sham control[5] - LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy and is being evaluated for patients with chronic rhinosinusitis, including those with nasal polyps[18] - The company received FDA feedback in December 2024, clarifying the potential path forward for LYR-210 in treating chronic rhinosinusitis with nasal polyps[9] - The company needs to conduct at least one additional Phase 3 clinical trial[20] - Clinical trials required for the company's product candidates are expensive and time-consuming, with uncertain outcomes[20] - The company relies on third parties to conduct its preclinical studies and clinical trials[21] - There are no approved products currently available from the company[20] Corporate Actions and Management - The company plans to implement a reverse stock split to comply with Nasdaq's minimum bid price requirement of $1.00[9] - Approximately 87 employees were terminated following the failure to meet the primary endpoint in the ENLIGHTEN 1 Phase 3 clinical trial[20] - Significant costs and management time are required due to operating as a public company[21] - The price of the company's common stock may be volatile and fluctuate substantially[21] - The company disclaims any obligation to update forward-looking statements even if subsequent events cause its views to change[21]

Core Insights - Lyra Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing long-acting, anti-inflammatory sinonasal implants for chronic rhinosinusitis (CRS) treatment [19] - The company reported its financial results for Q4 and full year 2024, highlighting a net loss of $93.4 million for the year, compared to a loss of $62.7 million in 2023 [12][16] Financial Highlights - Cash and cash equivalents as of December 31, 2024, were $40.6 million, down from $51.6 million at September 30, 2024 [9] - Research and development expenses for Q4 2024 were $6.4 million, and for the full year, they totaled $43.8 million, a decrease from $48.0 million in 2023 [10] - General and administrative expenses for Q4 2024 were $3.6 million, compared to $4.4 million in Q4 2023, with full-year expenses at $18.5 million, down from $19.1 million [11] Clinical Development - The company is awaiting results from the ENLIGHTEN 2 Phase 3 study, expected in Q2 2025, which will provide insights into the efficacy of LYR-210 for CRS patients [2][14] - The ENLIGHTEN program includes two pivotal Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, with approximately 180 CRS patients enrolled in each trial [3] - Positive post-hoc data analyses from the ENLIGHTEN 1 Extension Study indicate LYR-210's potential in treating CRS patients with nasal polyps [3][4] Regulatory Engagement - Lyra has engaged with the FDA regarding the registration path for LYR-210 in CRS patients with nasal polyps, receiving clarifications that the safety dataset from ongoing studies may be sufficient for a pivotal study [7] Corporate Actions - The company plans to implement a reverse stock split to comply with Nasdaq's minimum bid price requirement, pending approval from the board and stockholders [8]

Lyra Therapeutics, Inc. (LYRA) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked ...

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.27 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 21.74%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $0.29, delivering a surprise of 14.71%.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 September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |-------------------------------------------------------------------------------|--------------------------|---------------------------------| | | | | | For the transi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 001-39273 84-1700838 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per share LYRA The Nasdaq Global Market FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November ...

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 ...

-- Topline Results Expected Q2 2025 -- WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) ("Lyra" or the "Company"), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today 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, is fully enrolled. LYR-210 is a bioresorbable nasal ...

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 14.71%. A quarter ago, it was expected that this company would post a loss of $0.26 per share when it actually produced a loss of $0.35, delivering a surprise of -34.62%. Over the last four quarters, the company h ...

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ | --- | --- | |----------------------------------------------------------------------------------------|-------------- ...