Lyra Therapeutics Posts 85% Q2 Loss Drop

Key Points

• GAAP EPS loss of $5.51 was less negative than analyst estimates for Q2 2025.

• GAAP revenue missed expectations at $0.18 million for Q2 2025, down from $0.598 million (GAAP) in Q2 2024 year over year and below estimates for the second quarter.

• Positive LYR-210 clinical trial results position the company for a key regulatory meeting, but no clear timeline for regulatory submission was provided.

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Lyra Therapeutics (NASDAQ:LYRA), a clinical-stage biotechnology company focused on chronic rhinosinusitis (CRS) treatments, reported its second quarter 2025 results on August 12, 2025. The most noteworthy item was the recent pivotal ENLIGHTEN 2 clinical trial win for its primary product candidate, paired with significant cost reductions and new financing. The GAAP EPS loss of $5.51 was less negative than analyst expectations, but GAAP revenue was $0.18 million, which was below the GAAP estimate of $0.29 million. Cost controls led to a much lower GAAP net loss compared to Q2 2024. Overall, the period was highlighted by clinical progress, disciplined spending, and while the company remains reliant on future regulatory milestones.

Source: Analyst estimates for the quarter provided by FactSet.

Business Overview and Recent Focus Areas

Lyra Therapeutics develops bioabsorbable implant devices designed to treat chronic rhinosinusitis, an inflammatory nasal condition affecting millions of people. Its lead product candidate, LYR-210, is a long-acting implant intended to deliver steroid therapy directly to the nasal lining over six months. The company is targeting patients who have not responded to standard medical management and may otherwise require surgery.

In recent quarters, Lyra has focused on completing its pivotal clinical trials and reducing its cost structure after mixed clinical trial results. Achieving positive data from ENLIGHTEN 2 for LYR-210 has been a primary focus, as moving closer to regulatory submission is essential for future revenue. Key success factors include regulatory approval, partnerships or collaborations, and convincing payers and physicians of its product’s value in a space crowded by short-acting drugs and surgical alternatives.

Second Quarter Highlights and Performance Drivers

The period saw several major developments for Lyra. Most notably, On June 2, 2025, it reported that LYR-210, its bioabsorbable nasal implant, achieved statistically significant improvements in symptoms for CRS patients without nasal polyps at 24 weeks in the ENLIGHTEN 2 study (primary endpoint: 3CS score improvement of -1.13; p=0.0078). This marks the first time Lyra has delivered clear, positive late-stage data, a meaningful milestone after ENLIGHTEN 1 failed to meet its goals in May. While ENLIGHTEN 2’s primary endpoint success boosts Lyra’s position for regulatory filing, the company must still navigate mixed clinical results, as ENLIGHTEN 1 fell short of its primary and secondary endpoints as reported in May 2024.

On the regulatory front, Lyra reengaged with the U.S. Food and Drug Administration in preparation for a Type C meeting slated for the second half of 2025. The goal is to align on submission requirements for a New Drug Application for LYR-210 targeting CRS patients without polyps. In parallel, the company has resumed key chemistry, manufacturing, and controls activities to support future trial needs and regulatory compliance. However, it has not yet filed for approval, and details on the pathway and timing remain uncertain.

Financially, Lyra made sharp reductions in operating costs. GAAP research and development expenses dropped $8.2 million, largely due to trial completions and workforce reductions; general and administrative costs were also down, reflecting leaner operations. The company did not incur the asset impairments that drove prior-year losses, resulting in a much lower GAAP net loss. As of June 30, 2025, cash and cash equivalents were $29.8 million (GAAP). A $5.0 million financing round was completed in June 2025, which could provide enough cash to cover operations into the third quarter of 2026.

Lyra also executed a 1-for-50 reverse stock split in May, regaining compliance with the Nasdaq continued listing requirements. This move could help preserve its public listing while minimizing risk of involuntary delisting. The leaner cost base and recent capital boost improve near-term financial stability, though revenue remained minimal, limited to collaboration activities as commercialization is pending future regulatory milestones. There were no dividends declared or changed during the period as LYRA does not currently pay a dividend.

Looking Ahead: Outlook and Investor Watchpoints

Lyra’s management communicated that recent clinical progress has enabled the company to secure additional funding and resume regulatory and manufacturing activities. However, management did not offer specific revenue or EPS guidance for future quarters or years. The company stated it expects cash resources will be sufficient to fund operations into the third quarter of 2026.

Investors should watch closely for progress on the regulatory timeline, including the outcome of the planned FDA meeting and updates on the New Drug Application for LYR-210. The company’s ability to extend financing will remain a central theme into fiscal 2025 and beyond. LYRA does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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