Lyra Therapeutics Q2 2024 Financial Results and Corporate Update

Lyra Therapeutics, Inc., a clinical-stage biotechnology company based in Watertown, Massachusetts, reported its financial results for the second quarter ending June 30, 2024, along with providing a corporate update. The company focuses on developing long-acting anti-inflammatory sinonasal implants for chronic rhinosinusitis (CRS).

Despite not meeting the primary endpoint in the ENLIGHTEN 1 Phase 3 trial, further analysis revealed that LYR-210 showed improvement over control in symptomatic endpoints among CRS patients with nasal polyps. Dr. Maria Palasis, President and CEO, emphasized the potential of the product candidates and mentioned the ongoing evaluation to determine a pathway for approval of LYR-210 for CRS without nasal polyps.

Lyra remains focused on the ENLIGHTEN Phase 3 trials for LYR-210. The ENLIGHTEN 1 study is extended for 52 weeks, with results anticipated in the fourth quarter of 2024, while the ENLIGHTEN 2 pivotal trial is on schedule with enrollment and expects results in the first half of 2025. The company intends to take a pragmatic and data-driven approach to advance its goals for stakeholders, including patients and investors.

The results released in May from the Phase 3 ENLIGHTEN 1 trial showed that LYR-210 did not achieve a statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (CRS) at 24 weeks. Despite this, LYR-210 was generally well tolerated with no serious adverse events. Following these results, Lyra implemented cost-cutting measures, including reducing its workforce by approximately 75%, halting manufacturing and commercialization efforts, and seeking to sublease its three leaseholds to reduce operational costs significantly. Additionally, development of LYR-220 was paused to focus on the ongoing ENLIGHTEN Phase 3 programs.

In the subgroup of CRS patients with nasal polyps, further analysis of the ENLIGHTEN 1 data revealed a positive impact of LYR-210 compared to the sham control. At 24 weeks, the treatment resulted in a mean improvement in the 3CS score and nasal congestion scores.

Enrollment for the ENLIGHTEN 2 trial continues, with completion expected in the second half of 2024 and topline results in the first half of 2025. Results from the 52-week extension study of ENLIGHTEN 1 are expected in Q4 2024.

Financially, Lyra reported cash, cash equivalents, and short-term investments totaling $67.5 million as of June 30, 2024, compared to $102.8 million as of December 31, 2023. The company anticipates that its current financial resources are sufficient to fund operations into the first quarter of 2026. Research and development expenses increased to $13.3 million for the quarter, primarily due to higher costs in shared activities, professional fees, and clinical and product manufacturing efforts. General and administrative expenses also saw an increase to $5.1 million, mainly due to higher consulting costs and shared costs within the organization. The company incurred significant impairment costs related to property, equipment, and right-of-use assets, as well as restructuring charges due to the reduction in workforce. Net loss for the second quarter of 2024 was $48.1 million, compared to $15.6 million for the same period in 2023.

Lyra Therapeutics continues to develop its product candidates, LYR-210 and LYR-220, designed for CRS patients. LYR-210 is intended for patients with standard nasal anatomy, primarily those who have not undergone ethmoid sinus surgery, while LYR-220 is for patients with enlarged nasal cavities due to previous surgery. Both implants aim to deliver six months of continuous anti-inflammatory drug therapy through a simple in-office procedure.

In summary, Lyra Therapeutics is navigating challenges following the ENLIGHTEN 1 trial results and is focused on advancing its ENLIGHTEN Phase 3 trials. Financially, the company is taking measures to streamline operations and extend its cash runway while continuing to develop promising treatments for CRS patients.