Lyra Therapeutics Implements Cost-Cutting to Preserve Capital

Lyra Therapeutics, Inc., a clinical-stage biotechnology company based in Watertown, Massachusetts, is undertaking significant cost-reduction measures, including laying off about 75% of its workforce. This strategic move is aimed at preserving capital and extending the company’s financial viability into 2026. The layoffs will affect 87 employees, and Lyra has also halted its manufacturing and commercialization efforts, opting to sublease its facilities to cut operating expenses. Efforts on the LYR-220 project have also been paused as part of these measures.

Lyra’s immediate focus will be on its two ongoing ENLIGHTEN Phase 3 clinical trials for LYR-210, a bioabsorbable sinonasal implant designed to treat chronic rhinosinusitis (CRS). The company faced a setback when the ENLIGHTEN 1 trial did not meet its 24-week primary endpoint. However, data analysis from this trial is ongoing, with key insights expected to guide the 52-week extension phase, results of which are anticipated in the fourth quarter of 2024. Additionally, these insights will inform the ongoing ENLIGHTEN 2 trial.

Financially, as of March 31, 2024, Lyra Therapeutics had around $87.1 million in cash, cash equivalents, and short-term investments. The company plans to provide further financial updates when it reports its second-quarter results for 2024. Dr. Maria Palasis, President and CEO of Lyra Therapeutics, emphasized that these aggressive measures are essential to streamline operations and extend the company's cash runway. She expressed gratitude to the affected employees for their dedication and contributions to the company.

Parallel to these operational adjustments, Lyra plans to explore strategic options to enhance shareholder value. Though there is no certainty that this evaluation will lead to any transaction, the company remains open to possibilities that could potentially benefit its shareholders.

The ENLIGHTEN program consists of two randomized, blinded, sham-controlled Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, which assess the efficacy and safety of LYR-210 for treating CRS in patients who have failed medical management and have not undergone ethmoid sinus surgery. Each trial involves 180 patients, randomized in a 2:1 ratio to either receive LYR-210 (7500µg mometasone furoate) or a control over a 24-week period. ENLIGHTEN 1 includes an extension phase to evaluate the long-term safety and repeat use of LYR-210 for up to 52 weeks.

ENLIGHTEN 1 enrolled 190 patients, with approximately two-thirds from U.S. sites and the rest from Europe. Baseline scores for treatment and control arms were comparable, with mean 3CS scores of 6.9 and 6.7 points, respectively, and mean SNOT-22 scores of 61 points for both groups. Baseline CT opacification scores were also similar, at 44.9% for the treatment arm and 47.3% for the control arm.

LYR-210 is an investigational bioabsorbable implant intended for CRS patients in the U.S. who fail current therapies and require further intervention. It aims to provide continuous anti-inflammatory medication (7500µg mometasone furoate) for six months. CRS is a widespread inflammatory disease of the paranasal sinuses, causing severe symptoms and significant morbidities, making it one of the most common conditions in individuals under 65.

Lyra Therapeutics, Inc. continues to advance its clinical-stage biotechnology efforts, focusing on developing long-acting, anti-inflammatory sinonasal implants for CRS treatment. Their product candidates, LYR-210 and LYR-220, are designed for different patient anatomies and aim to deliver six months of continuous drug therapy with a single administration. These efforts target the estimated four million CRS patients in the U.S. who require alternative treatment options annually.