Lyra Therapeutics Q1 2024 Financial Results and Corporate Update

Lyra Therapeutics, Inc., a clinical-stage biotechnology firm situated in Watertown, Massachusetts, recently shared its financial outcomes for the first quarter ending March 31, 2024, and provided updates on its corporate and clinical advancements. The company is committed to developing long-acting, anti-inflammatory sinonasal implants to treat chronic rhinosinusitis (CRS).

Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics, emphasized the company's focus on delivering top-line data for its ENLIGHTEN 1 pivotal Phase 3 study of LYR-210 in CRS, expected in May. She highlighted the potential of LYR-210 to transform CRS treatment by providing a six-month therapy aimed at overcoming current treatment limitations faced by millions of patients.

Lyra Therapeutics is advancing two late-stage CRS product candidates, LYR-210 and LYR-220. Both are bioabsorbable sinonasal implants administered via a simple, in-office procedure, designed to deliver six months of continuous mometasone furoate drug therapy (7500µg MF) with one administration. LYR-210 is intended for patients with standard nasal anatomy who haven't undergone ethmoid sinus surgery, while LYR-220, a larger implant, targets CRS patients with an enlarged nasal cavity due to previous surgery.

The ENLIGHTEN program, comprising two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, aims to evaluate the efficacy and safety of LYR-210 in CRS patients who have failed medical management and have not had ethmoid sinus surgery. Each trial involves 180 patients randomized in a 2:1 ratio to either LYR-210 or control over 24 weeks, and ENLIGHTEN 1 includes a 52-week extension phase to assess long-term safety and repeat use. Results from the ENLIGHTEN 1 trial are anticipated in May 2024, with enrollment completion for ENLIGHTEN 2 expected in the latter half of 2024. The goal is to support a New Drug Application to the U.S. Food and Drug Administration (FDA) for LYR-210.

Additionally, Lyra plans to present secondary endpoint data from the BEACON Phase 2 clinical trial of LYR-220 at the 2024 Combined Otolaryngology Spring Meetings (COSM) in Chicago. The presentation, scheduled for May 15, 2024, will discuss LYR-220's impact on ethmoid opacification and CRS symptoms. An end-of-Phase 2 meeting with the FDA for LYR-220 is anticipated in the second half of 2024.

The BEACON Phase 2 trial, designed to evaluate the safety and feasibility of LYR-220 implantation in CRS patients post-ethmoid sinus surgery, showed positive results in September 2023. The trial was a randomized, controlled, parallel-group study over 28 weeks.

Financially, Lyra Therapeutics reported that as of March 31, 2024, it had cash, cash equivalents, and short-term investments totaling $87.1 million, down from $102.8 million at the end of December 2023. The company expects this funding to support operating expenses and capital expenditures into the first quarter of 2025.

For the first quarter of 2024, research and development expenses were $18.2 million, an increase from $12.6 million in the same period in 2023. This rise was due to higher headcount costs, increased professional and consulting fees, and elevated clinical costs as the company progressed its trials. General and administrative expenses were $5.8 million, up from $5.1 million in the first quarter of 2023, driven primarily by higher headcount costs and increased support costs.

Lyra Therapeutics reported a net loss of $22.5 million for the first quarter of 2024, compared to $16.3 million for the same period in 2023.

Lyra Therapeutics continues to focus on advancing its CRS product candidates, LYR-210 and LYR-220, through late-stage clinical trials, with the goal of addressing the needs of millions of CRS patients who do not respond to current medical management.