GRI Bio reports first-quarter 2026 results and new GRI-0621 data

GRI Bio, Inc. reported financial results for the quarter ended March 31, 2026, in a release dated May 14, 2026. The release also included continued analyses from a Phase 2a trial of its lead candidate, GRI-0621, in idiopathic pulmonary fibrosis (IPF). The company said cash and cash equivalents totaled approximately $11.0 million as of March 31, 2026, compared with approximately $8.2 million at December 31, 2025.

The Phase 2a data

The trial, GRI-0621-IPF-02, is a randomized, double-blind, placebo-controlled study that included 35 patients with IPF. Approximately 80% of them were on background standard-of-care antifibrotic therapy. The company said the trial met its primary safety and tolerability endpoint.

The release compares the active arm with placebo. Zero cough was observed in the active arm, against 25% in the placebo arm. Dyspnea was 4% in the active arm and 17% in the placebo arm, a 76% reduction. No weight loss was observed in the active arm, against 17% in the placebo arm. Treatment-related diarrhea was 13% in the active arm and 33% in the placebo arm, a 61% reduction, even though patients in the active arm used 67% more nintedanib than placebo patients.

No serious adverse events were reported in the active arm, and the placebo arm had a single serious adverse event. In an exploratory pulmonary function analysis, FVC improved by 99 mL overall, and by 139 mL in the subset receiving standard-of-care combination therapy, compared with placebo plus standard of care at 12 weeks. The company says the data point to immune rebalancing, active fibrolysis, basement membrane repair and epithelial regeneration. With 35 patients, the percentages rest on a handful of people per arm, the FVC result is exploratory, and the release gives no p-values.

The company and its pipeline

GRI Bio describes itself as a clinical-stage biopharmaceutical company that develops therapies aimed at Natural Killer T (NKT) cells, which it describes as key regulators earlier in the inflammatory cascade. GRI-0621 is a once-daily oral RARβ/γ selective agonist being developed for IPF. The company also develops type 2 diverse NKT agonists for systemic lupus erythematosus, and its GRI-0803 program is advancing toward IND-enabling activities.

The company's annual report for 2025, filed January 30, 2026, describes a need for substantial additional capital. Among its forward-looking risks, the report lists the company's ability to remain listed on The Nasdaq Capital Market and its ability to continue as a going concern. The report also refers to a January 2026 reverse stock split.

Financial position

For the first quarter, research and development expense was approximately $0.4 million, compared with approximately $1.6 million a year earlier. The decrease was mainly due to lower expenses after the Phase 2a trial ended in 2025. General and administrative expenses were approximately $1.6 million, compared with approximately $1.4 million. The net loss was approximately $2.0 million, compared with approximately $3.0 million.

During the first quarter, the company generated approximately $6.8 million in gross proceeds from its At The Market facility, which sells new shares. Cash rose over the quarter while the company still reported a net loss. The annual report shows research and development expense of $6.8 million for 2025, against $3.8 million for 2024. The net loss was $12.0 million for 2025, compared with $8.2 million for 2024. Cash from operations was negative $10.2 million in 2025 and negative $8.6 million in 2024.

Year-end cash and cash equivalents were $8.2 million for 2025 and $5.0 million for 2024. Based on its current operating plan, the company believes existing cash will fund planned operating expenses and capital expenditures into the second quarter of 2027. The release says that estimate assumes only initial preparatory activities for GRI-0621, and that substantial additional capital will be required to fund a Phase 2b trial.

What comes next

The company said it has advanced clinical development planning for GRI-0621 to support potential regulatory pathways in the United States and Europe. Chief Executive Officer Marc Hertz, PhD, said, "we believe we are positioned to continue advancing GRI-0621 towards pivotal studies." The release names no Phase 2b start date or funding for it.

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