- GRI Bio reports a net loss of $3.0 million for Q1 2025, with increased R&D expenses reaching $1.6 million.
- Enrollment for the 6-week interim analysis of the GRI-0621 Phase 2a trial in Idiopathic Pulmonary Fibrosis (IPF) is completed.
- Interim biomarker data suggests a positive anti-fibrotic effect, with safety profile remaining favorable.
GRI Bio, Inc. (GRI, Financial), a biotechnology company, has announced its financial results for the first quarter ending March 31, 2025. The company reported a net loss of $3.0 million, marking an increase in research and development (R&D) expenses to $1.6 million from $0.9 million in the same period last year. This rise parallels the advancement of their Phase 2a trial for GRI-0621 targeting Idiopathic Pulmonary Fibrosis (IPF).
The trial has shown early positive signs, with interim biomarker data from the first 12 patients indicating a potential anti-fibrotic effect. The patient enrollment for the 6-week interim analysis has been successfully completed (n=24), while over two-thirds of the total enrollment for the trial is also finalized. The 6-week interim data is anticipated in Q2 2025, followed by topline results in Q3 2025.
The safety profile of GRI-0621 continues to appear favorable, with no significant changes in LDL, HDL, or triglyceride levels observed at the 2-week mark. The Independent Data Monitoring Committee has recommended the continuation of the trial without modifications, owing to no substantial safety concerns emerging so far.
GRI Bio has extended its cash runway through Q3 2025 following a $5.0 million public offering. Despite this, the company is likely to require additional financing post-Q3 2025 to maintain its operations and progress the clinical trials further.
The company's efforts to expand its intellectual property portfolio have been fruitful, with new patents being granted in Europe and Japan, which could enhance its global market presence and potential for partnerships.
