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LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biotechnology company specializing in Natural Killer T (NKT) cell modulators and currently valued at $0.77 million in market capitalization, has announced interim results from its Phase 2a study of GRI-0621, a treatment for Idiopathic Pulmonary Fibrosis (IPF). The study showed encouraging safety and biomarker data at the two-week mark for the first 12 patients.
IPF is a rare lung disease characterized by progressive scarring that impairs oxygen transfer to the bloodstream. Current treatments have limited efficacy and significant side effects, highlighting the need for new therapeutic options. GRI-0621, an oral small molecule RAR-βγ dual agonist targeting iNKT cells, has shown potential in improving fibrosis and liver function in previous studies.
The recent interim analysis indicated that GRI-0621 was safe and well-tolerated with no significant changes in lipid levels. An Independent Data Monitoring Committee (IDMC) reviewed the biomarker data and found that changes in PRO-C3 levels in treated patients suggested an anti-fibrotic effect. The IDMC has recommended the trial to continue as planned.
GRI Bio has completed enrollment for a 6-week interim analysis and has over two-thirds of participants enrolled for the overall trial. The company anticipates reporting 6-week interim results in the second quarter of 2025 and topline results from the biomarker study in the third quarter of 2025.
Financially, GRI Bio reported a net loss of $3.0 million for the first quarter ended March 31, 2025. Research and development expenses were $1.6 million, and general and administrative expenses were $1.4 million. Following a $5.0 million public offering, the company expects its cash reserves to fund operations through the third quarter of 2025. According to InvestingPro data, the company maintains a healthy current ratio of 3.43, indicating strong short-term liquidity, though its overall financial health score remains weak at 1.4. The stock currently appears undervalued according to InvestingPro’s Fair Value model. For deeper insights into undervalued opportunities, visit our Most Undervalued Stocks list.
The company’s progress includes securing patents in Europe and Japan and preparing to present at the 2025 American Thoracic Society International Conference. This news is based on a press release statement and provides a glimpse into the ongoing efforts to advance IPF treatment. The stock has experienced significant volatility, with a year-to-date decline of 89.56%. InvestingPro subscribers have access to 14 additional exclusive insights about GRI Bio, including detailed analysis of its market performance and financial metrics.
In other recent news, GRI Bio has announced positive interim biomarker results from its Phase 2a study of GRI-0621, a treatment for Idiopathic Pulmonary Fibrosis (IPF). The Independent Data Monitoring Committee recommended the continuation of the study without modifications, highlighting no safety concerns. The trial has reached full enrollment for its 6-week interim analysis, with further data expected in the second and third quarters of 2025. In a separate development, GRI Bio has appointed WithumSmith+Brown, PC as its new independent registered public accounting firm, replacing Sadler Gibb & Associates LLC. This change was not due to any disagreements on accounting principles or practices. Additionally, H.C. Wainwright has maintained a Buy rating on GRI Bio, with a price target of $10, following the promising interim safety data from the GRI-0621 study. Furthermore, GRI Bio has announced a $5 million public offering, pricing shares at $3.60 each, with potential additional gross proceeds from warrant exercises. The company plans to use the proceeds for product development, working capital, and general corporate purposes.
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