Welcome to our dedicated page for GRI Bio news (Ticker: GRI), a resource for investors and traders seeking the latest updates and insights on GRI Bio stock.
Company Overview
GRI Bio Inc is a clinical-stage biotech company dedicated to discovering, developing, and commercializing novel therapeutics that target the complex mechanisms of dysregulated immune responses. With a strong emphasis on biotech innovation, immunotherapy, and clinical-stage drug development, the company is redefining approaches for treating inflammatory, fibrotic, and autoimmune disorders. The company’s core expertise lies in harnessing the power of natural killer T (NKT) cells, which serve as a critical link between the innate and adaptive immune systems. By modulating these unique cells, GRI Bio aims to restore immune homeostasis and mitigate the damaging inflammatory responses underlying several severe medical conditions.
Scientific and Clinical Approach
At the heart of GRI Bio’s research is the distinct role of NKT cells. These cells exhibit properties of both natural killer cells and T cells to orchestrate and regulate the immune response. In particular, type I NKT cells are known to trigger inflammatory cascades that contribute substantially to cellular and tissue injury. GRI Bio’s lead candidate, GRI-0621, is a small molecule designed as an inhibitor of type I NKT cell activity. This oral therapeutic formulation is engineered to counteract the excessive inflammatory response associated with diseases such as acute liver failure, while also offering promising applications for conditions like psoriasis and acne.
In addition to GRI-0621, the company is advancing GRI-0803, a novel oral agonist targeting type II NKT cells. By influencing this alternative pathway, GRI-0803 holds the potential to offer therapeutic relief for a range of autoimmune and inflammatory conditions. The strategic development of these products underscores GRI Bio’s commitment to offering innovative treatments that address high unmet needs in the market.
Pipeline and Therapeutic Portfolio
GRI Bio’s pipeline is thoughtfully designed to cater to multiple therapeutic areas while leveraging a unified scientific platform centered on NKT cell biology. The company’s dual approach involves:
- GRI-0621: An inhibitor of type I NKT cells, formulated as a novel oral therapeutic aimed primarily at acute liver failure. Its mechanism of action focuses on dampening the inflammatory processes that lead to hepatic injury. Additionally, the formulation explores topical applications for the treatment of dermatological conditions such as psoriasis and acne.
- GRI-0803: An innovative oral agonist that modulates type II NKT cells, thereby offering a potential therapeutic avenue for various autoimmune disorders. This candidate is designed to recalibrate immune responses where dysregulation plays a central role in disease pathology.
Market Position and Competitive Landscape
Within the evolving biotech sector, GRI Bio distinguishes itself through the targeted modulation of NKT cells—a mechanism that addresses the underlying causes of inflammatory and autoimmune diseases rather than merely managing symptoms. The company’s strategic focus on developing oral therapeutic options not only facilitates ease of administration compared to parenteral therapies but also enhances patient compliance. In an industry where treatment options for conditions like acute liver failure and certain autoimmune diseases remain limited, GRI Bio’s scientific approach represents a novel pathway that may transform traditional treatment paradigms.
GRI Bio’s emphasis on reestablishing immune homeostasis by directly influencing key cellular pathways positions it uniquely against competitors that primarily focus on symptomatic relief. Its rigorous clinical evaluation and commitment to scientific excellence underscore the company’s potential as a niche innovator within a competitive and rapidly advancing market environment.
Core Value Proposition and Industry Impact
GRI Bio offers a well-defined value proposition centered on precision immunomodulation. By targeting specific subtypes of NKT cells, its therapies are designed to intervene in the early stages of inflammatory cascades, providing a more precise and potentially safer treatment modality than conventional anti-inflammatory drugs. The company’s extensive research into the dual roles of NKT cells has led to actionable insights that bridge basic scientific discoveries with clinical applications.
This detailed understanding of immune regulation not only fuels its product development but also establishes GRI Bio as an entity with deep scientific expertise and a forward-thinking clinical strategy. Its programs underscore the potential benefits of combining rigorous preclinical research with the strategic development of therapies that cater to complex, multifactorial diseases.
Scientific Rigor and Operational Excellence
Every stage of GRI Bio’s development is underpinned by a commitment to scientific rigor and operational excellence. The company maintains a robust research framework that incorporates both in vitro studies and diverse animal models to validate its therapeutic approach. For example, its exploration of pulmonary fibrosis using established murine models underlines a commitment to understanding disease mechanisms in multiple biological contexts. This multifaceted approach aids in de-risking its clinical candidates and reinforces the company’s reputation for meticulous research planning and execution.
Furthermore, GRI Bio’s operational protocols are designed with a focus on safety, efficacy, and regulatory compliance. This careful calibration of scientific innovation with operational diligence enhances investor confidence and solidifies the company’s standing as a committed participant in the biotech sector.
Conclusion
In summary, GRI Bio Inc stands out as a clinical-stage biotech entity that is deeply invested in the discovery and development of NKT cell-targeted therapies. Its pioneering work in modulating immune responses through agents like GRI-0621 and GRI-0803 reflects both an innovative scientific approach and a sound business strategy geared toward addressing unmet medical needs. With a comprehensive research framework, an expansive therapeutic pipeline, and a clear focus on precision immunomodulation, GRI Bio continues to build an informational foundation that is as robust as it is forward-thinking, positioning the company as a significant contributor to the field of precision medicine and immunotherapy.
This detailed overview provides investors and industry professionals with a clear understanding of GRI Bio’s operational focus, scientific methodologies, and market positioning, all while ensuring that the content remains evergreen and relevant for years to come.
GRI Bio (NASDAQ: GRI) announced that its abstract has been selected for a poster discussion session at the 2025 American Thoracic Society (ATS) International Conference in San Francisco, CA, from May 18-21, 2025. The presentation, titled 'Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant Inhibition of Fibroblast Activation and Fibrosis in a Model of Pulmonary Fibrosis,' will be delivered by CEO Marc Hertz, PhD.
The presentation is scheduled for Wednesday, May 21, 2025, from 8:15-10:15 AM PT in Room 2022/2024 at the Moscone Center. It will be part of the session 'D21 - IMMUNOLOGICAL INSIGHTS IN LUNG INFLAMMATION AND REPAIR' and will be displayed on Poster Board Number 810.
GRI Bio (NASDAQ: GRI) has successfully closed its previously announced public offering, raising $5.0 million in gross proceeds. The offering included 1,388,888 shares of common stock along with three series of warrants (E-1, E-2, and E-3) at a combined price of $3.60 per share.
The warrants, exercisable immediately at $3.20 per share, have varying expiration periods: Series E-1 expires in 5 years, Series E-2 in 18 months, and Series E-3 in 9 months. If fully exercised, these warrants could generate additional gross proceeds of $13.3 million.
H.C. Wainwright & Co. served as the exclusive placement agent. The biotechnology company, focused on developing Natural Killer T cell modulators for inflammatory, fibrotic and autoimmune diseases, plans to use the net proceeds for product candidate development, working capital, and general corporate purposes.
GRI Bio (NASDAQ: GRI) has announced the pricing of a $5.0 million public offering consisting of 1,388,888 shares of common stock (or equivalents) and three series of warrants. The offering is priced at $3.60 per share with accompanying Series E-1, E-2, and E-3 warrants.
The warrants have an exercise price of $3.20 per share, with varying expiration periods: Series E-1 expires in 5 years, Series E-2 in 18 months, and Series E-3 in 9 months. If fully exercised, the warrants could generate additional gross proceeds of $13.3 million.
The offering, managed by H.C. Wainwright & Co. as exclusive placement agent, is expected to close around April 2, 2025. The company plans to use the proceeds for product candidate development, working capital, and general corporate purposes.
GRI Bio (NASDAQ: GRI) has reported encouraging interim safety results from its ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The Independent Data Monitoring Committee recommended continuing the study as planned, with no safety concerns identified in the first 12 patients evaluated.
The study evaluates GRI-0621, a RAR-βɣ dual agonist administered at 4.5mg orally once daily. Initial results show the drug is safe and well-tolerated, with no hyperlipidemia observed in the assessed patients. The Phase 2a trial will enroll approximately 36 subjects in a 2:1 ratio (GRI-0621 vs. placebo) for a 12-week treatment period.
The study's primary endpoint focuses on safety and tolerability, with secondary endpoints including changes in serum biomarkers and pharmacodynamic activity. Interim biomarker data is expected in Q2 2025, with topline results anticipated in Q3 2025.
GRI Bio (NASDAQ: GRI) has strengthened its intellectual property portfolio with two significant patent grants in Europe and Japan. The European patent covers GRI-0803, a novel activator of type 2 diverse NKT cells being developed for autoimmune disorders, particularly systemic lupus erythematosus. The Japanese patent focuses on methods for modulating dNKT and iNKT cells in treating inflammatory conditions through Retinoic Acid Receptor agonists.
The company's lead program, GRI-0621, is currently in a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF). Interim data is expected in Q2 2025, with topline results anticipated in Q3 2025. The study is designed as a randomized, double-blind, multi-center, placebo-controlled trial.
GRI Bio (NASDAQ: GRI) announced its President and CEO Marc Hertz's participation in a Virtual Investor CEO Connect segment. During the presentation, Dr. Hertz discussed the company's lead program, GRI-0621, which targets Idiopathic Pulmonary Fibrosis (IPF), a rare chronic progressive fibrosing interstitial lung disease with treatment options.
The company highlighted upcoming milestones, including interim data expected at the beginning of next quarter and topline data in the subsequent quarter. The presentation is now available for viewing online through Virtual Investor's platform.
GRI Bio (NASDAQ: GRI) has reported its financial results for fiscal year 2024 and provided updates on its lead program GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The company anticipates key data readouts in 2025, with interim data expected in Q2 and topline results in Q3 from its Phase 2a biomarker study.
Financial highlights include:
- Net loss of $8.2 million for 2024
- R&D expenses increased to $3.8 million from $3.2 million in 2023
- G&A expenses decreased to $4.5 million from $8.2 million in 2023
- Cash position of $5.0 million as of December 31, 2024
Recent achievements include presenting positive preclinical data showing GRI-0621 reduces inflammatory and fibrotic drivers in IPF, and receiving a European patent for GRI-0803. The company's cash runway is expected to fund operations into Q2 2025.
GRI Bio (NASDAQ: GRI), a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for inflammatory, fibrotic and autoimmune diseases, has announced regaining compliance with Nasdaq's minimum bid price rule. The company received official notice from Nasdaq on March 10, 2025, confirming its compliance with Listing Rule 5550(a)(2).
GRI Bio (NASDAQ: GRI) has announced a 1-for-17 reverse stock split, effective February 21, 2025, at 4:01 p.m. Eastern Time. The company's common stock will begin trading on a split-adjusted basis on February 24, 2025, under the same ticker symbol 'GRI' but with a new CUSIP number.
The reverse split aims to increase the per share trading price to regain compliance with Nasdaq's minimum bid price requirement. The split will reduce outstanding shares from approximately 8,933,366 to 525,492. Proportional adjustments will be made to exercise and conversion prices of outstanding stock options, warrants, and convertible securities.
No fractional shares will be issued; stockholders will receive cash payments for fractional shares. Stockholders with electronic book-entry shares require no action, while those holding physical certificates will receive instructions from Broadridge Corporate Issuers Solutions for exchanging certificates.
GRI Bio (NASDAQ: GRI), a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for inflammatory, fibrotic and autoimmune diseases, announced its participation in the Virtual Investor "Top 5 for '25" On-Demand Conference. The company's CEO, Marc Hertz, Ph.D., presented the top five reasons why investors and industry colleagues should watch GRI Bio in 2025. The presentation is available for viewing on the company's website and through the conference platform.
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