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GRI Bio, Inc. (symbol: GRI) is a pioneering clinical-stage biotech company dedicated to fundamentally transforming the treatment of inflammatory diseases. Specializing in the innovative development of therapies targeting dysregulated immune responses, GRI Bio focuses on inflammatory, fibrotic, and autoimmune disorders.
The company's core technology revolves around Natural Killer T (NKT) cell-based therapies. NKT cells are unique as they possess characteristics of both NK and T cells, serving as a critical bridge between innate and adaptive immune responses. Notably, Type 1 NKT cells are instrumental in initiating and propagating inflammatory responses and mediate the hepatic injury observed in liver diseases.
GRI Bio's lead program, GRI-0621, is an orally administered small molecule that acts as an inhibitor of Type 1 NKT cells. This groundbreaking therapy is being developed for the treatment of acute liver failure, aiming to curb hepatic inflammation by restoring immune system balance. Additionally, GRI-0621 serves as a RAR-beta and gamma dual agonist, further enhancing its therapeutic potential.
In addition to GRI-0621, the company boasts other promising candidates including GRI-0803, a novel oral agonist targeting Type 2 NKT cells. This candidate holds significant promise as a potential treatment for autoimmune disorders, further broadening GRI Bio's therapeutic arsenal.
GRI Bio's dedication to innovation and commitment to addressing unmet medical needs position it as a significant player in the biotech industry. With ongoing advancements and a robust pipeline, GRI Bio continues to drive forward in its mission to improve patient outcomes through cutting-edge science and targeted therapies.
GRI Bio presented positive preclinical data for GRI-0621, its lead program targeting Idiopathic Pulmonary Fibrosis (IPF), at the 8th Annual Antifibrotic Drug Development Summit. The data showed that GRI-0621 reduces inflammation and fibrotic drivers in IPF. Key findings demonstrated increased iNKT cell activity correlating with fibrosis progression, while GRI-0621 administration inhibited pro-inflammatory cytokines and decreased neutrophil accumulation. The company is currently conducting a Phase 2a clinical trial for IPF treatment, with interim data expected in Q1 2025 and topline results in Q2 2025.
GRI Bio reported Q3 2024 financial results and progress on GRI-0621, its lead program for Idiopathic Pulmonary Fibrosis (IPF). The company raised $13.9 million in gross proceeds since early 2024, extending cash runway into mid-Q1 2025. Net loss was $6.3 million for the nine months ended September 30, 2024, with R&D expenses at $2.9 million and G&A expenses at $3.3 million. Cash position stands at $4.7 million. The company expects interim data from Phase 2a biomarker study in Q1 2025 and topline results in Q2 2025.
GRI Bio (NASDAQ: GRI) has announced definitive agreements for the exercise of existing warrants to purchase 762,236 shares of common stock at a reduced price of $1.00 per share, down from the original $14.30. In exchange, the company will issue new unregistered Series D-1 and D-2 warrants, each for up to 762,236 shares at $1.00 per share. The D-1 warrants have a 5-year term, while D-2 warrants have an 18-month term.
The offering, expected to close around October 22, 2024, is anticipated to generate gross proceeds of approximately $0.8 million. H.C. Wainwright & Co. is acting as the exclusive placement agent. GRI Bio plans to use the net proceeds for working capital and general corporate purposes. The new warrants are being offered in a private placement and have not been registered under the Securities Act.
GRI Bio (NASDAQ: GRI) presented positive preclinical data for its lead program GRI-0621 at the 22nd International Colloquium on Lung and Airway Fibrosis. The data demonstrated GRI-0621's ability to inhibit invariant Natural Killer T (iNKT) cell activity and reduce inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).
Key findings include:
- Increased expression of pro-fibrotic factors in IPF patients
- Increased IFN-γ producing NKT cells in IPF patients
- GRI-0621 treatment improved inflammatory, fibrotic, and pathological features in a bleomycin model of pulmonary fibrosis
GRI Bio is currently conducting a Phase 2a biomarker study of GRI-0621 in IPF patients, with interim data expected in Q4 2024 and topline results in Q1 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 its participation in the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF 2024). The event will take place from October 12-16, 2024, in Athens, Greece.
The company's abstract has been accepted for a poster presentation titled "Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis." Dr. Vipin Kumar Chaturvedi, GRI Bio's Chief Scientific Officer, will present the poster (Number PP 184) on Tuesday, October 15, 2024, from 3:30 PM to 5:00 PM EEST.
This presentation highlights GRI Bio's ongoing research in the field of lung fibrosis and demonstrates the company's commitment to advancing its innovative pipeline of NKT cell modulators for treating various diseases.
GRI Bio (NASDAQ: GRI) has received a 'Decision to Grant' notice from the Japan Patent Office for patent application No. 2023-000750, titled 'Prevention and Treatment of Inflammatory Conditions.' The patent covers compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells in treating inflammatory, fibrotic, and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist.
Japan's pharmaceutical market, valued at approximately $106 billion in 2021, is the third largest worldwide. GRI Bio's lead program, GRI-0621, a small molecule RAR-βɣ dual agonist candidate, is currently in a Phase 2a study for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Interim data is expected in Q4 2024 and topline data in Q1 2025.
GRI Bio (NASDAQ: GRI) has received authorization from the Australian MHRA and HREC to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in Australia. This expands the global reach of their clinical development and is expected to accelerate enrollment. The company remains on track to report interim data in Q4 2024 and topline data in Q1 2025.
The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 4.5mg or placebo, administered orally once daily for 12 weeks. The primary endpoint is safety and tolerability, with secondary endpoints including changes in serum biomarkers, pharmacokinetics, and pharmacodynamic activity. The study also includes a sub-study examining NKT cells in bronchoalveolar lavage fluid.
GRI Bio (NASDAQ: GRI), a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for inflammatory, fibrotic, and autoimmune diseases, has announced its participation in a Virtual Investor CEO Connect segment. The event is scheduled for October 2, 2024, at 12:00 PM ET.
CEO Marc Hertz, PhD, will deliver a brief presentation followed by an interactive Q&A session. Investors can submit questions live during the event or in advance via email to GRI@jtcir.com. The presentation will be available as a live video webcast on the company's website, with a replay accessible for 90 days after the event.
GRI Bio (NASDAQ: GRI) recently participated in a Virtual Investor KOL Connect segment, featuring Albert Agro, PhD, CMO of GRI Bio, and Dr. Helen Parfrey, a prominent expert in Idiopathic Pulmonary Fibrosis (IPF). The discussion focused on IPF, current patient experiences, and GRI Bio's lead program, GRI-0621. This small molecule RAR-βɣ dual agonist inhibits iNKT cell activity and has shown promise in improving fibrosis and inflammation markers in preliminary trials.
GRI Bio is advancing GRI-0621 through a Phase 2a biomarker study, with interim data expected in Q4 2024 and topline data in Q1 2025. The company aims to address the limitations of current IPF treatments, which have significant side effects and impact on overall survival. GRI-0621 represents a potential new therapeutic approach to halt disease progression in fibrotic diseases like IPF.
GRI Bio (NASDAQ: GRI), a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for inflammatory, fibrotic, and autoimmune diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 in New York, NY.
CEO Marc Hertz, PhD, will deliver a presentation and engage in one-on-one meetings with qualified investors. A video webcast of the presentation will be available on-demand starting September 9, 2024, at 7:00 AM ET for registered attendees. The webcast will also be accessible on the company's website and archived for 90 days post-event.
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