Title: Groundbreaking Milestone: GRI Bio Secures Two Strategic Global Patents in Europe and Japan, Pioneering Innovative Treatments for Autoimmune Diseases

Introduction

In a remarkable stride forward for the biotechnology sector, GRI Bio, Inc. has successfully secured two pivotal patents in Europe and Japan, bolstering its intellectual property portfolio. These patents underscore GRI Bio's commitment to developing groundbreaking treatments for autoimmune, inflammatory, and fibrotic diseases by targeting Natural Killer T (NKT) cells. This announcement not only highlights GRI Bio's innovative approach but also demonstrates its growing presence in the global pharmaceutical landscape, particularly in areas with significant unmet medical needs.

Overview of GRI Bio's Patent Grants

GRI Bio has been granted two significant patents, one in Europe and one in Japan, each focusing on different aspects of NKT cell therapy. The European patent covers GRI-0803, a novel activator of type 2 diverse NKT cells, which is being developed to treat autoimmune disorders such as systemic lupus erythematosus (SLE). The Japanese patent, on the other hand, explores methods for modulating dNKT and iNKT cells in treating inflammatory conditions, primarily through Retinoic Acid Receptor (RAR) agonists.

Key Patent Details:

• European Patent: Application No. 19,166,502, titled "Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use," focuses on GRI-0803 for autoimmune diseases.
• Japanese Patent: Application No. 2023-000750, titled "Prevention and Treatment of Inflammatory Conditions," covers modulating NKT cells using RAR agonists for inflammatory and autoimmune conditions.

Significance of These Patents

The granting of these patents represents a substantial strategic milestone for GRI Bio, enhancing its competitive edge in the biotech industry. By securing patent protection in major markets like Europe and Japan, GRI Bio ensures robust commercial protection for its innovative therapeutic approaches. This move is crucial in safeguarding their intellectual property and potential future revenue streams from emerging treatments.

How These Patents Impact GRI Bio's Position:

• Strengthened Intellectual Property Portfolio: These patents bolster GRI Bio's position as a leader in NKT cell modulator therapy, providing significant defensive assets against competitors.
• Market Opportunities: The patents open up lucrative market opportunities in treating autoimmune diseases like SLE, which has a vast unmet need globally.
• Future Development Potential: The Japanese patent's focus on RAR agonists offers versatile applications across multiple therapeutic areas, including fibrotic and autoimmune conditions.

Targeting Autoimmune Diseases

Autoimmune diseases, such as SLE, pose significant health challenges with limited treatment options available. GRI Bio's focus on developing treatments that target the interplay between different NKT cell subtypes addresses these unmet needs. By activating type 2 diverse NKT cells and inhibiting type 1 invariant NKT cells, GRI Bio aims to restore immune homeostasis in affected patients.

Advantages of NKT Cell Therapy:

• Early Intervention in Inflammatory Cascade: NKT cells play a key role at the forefront of the immune response, allowing for early intervention in disease progression.
• Restoration of Immune Balance: Targeting NKT cells helps in maintaining immune balance, reducing inflammation and fibrosis.
• Potential for Broad Therapeutic Applications: This approach can be adapted for various inflammatory and autoimmune conditions, including fibrotic diseases.

GRI Bio's Current Developments and Future Prospects

In addition to the patent announcements, GRI Bio is actively advancing its lead program, GRI-0621, in a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF). Interim data from this study is expected in Q2 2025, with topline results anticipated in Q3 2025. This trial is designed as a randomized, double-blind, multi-center, placebo-controlled study, underscoring GRI Bio's commitment to rigorous scientific standards.

Key Developments in GRI-0621:

• Phase 2a Trial Design: Randomized, double-blind, multi-center, placebo-controlled study.
• Expected Outcomes: Interim data in Q2 2025 and topline results in Q3 2025.
• Therapeutic Focus: GRI-0621 is an inhibitor of iNKT cell activity, offering a novel approach to treating IPF.

Conclusion

GRI Bio's successful patent grants in Europe and Japan mark a significant achievement in its mission to innovate treatments for autoimmune and inflammatory diseases. By strengthening its intellectual property portfolio and advancing its pipeline of NKT cell modulators, GRI Bio positions itself as a leader in addressing the complex and varied needs of patients suffering from these conditions. As the company looks to the future, its focus on strategic patent acquisition and clinical development will continue to shape the landscape of autoimmune disease treatment.

GRI Bio's Future Outlook

With a library of over 500 proprietary compounds and a robust global patent estate, GRI Bio is well-equipped to drive further innovation and growth in the biotech sector. The company's dedication to expanding its intellectual property and advancing its therapeutic pipeline aligns with the evolving needs of patients and reflects a broader commitment to transforming the treatment paradigm for autoimmune, inflammatory, and fibrotic diseases.

Looking Forward:

• Expanded Intellectual Property: Continuous efforts to strengthen and expand its global patent portfolio.
• Clinical Trial Advancements: Ongoing development of its lead program, GRI-0621, and potential expansion into other therapeutic areas.
• Therapeutic Innovation: Continued focus on NKT cell modulators for addressing complex medical needs.

As the biotechnology industry continues to evolve, companies like GRI Bio that prioritize innovation and intellectual property protection will play a pivotal role in shaping the future of disease treatment.