GRI Bio Q2 2024 Financial Results and Corporate Update

GRI Bio, Inc., a biotechnology firm dedicated to developing Natural Killer T (NKT) cell modulators for combating inflammatory, fibrotic, and autoimmune diseases, has announced its financial results for Q2 2024 and provided a corporate update. The Company remains committed to advancing its lead program, GRI-0621, aimed at treating Idiopathic Pulmonary Fibrosis (IPF). According to CEO Marc Hertz, PhD, GRI Bio anticipates interim data from their Phase 2a biomarker study by the end of 2024 and expects topline data by Q1 2025. GRI-0621 is positioned to address a significant unmet medical need in the treatment of IPF. 

Aside from the progress with GRI-0621, GRI Bio is also making strides with its GRI-0803 program, targeted at systemic lupus erythematosus (SLE). The Company estimates it has sufficient cash to support its operations into Q1 2025 and intends to seek additional funding to sustain its planned activities.

Recent Achievements:
1. GRI Bio has expanded its intellectual property portfolio by securing a patent in Korea for its proprietary NKT cell modulators.
2. The Company raised $4.0 million through a public offering.
3. A manuscript titled "Type 1 invariant natural killer T cells drive lung fibrosis" was published in the American Journal of Respiratory and Critical Care Medicine.
4. Preclinical data presented by GRI Bio demonstrated that GRI-0621 effectively reduces key inflammatory and fibrotic drivers in IPF.
5. GRI Bio announced an oral presentation at the 8th Annual Idiopathic Pulmonary Fibrosis Summit to be held in late August 2024.
6. The Company also showcased promising preclinical data on type 2 NKT activating molecules, GRI-0803, and GRI-0124 at the 14th International Congress on Autoimmunity.

GRI-0621: A Novel Approach for IPF Treatment:
IPF is a progressive and chronic lung disease characterized by abnormal scarring, which hinders oxygen transfer to the bloodstream. Current therapies are limited, with only two approved drugs that have significant side effects and compliance issues, and do not improve overall survival. This presents a substantial opportunity for introducing new therapeutic options.

GRI-0621 is a small molecule RAR-βɣ dual agonist that targets human iNKT cells' activity. Preliminary and prior trials using the oral formulation of GRI-0621 have shown improvements in fibrosis across multiple disease models and have enhanced liver function tests and other inflammation markers in patients. The Company is leveraging the 505(b)(2) regulatory pathway and has initiated a Phase 2a biomarker study to evaluate GRI-0621 for treating IPF. 

Key Upcoming Milestones for GRI-0621:
- Q4 2024: Interim data from the Phase 2a biomarker study.
- Q1 2025: Topline results from the Phase 2a biomarker study.

GRI-0803: Targeting Autoimmune Disorders:
GRI-0803 is being developed as a novel activator of human type 2 NKT cells, focusing initially on systemic lupus erythematosus (SLE). SLE is an autoimmune condition where the immune system attacks the body’s tissues and organs, and current treatments involve mostly immunosuppressive therapies with only two new treatments approved in the past 50 years.

The type 2 NKT activators, including GRI-0803 and GRI-0124, have shown in preclinical studies to inhibit murine and human iNKT cells. These molecules, when administered orally, have been observed to reduce lupus nephritis and significantly improve overall survival rates. While GRI Bio is currently prioritizing GRI-0621, further development of GRI-0803 will continue in 2025, contingent upon additional funding.

Financial Summary for Q2 2024:
- Net Loss: $2.4 million.
- Research and Development Costs: $0.9 million for both Q2 2024 and Q2 2023.
- General and Administrative Expenses: $1.4 million for Q2 2024, down from $5.1 million in Q2 2023.
- Cash and Cash Equivalents: Approximately $6.4 million as of June 30, 2024. The recent public offering added $4.0 million in gross proceeds.

GRI Bio continues to strive toward innovative treatments for inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells, which are crucial regulators in the inflammatory process. With a promising pipeline and intellectual property portfolio, the Company is well-positioned to address significant unmet medical needs.

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