GRI Bio, Inc. filed a Current Report on Form 8-K with the Securities and Exchange Commission on September 8, 2026. The filing includes an updated corporate presentation and a press release regarding the company’s strategy for inflammatory diseases.
The corporate presentation, included as Exhibit 99.1, outlines the company's approach to Idiopathic Pulmonary Fibrosis (IPF). The presentation highlights the company's lead candidate, GRI-0621, an oral tazarotene. The filing notes that GRI-0621 has received Orphan Drug Designation (ODD) from the FDA, which provides seven years of US exclusivity from approval. The company also states that it has filed three new patent families in 2026 covering specific mechanisms of action, including safety and combination therapies.
The presentation details a proposed adaptive Phase 2b/3 clinical trial design for GRI-0621. According to the filing, this adaptive design aims to replace sequential Phase 2b and Phase 3 studies, potentially saving 12 to 24 months and approximately $50 million in costs. The filing also includes a comparative analysis of GRI-0621 against standard of care (SOC) therapies, such as nintedanib and pirfenidone, citing data from various clinical trials to illustrate potential differences in tolerability and efficacy.
Additionally, the filing references a press release (Exhibit 99.2) issued on September 8, 2026, which announced new translational biomarker data from the Phase 2a study evaluating GRI-0621 in patients with idiopathic pulmonary fibrosis.
