GRI Bio Presents Data Supporting Innovative Pipeline of NKT Cell Modulators for the Treatment of High-Value Inflammatory, Fibrotic and Autoimmune Diseases

Data presented at the 7^th Annual Antifibrotic Drug Development (AFDD) Summit

Company’s lead program, GRI-0621, has demonstrated ability to inhibit the activity of type I invariant NKT (iNKT) cells early in the inflammatory cascade to prevent cytokine release, cellular infiltration, and interrupts disease progression at the source

Daily oral administration of GRI-0621 (a human equivalent dose) leads to reduced lung damage and a significant reduction in Bleomycin-induced lung fibrosis

LA JOLLA, CA, Oct. 31, 2023 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of data supporting its novel approach to inflammatory diseases at the 7^th Annual Antifibrotic Drug Development (AFDD) Summit held October 24-26, 2023 in Boston, MA.

As part of the AFDD Summit, Vipin Kumar, PhD, Chief Scientific Officer of GRI Bio gave an oral presentation titled, “Exploration of NKT Cell Activation as an Immune Biomarker for Progression of Fibrosis,” and participated in a panel discussion titled, Reviewing Biomarkers Discussed in the Context of Fibrosis & Oncology, which discussed the promising new avenues for evaluating fibrosis staging in vivo, in vitro and in patient; review the advantages and pitfalls of fluid markers vs imaging for fibrosis diagnostics; and illuminate similarities and differences in biomarkers across fibrotic disease and tumor fibrosis. The slides accompanying Dr. Kumar’s oral presentation are available on the Publications page of the Company’s website.

“We continue to be encouraged by the data being generated by GRI-0621 and the translational work we are doing with our collaborators that demonstrate a significant increase in iNKT cell numbers in IPF patients and their correlation with biomarkers of fibrosis and disease,” commented Dr. Kumar. “Looking ahead, we are making progress toward launching our Phase 2a biomarker study for GRI-0621 before year end.”

Key Highlights:

• GRI-0621 has demonstrated itself as a potent inhibitor of iNKT cell activity.
• iNKT cells have an activated phenotype in NASH & IPF patients.
• Enhanced iNKT activity correlates with progression of fibrosis in NASH patients and with macrophage accumulation and key proinflammatory genes in BAL from IPF patients.
• iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models.
• iNKT promotes Type 1, Type 2 and Type 3 immune pathways involved in fibrosis.
• iNKT-deficient mice have reduced inflammatory damage and fibrosis.
• Daily oral administration of GRI-0621 in experimental animals
  • Inhibits pro-inflammatory cytokines and inflammation.
  • Decreases accumulation of neutrophils and proinflammatory macrophages
  • Inhibits key fibrogenic cytokines including TGF-b and fibrosis.
• Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers.

GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human type 1, iNKT cells. In preliminary trials to date¹ and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.

GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Company plans to leverage the 505(b)(2) regulatory pathway and to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. The Company is on track to launch its Phase 2a biomarker study of GRI-0621 before year-end.

About GRI Bio, Inc.

GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on February 24, 2023 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
GRI@jtcir.com

¹ I. Maricic et al., Differential Activation of Hepatic Invariant NKT Cell Subsets Plays a Key Role in Progression of Nonalcoholic Steatohepatitis. J Immunol 201, 3017-3035 (2018), Tazoral^™ for the Treatment of Moderate to Very Severe Plaque Psoriasis Briefing Document, Allergan (https://wayback.archive-it.org/7993/20170405104812/https://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4062B1_01_Allergan-Background.pdf)