GRI GRI Bio Inc

GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” 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 Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio presented encouraging preclinical data from the Company’s preclinical studies of type 2 NKT activating molecules, GRI-0803 and GRI-0124 at the 14th International Congress on Autoimmunity held May 17-20, 2024 in Ljubljana, Slovenia (the Congress).

GRI Bio’s second asset in development, GRI-0803, is a novel activator of human type 2 NKT cells. Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of type 1 invariant NKT (iNKT) cells. In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells. Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. The Company is currently advancing development of GRI-0803 for the treatment of systemic lupus erythematosus disease (SLE), an autoimmune disease in which the immune system attacks its own tissue and organs.

Dr. Chaturvedi commented, “There remains a significant unmet need for safe and effective treatment options for SLE as current treatments are limited, consisting primarily of immunosuppressive therapies. Based on the data demonstrated by GRI-0803 and GRI-0124 to date, we believe these innovative small molecules leveraging NKT science have the potential to target earlier in the inflammatory cascade to interrupt disease progression. We remain encouraged by GRI-0803’s potential and are working in earnest to validate bioanalytical methods, complete cGMP manufacturing, and complete toxicology studies in order to file our IND for GRI-0803 in the second half of 2024.”

Key Highlights Observed from GRI Preclinical Studies

• Data demonstrate iNKT cells accumulate in SLE patients and in NZBWF1 mice, have an activated phenotype and their hyporesponsiveness to in vitro stimulation suggests chronic activation
• Type 2 NKT cells accumulate in NZBWF1 kidney, and remain responsive to in vitro restimulation
• Type 2 NKT cell activation in NZBWF1 mice inhibits iNKT cell activity
• Once-weekly GRI-0124:
  • Inhibited pro-inflammatory cytokines and signaling pathways in NZBWF1 mice
  • Decreased pDC accumulation and MHC class II expression
  • Inhibited CD4+, CD8+ T cells, and B cells (↑ T1B and ↓ T2B cells)
  • Reduced renal cellular infiltration and fibrosis
  • Inhibited proteinuria, anti-dsDNA Ig, and improved overall survival and proteinuria-free survival
• GRI-0803 has demonstrated:
  • Chemistry backbone based on type 2 GRI-0124
    • <400g/mol
    • Favorable solubility profile
    • Excellent bioavailability
  • PK profile supporting q.d. administration orally
  • No CV toxicology issues observed, no genotox and no activation or inhibition within CYP450 pathway
  • No toxicology concerns to date

Dr. Chaturvedi’s presentation from the Congress is now available on the Publications page of the Company’s website (gribio.com).

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. 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 preclinical studies, clinical trials and availability of resulting data, the potential benefits and impact of the Company’s preclinical studies, clinical trials and product candidates and any implication that the data or results observed in preclinical studies or earlier studies or trials will be indicative of results of later studies or clinical trials, any implication that the Company’s product candidates will perform similarly to other candidates or approved therapies, the Company’s beliefs and expectations regarding future financial performance, and the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways. 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 and to comply with applicable listing requirements; (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 March 28, 2024 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, LLCJenene Thomas(833) 475-8247GRI@jtcir.com

1Projected sales of OFEV per Evaluate Consensus