GRI Bio (NASDAQ: GRI) Announces Corporate Rebranding and Launch of New Website

Company reiterates commitment to providing much-needed treatment options for inflammatory, fibrotic and autoimmune diseases

LA JOLLA, CA, June 13, 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 its new corporate branding and launch of its new corporate website, gribio.com.

“As we continue to evolve as a company, expand our awareness and reach in the public investment markets and advance our clinical development programs, we believed it was an important step to align our corporate branding identity and website with the vision we have for GRI Bio. We remain committed to advancing our leading NKT platform technology, which we believe holds an opportunity for all stakeholders as well as the potential for significant value creation. Over the course of the past several months, we have made encouraging progress on all fronts and are laser focused on successfully executing a number of value-driving milestones. We are excited to take this next step in the evolution of our Company and position ourselves to unlock further potential,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

Please click on the following link for a video message from Dr. Hertz discussing the Company’s rebranding: https://gribio.com/video613

The Company is currently advancing its lead development program GRI-0621, a type 1 invariant NKT (iNKT) antagonist, as a once-daily oral capsule for the treatment of idiopathic pulmonary fibrosis (IPF) with the potential to expand into additional fibrotic indications. In multiple disease models and preliminary data from trials to date¹improvement in fibrosis, liver function tests (LFTs), and other markers of inflammation and injury in patients were observed. GRI Bio plans to leverage the 505(b)(2) regulatory pathway to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF, expected to commence in the second half of 2023.

The Company’s second lead asset, GRI-0803, is a novel activator of human type 2 NKT cells currently in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Additionally, with a library of over 500 proprietary compounds, GRI has the potential to fuel a growing pipeline. The Company has ongoing evaluations for pipeline expansion opportunities targeting potential indications in multiple sclerosis, inflammatory bowel disease, and additional autoimmune indications.

For more information about the Company’s clinical development programs and ongoing pre-clinical and clinical trials, visit gribio.com and connect with the Company on Twitter and LinkedIn.

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 1 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 initiation or completion of clinical trials, the potential benefits and impact of the Company’s product candidates and the related timing of regulatory approvals, if any, evaluations and judgements regarding the Company’s intellectual property position, the ability of the Company to achieve the milestones presented and the timing of such milestones and any implication that the results or preliminary results of earlier or prior clinical trials will be representative or indicative of future 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 their 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 its ability to serve those markets, either alone or in partnership with others; (9) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (10) the Company’s ability to protect and enforce its intellectual property portfolio; and (10) 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 Quarterly Report on Form 10-Q filed with the SEC on May 15, 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)