GRI Bio (NASDAQ: GRI) Bolsters Patent Portfolio

– U.S. patent issuance for lead program, GRI-0621, in development for the treatment of idiopathic pulmonary fibrosis (IPF)

– Company building a robust global patent estate

LA JOLLA, CA, June 27, 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 provided an update to the progress of its patent portfolio development.

Most recently, the Company received notice that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,660,309 entitled, “Prevention and treatment of inflammatory conditions,” covering methods for the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory and fibrotic conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits type 1 invariant NKT (iNKT) cells, and at its broadest covers the administration of an RAR agonist that inhibits the activity of iNKT cells in a subject.

GRI-0621 is the Company’s small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells. In clinical trials/pre-clinical studies with GRI-0621, reduced aminotransferases and other LFTs in patients and improved fibrosis in multiple disease models were observed. GRI is 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 launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the second half of 2023.

“Establishing a strong global patent estate for our innovative pipeline continues to be an area of focus for the Company as we continue to advance development. We are pleased to have been issued this latest U.S. patent for GRI-0621 which extends our patent coverage to 2032 and which we believe provides further validation of our differentiated approach. Over the course of the past year, we have significantly added to our patent estate, underscoring our commitment to advance much needed treatment options for inflammatory, fibrotic and autoimmune diseases,” commented Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio.

Additionally, over the course of the past year, the Company has bolstered its IP protection with the issuance of several U.S. and ex-U.S. patents for the GRI-0621, GRI-0803, GRI-0124, and GRI-0729 development programs:

GRI-0621

• Russian Patent No. RU2789326
• Brazilian Patent No. BR112013033309B1

GRI-0803

• U.S. Patent No. 11,453,642

GRI-0124

• China Patent No. CN107206086B
• Hong Kong Patent No. HK1243961

GRI-0729

• U.S. Patent No. 11,564,895

The Company remains committed to bolstering its IP protection across its innovative pipeline of NKT cell modulators.

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 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, individual patents, patent portfolio and strategy, the ability of the Company to achieve the milestones presented and the timing of such milestones, the ability of the Company to utilize any particular regulatory approval strategy, any implication that the results or preliminary results of earlier or prior clinical trials or preclinical studies will be representative or indicative of future clinical trials or preclinical studies and any estimate or implication as to potential market size or potential revenue. 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, including any newly issued patents; 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. This press release also contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

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