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Workshop, poster and oral presentation of data given as part of the 8th Annual Antifibrotic Drug Development (AFDD) Summit Data demonstrate that NKT cells are activated in airways in IPF patients and inhibition of iNKT cell activity with GRI-0621 ameliorates pulmonary fibrosis in a preclinical model Ongoing Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers; Topline data readout expected in Q2 2025 Nov. 21, 2024 -- 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 positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF). The data were presented as part of an invited talk titled, "A New Approach to Inflammatory Diseases," delivered by Marc Hertz PhD, Chief Executive Officer of GRI Bio, at the 8th Annual Antifibrotic Drug Development (AFDD) Summit, held November 19-21, 2024, in Boston, MA. “We were pleased to participate at this prestigious event and engage with thought leaders in the field and present our novel approach for the treatment of inflammatory diseases. There remains a significant unmet need for therapeutic solutions that halt disease progression of fibrotic diseases such as IPF. Based on the growing body of positive data demonstrated by our lead program GRI-0621, we believe we have a validated and derisked clinical approach to address that need,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe GRI-0621 has the potential to provide meaningful benefit to IPF patients and we look forward to advancing it development and realizing its full value.” Enhanced iNKT activity correlates with progression of fibrosis in MASH patients and key proinflammatory genes in BAL from IPF patients iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models iNKT promote 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 key pro-inflammatory cytokines and inflammation Decreases accumulation of neutrophils and activation of pro-fibrotic fibroblasts Inhibits key fibrogenic cytokines including TGF-β Additionally, the Company presented a poster titled, “Involvement of Type 1 Invariant Natural Killer T Cells in Driving Lung Fibrosis,” outlining flow cytometry and quantitative PCR analysis in bronchoalveolar lavage (BAL) fluid from IPF patients and healthy controls to characterize NKT cells. A bleomycin (3.0 IU/Kg via the intratracheal route) model was used with or without daily administration of nintedanib or a small molecule selective inhibitor of iNKT activity, GRI-0621, during the fibrotic phase to study the role of iNKT cells in pulmonary fibrosis in a treatment protocol. Results highlighted in the poster demonstrated that IPF patients had increased expression of pro-fibrotic molecules in BAL, including Collagen 1-α1, osteopontin and TGF-β. There was an increase in IFN-γ producing CD45+CD3+CD56+ NKT cells in IPF patients compared to controls. In a second cohort, we confirmed the iNKT phenotype using an anti-Vα24-Jα18 TCR antibody. In the bleomycin model, GRI-0621 inhibition of iNKT cells improved a majority of inflammatory, fibrotic, and pathological features, including a reduction in lung injury, myofibroblast activity, collagen deposition, and fibrosis. GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date 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. The Company is currently advancing the development of GRI-0621 in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the first quarter of 2025 and topline results are expected in the second quarter of 2025. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624. 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 (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. 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$13.9 million in gross proceeds raised since the beginning of 2024 extending expected cash runway into mid Q1 2025 and through interim data readout from GRI-0621 Phase 2a biomarker study Topline data of GRI-0621 readout expected in Q2 2025 Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on overall survival LA JOLLA, CA, Nov. 14, 2024 (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 reported its financial results for the third quarter ended September 30, 2024 and provided a corporate update. “We continue to make fundamental progress on the development and regulatory fronts of our lead program GRI-0621 for the treatment of IPF. As we drive towards our interim data readout early next year, we are generating a robust and growing body of encouraging preclinical data with an innovative approach that we believe continues to validate and derisk our clinical approach,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “With our strengthened cash position and Phase 2a study execution, we believe we are poised to drive value for shareholders in both the near and long term.” Recent Highlights Presented positive preclinical data demonstrating GRI-0621’s ability to inhibit invariant Natural Killer T (iNKT) cell activity and reduce important inflammatory and fibrotic drivers in idiopathic pulmonary fibrosis (IPF) at the 22nd International Colloquium on Lung and Airway Fibrosis in Athens, Greece;Expanded intellectual property protection for proprietary NKT cell modulators with granting of Japan patent titled, “Prevention and Treatment of Inflammatory Conditions;Received authorization to conduct Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in Australia; andParticipated in a Virtual Investor KOL Connect segment with prominent key opinion leader in IPF – Dr. Helen Parfrey, Respiratory Consultant at the Royal Papworth Hospital and Affiliated Assistant Professor at the University of Cambridge. GRI-0621: Type 1 Invariant NKT (iNKT) Antagonist in Development for the Treatment of IPF. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on overall survival1 leaving significant opportunity to augment IPF treatment with a new therapeutic. GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date 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. The Company plans to leverage the 505(b)(2) regulatory pathway. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624. Expected GRI-0621 Upcoming Milestones Q1 2025: Report interim data from Phase 2a biomarker studyQ2 2025: Report topline results from Phase 2a biomarker study Summary of Financial Results for Third Quarter 2024 Net loss was $6.3 million for the nine months ended September 30, 2024. Research and development expenses were $2.9 million and $2.2 million for the nine months ended September 30, 2024 and 2023, respectively. General and administrative expenses were $3.3 million and $7.2 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, the Company had cash and cash equivalents of approximately $4.7 million. 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 (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 and availability of resulting data, 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, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones for the first half of 2025 and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms or at all, and capital expenditure requirements. 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(908) 824-0775GRI@jtcir.com 1 T. M. Maher et al., Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res 22, 197 (2021)