Workshop, poster and oral presentation of data given as part of the 8th Annual Antifibrotic Drug Development (AFDD) Summit

作为第八届年度抗纤维化药物开发（AFDD）峰会的一部分，研讨会，海报和口头介绍数据

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

数据表明，IPF患者的气道中NKT细胞被激活，GRI-0621抑制iNKT细胞活性可改善临床前模型中的肺纤维化

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

正在进行的IPF患者GRI-0621的2期研究，以检查iNKT活性以及关键生物标志物；预计2025年第二季度将公布Topline数据

LA JOLLA, CA, 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)..

加利福尼亚州拉霍亚，2024年11月21日-GRI Bio，Inc.（纳斯达克：GRI）（“GRI Bio”或“公司”）是一家生物技术公司，致力于推进自然杀伤T（“NKT”）细胞调节剂的创新管道，用于治疗炎症，纤维化和自身免疫性疾病，今天宣布提供积极的临床前数据，证明其领先项目GRI-0621可减少特发性肺纤维化（IPF）中重要的炎症和纤维化驱动因素。。

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.

这些数据是由GRI Bio首席执行官马克·赫兹博士在2024年11月19日至21日于马萨诸塞州波士顿举行的第八届年度抗纤维化药物开发（AFDD）峰会上发表的题为“炎症性疾病的新方法”的特邀演讲的一部分。

“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.

“我们很高兴参加这项享有盛誉的活动，并与该领域的思想领袖进行接触，并介绍我们治疗炎症性疾病的新方法。对于阻止纤维化疾病（如IPF）疾病进展的治疗方案，仍然存在大量未得到满足的需求。

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.”.

GRI Bio首席执行官马克·赫兹（MarcHertz）博士评论道：“基于我们的领先项目GRI-0621所展示的越来越多的积极数据，我们相信我们有一种经过验证和嘲笑的临床方法来满足这一需求。我们相信GRI-0621有可能为IPF患者提供有意义的益处，我们期待着推动其发展并实现其全部价值。”。

Key Highlights

主要亮点

Enhanced iNKT activity correlates with progression of fibrosis in MASH patients and key proinflammatory genes in BAL from IPF patients

增强的iNKT活性与MASH患者的纤维化进展以及IPF患者BAL中的关键促炎基因相关

iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models

在实验性纤维化模型中，iNKT细胞被激活并在肝和肺中积累

iNKT promote Type 1, Type 2 and Type 3 immune pathways involved in fibrosis

iNKT促进纤维化中涉及的1型，2型和3型免疫途径

iNKT-deficient mice have reduced inflammatory damage and fibrosis

缺乏iNKT的小鼠减少了炎症损伤和纤维化

Daily oral administration of GRI-0621 in experimental animals

实验动物每日口服GRI-0621

Inhibits key pro-inflammatory cytokines and inflammation

抑制关键的促炎细胞因子和炎症

Decreases accumulation of neutrophils and activation of pro-fibrotic fibroblasts

减少中性粒细胞的积累和促纤维化成纤维细胞的活化

Inhibits key fibrogenic cytokines including TGF-β

抑制关键的纤维化细胞因子，包括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..

此外，该公司还发布了一张题为“1型不变自然杀伤T细胞参与驱动肺纤维化”的海报，概述了IPF患者和健康对照组支气管肺泡灌洗液（BAL）中的流式细胞术和定量PCR分析，以表征NKT细胞。在纤维化阶段，使用博来霉素（通过气管内途径3.0 IU/Kg）模型，每天或不每天服用nintedanib或iNKT活性的小分子选择性抑制剂GRI-0621，以研究iNKT细胞在肺纤维化中的作用。治疗方案。。

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.

海报中突出显示的结果表明，IPF患者BAL中促纤维化分子的表达增加，包括胶原蛋白1-α1，骨桥蛋白和TGF-β。与对照组相比，IPF患者产生IFN-γ的CD45+CD3+CD56+NKT细胞增加。在第二个队列中，我们使用抗Vα24-Jα18 TCR抗体证实了iNKT表型。

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..

在博来霉素模型中，GRI-0621对iNKT细胞的抑制改善了大多数炎症，纤维化和病理特征，包括肺损伤，肌成纤维细胞活性，胶原沉积和纤维化的减少。。

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..

GRI Bio的主要项目GRI-0621是一种小分子RAR-ββββ双激动剂，可抑制人类iNKT细胞的活性。在迄今为止的初步试验和之前的口服制剂试验中，GRI-0621已被证明可以改善多种疾病模型中的纤维化，并改善患者的肝功能测试和其他炎症和损伤标志物。。

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.

该公司目前正在推进GRI-0621在治疗IPF的2a期，随机，双盲，多中心，安慰剂对照，平行设计，双臂研究中的开发。2a期生物标志物研究的中期数据预计将在2025年第一季度发布，而topline结果预计将在2025年第二季度发布。

For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624..

。。

About GRI Bio, Inc.

关于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.

GRI Bio是一家临床阶段的生物制药公司，专注于从根本上改变炎症，纤维化和自身免疫性疾病的治疗方式。GRI Bio的疗法旨在针对NKT细胞的活性，NKT细胞是炎症级联反应早期的关键调节因子，可中断疾病进展并恢复免疫系统的体内平衡。

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.

NKT细胞是先天性T细胞，具有NK细胞和T细胞的共同特性，是先天性和适应性免疫反应之间的功能联系。1型不变（iNKT）细胞在炎症和纤维化适应症中观察到的损伤，炎症反应和纤维化的传播中起关键作用。

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.

GRI Bio的主要项目GRI-0621是iNKT细胞活性的抑制剂，正在开发作为治疗特发性肺纤维化的新型口服治疗剂，这是一种严重的疾病，其需求尚未得到满足。该公司还正在开发用于治疗系统性红斑狼疮的新型2型NKT激动剂管道。

Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline..

此外，GRI Bio拥有500多种专有化合物的库，能够为不断增长的管道提供燃料。。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含1995年《私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”。前瞻性陈述可以通过使用诸如“预期”、“相信”、“沉思”、“可能”、“估计”、“预期”、“打算”、“寻求”、“可能”、“可能”、“计划”、“潜在”、“预测”、“项目”、“目标”、“目标”、“应该”、“将会”、“将会”等词语或这些词语或其他类似表达的否定词来识别。

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.

这些前瞻性陈述基于公司当前的信念和期望。前瞻性陈述包括但不限于以下方面的陈述：公司对公司候选产品开发和商业化的期望，临床试验的开始或完成时间以及所得数据的可用性，公司临床试验和候选产品的潜在益处和影响，以及在临床前试验或早期研究或试验中观察到的数据或结果将指示后期研究或临床试验结果的任何暗示，公司对潜在股东价值和未来财务业绩的信念和期望，公司对监管批准和潜在监管批准途径的时间和结果的信念，公司2025年上半年的预期里程碑，以及公司的信念和对其现有现金和现金等价物足以为其计划运营提供资金的预期，其筹集额外资金的能力（公司可能无法以可接受的条件或根本无法获得）以及资本支出要求。

Actual results may differ from the forward-looking statements expressed by the.

实际结果可能不同于所表达的前瞻性陈述。

Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775GRI@jtcir.com

投资者联系人：JTC团队，Llcjenne Thomas（908）824-0775GRI@jtcir.com