The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed

独立数据监测委员会（IDMC）建议按计划继续研究，因为审查的数据中未发现安全问题。

Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated

中期结果显示，GRI-0621在前12名受试患者中安全且耐受性良好。

Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025

中期生物标志物数据预计在2025年第二季度发布，初步结果预计在2025年第三季度公布。

Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival

目前可用的IPF治疗方法仅限于两种获批药物，这些药物伴随着显著的副作用、患者依从性有限且对生存率没有影响。

LA JOLLA, CA, April 01, 2025 —

拉霍亚，加利福尼亚州，2025年4月1日 —

GRI Bio, Inc.

GRI生物公司

(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 interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”)..

(NASDAQ: GRI)（“GRI Bio”或“公司”），一家致力于推进天然杀伤T细胞（“NKT”）调节剂创新管线的生物技术公司，用于治疗炎症、纤维化和自身免疫性疾病，今天公布了其正在进行的GRI-0621治疗特发性肺纤维化（“IPF”）的2a期研究的中期安全结果。

GRI-0621, is the Company’s small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (“iNKT”) cells. In preliminary clinical trials to date and previous clinical 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-0621是该公司的RAR-βɣ小分子双重激动剂，能够抑制人类1型恒定自然杀伤T细胞（“iNKT”）的活性。在迄今为止的初步临床试验以及之前使用口服制剂的临床试验中，GRI-0621已被证明可以在多种疾病模型中改善纤维化，并改善肝功能测试及患者其他炎症和损伤标志物。

The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit.

正在进行的 2a 期生物标志物研究的预先计划的中期分析显示，前 12 名按方案评估的患者中，GRI-0621（每日一次口服 4.5 毫克）是安全且耐受性良好的。在第 2 周访视时评估的 12 名患者中，未观察到由低密度脂蛋白 (LDL)、高密度脂蛋白 (HDL) 和甘油三酯 (TG) 水平评估的高脂血症。

There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks..

接受GRI-0621治疗的患者的高密度脂蛋白、低密度脂蛋白或甘油三酯水平没有显著变化，所有受试者的指标均保持在正常范围内。中期分析委员会建议研究按计划继续进行。中期结果显示，GRI-0621的受体选择性与早期研究中观察到的毒性特征一致，这些研究评估了逾1700名患者口服他扎罗汀长达52周的治疗情况。

Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “While preliminary, in the first 12 subjects evaluated these results are encouraging and in line with our expectations. We believe these results, particularly the safety data, underscore GRI-0621’s potential to provide a much needed safe and effective treatment option for the treatment of IPF, where there remains significant unmet need.

GRI Bio首席执行官马克·赫兹博士评论道：“虽然初步评估，但在前12名受试者中，这些结果令人鼓舞，并且与我们的预期一致。我们认为这些结果，特别是安全性数据，突显了GRI-0621在满足特发性肺纤维化（IPF）治疗中巨大未满足需求方面的潜力，有望提供一种安全有效的治疗选择。”

The two ant-fibrotic drugs currently approved for the treatment of IPF can slow the decline of lung function but are not curative, do not improve overall survival, and both come with significant side effects which limit their use. Based on the trends seen in these interim results, as well as the consistent toxicity profile with tazarotene, we believe GRI-0621 will continue to demonstrate that the molecule is safe and inhibits NKT cell activity in this patient population, providing much needed benefit to patients.

目前批准用于治疗 IPF 的两种抗纤维化药物可以减缓肺功能的下降，但不能治愈，不能改善总体生存率，并且都有显著的副作用，限制了它们的使用。根据这些中期结果中的趋势以及他扎罗汀一致的毒性特征，我们相信 GRI-0621 将继续证明该分子在这种患者群体中是安全的并能抑制 NKT 细胞活性，为患者提供非常需要的益处。

Our team remains focused on driving enrollment and treatment in the study and we look forward to reporting topline data in the third quarter of 2025.”.

我们的团队仍专注于推动研究中的患者招募和治疗，并期待在2025年第三季度报告初步数据。

The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks.

该二期a阶段、随机、双盲、多中心、安慰剂对照、平行设计、两组研究将招募约36名IPF患者，他们将以2:1的比例随机分配接受GRI-0621 4.5mg或安慰剂。在每日一次口服给药12周后，将比较GRI-0621 4.5mg与安慰剂的剂量效果。

Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment.

同时，一项子研究将对多达12名符合条件的受试者（来自各中心）的支气管肺泡灌洗液（“BAL”）中NKT细胞的数量和活性进行检测。当中有24名受试者（其中约8名为安慰剂组受试者）完成6周治疗时，将进行中期分析。

The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are baseline changes in serum biomarkers collected at week 6 and week 12; an assessment of the pharmacokinetics (PK) of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study.

本研究的主要终点是通过临床实验室、生命体征和不良事件评估口服GRI-0621在12周治疗后的安全性和耐受性。次要终点是第6周和第12周收集的血清生物标志物的基线变化；在第12周治疗访视时（稳态）对GRI-0621的药代动力学（PK）进行评估；以及通过在6周和12周后抑制血液中的iNKT细胞活化，以及在12周治疗后的支气管肺泡灌洗液（BAL）中测定口服GRI-0621的药效学活性（在一个子研究中进行）。

Additional exploratory endpoints for the study are to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment and flow cytometry and differential gene expression at various time points..

研究的其他探索性终点是评估 GRI-0621 在基线、治疗 6 周和 12 周后对肺功能的影响，以及在不同时间点的流式细胞术和差异基因表达。

The Company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.

公司预计将在2025年第二季度报告中期生物标志物数据。2025年第三季度将公布来自二期a阶段生物标志物研究的初步结果。

For more information about the Phase 2a study, please visit

有关第2a阶段研究的更多信息，请访问

clinicaltrials.gov

临床试验.gov

and reference identifier NCT06331624.

和参考标识符 NCT06331624。

About GRI Bio, Inc.

关于GRI Bio公司。

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 Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis.

GRI Bio是一家处于临床阶段的生物制药公司，致力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的治疗方法旨在针对自然杀伤T细胞（“NKT细胞”）的活性，这些细胞是炎症级联反应中较早的关键调节因子，通过干预疾病进展并恢复免疫系统的平衡来发挥作用。

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.

NKT细胞是一种先天样T细胞，兼具NK细胞和T细胞的特性，是连接先天免疫和适应性免疫的功能性纽带。I型不变NKT（“iNKT”）细胞在炎症和纤维化疾病中传播损伤、炎症反应和纤维化过程中发挥关键作用。

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 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus.

GRI Bio的主导项目GRI-0621是一种iNKT细胞活性抑制剂，正在被开发为一种用于治疗特发性肺纤维化的新颖口服疗法，特发性肺纤维化是一种具有重大未满足需求的严重疾病。该公司还正在开发一系列新型2型多样化NKT（“dNKT”）激动剂，用于治疗系统性红斑狼疮。

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

此外，GRI Bio拥有一个包含500多种专有化合物的库，能够为不断增长的研发管线提供支持。

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》“安全港”条款所指的“前瞻性陈述”。前瞻性陈述可以通过使用诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“意图”、“寻求”、“或许”、“也许”、“计划”、“潜在”、“预测”、“预计”、“目标”、“瞄准”、“应该”、“将会”、“不会”等词语或这些词语的否定形式或其他类似表述来识别。

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 and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones in 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 t.

这些前瞻性声明基于公司当前的信念和期望。前瞻性声明包括但不限于以下方面的声明：公司对其产品候选物的开发和商业化的预期、临床试验启动或完成的时间及结果数据的可用性、公司临床试验和产品候选物的潜在益处与影响，以及任何关于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预示后期研究或临床试验结果的暗示、公司对潜在股东价值和未来财务表现的信念和预期、公司对其现金和可用资源及其资助计划运营至特定日期能力的信念和估计、公司对监管批准的时间和结果以及潜在监管批准路径的看法、公司在2025年的预期里程碑，以及公司对其现有现金和现金等价物足以资助其计划运营、其筹集额外资金的能力（这些资金可能无法以公司可接受的条件获得）的信念和预期。

Investor Contact:

投资者联系方式：

JTC Team, LLC

JTC团队有限责任公司

Jenene Thomas

珍妮·托马斯

(908) 824-0775

(908) 824-0775

GRI@jtcir.com

GRI@jtcir.com