Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled

6周中期分析的入组已完成，计划入组的36名患者中已有24名入组。

Company on track to report interim biomarker data from the first 12 patients imminently

公司即将报告前12名患者的中期生物标志物数据。

Completion of patient enrollment and topline results expected Q3 2025

预计2025年第三季度完成患者招募并发布初步结果

LA JOLLA, CA, May 07, 2025 —

拉霍亚，加利福尼亚州，2025年5月7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 announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in 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，今天宣布，其正在进行的评估GRI-0621治疗特发性肺纤维化（“IPF”）的2a期研究中，计划的36名患者已有24名随机入组，6周中期分析的入组已经完成。

“We are pleased with the progress made in this Phase 2a biomarker study. With the patient participation seen in the trial to date, we remain on track to report interim data later this quarter and topline results from this important study in the third quarter of this year,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

“我们对这项 2a 期生物标志物研究取得的进展感到满意。根据迄今为止试验中的患者参与情况，我们仍有望在本季度晚些时候报告中期数据，并在今年第三季度公布这项重要研究的顶线结果，”GRI Bio 首席执行官 Marc Hertz 博士评论道。

“The momentum with enrollment combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need. We are grateful for the dedicated work and participation of our clinical staff, patients and families in this trial.

“注册势头加上我们最近公布的中期安全结果，增强了我们对GRI-0621潜力的信心，为特发性肺纤维化（IPF）的治疗提供了一个急需的治疗选择，而这一领域仍然存在显著的未满足需求。我们对参与本次试验的临床工作人员、患者及其家属的辛勤工作和奉献表示感谢。”

Our team is working to bring enrollment to its completion, expected this quarter and report topline data in the third quarter of 2025.”.

我们的团队正在努力完成注册，预计本季度完成，并于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.

这项二期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名特发性肺纤维化（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（来自各个中心）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、生命体征和治疗12周后的不良事件评估口服GRI-0621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；以及通过测量口服GRI-0621在治疗6周和12周后对血液中iNKT细胞活化的抑制作用，以及在一项子研究中治疗12周后从支气管肺泡灌洗液(BAL)中测定其药效学活性。

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。

As previously announced, 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.

正如之前宣布的，正在进行的 2a 期生物标志物研究的预计划中期分析显示，GRI-0621（每天一次 4.5 毫克口服）在按方案评估的前 12 名患者中表现出良好的安全性和耐受性。在两周随访时评估的 12 名患者中，未观察到通过低密度脂蛋白（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治疗的患者在高密度脂蛋白、低密度脂蛋白或甘油三酯水平上没有显著变化，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评估口服他扎罗汀的毒性特征一致，这些研究涉及超过1700名患者，治疗时间长达52周。

The Company expects to report interim biomarker data from the first 12 patients enrolled 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年第二季度报告首批入组12名患者的中期生物标志物数据。2a期生物标志物研究的初步结果预计将在2025年第三季度公布。

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生物公司

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，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的疗法旨在针对自然杀伤T细胞（“NKT”细胞）的活性，这些细胞是炎症级联反应早期的关键调节因子，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细胞是一种类似先天性的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、引发炎症反应和促进纤维化方面发挥关键作用。

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（一种存在重大未满足需求的严重疾病）的新型口服疗法。该公司还正在开发一系列新型2型多样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案》“安全港”条款所指的“前瞻性声明”。前瞻性声明可以通过使用诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“意图”、“寻求”、“或许”、“也许”、“计划”、“潜力”、“预测”、“预计”、“目标”、“瞄准”、“应该”、“将”、“会”，或这些词语的否定形式或其他类似表达来识别。

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.

这些前瞻性陈述基于公司当前的信念和预期。前瞻性陈述包括但不限于以下方面的陈述：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以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和影响，以及任何暗示预临床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内容、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在特定日期前资助计划运营能力的信念和估计、公司对监管审批时间与结果及潜在监管审批路径的看法、公司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、其筹集额外资金能力的信念和预期，而这些资金可能无法以公司可接受的条件获得。

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