公司管线和技术 - 公司正在开发一系列创新的NKT细胞调节剂管线，用于治疗炎症、纤维化和自身免疫性疾病[8] - 公司的NKT细胞调节剂GRI-0621正在进行IPF(特发性肺纤维化)的II期临床试验,预计2025年第一季度公布试验结果[39][40] - GRI-0621已获FDA同意的508条监管途径,这是一种罕见病的适应症,每年新诊断病例约4万例[40][41] - GRI-0621在动物模型中显示的疗效与领先的酪氨酸激酶抑制剂OFEV(预计2025年销售50亿美元)相当[11][62] - 公司正在开发另一种NKT细胞激动剂GRI-0803,初步关注适应症为系统性红斑狼疮(SLE),这是一种常见的自身免疫性疾病,约16万人确诊[78][81] - 公司拥有广泛的知识产权保护,包括已获得的专利和未来市场独占权[55][79] - 公司建立了一个500多个专有化合物的库,为管线的持续发展提供支持[20] - 公司的NKT细胞调节技术可以通过重置失调的免疫反应来实现选择性免疫调节[21][24] - 公司的NKT细胞调节剂可以在炎症级联反应的上游靶向iNKT细胞,提供潜在的竞争优势[25][63] 公司的创新管线 - 公司正在推进一项针对自身免疫性疾病的创新管线，主要针对狼疮性肾炎等适应症[90][91][92][93][94] - 公司正在开展IND使能和临床前研究,以推进该管线进入临床[97][98][99] - 公司正在探索该技术在类风湿性关节炎、多发性硬化症、炎性肠病等其他自身免疫性疾病的潜在应用[101][102] 公司团队和合作 - 公司拥有一支经验丰富的领导团队,在免疫治疗、自身免疫性疾病等领域具有深厚的专业背景[104][105][106][107] - 公司认为其NKT细胞调节技术具有吸引机构投资者和大型制药公司合作的潜力[112][113][114][115]

Company focused on execution of lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) GRI-0621 interim data readout of Phase 2a biomarker study on track for Q4 2024 and topline data on track for Q1 2025 LA JOLLA, CA, Aug. 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 repo ...

产品研发 - 公司正在开发一款名为GRI-0621的口服抑制型1天然杀伤性T细胞(iNKT)的产品候选药物,用于治疗特发性肺纤维化(IPF)等严重的纤维化肺部疾病[113] - GRI-0621已在超过1,700名患者中进行了长达52周的评估,初步数据显示该药物耐受性良好,可抑制iNKT细胞活性[113] - 公司还在开发另一款名为GRI-0803的新型口服2型天然杀伤性T细胞激动剂,主要针对自身免疫性疾病如系统性红斑狼疮(SLE)进行研究[114] - 研发费用主要用于GRI-0621产品候选物的开发[127,128] 融资活动 - 公司于2024年1月和6月分别进行了1:7和1:13的股票反向拆分,以满足纳斯达克的最低股价要求[116] - 公司于2024年2月和6月进行了两次公开发行,共募集资金约7,561万美元,用于支持公司的研发和运营[117,121] - 公司于2024年5月启动了最高10,000万美元的"随时市场"股票发行计划,截至2024年6月30日已发行29.39万股,募集资金约900万美元[119,120] - 公司于2023年11月收到纳斯达克的违规通知,由于股东权益不足,被要求在2024年5月前完成至少6,000万美元的股权融资以满足上市要求,公司已完成该要求[123] - 公司于2024年1月和6月进行了两次股票反向拆分,以满足纳斯达克最低股价1美元的要求,并最终于2024年7月重新符合该要求[124] - 公司完成与Vallon Pharmaceuticals, Inc.的合并[125] - 2024年6月完成3,200万美元的股票发行[152] - 2024年2月完成4,400万美元的股票发行[154] - 2023年6月完成1,170万美元的股票发行[155] 财务状况 - 现金及现金等价物余额为640万美元[146] - 2024年6月30日之前的6个月内,经营活动使用现金4,344万美元[147] - 预计现有现金可支持公司运营至2025年第一季度[157] - 公司需要获得大量额外资金以维持持续运营[158] - 公司目前无法强制行使T系列认股权证,因为其强制行使的条件尚未满足[158] - 公司计划通过发行股权证券和/或短期或长期债务安排来筹集资金,但无法保证在需要时能够获得融资[158] - 如果无法获得足够的额外资金,公司可能需要重新评估经营计划,并可能被迫减少开支、延长与供应商的付款期限、变卖资产、延迟、缩减或放弃部分或全部开发项目,或以不利条件放弃技术权利,甚至完全停止运营[158] - 这些行动可能会严重影响公司的业务、经营业绩和未来前景,以及普通股股票的价值[158] - 公司预计至少在可预见的未来将继续大幅亏损,除非成功完成开发、获得监管批准并成功商业化其当前或任何未来的产品候选药物,否则不会产生产品收入[158] 其他 - 公司不参与任何表外交易,没有任何担保或义务,除了正常业务运营中产生的[159] - 公司是一家新兴成长公司,可能会一直保持这一地位长达5年,并将继续利用相关豁免[162][163] - 一般及行政费用下降主要由于专业费用和人员费用的减少[136,137]

ST HELIER, Jersey, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Caledonia Mining Corporation Plc ("Caledonia" or "the Company") (NYSE AMERICAN, AIM and VFEX: CMCL) announces the publication of its 2023 ESG Report. The full report is available on the Company's website at www.caledoniamining.com/esg/esg-reports/. Caledonia has enhanced its sustainability reporting to align with the Global Reporting Initiative (GRI) and Sustainability Accounting Standards Board (SASB) standards for the first time. This reflects the Compa ...

Live video webcast on Wednesday, July 17th at 12:00 PM ET LA JOLLA, CA, July 15, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” 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 it will participate in the Virtual Investor Lunch Break Series on July 17, 2024 at 12:00 PM ET. As part of the event, Marc Hertz, PhD, Chief Exe ...

Live video webcast on Wednesday, July 17th at 12:00 PM ET LA JOLLA, CA, July 15, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) ("GRI Bio," "we," "our," 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 it will participate in the Virtual Investor Lunch Break Series on July 17, 2024 at 12:00 PM ET. As part of the event, Marc Hertz, PhD, Chief Exec ...

Marc Hertz, PhD, CEO of GRI Bio underscores importance of the interim data from their ongoing Phase 2a biomarker study for Idiopathic Pulmonary Fibrosis (IPF) LA JOLLA, CA, July 11, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ:GRI) ("GRI Bio," "we," "our," 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 release of a Virtual Investor "What This Mean ...

Marc Hertz, PhD, CEO of GRI Bio underscores importance of the interim data from their ongoing Phase 2a biomarker study for Idiopathic Pulmonary Fibrosis (IPF) LA JOLLA, CA, July 11, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” 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 release of a Virtual Investor “What This Mea ...

LA JOLLA, CA, July 08, 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 announced that it received notice on July 2, 2024 from The Nasdaq Stock Market LLC ("Nasdaq") that the Company regained compliance with all applicable Nasdaq listing standards for continued listing on the Nasdaq Capital Market, and t ...

LA JOLLA, CA, July 08, 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 announced that it received notice on July 2, 2024 from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company regained compliance with all applicable Nasdaq listing standards for continued listing on the Nasdaq Capital Market, and ...