– Continued progress toward commencement of Phase 1 human clinical study of lead product candidate, PALI-2108, for the treatment of Ulcerative Colitis (UC) before year end – Company continues to establish growing body of preclinical data for PALI-2108 and global patent estate – Sufficient cash on hand to execute on current business plan and reach clinical and regulatory milestones through first quarter of 2025 Carlsbad, CA, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Pa ...

PALI-2108 新药物开发 - 公司正在开发一种名为PALI-2108的新药物,作为治疗炎症性肠病(包括溃疡性结肠炎和克罗恩病)的潜在疗法[125][126][127] - PALI-2108是一种靶向磷酸二酯酶-4(PDE4)的前药,可以提高结肠组织中环腺苷酸(cAMP)分子的水平,从而减少炎症分子并增加抗炎分子[126] - 公司已成功完成PALI-2108的首批GMP生产,并完成了一系列前临床研究,包括毒理学和药代动力学研究,结果显示安全性良好[129][131][132] - 公司正在开发一种基于生物标志物的患者筛选方法,以帮助临床医生识别可能对PALI-2108疗法有反应的患者[130] - 公司计划于2024年第四季度提交IND/CTA申请,并启动PALI-2108的I期临床试验,预计2025年上半年获得I期试验的结果[129] 财务情况 - 公司最近完成了两轮融资,分别筹得约350万美元和220万美元,用于支持PALI-2108的开发[133] - 公司已终止LB1148的开发,未来研发费用将主要用于PALI-2108的临床前和临床开发[135][136] - 公司目前的现金和现金等价物余额为1140万美元,预计可为公司的计划运营提供资金支持至2025年第一季度[133][138] - 公司管理层认为存在重大不确定性,可能会对公司持续经营能力产生实质性影响[138] - 公司于2024年4月5日实施1比15的反向股票拆分[139] - 2024年6月30日季度研发费用为262.8万美元，较2023年同期增加21%[141,142] - 2024年6月30日季度一般及行政费用为158.3万美元，较2023年同期增加11%[141,143] - 2024年上半年研发费用为484.2万美元，较2023年同期增加42%[146,148] - 2024年5月完成4.0百万美元的私募股权融资[153] - 2023年9月完成2.0百万美元的定向增发[153] - 2024年2月公司与部分认可机构投资者达成认股权证行权协议,共收到现金2.2百万美元[154,155] - 公司在2024年6月30日结束的6个月内经营活动使用的净现金约为670万美元[1] - 公司在2023年6月30日结束的6个月内经营活动使用的净现金约为570万美元[1] - 2024年6月30日结束的6个月内,公司筹资活动提供的净现金约为560万美元[3][4] - 2023年6月30日结束的6个月内,公司筹资活动提供的净现金约为970万美元[4] - 截至2024年6月30日,公司拥有1140万美元的现金和现金等价物,预计可为公司计划的运营提供资金支持至2025年第一季度[4] - 公司预计在2024年第四季度启动PALI-2108的1期临床试验,届时现金使用可能会增加[5] - 公司与Giiant的许可协议修订将增加公司在PALI-2108联合开发计划下的近期现金承诺[5] - 公司的关键会计政策和估计在最近的10-K表中有详细披露,除了衍生金融工具政策不再是关键政策外,其他政策未发生重大变化[6][7]

– Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end – Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108 Carlsbad, CA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic d ...

Mitch Jones, MD, PhD, CMO of Palisade Bio highlights recent findings from a microbiome study confirming local bioactivation of lead product candidate, PALI-2108 Carlsbad, CA, July 31, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) (the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the release of a Virtual Investor "What This Means" segment. As part of this "Wh ...

Findings demonstrate that the microbiome and enzymes are sufficient in mouse, dog, and Normal Healthy Volunteers (NHV) and Ulcerative Colitis (UC) patients Company advancing toward commencement of Phase 1 human clinical study of PALI-2108 for the treatment of UC before year end Carlsbad, CA, July 29, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) (the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, a ...

Patent includes Composition of Matter claims for both PALI-2108 and PALI-1908 programs Patent includes broad claims for “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors” with similar structure to PALI-2108 and PALI-1908 This patent family provides Composition of Matter coverage beyond 2042 PALI-2108 is in development to treat patients with active moderate-to-severely active Ulcerative Colitis (UC) PALI-1908 is in development to treat patients with active fibro stenotic Crohn’s Disease (CD) Carlsbad, C ...

Company has now completed murine and non-murine pivotal nonclinical studies using GMP PALI-2108 drug substance Company has successfully formulated enteric-coated tablets of PALI-2108 and has demonstrated consistent and reliable drug release profiles Company on track to commence Phase 1 human clinical study of PALI-2108 for the treatment of moderate-to-severe ulcerative colitis (UC) before year end Carlsbad, CA, July 11, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company” ...

Live video webcast on Wednesday, June 26th at 4:00 PM ET Carlsbad, CA, June 24, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it will participate in the Virtual Investor Closing Bell Series on Wednesday, June 26, 2024 at 4:00 PM ET. As part of the event, J.D. Finley, Chief Executive Officer, ...

Live video webcast on Wednesday, June 26th at 4:00 PM ET Carlsbad, CA, June 24, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it will participate in the Virtual Investor Closing Bell Series on Wednesday, June 26, 2024 at 4:00 PM ET. As part of the event, J.D. Finley, Chief Executive Officer, ...

– Collaboration advancing Palisade Bio’s precision medicine approach through access to cutting-edge expertise and tools in bioinformatics – Candidate PDE4-related biomarkers overlapping with UC pathophysiology have been identified and innovative selection strategy development is underway Carlsbad, CA, June 21, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patient ...