业绩总结 - PLN-74809在12周内的FVC下降减少了80%，相较于安慰剂组的下降74.1 mL，PLN-74809组的下降为15.1 mL[33] - 在PLN-74809 80 mg剂量组中观察到FVC改善24.6 mL[33] - 在160 mg组中，12周时未观察到肺纤维化进展[33] - 研究中共筛选141名参与者，最终随机分配90名参与者接受治疗[39] - 参与者的平均年龄为71.7岁，男性占比79.1%[40] 用户数据 - 参与者中77.3%使用标准治疗（nintedanib或pirfenidone）[42] - 在PLN-74809组中，使用标准治疗的患者占比为82.1%[42] 不良事件 - 研究中大多数不良事件为轻度或中度，未因不良事件导致停药[33] - 在PLN-74809的所有剂量组中，68.7%的参与者报告了任何不良事件（AE），而安慰剂组为60.9%[45] - 在PLN-74809的所有剂量组中，67.2%的参与者报告了治疗相关的不良事件（TEAE），安慰剂组为60.9%[45] - 在使用背景标准治疗的PLN-74809组中，69.1%的参与者报告了任何不良事件，而安慰剂组为61.1%[46] - 在PLN-74809的所有剂量组中，最常见的TEAE为腹泻，发生率为17.9%，而安慰剂组为4.3%[47] - 在PLN-74809的所有剂量组中，18.2%的参与者出现了与研究药物相关的TEAE[45] - 在PLN-74809的160mg组中，9.1%的参与者报告了严重的TEAE，而安慰剂组为8.7%[45] 未来展望 - 公司已完成320 mg剂量组的INTEGRIS-IPF II期临床试验的入组，预计2023年初将公布中期数据[93] - 公司计划近期与监管机构分享数据，以讨论PLN-74809的后期开发计划[93] 新产品和新技术研发 - 研究中PLN-74809的剂量依赖性抗纤维化效果在QLF成像中得到验证[33] - 研究中PLN-74809组的血清胶原合成生物标志物（PRO-C3和PRO-C6）相较于安慰剂组有所降低[33] - 经过12周，PLN-74809治疗组的胶原合成生物标志物PRO-C3和PRO-C6均显示出显著降低[88] 市场扩张 - 在12周的随访中，PLN-74809的40mg组的FVC变化为-46.1 mL，80mg组为24.6 mL，160mg组为-25.1 mL，而安慰剂组为-74.1 mL[63] - 在PLN-74809的所有剂量组中，18.2%的参与者FVCpp下降≥10%[75] - 在使用背景标准治疗的PLN-74809组中，FVC变化为-58.3 mL，而安慰剂组为-95.2 mL[69] - PLN-74809治疗组在FVC变化方面的改善为-15.1 mL，而安慰剂组为-74.1 mL[77] - 在12周时，40 mg组的QLF平均百分比变化为3.15%，80 mg组为0.70%，160 mg组为0.00%，安慰剂组为1.15%[80] - 80 mg和160 mg组中，参与者保持稳定或改善的比例高于安慰剂组[84] - 在12周时，40 mg组中46.7%的参与者QLF评分改善，80 mg组为16.7%，160 mg组为21.4%，安慰剂组为29.4%[82]

财务状况 - 公司截至2022年9月30日的现金余额为3.6亿美元，预计运营资金可支持至2025年中[8] - 公司至今已筹集超过6.25亿美元，包括2020年首次公开募股和2022年7月的2.3亿美元后续融资[8] 产品研发与临床试验 - Bexotegrast在特发性肺纤维化（IPF）患者中表现出良好的耐受性，且对用力肺活量（FVC）和肺纤维化的治疗效果明显[8] - 2023年3季度将公布Bexotegrast在INTEGRIS-IPF研究中的12周数据[10] - Bexotegrast的剂量依赖性FVC改善在INTEGRIS-IPF研究中得到了验证[19] - Bexotegrast在临床前毒理学研究中未显示出限制临床进展的发现，包括无肺部浸润和膀胱癌风险[34] - 目前已有超过600名受试者在Bexotegrast的临床试验中接受了最高640毫克单剂量和320毫克多剂量的给药，未发现安全性问题[34] - Bexotegrast的靶向作用在IPF患者中表现出剂量和血浆浓度依赖性，最高可达98%的靶向参与率[36] - Bexotegrast治疗在12周内使FVC下降减少了80%[47] - 活性组的FVC变化为-15.1 mL，而安慰剂组为-74.1 mL[48] - 80 mg剂量组观察到FVC实际改善为+24.6 mL[48] - FVCpp下降≥10%的患者比例在40 mg、80 mg和160 mg组分别为18.2%、8.7%和4.5%，而安慰剂组为17.4%[55] - 在160 mg组的12周时，QLF成像显示无疾病进展[48] - Bexotegrast相较于安慰剂，降低了胶原合成的血清生物标志物PRO-C3和PRO-C6[48] - 40 mg、80 mg和160 mg组的QLF变化百分比分别为3.15%、0.70%和0.00%，安慰剂组为1.15%[58] - Bexotegrast治疗组在12周时的FVC变化为-44.3 mL，而安慰剂组为-74.1 mL[52] - Bexotegrast在治疗中未出现因不良事件导致的停药情况[48] - 没有因药物相关的严重不良事件导致的死亡[48] 市场环境 - 2021年，市场上两种已上市药物Esbriet和Ofev的全球总收入超过30亿美元[17] - Esbriet的首个仿制药于2022年5月上市，Ofev预计在2025年失去美国市场独占权[17]

Bexotegrast development in IPF discontinued Clinical oncology program and early-stage programs continue Recent workforce and operational changes align with next steps SOUTH SAN FRANCISCO, Calif., June 27, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following the review of data from the recently terminated BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). BEACON-IPF Trial Update BEA ...

SOUTH SAN FRANCISCO, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that the Company led oral and poster presentations of clinical and preclinical data this week as part of the American Thoracic Society (ATS) 2025 International Conference, held from May 16-21, 2025. Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS from Multiple ILD SubtypesIn a featured oral presentation, Johanna Schaub, Ph.D., Director of T ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject ...

Exhibit 99.1 Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results Activities supporting the close out of BEACON-IPF continue; topline data expected in the second quarter of 2025 Recently announced strategic realignment of workforce and operations will extend cash runway to support execution of late-stage clinical trials SOUTH SAN FRANCISCO, CA., May 8, 2025 - Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery ...

Activities supporting the close out of BEACON-IPF continue; topline data expected in the second quarter of 2025 Recently announced strategic realignment of workforce and operations will extend cash runway to support execution of late-stage clinical trials SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today p ...

- Implementation of cost reduction initiatives to position Pliant for execution of late-stage clinical trials - Pliant will reduce its current workforce by approximately 45% - Closing activities for BEACON-IPF trial ongoing; topline data expected in the second quarter of 2025 SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced a strategic restructuring of its workforce and other cost saving actions to extend the cash runway to support execut ...

NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Pliant Therapeutics, Inc (“Pliant” or the “Company”) (NASDAQ: PLRX). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Pliant and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Februar ...

NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Pliant Therapeutics, Inc (“Pliant” or the “Company”) (NASDAQ: PLRX). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Pliant and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On Februa ...