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 June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39303 PLIANT THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-4272481 (State or other jurisdiction of (I. ...

BEACON-IPF close out activities continue Previously announced workforce and operational realignment largely complete Phase 1 oncology trial on track to deliver additional data by the end of the year SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in integrin-based drug development, today provided a corporate update and reported second quarter 2025 financial results. “While our activities in the quarter ...

Clinical Trial Results of PLN-74809 - PLN-74809 demonstrated dose-dependent target engagement and TGF-β suppression in prior studies[24] - PLN-74809 was well-tolerated over 12 weeks of treatment in the INTEGRIS-IPF trial[32] - PLN-74809-treated patients experienced an 80% reduction in FVC decline over 12 weeks (-15.1 mL, Pooled Active Groups) compared to Placebo (-74.1 mL)[33] - An improvement in FVC (+24.6 mL) was observed in PLN-74809 80 mg dose cohort[34] - A dose-dependent antifibrotic effect was seen on QLF Imaging, with no progression in the 160 mg group at Week 12[34] - PLN-74809 decreased serum biomarkers of collagen synthesis (PRO-C3 and PRO-C6) relative to placebo[34] Safety and Tolerability - Most Treatment Emergent Adverse Events (TEAEs) were mild or moderate in severity, and there were no discontinuations due to adverse events, deaths, or drug-related Serious Adverse Events (SAEs)[34] - The most frequent TEAE seen was diarrhea, but it was only observed in patients on standard of care[54] FVC Analysis - PLN-74809-treated participants experienced a benefit in FVC change from Baseline to Week 12 (-15.1 mL for pooled PLN-74809 group) compared to those on placebo (-74.1 mL)[77] - A dose-dependent reduction was observed in the proportion of participants with FVCpp decline of ≥10%[34] - Quantitative Lung Fibrosis (QLF) imaging showed a dose-dependent antifibrotic effect, with no progression in the 160 mg group at Week 12 based on mean change from baseline[84]

Company Highlights and Financial Position - Pliant Therapeutics has raised over $625 million to date, including a 2020 IPO and a follow-on offering in July 2022 [8] - The company's cash balance was $360 million as of September 30, 2022, funding operations to mid-2025 [8] Bexotegrast (PLN-74809) in IPF and PSC - Bexotegrast is in Phase 2a development for Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC) [8] - In the INTEGRIS-IPF study, bexotegrast treatment resulted in an 80% reduction in FVC decline over 12 weeks compared to placebo (-15.1 mL vs -74.1 mL) [47, 48] - In the INTEGRIS-IPF study, an actual improvement in FVC (+24.6 mL) was observed in the 80 mg dose cohort [48] - In the INTEGRIS-IPF study, the proportion of participants with FVCpp decline ≥ 10% was 4.5% in the 160 mg group compared to 17.4% in the placebo group [55] PLN-101095 for Solid Tumors - An IND has been submitted for PLN-101095, a potential first-in-class small molecule dual αVβ8/αVβ1 inhibitor addressing ICI resistance in solid tumors, with Phase 1 initiation expected in 2Q 2023 [8, 9] - PLN-101095, combined with αPD-1, demonstrated high tumor growth inhibition in the EMT6 syngeneic mouse model [91] Market Opportunity in IPF - The two marketed agents for IPF, Esbriet® and Ofev®, had >$3 billion in total global revenues in 2021 [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 ...

Core Insights - Pliant Therapeutics presented clinical and preclinical data at the ATS 2025 International Conference, highlighting the antifibrotic activity of bexotegrast and its potential in treating fibrotic diseases [1] Group 1: Antifibrotic Activity of Bexotegrast - Bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, demonstrated reduced expression of genes related to TGF-β signaling and fibrogenesis in alveolar type 1 cells and various fibroblast subpopulations [2] - Single-nuclei RNAseq analysis showed that bexotegrast significantly reduced the expression of type I collagen and other profibrotic genes in aberrant basaloid cells and fibroblasts, indicating its distinct pharmacodynamic profile compared to nintedanib [4] Group 2: Biomarker Analysis - A comparative analysis of circulating plasma biomarkers identified dysregulated biomarkers across multiple ILD subtypes, which could aid in clinical decision-making for ILD [3] Group 3: Company Overview - Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for fibrotic diseases, with bexotegrast as its lead product candidate undergoing evaluation for idiopathic pulmonary fibrosis [6] - The company has received Fast Track and Orphan Drug Designations from the FDA for bexotegrast, and is also conducting Phase 1 studies for other drug candidates targeting solid tumors and muscular dystrophies [6]

Financial Performance - Net loss for the three months ended March 31, 2025, was $56,166 thousand, compared to a net loss of $46,955 thousand for the same period in 2024, representing an increase of 19.3%[22] - The company reported a comprehensive loss of $56,328 thousand for the three months ended March 31, 2025, compared to a comprehensive loss of $47,789 thousand for the same period in 2024, an increase of 18.5%[22] - Net loss for the three months ended March 31, 2025, was $56.2 million, compared to a net loss of $47.0 million for the same period in 2024, with an accumulated deficit of $766.2 million[101] - The net loss for the three months ended March 31, 2025, was $56.2 million, an increase of $9.2 million from a net loss of $47.0 million in the same period of 2024[112] - The company expects to continue incurring significant losses for the foreseeable future, emphasizing the need to develop and commercialize products with substantial market potential[144] Assets and Liabilities - Total current assets decreased from $362,264 thousand as of December 31, 2024, to $311,191 thousand as of March 31, 2025, a decline of approximately 14.1%[20] - Total stockholders' equity decreased from $304,081 thousand as of December 31, 2024, to $257,164 thousand as of March 31, 2025, a decline of approximately 15.4%[20] - As of March 31, 2025, total financial assets amounted to $278.260 million, a decrease from $339.361 million as of December 31, 2024[45] - Accrued liabilities totaled $7.429 million as of March 31, 2025, down from $12.353 million as of December 31, 2024[50] - The company had cash, cash equivalents, and short-term investments of $307.1 million as of March 31, 2025[101] Cash Flow - Cash and cash equivalents increased from $71,188 thousand as of December 31, 2024, to $91,936 thousand as of March 31, 2025, an increase of approximately 29.2%[20] - Net cash used in operating activities for the three months ended March 31, 2025, was $48,864 thousand, compared to $30,271 thousand for the same period in 2024, an increase of 61.1%[31] - Cash flows from investing activities provided $69,114 thousand for the three months ended March 31, 2025, compared to $59,546 thousand for the same period in 2024, an increase of 15.8%[31] - Net cash provided by investing activities increased to $69.1 million, driven by maturities of marketable securities exceeding related purchases[125] Research and Development - Research and development expenses increased to $43,436 thousand for the three months ended March 31, 2025, from $37,146 thousand in the same period of 2024, an increase of 17.5%[22] - The company’s research and development expenses for the three months ended March 31, 2025, were $3.702 million, compared to $3.070 million in 2024, indicating a 20.5% increase[77] - Research and development expenses rose by $6.3 million to $43.4 million, primarily due to acceleration of close-out activities for the BEACON-IPF study and increased employee-related expenses[113] Debt and Financing - The company drew an additional Term Loan of $20.0 million under the Amended Loan Agreement, which upsized the existing Term Loan facility to $150.0 million[51] - Future maturities of debt as of March 31, 2025, total $30.284 million, with $20.0 million due in 2028 and $10.0 million in 2029[56] - The Amended Loan Agreement provides a total of $150.0 million in available non-dilutive capital, with an additional Term Loan of $20.0 million drawn[118] - The company acknowledges the uncertainty in estimating future losses and the potential need for additional capital to support ongoing operations and development efforts[145] Clinical Trials and Product Development - The BEACON-IPF trial was discontinued due to an imbalance in adverse events, but early evidence of efficacy was observed, with topline data expected in Q2 2025[94][99] - PLN-101095, a dual selective inhibitor, is currently in a Phase 1 trial, showing confirmed partial responses in three of six patients treated[98][100] - The company plans to analyze data from the BEACON-IPF trial and re-prioritize development of less capital-intensive product candidates[106] - The company is conducting a Phase 1 clinical trial of PLN-101095 in solid tumors and is Phase-1 ready for PLN-101325 for muscular dystrophies, with no products currently approved for commercial sale[160] Market and Regulatory Challenges - The company faces significant financial challenges, as substantial investments are required for clinical development, regulatory review, and marketing efforts for any approved product candidates[161] - The regulatory approval process varies by country, and approval by the FDA does not guarantee approval by foreign regulatory authorities[170] - The company must comply with numerous foreign regulatory requirements, which can complicate the clinical trial and marketing authorization processes[170] - The FDA has substantial discretion in the approval process, and product candidates may not be approved even if they meet primary endpoints[183] Competition and Market Acceptance - The company faces substantial competition from major biopharmaceutical companies and research organizations, which may hinder its ability to develop and commercialize products successfully[203] - Competitors include well-resourced companies such as AbbVie, AstraZeneca, and Merck, which are also targeting fibrosis treatments[204] - Market acceptance of any approved product candidates will depend on factors such as efficacy, pricing, and third-party payor coverage[210][212] Future Outlook - The company may need additional funds for operational needs and capital requirements for product development and commercialization sooner than planned[120] - Future funding requirements will depend on various factors, including the success of clinical trials and the ability to secure collaboration agreements[149] - The company expects general and administrative expenses to remain relatively consistent for the foreseeable future[114]

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 ...

Core Insights - Pliant Therapeutics is undergoing a strategic restructuring, reducing its workforce by approximately 45% to extend its cash runway for late-stage clinical trials [1][3][4] - The company is awaiting topline data from the BEACON-IPF Phase 2b/3 trial of bexotegrast, expected in the second quarter of 2025, which will inform the next steps for the drug's development [2][3] Workforce Restructuring - The restructuring will impact all departments, but the company aims to maintain its late-stage clinical trial execution capabilities [3] - The process is expected to be substantially completed by the end of the second quarter of 2025 [3] Clinical Development - Bexotegrast is being developed for idiopathic pulmonary fibrosis (IPF) and has received Fast Track and Orphan Drug Designations from the FDA [4] - Pliant is also conducting a Phase 1 study for PLN-101095, targeting solid tumors, and has received clearance for a Phase 1 study of PLN-101325 for muscular dystrophies [4]