Core Insights - Biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and investor conference appearances across several small- and mid-cap companies [1] Company Summaries - **Immutep Ltd. (IMMP)**: Shares rose by 4.37% to $1.67 after-hours, following a decline of 6.98% during regular trading. The stock's rebound was fueled by the acceptance of data from its EFTISARC-NEO Phase II trial for oral presentation at CTOS 2025, focusing on a rare cancer with high unmet need [2][3] - **Nautilus Biotechnology Inc. (NAUT)**: Shares surged by 12.25% to $0.7521 after-hours, recovering from a 4.42% decline in regular trading. The increase was attributed to insider buying by CEO Sujal M. Patel, who purchased 83,500 shares, signaling confidence in the company [4][5] - **Pliant Therapeutics Inc. (PLRX)**: The stock ended regular trading at $1.75, up 1.16%, and jumped 16.00% to $2.03 after-hours. The upcoming third-quarter earnings report on November 6, 2025, is expected to provide updates on its lead candidate targeting idiopathic pulmonary fibrosis [6][7] - **Jin Medical International Ltd. (ZJYL)**: Shares closed at $0.6532, gaining 3.65% during regular trading and rising 7.15% to $0.6999 after-hours. The catalyst for this movement was the announcement of expanded production capabilities in China, aimed at enhancing global delivery of medical equipment [7][8] - **Phio Pharmaceuticals Corp. (PHIO)**: The stock rose 8.20% to $2.64 after-hours, building on a 13.49% increase during regular trading. The momentum was driven by participation in the H.C. Wainwright 27th Annual Global Investment Conference, where updates on its Phase 1b clinical trial for PH-762 will be presented [8][9] - **Kura Oncology Inc. (KURA)**: Shares increased by 6.12% to $8.50 after-hours, following a 1.60% decline in regular trading. The rally was linked to the company's presentation at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for Ziftomenib [10][11][12]

PART I. FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) Unaudited condensed financial statements for June 30, 2025, show total assets decreased to $299.8 million and a net loss of $99.5 million for the six-month period, reflecting operational cash usage and reduced R&D [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $299.8 million from $396.9 million, primarily due to reduced cash and investments, reflecting net losses Condensed Balance Sheet Highlights (In thousands) | Balance Sheet Highlights | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $86,820 | $71,188 | | Short-term investments | $176,053 | $284,536 | | **Total Assets** | **$299,824** | **$396,949** | | **Liabilities & Equity** | | | | Total Liabilities | $79,742 | $92,868 | | Total Stockholders' Equity | $220,082 | $304,081 | | **Total Liabilities and Stockholders' Equity** | **$299,824** | **$396,949** | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q2 2025 improved to $43.3 million from $55.9 million in Q2 2024, primarily due to decreased R&D expenses, with a six-month net loss of $99.5 million Condensed Statements of Operations (In thousands) | Statement of Operations | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(32,198) | $(45,617) | $(75,634) | $(82,763) | | General and administrative | $(13,394) | $(15,022) | $(28,893) | $(30,268) | | **Loss from operations** | **$(45,592)** | **$(60,639)** | **$(104,527)** | **$(113,031)** | | **Net loss** | **$(43,300)** | **$(55,854)** | **$(99,466)** | **$(102,809)** | | Net loss per share | $(0.71) | $(0.92) | $(1.62) | $(1.71) | [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to $220.1 million from $304.1 million, primarily due to a $99.5 million net loss, partially offset by stock-based compensation Stockholders' Equity Movement (In thousands) | Stockholders' Equity Movement | Amount | | :--- | :--- | | Balance at December 31, 2024 | $304,081 | | Net loss (Six months ended June 30, 2025) | $(99,466) | | Stock-based compensation expense | $15,291 | | Issuance of common stock under benefit plans | $498 | | Net unrealized loss on short term investments | $(322) | | **Balance at June 30, 2025** | **$220,082** | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $89.5 million for the six months ended June 30, 2025, with investing activities providing $104.6 million, leading to a $15.6 million net cash increase Cash Flow Summary (In thousands) | Cash Flow Summary | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(89,467) | $(75,568) | | Net cash provided by investing activities | $104,601 | $70,248 | | Net cash provided by financing activities | $498 | $22,472 | | **Net increase in cash and cash equivalents** | **$15,632** | **$17,152** | [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Key notes highlight the discontinuation of the bexotegrast program, a 45% workforce reduction incurring $3.8 million in restructuring costs, and the adoption of a stockholder rights agreement - In June 2025, the company announced the discontinuation of the development of bexotegrast in Idiopathic Pulmonary Fibrosis (IPF) after the Phase 2b BEACON-IPF trial demonstrated an unfavorable risk-benefit profile[35](index=35&type=chunk) - On May 1, 2025, the company announced a workforce reduction impacting approximately **45% of its employees**, with an expected total cost of about **$3.8 million**[91](index=91&type=chunk) - In March 2025, the company's board adopted a stockholder rights agreement (a "poison pill") intended to reduce the likelihood of a hostile takeover, expiring on March 11, 2026[64](index=64&type=chunk)[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the discontinuation of bexotegrast, strategic restructuring to extend cash runway, and focus on oncology and muscular dystrophy programs, with **$264.4 million** in cash as of Q2 2025 [Overview and Recent Developments](index=21&type=section&id=Overview%20and%20Recent%20Developments) The company discontinued bexotegrast development in IPF due to an unfavorable risk-benefit profile and initiated strategic restructuring, while advancing its oncology program PLN-101095 - Bexotegrast development in IPF was discontinued following an analysis of the full safety and efficacy data from the BEACON-IPF Phase 2b/3 trial, which showed an unfavorable risk-benefit profile[100](index=100&type=chunk) - The Phase 1 trial of PLN-101095 in solid tumors is ongoing, with initial data from the two highest dose cohorts expected by the end of **2025**[101](index=101&type=chunk) - A strategic restructuring of the workforce and other cost-saving actions were largely completed by the end of Q2 **2025** to extend the company's cash runway[102](index=102&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) R&D expenses decreased by **$13.4 million** for Q2 2025 due to the discontinuation of the BEACON-IPF trial, with general and administrative expenses also decreasing by **$1.6 million** R&D Expense Breakdown (In thousands) | R&D Expense Breakdown | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | $ Change | | :--- | :--- | :--- | :--- | | Bexotegrast - clinical trial costs | $13,359 | $26,360 | $(13,001) | | Other pipeline programs | $2,019 | $1,673 | $346 | | Unallocated internal expenses | $16,820 | $17,584 | $(764) | | **Total R&D Expenses** | **$32,198** | **$45,617** | **$(13,419)** | - General and administrative expenses decreased by **$1.6 million** for the three months ended June 30, 2025, primarily due to reduced employee-related costs following the workforce reduction[113](index=113&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$264.4 million** in cash and investments, deemed sufficient for over 12 months, despite increased cash used in operating activities to **$89.5 million** - The company had **$264.4 million** in cash, cash equivalents, and short-term investments as of June 30, 2025[121](index=121&type=chunk) - Management believes existing capital resources are sufficient to fund anticipated operating expenses and capital requirements for the next **12 months and beyond**[123](index=123&type=chunk) - Net cash used in operating activities increased by **$13.9 million** for the six months ended June 30, 2025, primarily due to settling payables related to the bexotegrast program close-out[127](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its investment portfolio and variable-rate term loan, though a 100 basis point change is not expected to be material - The company's main market risk is interest rate sensitivity on its **$264.4 million** of cash, cash equivalents, and short-term investments, and its **$30.0 million** term loan[137](index=137&type=chunk) - Due to the short-term nature of its investments, the company believes a hypothetical **10% change** in interest rates would not have had a material impact on its financial statements[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - As of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[140](index=140&type=chunk) - No changes to internal control over financial reporting occurred during the quarter ended June 30, 2025, that would be reasonably likely to have a material effect[141](index=141&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not a party to any material legal matters or claims, though future involvement in ordinary course legal matters is acknowledged - The company is not currently party to any material legal matters or claims[144](index=144&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, R&D, commercialization, intellectual property, third-party reliance, operational, and stock-related risks, including a history of losses and high dependence on early-stage candidates - **Financial Risk:** The company has incurred significant net losses since inception (**$809.5 million** accumulated deficit as of June 30, 2025) and expects to continue incurring losses, requiring substantial additional capital[147](index=147&type=chunk)[151](index=151&type=chunk) - **R&D Risk:** The business is highly dependent on the success of its remaining clinical-stage product candidates after discontinuing bexotegrast in IPF, with drug discovery being an unproven, lengthy, expensive, and uncertain process[165](index=165&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - **Third-Party Reliance Risk:** The company relies on single-source third-party suppliers, including some located in China, to manufacture its drug candidates, posing disruption risks from business or geopolitical events[17](index=17&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) - **Operational Risk:** The recent restructuring and **45% workforce reduction** may increase dependence on remaining key personnel and could lead to loss of institutional knowledge, decreased morale, or attrition[333](index=333&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - No unregistered sales of equity securities occurred during the period[400](index=400&type=chunk) [Item 5. Other Information](index=73&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the three months ended June 30, 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter[403](index=403&type=chunk) [Item 6. Exhibits](index=74&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and interactive data files (XBRL) - The report includes certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002, along with other corporate documents and XBRL data[405](index=405&type=chunk)

Core Insights - Pliant Therapeutics has largely completed its workforce and operational realignment while focusing on closing out the BEACON-IPF activities and maintaining core capabilities for future developments [2][5] - The company is on track to deliver additional data from its Phase 1 oncology trial by the end of 2025 [1][4] Second Quarter and Recent Developments - Development of bexotegrast for idiopathic pulmonary fibrosis (IPF) has been discontinued due to an unfavorable risk-benefit profile despite early signs of efficacy [3] - The Phase 1 trial of PLN-101095, targeting solid tumors, continues to enroll patients, with initial data expected by the end of 2025 [4] Financial Results - Research and development expenses decreased to $32.2 million from $45.6 million year-over-year, primarily due to the discontinuation of BEACON-IPF [8] - General and administrative expenses also decreased to $13.4 million from $15.0 million, attributed to personnel-related costs from the workforce restructuring [8] - The net loss for the second quarter was $43.3 million, down from $55.9 million in the prior year [8][13] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $264.4 million [8]

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]

Core Viewpoint - Pliant Therapeutics has discontinued the development of bexotegrast for idiopathic pulmonary fibrosis (IPF) following an unfavorable risk-benefit profile identified in the BEACON-IPF Phase 2b/3 clinical trial [1][3][5] Group 1: Clinical Trial Results - The BEACON-IPF trial was a randomized, double-blind, placebo-controlled study that revealed an imbalance in IPF-related adverse events, leading to its voluntary discontinuation [2] - Analysis of safety and efficacy data indicated that bexotegrast at doses of 160 mg and 320 mg increased the risk of adverse events related to IPF progression, with an average time to disease progression of 33 weeks for treated participants [3] - At Week 12, the 160 mg and 320 mg treatment groups showed improvements in forced vital capacity (FVC) decline of 72 mL (p<0.05) and 46 mL (p>0.05) respectively, while at Week 24, improvements were 58 mL (p>0.05) and 8 mL (p>0.05) respectively compared to placebo [4] Group 2: Future Development Plans - The company continues to enroll patients in a Phase 1 trial for PLN-101095, a dual-selective inhibitor targeting solid tumors resistant to immune checkpoint inhibitors, with interim results showing 50% confirmed partial responses at the highest dose tested [6] - Pliant's drug discovery platform includes over 15,000 integrin binding molecules and aims to support early-stage programs across multiple disease areas, focusing on tissue-specific delivery mechanisms [7][9]

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]

Corporate Update and First Quarter 2025 Financial Results Overview [Recent Developments and Program Highlights](index=1&type=section&id=Recent%20Developments%20and%20Program%20Highlights) Pliant Therapeutics updated on clinical programs, including BEACON-IPF trial close-out and promising Phase 1 PLN-101095 oncology data [Bexotegrast Program Updates](index=1&type=section&id=Bexotegrast%20Program%20Updates) BEACON-IPF Phase 2b/3 trial close-out continues, with topline data expected in Q2 2025; Phase 2a PET imaging trial results published - BEACON-IPF Phase 2b/3 trial close-out activities are ongoing, with **topline data anticipated in the second quarter of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[7](index=7&type=chunk) - Results from a Phase 2a positron emission tomography (PET) imaging trial, reporting positive findings on collagen deposition in IPF patients, were published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM)[7](index=7&type=chunk) [Oncology Program (PLN-101095) Updates](index=1&type=section&id=Oncology%20Program%20(PLN-101095)%20Updates) Interim Phase 1 data for PLN-101095 with pembrolizumab demonstrated antitumor activity and confirmed partial responses in solid tumors, with good tolerability - Interim Phase 1 data for PLN-101095 in combination with pembrolizumab showed antitumor activity with confirmed partial responses in solid tumors resistant to immune checkpoint inhibitors[2](index=2&type=chunk)[4](index=4&type=chunk) - **Three of six patients** treated at the **1000 mg BID dose** (non-small cell lung cancer, cholangiocarcinoma, and melanoma) experienced confirmed partial responses with tumor size reductions of **74%, 48%, and 42%**, respectively[4](index=4&type=chunk) - PLN-101095 was generally well tolerated across all doses tested, and the trial is currently enrolling the fourth of five potential cohorts[4](index=4&type=chunk) [Corporate Strategic Realignment](index=1&type=section&id=Corporate%20Strategic%20Realignment) Pliant Therapeutics announced a strategic realignment, including a 45% workforce reduction, to extend its cash runway and support clinical trials - A strategic realignment of workforce and operations was announced on May 1, 2025, including an approximately **45% reduction in workforce** and other cost-saving actions[5](index=5&type=chunk) - The realignment is expected to extend the cash runway to support the execution of clinical trials, including late-stage trials, and is anticipated to be substantially completed by the second quarter of 2025[1](index=1&type=chunk)[5](index=5&type=chunk) [First Quarter 2025 Financial Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20Highlights) Pliant Therapeutics reported a net loss of $56.2 million for Q1 2025, driven by higher operating expenses, while maintaining a strong cash position of $307.1 million Key Financial Highlights (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) | | :----------------------------- | :-------------------- | :-------------------- | :----------- | | Research and development expenses | $43.4 | $37.1 | +$6.3 | | General and administrative expenses | $15.5 | $15.2 | +$0.3 | | Net loss | $56.2 | $47.0 | +$9.2 | | Cash, cash equivalents and short-term investments (as of March 31) | $307.1 | N/A | N/A | - The increase in research and development expenses was primarily due to the acceleration of close-out activities for the BEACON-IPF study and increased employee-related expenses[11](index=11&type=chunk) [About Pliant Therapeutics, Inc.](index=3&type=section&id=About%20Pliant%20Therapeutics%2C%20Inc.) [Company Overview and Product Pipeline](index=3&type=section&id=Company%20Overview%20and%20Product%20Pipeline) Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on fibrotic diseases, with lead candidate bexotegrast for IPF and other programs in oncology and muscular dystrophies - Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on fibrotic diseases[8](index=8&type=chunk) - Bexotegrast (PLN-74809), the lead product candidate, is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins in development for idiopathic pulmonary fibrosis (IPF)[8](index=8&type=chunk) - Bexotegrast has received **Fast Track Designation** and **Orphan Drug Designation** from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency in IPF[8](index=8&type=chunk) - The pipeline includes PLN-101095 (Phase 1 for solid tumors resistant to immune checkpoint inhibitors) and PLN-101325 (Phase 1 for muscular dystrophies)[8](index=8&type=chunk) [Condensed Financial Statements](index=4&type=section&id=Condensed%20Financial%20Statements) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For Q1 2025, Pliant Therapeutics reported a net loss of $56.2 million, an increase from the prior year, primarily due to higher R&D expenses Condensed Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $(43,436) | $(37,146) | | General and administrative | $(15,499) | $(15,246) | | Total operating expenses | $(58,935) | $(52,392) | | Loss from operations | $(58,935) | $(52,392) | | Interest and other income (expense), net | $3,568 | $5,882 | | Interest expense | $(799) | $(445) | | Net loss | $(56,166) | $(46,955) | | Net loss per share - basic and diluted | $(0.92) | $(0.78) | | Shares used in computing net loss per share | 61,222,676 | 60,180,921 | [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $344.8 million from $396.9 million, mainly due to reduced short-term investments, while total liabilities also decreased Condensed Balance Sheets (Unaudited, in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $91,936 | $71,188 | | Short-term investments | $213,709 | $284,536 | | Total current assets | $311,191 | $362,264 | | Total assets | $344,770 | $396,949 | | Total current liabilities | $28,203 | $33,218 | | Total liabilities | $87,606 | $92,868 | | Total stockholders' equity | $257,164 | $304,081 | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section disclaims forward-looking statements, highlighting various risks and uncertainties that could cause actual results to differ materially - Statements regarding future events, conditions, or circumstances are identified as forward-looking statements, subject to risks and uncertainties[10](index=10&type=chunk) - Risks include those related to the development and commercialization of product candidates, delays in trials, macroeconomic conditions, reliance on single-source third parties, and capital requirements[10](index=10&type=chunk) - These and additional risks are discussed in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of the company's Quarterly Report on Form 10-Q for the period ended March 31, 2025[10](index=10&type=chunk) - Pliant Therapeutics does not undertake any obligation to update forward-looking statements[10](index=10&type=chunk) [Investor and Media Contact](index=3&type=section&id=Investor%20and%20Media%20Contact) [Contact Information](index=3&type=section&id=Contact%20Information) This section provides the contact details for investor relations and corporate communications at Pliant Therapeutics - Contact for Investor and Media: Christopher Keenan, Vice President, Investor Relations and Corporate Communications[11](index=11&type=chunk) - Email: ir@pliantrx.com[11](index=11&type=chunk)

Core Insights - Pliant Therapeutics is focused on closing out the BEACON-IPF trial, with topline data expected in the second quarter of 2025, while also making progress in its oncology program with PLN-101095 showing antitumor activity [1][2][7] First Quarter and Recent Developments - The company reported a net loss of $56.2 million for the first quarter of 2025, compared to a net loss of $47.0 million in the same quarter of the previous year, primarily due to increased operating expenses related to BEACON-IPF close-out activities [12] - Research and development expenses rose to $43.4 million from $37.1 million year-over-year, driven by the acceleration of close-out activities for BEACON-IPF [6][12] Oncology Program - Interim Phase 1 data from the PLN-101095 trial in combination with pembrolizumab demonstrated confirmed partial responses in three out of six patients treated at the highest dose, with tumor size reductions of 74%, 48%, and 42% in patients with non-small cell lung cancer, cholangiocarcinoma, and melanoma, respectively [4] - The trial is currently enrolling the fourth of five potential cohorts, evaluating PLN-101095 at a dose of 1000 mg administered three times daily [4] Corporate Highlights - A strategic realignment of workforce and operations was announced, including a 45% reduction in workforce, aimed at extending the cash runway to support clinical trials [5] - The realignment process is expected to be substantially completed by the second quarter of 2025 [5] Financial Position - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $307.1 million [12] - Total current assets decreased from $362.3 million at the end of 2024 to $311.2 million [16]