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]

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]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Pliant Therapeutics, Inc and its officers or directors [1] Company Developments - On February 7, 2025, Pliant announced a voluntary pause in enrollment and dosing for the BEACON-IPF Phase 2b trial of bexotegrast due to recommendations from the independent Data Safety Monitoring Board [3] - Following this announcement, analysts from Wells Fargo and Citi downgraded Pliant, expressing uncertainty regarding the future of bexotegrast [3] Stock Performance - Pliant's stock price experienced a significant decline, falling by $4.72 per share, or 60.59%, closing at $3.07 per share on February 10, 2025 [4]

Core Viewpoint - Pliant Therapeutics, Inc is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop after pausing a clinical trial for its drug bexotegrast [1][3]. Company Developments - On February 7, 2025, Pliant announced a voluntary pause in enrollment and dosing for the BEACON-IPF Phase 2b trial of bexotegrast due to recommendations from the independent Data Safety Monitoring Board [3]. - Following this announcement, analysts from Wells Fargo and Citi downgraded Pliant, indicating uncertainty regarding the future of bexotegrast [3]. Stock Performance - After the announcement of the trial pause, Pliant's stock price fell by $4.72 per share, representing a 60.59% decrease, closing at $3.07 per share on February 10, 2025 [4].

Pliant Therapeutics, Inc. (PLRX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual investo ...

Core Insights - Pliant Therapeutics will present three scientific posters at the 2025 American Thoracic Society (ATS) International Conference in San Francisco from May 16-21, 2025 [1][2]. Group 1: Presentations at ATS Conference - Pliant has been selected for a featured oral presentation at the ATS 2025 Mini Symposiums program [2]. - The oral presentation titled "Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS From Multiple ILD Subtypes" will be presented by Dr. Johanna Schaub on May 19, 2025, from 2:15 p.m. to 4:15 p.m. Pacific Time [3]. - Two posters will be presented on May 21, 2025, focusing on plasma proteome analysis and single-cell profiling related to antifibrotic effects of Bexotegrast, both scheduled from 8:15 a.m. to 10:15 a.m. Pacific Time [3]. Group 2: Company Overview - Pliant Therapeutics is a late-stage biopharmaceutical company specializing in novel therapeutics for fibrotic diseases [4]. - The lead product candidate, Bexotegrast (PLN-74809), is an oral small molecule targeting idiopathic pulmonary fibrosis (IPF) and has received Fast Track and Orphan Drug Designations from the FDA [4]. - Pliant is also developing PLN-101095 for solid tumors and has regulatory clearance for a Phase 1 study of PLN-101325 targeting muscular dystrophies [4].

Core Insights - Pliant Therapeutics Inc. (PLRX) is a biotech company focused on developing therapeutics for fibrotic diseases and is currently in a cash-rich position despite facing a significant setback with its lead drug candidate [1] Company Overview - Pliant Therapeutics is engaged in the discovery and development of treatments specifically targeting fibrotic diseases [1] - The company has a strong cash position, which may provide it with the necessary resources to navigate challenges [1] Investment Perspective - The company is considered attractive for investors looking for small-cap stocks with high upside potential relative to downside risk [1] - The investment approach is value-based, with an openness to exploring special situations and short opportunities [1]

Shares of Pliant Therapeutics (PLRX) have plunged 88.5% in the past three months following recent setbacks in the clinical development program of its lead product candidate, bexotegrast (PLN-74809), for treating idiopathic pulmonary fibrosis (IPF). Bexotegrast is an oral, small-molecule, dual selective inhibitor of αvß6 and αvß1 integrins.IPF is the most prevalent and severe type of progressive pulmonary fibrosis, impacting around 150,000 patients in the United States and more than three million worldwide.P ...