Bexotegrast

First participant dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095 Oral presentation at AACR 2026 featured updated data from Phase 1 trial of PLN-101095 showing deepening of confirmed responses in checkpoint inhibitor-refractory solid tumors PLN-101095 spotlighted as novel IO approach as part of AACR's 2026 Highlights Plenary Session SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported first quarter 2026 financial results. “In the first quarter, our team showcased its clinical development capabilities, initiating FORTIFY, the Phase 1b trial of PLN-101095, ahead of schedule and dosing the first patient in April,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “We were excited to highlight encouraging recent data from the Phase 1a trial of PLN-101095 at AACR showing deepening responses and increasing time on treatment. The team continues to make progress on pipeline programs emerging from Pliant's proprietary integrin platform while evaluating opportunities to expand our clinical-stage pipeline.” Oncology Program PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial ( NCT0670706 ) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. FORTIFY, a Phase 1b indication expansion trial, enrolling and dosing patients. In April, the Company announced the dosing of its first participant in the FORTIFY Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma and a subset of tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027. Oral presentation at AACR of updated Phase 1 data from PLN-101095 highlighted deepening of confirmed responses. In April, at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) 2026 Annual Meeting, the Company announced positive updated data from its Phase 1 trial of PLN-101095. Results showed that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab, an FDA-approved ICI. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported. These clinical responses were observed in patients with cholangiocarcinoma, NSCLC, melanoma and head and neck squamous cell carcinoma, respectively. All responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. Additionally, PLN-101095 was spotlighted as a novel immunotherapy approach as part of AACR’s 2026 Annual Meeting Highlights Plenary Session. Integrin-Targeted Delivery Platform Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads. First Quarter 2026 Financial Results Research and development expenses were $13.6 million, as compared to $43.4 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year. General and administrative expenses were $8.2 million, as compared to $15.5 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year. Net loss was $20.0 million as compared to $56.2 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year. As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of $172.4 million which the Company expects to be sufficient to fund operations into the second half of 2028. About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. Pliant’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of ICI-refractory advanced or metastatic solid tumors. PLN-101095 is being investigated in FORTIFY, a Phase 1b indication expansion trial enrolling patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Pliant’s preclinical research is focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules with programs focused on delivering siRNAs to skeletal muscle cells, adipocytes, and renal cells. For additional information, please visit: . Follow Pliant on social media at X , LinkedIn and Facebook . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include express or implied statements regarding ongoing clinical trial development of PLN-101095, including timing of enrollment and data; the potential benefits of PLN-101095; and Pliant’s plans for the continued development of PLN-101095 among others, including its integrin-based drug delivery platform. Because such statements deal with future events and are based on Pliant’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of Pliant’s product candidates, including any delays in Pliant’s ongoing or planned preclinical or clinical trials, the impact of current macroeconomic, geopolitical and marketplace conditions on Pliant’s business, operations, clinical supply and plans, Pliant’s reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of Pliant development operations, the risks inherent in the drug development process, the risks regarding the accuracy of Pliant’s estimates of expenses and timing of development, its capital requirements and the sufficiency of its cash to support Pliant’s planned operations, and Pliant’s ability to obtain and maintain intellectual property protection for Pliant’s product candidates. These and additional risks are discussed in the sections titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Pliant’s Quarterly Report on Form 10-Q for the period ended March 31, 2026, which Pliant is filing with the Securities and Exchange Commission (SEC) today, and which will be available on the SEC's website at Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Investor and Media Contact: Christopher Keenan Vice President, Investor Relations and Corporate Communications Pliant Therapeutics, Inc. ir@pliantrx.com Pliant Therapeutics, Inc. Condensed Statements of Operations (Unaudited) (In thousands, except number of shares and per share amounts) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ (13,584 ) $ (43,436 ) General and administrative (8,188 ) (15,499 ) Total operating expenses (21,772 ) (58,935 ) Loss from operations (21,772 ) (58,935 ) Interest and other income (expense), net 1,732 3,568 Interest expense — (799 ) Net loss $ (20,040 ) $ (56,166 ) Net loss per share - basic and diluted $ (0.32 ) $ (0.92 ) Shares used in computing net loss per share - basic and diluted 61,803,467 61,222,676 Pliant Therapeutics, Inc. Condensed Balance Sheets (Unaudited) (In thousands) March 31, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents $ 22,190 $ 45,445 Short-term investments 148,702 145,499 Prepaid expenses and other current assets 3,132 4,464 Property and equipment held for sale 906 1,040 Total current assets 174,930 196,448 Property and equipment, net 2,664 2,940 Operating lease right-of-use assets 23,131 23,966 Restricted cash 1,482 1,482 Other non-current assets 389 392 Total assets $ 202,596 $ 225,228 Liabilities and stockholders’ equity Current liabilities Accounts payable $ 362 $ 480 Accrued research and development 4,141 4,804 Accrued liabilities 4,143 9,634 Lease liabilities, current 1,713 1,447 Total current liabilities 10,359 16,365 Lease liabilities, non-current 27,071 27,658 Long-term debt — — Total liabilities 37,430 44,023 Commitments and Contingencies Stockholders’ equity Preferred stock — — Common stock 6 6 Additional paid-in capital 1,044,937 1,040,610 Accumulated deficit (879,436 ) (859,396 ) Accumulated other comprehensive loss (341 ) (15 ) Total stockholders’ equity 165,166 181,205 Total liabilities and stockholders’ equity $ 202,596 $ 225,228

PLN-101095 Phase 1 data showed deep and durable ongoing responses in checkpoint inhibitor refractory solid tumors PLN-101095 accelerated development plan underway with initiation of Phase 1b indication expansion trial SOUTH SAN FRANCISCO, Calif., March 11, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, today provided a corporate update and reported fourth quarter 2025 financial results. “We ended 2025 with encouraging data from our lead oncology program in ICI-refractory patients, an area of unmet medical need, that informed the initiation of our accelerated development plan for PLN-101095,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “In addition to oncology and the early-stage pipeline programs emerging from Pliant's proprietary integrin platform, we continue to assess opportunities to expand our clinical-stage pipeline that leverage our areas of expertise and align with creating shareholder value.” Fourth Quarter and Recent Developments Oncology Program PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab , in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. Data from the Phase 1 trial of PLN-101095 showed deep and durable ongoing responses. In December, the Company announced positive data showing that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab , an FDA-approved ICI. Four responders were observed consisting of one confirmed complete response and three partial responses (two confirmed, one unconfirmed) out of the 10 secondary ICI refractory patients. These clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer (NSCLC). Notably, all responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab . No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. Accelerated development plan of PLN-101095 underway with initiation of Phase 1b indication expansion trial. Based on the encouraging response data and supportive IFN- γ biomarker data from the Phase 1 trial, the Company is advancing an accelerated clinical development plan of PLN-101095 and has initiated a Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including NSCLC, clear cell renal cell carcinoma and tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Study start activities for this trial are underway with first patient enrollment anticipated in second quarter. Interim data is expected in 2027. PLN-101095 Phase 1 data accepted for presentation at AACR Annual Meeting 2026. Data from the Phase 1 trial of PLN-101095 will be the subject of a poster presentation and an oral presentation as part of the Clinical Trials Minisymposium at the upcoming American Association of Cancer Research (AACR) conference to be held April 17-22, 2026, in San Diego, California. Integrin-Targeted Delivery Platform Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. The Company believes this integrin-targeting delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads. Corporate Highlights Appointment of Minnie Kuo as Chief Operating Officer. Ms. Kuo joined Pliant in September 2023 as Chief Development Officer, bringing more than 20 years of multinational clinical development experience across various therapeutic areas. In this expanded role, Ms. Kuo bridges Pliant’s science and operations with oversight of clinical operations, early development, program management, regulatory affairs and compliance. INTEGRIS-PSC results published in the Journal of Hepatology . The manuscript, “ Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6 and αvβ1 integrin inhibitor, in primary sclerosing cholangitis ”, appears in the January 2026 issue of the Journal of Hepatology . Fourth Quarter 2025 Financial Results Research and development expenses were $15.6 million as compared to $38.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF. General and administrative expenses were $8.0 million as compared to $14.5 million for the prior-year quarter. The decrease was primarily due to lower personnel-related costs resulting from the strategic restructuring of our workforce. Net loss was $23.6 million as compared to $49.7 million for the prior-year quarter. The decrease was primarily attributable to the discontinuation of BEACON-IPF coupled with the decrease in personnel-related costs resulting from the strategic restructuring of our workforce. As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $192.4 million which the Company expects to be sufficient to fund operations into the second half of 2028. About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. The Company’s lead program is PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. Pliant’s early-stage platform includes preclinical research focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules. For additional information, please visit: . Follow us on social media X , LinkedIn and Facebook . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These express or implied statements include those regarding PLN-101095's development plan, including anticipated timing of data from our ongoing Phase 1 trial and our Phase 1b indication expansion trial, expansion of our clinical-stage pipeline and creation of shareholder value, and the potential of our integrin-targeted delivery platform, among others. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and our actual results, performance or achievements could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the clinical development of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, or interactions with regulators, as well as the impact of current macroeconomic, geopolitical and marketplace conditions on our business, operations, clinical supply and plans, our reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the period ended December 31, 2025 which we are filing with the SEC today, available on the SEC's website at Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Investor and Media Contact: Christopher Keenan Vice President, Investor Relations and Corporate Communications Pliant Therapeutics, Inc. ir@pliantrx.com Pliant Therapeutics, Inc. Condensed Statements of Operations (Unaudited) (In thousands, except number of shares and per share amounts) Three Months Ended December 31, Twelve Months Ended December 31, 2025 2024 2025 2024 Operating expenses: Research and development $ (15,585 ) $ (38,793 ) $ (109,157 ) $ (169,310 ) General and administrative (7,992 ) (14,527 ) (47,216 ) (59,055 ) Total operating expenses (23,577 ) (53,320 ) (156,373 ) (228,365 ) Loss from operations (23,577 ) (53,320 ) (156,373 ) (228,365 ) Interest and other income (expense), net 1,964 4,422 11,416 21,085 Interest expense (136 ) (834 ) (2,559 ) (3,024 ) Loss on extinguishment of debt (1,828 ) — (1,828 ) — Net loss $ (23,577 ) $ (49,732 ) $ (149,344 ) $ (210,304 ) Net loss per share - basic and diluted $ (0.38 ) $ (0.82 ) $ (2.43 ) $ (3.47 ) Shares used in computing net loss per share - basic and diluted 61,449,290 60,854,322 61,366,887 60,538,639 Pliant Therapeutics, Inc. Condensed Balance Sheets (Unaudited) (In thousands) December 31, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 45,445 $ 71,188 Short-term investments 145,499 284,536 Prepaid expenses and other current assets 4,464 6,540 Property and equipment held for sale 1,040 — Total current assets 196,448 362,264 Property and equipment, net 2,940 5,525 Operating lease right-of-use assets 23,966 27,243 Restricted cash 1,482 1,482 Other non-current assets 392 435 Total assets $ 225,228 $ 396,949 Liabilities and stockholders’ equity Current liabilities Accounts payable $ 480 $ 5,960 Accrued research and development 4,804 14,363 Accrued liabilities 9,634 12,353 Lease liabilities, current 1,447 542 Total current liabilities 16,365 33,218 Lease liabilities, non-current 27,658 29,439 Long-term debt — 30,211 Total liabilities 44,023 92,868 Commitments and Contingencies Stockholders’ equity Preferred stock — — Common stock 6 6 Additional paid-in capital 1,040,610 1,013,806 Accumulated deficit (859,396 ) (710,052 ) Accumulated other comprehensive (loss) gain (15 ) 321 Total stockholders’ equity 181,205 304,081 Total liabilities and stockholders’ equity $ 225,228 $ 396,949