Oncology data and cost cuts reshape Pliant Therapeutics (NASDAQ: PLRX)
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8-K
Rhea-AI Filing Summary
Pliant Therapeutics reported fourth quarter 2025 results alongside a major update on its oncology pipeline. Lead candidate PLN-101095, an oral dual-selective αvβ8/αvβ1 inhibitor, showed deep and durable responses in a Phase 1 trial in immune checkpoint inhibitor–refractory solid tumors, including one confirmed complete response and three partial responses among 10 secondary ICI refractory patients. The company has begun an accelerated development plan with a Phase 1b indication expansion trial in non-small cell lung cancer, clear cell renal cell carcinoma and tumors with high tumor mutational burden, and Phase 1 data will be presented at the AACR Annual Meeting 2026.
Research and development expenses fell to $15.6 million from $38.8 million in the prior-year quarter, and general and administrative expenses declined to $8.0 million from $14.5 million, mainly due to discontinuation of BEACON-IPF and workforce restructuring. Quarterly net loss narrowed to $23.6 million from $49.7 million, and full-year 2025 net loss was $149.3 million versus $210.3 million in 2024. As of December 31, 2025, Pliant held $192.4 million in cash, cash equivalents and short-term investments, which it expects to fund operations into the second half of 2028.
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Insights
Pliant cuts losses, extends cash runway while advancing early oncology data.
Pliant Therapeutics is pivoting around oncology asset PLN-101095. Early Phase 1 data in checkpoint inhibitor–refractory tumors, with one complete and three partial responses among 10 secondary ICI refractory patients, support its mechanism and justify a Phase 1b indication expansion trial.
On the financial side, the discontinuation of BEACON-IPF and workforce restructuring reduced quarterly research and development expenses from
With
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 11, 2026
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Registrant’s Telephone Number, Including Area Code: (650 ) 481-6770
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
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Item 2.02 Results of Operations and Financial Condition.
On March 11, 2026, Pliant Therapeutics, Inc. (the "Company") issued a press release announcing the Company’s financial results for the fourth quarter ended December 31, 2025. A copy of this press release is furnished as Exhibit 99.1 to this report.
The information in this Current Report on Form 8-K including the exhibits furnished herewith shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (as amended, the "Exchange Act") or otherwise subject to the liabilities of that Section, and shall not be or be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||||||
99.1 | Press Release issued by the Company dated March 11, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| PLIANT THERAPEUTICS, INC. | ||||||||
Date: March 11, 2026 | By: | /s/ Keith Cummings | ||||||
| Keith Cummings, M.D., MBA | ||||||||
| Chief Financial Officer | ||||||||
Exhibit 99.1
Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2025 Financial Results
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
PLN-101095 accelerated development plan underway with initiation of Phase 1b indication expansion trial
SOUTH SAN FRANCISCO, CA., March 11, 2026 - 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: www.PliantRx.com. 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 www.sec.gov. 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 | |||||||
FAQ
What did Pliant Therapeutics (PLRX) report in its Q4 2025 financial results?
Pliant Therapeutics reported a narrower Q4 2025 net loss of $23.6 million, down from $49.7 million a year earlier, driven by lower research and development and general and administrative expenses following the discontinuation of BEACON-IPF and a strategic workforce restructuring.
How strong is Pliant Therapeutics’ cash position and runway after 2025?
As of December 31, 2025, Pliant held $192.4 million in cash, cash equivalents and short-term investments. The company expects this balance to fund operations into the second half of 2028, providing multiple years of runway for ongoing and planned clinical development activities.
What clinical results did Pliant Therapeutics announce for PLN-101095?
Pliant reported Phase 1 data for PLN-101095 showing deep and durable responses in immune checkpoint inhibitor–refractory solid tumors, including one confirmed complete response and three partial responses among 10 secondary ICI refractory patients, when combined with pembrolizumab in a heavily pretreated population.
What is the design of Pliant Therapeutics’ new Phase 1b trial for PLN-101095?
The Phase 1b indication expansion trial is an open-label, single-dose study enrolling three cohorts: non-small cell lung cancer, clear cell renal cell carcinoma and tumors with high tumor mutational burden. Patients receive 1,000 mg PLN-101095 twice daily for 14 days before adding pembrolizumab.
How did operating expenses change for Pliant Therapeutics in Q4 2025?
Fourth quarter 2025 research and development expenses declined to $15.6 million from $38.8 million, and general and administrative expenses fell to $8.0 million from $14.5 million. The reductions mainly reflect discontinuation of the BEACON-IPF program and a strategic restructuring of the workforce.
What is Pliant Therapeutics’ integrin-targeted delivery platform?
Pliant has developed an integrin-targeted delivery platform that uses cell-specific integrin receptors to deliver drug payloads, including siRNAs, to selected tissues. Current efforts focus on skeletal muscle cells and other tissues, with potential application across multiple disease areas using various payload types.
Will Pliant Therapeutics present PLN-101095 data at a major conference?
Yes. Phase 1 data for PLN-101095 have been accepted for both a poster and an oral Clinical Trials Minisymposium presentation at the AACR Annual Meeting 2026, scheduled for April 17–22, 2026, in San Diego, California, highlighting external interest in the program.
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Mar 11, 2026
[10-K] PLIANT THERAPEUTICS, INC. Files Annual Report