PLIANT THERAPEUTICS, INC.
For the period ended Mar 31, 2026. Filed May 11, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 11, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001746473-25-000175
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001746473-26-000090
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 106 previous paragraphs and 90 current paragraphs.
67 unchanged; 12 reworded; 10 added; 24 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
First Quarter and Recent Developments
Current report
•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 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.
Current report
•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, non-small cell lung cancer (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.
Current report
Integrin-Targeted Delivery Platform
Current report
•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.
Current report
Our interest expense was derived from a term loan executed under the Amended Loan Agreement with Oxford Finance LLC that was terminated in October 2025.
Current report
Net cash used in operating activities decreased $29.6 million, primarily due to the discontinuation of the BEACON-IPF study in 2025 and the related restructuring of operations that reduced workforce and refocused development efforts toward PLN-101095, which is in an earlier, less capital-intensive phase of development.
Current report
Cash Used in Investing Activities
Current report
Net cash used in investing activities was $4.1 million compared to net cash provided by investing activities of $69.1 million. The $73.2 million change compared to the same period of the prior year was driven by purchases of marketable securities exceeding maturities during the three months ended March 31, 2026.
Current report
Net cash provided by financing activities decreased $0.4 million, as lower headcount and a decreased stock price yielded smaller proceeds associated with our Employee Stock Purchase Plan during the three months ended March 31, 2026.
Removed paragraphs (24)
Previous report
Our Phase 1-ready program PLN-101325, is in development for treatment of muscular dystrophies, including Duchenne muscular dystrophy. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1. PLN-101325 has received a clinical trial approval (CTA) in Australia.
Previous report
In June 2025, we announced that we were discontinuing the development of bexotegrast in IPF as the results of our global Phase 2b/3 trial, BEACON-IPF, demonstrated an unfavorable risk-benefit profile.
Previous report
In addition to our clinical pipeline, we have developed an integrin-based drug delivery platform. In preclinical research, our platform has shown the ability to deliver drug payloads to individual tissues through tissue-specific integrin receptors.
Previous report
Third Quarter and Recent Developments
Previous report
Bexotegrast
Previous report
•BEACON-IPF close out activities to be completed in fourth quarter. Close out activities from the BEACON-IPF Phase 2b/3 clinical trial are expected to be completed in the fourth quarter of 2025 with full results from the trial to be submitted for future publication.
Previous report
•Phase 1 open-label trial of PLN-101095 in solid tumors has completed enrollment. 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. The Phase 1 open-label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March of 2025, we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment of all five dose cohorts. Data from the trial, including the two highest dose cohorts, is expected by the end of 2025.
Previous report
Corporate Highlights
Previous report
Our interest expense is derived from a term loan executed under the Amended Loan Agreement. Borrowings under the Amended Loan Agreement bear interest at a rate per annum equal to 1-month term SOFR plus 5.25%, subject to an agreed upon floor of 8.75%. Refer to Note 19 to our financial statements appearing elsewhere in this Report for further information regarding the Amended Loan Agreement.
Previous report
We currently expect general and administrative expenses to remain relatively consistent for the foreseeable future.
Previous report
Comparison of the nine months ended September 30, 2025 and 2024 (in thousands)
Previous report
Research and development expenses
Previous report
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report
Research and development expenses for the nine months ended September 30, 2025 decreased $36.9 million, primarily due to discontinuing development of bexotegrast in IPF.
Previous report
General and Administrative Expenses
Previous report
General and administrative expenses for the nine months ended September 30, 2025 decreased $5.3 million, primarily attributable to decreased employee-related costs, driven by our restructuring of operations initiated on May 1, 2025.
Previous report
We expect our general and administrative expenses to remain relatively consistent for the foreseeable future.
Previous report
Interest Expenses
Previous report
Interest expense for the nine months ended September 30, 2025 increased $0.2 million due to additional borrowings under the Amended Loan Agreement.
Previous report
Comparison of the nine months ended September 30, 2025 and 2024
Previous report
Net cash used in operating activities increased $2.7 million, primarily due to settling payables and accrued expenses relating to the bexotegrast program including close-out activities for the BEACON-IPF study which is projected to be completed in the fourth quarter of 2025.
Previous report
Cash Provided by Investing Activities
Previous report
Net cash provided by investing activities increased over the same period of the prior year as maturities of marketable securities exceeded related purchases during the nine months ended September 30, 2025.
Previous report
Net cash provided by financing activities decreased $22.4 million, primarily due to additional Term Loans entered into during the nine months ended September 30, 2024 associated with the Amended Loan Agreement as well as decreased proceeds from the issuance of common stock under benefit plans during the nine months ended September 30, 2025.
Reworded paragraphs (12)
Previous wording
We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. We have applied our deep understanding of integrin biology, along with our medicinal chemistry and translational medicine expertise to develop a set of proprietary tools designed to discover and de-risk product candidates quickly and efficiently.
Current wording
We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β). We have applied our deep understanding of integrin biology, along with our medicinal chemistry and translational medicine expertise to develop a proprietary drug discovery platform that we believe has broad applicability across multiple areas of disease.
Previous wording
We are developing PLN-101095, a small molecule, dual selective inhibitor of integrins αvβ8 and αvβ1 for the treatment of solid tumors that are resistant to immune checkpoint inhibitors. We have completed enrollment of the fifth of five planned dose cohorts in a Phase 1 open-label, dose-escalation trial as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March 2025, we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third ascending dose cohort.
Current wording
Our wholly owned lead product candidate, PLN-101095, is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors. In 2025, we announced positive data from a Phase 1 open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with the immunotherapy pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. We also continue to explore the full potential of our drug discovery platform consisting of a proprietary library of over 15,000 integrin binding molecules, focusing on integrin-based target-mediated drug delivery.
Previous wording
Since inception, we have had significant operating losses. Our net loss was $26.3 million and $57.8 million for the three months ended September 30, 2025 and 2024, respectively. Our net loss for the nine months ended September 30, 2025 and 2024 was $125.8 million and $160.6 million, respectively. As of September 30, 2025, we had an accumulated deficit of $835.8 million and cash, cash equivalents, and short-term investments of $243.3 million. We expect to continue to incur net losses for the foreseeable future as we:
Current wording
Since inception, we have had significant operating losses. Our net loss was $20.0 million and $56.2 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $879.4 million and cash, cash equivalents, and short-term investments of $172.4 million. We expect to continue to incur net losses for the foreseeable future as we:
Previous wording
Due to discontinuing development of bexotegrast in IPF, we expect research and development expenses to decrease in the near term as we have re-prioritized our development of product candidates that are in earlier, less capital-intensive stages of development. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Current wording
Following the discontinuation of bexotegrast development, our current quarter results are reflective of the re-prioritized development pipeline and research and development expenses should be relatively consistent in the near term, increasing commensurate with the progress of our phase 1b trial. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Previous wording
Research and development expenses for the three months ended September 30, 2025 decreased $29.8 million, primarily due to discontinuing development of bexotegrast in IPF and lower employee-related expenses, driven by a reduction in headcount resulting from our restructuring initiated on May 1, 2025.
Current wording
Research and development expenses for the three months ended March 31, 2026 decreased $29.9 million, primarily due to discontinuing development of bexotegrast in IPF and lower employee-related expenses, driven by a reduction in headcount resulting from our 2025 restructuring activities.
Previous wording
General and administrative expenses for the three months ended September 30, 2025 decreased $3.9 million, primarily due to a decrease in employee related costs driven by reduced headcount resulting from our restructuring initiated on May 1, 2025.
Current wording
General and administrative expenses for the three months ended March 31, 2026 decreased $7.3 million, primarily due to a decrease in employee related costs driven by reduced headcount resulting from our 2025 restructuring activities.
Previous wording
Interest and other income (expense), net decreased $2.3 million due to lower investment balances due to continued funding of operating activities.
Current wording
Interest and other income (expense), net decreased $1.8 million due to lower investment balances due to continued funding of operating activities.
Previous wording
Interest expense for the three months ended September 30, 2025 decreased $0.1 million due to changing interest rates associated with the Amended Loan Agreement.
Current wording
Interest expense for the three months ended March 31, 2026 decreased $0.8 million due to full repayment of the Amended Loan Agreement in 2025.
Previous wording
As of September 30, 2025, we had $243.3 million of cash, cash equivalents and short-term investments. Our short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities.
Current wording
As of March 31, 2026, we had $172.4 million of cash, cash equivalents and short-term investments. Our short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities.
Previous wording
During the third quarter of 2021, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent, pursuant to which we may issue and sell shares of common stock in an "at-the-market" offering. In March 2023, we filed a prospectus registering the offer and sale of up to $150.0 million of shares of common stock from time to time pursuant to the Sales Agreement. As of the date of this Report, we have not issued any shares pursuant to any at-the-market offerings, including pursuant to the Sales Agreement, but may do so at a future date.
Current wording
On March 30, 2026 we entered into a Sales Agreement with Leerink Partners LLC (the "Leerink Sales Agreement"), as sales agent, pursuant to which we may issue and sell shares of common stock in an "at-the-market" offering. On March 30, 2026 we filed a registration statement on Form S-3 (File No. 333-294737) which included an "at the market offering" prospectus covering the offering, issuance and sale of up to $50.0 million of common stock under the Leerink Sales Agreement and a base prospectus registering the offer and sale of up to $300.0 million of debt securities, common stock, preferred stock, units and/or warrants. As of the date of this Report, we have not issued any shares pursuant to any at-the-market offerings, including pursuant to the Leerink Sales Agreement, but may do so at a future date.
Previous wording
In October 2025, we completed a voluntary prepayment of our Amended Loan Agreement with Oxford for $32.4 million, representing all outstanding principal, accrued and unpaid interest, fees, costs and expenses. Upon prepayment, all obligations, covenants, debts and liabilities under the Amended Loan Agreement were satisfied and discharged in full, and the Amended Loan Agreement and all other documents entered into in connection with the Amended Loan Agreement were terminated.
Current wording
In October 2025, we completed a voluntary prepayment of our Amended Loan Agreement with Oxford for $32.4 million, representing all outstanding principal, accrued and unpaid interest, fees, costs and expenses. Upon prepayment, all obligations, covenants, debts and liabilities under the Amended Loan Agreement were satisfied and discharged in full.
Previous wording
At September 30, 2025, we have a non-cancelable operating lease for office and laboratory space for a period of seven years through March 31, 2031. Refer to Note 14 and Note 15 to our financial statements appearing elsewhere in this Report for a discussion of material obligations and commitments.
Current wording
At March 31, 2026, we have a non-cancelable operating lease for office and laboratory space through March 31, 2031. Refer to Note 14 and Note 15 to our financial statements appearing elsewhere in this Report for a discussion of material obligations and commitments.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Comparison of the three months ended March 31, 2026 and 2025
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
•In October, the Company announced that it completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended Loan Agreement with Oxford Finance LLC.
Previous report — wording carried elsewhere
Interest and Other Income (Expense), net
Previous report — wording carried elsewhere
Interest and other income (expense), net decreased $7.2 million, attributable to lower investment balances due to continued funding of operating activities.