PLIANT THERAPEUTICS, INC.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
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.
Sep 30, 2025 · Filed Nov 6, 2025
PLRX$0.81-0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001746473-25-000150
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 105 previous paragraphs and 106 current paragraphs.
81 unchanged; 16 reworded; 9 added; 8 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 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 (9)
Current 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.
Current report
Third Quarter and Recent Developments
Current 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.
Current report
•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.
Current report
Comparison of the nine months ended September 30, 2025 and 2024 (in thousands)
Current report
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Current 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.
Current report
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 report
Comparison of the nine months ended September 30, 2025 and 2024
Removed paragraphs (8)
Previous report
Second Quarter and Recent Developments
Previous report
•Bexotegrast development in idiopathic pulmonary fibrosis (IPF) discontinued. Following an analysis of the full safety and efficacy data from the BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). While bexotegrast-treated patients demonstrated early signs of efficacy, the drug was shown to have an unfavorable risk-benefit profile based on IPF-related adverse events. Full results from BEACON-IPF will be submitted for future publication.
Previous report
•In May, the Company announced a strategic restructuring of its workforce and other cost saving actions intended to extend its cash runway. By the end of the second quarter, the restructuring was largely complete.
Previous report
Comparison of the six months ended June 30, 2025 and 2024 (in thousands)
Previous report
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Previous report
Research and development expenses for the six months ended June 30, 2025 decreased $7.1 million, primarily due to the discontinuation of BEACON-IPF.
Previous report
In March 2024, we entered into an Amended Loan Agreement with Oxford Finance LLC (or the “Lender” or “Oxford”) which upsized our existing Term Loan facility to a total size of $150.0 million aggregate principal amount (the "Term Loans"). Pursuant to the Amended Loan Agreement, we drew an additional Term Loan of $20.0 million and given the discontinuation of development of bexotegrast in IPF, we do not expect to have access to additional borrowing under the Oxford Agreement. See Note 7 to the Notes to our 2024 Form 10-K for more information.
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Reworded paragraphs (16)
Previous wording
We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. We have applied our deep understanding of fibrosis 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. 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.
Previous wording
In January 2023, we received United States Food and Drug Administration, or FDA, clearance of an investigational new drug application, or IND, for 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 are currently enrolling the fifth of five potential dose cohorts in a Phase 1 open-label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors.
Current 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.
Previous wording
•Phase 1 trial of PLN-101095 in solid tumors continues to enroll. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 trial as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. The trial is currently dosing the fifth of five planned dose cohorts, evaluating PLN-101095 at 2000 mg administered twice daily (BID). Initial data from the two highest dose cohorts of the trial is expected by the end of 2025.
Current wording
•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 wording
Since inception, we have had significant operating losses. Our net loss was $43.3 million and $55.9 million for the three months ended June 30, 2025 and 2024, respectively. Our net loss for the six months ended June 30, 2025 and 2024 was $99.5 million and $102.8 million, respectively. As of June 30, 2025, we had an accumulated deficit of $809.5 million and cash, cash equivalents, and short-term investments of $264.4 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 $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:
Previous wording
Our interest expense is derived from a term loan executed under the Oxford Loan Agreement that we entered into in May 2022 and amended in March 2024 (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%.
Current wording
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 wording
Research and development expenses for the three months ended June 30, 2025 decreased $13.4 million, primarily due to the discontinuation of BEACON-IPF and lower employee-related expenses, driven by a reduction in headcount resulting from our restructuring initiated May 1, 2025.
Current 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.
Previous wording
General and administrative expenses for the three months ended June 30, 2025 decreased $1.6 million, primarily due to a decrease in employee related costs driven by the reduction in workforce and associated reversal of expense for unvested, forfeited stock awards.
Current 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.
Previous wording
We currently expect general and administrative expenses to decrease in the near-term in response to the reduction in workforce then remain relatively consistent for the foreseeable future.
Current wording
We currently expect general and administrative expenses to remain relatively consistent for the foreseeable future.
Previous wording
Interest and other income (expense), net decreased $2.6 million due to lower investment balances due to continued funding of operating activities.
Current wording
Interest and other income (expense), net decreased $2.3 million due to lower investment balances due to continued funding of operating activities.
Previous wording
General and administrative expenses for the six months ended June 30, 2025 decreased $1.4 million, primarily attributable to decreased employee-related costs, driven by our restructuring of operations.
Current wording
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 wording
Interest and other income (expense), net decreased $4.9 million, attributable to lower investment balances due to continued funding of operating activities.
Current wording
Interest and other income (expense), net decreased $7.2 million, attributable to lower investment balances due to continued funding of operating activities.
Previous wording
Interest expense for the six months ended June 30, 2025 increased $0.3 million due to additional borrowings under the Amended Loan Agreement.
Current wording
Interest expense for the nine months ended September 30, 2025 increased $0.2 million due to additional borrowings under the Amended Loan Agreement.
Previous wording
As of June 30, 2025, we had $264.4 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.
Current 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.
Previous wording
Net cash used in operating activities increased $13.9 million, primarily due to settling payables and accrued expenses relating to the bexotegrast program including close-out activities for the BEACON-IPF study.
Current wording
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 wording
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 six months ended June 30, 2025.
Current wording
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 wording
Net cash provided by financing activities decreased $22.0 million, primarily due to additional Term Loans entered into during the six months ended June 30, 2024 associated with the Amended Loan Agreement as well as decreased proceeds from the issuance of common stock under benefit plans during the six months ended June 30,2025.
Current wording
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.