PLIANT THERAPEUTICS, INC.

Previous wording

We are a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis and related diseases. Our initial focus is on treating fibrosis by inhibiting integrin-mediated activation of TGF-β. 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. Our wholly owned lead product candidate, bexotegrast, is an oral, small molecule, dual selective inhibitor of αvβ6 and αvβ1 integrins that we are developing for the treatment of idiopathic pulmonary fibrosis, or IPF. We have recently discontinued BEACON-IPF trial, a global Phase 2b trial in patients with idiopathic pulmonary fibrosis (IPF). While an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the discontinuation of the trial, early evidence of efficacy on the forced vital capacity (FVC) endpoint was also observed. The Company plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast’s development.

Current 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.

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 fourth 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

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.

Previous wording

Since inception, we have had significant operating losses. Our net loss was $56.2 million and $47.0 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $766.2 million and cash, cash equivalents, and short-term investments of $307.1 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 $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:

Previous wording

Due to the discontinuation of the BEACON-IPF Phase 2b/3 trial in IPF, we expect research and development expenses to decrease in the near term as we curtail spending on the BEACON-IPF trial. While we plan to analyze data from the BEACON-IPF trial and evaluate next steps for bexotegrast's development, in the near term we will re-prioritize 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

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.

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 Secured Overnight Financing Rate (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 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%.

Previous wording

Research and development expenses for the three months ended March 31, 2025 increased $6.3 million, primarily due to acceleration of close-out activities for BEACON-IPF and employee-related expenses, driven by increased headcount.

Current 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.

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 $2.6 million due to lower investment balances due to continued funding of operating activities.

Previous wording

We expect general and administrative expenses to remain relatively consistent for the foreseeable future.

Current wording

We expect our general and administrative expenses to remain relatively consistent for the foreseeable future.

Previous wording

Interest expense for the three months ended March 31, 2025 increased $0.4 million due to additional borrowings under the Amended Loan Agreement executed March 11, 2024.

Current wording

Interest expense for the six months ended June 30, 2025 increased $0.3 million due to additional borrowings under the Amended Loan Agreement.

Previous wording

As of March 31, 2025, we had $307.1 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 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.

Previous wording

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 of available non-dilutive capital. Pursuant to the Amended Loan Agreement, we drew an additional Term Loan of $20.0 million. Given the discontinuation of the BEACON-IPF trial, 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.

Current wording

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 wording

Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all. In addition, the discontinuation of the BEACON-IPF trial may intensify the risk that we will be unable to access capital on favorable terms, or at all, as and when needed. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

Current wording

Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all. In addition, the discontinuation of our development of bexotegrast in IPF may intensify the risk that we will be unable to access capital on favorable terms, or at all, as and when needed. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

Previous wording

Net cash used in operating activities increased $18.6 million, primarily due to higher spending related to third-party vendors to support acceleration of close-out activities for the BEACON-IPF study.

Current 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.

Previous wording

Net cash provided by investing activities increased over the same period of prior year as maturities of marketable securities exceeded related purchases during the three months ended March 31, 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 six months ended June 30, 2025.

Previous wording

Net cash provided by financing activities decreased $21.3 million, primarily due to net proceeds of $20.0 million from the additional Term Loans entered into during the current three months ended March 31, 2024 associated with the Amended Loan Agreement.

Current 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.