Pliant Therapeutics Announces Strategic Realignment of Workforce and Operations

Rhea-AI Summary

Pliant Therapeutics (PLRX) announced a strategic restructuring initiative that includes a significant 45% reduction in its workforce. The restructuring aims to extend cash runway and optimize resources as the company awaits topline data from its BEACON-IPF Phase 2b/3 trial of bexotegrast in idiopathic pulmonary fibrosis patients, expected in Q2 2025. The restructuring will affect all departments but maintains focus on late-stage clinical trial execution capabilities. The process is anticipated to be substantially completed by the end of Q2 2025. The company plans to evaluate the final dataset once available to determine next steps for bexotegrast's development.

Positive

• Cost reduction initiatives will extend cash runway
• Company maintains focus on late-stage clinical trial execution capabilities
• BEACON-IPF trial topline data expected soon (Q2 2025)

Negative

• Significant workforce reduction of 45%
• All departments impacted by restructuring
• Uncertainty around bexotegrast's future development pending trial results

-  Implementation of cost reduction initiatives to position Pliant for
execution of late-stage clinical trials

-  Pliant will reduce its current workforce by approximately 45%

-  Closing activities for BEACON-IPF trial ongoing; topline data expected in the second quarter of 2025

SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced a strategic restructuring of its workforce and other cost saving actions to extend the cash runway to support execution of late-stage clinical trials.

The restructuring aims to minimize costs and preserve cash reserves as the Company awaits topline data from the BEACON-IPF Phase 2b/3 trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).

Pliant expects topline data from the BEACON-IPF trial to be available in the second quarter of 2025. Once available, the Company will evaluate the final dataset and determine next steps for bexotegrast’s development.

The restructuring will result in a reduction of approximately 45% of Pliant’s current workforce. While all departments will be impacted, Pliant’s focus is to maintain the strong late-stage clinical trial execution capability it has built. The process is expected to be substantially completed by the end of the second quarter 2025. The Company plans to announce its first quarter 2025 financial results and corporate update on May 8, 2025.

“Today’s actions, while difficult, provide us the flexibility to prepare for, and execute on our mission to make a difference in the lives of patients,” said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. “I want to extend my sincere thanks to those impacted by today’s restructuring for their extensive contributions to the advancement of our mission.”

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of α_vß₆ and α_vß₁ integrins that is in development in the lead indication for the treatment of idiopathic pulmonary fibrosis, or IPF and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is conducting a Phase 1 study for PLN-101095, a small molecule, dual-selective inhibitor of α_vß₈ and α_vß₁ integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α₇β₁ targeting muscular dystrophies.

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 statements include those regarding the Company’s intentions to extend its cash runway and support execution of potential future late-stage clinical trials; the anticipated timing and cost savings of the restructuring and workforce reduction; the timing of topline data from the BEACON-IPF trial; the Company’s intention to maintain strong late-stage clinical trial execution capabilities and the timing of future corporate updates. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics 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 our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, including the timing and results from the topline BEACON-IPF data, 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, including the availability of additional term loans under our loan facility, 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, 2024 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

FAQ

Why is Pliant Therapeutics (PLRX) reducing its workforce in 2025?

Pliant is reducing its workforce by 45% to extend cash runway and optimize resources while awaiting topline data from the BEACON-IPF Phase 2b/3 trial of bexotegrast, expected in Q2 2025.

When will Pliant Therapeutics complete its 2025 restructuring?

Pliant expects to substantially complete the restructuring process by the end of the second quarter of 2025.

What is the BEACON-IPF trial testing at Pliant Therapeutics?

The BEACON-IPF is a Phase 2b/3 trial testing bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).

When will Pliant Therapeutics release BEACON-IPF trial results?

Pliant expects to release topline data from the BEACON-IPF trial in the second quarter of 2025.

How many employees will be affected by Pliant's 2025 restructuring?

The restructuring will reduce Pliant's current workforce by approximately 45%, affecting all departments.