Pliant Therapeutics, Inc. Stock Price, News & Analysis

Pliant Therapeutics (PLRX) presented clinical and preclinical data at the American Thoracic Society 2025 International Conference, highlighting three key studies on their drug bexotegrast. The first study showed that bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, reduced fibrosis-related gene expression in lung cells from non-IPF ILD patients. A second study identified biomarkers across different ILD subtypes that could help inform clinical decisions. The third study demonstrated bexotegrast's distinct antifibrotic effects, showing superior results compared to nintedanib in reducing profibrotic genes in specific cell types, both alone and in combination therapy.

Pliant Therapeutics (NASDAQ: PLRX) reported Q1 2025 financial results and provided corporate updates. The company is finalizing its BEACON-IPF Phase 2b/3 trial with topline data expected in Q2 2025. Their oncology program showed promising results, with PLN-101095 demonstrating antitumor activity in combination with pembrolizumab, achieving confirmed partial responses in 3 out of 6 patients at the highest dose tested. The company announced a strategic realignment including a 45% workforce reduction to extend cash runway. Financial results showed R&D expenses of $43.4M (up from $37.1M YoY), G&A expenses of $15.5M, and a net loss of $56.2M (compared to $47.0M YoY). As of March 31, 2025, Pliant maintained a strong cash position of $307.1M in cash, cash equivalents, and short-term investments.

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.

Pliant Therapeutics (Nasdaq: PLRX) has announced its participation in the 2025 American Thoracic Society (ATS) International Conference in San Francisco from May 16-21, 2025. The company will present three scientific works, including:

1. A featured oral presentation by Dr. Johanna Schaub on Bexotegrast's antifibrotic activity in ILD subtypes (May 19, 2:15-4:15 PM PT)

2. A poster presentation by Dr. Richard Ahn on plasma proteome analysis of ILD subtypes (May 21, 8:15-10:15 AM PT)

3. A poster by Dr. Mahru An on single-cell profiling of Bexotegrast's antifibrotic effects (May 21, 8:15-10:15 AM PT)

All presentations will be available for registered conference attendees and later on Pliant's website.

Pliant Therapeutics (PLRX) has announced promising interim Phase 1 data for PLN-101095, their integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab for treating immune checkpoint inhibitor-refractory advanced solid tumors.

Key findings from the first three cohorts include:

• 50% objective response rate at the highest tested dose (1000mg BID)
• Three confirmed partial responses observed in cohort three, with patients showing tumor size reductions of:
  • 74% in Non-Small Cell Lung Cancer at Week 18
  • 48% in Cholangiocarcinoma at Week 42
  • 42% in Melanoma at Week 27
• PLN-101095 was generally well tolerated across all doses

The trial enrolled nine patients with six different tumor types across three cohorts, testing doses of 250mg, 500mg, and 1000mg BID. The study is currently enrolling its fourth cohort, evaluating PLN-101095 at 1000mg three times daily.

Pliant Therapeutics (PLRX) has announced the adoption of a duration stockholder rights agreement ('poison pill') by its Board of Directors, effective until March 11, 2026. The measure comes in response to recent stock accumulations and aims to prevent unauthorized control through market purchases.

Under the agreement, stockholders of record by March 25, 2025, will receive one preferred share purchase right per common stock share. These rights activate if an entity acquires 10% ownership (20% for Schedule 13G investors) without Board approval. In such cases, existing stockholders can purchase additional PLRX shares at a 50% discount. Similar provisions apply if Pliant is acquired in a merger after such unauthorized accumulation.

The Board retains the right to redeem these rights at $0.001 per right or exchange them at one common share per right. Existing stockholders above threshold levels will be grandfathered, unless they increase their holdings after the announcement.

Pliant Therapeutics (PLRX) has announced the discontinuation of its BEACON-IPF Phase 2b trial following recommendations from both the data safety monitoring board and an outside expert panel. The trial was halted due to an imbalance in IPF-related adverse events between treatment and placebo groups, though early efficacy signals were observed in forced vital capacity endpoints.

The company continues to advance its other programs, including a Phase 1 trial of PLN-101095 in solid tumors, currently in its fourth of five planned dose cohorts, with interim data expected in Q1 2025. Additionally, PLN-101325 for muscular dystrophies is Phase 1 ready with clinical trial approval in Australia.

Financial results for Q4 2024 show R&D expenses of $38.8M (up from $33.2M YoY) and G&A expenses of $14.5M (up from $13.9M YoY). Net loss increased to $49.7M from $41.1M in the prior-year quarter. The company maintains a strong financial position with $357.2M in cash and investments, expected to fund operations beyond 12 months.

Pliant Therapeutics (PLRX) has discontinued its BEACON-IPF Phase 2b trial of bexotegrast in idiopathic pulmonary fibrosis (IPF) patients following safety concerns, despite showing early efficacy signs in forced vital capacity (FVC). The discontinuation came after reviews by the trial's Data Safety Monitoring Board and an external expert panel.

The trial, with approximately 17 weeks mean exposure duration, showed comparable IPF-related adverse events (around 10%) in both dose groups. However, an imbalance was noted due to unusually low adverse event rates (<3%) in the placebo group. This contrasts with the Phase 2a INTEGRIS-IPF trial, where adverse events were similar between bexotegrast-treated (7%) and placebo groups (10%).

The company plans to analyze the complete data and consider additional Phase 2b studies with lower doses for pulmonary fibrosis and other non-respiratory indications. Meanwhile, Pliant continues developing other assets, including PLN-101095 in oncology, currently in Phase 1 trials.

Pliant Therapeutics (PLRX) has initiated the assembly of an external expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in idiopathic pulmonary fibrosis (IPF) patients. This decision follows a recommendation from the trial's independent Data Safety Monitoring Board (DSMB) to pause enrollment and dosing.

The company has been unable to determine the rationale for the DSMB's recommendation through review of blinded data. The newly assembled panel, comprising experts in pulmonary diseases and biostatistics, will provide an independent recommendation and subsequently join an expanded DSMB to reach a consensus recommendation regarding BEACON-IPF.

The process is expected to conclude in 2-4 weeks. Pliant has voluntarily paused enrollment and dosing while maintaining trial blinding to preserve data integrity and the trial's potential registrational status.