On November 12, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced third quarter 2026 financial results.
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"The third quarter reflected continued strong execution across the Organization, including robust FORTIFY enrollment and compelling proof-of-concept data generated from our integrin-mediated drug delivery platform," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "FORTIFY continues to enroll ahead of schedule, with a number of European sites onboarded during the quarter. In addition, we continue to explore the potential of our proprietary drug delivery platform with cross-species preclinical data demonstrating successful selective delivery of siRNA payloads to extrahepatic tissues. With emerging data continuing to inform our next steps, potential therapeutic applications and paths forward, we will provide a comprehensive overview of the program in the coming months."
Oncology Program
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. Pliant is currently conducting FORTIFY, a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT06270706), to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
•Strong enrollment continues in FORTIFY, a Phase 1b indication expansion trial. FORTIFY will enroll up to 102 patients across three cohorts including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC) and tumors with high tumor mutational burden. Patients are treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab is added as combination therapy. Enrollment remains strong, progressing ahead of schedule with active sites in the United States and Spain with additional countries onboarding in the next several months. Interim data is expected in 2027.
•Presentations at Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) highlight PLN-101095 Phase 1 biomarker data and mechanism of action.
◦Researchers from Pliant presented new biomarker data from the Phase 1 trial showing that early induction of immune activation biomarkers during PLN-101095 monotherapy was associated with subsequent clinical response following pembrolizumab initiation. These findings support the hypothesis that TGF-β pathway inhibition promotes immune activation, T-cell recruitment into the tumor microenvironment, and enhanced cytotoxic effector function.
◦Researchers from the National Cancer Institute presented data demonstrating that the blockade of integrins αvβ8 and αvβ1 in combination with anti-PD-1 reduced TGF-β signaling leading to modulation of fibroblastic cell populations in the tumor microenvironment and increased infiltration and activation of cytotoxic CD8+ T cells. This resulted in an improvement in anti-tumor activity and survival.
Selective, Targeted, Integrin-mediated Delivery Platform
Utilizing our fully annotated library of 15,000+ integrin binding molecules, as well as our biological knowledge of cell-specific integrin receptor expression, Pliant has created a selective, targeted integrin-mediated delivery platform for cell- and tissue-selective extrahepatic delivery of drug payloads, including RNAi. The platform has broad applicability across multiple disease areas utilizing a variety of drug payloads.
•Tissue Specificity, Potency and Durability – Pliant has initiated multiple RNAi delivery programs targeting specific tissues through unique integrin expression profiles. The most advanced compounds to date selectively target skeletal and skeletal/cardiac muscle, respectively. In non-human primate studies, we have observed >75% target gene knockdown at eight weeks while avoiding liver and other non-targeted tissues.
•Plug-and-Play Compatibility – Pliant’s integrin-directed small molecule delivery compounds can be loaded with RNAi payloads directed at any gene of interest. This allows a single compound to serve as the basis for rapid development of tissue-specific therapies to a broad array of indications. Additionally, while initial efforts are directed at RNAi, the platform is potentially capable of delivering a variety of therapeutic payloads.
•Initial Indications – Based on early findings showing the successful selective delivery of Pliant’s skeletal and cardiac muscle compounds, the Company plans to accelerate development with initial therapeutic programs focused in areas of high unmet need including neuromuscular diseases and rare cardiomyopathies where gene suppression modalities show promise.
Pliant plans to share additional details regarding muscle and cardiac, as well as other RNAi programs, including detailed preclinical data and specific indication and gene targets for development over the coming months.
A presentation on the platform, including preclinical data, titled "Pliant’s Selective Targeted Integrin-Mediated Drug Delivery Platform" can be found in the "Investors & Media" section of Pliant’s website at www.PliantRx.com.
Corporate Highlights
•Appointment of David Raben, M.D., as Chief Medical Officer. Dr. Raben is a leader in targeted immuno-oncology drug development and brings three decades of academic and biopharmaceutical oncology expertise. Most recently, Dr. Raben served as Chief Medical Officer at Bicara Therapeutics.
•Appointment of Craig Blanchette, Ph.D., as Senior Vice President, Research (RNAi). Dr. Blanchette is a recognized leader in RNAi drug discovery with a track record of advancing novel delivery platforms and therapeutics. Dr. Blanchette brings more than two decades of drug discovery and development expertise, having most recently served as Chief Scientific Officer at Switch Therapeutics.
Third Quarter 2026 Financial Results
•Research and development expenses were $17.9 million in the current and prior-year quarter. Expenses remained consistent as increased spending on PLN-101095 development in the current period was offset by decreased costs resulting from the termination of bexotegrast development in IPF and reduced personnel- related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $7.8 million, as compared to $10.3 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
•Net loss was $24.4 million as compared to $26.3 million for the prior-year quarter. The decrease was primarily due to lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
•As of September 30, 2026, the Company had cash, cash equivalents and short-term investments of $142.6 million which the Company expects to be sufficient to fund operations to mid-2028.
(Press release, Pliant Therapeutics, NOV 12, 2026, View Source [SID1234674682])