Pliant Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses were $17.9 million for the quarter ended September 30, 2026, compared to $17.9 million in the prior-year quarter.
• General and administrative expenses were $7.8 million for the quarter, a decrease from $10.3 million in the prior-year quarter.
• Net loss was $24.4 million for the quarter, compared to $26.3 million in the prior-year quarter.
• For the nine months ended September 30, 2026, total operating expenses were $71.4 million, compared to $132.8 million in the prior-year period.
• Net loss for the nine months ended September 30, 2026, was $66.8 million, compared to $125.8 million in the prior-year period.
• As of September 30, 2026, the Company held $142.6 million in cash, cash equivalents, and short-term investments, sufficient to fund operations to mid-2028.
• Total assets were $169.9 million as of September 30, 2026, down from $225.2 million as of December 31, 2025.
• Total liabilities were $43.2 million as of September 30, 2026, compared to $44.0 million as of December 31, 2025.
• Stockholders' equity was $126.6 million as of September 30, 2026, compared to $181.2 million as of December 31, 2025.

Guidance and Future Outlook:

• Interim data from the FORTIFY trial is expected in 2027.
• The Company plans to provide a comprehensive overview of the program in the coming months as emerging data informs next steps.
• Pliant plans to share additional details regarding muscle and cardiac RNAi programs, including preclinical data and specific indication and gene targets, over the coming months.
• The Company intends to accelerate development of initial therapeutic programs focused on neuromuscular diseases and rare cardiomyopathies based on early findings.

Business Segments and Product Lines:

• Oncology Program: PLN-101095 is an oral, small molecule dual selective inhibitor of αvβ8 and αvβ1 integrins currently in the FORTIFY Phase 1a/1b trial.
• FORTIFY Trial: Enrollment is ahead of schedule with up to 102 patients across three cohorts: non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), and tumors with high tumor mutational burden.
• Trial Design: Patients receive PLN-101095 (1,000 mg twice daily) as monotherapy for 14 days, followed by combination therapy with pembrolizumab.
• Platform: The integrin-mediated delivery platform utilizes a library of 15,000+ integrin binding molecules for cell- and tissue-selective extrahepatic delivery of drug payloads, including RNAi.
• Preclinical Data: Non-human primate studies showed >75% target gene knockdown at eight weeks for skeletal and skeletal/cardiac muscle compounds while avoiding liver and non-targeted tissues.
• Biomarker Data: Presentations at the Society for Immunotherapy of Cancer (SITC) highlighted that early induction of immune activation biomarkers during PLN-101095 monotherapy was associated with subsequent clinical response following pembrolizumab initiation.
• NCI Data: Data from the National Cancer Institute demonstrated that blocking integrins αvβ8 and αvβ1 in combination with anti-PD-1 reduced TGF-β signaling, modulated fibroblastic cell populations, and increased infiltration of cytotoxic CD8+ T cells, resulting in improved anti-tumor activity and survival.

Market and Competitive Landscape:

• The Company is targeting areas of high unmet need in neuromuscular diseases and rare cardiomyopathies where gene suppression modalities show promise.
• The platform is designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment.

Risks and Challenges:

• Risks include delays in ongoing or planned preclinical studies or clinical trials.
• The Company relies on single-source third parties located in foreign jurisdictions, including China, for critical aspects of development operations.
• Risks exist regarding the accuracy of expense estimates, timing of development, capital requirements, and cash sufficiency.
• Risks include the impact of macroeconomic, geopolitical, and marketplace conditions on business operations and clinical supply.
• Risks involve the ability to obtain and maintain intellectual property protection.

Management Commentary and Tone:

• Bernard Coulie, M.D., Ph.D., President and CEO, stated that the third quarter reflected "continued strong execution" with robust FORTIFY enrollment and compelling proof-of-concept data.
• Management noted that FORTIFY enrolled ahead of schedule with European sites onboarded during the quarter.
• Dr. Coulie expressed confidence that emerging data will inform potential therapeutic applications and paths forward.

Other Key Points:

• Leadership Appointments: David Raben, M.D., was appointed Chief Medical Officer, bringing three decades of oncology expertise. Craig Blanchette, Ph.D., was appointed Senior Vice President, Research (RNAi), with over two decades of drug discovery experience.
• Program Termination: Development of bexotegrast in idiopathic pulmonary fibrosis (IPF) was terminated in 2025, contributing to reduced operating expenses.
• Headcount Reduction: Decreased personnel-related expenses, including stock-based compensation, were driven by reduced headcount compared to the prior year.
• Investor Resources: A presentation on the drug delivery platform is available on the Company's website under the "Investors & Media" section.