Pirfenidone

Presentations will highlight Celea’s differentiated approach to advancing deupirfenidone for idiopathic pulmonary fibrosis (IPF), including details of the Phase 3 SURPASS-IPF trial design and key insights from a Phase 1 drug-drug interaction study with nintedanib BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics (“Celea”) today announced that it will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The full text of the announcement from Celea is as follows: Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON, August 25, 2026 – Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). The presentations will detail the design and rationale for SURPASS-IPF, Celea’s global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. “Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone’s potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients’ quality of life,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches.” Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 – Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 – Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. About SURPASS-IPF SURPASS-IPF ( NCT07284602 ) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019. 1 Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, 2 and currently there is no cure. About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” the name reflects the company’s mission to rise above the status quo and deliver therapies that change lives. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the planned development of deupirfenidone and our and Celea’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. [1] Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the American Thoracic Society, 18(7), 1121-1128. [2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23 (3-b Suppl), S17-S24. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com