PRTC Launches Celea to Advance Ph3-Ready IPF Drug

PureTech Announces the Launch of Celea Therapeutics with a Mission to Transform the Treatment of Respiratory Diseases

Former Teva North America CEO Sven Dethlefs, PhD, to lead Celea

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced the launch of a new Founded Entity Celea Therapeutics ("Celea").

Celea's mission is to deliver therapies that transform the lives of people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate that holds promise across multiple fibrotic and inflammatory lung conditions and is initially being advanced for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Sven Dethlefs, PhD, has been appointed to lead Celea, bringing deep expertise and a clear vision to accelerate the program's advancement. The launch of Celea reflects PureTech's commitment to advancing differentiated programs through focused, capital-efficient structures with seasoned leadership.

Dr. Dethlefs is a proven pharmaceutical executive with more than 25 years of experience in global commercialization, R&D strategy, business development, and operations. He has played a central role at PureTech, driving forward the deupirfenidone program for more than a year. Prior to joining PureTech, Dr. Dethlefs served as CEO of Teva North America, where he oversaw the company's $8 billion specialty branded and generic businesses across the U.S. and Canada. At Teva, he also held senior leadership roles as Global Head of Marketing and Portfolio, Head of Respiratory Medicines, and COO Operations. He played a key role in the successful launch of AUSTEDO®, Teva's blockbuster treatment for Tardive Dyskinesia and Huntington's Disease, which is a deuterated form of tetrabenazine. Prior to joining Teva, Dr. Dethlefs was a partner at McKinsey & Company. He holds a PhD in Biochemistry.

Dr. Sven Dethlefs commented: "Bringing meaningful innovation to patients with serious diseases has been a consistent theme throughout my career, and I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF. Our Phase 2b data demonstrated the potential for best-in-class efficacy with a favorable safety and tolerability profile-addressing two of the most critical limitations of current therapies. The strength of the clinical data, combined with the team and mission behind Celea, make this a uniquely compelling opportunity. I'm excited to lead the next phase of development as we work to deliver a new standard of care for people living with IPF and other debilitating lung conditions."

PureTech completed a successful Phase 2b trial of deupirfenidone in December 2024. A meeting with the U.S. Food and Drug Administration to discuss these results and the proposed Phase 3 trial design is expected by the end of the third quarter of 2025. Consistent with its capital-efficient innovation model, PureTech is pursuing third-party funding for Celea to advance the program through Phase 3 and potential commercialization.

Robert Lyne, PureTech's Interim Chief Executive Officer, added: "The launch of Celea is an important value driver for PureTech. Sven brings deep experience in respiratory medicine and a strong track record of commercial success, including having played a critical role in the growth of AUSTEDO®, a deuterated medicine developed using the same underlying chemistry approach as deupirfenidone. He is uniquely suited to lead Celea and advance this important program."

About Deupirfenidone (LYT-100)

Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a deuterated form of pirfenidone, which - along with nintedanib - is one of the two FDA-approved treatments for IPF. Both approved therapies offer only modest efficacy in slowing lung function decline, largely due to tolerability challenges that limit the ability to achieve higher doses that could significantly improve patient outcomes. These limitations have contributed to low treatment uptake and poor adherence, with approximately 25% of people with IPF in the U.S. ever receiving either drug. Despite this, combined peak global sales exceed $5 billion, representing a significant market opportunity in IPF and other fibrotic lung diseases. [1]

Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, 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 an ongoing open-label extension study suggest that 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)

About Celea Therapeutics

Celea Therapeutics is dedicated to delivering transformative treatments for people with serious respiratory diseases. The company's lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.