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)

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, and currently there is no cure.²

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.

Celea was founded by PureTech Health plc (NASDAQ:PRTC, LSE: PRTC)), a biotherapeutics company dedicated to giving life to science. PureTech's innovative R&D model drives the creation of Founded Entities like Celea, enabling the advancement of highly promising medicines to patients in a capital-efficient manner. For more information, please visit www.celeatx.com and www.puretechhealth.com.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on 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 statements that relate to continued development of and regulatory interactions related to deupirfenidone, the potential of deupirfenidone in IPF and other indications, our expectations around our therapeutic candidates and approach towards addressing major diseases, our plans to advance our programs and deliver on our milestones, our future plans, 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, 2024 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.

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