Three presentations inform clinical, commercial and patient engagement strategies for LYT-100 for the treatment of idiopathic pulmonary fibrosis (IPF)

Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the end of 2024

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 its onsite presence at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9. The Company will deliver two oral presentations and one poster relating to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) as well as the Company’s research surrounding the experiences of patients with IPF.

The data to be presented have informed the clinical and commercial strategies supporting LYT-100 as well as advocacy and patient engagement work around the management and treatment of people with IPF. Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of 2024. A streamlined development program for LYT-100 is planned using the same endpoints that have supported past IPF product approvals. Pending positive clinical outcomes from the Phase 2b trial and regulatory feedback, the program is expected to advance into a Phase 3 trial. PureTech believes the results of the Phase 2b trial, together with a successful Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.

Presentation Details

Presentation Title: Comparing experiences at interstitial lung disease (ILD) centers and community practices (CP) from the perspective of people with idiopathic pulmonary fibrosis (IPF)

Session: Oral presentation

Date and Time: October 8, 2024 | 10:20-11:05am EDT

Presentation Title: Ongoing burden of idiopathic pulmonary fibrosis (IPF) in the era of antifibrotics

Session: Poster presentation

Date and Time: October 8, 2024 | 1:45-2:30pm EDT

Presentation Title: Bayesian approach for ELEVATE IPF: Randomized, double-blind, placebo-controlled trial to evaluate efficacy, safety, and dose response of deupirfenidone (LYT-100) in IPF

Session: Oral presentation

Date and Time: October 8, 2024 | 1:45-2:30pm EDT

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a rare, progressive and fatal lung disease with a median survival of 2-5 years.¹ Pirfenidone is one of only two drugs approved to treat IPF, and for those patients able to tolerate treatment, it has been shown to improve survival by approximately 2.5 years compared to supportive care alone.¹ However, tolerability issues with both of the standard-of-care drugs result in patients discontinuing treatment or reducing their dose. This contributes to nearly three out of every four people with IPF choosing to forego treatment with these otherwise efficacious medicines.²

About LYT-100 (Deupirfenidone)

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions involving inflammation and fibrosis, including IPF. It is a deuterated form of pirfenidone that is designed to retain the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated PK profile. LYT-100 has also demonstrated favorable tolerability across multiple clinical studies in more than 400 individuals.

Pirfenidone is one of the two standard-of-care treatments approved for IPF, along with nintedanib, both of which are efficacious but associated with significant tolerability issues. These tolerability issues result in treatment discontinuations and/or dose reductions below the FDA-approved dose, thereby limiting the effectiveness of these otherwise efficacious medicines. With LYT-100, PureTech aims to deliver better outcomes for patients by enabling individuals to maintain the same or higher pirfenidone-equivalent doses for longer. PureTech believes LYT-100 has the potential both to supplant the current standard-of-care treatments and to serve a larger market of patients who are unable to tolerate current therapies. Topline data for the global Phase 2 ELEVATE IPF trial are expected by the end of 2024.

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 pipeline 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 pipeline 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 those related to the LYT-100 development program and development plans, its potential benefits to patients, the timing for results from the Phase 2b clinical trial of LYT-100, the advancement of the program into a Phase 3 trial, and our 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, 2023, 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 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. https://doi.org/10.18553/jmcp.2017.23.3-b.s17

² Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128

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