• Company summarizes third quarter progress across its Wholly Owned Pipeline and Founded Entities

BOSTON / Oct 17, 2023 / Business Wire / 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 that members of the management team will participate in fireside chats at two upcoming investor conferences. Webcasts of the presentations will be available at https://investors.puretechhealth.com.

Jefferies London Healthcare Conference
Presenters: Daphne Zohar, Founder and Chief Executive Officer, and Julie Krop, M.D., Chief Medical Officer
Date: Wednesday, November 15, 2023

Evercore ISI 6^th Annual Healthcare Conference
Presenter: Daphne Zohar, Founder and Chief Executive Officer, and Julie Krop, M.D., Chief Medical Officer
Date: Wednesday, November 29, 2023

Commenting on the third quarter progress, Daphne Zohar, Founder and Chief Executive Officer of PureTech, said:

“It has been a very productive third quarter across our Wholly Owned Pipeline and Founded Entities, with multiple milestones reached as well as the continued progression toward several more major catalysts by the end of this year.

“Across our Wholly Owned Pipeline, we are looking forward to data from two clinical trials by the end of 2023, including data from the Phase 1b trial of LYT-200 in oncology, and the Phase 2a trial of LYT-300 in a validated clinical model of anxiety.

“Recently, we have been increasing our focus on our central nervous system (CNS) programs, including LYT-300 and LYT-310, that originated from our Glyph^™ technology platform. Our increased focus reflects the historic success we’ve had in CNS by enabling drugs with proven human efficacy to realize their full therapeutic potential by applying an innovative solution to a previous limitation. As a result, we have now generated an additional two programs based on our Glyph platform, expanding our CNS pipeline to seven programs.”

“Our increasing focus on this proven strategy for treating brain diseases builds on the success we had with KarXT and we are also pleased to note the important milestone of Karuna’s submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for KarXT for the treatment of schizophrenia. If approved, KarXT, invented at PureTech, will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.

“We plan to provide more guidance on our capital allocation and returns strategy in the fourth quarter. We look forward to another catalyst-rich quarter and continuing to deliver on our mission of changing the lives of patients with devastating diseases.”

Key Highlights & Progress

Wholly Owned Programs

• LYT-100 (deupirfenidone), is currently in development for the treatment of conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis (IPF).
  • Progressed Phase 2b dose-ranging trial of LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). Topline results are expected in 2024. We plan to pursue a streamlined development program for LYT-100 in IPF and are using the same endpoints that have supported past approvals. Pending positive clinical and regulatory feedback, we intend to advance the program into a Phase 3 trial. We believe the results of the Phase 2b trial, together with a Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.
  • Presented expanded data from a completed trial of LYT-100 in healthy older adults, which informed the two doses selected for the ongoing, global Phase 2b dose-ranging trial of LYT-100 (ELEVATE IPF) in patients with IPF. In addition to supporting the improved tolerability of LYT-100 versus the FDA-approved dose of pirfenidone, the new data presented supported the selection of a higher dose of LYT-100 with the potential for improved efficacy that is now being evaluated in ELEVATE IPF.
• LYT-300 (oral allopregnanolone) is an oral prodrug of allopregnanolone, enabled by our Glyph^™ technology platform, that is currently in development for the treatment of a range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
  • Progressed a Phase 2a proof-of-concept trial of LYT-300 using a validated clinical model of anxiety in healthy volunteers. Results are expected by the end of 2023.
  • Awarded up to $11.4 million from the U.S. Department of Defense to advance LYT-300 for Fragile X-associated Tremor/ Ataxia Syndrome (FXTAS). The Phase 2 trial of LYT-300 in FXTAS in collaboration with the University of California, Davis is expected to initiate in 2024.
• LYT-310 (oral cannabidiol [CBD]), is currently in development for the treatment of epilepsies and other neurological indications.
  • A Phase 1 clinical trial of LYT-310 is expected to begin in the fourth quarter of 2023.
• LYT-200 (anti-galectin-9 mAb) is currently in development for the treatment of metastatic/locally advanced solid tumors, including urothelial and head and neck cancers, and hematological malignancies, such as acute myeloid leukemia (AML).
  • Progressed a Phase 1b trial of LYT-200 in combination with tislelizumab in urothelial and head and neck cancers. Topline results are expected in 2024.
  • Progressed a Phase 1b trial evaluating LYT-200 as a single agent for the treatment of AML. Initial results from a subset of patients are expected by the end of 2023.

Founded Entities

• Karuna Therapeutics (Nasdaq: KRTX) (Karuna) submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the potential approval of KarXT for the treatment of schizophrenia.
• Vedanta dosed the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 for the treatment of ulcerative colitis. The FDA also granted Fast Track designation to VE202. The phase 3 RestoratiVE303 pivotal study of VE303, designed for the prevention of recurrent Clostridioides difficile infection, is expected to initiate in the coming months.
• Akili, Inc. (Nasdaq: AKLI) (Akili) announced its strategic plan to transition from a prescription to a non-prescription business model. Akili is on track to submit its adult clinical trial data later this year to the FDA for over-the-counter (OTC) authorization of EndeavorOTC, and is planning to submit data to the FDA to convert its pediatric prescription product, EndeavorRx^Ⓡ, to OTC in 2024.
• Sonde Health has partnered with Together, an AI-based health assistant, to provide enhanced mental health detection and monitoring through its new Mental Vitals feature. This collaboration integrates Sonde’s technology into the Together app, allowing users to access advanced voice analysis for early detection of symptoms related to depression and anxiety.
• PureTech will not move forward with the contemplated plan of merger with Gelesis and will instead focus on other strategic business initiatives.

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 27 therapeutics and therapeutic candidates, including two (Plenity^® and EndeavorRx^®) that have received both US FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. 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 known as 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 our and our Founded Entities’ plans, future prospects, objectives, developments, strategies and expectations, the progress and timing of clinical trials and data readouts, the timing of potential Investigational New Drug (IND) and NDA submissions, and the timing of regulatory approvals or clearances from the FDA.. 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, the following: our history of incurring significant operating losses since our inception; our need for additional funding to achieve our business goals, which may not be available and which may force us to delay, limit or terminate certain of our therapeutic development efforts; our limited information about and limited control or influence over our Non-Controlled Founded Entities; the lengthy and expensive process of preclinical and clinical drug development, which has an uncertain outcome and potential for substantial delays; potential difficulties with enrolling patients in clinical trials, which could delay our clinical development activities; side effects, adverse events or other safety risks which could be associated with our therapeutic candidates and delay or halt their clinical development; our ability to obtain regulatory approval for and commercialize our therapeutic candidates; our ability to realize the benefits of our collaborations, licenses and other arrangements; our ability to maintain and protect our intellectual property rights; our reliance on third parties, including clinical research organizations, clinical investigators and manufacturers; our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events; and 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, 2022 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.