PureTech Announces Annual Results for Year Ended December 31, 2024

Innovation engine drives meaningful clinical, regulatory, and financial milestones, including positive Phase 2b results for wholly-owned deupirfenidone (LYT-100) in IPF, compelling Phase 1b data for wholly-owned LYT-200 in AML and solid tumors, FDA approval of PureTech-invented Cobenfy™¹ for schizophrenia, and rapid growth of Founded Entity², Seaport Therapeutics, which raised over $325 million

Capital-efficient operations support robust balance sheet with PureTech level cash, cash equivalents, and short-term investments of $366.8 million³ and consolidated cash, cash equivalents, and short-term investments of $367.3 million⁴ as of December 31, 2024, with operational runway into at least 2027

As of March 31, 2025, PureTech level cash, cash equivalents and short-term investments were $339.1 million⁵

Company to host a webcast and conference call today at 9:00am EDT / 2:00pm BST

BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”) today announces its results for the year ended December 31, 2024, as well as its cash balance as of the first quarter ended March 31, 2025. The following information represents select highlights from the full UK Annual Report and Accounts, except as noted herein, a portion of which will be filed as an exhibit to PureTech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024, to be filed with the United States Securities and Exchange Commission (the “SEC”) and will also be available later today at https://investors.puretechhealth.com/financials-filings/reports.

Webcast and conference call details

Members of the PureTech management team will host a conference call at 9:00am EDT / 2:00pm BST today, April 30, 2025, to discuss these results. A live webcast and presentation slides will be available on the investors section of PureTech’s website under the Events and Presentations tab. To join by phone, please dial:

United Kingdom (Local): +44 20 3936 2999
United States (Local): +1 646 233 4753
Global Dial-In Numbers
Access Code: 018948

For those unable to listen to the call live, a replay will be available on the PureTech website.

Commenting on the annual results, Bharatt Chowrira, Ph.D., J.D., Chief Executive Officer of PureTech, said:

“2024 was a defining year for PureTech. Our unique hub-and-spoke model delivered transformative progress across our Wholly-Owned⁶ and Founded Entity programs, advancing our mission and generating meaningful value for patients and shareholders.

“The FDA approval of Cobenfy™ (formerly KarXT)—the first new mechanism for schizophrenia in over 50 years—was a milestone, not only for the field, but for PureTech. Invented by our team and advanced by Karuna Therapeutics, now part of Bristol Myers Squibb (BMS), the program exemplifies our ability to translate bold scientific ideas into impactful therapies. With approximately $1.1 billion in cash generated from an initial $18.5 million investment, it also demonstrates the financial strength of our model.

“That strength was further validated by the positive results from our Phase 2b trial of our wholly-owned deupirfenidone (LYT-100), which showed the potential to stabilize lung function decline over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF)—a result that, to our knowledge, has not been demonstrated with any other investigational therapy in IPF to date. Based on these data, we believe that deupirfenidone has the potential to become a new standard-of-care treatment for this debilitating rare disease and to help many patients who currently remain untreated. We are targeting a meeting with the FDA before the end of the third quarter, with the goal of initiating a Phase 3 trial by the end of the year. Subject to feedback from the FDA with respect to trial design, we don’t believe our current cash balance would be sufficient to fully fund a Phase 3 trial. As such, we are focused on identifying external sources of capital to advance this program and unlock the full potential of this promising therapy.

“We also advanced LYT-200 through our Founded Entity, Gallop Oncology, where it is emerging as a promising candidate for the treatment of both hematological malignancies and solid tumors. In the ongoing acute myeloid leukemia (AML) trial, LYT-200 has demonstrated clinical activity and disease stabilization in heavily pretreated patients, both as a monotherapy and in combination with standard-of-care therapy. In the recently completed head and neck cancer trial, topline data with LYT-200 shared for the first time today demonstrate a favorable safety profile, disease control, and early signs of efficacy.

“We also launched Seaport Therapeutics, which raised over $325 million in two oversubscribed financings to advance neuropsychiatric candidates that were identified at PureTech based on our Glyph platform. This momentum underscores the durability and scalability of our innovation engine, which has produced 29 therapeutic candidates to date—three of which have achieved FDA approval.

“As we look ahead, our focus remains clear: to execute with discipline, continue to harness our highly productive innovation R&D engine with high capital efficiency, maintain a strong balance sheet, and unlock the full potential of our programs to drive long-term patient impact and shareholder value. We are proud of what we achieved in 2024—and we are energized by the opportunities that lie ahead.”

2024 and Early 2025 Operational Highlights
For full details, please see PureTech’s 2024 Annual Report.

Delivered clinical, regulatory, and financial milestones across our Wholly-Owned Programs and Founded Entities, reinforcing the strength of our innovative R&D engine and its potential to drive long-term value for patients and shareholders. Key highlights include the following:

• Deupirfenidone (LYT-100)
  • PureTech continued to progress the development of deupirfenidone as a potential new standard of care for the treatment of IPF, a progressive and fatal lung disease.
  • In December 2024, PureTech announced positive topline results from the ELEVATE IPF Phase 2b clinical trial, which achieved its primary endpoint and key secondary endpoints. In addition to the overall strong, consistent and durable efficacy seen, both doses of deupirfenidone were generally well tolerated, with the higher dose demonstrating the unprecedented potential to stabilize lung function over 26 weeks. The deupirfenidone 825 mg TID arm also had an effect size, compared to placebo, that was 50% greater than that seen with pirfenidone (80.9% vs. 54.1%, respectively). Additionally, preliminary pharmacokinetic results indicate that deupirfenidone 825 mg TID achieved ~50% higher exposure than pirfenidone 801 mg TID, corresponding with the greater efficacy results demonstrated with deupirfenidone 825 mg TID.
  • The ELEVATE IPF open label extension (OLE) study is ongoing. As of the March 2025 post-period, 140 patients have continued in the OLE, with 85 patients having received at least 52 weeks of treatment with deupirfenidone. Preliminary data from those receiving deupirfenidone 825 mg TID indicate that the significant slowing of lung function decline observed in Part A of the trial has been sustained through 52 weeks of treatment, supporting the durability of the treatment effect with this dose and its potential to stabilize lung function decline over time.
  • PureTech intends to discuss the results from the Phase 2b trial with the FDA and is targeting a meeting before the end of Q3 2025, with the goal of initiating a Phase 3 trial by the end of 2025. The Company anticipates providing further guidance later this year following the finalization of the trial design and FDA interactions.
  • PureTech will present additional details from the Phase 2b trial at the American Thoracic Society International Conference in May 2025.
• Gallop Oncology (Gallop):
  • PureTech continued to progress its wholly-owned Founded Entity, Gallop, which is advancing LYT-200 (anti-galectin-9 mAb) for the treatment of hematological malignancies, such as AML and high-risk myelodysplastic syndromes (MDS), and locally advanced/metastatic, relapsed/refractory solid tumors including head and neck cancers.
  • LYT-200 is currently being evaluated in an ongoing Phase 1b trial in relapsed/refractory AML and MDS, both as a monotherapy and in combination with venetoclax/hypomethylating agents (HMA). As of the April 2025 post-period, LYT-200 has shown a favorable safety profile across both arms and all dose levels with no dose limiting toxicities, as well as promising clinical efficacy, as characterized by complete and partial responses, hematological improvement, and sustained disease management. Importantly, treatment with LYT-200 in combination with venetoclax/HMA has resulted in 6 complete responses, 1 morphological leukemia-free state, and 50% of patients experiencing stable disease. Topline results are expected in Q3 2025.
  • In the 2025 post-period, the Phase 1b trial evaluating LYT-200 as a monotherapy and in combination with tislelizumab for the treatment of locally advanced/metastatic, relapsed/refractory solid tumors including head and neck cancers was successfully completed. LYT-200 demonstrated a favorable safety profile in all cohorts and showed disease control and initial efficacy signals. The trial demonstrated durable responses—including a complete response lasting over two years—in head and neck cancer patients treated with LYT-200 in combination with tislelizumab. For additional trial details, please see pages 14 to 15 of PureTech’s 2024 Annual Report.
  • In 2024 and the early 2025 post-period, LYT-200 received both Fast Track (January 2025 post-period) and Orphan Drug (February 2024) designations from the FDA for the treatment of AML, underscoring its potential to address a serious condition with high unmet need.
  • In March 2024, the FDA granted Fast Track designation to LYT-200 in combination with anti-PD-1 therapy for the treatment of recurrent/metastatic head and neck cancer, supporting the advancement of the program in solid tumors.
• Karuna Therapeutics (Karuna; a wholly owned subsidiary of BMS):
  • In September 2024, BMS announced that Cobenfy™ (formerly known as KarXT) received FDA approval for the treatment of schizophrenia in adults. The FDA approval triggered two separate milestone payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech's Founded Entity, Karuna (now BMS). Under these agreements, PureTech is also entitled to potential future payments related to additional milestones as well as approximately 2% royalties on net annual sales over $2 billion.
• Seaport Therapeutics (Seaport):
  • PureTech launched Seaport with a $100 million oversubscribed Series A financing to advance novel neuropsychiatric medicines powered by the Glyph platform identified by, characterized, and validated at PureTech. This was followed by a $226 million oversubscribed Series B financing, bringing the total capital raised by Seaport to $326 million since April 2024.
• Vedanta Biosciences (Vedanta):
  • In May 2024, Vedanta enrolled the first patient in the pivotal Phase 3 RESTORATiVE303 study of VE303 for the prevention of recurrent C. difficile infection (rCDI). This study is intended to form the basis for a Biologics License Application to be filed with the FDA.
  • In the January 2025 post-period, Vedanta published additional results from the VE303 Phase 2 CONSORTIUM clinical trial in Nature Medicine, providing a new level of profiling of the multiple mechanisms by which VE303 may decrease the odds of rCDI.
  • Vedanta anticipates topline results from its Phase 2b clinical trial of VE202 in ulcerative colitis in 2025.
• Vor Biopharma (Nasdaq: VOR)
  • In 2024, Vor continued to progress its Phase 1/2 VBP101 study of treatment with trem-cel, a shielded stem cell transplant lacking CD33 manufactured by Vor, followed by Mylotarg™, a CD33-directed Antibody Drug Conjugate therapy, in patients with AML and MDS. Trem-cel + Mylotarg continued to show durable engraftment, shielding from Mylotarg on-target toxicity, a broadened Mylotarg therapeutic window and early evidence of improved relapse-free survival compared to published high-risk AML comparators. Vor received supportive feedback from the FDA regarding a registrational clinical trial design.
  • In 2024, Vor also dosed the first patient in VBP301, a Phase 1/2, multicenter, open-label, first-in-human study of VCAR33^ALLO, a CAR-T cell therapy, in patients with relapsed or refractory AML after standard-of-care transplant or a trem-cel transplant and received both Fast Track designation and Orphan Drug designation from the FDA.

Financial Highlights

• PureTech level cash, cash equivalents and short-term investments were $366.8 million³ as of December 31, 2024, based on consolidated cash, cash equivalents and short-term investments were $367.3 million⁴ as of December 31, 2024.
• PureTech’s Founded Entities raised $397.5 million in 2024,⁷ of which over 88% came from third parties.
• PureTech level cash, cash equivalents and short-term investments were $339.1 million⁵, based on consolidated cash, cash equivalents and short-term investments of $339.5 million⁴, as of March 31, 2025.
• PureTech has operational runway into at least 2027.

PureTech Health will release its Annual Report for the year ended December 31, 2024, today. In compliance with the Financial Conduct Authority’s Listing Rule 9.6.3, the following documents will be submitted to the National Storage Mechanism today and be available for inspection at https://data.fca.org.uk/#/nsm/nationalstoragemechanism.

• Annual Report and Accounts for the year ended December 31, 2024; and
• Notice of 2025 Annual General Meeting (AGM).

Printed copies of these documents together with the Form of Proxy will be posted to shareholders in accordance with applicable UK rules. The Company will provide a hard copy of the Annual Report containing its audited financial statements, free of charge, to its shareholders upon request in accordance with Nasdaq requirements. Requests should be directed in writing by email to ir@puretechhealth.com. Copies will also be available electronically on the Investor Relations section of the Company's website at https://investors.puretechhealth.com/financials-filings/reports.

PureTech’s 2025 AGM will be held on June 16, 2025, at 11:00am EDT /4:00pm BST at the Company's Corporate Headquarters at 6 Tide Street, Suite 400, Boston, Massachusetts, United States.

Shareholders are strongly encouraged to submit a proxy vote in advance of the meeting and to appoint the Chair of the meeting to act as their proxy. If a shareholder wishes to attend the meeting in person, we ask that the shareholder notify the Company by email to ir@puretechhealth.com to assist us in planning and implementing arrangements for this year’s AGM.

Any specific questions on the business of the AGM and resolutions can be submitted ahead of the meeting by e-mail to ir@puretechhealth.com (marked for the attention of Mr. Charles Sherwood).

Shareholders are encouraged to complete and return their votes by proxy, and to do so no later than 4:00pm BST on June 12, 2025. This will appoint the chair of the meeting as proxy and will ensure that votes will be counted even though attendance at the meeting is restricted and you are unable to attend in person. Details of how to appoint a proxy are set out in the notice of AGM.

PureTech will keep shareholders updated of any changes it may decide to make to the current plans for the AGM. Please visit the Company’s website at www.puretechhealth.com for the most up to date information.

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 those statements that relate to expectations regarding PureTech’s and its Founded Entities’ future prospects, development plans and strategies, including the success and scalability of the Company’s R&D model, the progress and timing of clinical trials and data readouts, the timing of potential regulatory submissions, and the sufficiency of available resources and expected operational runway. 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 ability to realize value from our Founded Entities; 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 compete with companies currently marketing or engaged in the development of treatments for indications within our programs are designed to target; our ability to realize the benefits of our collaborations, licenses and other arrangements; the impact of government laws and regulations; 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 additional important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2024, to be 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.

Letter from the Chair

A Year of Successes for PureTech Innovation

These achievements highlight the power of our proven hub-and-spoke model to advance science, build value, and deliver meaningful outcomes.

2024 was a landmark year for PureTech—one defined by breakthrough achievements that created long-term value for both patients and shareholders.

PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com

EU/UK media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
puretech@fticonsulting.com

U.S. media
Justin Chen
+1 609 578 7230
jchen@tenbridgecommunications.com