U.S. stock futures were mixed this morning, with the Dow futures falling around 0.1% on Monday.Shares of Meihua International Medical Technologies Co., Ltd. (NASDAQ:MHUA) fell sharply in pre-market trading after the company announced that it will be delisted from the Nasdaq.Meihua International Medical Technologies shares dipped 32.9% to $9.41 in pre-market trading.Here are some other stocks moving lower in pre-market trading.SMX (Security Matters) Public Limited Company (NASDAQ:SMX) shares dipped 17.2% to ...

U.S. stock futures were mixed this morning, with the Dow futures falling around 0.1% on Monday.Shares of Meihua International Medical Technologies Co., Ltd. (NASDAQ:MHUA) fell sharply in pre-market trading after the company announced that it will be delisted from the Nasdaq.Meihua International Medical Technologies shares dipped 32.9% to $9.41 in pre-market trading.Here are some other stocks moving lower in pre-market trading.SMX (Security Matters) Public Limited Company (NASDAQ:SMX) shares dipped 17.2% to ...

BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced the successful completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). Deupirfenidone is being advanced by Celea Therapeutics ...

Core Insights - PureTech has presented new Phase 2b analyses that demonstrate the consistent safety and efficacy of Deupirfenidone in older patients with Idiopathic Pulmonary Fibrosis (IPF) [1] Group 1: Safety and Efficacy - The analyses indicate that Deupirfenidone shows a favorable safety profile in older patients [1] - Efficacy results suggest that Deupirfenidone effectively slows disease progression in this demographic [1] Group 2: Patient Demographics - The focus of the study is on older patients, highlighting the need for effective treatments in this age group suffering from IPF [1]

Core Viewpoint - PureTech Health PLC has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook driven by an upward trend in earnings estimates [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to significant buying or selling activity that impacts stock prices [4]. Recent Performance and Outlook - For the fiscal year ending December 2025, PureTech Health is expected to earn -$3.80 per share, which remains unchanged from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for PureTech Health has increased by 22.2%, reflecting a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - PureTech Health's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10].

Financial Data and Key Metrics Changes - The company ended the half year with cash, cash equivalents, and short-term investments of just under $320 million, compared to over $366 million at the end of 2024 [50][51] - Operating expenses for the first half of 2025 were just under $50 million, down from $66.7 million in the same period last year, reflecting a reduction in R&D and G&A costs [51][52] - The company has maintained a self-funding model, allowing it to avoid shareholder dilution and providing operational runway well into 2028 [17][50] Business Line Data and Key Metrics Changes - The company is focusing on three core founded entities: Seaport Therapeutics, Gallup Oncology, and Solea Therapeutics, which are expected to deliver significant financial upside and new treatments for patients [11][12] - Seaport Therapeutics has raised over $325 million from top-tier life science investors, maintaining a 35.1% equity interest in the company [22][23] - Gallup Oncology's lead program, LYT200, has received multiple FDA designations, including Fast Track and Orphan Drug Designation for AML, indicating strong clinical progress [44] Market Data and Key Metrics Changes - The company is looking to strengthen its engagement with UK capital markets through a renewed focus on its LSE listing, aiming to deliver value for its UK shareholder base [7][8] - The potential market opportunity for new treatments in idiopathic pulmonary fibrosis (IPF) is significant, with combined peak sales of existing medications reaching over $5 billion annually [30] Company Strategy and Development Direction - The company is prioritizing three strategic pillars: developing new treatments for patients, strengthening engagement with UK capital markets, and maintaining a disciplined capital allocation approach [6][8] - The hub and spoke model allows the company to allocate modest capital to early-stage assets and discontinue those that do not show promise, while investing significantly in areas with high potential [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for dupafenidone, which has shown unprecedented efficacy in treating IPF, and is preparing for a Phase III trial initiation in 2026 [39][41] - The company is actively seeking external funding for its spun-out entities to reduce R&D costs on its balance sheet and extend its cash runway [59][60] Other Important Information - The company has a healthy balance sheet with just under $320 million in cash, allowing it to fund operations without external capital for several years [17][50] - Management has indicated that they are continually reviewing new opportunities for innovation and potential assets for development [73] Q&A Session Summary Question: Can you provide insight into the operating costs for the first half of 2025? - The majority of the R&D spend is attributed to Solea and Gallup, with expectations for further reductions in R&D overhead as these entities spin out [56][57] Question: What is the timeline for partnering discussions regarding Solea? - The company is confident in the trial design for dupafenidone and is actively working on financing packages while awaiting FDA engagement [61][63] Question: What are the key variables for the FDA regarding the Phase III trial design for LYT100? - The briefing book for the Phase III trial design has been submitted to the FDA, with a meeting expected in September to discuss the trial design [70][71] Question: Is there potential for business development to expand the pipeline? - The company is continually looking at new opportunities for innovation and has several assets under internal review [73] Question: What is the focus of partnering discussions for Gallup Oncology? - Current partnering discussions are primarily focused on liquid tumors, particularly AML, but the company remains open to all discussions [81]

Financial Data and Key Metrics Changes - The company ended the half year with cash, cash equivalents, and short-term investments of just under $320 million, compared to over $366 million at the end of 2024, indicating a decrease in cash reserves [54][19] - Operating expenses for the first half of 2025 were just under $50 million, down from $66.7 million in the same period last year, reflecting a reduction in costs as a result of the spin-out of Seaport [55][56] Business Line Data and Key Metrics Changes - The company is focusing on three core founded entities: Seaport Therapeutics, Gallup Oncology, and Silea Therapeutics, which are expected to deliver significant financial upside and new treatments for patients [12][13] - Seaport Therapeutics has raised over $325 million since its founding in April 2024, indicating strong investor interest and validation of its business model [25][24] Market Data and Key Metrics Changes - The company has a healthy balance sheet with operational runway extending well into 2028, allowing it to avoid dilution of shareholders [19] - The potential value from Cabenci, a drug developed internally, is projected to be around $300 million over time based on third-party analyst forecasts [18][20] Company Strategy and Development Direction - The company is prioritizing three strategic pillars: developing new treatments for patients, strengthening engagement with UK capital markets, and maintaining a disciplined capital allocation approach [6][8] - The hub and spoke model allows the company to allocate modest capital to early-stage assets and discontinue those that do not show promise, while investing significantly in areas with high potential [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress of their lead program, dupafenadone, and its potential to address high unmet medical needs [5][6] - The company is actively seeking external funding for its founded entities to reduce R&D costs on its balance sheet, which will enhance cash runway and shareholder value [62][63] Other Important Information - The company is committed to maintaining its primary listing in London due to its attractiveness for portfolio businesses and the support from UK shareholders [87][89] - Management is open to exploring various financing structures for its founded entities, including equity contributions from external parties [80][81] Q&A Session Summary Question: What proportion of the operating costs is attributed to Solaya and Gallup? - The majority of R&D spend is attributed to Solaya and Gallup, with expectations for further reductions in R&D overhead as these entities spin out [60][61] Question: What are the key variables for FDA discussions regarding phase three trial design for LYT100? - The briefing book for the Phase 3 trial design has been submitted to the FDA, with a meeting expected in September to discuss trial design questions [72][73] Question: When should investors expect disclosure of pipeline activities beyond LYT100 and LYT200? - The company is continually reviewing new opportunities for innovation and will disclose promising assets when they are ready [75][76] Question: Is there a preference for the format of partnering for Solaya? - The company typically expects equity contributions from external parties as the default method for funding, but is open to other capital structures [79][80] Question: Is interest in partnering discussions focused more on liquid or solid tumors for Gallup? - Current partnering discussions are primarily focused on liquid tumors, particularly AML, but the company remains open to all discussions [82][83]

Exhibit 99.3 Condensed Consolidated Statement of Comprehensive Income/(Loss) (Unaudited) For the six months ended June 30 | | | 2025 | 2024 | | --- | --- | --- | --- | | | Note | $000s | $000s | | Contract revenue | | 1,851 | — | | Grant revenue | | — | 288 | | Total revenue | | 1,851 | 288 | | Operating expenses: | | | | | General and administrative expenses | | (24,883) | (27,758) | | Research and development expenses | | (24,900) | (38,928) | | Operating income/(loss) | | (47,931) | (66,398) | | Other in ...

Industry Competition and Development - The biotechnology and pharmaceutical industries are characterized by intense competition and rapid technological advancements, with a strong emphasis on intellectual property and proprietary products[32]. - The company is developing LYT-100 for idiopathic pulmonary fibrosis (IPF), competing against approved drugs like pirfenidone and nintedanib, which have unfavorable tolerability profiles[34]. - LYT-200 is being developed as an immuno-oncology treatment, with competition from currently approved therapies such as BMS' Yervoy and Merck's Keytruda[35]. Regulatory Challenges and Compliance - The company faces regulatory challenges, requiring substantial time and financial resources for compliance with U.S. FDA regulations and other international standards[36]. - The company must submit an Investigational New Drug (IND) application to the FDA before commencing human clinical trials, which becomes effective 30 days after submission unless safety concerns arise[38]. - The NDA or BLA submission process requires comprehensive data from clinical trials, including both positive and negative results, along with a substantial application user fee[47]. - Under the Pediatric Research Equity Act, the company must include data assessing the safety and effectiveness of its products in pediatric populations in its NDA or BLA submissions[48]. - The FDA reviews submitted NDAs or BLAs within 60 days to determine if they are substantially complete before acceptance for filing[49]. - Approval of an NDA or BLA is contingent upon compliance with manufacturing processes and facility inspections[51]. - A Complete Response letter outlines deficiencies identified by the FDA, which may include requests for additional clinical studies[53]. - The FDA may grant orphan drug exclusivity for seven years if a product receives the first approval for a rare disease[64]. - The FDA offers expedited programs like fast track and breakthrough therapy to facilitate the review of products addressing serious conditions[56][57]. - Products receiving accelerated approval must conduct confirmatory studies to verify clinical benefits[59]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained post-marketing[68]. - Manufacturers must comply with cGMPs and are subject to ongoing inspections and reporting requirements[66][67]. - The FDA restricts manufacturers from promoting off-label uses of their products, although physicians can prescribe them for such uses[69]. - The Hatch-Waxman Act allows for three types of marketing applications: 505(b)(1) NDA, 505(b)(2) NDA, and ANDA, with ANDAs enabling generic drug approval without extensive preclinical and clinical data[70]. - A 505(b)(2) NDA can rely on existing FDA findings for safety and efficacy, potentially expediting the approval process[70]. - The FDA grants five years of non-patent data exclusivity for new drugs containing new chemical entities, preventing ANDA or 505(b)(2) applications during this period[73]. - A three-year exclusivity period is available for NDA holders for new formulations or changes requiring new clinical studies, protecting against ANDA and 505(b)(2) approvals for those specific conditions[73]. - The Biologics Price Competition and Innovation Act (BPCIA) establishes a 12-year exclusivity period for reference biological products, during which biosimilar applications cannot be approved[75]. - Pediatric market exclusivity can add six months to existing exclusivity periods if a pediatric study is completed as per FDA request[76]. Medical Device Regulations - Medical devices in the U.S. require either 510(k) clearance or PMA approval, classified into three classes based on risk, with Class III devices requiring the most rigorous approval[81]. - The 510(k) clearance process typically takes three to twelve months, allowing manufacturers to demonstrate substantial equivalence to existing devices[83]. - Any significant modification to a cleared device requires a new 510(k) clearance or PMA approval, with potential regulatory penalties for non-compliance[85]. - The PMA process requires manufacturers to demonstrate device safety and effectiveness, supported by extensive data from pre-clinical studies and human clinical trials[86]. - The FDA has 180 days to review a PMA application, although actual review times can extend to several years[86]. - Post-approval conditions may be imposed by the FDA to ensure ongoing safety and effectiveness of the device[87]. - Changes to an approved device that affect safety or effectiveness require submission of a PMA supplement[88]. - The de novo classification process allows manufacturers to request down-classification of low-to-moderate risk devices automatically classified as Class III[89]. - The FDA must classify a de novo request within 120 days, but this process may take longer in practice[90]. - Clinical trials for medical devices must comply with FDA regulations and may require an IDE application if the device presents significant risk[91]. - Post-market regulations include compliance with QSR, which covers manufacturing processes and quality assurance[94]. - The FDA issued a final rule to amend the QSR, establishing the Quality Management System Regulation (QMSR) expected to take effect on February 2, 2026[95]. International Regulatory Framework - Manufacturers must obtain approval from foreign regulatory authorities before commencing clinical trials or marketing products outside the U.S.[100]. - In the EU, innovative medicinal products receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization (MA)[111]. - The overall ten-year exclusivity period can be extended to a maximum of 11 years if the MA holder obtains authorization for new therapeutic indications that provide significant clinical benefits during the first eight years[111]. - Orphan medicinal products are entitled to ten years of market exclusivity for the approved indication, which can be extended by two years if they comply with an agreed Pediatric Investigation Plan (PIP)[114]. - The MA process includes a risk-benefit assessment based on scientific criteria concerning quality, safety, and efficacy, with an initial duration of five years before renewal[109]. - The centralized procedure for MA evaluation by the EMA has a maximum timeframe of 210 days, with potential accelerated reviews in exceptional cases within 150 days[107]. - The EU regulates drug-device combination products separately, requiring compliance with both medicinal product and medical device regulations[128]. - The EMA or national competent authorities assess the quality, safety, and efficacy of drug-delivery products, including the device's safety and performance[129]. - Controlled substances are regulated under UN conventions, with individual EU member states responsible for implementation and compliance[120]. - The advertising and promotion of medicinal products must align with approved product characteristics, prohibiting off-label promotion and direct-to-consumer advertising[123]. - Non-compliance with EU regulations can result in administrative, civil, or criminal penalties, including delays or refusals in MA and product withdrawals[126]. - The EU Medical Devices Regulation requires compliance with general safety and performance requirements for medical devices to obtain CE marking, which is essential for marketing in the EU[134]. - Manufacturers must undergo a conformity assessment procedure, which varies by device type and risk classification, to demonstrate compliance with safety and performance standards[134]. - Medical devices must be registered in the Eudamed system, including a unique device identifier (UDI), to ensure better identification and traceability[137]. - The EU medical device vigilance system mandates reporting of serious incidents and Field Safety Corrective Actions (FSCAs) to relevant authorities[138]. - The IVDR, applicable since May 26, 2022, introduces a tiered system for compliance based on risk classification for in vitro diagnostic medical devices[142]. - Companion diagnostics must undergo conformity assessment by a notified body and may require a scientific opinion from the EMA if linked to specific medicinal products[145]. UK Regulatory Changes - The UK has established its own regulatory framework for medical devices post-Brexit, with the MHRA as the standalone regulator since January 1, 2021[147]. - The Windsor Framework, effective January 1, 2025, reintegrates Northern Ireland under the MHRA's regulatory authority for medicinal products[147]. - The MHRA has introduced changes to national licensing procedures, including a 150-day assessment and rolling review for new medicines[150]. - The MHRA will consider decisions from trusted regulatory partners when determining applications for new UK marketing authorizations[150]. - The UK government published an amendment to the UK's Medical Devices Regulations 2002, which will come into force on June 16, 2025, to enhance post-market surveillance requirements for medical devices[156]. - The MHRA allows fast-tracked reviews for medicinal products approved by trusted regulatory partners, with decisions made within a maximum of 60 days if no major objections are identified[152]. - Medical devices must be registered with the MHRA, and since January 1, 2022, manufacturers outside the UK are required to appoint a UK responsible person for registration[155]. - Class I medical devices need to be "UKCA" self-certified to be placed on the GB market, while other devices require certification by a UK approved body[156]. - Certain medical devices compliant with the EU Medical Devices Directive can continue to be marketed in GB until June 30, 2028, or June 30, 2030, depending on the regulation[156]. - The MHRA launched a consultation on proposals to update pre-market requirements for medical devices in GB, expected to be implemented in 2026[156]. - The UK MDR requires class A IVD MDs to be "UKCA" self-certified, while other IVDs need certification by a UK approved body[157]. - Under the Northern Ireland Protocol, medical devices marketed in Northern Ireland must comply with EU regulatory standards[158]. - The MHRA's new legislation aims to facilitate greater international collaboration and patient-centered requirements for medical devices[156]. Financial and Market Considerations - The company faces challenges in securing coverage and reimbursement for its products, as third-party payors may not consider them medically necessary or cost-effective, potentially impacting sales and financial condition[172]. - In the U.S., the Medicare payment reductions from the Budget Control Act of 2011 will remain in effect through 2032, affecting revenue generation from approved products[179]. - The Inflation Reduction Act of 2022 requires manufacturers to negotiate drug prices with Medicare starting in 2026, which may impact pricing strategies[180]. - The company must navigate varying drug pricing and reimbursement regulations across different countries, with the EU requiring cost-effectiveness trials for pricing negotiations[185]. - Health Technology Assessment (HTA) outcomes in the EU can significantly influence pricing and reimbursement status, with negative assessments potentially undermining market access[186]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to secure reimbursement[172]. - The downward pressure on healthcare costs is intensifying, creating high barriers for new product entries in the market[176]. Company Financials and Shareholder Information - As of December 31, 2024, the company reported milestone payments related to developmental milestones amounting to approximately $7.1 million, which are dependent on events outside the company's control[199]. - The company has a working capital deemed sufficient for its present requirements as of December 31, 2024[202]. - Major shareholders include Invesco Ltd. with 17.1%, Baillie Gifford & Co with 6.3%, and Lansdowne Partners Limited with 6.0% of the outstanding ordinary shares[215]. - The total number of ordinary shares outstanding as of March 31, 2025, is 240,189,449[213]. - The company has no off-balance sheet arrangements that are likely to have a material effect on its financial condition or results of operations[201]. - The company does not have a present obligation to make milestone payments under various license and collaboration agreements as of December 31, 2024[199]. - The company’s financial statements have been prepared in accordance with IFRSs as issued by the IASB for the years ended December 31, 2024, 2023, and 2022[193]. - The company is not aware of any trends or uncertainties that could materially affect its net revenue or profitability from January 1, 2024, to the present[204]. - Preferred shares issued by subsidiaries are classified as liabilities and are redeemable only upon liquidation events, which are unpredictable[200]. - The company maintains significant influence over its associates and recognizes holdings in entities without control as investments at fair value[194]. - Major shareholders include Invesco Ltd. with 41,011,890 shares, Baillie Gifford & Co. with 15,123,383 shares, and Lansdowne Partners Limited with 14,442,261 shares[220]. - Citigroup Inc. holds 12,340,665 shares, while Vanguard Group, Inc. has 9,478,214 shares beneficially held[220]. - Fidelity International Ltd. possesses 8,201,046 shares, and there are 1,950,000 vested but unexercised options reported[220]. - No significant change in percentage ownership held by any major shareholder has occurred since January 1, 2022[222].

Executive Summary & Company Highlights PureTech Health achieved significant clinical, regulatory, and financial milestones in 2024, securing FDA approval and maintaining a strong balance sheet [Overview of 2024 Achievements](index=1&type=section&id=Overview%20of%202024%20Achievements) PureTech Health achieved significant clinical, regulatory, and financial milestones in 2024, including positive Phase 2b results for LYT-100, FDA approval of Cobenfy™, and rapid growth of Seaport Therapeutics, maintaining a robust balance sheet into at least 2027 - PureTech's innovation engine drove meaningful clinical, regulatory, and financial milestones in **2024**[2](index=2&type=chunk) - Key achievements include positive Phase 2b results for wholly-owned **deupirfenidone (LYT-100)** in IPF and compelling Phase 1b data for wholly-owned **LYT-200** in AML and solid tumors[2](index=2&type=chunk) - FDA approval of PureTech-invented **Cobenfy™** for schizophrenia and rapid growth of Founded Entity **Seaport Therapeutics**, which raised over **$325 million**, were also significant[2](index=2&type=chunk) Cash, Cash Equivalents, and Short-Term Investments | Metric | As of Dec 31, 2024 | As of Mar 31, 2025 | | :------------------------------------------------ | :------------------- | :------------------- | | PureTech level cash, cash equivalents, and short-term investments | $366.8 million | $339.1 million | | Consolidated cash, cash equivalents, and short-term investments | $367.3 million | $339.5 million | - The company has an operational runway into at least **2027**[2](index=2&type=chunk)[26](index=26&type=chunk) [Webcast and Conference Call Information](index=1&type=section&id=Webcast%20and%20Conference%20Call%20Information) PureTech Health plc will host a webcast and conference call on April 30, 2025, at 9:00 am EDT / 2:00 pm BST to discuss its annual results - A webcast and conference call will be held on **April 30, 2025**, at **9:00 am EDT / 2:00 pm BST** to discuss the results[4](index=4&type=chunk) - Live webcast and presentation slides are available on PureTech's investor relations website under 'Events and Presentations'[4](index=4&type=chunk) - Dial-in numbers for the UK and US, along with a global access code (**018948**), are provided for phone participation[4](index=4&type=chunk) Operational Highlights PureTech's wholly-owned programs and Founded Entities achieved significant clinical, regulatory, and financial milestones in 2024 and early 2025 [Wholly-Owned Programs](index=2&type=section&id=Wholly-Owned%20Programs) PureTech's wholly-owned programs, deupirfenidone (LYT-100) and LYT-200, demonstrated significant clinical progress in 2024 and early 2025 - PureTech's wholly-owned programs, **deupirfenidone (LYT-100)** and **LYT-200**, delivered significant clinical and regulatory milestones[10](index=10&type=chunk) [Deupirfenidone (LYT-100)](index=2&type=section&id=Deupirfenidone%20(LYT-100)) Deupirfenidone (LYT-100) achieved positive Phase 2b results in IPF, showing potential to stabilize lung function, with plans for a Phase 3 trial by year-end 2025 - Positive topline results from the **ELEVATE IPF Phase 2b clinical trial** were announced in **December 2024**, meeting primary and key secondary endpoints[10](index=10&type=chunk) - The higher dose (**825 mg TID**) demonstrated the potential to stabilize lung function over **26 weeks**, with an effect size **50% greater** than pirfenidone[10](index=10&type=chunk) - Preliminary data from the ongoing open label extension (OLE) study indicate sustained slowing of lung function decline through **52 weeks**[10](index=10&type=chunk) - PureTech plans to meet with the FDA before the end of **Q3 2025** to discuss Phase 2b results and aims to initiate a Phase 3 trial by the end of **2025**[10](index=10&type=chunk) [Gallop Oncology (LYT-200)](index=3&type=section&id=Gallop%20Oncology%20(LYT-200)) LYT-200, advanced by Gallop Oncology, showed promising clinical activity and a favorable safety profile in AML/MDS and head and neck cancers, receiving FDA Fast Track and Orphan Drug designations - **LYT-200 (anti-galectin-9 mAb)** is being advanced for hematological malignancies (AML, MDS) and solid tumors (head and neck cancers)[16](index=16&type=chunk) - In an ongoing Phase 1b trial for relapsed/refractory AML and MDS, **LYT-200** showed a favorable safety profile and promising clinical efficacy, including complete and partial responses[16](index=16&type=chunk) - The Phase 1b trial for solid tumors (head and neck cancers) was completed, demonstrating a favorable safety profile, disease control, and initial efficacy signals, including a complete response lasting over **two years**[16](index=16&type=chunk) - **LYT-200** received FDA **Fast Track designation** for AML (**January 2025**) and recurrent/metastatic head and neck cancer (**March 2024**), and **Orphan Drug designation** for AML (**February 2024**)[16](index=16&type=chunk) [Founded Entities](index=3&type=section&id=Founded%20Entities) PureTech's Founded Entities achieved significant milestones, including FDA approval of Cobenfy™ for schizophrenia, triggering $29 million in milestone payments and future royalties - PureTech's Founded Entities continued to advance their programs, securing regulatory approvals, significant financings, and clinical progress[5](index=5&type=chunk) [Karuna Therapeutics (Cobenfy™)](index=3&type=section&id=Karuna%20Therapeutics%20(Cobenfy%E2%84%A2)) Cobenfy™ (formerly KarXT) received FDA approval in September 2024 for schizophrenia, triggering $29 million in milestone payments and future royalties - **Cobenfy™ (formerly KarXT)** received FDA approval in **September 2024** for the treatment of schizophrenia in adults[13](index=13&type=chunk) - The FDA approval triggered **$29 million** in milestone payments to PureTech[13](index=13&type=chunk) - PureTech is entitled to potential future milestone payments and approximately **2% royalties** on net annual sales over **$2 billion**[13](index=13&type=chunk) [Seaport Therapeutics](index=3&type=section&id=Seaport%20Therapeutics) Seaport Therapeutics launched with a $100 million Series A financing, followed by a $226 million Series B, totaling $326 million raised since April 2024 - PureTech launched **Seaport Therapeutics** with a **$100 million** oversubscribed Series A financing[14](index=14&type=chunk) - This was followed by a **$226 million** oversubscribed Series B financing, bringing the total capital raised by Seaport to **$326 million** since **April 2024**[14](index=14&type=chunk) - Seaport is advancing novel neuropsychiatric medicines powered by the **Glyph platform**[14](index=14&type=chunk) [Vedanta Biosciences](index=3&type=section&id=Vedanta%20Biosciences) Vedanta Biosciences initiated a pivotal Phase 3 study for VE303 and anticipates Phase 2b results for VE202 in 2025 - Vedanta enrolled the first patient in the pivotal **Phase 3 RESTORATiVE303 study** of **VE303** for the prevention of recurrent *C. difficile* infection (rCDI) in **May 2024**[17](index=17&type=chunk) - Additional results from the **VE303 Phase 2 CONSORTIUM clinical trial** were published in *Nature Medicine* in **January 2025**[17](index=17&type=chunk) - Vedanta anticipates topline results from its **Phase 2b clinical trial** of **VE202** in ulcerative colitis in **2025**[17](index=17&type=chunk) [Vor Biopharma](index=3&type=section&id=Vor%20Biopharma) Vor Biopharma continued clinical progress with trem-cel and VCAR33ALLO, receiving Fast Track and Orphan Drug designations - Vor continued to progress its **Phase 1/2 VBP101 study** of **trem-cel** in AML and MDS, showing durable engraftment and shielding from Mylotarg toxicity[15](index=15&type=chunk) - Vor received supportive feedback from the FDA regarding a registrational clinical trial design for **trem-cel**[15](index=15&type=chunk) - In **2024**, Vor dosed the first patient in **VBP301**, a **Phase 1/2 study** of **VCAR33ALLO** (CAR-T cell therapy) in relapsed/refractory AML, which received **Fast Track** and **Orphan Drug designations**[18](index=18&type=chunk) Company Information This section provides an overview of PureTech Health, its forward-looking statements, and contact information [About PureTech Health](index=4&type=section&id=About%20PureTech%20Health) PureTech Health is a clinical-stage biotherapeutics company focused on developing new classes of medicine for devastating diseases, leveraging a hub-and-spoke R&D model - PureTech is a clinical-stage biotherapeutics company dedicated to developing new medicines for devastating diseases[26](index=26&type=chunk) - Its R&D engine has developed **29 therapeutic candidates**, with **three** having received FDA approval[27](index=27&type=chunk) - Programs are advanced both internally and through Founded Entities, utilizing a **hub-and-spoke model**[26](index=26&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20