Puretech Health(PRTC) - 2022 Q4 - Annual Report

Executive Summary & Company Highlights PureTech Health demonstrated a strong financial position and significant pipeline advancement in 2022, with its wholly-owned candidates progressing and Founded Entities achieving key clinical and commercial milestones Key Financial and Operational Highlights PureTech Health reported a strong capital base with $339.5 million in PureTech level cash and $350.1 million consolidated cash as of December 31, 2022, extending its operational runway into Q1 2026. The company rapidly advanced its wholly-owned pipeline, with four clinical-stage therapeutic candidates, and saw significant clinical, commercial, and financial momentum across its Founded Entities, which raised $1.28 billion in 2022 Cash, Cash Equivalents and Short-Term Investments (as of Dec 31, 2022) | Category | Amount (Millions USD) | | :----------------------------------- | :-------------------- | | PureTech Level Cash | $339.5 | | Consolidated Cash | $350.1 | - Operational runway extends into Q1 2026[4][17] - Founded Entities raised $1.28 billion in 2022, almost entirely from third parties[4][17] - Wholly Owned Pipeline includes four clinical-stage therapeutic candidates: LYT-100 (registration-enabling trial in IPF), LYT-300 (Phase 2 ready in anxiety and postpartum depression), LYT-200 (two Phase 1b trials in solid tumors and hematological malignancies), and LYT-503 (Phase 1 partnered program)[3][14] - Founded Entities achieved significant milestones, including Karuna's KarXT two positive Phase 3 trials for KarXT in schizophrenia, clinical data from Vor and Vedanta, and commercial progress with EndeavorRx® and Plenity®[4] CEO and Chair's Strategic Outlook The CEO highlighted 2022 as an exceptional year, shaping PureTech's next development phase and advancing its mission to create new classes of medicines. The company boasts a highly productive track record in biopharma, with 27 therapeutics and candidates developed, two FDA/EU cleared, and a third (KarXT) expected for FDA filing soon. The unique model has generated significant non-dilutive funding, avoiding capital market raises for over five years. The Chair emphasized PureTech's disciplined approach, capital efficiency, and clinical success rate, which is six times the industry average, positioning the company for continued growth and impact - PureTech has developed 27 therapeutics and therapeutic candidates across its Wholly Owned Pipeline and Founded Entities[8][43] - Two therapeutics (EndeavorRx® and Plenity®) have received FDA and EU regulatory clearances, and a third (Karuna's KarXT) is expected to be filed soon for FDA approval[8][43] - The company has generated approximately $215.4 million in non-dilutive funding in the last 8 months from stock sales and an upfront payment from Royalty Pharma for KarXT royalties[9] - PureTech's clinical success rate is six times the industry average[11][43] - Multiple important catalysts are anticipated over the next 12 months, with new candidates expected to progress towards the clinic[10][11] Business Overview & Strategy PureTech's strategy focuses on developing new classes of medicines by enhancing existing therapies, leveraging innovative technologies, and employing a disciplined R&D process to advance a diverse pipeline Company Mission and Innovation Strategy PureTech's mission is to develop new classes of medicines for devastating diseases, driven by a strategy focused on unlocking the potential of therapies with proven efficacy but historical limitations. This approach involves leveraging a network of collaborators, applying innovative technologies (like Glyph™ platform), and employing a disciplined R&D process with 'killer experiments' to rapidly advance promising candidates and discontinue less successful programs - PureTech's strategy is underpinned by three pillars: a network of collaborators, innovative technologies and approaches (e.g., Glyph™ platform), and 'killer experiments' for disciplined R&D[44] - The company focuses on enhancing on-target efficacy, improving tolerability, or enabling oral administration for medicines previously held back by these issues[14][45] - PureTech discontinued the Orasome technology platform and Meningeal lymphatics platform due to lack of promising candidates[44] Wholly Owned Pipeline Advancement PureTech's wholly-owned pipeline rapidly advanced in 2022, completing five clinical trials and generating compelling data. Key candidates like LYT-100, LYT-300, LYT-200, and LYT-310 are progressing, with several important milestones anticipated in the next 12 months. The Glyph™ technology platform, validated by LYT-300, shows potential for improving oral bioavailability and tolerability of other compounds LYT-100 (deupirfenidone) LYT-100 is an investigational therapy for idiopathic pulmonary fibrosis, demonstrating improved gastrointestinal tolerability compared to pirfenidone, with a registration-enabling trial underway - LYT-100 is in development for idiopathic pulmonary fibrosis (IPF), a condition where current treatments have significant tolerability issues[17][51] - It has shown a 50% reduction in gastrointestinal tolerability issues in a head-to-head study versus pirfenidone[17][51] - A global, randomized, double-blind, placebo-controlled trial in IPF patients is ongoing, expected to be the first of two registration-enabling trials, with topline results anticipated in 2024[17][51] LYT-300 (oral allopregnanolone) LYT-300, utilizing Glyph™ technology, is being developed for anxiety and postpartum depression, showing significantly enhanced oral bioavailability and preparing for Phase 2 trials - LYT-300 is being developed for anxiety disorders and postpartum depression (PPD), aiming for faster, better-tolerated, and orally administered treatments[17][50] - A Phase 2a proof-of-concept trial for anxiety is expected to begin in H1 2023 with results by end of 2023; an open-label Phase 2a trial for PPD is expected in H2 2023[17] - Achieved ninefold greater oral bioavailability in humans compared to published data for orally administered allopregnanolone, leveraging the Glyph™ technology[50] LYT-200 (anti-galectin-9 mAb) LYT-200 is an anti-galectin-9 monoclonal antibody in Phase 1b trials for metastatic solid tumors and hematological malignancies, with initial results expected in 2023 and 2024 - LYT-200 is in development for metastatic solid tumors and hematological malignancies like acute myeloid leukemia (AML)[17] - A Phase 1b trial in AML was initiated in 2022, with initial results from a subset of patients expected by end of 2023[17][48] - A Phase 1b trial of LYT-200 in combination with an anti-PD-1 antibody (tislelizumab) for urothelial or head and neck cancer was initiated post-period, with topline results expected in 2024[17] LYT-310 (oral cannabidiol [CBD]) LYT-310 aims to improve the safety and oral administration of cannabidiol for epilepsies and neurological disorders, with clinical entry anticipated in Q4 2023 - LYT-310 aims to expand CBD's therapeutic application across epilepsies and neurological disorders through patient-friendly oral administration[17] - Designed to improve safety, reduce GI and liver exposure, and allow for scalable, consistent, cost-effective production[17] - Expected to enter the clinic in Q4 2023[17] - PureTech completed five clinical studies in 2022, including compelling safety and tolerability data for LYT-100 and proof-of-principle, oral bioavailability, and tolerability for LYT-300[48] - The Glyph™ technology platform received its first clinical validation with LYT-300, demonstrating potential for compounds with challenging oral bioavailability, safety, and tolerability profiles[49] - Multiple important catalysts are anticipated over the next 12 months to guide pipeline prioritization, including potential commercial launches, partnerships, sales, or spinouts[52] Founded Entities Progress and Contributions PureTech's Founded Entities continued to achieve significant milestones, generating non-dilutive funding and advancing their respective programs. Karuna Therapeutics is preparing for FDA submission of KarXT for schizophrenia after strong Phase 3 data, and its value increased over 60% in 2022. Gelesis and Akili made commercial progress with their FDA-cleared products, Plenity and EndeavorRx, respectively, with Gelesis's sales increasing 129% YoY. Vor Bio delivered initial positive data for trem-cell in AML - PureTech generated approximately $115.4 million from the sale of Karuna stock in August 2022[17][54] - Royalty Pharma acquired an interest in PureTech's royalty in Karuna's KarXT for up to $500 million ($100 million upfront cash, up to $400 million contingent on milestones)[54] - Karuna delivered strong Phase 3 clinical data for KarXT in schizophrenia, with its value increasing over 60% in 2022[55] Gelesis Plenity Sales Performance | Metric | Amount (Millions USD) | | :----- | :-------------------- | | Total Sales since launch | $39.5 | | Sales in 2022 | $25.5 | | YoY Increase (2022) | 129% | - Gelesis applied with the FDA to make Plenity available without a prescription, potentially by Q3 2023[56] - Akili formed a partnership with Roblox to expand growth opportunities for EndeavorRx[56] - Vor Bio delivered initial data for trem-cell in AML, supporting its potential[57] Components of Value PureTech's value is derived from four key components: its Wholly Owned Programs, its Founded Entities (through equity appreciation, royalties, and sublicense revenues), its available cash, cash equivalents, and short-term investments, and its commitment to returning capital to shareholders through initiatives like share buyback programs - Value components include Wholly Owned Programs, Founded Entities (equity, royalties, sublicense revenues), available cash, and return of capital to shareholders[63][65][66] - PureTech implemented a share buyback program of up to $50 million in 2022 as part of its capital allocation strategy[68] - The company prioritizes funding its Wholly Owned Pipeline and strategic investment in Founded Entities, while also planning to return proceeds to shareholders via buybacks or special dividends[68] Risk Management PureTech operates in a high-risk biotherapeutics environment, facing principal business and financial risks that are mitigated through rigorous due diligence, diversified assets, and careful monitoring of external disruptions Principal Business Risks PureTech operates in a high-risk biotherapeutics environment, facing principal business risks such as science and technology failure, clinical trial failure, regulatory approval challenges, therapeutic safety concerns, and issues with therapeutic profitability due to competition or reimbursement. The company mitigates these risks through extensive due diligence, a capital-efficient approach, diversified assets, expert consultation, and robust clinical program design - Key business risks include science and technology failure, clinical trial failure, regulatory approval, therapeutic safety, therapeutic profitability, intellectual property protection, enterprise profitability, and hiring/retaining qualified employees[73][77][80][81][82][93][94][95] - Mitigation strategies include extensive due diligence, a capital-efficient approach, diversified assets, board/management oversight, expert network utilization, and rigorous R&D committee reviews[75][76][88] - The company maintains insurance for product liability claims during clinical trials to mitigate therapeutic safety risks[89] Financial Risks PureTech identifies business, economic, financial, or geopolitical disruptions as increasing risks, which could harm development efforts and increase costs. The company monitors its suppliers, clinical trial sites, regulators, and financial service providers, and develops contingency plans. While the investment portfolio is conservative, the company acknowledges potential adverse changes in market conditions and equity price risks from its holdings in public Founded Entities - Business, economic, financial, or geopolitical disruptions (e.g., global health concerns, invasion of Ukraine, banking system stability) are considered increasing risks[102][103] - The company monitors its suppliers, clinical trial sites, regulators, and financial service providers, and develops contingency plans[104] Financial Review PureTech Health's 2022 financial performance showed a reduced net loss, driven by decreased revenue, increased R&D expenses, and significant shifts in other income and net finance income, while total assets and liabilities decreased Reporting Framework and Basis of Presentation PureTech Health's Consolidated Financial Statements are prepared in accordance with UK-adopted International Financial Reporting Standards (IFRS) and comply with IFRSs issued by the IASB. The financial statements consolidate subsidiaries and include interests in associates and investments held at fair value, with the accounting treatment depending on the level of control or significant influence over each entity - Financial statements are prepared in accordance with UK-adopted IFRS and comply with IFRSs issued by the IASB[106] - Founded Entities are classified as subsidiaries (control), associates (significant influence), or investments held at fair value (neither control nor significant influence)[107] Segment Information PureTech's operating segments are based on financial information provided to its Directors for resource allocation and performance assessment. The company aggregates multiple operating segments into four reportable segments: Internal, Controlled Founded Entities, Non-Controlled Founded Entities, and Parent Company and Other. Changes in control, such as the deconsolidation of Sonde Health, Inc. in May 2022, lead to restatement of segment disclosures - Operating segments are based on financial information provided to Directors for resource allocation and performance assessment[126] - Reportable segments include Internal, Controlled Founded Entities, Non-Controlled Founded Entities, and Parent Company and Other[131][132][133][135] - Sonde Health, Inc. was transferred to the Non-Controlled Founded Entities segment due to deconsolidation on May 25, 2022[127][129] Internal Segment The Internal segment focuses on advancing PureTech's wholly-owned therapeutic programs, funded internally or through non-dilutive sources, with operational oversight by the PureTech Health team - The Internal segment advances Wholly Owned Programs, funded by PureTech Health or non-dilutive sources, with operational management by the PureTech Health team[131] - As of December 31, 2022, this segment included PureTech LYT, Inc., PureTech LYT-100, Inc., and Alivio Therapeutics, Inc[131] Controlled Founded Entities Segment This segment comprises consolidated operational subsidiaries with independent management, active R&D programs, and plans to secure third-party dilutive capital - Controlled Founded Entities are consolidated operational subsidiaries with active R&D programs, independent management teams, and plans to raise third-party dilutive capital[132] - As of December 31, 2022, this segment included Entrega, Inc., Follica, Inc., and Vedanta Biosciences, Inc[132] Non-Controlled Founded Entities Segment This segment includes entities over which PureTech no longer exercises control, with their operational results consolidated only up to the date of deconsolidation - Non-Controlled Founded Entities are those over which PureTech no longer has control, with operational results included up to the deconsolidation date[133][134] - As of December 31, 2022, this segment included Sonde Health, Inc[133] Parent Company and Other Segment This segment encompasses corporate support functions, R&D support, intercompany eliminations, and accounting for holdings in deconsolidated entities and other non-operating activities - This segment includes activities not directly attributable to operating segments, corporate support, R&D support, intercompany eliminations, and accounting for holdings in deconsolidated entities[135] - It captures gains/losses on deconsolidation, investments held at fair value, realized losses on sales, share of net income/loss of associates, and impairment of investments[135] Recent Developments (Post-December 31, 2022) Subsequent to December 31, 2022, PureTech Health reported several key developments. Vedanta Biosciences issued convertible debt, leading to PureTech losing control over Vedanta. PureTech entered an agreement with Royalty Pharma for Karuna's KarXT royalty, receiving $100 million upfront. Additionally, PureTech invested $5.0 million in Gelesis via a convertible note and warrants, and later submitted a non-binding proposal to acquire all outstanding equity of Gelesis, following its delisting from the NYSE - On March 1, 2023, Vedanta issued convertible debt for approximately $88.5 million, resulting in PureTech losing control over Vedanta[119] - On March 22, 2023, PureTech agreed with Royalty Pharma for an interest in Karuna's KarXT royalty, with $100.0 million upfront cash and up to $400.0 million contingent on milestones[120] - On February 21, 2023, PureTech invested $5.0 million in Gelesis via a convertible senior secured note and warrants[121] - Gelesis was delisted from the NYSE in April 2023, and PureTech submitted a non-binding proposal to acquire all its outstanding equity[122][123] Results of Operations (Income Statement Analysis) PureTech Health reported a net loss attributable to owners of $50.4 million for 2022, an improvement from a $60.6 million loss in 2021, but a significant decline from a $6.0 million net income in 2020. Total revenue decreased by 10.2% in 2022 to $15.6 million, primarily due to a drop in Internal Segment contract revenue. Operating expenses increased, driven by a 38.0% rise in R&D to $152.4 million. Other income shifted from a gain of $160.0 million in 2021 to a loss of $26.0 million in 2022, mainly due to fair value adjustments of investments. Net finance income significantly increased to $138.9 million in 2022, largely from changes in fair value of subsidiary preferred share liabilities Net Income/(Loss) Attributable to Owners of the Company (in thousands USD) | Year | Amount | | :--- | :----- | | 2022 | $(50,354) | | 2021 | $(60,558) | | 2020 | $5,985 | Total Revenue (in thousands USD) | Year | Amount | Change (YoY) | | :--- | :----- | :----------- | | 2022 | $15,618 | $(1,770) (10.2%) | | 2021 | $17,388 | $5,621 (47.8%) | | 2020 | $11,768 | | Research and Development Expenses (in thousands USD) | Year | Amount | Change (YoY) | | :--- | :----- | :----------- | | 2022 | $(152,433) | $(41,962) (38.0%) | | 2021 | $(110,471) | $(28,612) (35.0%) | | 2020 | $(81,859) | | Other Income/(Loss) (in thousands USD) | Year | Amount | Change (YoY) | | :--- | :----- | :----------- | | 2022 | $(25,981) | $(185,965) | | 2021 | $159,983 | $(18,749) | | 2020 | $178,732 | | Net Finance Income/(Costs) (in thousands USD) | Year | Amount | Change (YoY) | | :--- | :----- | :----------- | | 2022 | $138,924 | $133,875 | | 2021 | $5,050 | $11,164 | | 2020 | $(6,115) | | Total Revenue Total revenue for PureTech Health decreased in 2022, primarily due to a significant reduction in contract revenue from the Internal Segment, partially offset by increases in grant revenue - Total revenue decreased by $1.8 million (10.2%) in 2022, primarily due to an $8.1 million decrease in Internal Segment contract revenue, partially offset by a $4.5 million increase in Controlled Founded Entities grant revenue and a $1.6 million increase in Internal Segment grant revenue[159] Operating Expenses (R&D, G&A) Operating expenses increased in 2022, driven by a substantial rise in R&D costs within the Internal segment for clinical testing, alongside an increase in general and administrative expenses - R&D expenses increased by $42.0 million (38.0%) in 2022, mainly due to a $50.6 million increase in the Internal segment for clinical testing, partially offset by decreases in Controlled and Non-Controlled Founded Entities[161] - G&A expenses increased by $3.8 million (6.6%) in 2022, driven by a $7.1 million increase in the Parent Company and other segment (headcount, compensation, taxes), offset by decreases in Founded Entities[162] Other Income/(Loss) Other income shifted from a significant gain in 2021 to a loss in 2022, primarily due to fair value adjustments of investments, partially offset by gains from deconsolidation and a back-stop agreement - Other income shifted from a $160.0 million gain in 2021 to a $26.0 million loss in 2022, a $186.0 million change[163] - This was primarily due to a $32.1 million loss on investments held at fair value in 2022 (vs. $179.3 million gain in 2021), partially offset by a $27.3 million gain from Sonde deconsolidation and a $7.6 million gain from the Gelesis back-stop agreement[163] Net Finance Income/(Costs) Net finance income saw a substantial increase in 2022, predominantly driven by favorable changes in the fair value of subsidiary preferred shares, warrant, and convertible note liabilities - Net finance income increased by $133.9 million to $138.9 million in 2022, primarily due to a $127.5 million increase from changes in fair value of subsidiaries' preferred shares, warrant, and convertible note liabilities (mainly Vedanta)[164] Share of Net Income/(Loss) of Associates & Impairment The share in net loss of associates decreased in 2022, mainly due to reduced equity interest and lower IFRS losses from Gelesis, alongside a gain on dilution and an impairment charge - Share in net loss of associates decreased to $27.7 million in 2022 from $73.7 million in 2021, mainly due to a decrease in equity interest and lower IFRS losses from Gelesis[165] - PureTech recorded a $28.2 million gain on dilution of its equity ownership in Gelesis and an $8.4 million impairment in its Gelesis investment in 2022[165] Taxation PureTech Health reported an income tax benefit in 2022, a shift from an expense in the prior year, primarily attributable to increased non-taxable gains and changes in state apportionment - Income tax expense was a benefit of $55.7 million in 2022, compared to an expense of $3.8 million in 2021, primarily due to an increase in non-taxable gains and a change in state apportionment[166] Financial Position (Balance Sheet Analysis) PureTech Health's total assets decreased by $243.4 million to $702.6 million as of December 31, 2022, primarily driven by a $145.3 million decrease in investments held at fair value and a $115.6 million decrease in consolidated cash, cash equivalents, and short-term investments. Total liabilities also decreased significantly by $206.8 million to $155.1 million, mainly due to declines in deferred tax liabilities and preferred share liabilities Summary Financial Position (in thousands USD) | Category | 2022 | 2021 | Change | | :------------------------------------ | :----- | :----- | :------- | | Total assets | $702,647 | $946,006 | $(243,359) | | Total liabilities | $155,057 | $361,859 | $(206,802) | | Net assets (Total equity) | $547,589 | $584,147 | $(36,557) | - Investments held at fair value decreased by $145.3 million to $251.9 million, primarily consisting of common shares in Karuna, Vor, Akili, and preferred shares in Sonde[203] - Consolidated cash, cash equivalents, and short-term investments decreased by $115.6 million to $350.1 million, reflecting operating losses partially offset by proceeds from Karuna and Vor share sales[204] - Non-current liabilities decreased by $77.6 million, driven by declines in long-term lease liability ($4.9 million) and deferred tax liabilities ($70.1 million)[205] - Preferred share liability in subsidiaries decreased by $146.7 million to $27.3 million, mainly due to a $130.8 million decrease in fair value and a $15.9 million decrease from Sonde deconsolidation[208] Cash Flow and Liquidity PureTech Health's net cash used in operating activities increased to $178.8 million in 2022, reflecting higher operating losses and increased R&D. Net cash from investing activities shifted from a $197.4 million inflow in 2021 to a $107.2 million outflow in 2022, primarily due to decreased proceeds from investment sales and significant purchases of short-term investments. Financing activities also shifted from a $22.7 million inflow to a $29.8 million outflow, mainly due to no subsidiary preferred share issuance and treasury share purchases in 2022. The company believes its existing financial assets will fund operations into Q1 2026 but anticipates substantial future funding needs Summary Cash Flows (in thousands USD) | Activity | 2022 | 2021 | 2020 | | :---------------------------------- | :--------- | :--------- | :--------- | | Net cash used in operating activities | $(178,792) | $(158,274) | $(131,827) | | Net cash provided by (used in) investing activities | $(107,223) | $197,375 | $364,478 | | Net cash provided by (used in) financing activities | $(29,827) | $22,727 | $38,869 | | Net increase (decrease) in cash and cash equivalents | $(315,842) | $61,827 | $271,520 | - As of December 31, 2022, PureTech had $339.5 million in PureTech Level cash, cash equivalents, and short-term investments[189] - Existing financial assets are believed to be sufficient to fund operations and capital expenditure requirements into Q1 2026[198] Operating Activities Net cash used in operating activities increased in 2022, reflecting higher operating losses primarily driven by increased research and development expenditures in the Internal Segment - Net cash used in operating activities increased by $20.5 million to $178.8 million in 2022, primarily due to higher operating losses from increased R&D in the Internal Segment[191] Investing Activities Net cash from investing activities shifted from a significant inflow to an outflow in 2022, mainly due to decreased proceeds from investment sales and substantial net purchases of short-term investments - Net cash from investing activities decreased by $304.6 million, shifting from a $197.4 million inflow in 2021 to a $107.2 million outflow in 2022[193] - This change was mainly attributed to a $99.4 million decrease in proceeds from investment sales and $198.7 million in net purchases of short-term investments[193] Financing Activities Net cash from financing activities shifted from an inflow to an outflow in 2022, primarily due to the absence of subsidiary preferred share issuances and the initiation of treasury share purchases - Net cash from financing activities decreased by $52.6 million, shifting from a $22.7 million inflow in 2021 to a $29.8 million outflow in 2022[195] - This was primarily due to no issuance of subsidiary preferred shares in 2022 (vs. $37.6 million in 2021) and $26.5 million in treasury share purchases in 2022[196] Funding Requirements PureTech anticipates substantial future expenditures and operating losses, with funding dependent on planned financings, monetization of public Founded Entity shares, and potential business development activities - PureTech expects to incur substantial additional expenditures and net operating losses for the foreseeable future[198] - Future funding will depend on planned financings, monetization of public Founded Entity shares, and potential business development activities[198] - The company currently has no credit facility or other committed sources of capital beyond existing financial assets[200] Critical Accounting Policies and Estimates PureTech's financial reporting relies on critical accounting policies and estimates, particularly for financial instruments, consolidation, and investments in associates, which involve complex judgments about control and fair value Critical Accounting Policies and Estimates PureTech's financial statements, prepared under IFRS, require significant judgments and estimates, particularly concerning financial instruments, consolidation, and investments in associates. Key areas include classifying financial instruments as liability or equity, valuing financial instruments at fair value through profit and loss (FVTPL), and determining control or significant influence over investees. These assessments involve complex evaluations of contractual obligations, voting power, board representation, and the nature of financial instruments held - Financial statements are prepared in accordance with UK-adopted IFRS, requiring judgments and estimates for asset and liability carrying amounts[176] - Critical policies involve financial instruments (liability/equity classification, embedded derivatives), consolidation (power, variable returns, ability to affect returns), and investment in associates (significant influence, classification of instruments)[179][181][182][185] - Valuation of financial instruments at FVTPL requires significant estimates, including future expected returns, earnings potential, discount rates, volatility, and term to exit[180] Additional Information This section provides essential supplementary details, including the upcoming Annual General Meeting, an overview of PureTech Health's mission, cautionary notes on forward-looking statements, contact information, and its foreign private issuer status Annual General Meeting (AGM) PureTech Health's 2023 Annual General Meeting (AGM) is scheduled for June 13, 2023, at 11:00am EDT / 4:00pm BST at its Boston headquarters. Shareholders are strongly encouraged to submit proxy votes in advance and appoint the Chair as their proxy, with a deadline of 4:00 pm (BST) on June 9, 2023. The company encourages remote participation due to the location and will keep shareholders updated on any changes - The 2023 AGM will be held on June 13, 2023, at 11:00am EDT / 4:00pm BST in Boston, Massachusetts[20] - Shareholders are encouraged to submit proxy votes by 4:00 pm (BST) on June 9, 2023, and to participate remotely[21][22][23] About PureTech Health PureTech Health is a clinical-stage biotherapeutics company focused on developing new classes of medicines for devastating diseases. It has built a broad pipeline through its R&D team and network, resulting in 27 therapeutics and candidates. Two products (Plenity® and EndeavorRx®) have received FDA and EU clearances, and KarXT is expected to be filed soon for FDA approval. The company's model involves identifying, discovering, and advancing programs through key validation points, both internally and via its Founded Entities - PureTech is a clinical-stage biotherapeutics company focused on developing new classes of medicine for devastating diseases[25] - The company has developed 27 therapeutics and therapeutic candidates, with two (Plenity® and EndeavorRx®) having received FDA and EU regulatory clearances, and a third (KarXT) expected for FDA approval filing soon[25] - All underlying programs and platforms were initially identified or discovered and advanced by the PureTech team through key validation points[25] Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements regarding PureTech's future prospects, development plans, clinical trials, regulatory submissions, and operational runway. These statements are based on current expectations and are subject to known and unknown risks, uncertainties, and important factors that could cause actual results to differ materially. Key risks include operating losses, need for additional funding, limited control over Non-Controlled Founded Entities, lengthy and expensive drug development, clinical trial delays, safety risks, regulatory approval challenges, intellectual property, reliance on third parties, and macroeconomic conditions. The company disclaims any obligation to update these statements, except as required by law - The press release contains forward-looking statements about future prospects, development plans, clinical trials, regulatory submissions, and operational runway[28] - These statements are subject to known and unknown risks, uncertainties, and important factors that could cause actual results to differ materially[28] - Key risks include significant operating losses, need for additional funding, limited control over Non-Controlled Founded Entities, lengthy and expensive drug development, clinical trial delays, safety risks, regulatory approval challenges, intellectual property, reliance on third parties, and vulnerability to global events[28] Contact Information Contact information for PureTech Health's Public Relations and Investor Relations teams is provided for both EU media and U.S. media inquiries Contact Information | Department | Contact (EU Media) | Contact (U.S. Media) | | :--------- | :----------------- | :------------------- | | Public Relations | Ben Atwell, Rob Winder (+44 (0) 20 3727 1000, ben.atwell@FTIconsulting.com) | Nichole Sarkis (+1 774 278 8273, nichole@tenbridgecommunications.com) | | Investor Relations | IR@puretechhealth.com | IR@puretechhealth.com | Foreign Private Issuer Status As a foreign private issuer under the U.S. Securities Exchange Act of 1934, PureTech Health is exempt from certain provisions applicable to U.S. domestic public companies. These exemptions include rules regarding proxy solicitations, insider stock ownership and trading reports, quarterly reports on Form 10-Q, current reports on Form 8-K, and Regulation FD - PureTech Health qualifies as a foreign private issuer under the Exchange Act[218] - Exemptions include rules on proxy solicitations, insider trading reports, quarterly reports (Form 10-Q), current reports (Form 8-K), and Regulation FD[220]