Xanomeline Tartrate/Trospium Chloride

Bristol Myers Squibb is facing a bit of an identity crisis. CEO Chris Boerner is nearly two and a half years into his tenure, with most of his time defined by stringent cost-cutting . In the aftermath of the massive, $74 billion Celgene acquisition, the cuts have positioned Bristol Myers as a more “agile” company with a slate of pipeline readouts coming this year that has drawn excitement from Wall Street. But as BMS also manages two looming patent cliffs for the blood thinner Eliquis and cancer drug Opdivo, analysts say the company is struggling to clearly chart a path beyond these multibillion-dollar franchises. That’s particularly true in immuno-oncology, William Blair analyst Matt Phipps said. After Opdivo, it’s difficult to see what the next big megablockbuster is. “I don’t know what you really say right now, if you say, like, ‘What is Bristol Myers?’” Phipps said. Compounding the dilemma is the slower-than-expected launch of Cobenfy, a schizophrenia drug approved in 2024 that Bristol Myers acquired in its $14 billion buyout of Karuna Therapeutics . Once estimated to reach more than $6 billion in yearly sales, Cobenfy has struggled to gain a foothold in its most promising market as doctors and insurers are reportedly reluctant to prescribe and pay for it . But other recent deals have also stumbled — or are yet to bear fruit. Krazati, the KRAS drug from BMS’ acquisition of Mirati Therapeutics, has also faced market headwinds as next-generation programs threaten to outperform it. Sotyktu, an immunology drug developed in-house at BMS, has seen strong uptake since its first approval in 2022 but is expected to meet similar pressure. The lead drug from RayzeBio will also have pivotal data this year, though that trial was delayed due to supply issues for its radioisotope component. All of that combined leaves a lot still up in the air. And as the patent cliffs approach, investors will likely get more antsy. “There’s definitely interest in some of their clinical catalysts,” Phipps said. “But people just want to see it now.” Bristol Myers’ stock $BMY is up about 35% over the last six months as anticipation for the readouts builds. A spokesperson for BMS declined to comment, but pointed to Boerner’s remarks from the company’s most recent earnings call in February, where he said, “Our North Star remains to deliver industry-leading sustainable growth into the 2030s and beyond.” Few things encapsulate the uncertainty surrounding Bristol Myers more than Cobenfy. The landmark approval a little over 18 months ago heralded a sea change in schizophrenia treatment. Not only was Cobenfy the first new schizophrenia drug approved in decades, but it promised to come without the hallmark side effects that often force patients to switch between antipsychotics whose effects wane over time. Bristol Myers laid out plans for Cobenfy that were more than ambitious enough to justify the $14 billion it paid for Karuna, a deal that closed about six months before the schizophrenia approval. Executives hoped to bring the drug into at least six other indications, including multiple conditions related to Alzheimer’s disease and bipolar disorder. But Cobenfy quickly ran into setbacks in the clinic. In early 2025, the drug failed a Phase 3 study testing it as an add-on therapy to standard antipsychotics. Another readout for Alzheimer’s-associated psychosis was delayed in December due to unspecified trial site irregularities . Former chief medical officer Samit Hirawat also left the company last year. It sets up three pivotal Cobenfy readouts later this year in Alzheimer’s disease psychosis, which investors view as the most promising area outside schizophrenia, Stifel analyst Paul Matteis said. There’s also added interest in these readouts, Matteis noted, because the rollout for Cobenfy has been slow. “The way I would say it is, people aren’t impatient, but there’s more pressure on these other indications to deliver now, because schizophrenia is just not growing as robustly as expected,” Matteis said. The gradual launch might also have been anticipated. Chief commercialization officer Adam Lenkowsky previously told Endpoints News after Cobenfy’s approval that the company expected “uptake to really happen in the back end of ‘25 and certainly well into ‘26 and beyond.” Lenkowsky attributed that to most schizophrenia patients being covered by Medicare and Medicaid. The drug’s annual list price is roughly $23,000. As of June 2025, Cobenfy was covered for 98% of Medicare and Medicaid patients, according to a BMS website for physicians . Cobenfy sales reached $51 million in the fourth quarter last year, below consensus estimates by 3%, Leerink analyst David Risinger wrote in a February note to investors. With an eye on the Eliquis and Opdivo patent cliffs, there may not be much Bristol Myers can do other than hope for the best in its clinical trial readouts. The company doesn’t have the ability to pull off another Celgene-sized deal to help bridge the gap, Phipps said. As such, in the near term, BMS will have to rely on strong data from Cobenfy, the RayzeBio drug and other programs developed in-house and acquired from Celgene. Phipps said Bristol Myers may have already realized this. “Now it’s a little more accepting of how there is going to be a decent step down at some point. You’re gonna hit a floor,” Phipps said. “The goal is to make sure [BMS] has a great growth profile coming out of that floor.” The patent expiry for Eliquis was extended to 2028 after a long court fight, but its Medicare price was capped under former President Joe Biden’s Inflation Reduction Act. Bristol Myers has also agreed to lower Eliquis’ direct-to-consumer price after President Donald Trump’s threats of implementing a “most favored nation” plan. Opdivo’s main patents are also expected to expire in 2028 or 2029. The immunotherapy was likely going to be selected for this year’s round of IRA negotiations, but due to legislative changes regarding orphan drug exclusions, that selection has been delayed beyond this year , according to the Kaiser Family Foundation. The losses of exclusivity are coming one way or another, and as Bristol Myers emerges from its cost-cutting era, it will need to figure out how to stave off the worst-case scenario where most or all of its new drugs underwhelm in the clinic or on the market. “There’s still a lot of room for this to play out,” Phipps said. Bristol Myers reports its first-quarter 2026 earnings on Thursday morning.

Refined strategy and disciplined execution position Company to unlock value from its portfolio, which includes Celea Therapeutics’ Phase 3-ready deupirfenidone for idiopathic pulmonary fibrosis, Gallop Oncology’s clinically-validated LYT-200 for myeloid malignancies, and Seaport Therapeutics’ advancing clinical-stage pipeline for neuropsychiatric disorders PureTech level cash, cash equivalents and short-term investments of $277.1 million 1 and Consolidated cash, cash equivalents and short-term investments of $277.3 million 1 as of December 31, 2025; Operational runway at least through the end of 2028, inclusive of the Company’s expected participation in Founded Entity fundraisings As of March 31, 2026, PureTech level cash and cash equivalents were $248.1 million 2 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, 2025, as well as its cash balance as of the first quarter ended March 31, 2026. The following information represents select highlights and references page numbers 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, 2025, to be filed with the United States Securities and Exchange Commission (the “SEC”) and will also be available later today at . 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 29, 2026, 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: 932950 For those unable to listen to the call live, a replay will be available on the PureTech website. Commenting on the annual results, Robert Lyne, Chief Executive Officer of PureTech, said: “2025 was a year of continued progress for PureTech, as we built on the strength of our portfolio and took important steps to sharpen our strategic focus. We have refined how we deploy capital and scale our programs, with an emphasis on advancing therapeutic candidates through key value-inflection points and leveraging external investment to support later-stage development. This approach enables us to operate with greater discipline and efficiency while maintaining meaningful long-term exposure to the value we create. “Alongside these efforts, we have continued to advance our portfolio. During the year, we advanced deupirfenidone to Phase 3 readiness in idiopathic pulmonary fibrosis through our Founded Entity Celea Therapeutics (Celea). I’m pleased to note that Celea has secured sufficient non-binding commitments from external investors, in addition to participation from PureTech, such that the fundraising is substantially complete, subject to continued negotiations. Whilst mindful of macro factors, Celea is targeting to close the financing by early in the third quarter of 2026. The financing is intended to support the Phase 3 SURPASS-IPF trial, which Celea expects to commence in close proximity to closing the financing. “We also reported positive clinical results from LYT-200 in relapsed/refractory myeloid malignancies and, with these data in hand, intend to pursue external financing for Gallop Oncology to support its next phase of development, with an initial focus on relapsed/refractory high-risk myelodysplastic syndrome. Additionally, Seaport Therapeutics continued to advance its neuropsychiatric pipeline, including encouraging initial results from one of two ongoing clinical trials initiated in 2025, and filed a registration statement with the United States Securities and Exchange Commission for a potential initial public offering, though the timing, number of shares to be offered, and the price range for the offering has not yet been determined. “We are also focused on ensuring that the value we create is more clearly reflected for shareholders. Our model has historically generated meaningful returns through a combination of equity ownership and non-dilutive economics, and we believe our continued progress positions us to deliver this more consistently over time. Critically, following the completion of Celea's financing, we expect to reduce our operational burn significantly compared to our historical run rate, with a lower and more predictable cost base going forward. This will be driven in part by the transition of the Celea team and related development activities into the externally funded Founded Entity, reducing operating costs at the PureTech hub. “As part of this broader focus on efficiency and alignment, we have announced our intention to voluntarily delist our American Depositary Shares from Nasdaq and concentrate our listing on the London Stock Exchange, where the substantial majority of trading volume and liquidity in our shares has consistently occurred. We believe this step simplifies our structure and reduces cost and administrative burden for the business, whilst retaining our primary London listing, providing access to both the UK and global investment community. “Together, these actions are intended to create a leaner, more focused business. As part of this approach, we will look to return a greater proportion of future cash generation to shareholders, particularly in the event of any outsized returns, whilst maintaining appropriate operational runway. “Looking ahead, our priorities remain clear. We are focused on advancing our most promising programs with urgency and discipline. At the same time, we will continue to invest in our innovation engine to generate the next wave of Founded Entities, while maintaining a thoughtful approach to capital allocation. “PureTech was founded on the belief that innovative science and disciplined capital allocation can work hand in hand to deliver meaningful impact. As we move forward with greater focus and clarity, we believe we are well positioned to translate that approach into sustained value for both patients and shareholders.” 2025 and Early 2026 Operational Highlights For full details, please see PureTech’s 2025 Annual Report. Celea Therapeutics (Celea) Delivering transformative treatments for people with serious respiratory diseases Economic interest: 3 100% KEY HIGHLIGHTS – April 2026 post-period: Publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) in people with idiopathic pulmonary fibrosis (IPF) in The American Journal of Respiratory and Critical Care Medicine . – February 2026 post-period: Announced the U.S. Food and Drug Administration (FDA) and European Commission had granted Orphan Drug Designation to deupirfenidone for the treatment of IPF, providing financial and commercial advantages for the development of deupirfenidone. – December 2025: Announced successful completion of the End-of-Phase 2 meeting with the FDA regarding development of deupirfenidone for the treatment of IPF and shared plans for pivotal, Phase 3 head-to-head SURPASS-IPF trial evaluating superiority of deupirfenidone compared with pirfenidone. – Through 2025: Presented data from the Phase 2b ELEVATE IPF trial at various medical meetings, including the American Thoracic Society (ATS) and European Respiratory Society (ERS) annual meetings. UPCOMING MILESTONES – Celea has secured sufficient non-binding commitments from external investors, in addition to participation from PureTech, such that the fundraising is substantially complete, subject to continued negotiations. Whilst mindful of macro factors, Celea is targeting to close the financing by early in the third quarter of 2026. The financing is intended to support the Phase 3 SURPASS-IPF trial, which Celea expects to commence in close proximity to closing the financing. Gallop Oncology (Gallop) Targeting galectin-9 to transform treatment paradigm for people with myeloid malignancies Economic interest: 3 100% KEY HIGHLIGHTS – April 2026 post-period: Publicly filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of shares of its common stock. The timing, number of shares to be offered, and the price range for the offering has yet been determined as of the date of this release. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. – December 2025: Presented initial topline results from the Phase 1b clinical trial of LYT-200 in patients with R/R HR-MDS and R/R AML at the American Society of Hematology Annual Meeting. – January 2025: FDA granted Fast Track Designation to LYT-200 for the treatment of AML, which is intended to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. LYT-200 was also granted Orphan Drug Designation in 2024, providing financial and commercial advantages for the development of LYT-200 in AML. UPCOMING MILESTONES – Gallop has selected a recommended Phase 2 dose and intends to engage with the FDA to discuss the design of a subsequent trial that could potentially support registration of LYT-200 in R/R HR-MDS. – Gallop intends to pursue third-party capital to support a potentially registration-enabling trial in R/R HR-MDS, with the round targeted to close in the first quarter of 2027. Seaport Therapeutics (Seaport) Inventing and developing new medicines for patients with neuropsychiatric disorders Economic interest: 3 35.0% equity; 3-5% tiered royalties on Glyph product net sales; modest regulatory and commercial milestone payments KEY HIGHLIGHTS – April 2026 post-period: Publicly filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of shares of its common stock. The timing, number of shares to be offered, and the price range for the offering has yet been determined as of the date of this release. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. – April 2026 post-period: Announced positive topline data from the single-ascending dose and crossover portions of the ongoing Phase 1 proof-of-concept clinical trial of GlyphAgo™ (SPT-320 or Glyph Agomelatine) in healthy adults for the potential treatment of generalized anxiety disorder (GAD), having announced first patient dosed in September 2025. – March 2026 post-period: Published first-in-human clinical and preclinical data for GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in Science Translational Medicine . – July 2025: Announced first patient dosed in the Phase 2b BUOY-1 trial of GlyphAllo in patients with major depressive disorder (MDD) with or without anxious distress. – February 2025: Published new data in Molecular Pharmaceutics showcasing the Glyph platform's unique ability to enhance drug transport through the lymphatic system for increased therapeutic exposure. UPCOMING MILESTONES – Seaport anticipates topline data from the Phase 2b BUOY-1 trial of GlyphAllo in patients with MDD with or without anxious distress in the first half of 2027. – Seaport plans to initiate a Phase 2a proof-of-pharmacology trial designed to evaluate the potential sleep benefit of GlyphAgo in patients with GAD and sleep disturbance, with topline data expected in early 2028. – Seaport also plans to initiate, in parallel, a Phase 2b trial evaluating the efficacy and safety of GlyphAgo in patients with GAD, with topline data expected by the end of 2028. Karuna Therapeutics (Karuna) (Acquired by Bristol Myers Squibb as of March 18, 2024) Economic interest: 2% royalty on annual Cobenfy ™4 sales above $2 billion in addition to milestone payments under its agreements with Royalty Pharma and Bristol Myers Squibb upon the achievements of certain regulatory approvals and Cobenfy sales milestones KEY HIGHLIGHTS Karuna was a PureTech Founded Entity through which Cobenfy™ (xanomeline and trospium chloride; formerly known as KarXT) was invented and advanced. Cobenfy was approved by the U.S. Food and Drug Administration on September 26, 2024, for the treatment of schizophrenia in adults. It is the first new mechanism approved to treat schizophrenia in decades. UPCOMING MILESTONES Under Bristol Myers Squibb, Cobenfy continues to be evaluated across additional indications, including in the Phase 3 ADEPT program for the treatment of psychosis associated with Alzheimer’s disease. For additional details and updates, please refer to Bristol Myers Squibb’s disclosures. Financial Highlights PureTech level cash, cash equivalents and short-term investments were $277.1 million, 1 based on consolidated cash, cash equivalents and short-term investments of $277.3 million as of December 31, 2025. PureTech level cash and cash equivalents were $248.1 million, based on consolidated cash and cash equivalents of $248.2 million, 2 as of March 31, 2026. PureTech has operational runway at least through the end of 2028. PureTech Health will release its Annual Report for the year ended December 31, 2025, today. In compliance with the Financial Conduct Authority’s UK Listing Rule 6.4.3, the following documents will be submitted to the National Storage Mechanism today and be available for inspection at . Annual Report and Accounts for the year ended December 31, 2025; and Notice of 2026 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 . PureTech’s 2026 AGM will be held on June 10, 2026, at 11:00am EDT / 4:00pm BST at the Company's Corporate Headquarters at 6 Tide Street, Suite 400, Boston, Massachusetts, 02210, 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 8, 2026. 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 for the most up-to-date information. About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and 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, 2025, 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. 1 PureTech level cash, cash equivalents and short-term investments excludes cash and cash equivalents at non-wholly owned subsidiary of $0.2m. PureTech level cash, cash equivalents and short-term investments is a non-IFRS measure. For more information in relation to the PureTech level cash, cash equivalents and short-term investments and Consolidated cash, cash equivalents and short-term investments measures, please see below under the heading "Financial Review." 2 PureTech level cash and cash equivalents as of March 31, 2026, is an unaudited figure and excludes cash and cash equivalents at non-wholly owned subsidiary of $0.1m. PureTech level cash and cash equivalents is a non-IFRS measure. 3 Relevant ownership interests were calculated on a partially diluted basis (as opposed to a voting basis) as of December 31, 2025, including outstanding shares and stock options, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. PureTech controls Celea Therapeutics and Gallop Oncology, Inc. 4 Certain third-party trademarks are included here; PureTech does not claim any rights to any third-party trademarks. COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. For Important Safety Information, see U.S. Full Prescribing Information, including Patient Information on COBENFY.com. Following the acquisition of Karuna, KarXT is now under the stewardship of Bristol Myers Squibb and will be marketed as Cobenfy. Letter from the Chair Strengthening Our Foundation for Sustainable Value Creation With a refreshed strategic focus, we have sharpened our hub-and-spoke model to more effectively advance differentiated programs through our Founded Entities, while cultivating the next wave of innovation with increased discipline. 2025 marked a defining year for PureTech, as we sharpened our strategic focus, strengthened our leadership, and positioned the Company for a new phase of disciplined value creation. Building on more than two decades of translating breakthrough science into value, we have taken important steps to align our model, portfolio, and governance with the opportunities ahead. At the core of this progress is a renewed clarity around our differentiated hub-and-spoke model. By advancing programs through our Founded Entities, we are enhancing capital efficiency, reducing risk concentration, and accelerating paths to value realization. This approach reflects a more disciplined approach to portfolio management while preserving the scientific ambition that has long defined PureTech. A key milestone in the year was the appointment of Robert Lyne as Chief Executive Officer in December 2025, following his tenure as Interim CEO. After a thorough and deliberate process, the Board unanimously concluded that Rob is the right leader to guide PureTech through this next phase. His deep understanding of our model, combined with a strong track record of aligning scientific innovation with disciplined execution, positions the Company to deliver on its strategic priorities with clarity and focus. Under Rob’s leadership, we are sharpening operational execution across the portfolio while maintaining our capital-efficient approach. During the year, we continued to advance key programs and support our Founded Entities in attracting external capital, reinforcing the strength and scalability of our model. These efforts underscore our ability to translate scientific insight into meaningful progress for patients while creating long-term value for shareholders. Contacts 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 Read full story here