QIAGEN Sets 2026 Priorities to Drive Growth Across Five Pillars Toward Achieving 2028 Goals for Solid Profitable Growth




QIAGEN Sets 2026 Priorities to Drive Growth Across Five Pillars Toward Achieving 2028 Goals for Solid Profitable Growth

Building on strong momentum in 2025, new product launches and regulatory milestones planned for 2026 to support goal of at least $2 billion in combined annual pillar sales in 2028

VENLO, Netherlands–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its 2026 priorities across its five growth pillars focused on advancing product commercialization, regulatory milestones and automation system innovations to support its goal for $2 billion of combined annual pillar sales in 2028.

Following strong operational execution in 2025, QIAGEN enters 2026 with plans for new product launches and submissions among its pillars designed to expand addressable markets, increase its installed base of automation systems and strengthen recurring consumables and software revenues across the continuum from life sciences to diagnostics customers.

The five pillars – Sample technologies, QIAstat-Dx syndromic testing, QIAcuity digital PCR, QIAGEN Digital Insights (QDI) bioinformatics and QuantiFERON for latent tuberculosis testing – represent areas where QIAGEN has established leadership and scaling differentiated platforms with growth potential.

“We delivered on key targets in 2025 and enter 2026 with strong momentum,” said Thierry Bernard, CEO of QIAGEN. “Our investments we are making in automation, menu expansion and AI, together with targeted and differentiated acquisitions, are designed to accelerate growth, advancing in high-value areas of life sciences and diagnostics and sharpening our competitive edge as we move toward achieving our 2028 ambitions.”

Sample technologies: Adding Parse single-cell analysis and launching new systems

In December 2025, QIAGEN completed the acquisition of Parse Biosciences, expanding its Sample technologies portfolio into single-cell analysis. Parse’s instrument-free Evercode chemistry is used by more than 3,000 customers and supports large-scale single-cell studies, strengthening QIAGEN’s exposure to a fast-growing research segment.

Parse is expected to contribute approximately $40 million in sales in 2026, with opportunities to scale through QIAGEN’s global commercial infrastructure. Recent launches such as Evercode Whole Blood Fixation, a new kit that enables immediate fixation of whole blood directly at the point of collection, are set to extend Parse’s reach into translational and clinical research workflows.

QIAGEN is also advancing the launches of three new sample preparation systems in 2026 to address demand for automation and throughput in applications, in particular liquid biopsy, minimal residual disease testing and microbiome research. These new systems, which will be exhibited at the SLAS Show in February 2026, are designed to expand the installed base of instruments and drive consumables pull-through over time:

• QIAsymphony Connect: Controlled placements began in late 2025, with IVDR commercialization targeted for mid-2026. This new generation of QIAsymphony enables faster processing, improved connectivity and workflow standardization, especially with up to 50% higher throughput for certain liquid biopsy applications.

• QIAsprint Connect: First purchase orders were received in 2025 ahead of launch in February 2026 of this new system that marks QIAGEN’s entry into high-throughput sample processing. It enables preparation of up to 192 samples per run while reducing plastic consumption.

• QIAmini: On track for launch in Fall 2026, this compact system offers walkaway automation for lower-throughput labs seeking affordable, user-friendly solutions.

QIAstat-Dx: Expanding test menu and building installed base

QIAGEN submitted in December 2025 its first blood culture identification (BCID) panels for regulatory clearance in the U.S. and CE-IVDR registration, extending the QIAstat-Dx menu into bloodstream infections and sepsis-related applications.

At year-end 2025, cumulative QIAstat-Dx placements exceeded 5,200 instruments worldwide, providing a solid foundation for future growth. The BCID submissions build on six U.S.-cleared panels and three CE-IVDR panels already commercialized internationally. In the U.S., gastrointestinal panels have also been submitted for use on QIAstat-Dx Rise, the higher-throughput platform designed for larger laboratories with capacity of up to 160 tests per day.

The development pipeline includes panels for complicated urinary tract infections (cUTI) and pneumonia, as well as additional panels for companion diagnostics developed with pharmaceutical partners.

QIAcuity digital PCR: Scaling pharma adoption and improving workflow automation

QIAGEN plans to expand its QIAcuity digital PCR portfolio in 2026 with the launch of thousands of new gene expression assays, further strengthening adoption in pharmaceutical and biopharma applications.

To support higher-throughput and standardized workflows, QIAGEN and Hamilton® have co-developed an automated nanoplate handling solution on the Microlab® STAR platform, enabling walkaway automation from pipetting through plate sealing prior to QIAcuity loading. This integration supports reproducibility across sites, an important requirement for regulated and GMP-compliant environments.

QIAcuity adoption continues to grow across academia, biopharma and clinical research, with over 3,200 cumulative placements at the end of 2025. New assay offerings, including lentivirus detection and host-cell DNA sizing kits planned for 2026, are designed to expand use in Cell and Gene Therapy manufacturing and quality control.

QDI: Advancing AI-enabled bioinformatics and expanding single-cell applications

QIAGEN Digital Insights (QDI) plans for multiple new product advancements in 2026 as part of its roadmap to introduce at least 14 AI-enabled software solutions by 2028.

Key priorities for 2026 include the rollout of new AI capabilities for pharmaceutical R&D, multilingual automation for clinical reporting and agentic AI decision support for novel target identification. These AI offerings aim to better identify insights from high-quality curated genomics knowledge and accelerate precision in clinical decision-making in areas such as oncology and hereditary disease diagnostics.

QDI is also gaining momentum from the integration and expansion of the Franklin platform, which was acquired with Genoox in 2025. Franklin now combines trusted content from QIAGEN’s clinical interpretation portfolio with intuitive AI-supported workflows to guide genetic analysis and reporting across hereditary and oncology applications.

QDI is also planning to integrate single-cell datasets generated through Parse Biosciences, enabling development of predictive modeling and target discovery tools for pharmaceutical partners in areas including oncology, neurology and immunology.

QuantiFERON: Accelerating workflow automation and AI-related investments

QIAGEN is developing a fifth generation of its QuantiFERON test, with updates planned during 2026 as part of its commitment to leadership in tuberculosis diagnostics. The new version will build on the proven performance of earlier generations while introducing improvements to support laboratories facing increasing testing demands.

In parallel, a new generation of chemistry for partner Diasorin’s LIAISON QuantiFERON-TB Gold Plus II assay is planned for U.S. launch in early 2026, following its introduction in Europe in 2025. The updated assay enables laboratories to test up to 75% more patients per hour and deliver results 25% faster than the previous version on the automated LIAISON platforms. QIAGEN is continuously working on workflow solutions to help customers handle increasing testing demands.

Latent TB infection affects an estimated one in four people globally, with up to 10% at risk of progressing to active disease if left untreated. To support assessment of progression risk, QIAGEN is investigating the use of AI to facilitate clinical decision making to guide preventive treatment and improve patient care. About 60% of the global latent TB testing market still relies on the 120-year-old skin test, offering significant opportunities for ongoing conversion to modern blood-based diagnostics like QuantiFERON.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of December 31, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this presentation may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology such as “believe”, “hope”, “plan”, “intend”, “seek”, “may”, “will”, “could”, “should”, “would”, “expect”, “anticipate”, “estimate”, “continue”, “target” or other similar words. To the extent that any of the statements contained herein relating to QIAGEN’s products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, acquisitions, collaborations, markets, strategy or operating results, including without limitation its expected net sales, net sales of particular products, net sales in particular geographies, adjusted net sales, expansion of adjusted operating income margin, returns to shareholders, progressive dividend payments, product portfolio management, product launches (including anticipated launches of our sequencing solutions, testing platforms, panels and systems), leveraging AI technology, improvements in operating and financial leverage, currency movements against the U.S. dollar, plans for investment in our portfolio and share repurchase commitments, our expectations relating to our adjusted tax rate, debt maturity and repayment, our ability to grow adjusted earnings per share at a greater rate than sales, our ability to improve operating efficiencies and maintain disciplined capital allocation, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with our dependence on the development and success of new products; management of growth and expansion of operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies); variability of operating results; integration of acquired businesses; changes in relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors, including delays or limits in the amount of reimbursement approvals or public health funding); our ability to obtain and maintain product regulatory approvals; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, including inflation and changing interest rates, weather or transportation delays, natural disasters, cyber security breaches, political or public health crises, and the resulting impact on the demand for our products and other aspects of our business, or other force majeure events; litigation risk, including patent litigation and product liability; debt service obligations; volatility in the public trading price of our common shares; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” in our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Corporate

Contacts

Public Relations
e-mail: pr@QIAGEN.com

Investor Relations
e-mail: ir@QIAGEN.com

Oxford Nanopore Receives Regulatory Approval for its First Diagnostic Device in the UK and Europe




Oxford Nanopore Receives Regulatory Approval for its First Diagnostic Device in the UK and Europe

Oxford Nanopore has reached a major regulatory milestone with the registration of its first In Vitro Diagnostic (“IVD”) device in the UK and Europe: the GridION™ Dx.

OXFORD, England–(BUSINESS WIRE)–#Nanopore–Oxford Nanopore Technologies today announces that the GridION™ Dx is now both CE and UKCA marked, making it the company’s first IVD device registered in the UK and Europe. The CE and UKCA certification confirms that GridION™ Dx meets stringent international standards for quality, safety, and performance, positioning Oxford Nanopore for future adoption in regulated clinical markets and reflecting its long-term commitment to sequencing-based diagnostics.

“Being CE and UKCA marked for GridION™ Dx is an important step as we build the foundations for clinical use in regulated markets,” said Gordon Sanghera, CEO Oxford Nanopore Technologies. “This milestone demonstrates regulatory readiness and supports the deployment of GridION™ Dx as a diagnostic product for use in clinical environments within the UK and Europe.”

GridION Dx will initially be available through specified partnerships, with the first application being infectious disease characterisation. The Oxford Nanopore platform delivers information-rich insights and rapid time to results, in a way that is accessible and affordable – critical factors for shaping future clinical workflows and enabling expansion into areas such as oncology and genetic conditions.

The first product, available in partnership with bioMérieux, will integrate with AmPORE-TB, a multidrug-resistant tuberculosis assay, and underscores this strategic approach. bioMérieux is a world leader in the field of in vitro diagnostics recognised for its extensive portfolio of CE-marked solutions spanning microbiology, immunoassays, and molecular biology. AmPORE-TB has been introduced as a research use only (“RUO”) application and, already in clinical trials, is on a defined pathway towards a fully regulated IVD assay on GridION Dx. This underlines both companies’ commitment to bringing sequencing-based tuberculosis testing to clinical settings over time.

Dr Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux stated: “The regulatory approval of GridION™ Dx represents a major milestone in expanding access to innovative sequencing-based solutions like AmPORE-TB. This achievement brings us closer to equipping healthcare professionals with advanced tools to combat antimicrobial resistance, enabling faster, more informed decisions and improving patient outcomes worldwide.”

About Oxford Nanopore Technologies

Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used in more than 125 countries to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments.

Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes. For more, visit: https://nanoporetech.com/

Contacts

Contact Oxford Nanopore Technologies
Media@nanoporetech.com

ChemWerth Appoints New General Sales Manager To Increase Its Generic API Footprint in India




ChemWerth Appoints New General Sales Manager To Increase Its Generic API Footprint in India

WOODBRIDGE, Conn.–(BUSINESS WIRE)–ChemWerth, Inc., a global leader in generic active pharmaceutical ingredient (API) development and supply, continues to expand its footprint and strengthen its position in the Indian market. To support its growth in the region, ChemWerth has hired Chandrakanth Reddy as general sales manager of its India office.

“The addition of a general sales manager in India signals our desire to grow our presence and customer base in the world’s most important generic pharmaceutical market,” said Pete Werth III, president, ChemWerth. “Chandrakanth will add tremendous value for our customers and contract manufacturing organizations (CMOs) in India.”

Reddy is a seasoned pharmaceutical professional with more than 16 years of experience spanning API sourcing, business development, market expansion and regulatory-driven commercial strategy. He has successfully led high-value markets across India, the Middle East, North Africa, Europe, and the United States, building strong customer partnerships and supporting sustainable revenue growth.

In his new role, Reddy will be responsible for leading ChemWerth’s sales strategy in India and strengthening regional customer relationships. He will also support the company’s focused initiative to roll out new generic APIs in the market, including fermentation, peptide and oncology injectable APIs.

“After reviewing ChemWerth’s strategic plan to unveil a strong pipeline of new generic fermentation, peptide and oncology injectable APIs for the Indian market, I knew that was something I wanted to be a part of,” said Reddy.

About ChemWerth, Inc.:

Established in 1982, ChemWerth is a full-service generic active pharmaceutical ingredient (API) development and supply company providing cGMP-quality APIs to regulated markets worldwide. ChemWerth is a global company headquartered in the United States, with offices in China and India. For more information, please visit www.chemwerth.com.

Contacts

Patrick Lajoie

Patrick.Lajoie@chemwerth.com

Enginzyme and AGC Create Scalable Process for Key mRNA Ingredient




Enginzyme and AGC Create Scalable Process for Key mRNA Ingredient

STOCKHOLM–(BUSINESS WIRE)–At the mRNA Health conference in Berlin, enginzyme and AGC Inc. presented a scalable process to produce a key mRNA vaccine and therapy ingredient, N1-methylpseudouridine-5′-triphosphate (m¹ΨTP).

The rapid growth of mRNA-based vaccines and therapeutics has driven significant demand for modified nucleotides like m¹ΨTP, which enhances mRNA stability and expression, while reducing immunogenicity.

Enginzyme is a deep-tech company delivering optimized biomanufacturing solutions through cell-free enzyme engineering technology. AGC Inc. is a leading global player in fields spanning from architectural glass to chemicals and life science. AGC Inc. provides services in a wide range of life science fields, from synthetic pharmaceuticals and agrochemicals, to biopharmaceuticals and leading-edge cell and gene therapies, as well as messenger RNAs. The presentation in November detailed the latest collaboration between the companies, with a focus on the biomanufacturing of nucleotides for mRNA therapy, building on enginzyme’s proprietary pseudouridine synthesis process.

The new process is innovative, combining selective chemical methylation with a multi-enzyme phosphorylation cascade. Uridine, a readily available ingredient, is the starting material. Manufacturing, which will be carried out in Europe, is designed to be animal-free and conform to cGMP standards

“This elegant, hybrid approach allows us to leverage the efficiency and precision of our enzymes while remaining flexible and within cost targets,” said Aymeric de Gantes, CEO at enginzyme.

The companies plan a comprehensive analytical characterization to confirm that the m¹ΨTP produced by this new process meets stringent commercial-quality specifications for purity, safety, and functional performance. All critical impurities that could interfere with mRNA function are minimized during synthesis and thoroughly removed during purification.

Initial sample material is available on request; kilogram-scale manufacturing is planned for 2026 to meet future commercial demand.

About AGC

AGC Group is a global company with diverse businesses spanning glass, electronics, chemicals, and life sciences, among others. Its Life Science business provides CDMO services across Japan, the U.S., and Europe, covering small-molecule pharmaceuticals, agrochemicals, biopharmaceuticals, and advanced gene and cell therapies.

About enginzyme

Enginzyme is enabling the shift to biomanufacturing by unlocking the power of enzymes for more cost-efficient and sustainable production of everyday products. The company’s patented enzyme immobilization technology enables biomanufacturing without living organisms. It can be deployed using the same tools and techniques used in traditional chemical manufacturing, with lower costs and a much smaller environmental footprint. Enginzyme has a multidisciplinary team of experts in biocatalysis, organic chemistry, enzyme and process engineering, as well as AI and machine learning. This elite team partners with global manufacturers in industries including personal care, food, and pharma, to develop and scale complete processes, incorporating a high degree of automation for safe, rapid, and reliable development. With a focus on reaching break-even by the first half of 2027, the company reshaped its management team in 2025, bringing on a commercially experienced CEO and a CCO. Enginzyme also launched its first turnkey biocatalyst to spark near-term commercial growth.

Contacts

Press Contact – enginzyme
James Connell

Business inquiries and sample requests:

business@enginzyme.com

Natera Announces Strong Preliminary Fourth Quarter and 2025 Financial Results Driven by Record Signatera™ Growth




Natera Announces Strong Preliminary Fourth Quarter and 2025 Financial Results Driven by Record Signatera™ Growth

2025 revenues are expected to increase by approximately 35% compared to 2024, which is approximately $40 million above the top end of Natera’s financial outlook

Additional business updates will be presented at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today released preliminary unaudited results for the fourth quarter and full year ended December 31, 2025. The Company expects the following:

• Total revenues of approximately $660 million in the fourth quarter of 2025 compared to $476 million in the fourth quarter of 2024, an increase of approximately 39%. Total revenues, excluding revenue true-ups, were greater than $600 million.
• Total revenues of approximately $2.3 billion in the full year 2025 compared to $1.7 billion in the full year 2024, an increase of approximately 35%.
• Approximately 923,600 tests were processed in the fourth quarter of 2025 compared to 792,800 tests in the fourth quarter of 2024, an increase of 17%.
• Approximately 3,525,500 tests were processed in the full year 2025 compared to 3,064,600 tests in the full year 2024, an increase of approximately 15%.
• Approximately 233,300 oncology tests, including approximately 225,300 clinical molecular residual disease (MRD) tests, were processed in the fourth quarter of 2025 compared to 150,800 oncology tests, including 144,500 clinical MRD tests, in the fourth quarter of 2024, an increase of 55%.
• Clinical MRD tests increased by approximately 22,800 tests in the fourth quarter of 2025 over the third quarter of 2025, representing a record sequential growth quarter. This tops the previous record set in the third quarter of 2025, despite fewer days to receive samples in the fourth quarter.
• Approximately 800,800 oncology tests, including approximately 769,700 clinical MRD tests, were processed in the full year 2025 compared to 528,200 oncology tests, including 498,300 clinical MRD tests, in the full year 2024, an increase of 52%.
• The Company achieved cash inflows of approximately $30 million¹ in the fourth quarter of 2025 compared to approximately $46 million² in the fourth quarter of 2024.
• The Company achieved cash inflows of greater than $100 million¹ in the full year 2025.

“2025 was a record year for oncology, organ health and women’s health,” said Steve Chapman, CEO of Natera. “The fourth quarter was particularly strong, with excellent growth in volume, revenue and gross margins. We believe we are well positioned to continue building on this momentum in 2026 and beyond.”

These results will be included in a presentation at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 4:30 pm PT, and also posted to the investor relations section of the Natera website at www.investor.natera.com. Natera will also present additional business updates at the J.P. Morgan conference.

Natera plans to release its complete fourth quarter and full year 2025 financial results during its earnings call in February 2026.

References

1. Non-GAAP cash inflow / outflow for the quarter and year ended December 31, 2025 is estimated based on estimated unaudited GAAP Statement of Cash Flows amounts including net cash from operating activities, net cash from investing activities excluding amounts related to short-term investments, and net cash from financing activities.
2. Non-GAAP cash inflow / outflow are calculated based on GAAP Statement of Cash Flows amounts including net cash from operating activities, net cash from investing activities excluding amounts related to short-term investments, and net cash from financing activities excluding proceeds from public offerings. Please refer to our website at www.investor.natera.com/financials for a reconciliation of non-GAAP cash inflow / outflow to the most directly comparable GAAP financial measure. Management uses non-GAAP cash flow as an indicator of the Company’s operational cash generating capabilities.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

This release contains forward-looking statements, including our preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2025. The preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2025 have not been audited by our independent registered public accounting firm and are based on management’s initial review of our operations and results for the completed fiscal year. These preliminary operational and financial results are subject to revision based upon our year-end closing procedures, final adjustments and the audit to be conducted by our independent registered public accounting firm. As a result, our actual operational and financial results may differ materially from these preliminary results. In addition, these preliminary operational and financial results are not a comprehensive statement of our operational and financial results for the fourth quarter and for fiscal 2025, and should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles. Any forward-looking statements contained in this release are based upon Natera’s current plans, estimates, and expectations as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.

Our forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: our preliminary operational and financial results for the fourth quarter and for fiscal 2025 are subject to material changes and adjustments as noted above; we face numerous uncertainties and challenges in achieving our financial projections and goals; we have incurred net losses since our inception and we anticipate that we will continue to incur net losses for the foreseeable future; our quarterly results may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate. Additional risks and uncertainties that could affect our financial results are discussed in greater detail in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available at www.investor.natera.com and on the SEC’s website at www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Tempus Achieves Record Total Contract Value Exceeding $1.1 Billion




Tempus Achieves Record Total Contract Value Exceeding $1.1 Billion

Reported preliminary, unaudited Data and application revenue of ~$316 million for the full year 2025, representing ~31% year-over-year growth, with Insights (data licensing) growing 38%

2025 Net revenue retention of ~126%

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced a record Total Contract Value (TCV) of >$1.1 billion as of December 31, 2025. During 2025, Tempus signed data agreements with over 70 customers, spanning both large and mid-sized pharma, including AstraZeneca, GlaxoSmithKline, Bristol Myers Squibb, Pfizer, Novartis, Merck, Abbvie, Daiichi Sankyo, Eli Lilly, Boehringer Ingelheim, and biotechs including Incyte, Servier, Aspera Biomedicines, and Whitehawk Therapeutics, as an increasing number of biopharma companies are incorporating Tempus’ unique, multimodal dataset into their drug discovery and development efforts.

In addition to TCV rising to the highest level in Tempus’s history, the company reported net revenue retention of ~126% in 2025, demonstrating the continued expansion of relationships with existing customers, even at increased scale.

“2025 was a record year for our Data and applications business – both from a revenue and TCV perspective,” said Jim Rogers, Chief Financial Officer at Tempus. “Our engagement with life sciences companies has never been stronger, and our data business has never been better positioned, giving us tremendous visibility to continued growth in 2026 and beyond.”

Tempus has not completed preparation of its financial statements for the fourth quarter or full year 2025. The Data and applications revenue estimate disclosed in this release for the year ended December 31, 2025 is preliminary and unaudited and inherently uncertain, and therefore subject to change as Tempus completes preparation of its financial results for these periods. Tempus is in the process of completing its customary year-end close and review procedures for the quarter and year ended December 31, 2025, and there can be no assurance that final result will not differ from this estimate, and any such difference may be material. During the preparation of Tempus’ consolidated financial statements for the year ended December 31, 2025, Tempus or its independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimate presented herein.

Tempus plans to report its complete fourth quarter and full year 2025 financial results during its earnings call in February 2026.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding Tempus’ preliminary unaudited financial results for the fourth quarter and full year 2025 and Tempus’ expected financial results for the full year 2026, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; completed and future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”), as supplemented by Tempus’ Quarterly Report on Form 10-Q for the period ended September 30, 2025, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Key Metrics

Total Remaining Contract Value (TCV) is equal to the total potential value of signed contracts and assumes the exercise of all contract options, all discretionary opt-ins, and no early termination. Remaining TCV excludes any revenue recognized to date on these contracts or any future adjustments made to the contractual value as a result of amendments or terminations.

Net Revenue Retention compares the annual Insights product revenue generated from all customers that made an Insights purchase in one year to the annual Insights product revenue generated from the same cohort of customers in the subsequent year.

Contacts

Erin Carron

media@tempus.com

Alnylam Launches “Alnylam 2030” Strategy to Drive Next Era of Growth and Patient Impact




Alnylam Launches “Alnylam 2030” Strategy to Drive Next Era of Growth and Patient Impact

− Full Year 2025 Preliminary* Net Product Revenues of $2,987 Million (81% Growth vs. 2024), Driven Primarily by Preliminary* Total TTR Revenues of $2,487 Million (103% Growth vs. 2024) –

− Company Provides 2026 Combined Net Product Revenue Guidance of $4,900 Million to $5,300 Million, Driven Primarily by Total TTR Net Product Revenue Guidance of $4,400 Million to $4,700 Million –

– 2026 Pipeline Goals Focused on Continued Advancement of Numerous Multi-Billion-Dollar Opportunities –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its new five-year strategy, “Alnylam 2030,” focused on scaling the Company’s operations through achieving leadership in ATTR amyloidosis, driving long-term growth through sustainable innovation, and delivering exceptional financial results with discipline and agility. Alnylam also today reported preliminary* fourth quarter and full year 2025 global net product revenues for AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO.

New Five-Year Strategy: Alnylam 2030

Alnylam 2030 continues the Company’s 15-year heritage of establishing and delivering on ambitious five-year goals, the most recent of which was Alnylam P⁵x25. Over that time period, Alnylam has either met or exceeded all of its prior five-year goals.

Alnylam 2030 is focused on continuing to successfully scale the Company’s operations. Specifically, the Company intends to achieve the following by the end of 2030:

• Achieve Global TTR Leadership: Build a Durable TTR Franchise
  • Lead TTR market in revenue by 2030 and cumulatively across five-year period
  • Launch best-in-class, next-gen silencer, nucresiran, in polyneuropathy by 2028 and cardiomyopathy by 2030

• Grow Through Sustainable Innovation: Deliver Therapies that Prevent, Halt, or Reverse Disease
  • Deliver 2+ new transformative medicines beyond TTR with blockbuster potential
  • Expand to 10 tissue types and >40 clinical programs
  • Invest ~30% of revenues in non-GAAP R&D, including select external innovation

• Scale with Discipline & Agility: Drive Sustained, Profitable Growth
  • Achieve 25%+ total revenue CAGR through year-end 2030
  • Deliver ~30% non-GAAP operating margin

“The past five years have been transformational, as we delivered on our ambitious goals to expand the reach of our commercial product portfolio, grow our pipeline of transformative RNAi therapeutics, and achieve strong financial results leading to sustainable profitability,” said Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam. “The success we have delivered with the early launch momentum of AMVUTTRA in ATTR-CM has laid the foundation for our first flagship commercial franchise. Our focus for the next five-year period is clear: continue to establish durable leadership in TTR; harness topline growth to invest in a high-yielding pipeline with blockbuster opportunities; and continue to operate with financial discipline and agility to enable the Company to scale efficiently. As the pioneer in RNAi therapeutics that has delivered six approved products, Alnylam 2030 provides the strategic direction to catalyze our growth during the next stage of our evolution.”

Preliminary Fourth Quarter and Full Year 2025 Commercial and Financial Performance*

Total TTR: AMVUTTRA^® (vutrisiran) & ONPATTRO^® (patisiran)

• Preliminary* global net product revenues for AMVUTTRA and ONPATTRO for the fourth quarter were approximately $827 million and $32 million, respectively, together representing 151% total TTR growth compared to Q4 2024, and for the full year 2025 were approximately $2,314 million and $173 million, respectively, together representing 103% total TTR growth compared to full year 2024.

Total Rare: GIVLAARI^® (givosiran) & OXLUMO^® (lumasiran)

• Preliminary* global net product revenues for GIVLAARI and OXLUMO for the fourth quarter were approximately $87 million and $50 million, respectively, together representing 26% total Rare growth compared to Q4 2024, and for the full year 2025 were approximately $308 million and $191 million, respectively, together representing 18% total Rare growth compared to full year 2024.

2026 Combined Net Product Revenue Guidance

Alnylam announced today full year 2026 combined net product revenue guidance for AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO of $4,900 million to $5,300 million, representing 71% growth compared to 2025* at the mid-point of the guidance range. On a franchise level, the guidance is as follows:

• Total TTR (AMVUTTRA & ONPATTRO): $4,400 million to $4,700 million, representing 83% growth compared to 2025* at the mid-point of the guidance range.
• Total Rare (GIVLAARI & OXLUMO): $500 million to $600 million, representing 10% growth compared to 2025* at the mid-point of the guidance range.

The Company plans to provide additional guidance for collaboration and royalty revenue and operating expenses when fourth quarter and full year 2025 earnings are released.

2026 Pipeline Goals

Nucresiran – an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. Alnylam expects to:

• Advance the TRITON-CM Phase 3 trial in ATTR-CM and the TRITON-PN Phase 3 trial in hATTR-PN.

Zilebesiran – an investigational RNAi therapeutic in development for the treatment of hypertension, in collaboration with Roche. Alnylam expects to:

• Advance the ZENITH Phase 3 cardiovascular outcomes trial.

Mivelsiran – an investigational RNAi therapeutic in development for the treatment of cerebral amyloid angiopathy (CAA) and Alzheimer’s disease. Alnylam expects to:

• Complete enrollment of the cAPPricorn-1 Phase 2 trial in cerebral amyloid angiopathy in H1.
• Initiate a Phase 2 trial in Alzheimer’s disease in H1.

ALN-6400 – an investigational RNAi therapeutic in development for the treatment of bleeding disorders. Alnylam expects to:

• Report Phase 1 data in healthy volunteers in H2.
• Report clinical proof of concept in hereditary hemorrhagic telangiectasia in H2.
• Initiate a Phase 2 trial in a second bleeding disorder in H1.

ALN-4324 – an investigational RNAi therapeutic in development for the treatment of type 2 diabetes mellitus. Alnylam expects to:

• Initiate a Phase 2 trial in H1.

ALN-HTT02 – an investigational RNAi therapeutic in development for the treatment of Huntington’s disease, in collaboration with Regeneron. Alnylam expects to:

• Report Phase 1 data in H2.

ALN-2232 – an investigational RNAi therapeutic in development for the treatment of obesity & weight management. Alnylam expects to:

• Report Phase 1 data in H2.

In addition, the Company plans to file Investigational New Drug (IND) applications for three to four new Alnylam-led programs by the end of 2026.

Alnylam management will discuss its preliminary 2025 net product revenues, as well as 2026 goals and guidance during a webcast presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco, California tomorrow, Monday, January 12, 2026 at 9:00 am PT (12:00 pm ET).

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is a leading global biopharmaceutical company and the pioneer of the RNA interference (RNAi) revolution. The Company is focused on developing transformative therapies with the potential to prevent, halt, or reverse disease. For more than two decades, Alnylam has advanced the Nobel-Prize-winning science of RNAi, delivering critical breakthroughs and six approved medicines. Alnylam has medicines available in more than 70 countries and a rapidly expanding and robust pipeline, in addition to consistently being recognized as an exceptional workplace and socially responsible organization. The Company is executing on its Alnylam 2030 strategy to accelerate innovation and scale impact to transform human health. For more information, please visit www.alnylam.com or follow Alnylam on X, LinkedIn, Facebook, Instagram, or YouTube.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, statements regarding: Alnylam’s potential achievement of the goals in its “Alnylam 2030” strategy and its ability to drive the next era of growth and patient impact; Alnylam’s ability to achieve global TTR leadership, drive long-term growth through sustainable innovation, and deliver exceptional financial results with discipline and agility; the size of the opportunities of any of the product candidates in Alnylam’s pipeline; the potential for AMVUTTRA in ATTR-CM to be Alnylam’s flagship commercial franchise; the potential for Alnylam to advance its research and development programs, including its goals and expectations regarding the clinical development of nucresiran, zilebesiran, mivelsiran, ALN-6400, ALN-4324, ALN-HTT02, and ALN-2232, including the timeline of the initiation, completion of enrollment, and reporting of data and/or proof of concept from, any clinical trials; the number of IND applications Alnylam plans to file for Alnylam-led programs by the end of 2026; and Alnylam’s projected commercial and financial performance, including the expected range of global net product revenues for 2026 should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to Alnylam’s ability to successfully execute on its “Alnylam 2030” strategy; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates, including nucresiran, zilebesiran, mivelsiran, ALN-6400, ALN-4324, ALN-HTT02, and ALN-2232; the possibility of unfavorable new clinical data and further analyses of existing clinical data; interim and preliminary data; the possibility that clinical data are subject to differing interpretations and assessments by regulatory agencies; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally; delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products; the outcome of litigation; the potential risk of future government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing Alnylam’s views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Use of Non-GAAP Financial Measures

This press release contains references to forward-looking financial measures of non-GAAP R&D and non-GAAP operating margin that were not prepared in accordance with U.S. generally accepted accounting principles (GAAP). We do not provide a reconciliation of these forward-looking non-GAAP financial measures to the most directly comparable financial measures calculated and presented in accordance with GAAP on a forward-looking basis because such reconciliation is not accessible with reasonable effort, due to the uncertainty and inherent difficulty of predicting the occurrence and the financial impact of adjustments, such as stock-based compensation expense; such adjustments could be material. We use these non-GAAP measures as an indicator of financial performance for the purpose of internal evaluation of progress toward financial objectives. We also believe that these non-GAAP measures provide investors with useful information with respect to our operational goals. A non-GAAP financial measure is not, and should not be viewed as, a substitute for financial measures required by GAAP, has no standardized meaning prescribed by GAAP, and may not be comparable to the calculation of the measure by other companies.

* The preliminary selected financial results are unaudited, subject to adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results in February 2026.

Contacts

Alnylam Pharmaceuticals, Inc.

Christine Akinc

(Investors and Media)

+1-617-682-4340

Josh Brodsky

(Investors)

+1-617-551-8276

Guardant Health Announces Preliminary Fourth Quarter and Full Year 2025 Results




Guardant Health Announces Preliminary Fourth Quarter and Full Year 2025 Results

Fourth quarter revenue growth of 39% driven by strong Oncology and Screening volume

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2025.

Fourth quarter 2025 preliminary unaudited financial results

For the three-month period ended December 31, 2025, as compared to the same period of 2024:

• Total revenue of approximately $280 million, an increase of 39%
• Reported approximately 79,000 oncology tests, an increase of 38%
• Reported approximately 38,000 Shield screening tests, compared to 6,400 tests in the prior year period

Full year 2025 preliminary unaudited financial results

For the twelve-month period ended December 31, 2025, as compared to the same period of 2024:

• Total revenue of approximately $981 million, an increase of 33%
• Reported approximately 276,000 oncology tests, an increase of 34%
• Reported approximately 87,000 Shield screening tests

“2025 was a breakout year for Guardant, with total revenue growth accelerating to 33% year-over-year,” said Helmy Eltoukhy, co-founder and co-CEO. “We saw exceptional volume growth in Oncology over the last year, primarily driven by pioneering innovation from our Smart Platform and best-in-class commercial execution. We expect this momentum to continue throughout the year with the launch of multiple groundbreaking products that will fuel the next phase of growth in our Oncology business.”

“We are incredibly proud of Shield’s strong momentum as we continue to strengthen our leadership in the blood-based colorectal cancer screening market, with Shield positioned as one of the most successful diagnostic launches to date,” said AmirAli Talasaz, co-founder and co-CEO. “Since FDA approval, nearly 100,000 patients have been screened with Shield. We have now expanded Shield to include multi-cancer detection findings, further enhancing the clinical value of the platform for both patients and physicians. Together, these milestones will further advance the fight against cancer in 2026 and beyond.”

Preliminary unaudited free cash flow was approximately negative $54 million for the fourth quarter of 2025, and approximately negative $233 million for the full year 2025. Cash, cash equivalents, restricted cash, and marketable debt securities were approximately $1.3 billion as of December 31, 2025.

Guardant Health has not completed preparation of its financial statements for the fourth quarter or full year of 2025. The revenue, test volumes and free cash flow presented in this release for the fourth quarter and the year ended December 31, 2025, are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results. The company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2025, and there can be no assurance that final results for this period will not differ from these estimates. During the preparation of Guardant Health’s consolidated financial statements and related notes as of and for the year ended December 31, 2025, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Upcoming events

Guardant Health plans to report its fourth quarter and full year audited financial results for the period ended December 31, 2025, during its February 2026 earnings call.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Source: Guardant Health, Inc.

Contacts

Investor Contact:
Zarak Khurshid

investors@guardanthealth.com

Media Contact:
Meaghan Smith

press@guardanthealth.com
+1 650-647-3711

Tempus Announces Preliminary Fourth Quarter and Full Year 2025 Results




Tempus Announces Preliminary Fourth Quarter and Full Year 2025 Results

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced select, preliminary, unaudited results for the fourth quarter and full year ended December 31, 2025.

Full Year 2025 Select, Preliminary, Unaudited Financial Results

• Revenue of ~$1.27 billion, representing ~83% growth year-over-year, including ~30% organic growth (excluding Ambry)
• Diagnostics revenue of ~$955 million, representing ~111% growth year-over-year, driven by Oncology volume growth of ~26% and Hereditary volume growth of ~29%
• Data and applications revenue of ~$316 million, representing ~31% growth year-over-year, driven by ~38% growth in Insights (Data Licensing)

Fourth Quarter 2025 Select, Preliminary, Unaudited Financial Results

• Revenue of approximately ~$367 million, an increase of approximately 83% year-over-year
• Diagnostics revenue of ~$266 million, representing ~121% growth year-over-year, driven by Oncology volume growth of ~29% and Hereditary volume growth of ~23%
• Data and applications revenue of ~$100 million, representing ~25% year-over-year growth, with Insights growing ~68%, excluding the impact of the AstraZeneca warrant in Q4 of 2024.

“2025 was an exceptional year for Tempus with the strength of both of our product lines exceeding our initial expectations for the year,” said Eric Lefkofsky, Founder and CEO of Tempus. “Within Diagnostics, year-over-year volume growth of our genomics (oncology) offering accelerated for the third consecutive quarter hitting the highest unit growth rate we have seen in years. Our Data and Application business is performing even better with record revenue of ~$100 million in the fourth quarter, achieving full-year growth of ~31%, with our data licensing business growing ~38%. We enter 2026 in an exceptionally strong position with both of our main businesses accelerating in growth and delivering the financial leverage inherent in our platform. With AI as a catalyst across all of our products, we couldn’t be more excited for 2026.”

This announcement comes ahead of the Company’s presentation today at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of the presentation and our updated investor deck can be found on Tempus’ investor relations website at investors.tempus.com.

Tempus has not completed preparation of its financial statements for the fourth quarter or full year 2025. The estimates disclosed in this release for the fourth quarter and year ended December 31, 2025, are preliminary, and unaudited and inherently uncertain, and therefore subject to change as Tempus completes preparation of its financial results for these periods. Tempus is in the process of completing its customary year-end close and review procedures for the quarter and year ended December 31, 2025, and there can be no assurance that final results for these periods will not differ from these estimates, and any such difference may be material. During the preparation of Tempus’ consolidated financial statements for the year ended December 31, 2025, Tempus or its independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Tempus plans to report its complete fourth quarter and full year 2025 financial results during its earnings call in February 2026.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding Tempus’ preliminary, unaudited financial results for fourth quarter and full year 2025 and Tempus’ expected financial results for full year 2026. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; completed and future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”), as supplemented by Tempus’ Quarterly Report on Form 10-Q for the period ended September 30, 2025, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Erin Carron

media@tempus.com

Stoke Therapeutics Announces Updates to Timelines for the Completion of Enrollment and a Phase 3 Data Readout from the EMPEROR Study of Zorevunersen for the Treatment of Dravet Syndrome




Stoke Therapeutics Announces Updates to Timelines for the Completion of Enrollment and a Phase 3 Data Readout from the EMPEROR Study of Zorevunersen for the Treatment of Dravet Syndrome

— Company now expects to complete enrollment of 150 patients in Q2 2026, with a Phase 3 data readout in mid-2027; Rolling NDA submission planned to initiate in first half 2027—

— Discussions with FDA ongoing following recent multidisciplinary meeting; Company continues to explore potential for expedited development, registration and delivery of zorevunersen to patients —

— Company to present at 44^th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 —

BEDFORD, Mass.–(BUSINESS WIRE)–Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development with Biogen (Nasdaq: BIIB) as a first-in-class potential disease-modifying treatment for Dravet syndrome. Today, the Company announced accelerated timelines for the completion of enrollment and a Phase 3 data readout from the EMPEROR study. Completion of enrollment of 150 patients is now expected in the second quarter of 2026. This enrollment progress puts the Phase 3 EMPEROR study on track for a data readout in mid-2027 that is anticipated to support the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The Company plans to initiate a rolling NDA submission in the first half of 2027.

In addition, as part of zorevunersen’s Breakthrough Therapy Designation, a multidisciplinary meeting was held with the FDA to discuss the ongoing clinical development of zorevunersen, including the exploration of potential expedited regulatory pathways. No immediate changes to the zorevunersen development program were agreed to at the meeting. The FDA has requested additional information, and discussions between the Company and the Agency are ongoing regarding potential opportunities to expedite the development, registration and delivery of zorevunersen to patients.

“The rate of enrollment in the Phase 3 EMPEROR study is highly encouraging and supports the significant need for a disease-modifying treatment for Dravet syndrome. The accelerated timing for completion of enrollment of 150 patients, in addition to Breakthrough Therapy Designation, positions us to initiate a rolling NDA submission in the first half of 2027 resulting in the potential to deliver zorevunersen to patients sooner than originally expected,” said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. “Our recent multidisciplinary meeting was productive and we appreciate the FDA’s interest in deepening their understanding of Dravet syndrome and its impacts on patients and their families while also taking time to review and discuss our four years of clinical data. Subsequently, we have responded to the Agency’s request for additional information and we look forward to continuing to engage with them as part of our commitment to explore every opportunity to deliver zorevunersen to patients as quickly as possible.”

As of January 9, 2026, nearly 330 patients globally had been identified by investigators as potential study candidates. Of these, approximately 60 patients are currently in the formal 8-week screening period that immediately precedes randomization and an additional approximately 60 patients have advanced to randomization and dosing.

Financial Guidance

The Company has approximately $391.7 million in cash, cash equivalents and marketable securities as of December 31, 2025. These funds, combined with eligible proceeds from the Biogen collaboration, are anticipated to fund operations into 2028.

J.P. Morgan Healthcare Conference Webcast Information

Chief Executive Officer Ian F. Smith will present at the 44^th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 7:30 p.m. Eastern Time (4:30 p.m. Pacific Time) in San Francisco, CA. A live audio webcast of the presentation will be available on the Investors & News section of Stoke’s website at https://investor.stoketherapeutics.com/ and can be accessed by following this Link. A replay of the webcast will be available for 30 days following the presentation.

About Dravet Syndrome

Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve ≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections¹. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan.² There are no approved disease-modifying therapies for people living with Dravet syndrome.

About Zorevunersen

Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the non-mutated (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights.

About the EMPEROR Study

The EMPEROR Phase 3 Study (NCT06872125) is a global, double-blind, sham-controlled study evaluating the efficacy, safety and tolerability of zorevunersen in children ages 2 to <18 with Dravet syndrome with a confirmed variant in the SCN1A gene not associated with gain-of-function. The trial is currently enrolling approximately 150 patients in the United States, United Kingdom and Japan which are anticipated to support an NDA. At least 20 additional patients are expected to enroll in Germany, Spain, France and Italy starting in the second quarter of 2026. Participants are randomized 1:1 to receive either zorevunersen via intrathecal administration or a sham comparator for a 52-week treatment period following an 8-week baseline period. Following the completion of the study treatment period, eligible participants will be offered ongoing treatment with zorevunersen as part of an OLE study. The primary endpoint of the study is percent change from baseline in major motor seizure frequency at week 28 in patients receiving zorevunersen as compared to sham. The key secondary endpoints are the durability of effect on major motor seizure frequency and improvements in behavior and cognition as measured by Vineland-3 subdomains, including expressive communication, receptive communication, interpersonal relationships, coping skills and personal skills. Additional endpoints include safety, Clinician Global Impression of Change (CGI-C), Caregiver Global Impression of Change (CaGI-C) and the Bayley Scales of Infant Development (BSID-IV). For more information, visit https://www.emperorstudy.com/.

About Stoke Therapeutics

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/.

Stoke Therapeutics Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the potential benefits, safety and efficacy of zorevunersen; the timing and expected progress of clinical trials, data readouts, regulatory meetings, regulatory decisions and other presentations; the characterization of the Company’s meeting and discussions with the FDA; and the ability of the Company to achieve an NDA submission or approval on the expedited timeframe disclosed or at all. Statements including words such as “plan,” “potential,” “will,” “continue,” “expect,” or similar words and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause Stoke’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the Company’s ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if collaborators were to breach or terminate their agreements, the Company would not obtain the anticipated financial or other benefits; the possibility that the Company and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully commercialize zorevunersen; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; the Company’s ability to protect its intellectual property; the Company’s ability to fund development activities and achieve development goals into 2028; and the other risks and uncertainties described under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2024, its quarterly reports on Form 10-Q, and the other documents it files with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

References:

1. Symonds, J. et al. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic determinants. Brain. 2021;144(9):2879-2891.
2. Based on Stoke Therapeutics’ preliminary estimates, which scaled annual incidence to prevalence using country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by Wu et al., Pediatrics, 2015.

Contacts

Media & Investor Contacts:
Susan Willson

Vice President, Corporate Communications

swillson@stoketherapeutics.com
415-509-8202

Doug Snow

Director, Communications & Investor Relations

IR@stoketherapeutics.com
508-642-6485