Astoriom Appoints Will Edwards as Chief Executive Officer

Astoriom Appoints Will Edwards as Chief Executive Officer




Astoriom Appoints Will Edwards as Chief Executive Officer

Strategic appointment to support global scale-up of sample management operations

ROCHDALE, United Kingdom–(BUSINESS WIRE)–#Astoriom–Astoriom, a global quality expert in safeguarding scientific research and consumer product sample assets, today announced the appointment of Will Edwards, as Chief Executive Officer. Will will continue to build on Astoriom’s strong foundations to support the next phase of growth across its international portfolio of sample stability storage, biorepository services, validation solutions, as well as sample storage design and disaster recovery. His appointment reflects Astoriom’s continued focus on operational excellence, resilience and scaling high-quality, compliant sample management solutions for organizations operating in complex, regulated life science and consumer product environments. He succeeds Lori A. Ball, who has decided to transition into a board seat.


Will brings extensive international leadership experience in the storage, logistics and technology sectors, most recently as CEO of Spectrum Storage Group. With a customer-focused, data-driven approach honed at global companies, including Google and Bain & Co, he has led businesses through periods of rapid growth and operational transformation over the last two decades. Will holds an MBA from INSEAD and an MS from Stanford University.

Will’s appointment comes at a pivotal moment for Astoriom, as demand continues to grow for outsourced, resilient, and compliant sample management and storage solutions to protect high-value research and product samples across pharmaceutical, biotechnology, medical device, and consumer product sectors worldwide. His experience leading complex storage operations and scaling service-led platforms will support Astoriom’s ambition to continue to expand internationally, working with global life science organizations, while maintaining the highest standards of quality, compliance, and customer trust.

Will Edwards, CEO of Astoriom, said:Astoriom has built a strong reputation as a global industry leader for quality, reliability, and technical excellence in a sector where trust and resilience are essential. The business has grown significantly in the last couple of years and is at an exciting stage of development. The team is committed to providing accessible stability storage and biorepository solutions to safeguard the integrity and viability of valuable sample assets; I look forward to working with them to continue to scale capabilities worldwide, while remaining firmly focused on compliance, operational excellence, and long-term customer partnerships.”

For more information about Astoriom and its leadership team, please visit: https://www.astoriom.com/about/

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +447789053885

Email: michelle.ricketts@codoncommunications.com

Nuclera Extends Series C Funding to $87M to Advance Antibody Engineering

Nuclera Extends Series C Funding to $87M to Advance Antibody Engineering




Nuclera Extends Series C Funding to $87M to Advance Antibody Engineering

  • Additional $12M financing led by Elevage Medical Technologies and Jonathan Milner alongside existing investors British Business Bank, and GK Goh
  • The funding will accelerate development of eProtein Discovery for full-format antibody expression, purification, and binding validation

CAMBRIDGE, England and BOSTON–(BUSINESS WIRE)–Nuclera, the biotechnology company accelerating drug discovery by providing rapid, easy access to functional proteins through its benchtop eProtein Discovery™ System, today announced a USD $12 million financing extension, bringing the Company’s total Series C funding to USD $87 million. The raise was led by Elevage Medical Technologies and Jonathan Milner, joined by existing investors British Business Bank and GK Goh. The investment will accelerate the integration of antibody expression and binding validation capabilities into the Company’s eProtein Discovery benchtop system, which enables multiplex protein screening, characterization, and expression in-house.


Expanding eProtein Discovery with antibody-specific capabilities represents a strategic step as Nuclera moves into AI-enabled protein engineering, addressing a critical industry need for scalable, standardized, and high-quality datasets that can be used to power next-generation AI models in biologics discovery. The advancement will enable researchers to perform end-to-end expression, purification, and binding validation of full-format antibodies on an integrated, high-throughput system.

Since the closure of its previous Series C financing1 in 2024, the Company has advanced its eProtein Discovery capabilities with the addition of a membrane protein workflow2, extended its global footprint to broaden customer access across APAC and the Middle East3,4,5, and initiated a collaboration with Cytiva to accelerate the path from DNA to fully purified and characterized proteins to better understand drug-target interactions6. In parallel, the eProtein Discovery system was installed at Domainex7, the first CRO implementation of the system, streamlining protein production services and further validating the system’s commercial and scientific impact.

Dr Michael Chen, CEO and co-founder, Nuclera, said: “This financing underscores our growing momentum and demonstrates that we are expanding eProtein Discovery into one of the fastest-growing segments of biologics R&D. Scientists increasingly require scalable, high-quality datasets to power AI models in biologics discovery. We are positioning Nuclera to become a foundational platform for the future of protein and antibody engineering, ultimately accelerating therapeutic discovery timelines.”

Dr Michael Wasserman, Chief Operating Officer, Elevage Medical Technologies, commented: “Since our initial investment, Nuclera has made meaningful progress in expanding the capabilities, adoption, and global reach of the eProtein Discovery platform. The extension of the system into full-format antibody expression, purification, and binding validation represents a significant step forward, particularly as biologics discovery becomes increasingly driven by AI-enabled workflows that require scalable, high-quality datasets. Elevage is proud to continue supporting Nuclera as it evolves into a foundational platform for protein and antibody engineering, helping researchers accelerate discovery timelines and reduce friction across the drug development process.”

Dr Jonathan Milner, Chairman of the Nuclera Board of Directors, founder and former CEO of Abcam, Inc and CEO of Meltwind Advisory, added: “Nuclera is solving one of the most pressing bottlenecks in biologics discovery – the slow, fragmented, and resource-intensive process of synthesising full-format antibodies. The team’s success in membrane proteins, one of the most challenging protein classes, combined with their microfluidic expertise, places them in a unique position to transform antibody development workflows.”

Combining unique cell-free expression systems, novel digital microfluidics, and robust screening data, eProtein Discovery provides clear guidance on which protein has the best chance of success early on, thereby reducing the time, cost, and uncertainty traditionally associated with protein expression and purification.

Taylor Wessing LLP acted as legal advisor to Nuclera on the financing.

  1. Nuclera closes $75 million USD financing
  2. Nuclera Expands eProtein Discovery™ with New Membrane Protein Workflow
  3. Nuclera Expands Global Footprint with New Distribution Partnerships Across APAC and the Middle East
  4. Nuclera expands access to eProtein Discovery for APAC customers with distributor agreement in Australia and New Zealand
  5. Nuclera eProtein Discovery System installed at leading Universities in Taiwan – Nuclera
  6. Nuclera and Cytiva Join Forces to Accelerate Drug Discovery
  7. Nuclera’s eProtein Discovery system installed at Domainex to streamline protein production services

For more information about Nuclera’s eProtein Discovery system, please visit: https://www.nuclera.com/system/

Contacts

Dr Ben Rutter

Zyme Communications

+44(0)7920 770 935

ben.rutter@zymecommunications.com

ESTEVE to Acquire TerSera Therapeutics’ Infusion Specialty Therapies Business Unit, Expanding U.S. Presence

ESTEVE to Acquire TerSera Therapeutics’ Infusion Specialty Therapies Business Unit, Expanding U.S. Presence




ESTEVE to Acquire TerSera Therapeutics’ Infusion Specialty Therapies Business Unit, Expanding U.S. Presence

BARCELONA & DEERFIELD, Ill.–(BUSINESS WIRE)–ESTEVE and TerSera Therapeutics LLC announced today that they have entered into an agreement in which ESTEVE will acquire TerSera’s Infusion Specialty Therapies Business Unit (IST). This strategic acquisition enables ESTEVE to expand its U.S. presence, with two highly specialized on-market assets and a dedicated team of sales, marketing and medical professionals.




TerSera’s IST business unit includes two specialty medications, Prialt® (ziconotide intrathecal infusion) and Quzyttir® (cetirizine hydrochloride injection). Prialt is the only FDA-approved, non-opioid agent indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.1 Prialt is currently marketed in Europe by ESTEVE.2 Quzyttir is the first and only injectable second-generation H1 antihistamine approved by the FDA for the treatment of acute urticaria in adults and children six months of age and older.3

With this transaction, ESTEVE will obtain worldwide rights for Quzyttir in all territories (except for China) and consolidates its rights for Prialt worldwide.

Staffan Schüberg, ESTEVE’s Chief Executive Officer stated: “We are excited to welcome the Infusion Specialty Therapies Business Unit and look forward to welcoming TerSera’s talented team to ESTEVE. This acquisition perfectly aligns with our strategic vision of providing highly specialized solutions where there is a significant unmet medical need. By adding Quzyttir to our portfolio and expanding to the US market with Prialt, we not only strengthen our expertise in highly specialized therapies but also accelerate our expansion in the United States—the world’s largest pharmaceutical market.”

“ESTEVE has been our long-term partner for Prialt in Europe. Their expertise and core areas of focus make them the ideal future owner for IST,” said Edward Donovan, Chief Executive Officer of TerSera. “We believe this transaction provides an excellent home for Prialt and Quzyttir to continue the strong momentum we have established with these medicines, while we sharpen our focus on our core therapeutic areas of oncology and rare disease.”

This deal reinforces ESTEVE’s growth in the United States, a growth that began with the acquisition in 2024 of a business specialized in rare and ultra-rare diseases in the areas of endocrinology and onco-endocrinology. ESTEVE’s highly specialized portfolio has been further strengthened by the subsequent expansion in 2025: licensing-in for Ex US a biologic product used to treat children and adolescents from 2 to 18 years-old who suffer from severe primary insulin-like growth factor 1 deficiency4; an adjuvant treatment being investigated in the U.S. and considered standard of care outside of the U.S. where it is approved for high-grade resectable non-metastatic osteosarcoma in patients aged between 2 and 30 years5 ; and a medicine that is used in adults and children above 5 years of age to treat aggressive and symptomatic medullary thyroid cancer.6

The current transaction is expected to close in the first quarter of 2026, subject to regulatory clearances.

Perella Weinberg Partners are the financial advisor to ESTEVE on this transaction, and Arnold & Porter are serving as legal counsel. Leerink Partners acted as the lead financial advisor to TerSera, and Kirkland & Ellis LLP is serving as legal counsel.

About PRIALT® (Ziconotide Intrathecal Infusion)

PRIALT is a non-opioid intrathecal analgesic indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. Derived from a marine snail peptide, ziconotide acts as a selective N-type calcium channel blocker, interrupting pain signal transmission in the spinal cord. Ziconotide is administered via continuous intrathecal infusion and is not associated with the risk of addiction or respiratory depression commonly seen with opioid therapies.1

IMPORTANT SAFETY INFORMATION

WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS

 

PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.

Contraindications

PRIALT is contraindicated in patients with:

  • A known hypersensitivity to ziconotide or any of its formulation components.
  • Any other concomitant treatment or medical condition that would render intrathecal administration hazardous, such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF).
  • A pre-existing history of psychosis.

Warnings and Precautions

Cognitive and Neuropsychiatric Adverse Reactions

Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients frequently for cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.

In clinical trials, 12% of patients reported hallucinations; other acute psychiatric events included paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%).

Patients with pretreatment psychiatric disorders may be at increased risk. Management of psychiatric complications may need to include discontinuation of PRIALT, treatment with psychotherapeutic agents and/or short-term hospitalization.

In clinical trials, cognitive adverse reactions included confusion (33%), memory impairment (22%), speech disorder (14%), aphasia (12%), thinking abnormal (8%), and amnesia (1%). Cognitive impairment may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop, but other contributing causes must also be considered. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation. The elderly (≥65 years) are at higher risk for confusion. Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects.

Meningitis and Other Infections

Meningitis can occur due to inadvertent contamination of the microinfusion device and other means. In clinical trials, the rate of meningitis was 3% (40 cases) in the PRIALT group using either internal or external microinfusion devices and 1% (1 case) with placebo. In patients with external microinfusion devices and catheters, meningitis occurred in 38 out of 41 patients (93%), 37 of whom received PRIALT and one who received placebo. Patients, caregivers, and healthcare providers must be particularly vigilant for the signs and symptoms of meningitis including, but not limited to, fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.

Strict aseptic procedures must be used during the preparation of the PRIALT solution and refilling of the microinfusion device.

Reduced Level of Consciousness

In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, and other etiologies (e.g., meningitis) must be considered.

Elevation of Creatine Kinase

In clinical trials, serum creatine kinase (CK) levels above the upper limit of normal (ULN) were reported in 40% of patients, with 11% of patients having CK levels >3 times ULN. Incidences were higher during the first 2 months of treatment. Serum CK should be monitored periodically. In the setting of new neuromuscular symptoms, evaluate patients, obtain CK measurements, and if symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.

Withdrawal From Opiates

PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates. To avoid withdrawal syndrome when opiate withdrawal is necessary, do not abruptly reduce or withdraw opioid medications.

Driving and Operating Machinery

Use of PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥25%) in clinical trials (n=1254 PRIALT-treated patients) were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.

Indication

PRIALT® (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.

Please see PRIALT Full Prescribing Information, including BOXED Warning.

About QUZYTTIR® (Cetirizine Hydrochloride Injection)

QUZYTTIR is a second-generation intravenous antihistamine indicated for the treatment of acute urticaria in adults and children six months of age and older. As a selective H1 receptor antagonist, cetirizine works by blocking histamine activity, helping to rapidly relieve symptoms of allergic reactions. QUZYTTIR is administered via intravenous infusion and offers fast onset of action with less sedation compared to first-generation antihistamines.2

IMPORTANT SAFETY INFORMATION

Contraindications

Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.

Warnings and Precautions

The occurrence of somnolence/sedation has been reported in some patients. Advise patients to exercise due caution when driving or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.

Adverse Reactions

The most common adverse reactions (incidence <1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The most common adverse reactions (incidence ≥2%) with chronic dosing of oral cetirizine hydrochloride in adults are somnolence, fatigue, dry mouth, pharyngitis and dizziness. Adverse reactions observed in pediatric patients with chronic use of oral cetirizine hydrochloride are headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting.

Indication and Usage

QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.

Please see QUZYTTIR Full Prescribing Information.

About ESTEVE

ESTEVE (esteve.com) is a global pharmaceutical company with a clear purpose: to improve people’s lives. Founded in 1929 and headquartered in Barcelona, ESTEVE has a strong international presence with pharmaceutical affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA.

ESTEVE is focused on delivering highly specialized treatments that address significant unmet medical needs in several therapeutic areas. In addition to our innovative pharma business, we offer comprehensive Contract Manufacturing and Development services (CDMO), specializing in the production of Active Pharmaceutical Ingredients (APIs) through world-class facilities in Spain, Mexico, China and the USA.

ESTEVE’s strong commitment to its core values—people matter, transparency, and accountability—remains at the heart of everything it does.

About TerSera Therapeutics

TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and rare disease. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2025 Top Workplace. For additional information, please visit TerSera.com and follow us on LinkedIn.

References

  1. PRIALT® (ziconotide). Prescribing information. TerSera Therapeutics LLC. www.accessdata.fda.gov/drugsatfda_docs/label/2023/021060s012lbl.pdf
  2. Prialt®– www.ema.europa.eu/en/medicines/human/EPAR/prialt
  3. QUZYTTIR® (cetirizine hydrochloride injection). Prescribing Information. TerSera Therapeutics LLC. www.accessdata.fda.gov/drugsatfda_docs/label/2025/211415s008lbl.pdf
  4. Increlex – www.ema.europa.eu/en/medicines/human/EPAR/increlex
  5. Mepact – www.ema.europa.eu/en/medicines/human/EPAR/mepact
  6. Caprelsa – www.ema.europa.eu/en/medicines/human/EPAR/caprelsa

PRIALT, QUZYTTIR, TERSERA, and the TERSERA logo are registered trademarks of TerSera Therapeutics LLC or its affiliates.

Contacts

For more information:

Esteve:
Irene Simón

Head of Global External Communications & ESG

+34 934 466 000

isimon@esteve.com

TerSera Therapeutics:
Mark Leonard

847-651-9682

mleonard@tersera.com

Owkin Advances Frontier Model Development for Biological Artificial Super Intelligence, Accelerated by NVIDIA

Owkin Advances Frontier Model Development for Biological Artificial Super Intelligence, Accelerated by NVIDIA




Owkin Advances Frontier Model Development for Biological Artificial Super Intelligence, Accelerated by NVIDIA

Collaboration Leverages NVIDIA’s Open Models, AI Infrastructure and Expertise to Build Next-Generation Biological Reasoning Models for Drug Development




SAN FRANCISCO & PARIS–(BUSINESS WIRE)–Owkin, an AI company on a mission to solve the complexity of biology, today announced a collaboration with NVIDIA to enhance OwkinZero, Owkin’s biological large reasoning model. The collaboration will leverage NVIDIA’s advanced AI computing ecosystem, including the Nemotron family of open models and the NVIDIA NeMo framework to improve the performance, scalability, guardrails, and robustness of Owkin’s biological reasoning capabilities to accelerate future breakthroughs in drug discovery and development.

This marks Owkin’s first collaboration with NVIDIA and represents a significant milestone in building the agentic infrastructure necessary for achieving Biological Artificial Super Intelligence (BASI). The work brings together Owkin’s expertise in biological AI and access to proprietary multimodal patient data with NVIDIA’s leadership in accelerated computing, open models, and AI infrastructure. The new OwkinZero model leverages the NVIDIA NeMo RL, an open library part of the NVIDIA NeMo Framework for reinforcement learning that improves model customization and performance at scale. It will power the next generation of Owkin’s agentic AI capabilities, available through Owkin’s interoperable agentic infrastructure, Owkin K, for biopharma and Owkin’s internal AI Scientist that will automate the discovery of new cures and diagnostics.

“Building the first Biological Artificial Super Intelligence requires not just powerful models, but the right agentic infrastructure and toolkits to scale them,” said Thomas Clozel, M.D., co-founder and CEO of Owkin. “Our collaboration with NVIDIA represents a crucial step in developing the intelligent infrastructure for biology. By combining NVIDIA’s world-class AI ecosystem with our domain-specific biological reasoning capabilities and multimodal patient data, we’ll be able to create AI agents that can truly understand and reason about the complexity of biology at a scale that was previously impossible.”

This collaboration underscores both companies’ commitment to advancing AI-driven biological research and delivering technologies that can accelerate drug discovery, improve clinical success rates, and ultimately deliver better treatments to patients faster.

About Owkin

Owkin is an AI company on a mission to solve the complexity of biology. It is building the first Biological Artificial Super Intelligence (BASI) by combining powerful biological large language models, multimodal patient data, and agentic software. At the heart of this system is Owkin K, an AI copilot, powered by OwkinZero, its new LLM fine-tuned on biological reasoning used by researchers, clinicians, and drug developers to better understand biology, validate scientific hypotheses, and deliver diagnostics and therapies faster.

Contacts

Press Contact:
– US: Erica Zeidenberg – erica@hottomato.net
– UK: Ali Jennings – alistair.jennings@owkin.com
– EU: Malika Labou – malika.labou-ext@owkin.com

FairJourney Bio Launches Cryo-EM Services With Advanced Laboratories in San Diego, USA

FairJourney Bio Launches Cryo-EM Services With Advanced Laboratories in San Diego, USA




FairJourney Bio Launches Cryo-EM Services With Advanced Laboratories in San Diego, USA

Expanded offering provides high-resolution structural insights to support antibody discovery and biologic design

PORTO, Portugal and SAN DIEGO, Calif.–(BUSINESS WIRE)–FairJourney Bio (FJBio), a leading global provider of antibody discovery and development services, today announced the expansion of its portfolio with the launch of state-of-the-art cryo-electron microscopy (cryo-EM) services, supported through the Company’s advanced laboratories in San Diego, CA.


This strategic addition strengthens FJBio’s position as a trusted partner for pharmaceutical and biotechnology companies worldwide by providing accessible, high-resolution structural insights that accelerate antibody discovery, selection, and design. By combining cutting-edge technology with FJBio’s team of expert scientists, the service offering ensures partners gain access to top-quality data and receive comprehensive guidance throughout the discovery and development process.

Benefitting from industry-leading, high-throughput cryo-EM capabilities, utilizing two state-of-the-art ThermoFisher Titan Krios 5 systems, the cryo-EM services enable rapid and scalable analysis, with models delivered within 2-3 weeks from sample delivery. The offering supports both intermediate- and high-resolution validation of proteins, protein-protein, and protein-ligand complexes, producing high-quality and highly interpretable protein structures to inform confident decision-making.

Tailored specifically for antibody discovery, the cryo-EM services deliver value across the R&D value chain, supporting programs from early evaluation through to advanced optimization:

  • Evaluation – Early structural insights into epitope diversity of immune libraries
  • Discovery – cryo-EM-based hit discovery supported by sequence-from-structure workflows
  • Selection – Structure-informed insights into therapeutic binding modes to guide lead selection
  • Control – Computational protein design campaigns and development of next-generation synthetic libraries

Dr. Werner Lanthaler, Chief Executive Officer of FairJourney Bio, commented:Cryo-EM enables unique and powerful insights into molecular structures and interactions at an atomic level. Adding structure-based information from real-world images is a paradigm shift that allows researchers to de-risk their R&D projects along the entire value chain. The improved resolution removes guesswork at critical junctures in the R&D process and thus serves to both accelerate discovery projects as well as improving their success rates. FJBio’s cryo-EM platform with a dedicated team of experts is unmatched in terms of speed, scale and quality.”

With the addition of cryo-EM services, supported by our high-end San Diego labs, we can provide our partners with the structural precision and expert support needed to accelerate the development of next-generation therapies,” said Dr. Christopher Arthur, CSO Structural Biology, FairJourney Bio.

For more information, visit: https://fjbio.com/fjb-cryo-em

Contacts

For high resolution images, contact Zyme Communications
Lily Jeffery

Email: lily.jeffery@zymecommunications.com
Tel: +44 (0)7891 477 378

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




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 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




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




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




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