First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication




First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication

• More than half of ENTYVIO patients who met their assigned treatment target reached disease clearance (composite of corticosteroid-free symptomatic, endoscopic and histologic remission) at Week 16
• VERDICT is the first trial to provide macroscopic and microscopic evidence of intestinal tissue repair associated with disease clearance in largely bio-naïve patients treated with an advanced therapy​

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) announced new data from VERDICT (NCT04259138), showing that treating adults with intravenous ENTYVIO^® (vedolizumab) to achieve corticosteroid-free (CSF) disease clearance versus CSF symptomatic remission alone, resulted in a significantly longer time to first ulcerative colitis (UC)-related complication (hazard ratio 0.33 [95% confidence interval 0.17-0.67]; P=0.0014), reducing UC complication risk by nearly 70 percent. VERDICT, a Phase 4 ENTYVIO clinical trial, provides the first prospective, randomized evidence that disease clearance is an achievable and clinically relevant target in the treatment of moderate to severe ulcerative colitis.¹ Results were presented during late-breaker and poster sessions at United European Gastroenterology (UEG) Week 2026 and published in the United European Gastroenterology Journal.

“There has been increasing conversation about whether achieving deeper levels of remission – addressing both visible and microscopic inflammation – ameliorates the burden of ulcerative colitis in the long-term,” said Vipul Jairath MBChB, DPhil, FRCP, FRCPC, Professor of Medicine at Western University, Alimentiv chief medical officer and lead study author. “VERDICT suggests that implementation of a treat-to-target strategy can change the disease course. It also expands the body of evidence for treating with ENTYVIO, with the goal of achieving deeper and durable disease control within 16 weeks.”

“For people living with UC, symptom relief does not always tell the full story of what is happening beneath the surface. Achieving deep healing and disease control without corticosteroids is an important goal of treatment. The VERDICT data further support the strength of gut-focused ENTYVIO in achieving outcomes such as disease clearance – within 16 weeks of treatment initiation – while also adding new molecular and cellular evidence suggesting restoration of gut function in bio-naïve patients,” said Vijay Yajnik, Vice President, Global Medical Affairs, GI & Inflammation at Takeda. “VERDICT reflects our commitment to generating evidence that aims to answer some of the most complex questions in ulcerative colitis treatment strategies and standards of care.”

VERDICT randomized adults with moderate to severe ulcerative colitis to three increasingly stringent CSF treatment targets (Group 1: symptomatic remission; Group 2: symptomatic + endoscopic remission; and Group 3: symptomatic + endoscopic + histologic remission, or disease clearance) to assess whether deeper levels of remission were associated with longer time to UC-related complications. Treatment was escalated based on assigned targets using ENTYVIO-based algorithms, which may have included an increase in dose frequency. The study’s primary outcome compared time to first UC-related complication (hospitalization, colectomy, use of rescue therapy, treatment-related, and other UC-related complications) between groups 3 and 1 up to 80 weeks after target achievement. Among the achieved-target population, key findings include:

• After treatment with ENTYVIO, nearly 60% (400/672) of randomized patients achieved their assigned CSF target by Week 48 (Group 1: 137 [74.1%]; Group 2: 125 [56.3%]; Group 3: 138 [52.1%])
• The primary endpoint was met with the disease-clearance group (Group 3) experiencing a longer time to first UC-related complication than the symptomatic-remission group (HR 0.33; 95% CI, 0.17–0.67; P=0.0014)
• Treating to stringent composite targets (disease clearance) with ENTYVIO reduced UC complication risk by ~70%, up to 80 weeks after target achievement
• Among patients achieving the CSF symptomatic + endoscopic remission target (Group 2), more than 80% also achieved histologic remission at Week 48
• Time to UC-related complication was similar between patients in groups 2 and 3 (1.10 [0.45-2.69] P=0.8023)
• 51 UC-related complications occurred, with use of rescue therapy being the most frequent
• Adverse event rates were similar across groups and unaffected by treatment escalation and more frequent ENTYVIO dosing to achieve more stringent targets

The safety profile observed throughout 96 weeks was generally consistent with previously reported data, with no new safety signals identified. The most common adverse events (≥5%) were ulcerative colitis, anaemia, haematochezia, COVID-19 infection, influenza, nasopharyngitis and arthralgia.¹

Additional analyses from VERDICT also presented at UEG Week explored molecular changes associated with early disease clearance.^2,3 Proteomic and transcriptomic analyses identified distinct molecular patterns among bio-naïve patients who achieved disease clearance by Week 16, including changes in pathways related to inflammation, mucosal homeostasis and tissue repair. These exploratory findings may contribute to a better understanding of the biology associated with disease clearance and warrant further investigation.

The impact of ulcerative colitis can extend well beyond day-to-day symptoms.⁴ Over time, up to 30 percent of patients may experience complications, including painful flares, hospitalization and surgery, that can disrupt their lives and take an emotional and financial toll.^5,6 This underscores the importance of addressing not only symptoms but also facilitating gut healing with the goal of changing the course of disease to minimize long-term impact and improve outcomes.

Frequently Asked Questions

What is “disease clearance” in ulcerative colitis?
Disease clearance is a treatment target that combines three levels of remission: corticosteroid-free (CSF) symptomatic remission (no symptoms without steroids), endoscopic remission (visible healing of the gut lining), and histologic remission (healing at the microscopic level).^1,7,8 It is a deeper standard than symptom relief alone and proposed by the International Organisation for the Study of Inflammatory Bowel Diseases (IOIBD) as having potential to reduce the risk of disease recurrence and progression in the long term. VERDICT is the first randomized trial in UC to include this stringent treatment target in a prespecified hypothesis.

What is the VERDICT trial and what are the results?
The VERDICT trial (NCT04259138) is a Phase 4 ENTYVIO randomized trial, the first and only prospective trial in UC to assess the optimal treatment target to prolong time to ulcerative colitis (UC)-related complications.¹ The study found that treating adults with moderate to severe ulcerative colitis to a corticosteroid-free (CSF) disease clearance target with ENTYVIO lengthened the time to first UC-related complication, compared with treating to CSF symptomatic remission alone. VERDICT is the first randomized trial in UC to include this stringent treatment target in a prespecified hypothesis. Additionally, among those who achieved their treatment target, disease clearance was reached by more than half (57%) of ENTYVIO-treated patients at Week 16.

What is a “treat-to-target” approach?
Treat-to-target means actively monitoring a patient’s disease and adjusting treatment on a set schedule until a specific, pre-defined clinical target is reached, rather than evaluating the clinical status of the patient out of the framework of an assigned target.¹ In VERDICT, patients were assessed for target achievement at Weeks 16 and 32 and had treatment adjusted according to a pre-established algorithm if assigned treatment target was not achieved. The achieved-target population for VERDICT included patients who reached their assigned targets at Weeks 16, 32 or 48.

Was the ENTYVIO safety profile in the VERDICT trial consistent with previous data?
The safety profile observed through 96 weeks in VERDICT was generally consistent with previously reported ENTYVIO data, with no new safety signals identified.¹

About ENTYVIO^® (vedolizumab)
ENTYVIO, a biologic therapy, is the only gut-focused treatment available for ulcerative colitis and Crohn’s disease in adults. It specifically binds to the α4β7 integrin and blocks its interaction with MAdCAM-1, which is mainly expressed on the gut endothelial cells.⁹ ENTYVIO is approved for IV and subcutaneous (SC) administration in adults with moderately to severely active ulcerative colitis and Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist (approvals vary by market).¹⁰ Marketing authorization has been granted in more than 80 countries for ENTYVIO IV and in more than 50 countries for ENTYVIO SC. Globally, ENTYVIO IV and SC have more than 2.3 million patient years of exposure to date.¹¹

About the VERDICT Trial
VERDICT (NCT04259138) is a Phase 4 randomized treat-to-target trial conducted by Alimentiv, in collaboration with Takeda.¹ VERDICT included 672 adults with active moderate to severe UC (Mayo rectal bleeding subscore [RBS]≥1; Mayo endoscopic score [MES]≥2), with most being bio-naïve and/or having severe disease (as measured by MES). Patients were randomly divided into three groups, each assigned an increasingly stringent treatment target: corticosteroid-free (CSF) symptomatic remission (Group 1); CSF symptomatic plus endoscopic remission (Group 2); and CSF symptomatic, endoscopic and histologic remission (Group 3). Treatment was escalated to assigned targets using ENTYVIO-based algorithms, which may have included an increase in dose frequency. Achievement of treatment targets was assessed at Weeks 16, 32 and 48. The study’s primary outcome compared time to first UC-related complication (hospitalization, colectomy, use of rescue therapy, treatment-related, and other UC-related complications) up to 80 weeks after target achievement between groups 3 and 1.

EUROPEAN UNION IMPORTANT SAFETY INFORMATION

Please consult the ENTYVIO (Vedolizumab) Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring.

GUIDANCE FOR USE: Entyvio should be initiated and supervised by a specialist healthcare professional experienced in diagnosis and treatment of ulcerative colitis, Crohn’s disease or pouchitis. Patients should be given the package leaflet.

CONTRAINDICATIONS: include Hypersensitivity to the active substance or to any of the excipients. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).

UNDESIRABLE EFFECTS: The most commonly reported undesirable effects with ENTYVIO are nasopharyngitis, headache, arthralgia, pneumonia, Clostridium difficile infection, bronchitis, gastroenteritis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, Herpes Zoster, paraesthesia, hypertension, oropharyngeal pain, nasal congestion, cough, anal abscess, anal fissure, nausea, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids, rectal haemorrhage, liver enzyme increased, rash, pruritus, eczema, erythema, night sweats, acne, muscle spasms, back pain, muscular weakness, fatigue, pain in the extremity, pyrexia, injection site reaction.

No clinically relevant differences in the overall safety profile and adverse reactions were observed in patients who received subcutaneous vedolizumab compared to the safety profile observed in clinical studies with intravenous vedolizumab with the exception of injection site reactions.

Please click for the full EU SmPC.

Please click for Full U.S. Prescribing Information.

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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References

¹ Jairath V, Colombel JF, D’Haens GR, et al. VERDICT: Randomized treat-to-target trial of corticosteroid-free targets with vedolizumab-based treatment algorithms in ulcerative colitis. Presented at UEG Week 2026. 2026 Oct 17-20; Barcelona, ES.

² Mehandru S, Powell N, Paraskevopoulou MD, et al. Proteomic signatures accompanying early disease clearance in ulcerative colitis patients treated with vedolizumab in the VERDICT trial. Accepted abstract, UEG Week 2026.

³ Mehandru S, Powell N, Paraskevopoulou MD, et al. Proteotranscriptomic signatures accompanying early disease clearance in ulcerative colitis patients treated with vedolizumab in the VERDICT trial. Accepted abstract, UEG Week 2026.

⁴ Crohn’s and Colitis Foundation. The Facts About Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation; 2014. Accessed October 1, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.

⁵ Tsai L, Nguyen NH, Ma C, Prokop LJ, Sandborn WJ, Singh S. Dig Dis Sci. 2022;67(6):2451-2461. doi:10.1007/s10620-021-07200-1.

⁶ DeLeon MF, Stocchi L. Clin Colon Rectal Surg. 2022;35:437-444.

⁷ D’Amico F, Magro F, Siegmund B, et al. Inflamm Bowel Dis. 2024;30(6):1009-1017. doi:10.1093/ibd/izad159.

⁸ Le Berre C, Peyrin-Biroulet L; SPIRIT-IOIBD Study Group. Gastroenterology. 2021;160(5):1452-1460.e21.

⁹ Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875.

¹⁰ ENTYVIO Summary of Product Characteristics (SmPC). Takeda Pharmaceuticals. Available at: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf.

¹¹ Data on file. Takeda Pharmaceuticals.

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Sensorion Announces the Appointment of Peter Weber, MD, MBA, as Chief Medical Officer




Sensorion Announces the Appointment of Peter Weber, MD, MBA, as Chief Medical Officer

• Dr. Weber, an otologist and neurotologist who led the clinical development of the first FDA-approved gene therapy for genetic hearing loss, joins as SENS-601 advances into the clinic

MONTPELLIER, France & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News:

Sensorion (FR001401A9Z0 – ALSEN) (“the Company”), a pioneering clinical-stage biotechnology company that develops novel therapies to restore hearing and to treat and prevent hearing loss disorders, today announced the appointment of Peter Weber, MD, MBA, as Chief Medical Officer, effective November 2, 2026.

Dr. Weber is an otologist and neurotologist with more than two decades of clinical and industry leadership in hearing loss. Dr. Weber possesses deep expertise in rare genetic ear disorders and is one of the few physicians to have led the clinical development of gene therapies for genetic hearing loss.

Earlier, as Chief Medical Officer of Decibel Therapeutics, and later as Senior Medical Consultant to Regeneron, Dr. Weber guided several monogenic gene therapy programs for the inner ear. These included the otoferlin gene therapy that became the first FDA-approved gene therapy for genetic hearing loss. At Decibel, he also led a small molecule program to prevent hearing loss caused by cisplatin chemotherapy.

Most recently, Dr. Weber was Chief Medical Officer of Auregen BioTherapeutics. There he led a Phase I/II trial under an FDA-cleared IND of an autologous, 3D-printed cartilage implant to repair microtia in children, and the regulatory strategy that secured Orphan Drug Designation and Breakthrough Designation.

His other industry leadership roles include Chief Medical Officer of Frequency Therapeutics, where he led the IND and Phase I studies of a small molecule program to regenerate cochlear hair cells. He was also Global Chief Medical Officer and Vice President of Reimbursement at Cochlear Limited, where he led several successful PMA and 510(k) submissions worldwide.

Alongside his industry experience, Dr. Weber is Professor and Head of Otology, Neurotology and Skull Base Surgery at Boston University Medical Center, having previously held professorships at Mount Sinai Health System, the University of Massachusetts Medical Center, the Cleveland Clinic and the Medical University of South Carolina. He is board certified in Otolaryngology – Head and Neck Surgery and in Neurotology, has served as Editor-in-Chief of the American Journal of Otolaryngology since 2002, and has authored more than 125 publications and three books. Dr. Weber holds an MD from Albany Medical College, an MBA from Duke University, and a BS/MS in chemical and biomedical engineering from Washington University in St. Louis.

Peter Weber, MD, MBA, said: “Having worked on some of the first gene therapies for genetic forms of hearing loss, including otoferlin-related hearing loss, I have seen what these treatments can mean for children and their families. I have also seen how quickly the field has matured. SENS-601 targets one of the most common genetic causes of hearing loss, so it has the potential to reach a much larger patient population. I am delighted to join Sensorion at this pivotal time and look forward to working with the team to advance SENS-601 through the clinic.”

Frédéric Chereau, Chief Executive Officer of Sensorion, said: “We are delighted to welcome Peter to Sensorion as we advance SENS-601 into the clinic. Peter combines decades of hands-on clinical practice in otology and neurotology with direct experience leading gene therapy programs for hearing loss, including otoferlin-related hearing loss. Few people have taken inner-ear gene therapy from the clinic toward approval. His regulatory track record across drugs, biologics and devices, together with his understanding of patients and treating physicians, will be a strong asset as we build Sensorion’s clinical and medical capabilities.”

About Sensorion

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore hearing and to treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. SENS-601 (GJB2-GT) is the Company’s lead gene therapy program, targeting hearing loss related to mutations in the GJB2 gene to address important hearing loss segments in adults and children developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. Sensorion’s pipeline also consists of a clinical-stage small molecule program, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion’s small molecule progressed in three Phase II proof of concept clinical studies: firstly, in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing, with analysis completed in Q1 2026. Secondly, with partner Cochlear Limited, a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation, completed in 2024. Thirdly, a Phase II study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in 2022.

www.sensorion.com

Label: SENSORION

ISIN: FR001401A9Z0

Mnemonic: ALSEN

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This press release contains certain forward-looking statements concerning Sensorion, its business and its financial position. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2025 full year report published on March 18, 2026 and in the 2026 half-year report published on September 23, 2026, both available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

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IMU and UK Biobank to generate the world’s most detailed, large-scale picture of the human immune system for advancing research into health and disease




IMU and UK Biobank to generate the world’s most detailed, large-scale picture of the human immune system for advancing research into health and disease

IMU is collaborating with UK Biobank, Waters Corporation and Ultima Genomics to profile blood samples from an initial cohort of 80,000 UK Biobank blood samples

IMU will generate more than 100 million immune data points from each sample to create the largest, most detailed immune dataset assembled to date

The study will add a high-resolution immune profiling layer to UK Biobank’s existing de-identified genomic, imaging, clinical and lifestyle data to enable a better understanding of how immune variation relates to disease risk, progression, treatment response and long-term health outcomes

LONDON–(BUSINESS WIRE)–IMU Biosciences (‘IMU or the ‘Company’), a biotechnology company using its High Definition Immunology™ platform to better understand the immune system and drive a shift in how we understand, diagnose, and treat disease, has today announced a new collaboration with UK Biobank to generate large-scale multi-omic immune profiling data from 80,000 blood samples collected from UK Biobank participants.

The project will use IMU’s HD Immunology™ platform in conjunction with Waters Corporation’s flow cytometry and multi-omic instrumentation as part of the strategic partnership announced in June. Ultima Genomics’ (‘Ultima’) recently launched UG200 Sequencing Platform will produce the project’s readouts, providing the magnitude and economics for large scale omics data generation, complementing Ultima’s existing work as part of UK Biobank Pharma Proteomics Project. By integrating high-dimensional immune-cell profiling, transcriptomic analysis and AI-based computational methods, the study aims to create the most detailed large-scale picture of the human immune system ever seen.

UK Biobank is the world’s most comprehensive source of biomedical data for health research in the public interest. Its dataset includes de-identified biological, clinical, imaging and lifestyle data collected from 500,000 volunteers over the last 15 years and continues to grow. In line with UK Biobank’s established access procedures, data generated through the study will, over time, be returned to UK Biobank and made available to approved researchers. This will add a new immune profiling layer to an established international research resource.

IMU is building a high-resolution immune dataset designed to connect individual immune profiles with large-scale clinical data. In the first phase of the study, IMU will apply its high-throughput immune profiling platform to blood samples from over 80,000 UK Biobank blood samples, with the ambition to expand across the full UK Biobank cohort of 500,000 participants.

The collaboration will add detailed immune profiling to UK Biobank to create a powerful new layer of biological information for researchers studying immune variation across health and disease. The immune system is central to ageing, infection, cancer, autoimmunity, metabolic disease and neurodegeneration, but large-scale studies often lack the resolution needed to examine how immune variation relates to future outcomes. This study aims to reveal how immune profiles relate to disease risk, progression, treatment response and long-term health outcomes.

IMU has recently been awarded a £1.57 million Sovereign AI grant from the UK government as part of its Strategic Assets programme for the delivery of the project. The funding is a testament to both the value of IMU’s technology, as well as the collaboration’s potential to create a valuable piece of shared infrastructure which will further cement the UK’s place as a global leader in sciences and medical discovery.

For IMU, the study will strengthen the Company’s ability to develop and validate immune profiles for patient stratification, biomarker discovery, translational research and future clinical applications, and to generate new foundational AI models of immunology for target discovery. By working with UK Biobank, Waters Corporation and Ultima Genomics, IMU aims to generate immune data at the scale, reproducibility and resolution needed to support both broad biomedical research and future studies of immune prediction.

Dr Adam Laing PhD, Co-Founder and Chief Scientific Officer of IMU Biosciences said:

“IMU and UK Biobank’s collaboration represents an important opportunity to add a new immune dimension to one of the world’s most important and comprehensive biomedical research resources. UK Biobank has transformed how researchers study the genetic, molecular and lifestyle factors that contribute to health and disease and this study will help generate an unrivalled resource that we believe will bring huge value across biomedical research and, ultimately, patients.

By adding a high-resolution immune profiling layer to the UK Biobank’s existing data researchers studying immune variation across a number of disease areas will be able to identify how immune profiles relate to disease risk, progression, treatment response and long-term health outcomes.”

Professor Naomi Allen, Chief Scientist at UK Biobank, said:

“This new dataset will provide our global research community with a valuable insight into how the immune system changes with ageing. Scientists will be able to study which specific immune cell changes contribute to the future risk of conditions like cancer, diabetes and dementia, paving the way for earlier disease detection and more accurate diagnosis.

“Blood samples from UK Biobank’s generous participants have already been turned into genetic, proteomic and metabolomic data. When complete, this detailed map of the immune system will in turn fuel the detection of new drug targets and help clinicians to understand who might respond best to a particular treatment.”

Gilad Almogy, Chief Executive Officer of Ultima Genomics said:

“IMU’s work with UK Biobank represents exactly the type of large-scale, data-intensive program our recently launched UG200 Platform was designed to enable. Having also recently been selected for UK Biobank’s 600,000 sample Pharma Proteomics Project, Ultima is proud to continue enabling the addition of new omics data layers from one of the world’s most important biomedical research resources. Generating data at this scale requires a combination of throughput, quality, cost efficiency and operational execution. We are pleased to support IMU as it creates a high-resolution view of the human immune system across a population-scale cohort, generating data that can advance immune prediction, disease understanding, therapeutic research and AI-enabled biomedical discovery.”

Steve Conly, Senior Vice President, Waters Biosciences at Waters Corporation said:

“This pioneering collaboration showcases how the convergence of advanced flow cytometry, single-cell multi-omics, sequencing, AI-driven analysis, and large-scale sample sets can unlock entirely new dimensions of immune insights. Together, our cutting-edge BD FACSDiscover™ Cell Analyzer platform, BD flow cytometry reagents, BD Rhapsody™ instruments, and BD OMICS-One™ WTA Next Assay and Protein Panels will support IMU and our shared vision of advancing immune profiling into a standardized, widely accessible tool that can help transform how diseases like cancer are understood, monitored and treated.”

About IMU Biosciences

IMU Biosciences is using its High Definition (HD) Immunology™ platform to decode the immune system at unprecedented resolution, speed, and scale to pioneer a paradigm shift in how we understand, diagnose and treat disease.

Founded by leading experimental immunologists and computational biologists with over a decade of systems immunology expertise, IMU combines deep immune profiling from small blood samples with population scale immune reference data and AI analysis as it builds the world’s largest immune dataset.

The HD Immunology™ platform uses a simple blood sample to measure the immune system in unprecedented detail to help clinical, pharma and biotech partners interpret immune biology with greater resolution and predict clinical outcomes earlier, while also establishing a universal standard for immune profiling to fuel discoveries.

IMU is applying its platform across a broad range of immune-mediated diseases and therapeutic contexts, with active programmes in stem cell and bone marrow transplantation, solid organ transplantation, and immuno-oncology. To learn more, www.imubiosciences.com.

About UK Biobank

UK Biobank is the world’s most comprehensive source of biomedical data available for health research in the public interest. Over the past 15 years we have collected biological, health and lifestyle information from 500,000 UK volunteers. The dataset is continuously growing, with additions including the world’s largest set of whole genome sequencing data, imaging data from 100,000 participants and a first-of-its kind set of protein biomarkers from 54,000 participants. Since 2012, scientists from universities, charities, companies and governments across the world can apply to use the data to advance modern medicine and drive the discovery of new preventions, treatments and cures. Over 22,000 researchers, based in more than 60 countries, use UK Biobank data, and more than 18,000 peer-reviewed scientific papers have been published as a result. The data are de-identified and stored on our cloud-based platform. UK Biobank is a registered charity and was established by Wellcome and the Medical Research Council in 2003. You can read more about our funding here. www.ukbiobank.ac.uk, LinkedIn, X (Twitter), Facebook, Instagram

About Ultima Genomics

Ultima Genomics is unleashing the power of genomics at scale. The Company’s mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. With humanity on the cusp of a biological revolution, there is a virtually endless need for more genomic information to address biology’s complexity and dynamic change—and a further need to challenge conventional next-generation sequencing technologies. Ultima’s revolutionary new sequencing architecture drives down the costs of sequencing to help overcome the tradeoffs that scientists and clinicians are forced to make between the breadth, depth and frequency with which they use genomic information. The new sequencing architecture was designed to scale far beyond conventional sequencing technologies, lower the cost of genomic information, and catalyze the next phase of genomics in the 21st century. To learn more, visit www.ultimagenomics.com

About Waters Corporation:

Waters Corporation (NYSE: WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide. For more information, please visit www.waters.com/about.

The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation (“Waters”). Becton, Dickinson and Company or one of its affiliates or subsidiaries (“BD”) remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD’s regulatory authority. To learn more about the relationship between Waters and BD during this transition period, please see our detailed summary: www.waters.com/bdtransaction.

Contacts

Enquiries
IMU Biosciences
Dr John Baker, Chief Executive

john@imubiosciences.com

FTI Consulting – Media
Ben Atwell, Ciara Martin, Lucy Molloy

imubiosciences@fticonsulting.com

PureTech Announces Presentation of Phase 1b Results for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic Syndromes (HR-MDS) and Acute Myeloid Leukemia (AML) at ESMO 2026




PureTech Announces Presentation of Phase 1b Results for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic Syndromes (HR-MDS) and Acute Myeloid Leukemia (AML) at ESMO 2026

Oral presentation to highlight encouraging clinical activity and favorable safety of LYT-200 in heavily pretreated patients with R/R HR-MDS and AML

Results reinforce the potential of LYT-200 as a first-in-class, mutation-agnostic treatment for a broad R/R HR-MDS population, where treatment options remain extremely limited

PureTech Founded Entity, Gallop Oncology, plans to advance LYT-200 into Phase 2 STRIDE-MDS trial in patients with R/R HR-MDS following successful FDA End-of-Phase 1 meeting and receipt of Fast Track designation

BOSTON–(BUSINESS WIRE)–PureTech Health plc (LSE: PRTC) (“PureTech” or the “Company”), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced that results from the completed Phase 1b clinical trial of LYT-200 will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain. LYT-200 is a first-in-class monoclonal antibody targeting galectin-9, an important oncogenic driver and potent immunosuppressor, being advanced by PureTech’s Founded Entity, Gallop Oncology (Gallop).

“The Phase 1b results provide a strong foundation for the continued development of LYT-200, particularly in relapsed/refractory high-risk MDS, where patients have extremely limited treatment options,” said Aleksandra Filipovic, MD, PhD, Head of Oncology at PureTech and Chief Medical Officer of Gallop Oncology. “The encouraging clinical activity observed, together with the favorable safety profile, reinforces our confidence in the potential of LYT-200 to offer a differentiated treatment approach for a broad population of patients, regardless of mutation status. We look forward to sharing these findings with the oncology community in an oral presentation at ESMO as we prepare to advance LYT-200 into Phase 2 development.”

Details of the presentation are as follows:

Title: Topline Results from a Phase 1b Study of LYT-200 (Anti-Galectin-9 mAb) Alone and with HMA ± Venetoclax in Relapsed/Refractory High-Risk MDS and AML

Presenter: Guenther Koehne, MD, PhD, Deputy Director and Chief of Blood & Marrow Transplant and Hematologic Oncology at Baptist Health Herbert Wertheim Cancer Institute

Session: Proffered Paper: Hematological Malignancies (located at Salamanca Auditorium – Hall 10)

Date and Time: October 24, 2026, 8:30 AM – 10:00 AM CEST

About LYT-200

LYT-200 is a Phase 2-ready, fully human monoclonal antibody in development for the treatment of relapsed/refractory (R/R) high-risk myelodysplastic syndromes (HR-MDS). It is the most advanced therapeutic candidate targeting galectin-9, which is an important oncogenic driver and potent immunosuppressor that plays a central role in some of the most difficult-to-treat cancers. With its mutation-agnostic, dual mechanism of action, LYT-200 is designed to address both the malignant cells and the immunosuppressive environment that sustain disease. LYT-200 has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R HR-MDS in combination with a hypomethylating agent. LYT-200 has also been granted Fast Track designation from the U.S. FDA for the treatment of acute myeloid leukemia (AML).

About Gallop Oncology

Gallop Oncology is a clinical-stage biotechnology company dedicated to transforming the treatment paradigm for hematological malignancies. Its lead candidate, LYT-200, is a first-in-class, mutation-agnostic antibody in development for the treatment of relapsed/refractory (R/R) high-risk myelodysplastic syndromes (HR-MDS). Gallop Oncology was founded by and is currently wholly owned by PureTech Health plc (LSE: PRTC). For more information, please visit www.galloponcology.com.

About PureTech Health

PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Contacts

PureTech

Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

Genentech to Present Pivotal Data at ESMO 2026, Showcasing Advances Across Its Lung and Breast Cancer Late-Stage Portfolio




Genentech to Present Pivotal Data at ESMO 2026, Showcasing Advances Across Its Lung and Breast Cancer Late-Stage Portfolio

• Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors, in previously treated advanced G12C-mutated non-small cell lung cancer
• Patient-reported outcomes from Phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer
• Second Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3 targeted ADC, to deliver robust efficacy with a favorable safety profile in high-unmet-need solid tumors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$RHHBY–Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from October 23 to 27 in Madrid.

“Our presentations at ESMO 2026 highlight the depth and impact of Genentech’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer.”

Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC

Genentech will share Phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer.

• Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors.

• Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium.

Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer

Genentech will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective estrogen receptor degrader (SERD) and full antagonist, in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early stage (I-III). Key presentations from early-stage to advanced disease include:

• Patient-reported outcomes from the Phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life.

• Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting.

• Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer.

Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan)

New data will also be presented for Tam-Peli, an investigational next-generation B7-H3-targeted ADC designed to deliver high-potency anti-tumor activity while limiting off-target toxicity. Tam-Peli is currently being investigated across multiple solid tumor indications:

• ESMO data include late-breaking interim Phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumors from Phase I/II studies, and Phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC.

• These findings build on the TAISHAN-302 Phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis.

• Roche is developing and commercializing Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumor types.

Overview of key presentations featuring Genentech medicines and molecules:

What is Itovebi?

Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

• High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
  • difficulty breathing
  • nausea and vomiting (lasting more than 2 hours)
  • stomach pain
  • excessive thirst
  • dry mouth
  • more frequent urination than usual or a higher amount of urine than normal
  • blurred vision
  • unusually increased appetite
  • weight loss
  • fruity-smelling breath
  • flushed face and dry skin
  • feeling unusually sleepy or tired
  • confusion
• Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
  • pain
  • swelling
  • redness
  • ulcers
• Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea.

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

• decreased white blood cell counts, red blood cell counts, and platelet counts
• decreased blood levels of calcium, potassium, sodium, and magnesium
• increased creatinine blood levels
• tiredness
• increased blood levels of the liver enzyme alanine transaminase (ALT)
• nausea
• rash
• loss of appetite
• COVID-19 infection
• headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of diabetes or high blood sugar
• have kidney problems
• are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
• You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.

Males with female partners who are able to become pregnant:

• You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
• are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit https://www.itovebi.com.

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

• Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer:
  • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and
  • you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and
  • your cancer tests positive for “PD-L1”.

• Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer:
  • has spread or grown, and
  • your cancer tests positive for “high PD-L1”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.

• Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer:
  • has spread or grown, and
  • is a type called “non-squamous NSCLC”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.

• Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer:
  • has spread or grown, and
  • is a type called “non-squamous NSCLC”, and
  • your tumor does not have an abnormal “EGFR” or “ALK” gene.

• Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer:
  • has spread or grown, and
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
  • If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
• Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
  • has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer:

• has spread or cannot be removed by surgery, and
• you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer.

Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma:

• has spread to other parts of the body or cannot be removed by surgery, and
• has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you.

Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma:

• has spread to other parts of the body or cannot be removed by surgery.

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer:

• to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
• small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you.

Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more). Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine:

• to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and
• you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR).

It is not known if Tecentriq Hybreza is safe and effective when used:

• in children younger than 12 years of age for the treatment of ASPS or colon cancer.
• in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

It is not known if Tecentriq is safe and effective when used:

• in children younger than 2 years of age for the treatment of ASPS or colon cancer.
• in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

Important Safety Information

Who should not receive Tecentriq Hybreza?

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza.

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain

Intestinal problems

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in your mouth or your nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including corneal transplant
• have received or plan to receive a st

Contacts

Media Contact: Stella Belonwu, (650) 467-6800

Advocacy Contact: Catherine Creme Henry, (202) 258-8828

Investor Contacts: Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 68-75284

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NUCLIDIUM and NorthStar Enter Long-term Strategic Partnership to Advance NUCLIDIUM’s Copper-67 Radiotheranostic Oncology Pipeline




NUCLIDIUM and NorthStar Enter Long-term Strategic Partnership to Advance NUCLIDIUM’s Copper-67 Radiotheranostic Oncology Pipeline

• Collaboration spans Copper-67 supply and radiopharmaceutical manufacturing from clinical development through commercialization.
• Partnership leverages NorthStar’s vertically integrated campus, combining proprietary Copper-67 production technology, cGMP manufacturing, and commercial-scale infrastructure.

BASEL, Switzerland & MUNICH & BELOIT, Wis.–(BUSINESS WIRE)–NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, and NorthStar Medical Technologies, LLC (NorthStar), a global radiopharmaceutical supply-chain partner, today announced a long-term strategic partnership through which NorthStar will produce Copper-67 (Cu-67) and provide comprehensive radiopharmaceutical manufacturing services to support NUCLIDIUM’s therapeutic programs from clinical development through commercialization. Copper-67 is the therapeutic isotope component of NUCLIDIUM’s radiotheranostic programs to treat cancers with high unmet medical need.

The partnership underscores NUCLIDIUM and NorthStar’s mutual commitment to expanding global patient access to precision radiopharmaceutical therapies. NUCLIDIUM’s pipeline includes lead programs NU101 addressing metastatic castration resistant prostate cancer (mCRPC) and NU201 for metastatic breast cancer (mBC) as well as earlier stage programs in other solid tumor indications with a focus on women’s oncology.

The work will be led through NorthStar’s vertically integrated U.S.-based radiopharmaceutical campus, where the company has pioneered advanced isotope production technologies, made significant investments in cGMP manufacturing, and maintains commercial-scale infrastructure to support growing global demand for targeted radiopharmaceutical therapies. NorthStar’s comprehensive approach enables a seamless transition from clinical development to commercialization, while reducing supply-chain complexity and accelerating program execution.

“Our collaboration with NorthStar strengthens our copper isotope supply chain at a critical moment, ensuring we are well prepared to execute on our near-term clinical development objectives and meet the long-term demand for our radiotheranostics,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. “NUCLIDIUM remains on track to initiate multiple therapeutic studies utilizing Copper-67 for mCRPC and mBC in the coming months, while expanding our radiotheranostic portfolio into the clinic, including specifically women´s oncology indications.”

“As demand for copper-based radiotheranostics continues to grow, reliable isotope supply and scalable manufacturing infrastructure will be essential for successful commercialization,” said Dr. Frank Scholz, President & CEO of NorthStar. “NorthStar’s integrated platform is designed to provide both, allowing NUCLIDIUM to advance its programs efficiently from clinical development through future commercial launch.”

Copper-67 is a short-range radioisotope that emits beta radiation to induce cell death in targeted tumor cells. The short half-life and lower radiation burden of Copper-67 limit the impact on surrounding healthy tissue. NUCLIDIUM’s radiopharmaceutical programs link Copper-67 to tumor-specific ligands to enable precision delivery and have the potential to achieve a best- or first-in-class clinical profile. The use of copper isotopes offers several distinct advantages over competing radioligands, including streamlined manufacturing, seamless integration into hospital workflows, reduced waste burden, and the potential for a wider therapeutic window.

About NUCLIDIUM

NUCLIDIUM AG is pioneering next-generation copper-based radiotheranostics that enable the direct conversion from cancer diagnosis to treatment. Leveraging copper isotopes, Copper-61 for diagnostics and Copper-67 for therapeutics, NUCLIDIUM has built a pipeline of differentiated candidates combining superior clinical performance, easy-to-scale production, and seamless integration into hospital workflows. The company’s lead programs NU101 in metastatic castration-resistant prostate cancer (mCRPC) and NU201 in metastatic breast cancer (mBC) have demonstrated compelling efficacy and safety in Phase 1/2 diagnostics trials and are advancing into Phase 1/2 theranostics trials. Our goal is to expand the reach and clinical profile of radiotheranostics to deliver the full value of the modality and address critical unmet medical needs in oncology and women’s health.

About NorthStar

NorthStar is building the supply chain that powers the future of radiopharmaceutical medicine. Through its vertically integrated campus in Beloit, Wisconsin, NorthStar produces Copper-67 (Cu-67) and is the industry’s first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron accelerator technology. The company combines isotope production, cGMP radiopharmaceutical manufacturing, and CDMO services in a single infrastructure platform designed to accelerate the development, commercialization, and delivery of life-changing cancer therapies to cancer patients worldwide.

Contacts

For NorthStar:

Eric Nelson

Communications Specialist

608-239-6812

Email: enelson@northstarnm.com