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How foundational immunology, advanced cell engineering and open collaboration enabled a groundbreaking new therapy tested in the POLARIS clinical trial. CAMBRIDGE, MA, and SEATTLE, WA, April 23, 2026 — Seattle Children’s Research Institute (SCRI), Benaroya Research Institute (BRI) at Virginia Mason Franciscan Health and GentiBio, Inc. today issued a joint statement highlighting their long standing scientific collaboration supporting the development of GNTI-122 and the ongoing POLARIS Phase 1 clinical trial in adults recently diagnosed with Type 1 diabetes (T1D). The collaboration brings together foundational discoveries from the laboratories of GentiBio scientific co founders Dr. Jane Buckner (BRI) and Dr. David Rawlings (SCRI) with GentiBio’s leadership in cell engineering, translational development, manufacturing and clinical execution. Together, these efforts enabled the advancement of GNTI 122 from early discovery research into a clinic ready investigational therapy. This includes the recent dosing of the first participant in the POLARIS trial. Each group brought a different piece of the puzzle to the table. “GNTI 122 is the result of a rare kind of collaboration, one where discovery science, engineering and development were tightly linked from the beginning,” said Tom Wickham, Ph.D., chief scientific officer of GentiBio. “By evolving and expanding upon our core technologies and unique partnership with BRI and GentiBio, we’ve created a roadmap for a promising precision therapy in T1D,” said Rawlings, director of the Center for Immunity and Immunotherapies at Seattle Children’s Research Institute and Professor, Pediatrics and Adjunct Professor, Immunology at University of Washington. “This program reflects years of shared learning across institutions and emphasizes BRI’s commitment to translating immunology into therapies that can impact the lives of patients and their families” said Buckner, president of Benaroya Research Institute at Virginia Mason Franciscan Health. GNTI 122 brings together three key technological pillars in a single engineered cell therapy, assembled through close collaboration across the three organizations. The foundational discovery for the clinical stage product originated from the Rawlings Lab at Seattle Children’s Research Institute and established methods to generate stable regulatory T cells from bulk CD4 T cells by enforcing expression of the FOXP3 transcription factor, effectively programming the cells with a regulatory identity. The Rawlings Lab also developed the chemically inducible signaling complex (CISC), an engineered module that delivers a targeted IL 2 pathway signal; a critical requirement for regulatory T cell survival and persistence after infusion. BRI leveraged its expertise in identifying human T cell receptors (TCR) to develop a cell product targeting pancreatic islets, selecting a naturally occurring TCR that recognizes a T1D-relevant islet antigen and directs GNTI-122 cells to the pancreas. To establish human proof of principle, the Buckner Lab also developed and applied polyclonal suppression assays using effector T cells derived from people with T1D, demonstrating that GNTI 122 cells could suppress pathogenic immune responses in a disease relevant, patient cell-based system. About GNTI-122 and EngTreg Therapy GNTI-122 is a novel, single-treatment, autologous engineered regulatory T cell (EngTreg) investigational therapy designed to restore immune tolerance by selectively suppressing autoreactive immune responses that drive type 1 diabetes. GNTI-122 cells are designed to migrate to the pancreas and associated lymphoid tissues and remain there to stably mitigate the immune response, preserving endogenous insulin production. GentiBio’s EngTreg platform builds on foundational discoveries in Treg biology, recognized by the 2025 Nobel Prize in Physiology or Medicine, and is designed to deliver targeted, durable immunomodulation with the goal of addressing the root cause of autoimmune disease. About the POLARIS Study Phase 1, Single Dose, Open-LAbel Study of GNTI-122 in Adults with Recently dIagnoSed Type 1 Diabetes (T1D) [POLARIS (NCT06919354)] is a clinical trial enrolling adults aged 18–45 years within 120 days of T1D diagnosis. The study evaluates the safety and tolerability of escalating doses of GNTI-122 and includes secondary and exploratory assessments of pharmacodynamic activity and clinical biomarkers, including measures of beta cell function. Participants are followed for up to 78 weeks. For more information, visit polarisstudy.com or ClinicalTrials.gov. About GentiBio GentiBio is a biotechnology company developing engineered regulatory T cell (EngTreg) therapies to restore immune tolerance and transform the treatment of autoimmune and inflammatory diseases. GentiBio’s EngTregs harness the underlying power of Tregs and are engineered for precision, durability, and scalable manufacture. GentiBio seeks to deliver disease modifying, and potentially curative, therapies for patients with significant unmet need. Learn more at www.gentibio.com. About Seattle Children’s Seattle Children’s mission is to provide hope, care and cures to help every child live the healthiest and most fulfilling life possible. Together, Seattle Children’s Hospital, Research Institute and Foundation deliver superior patient care, identify new discoveries and treatments through pediatric research, and raise funds to create better futures for patients. Ranked as one of the top children’s hospitals in the country by U.S. News & World Report, Seattle Children’s serves as the pediatric and adolescent academic medical center for Washington, Alaska, Montana and Idaho – the largest region of any children’s hospital in the country. As one of the nation’s top five pediatric research centers, Seattle Children’s Research Institute is internationally recognized for its work in neurosciences, immunology, cancer, infectious disease, injury prevention and much more. Seattle Children’s Foundation, along with Seattle Children’s Guild Association – the largest all-volunteer fundraising network for any hospital in the country – works with our generous community to raise funds for lifesaving care and research. For more information, visit seattlechildrens.org; follow us on X, Facebook, LinkedIn and Instagram; or subscribe to our Healthy Tides newsletter. About Benaroya Research Institute at Virginia Mason Franciscan Health Benaroya Research Institute (BRI) is a world leader in human immune system research, working to advance the science that will predict, prevent, reverse and cure immune system diseases like allergies, asthma, cancer and autoimmune diseases. BRI accelerates discovery through laboratory breakthroughs in immunology that are then translated to clinical therapies. We believe that a breakthrough in one immune system disease can lead to progress against them all and work tirelessly toward our vision of a healthy immune system for everyone. BRI is an independent nonprofit research institute affiliated with Virginia Mason Franciscan Health and based in Seattle. To learn more, visit benaroyaresearch.org and connect with us on Facebook, Instagram, Threads, LinkedIn, Bluesky and YouTube. Contact Media email: Hatem.Heikal@gentibio.com Clinical Email: Clinical_Ops@gentibio.com

CHICAGO--(BUSINESS WIRE)--Payment for certain contrast-enhanced ultrasound (CEUS) imaging procedures will double under a newly assigned billing code, according to an announcement by the International Contrast Ultrasound Society (ICUS) which advocated for the reimbursement upgrade. Payment for certain contrast-enhanced ultrasound (CEUS) imaging procedures will double under a newly assigned billing code, according to an announcement by the International Contrast Ultrasound Society (ICUS) which advocated for the reimbursement upgrade. The change, published in the Federal Register today and effective January 1, 2026, will increase non-cardiac CEUS reimbursement from $170.02 to $358.35. It also reassigns non-cardiac CEUS to the same billing code used for contrast-enhanced computed tomography (CT) and magnetic resonance (MR) procedures – namely, APC 5572 (Level 2 Imaging with Contrast). “This change recognizes the specialized nature of contrast-enhanced ultrasound technology and ensures appropriate payment for these services,” according to the final rule promulgated by the Centers for Medicare and Medicaid Services (CMS). ICUS commended CMS for giving hospitals and physicians “a financial incentive that is aligned with best-practice medicine and recognizes the clinical and economic benefits of noninvasive CEUS imaging.” CEUS scans use intravenously-infused microbubble contrast agents to enhance ultrasound images, allowing for visualization of abnormal microvascular blood flow patterns in real time without exposing patients or hospital staff to ionizing radiation. CEUS is used worldwide to help identify and characterize cancers, diagnose heart and vascular disease, monitor chronic gastro-intestinal diseases and monitor therapy. However, its use in the US has lagged in part due to under-reimbursement, according to ICUS. “Studies show that a simple, low-cost CEUS scan can offer sensitivity and specificity equivalent to that of CT and MRI,” according to Dr. Richard G. Barr, Professor of Radiology at Northeast Ohio Medical University and an officer of ICUS. He said studies also consistently show that ultrasound contrast agents are among the safest of all contrast media. “They do not contain iodine or gadolinium, and have not been shown have an effect on thyroid or renal function; in addition, CEUS is considered an ideal imaging option for pregnant patients because it avoids exposure to ionizing radiation and iodinated contrast media, and because ultrasound contrast agents do not cross the placental barrier,” Barr said. In addition, contrast CT or MR are not options for many patients with impaired kidneys due to potential nephrotoxicity or allergic reactions to the CT or MR contrast agents, Barr added. CEUS often reduces health care costs by reducing the need for more expensive downstream testing and unnecessary interventional procedures, according to Dr. Steven Feinstein, Co-President of ICUS. Feinstein said that because CEUS may be administered at the bedside and offers a reliable diagnosis in real time, it can avoid the need to transport patients to a CT or MR imaging suite, reduce delays associated with CT and MR, streamline workflows, speed up the time to diagnosis, improve patient outcomes and save lives – even in the sickest patients. “CEUS costs far less than contrast MR or CT, and it often does a better job,” Barr said. Three ultrasound contrast agents are commercially available in the United States: Lumason (Bracco Imaging); Definity (Lantheus); and Optison (GE Healthcare). However, Lumason is the only ultrasound contrast agent approved non-cardiac indications by the U.S. Food and Drug Administration. ABOUT ICUS: The International Contrast Ultrasound Society (ICUS) is a nonprofit medical society dedicated to advancing the safe and medically appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care. Membership in ICUS is free of charge and there is no fee for ICUS educational programs, CME credits, newsletters or other resources. To join ICUS and learn more about CEUS, visit www.icus-society.org and download ICUS CONNECT, the free ICUS mobile app.