Satellite Biosciences, Inc. (Satellite Bio), a clinical-stage biotechnology company developing off-the-shelf liver therapies designed to restore liver function in patients with severe liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SB-101, an investigational medicine for the treatment of urea cycle disorders (UCDs). SB-101 is a first-in-class, off-the-shelf liver cell therapy being developed to restore essential liver function and help protect the brain in individuals with severe liver disease. The UCD diseases SB-101 is designed to treat are among the most devastating diseases affecting infants with no curative treatments available in the first weeks of life.

The liver performs more than 500 vital functions, including detoxifying harmful substances such as ammonia, processing nutrients, and producing essential blood proteins. Severe liver diseases occur when hepatocytes, the liver’s functional cells, can no longer perform these critical activities. Satellite Bio is developing off-the-shelf therapies that deliver healthy liver cells into the body to replace lost liver function and restore the vital processes patients need to survive. Satellite Bio’s therapies are enabled by a proprietary cell expansion and manufacturing process designed for large-scale production.

“We are thrilled to transition to clinical-stage company with this cleared IND. While Satellite Bio is initially focused on UCDs, our platform’s ability to deliver healthy hepatocytes to address a broad range of liver diseases means the clinical entry of SB-101 is the first of a much broader pipeline,” said Tom Lowery, PhD, President and Chief Executive Officer of Satellite Bio. “We believe SB-101 has the potential to be a transformative treatment for individuals with early onset UCDs as well as other severe liver diseases. FDA clearance of our IND, together with the Agency’s recent Rare Pediatric Disease designation for SB-101, represent important milestones as we enter the clinic for the first time.”

Urea cycle disorders are rare inherited diseases in which the liver cannot effectively convert toxic ammonia into urea for elimination. As ammonia accumulates, patients can rapidly develop irreversible brain injury, seizures, encephalopathy, coma, multi-organ failure, and death. Current treatment options remain inadequate, with mortality rates exceeding 25%, cognitive impairment affecting approximately half of surviving patients, and no curative treatment available during the first weeks of life.

Satellite Bio plans to initiate a Phase 1/2 clinical trial designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of SB-101 in infants with severe early onset UCDs in late 2026.

Manufactured in advance, cryopreserved, and ready when needed, SB-101 is intended to provide an off-the-shelf therapeutic option for infants with UCDs requiring urgent treatment. Satellite Bio’s platform supports multiple therapeutic strategies by delivering healthy liver cells to receptive sites in the body, where they can engraft and restore function. Just as prior breakthrough biologic therapies reshaped treatment across cancer and autoimmune diseases, Satellite Bio aims to harness living cells as medicines to address severe liver disease at its source.

About Satellite Bio

Satellite Bio is a biotechnology company developing off-the-shelf liver therapies designed to address dysfunctional liver cells, the root cause of hepatic insufficiency, with the goal of restoring failing cellular function and improve liver performance in patients with severe life-threatening liver diseases. By combining deep biological understanding with a proprietary, scalable manufacturing and two complementary therapeutic strategies, the company is positioned to redefine how hepatic insufficiency is treated. For more information, visit www.satellite.bio.

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