ReAlta Life Sciences announced it has closed an oversubscribed $40 million financing round to support the continued development of its lead therapeutic candidate, Pegtarazimod, for the treatment of Hypoxic Ischemic Encephalopathy. The latest financing brings the company’s total capital raised to more than $150 million since its founding.
The proceeds will be used to advance pegtarazimod through key clinical and regulatory milestones, including completion of the ongoing Phase 2 STAR trial, top-line data readout, and an End-of-Phase 2 meeting with the U.S. Food and Drug Administration. The STAR trial is currently enrolling patients across 13 neonatal intensive care units in the United States and is evaluating the therapy in newborns with moderate to severe HIE undergoing therapeutic hypothermia.
ReAlta is developing pegtarazimod as a first-in-class dual-targeting peptide designed to address the underlying inflammatory drivers of HIE. The therapy works by inhibiting complement activation and neutrophil-mediated inflammation, mechanisms believed to contribute to brain injury following oxygen deprivation at birth.
HIE remains a serious and often devastating condition affecting thousands of newborns each year, with no approved drug therapies currently available. Existing treatment options are limited to therapeutic hypothermia, which provides only modest benefit. The company believes its approach could represent a fundamentally new treatment category aimed at improving neurological outcomes in affected infants.
Pegtarazimod has received both Orphan Drug and Fast Track designations from the FDA, as well as Orphan Drug designation from the European Medicines Agency, reflecting the significant unmet medical need and potential impact of the therapy.
KEY QUOTES
“Every year, thousands of newborns suffer devastating brain injury from HIE with no approved drug therapy to offer them. Rarely in a career does one have the opportunity to work on a program with this level of both scientific rigor and human urgency. This financing reflects strong conviction in pegtarazimod’s potential to change that reality. By targeting both complement activation and neutrophil-driven inflammation, which are the upstream drivers of brain injury in HIE, pegtarazimod represents a fundamentally different and potentially transformative approach. We believe that we are well-positioned to deliver on the key milestones ahead.”
Howard Berman, Ph.D., Chief Executive Officer, ReAlta Life Sciences
“This financing allows us to execute against key value-inflection points with a disciplined and focused strategy. We are committed to deploying this capital efficiently to generate meaningful clinical and strategic milestones. Our team is creating a new category of medicine for HIE patients where currently no drug therapeutic option is available. The financing enables us to accelerate our work toward realizing that vision. The goal here is not to provide incremental improvement, but to fundamentally change how doctors treat newborn babies who develop HIE.”
Kia Motesharei, Ph.D., President And Chief Operating Officer, ReAlta Life Sciences
