HepaRegeniX to Present Interim Phase 1b Data for Darizmetinib (HRX215) in a Late-Breaking Oral Presentation at the European Association for the Study of the Liver (EASL) Congress 2026

Tuebingen, Germany, May 13, 2026 – HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage biotech company advancing novel therapies for acute and chronic liver diseases, announces that its abstract highlighting clinical data for the lead candidate darizmetinib (formerly HRX215) has been selected for a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2026, taking place from May 27-30, in Barcelona, Spain. Dr. Tillmann Taube, Senior Medical Director at HepaRegeniX, will present late-breaking interim Phase 1b data for darizmetinib, an orally available small molecule inhibitor of Mitogen-Activated Protein Kinase Kinase 4 (MKK4), a key regulator of liver regeneration being investigated in patients after hepatectomy due to colon carcinoma metastases. HepaRegeniX will also present the scientific rationale for darizmetinib and MKK4 inhibition at the 5^th International Symposium on Regenerative Hepatology on May 26, organized by the EASL Consortium for Regenerative Hepatology.

“Darizmetinib is the first targeted therapy designed to accelerate and enhance the liver’s natural regenerative capacity in both healthy and diseased liver tissue,” said Dr. Tillmann Taube, Senior Medical Director at HepaRegeniX. “By accelerating liver regeneration, our approach may prevent liver failure after liver resections or after transplantation of small liver grafts, thereby expanding access to potentially life-saving treatment options. At the EASL Congress, I will be presenting interim clinical data from the pilot cohort of an ongoing Phase 1b/2a study, which is investigating darizmetinib in patients undergoing liver resection surgery due to colorectal cancer liver metastases.”

EASL Congress Presentation Details

Title: Safety, pharmacokinetics, and clinical activity of HRX215 after hepatectomy due to colon carcinoma metastases: interim results from pilot cohort of a 1b/2a clinical trial

Presenter: Dr. Tillmann Taube

Date and Time: May 30, 2026, from 1:45 – 2:00 pm CEST

Session: Late breaker

Abstract number: LB26-5130

Presentation number: LBO-004

About Darizmetinib (HRX215) and Liver Regeneration

For patients with colorectal cancer liver metastases (CRLM) and other cancers affecting the liver, surgical resection remains the most effective potentially curative treatment. Successful liver resection depends on the ability of the remaining liver, known as the future liver remnant (FLR), to sustain essential functions and regenerate. When the FLR is insufficient in volume or function, the risk of post-operative liver failure increases significantly, rendering many patients ineligible for potentially curative surgery.

Darizmetinib (formerly HRX215) is an orally available small molecule inhibitor of Mitogen-Activated Protein Kinase Kinase 4 (MKK4), a key regulator of liver regeneration. In preclinical models, darizmetinib has been shown to selectively inhibit MKK4, stabilizing and protecting hepatocytes while accelerating and enhancing regenerative processes, even in compromised or diseased livers. This therapeutic approach, currently explored in a Phase 1b/2a trial (NCT06638502), has the potential to expand surgical eligibility to patients requiring extended liver resection who would otherwise be deemed inoperable, offering a new path to potentially lifesaving treatment. Darizmetinib has the potential to transform the field of liver transplantation by preventing liver failure after the transplant of small liver grafts, thereby expanding living donor transplantation and offering novel therapeutic approaches for acute and chronic liver diseases with limited therapeutic options.

About HepaRegeniX GmbH

HepaRegeniX is advancing therapies to treat acute and chronic liver diseases based on groundbreaking discoveries of a novel cellular target and small molecules that enable rapid liver regeneration. We do so by harnessing the liver’s inherent regenerative power not only in healthy but also in diseased livers. HepaRegeniX’s lead candidate, darizmetinib (HRX215), is an orally available small molecule that selectively inhibits Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a master regulator of liver regeneration. Building on demonstrated safety in clinical trials, HepaRegeniX is advancing darizmetinib in a Phase 1b/2a trial to prevent post-hepatectomy liver failure, with potential applications in living donor liver transplantation and severe alcohol-associated hepatitis. Beyond liver diseases, the company is also developing HRX233 in oncology.

HepaRegeniX is backed by experienced life science investors, including Vesalius Biocapital IV, Novo Holdings A/S, Boehringer Ingelheim Venture Fund (BIVF), Coparion, High-Tech Gründerfonds, Ascenion GmbH and Wellington Partners.

Visit our website at www.heparegenix.com to learn more about the company.