HepaRegeniX completes €21.5 million financing to support clinical advancement of HRX-215 for liver regeneration

HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage company advancing novel therapies to treat acute and chronic liver diseases, today announced the second closing and completion of a €21.5 million financing round with the addition of Wellington Partners to its investor syndicate.

HepaRegeniX plans to use the proceeds to complete its ongoing Phase Ib trial and to advance the Phase IIa clinical trial for HRX-215, the company’s lead clinical candidate in liver regeneration.

“We continue to make significant progress in the clinical evaluation of our lead candidate, HRX-215, and the additional investment is a strong acknowledgment of our achievements and the impressive safety results of HRX-215 in the completed Phase I trials,” said Elias Papatheodorou, Chief Executive Officer at HepaRegeniX. “HepaRegeniX has brought to light the significant therapeutic potential of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4) in multiple indications of high medical need, and we remain committed to making a real difference in the lives of patients that need liver resections due to tumors, for patients in need of a liver transplant, and for patients with chronic and acute liver diseases. As we gain momentum in our clinical development strategy, we appreciate the continued support of our existing investors and the support of Wellington Partners at this important stage in our journey.”

“Wellington Partners is very excited to join and further strengthen the HepaRegeniX investor base in this financing round,” commented Dr. Rainer Strohmenger, Managing Partner at the Munich-based life science venture capital fund. “HepaRegeniX’ approach is highly differentiated and has demonstrated efficacy in several in vivo models for liver diseases with extraordinarily high unmet medical need. We look forward to supporting the generation of meaningful clinical efficacy data in human patients in the near future.”

HRX-215 is a first-in-class, orally available small molecule inhibitor designed to target Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a master regulator of liver regeneration. By selectively inhibiting MKK4, HRX-215 enhances the liver’s natural ability to regenerate. Extensive preclinical studies in mice and pigs have demonstrated that HRX-215 enhances liver regeneration of healthy and diseased livers. Impressively, HRX-215 helps prevent liver failure after extended liver resection. A Phase I clinical trial in healthy participants has further validated its favorable safety and pharmacokinetic profile. HRX-215 represents a new therapeutic approach for indications requiring rapid liver repair, offering a new possibility beyond conventional treatments.

About HepaRegeniX GmbH

HepaRegeniX is advancing therapies to treat acute and chronic liver diseases based on the groundbreaking discoveries of a novel cellular target and small molecules that enable the liver to regenerate rapidly. We do so by harnessing the liver’s inherent regenerative power not only in healthy but also in diseased livers. The company’s lead candidate, HRX-215, an orally available small molecule currently in a Phase Ib/IIa trial, 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 progressing HRX-215 to prevent post-hepatectomy liver

failure, facilitate transplantation of smaller living donor liver grafts, and treat severe alcohol-associated hepatitis. Beyond liver diseases, the company is also developing HRX-233 to target kinase inhibitor treatment resistance in KRAS-driven tumors.

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.

For further information, please contact:

HepaRegeniX GmbH
Elias Papatheodorou
Chief Executive Officer
info@heparegenix.com

Media Inquiries
Trophic Communications
Charlotte Spitz or Jacob Verghese
Email: heparegenix@trophic.eu