10.07.2024 09:00:24 - dpa-AFX: EQS-News: HepaRegeniX raises EUR15 million Series C round to advance clinical development of HRX-215 for liver regeneration (english)

HepaRegeniX raises EUR15 million Series C round to advance clinical
development of HRX-215 for liver regeneration

EQS-News: HepaRegeniX GmbH / Key word(s): Financing/Personnel
HepaRegeniX raises EUR15 million Series C round to advance clinical
development of HRX-215 for liver regeneration

10.07.2024 / 09:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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HepaRegeniX raises EUR15 million Series C round to advance clinical
development of HRX-215 for liver regeneration

  * Funds to support Phase Ib clinical trial of HRX-215 in the US and an
    international multicenter Phase IIa clinical trial in liver regeneration


* Elias Papatheodorou moves from Chair of the Board to CEO of HepaRegeniX

* Dr. Linda Greenbaum joins HepaRegeniX as CMO

Tuebingen (Germany), July 10, 2024 - HepaRegeniX GmbH, a clinical stage
company developing a novel regenerative therapy for the treatment of acute
and chronic liver diseases, today announced the closing of a Series C round
led by Vesalius Biocapital IV with participation of existing investors Novo
Holdings, Boehringer Ingelheim Venture Fund (BIVF), and High-Tech
Gründerfonds (HTGF). The new funds of EUR15 million will be used to advance
the clinical development of the Company's clinical candidate HRX-215.

As part of the financing, Fabienne Roussel, Partner at Vesalius Biocapital,
joins the Non-Executive Board of Directors. Elias Papatheodorou will become
Chief Executive Officer, moving from Chair of the Board.

Elias Papatheodorou, Chair of the Board, said: "We are thrilled to secure
this significant financing, which underscores the confidence our investors
have in our science and our capabilities to bring effective treatments to
patients suffering from liver diseases. With the new funds, HepaRegeniX will
advance with its clinical plans for a Phase Ib study in the US and an
international Phase IIa study to enhance liver recovery and prevent liver
failure."

HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP)
Kinase
Kinase 4 (MKK4). Inhibition of MKK4 unlocks the regenerative capacity of
hepatocytes and can strongly boost liver regeneration in patients. This is
highly relevant for patients with liver metastases or primary liver tumors,
as resection of the tumors is the only curative therapeutic approach. Liver
regeneration is also key in liver transplant and especially in enabling left
liver lobe living donor transplant. This strategy could significantly reduce
waiting lists for liver transplant candidates. Promising preclinical data
have confirmed HRX-215's capacity for liver regeneration, and HepaRegeniX
has successfully completed a Phase I trial. These results have been
published in the prestigious journal Cell.

"Vesalius Biocapital is excited to support HepaRegeniX as it progresses into
the next phase of clinical development for HRX-215. There is an immense need
for a treatment that can induce liver regeneration in patients suffering
from liver damage, liver tumors, as well as in transplant settings. HRX-215
has potential to help these patients and make a meaningful impact on their
lives. I look forward to working with HepaRegeniX' excellent leadership team
to advance this promising treatment candidate," commented Fabienne Roussel,
Partner at Vesalius Biocapital IV.

Importantly, to take HepaRegeniX through the next stages of clinical
development and value creation, Dr. Linda Greenbaum is joining HepaRegeniX
as Chief Medical Officer (CMO). She brings extensive expertise and
experience in clinical development and translational medicine. She recently
served as Executive Director, Translational Medicine at Novartis in the US.
Before joining Novartis, she held the position of Director of Clinical
Development at Janssen R&D and served on the faculty of Thomas Jefferson
University and University of Pennsylvania where she led a research
laboratory investigating liver regeneration and fibrosis. Dr. Greenbaum
holds an MD from the Columbia University Vagelos College of Physicians and
Surgeons.

"I am honored to join HepaRegeniX at such a critical juncture in its
development," added Dr. Linda Greenbaum, Chief Medical Officer of
HepaRegeniX. "MKK4 is a key regulator of liver regeneration, and MKK4
inhibition has been shown to induce liver regeneration after a partial
hepatectomy. With this mode of action, HRX-215 has an immense potential to
improve outcomes for patients who are currently not able to undergo
potentially curative surgical resections due to liver tumors, and other
patient groups affected by liver failure. I look forward to working with the
talented team at HepaRegeniX to advance the clinical development of HRX-215
through Phase II trials and beyond, with the ultimate goal of improving
outcomes for patients with liver diseases worldwide."

Elias Papatheodorou concluded: "It is a pleasure to welcome Dr. Linda
Greenbaum to our leadership team. With her extensive knowledge and
expertise, she will guide the future clinical development of HRX-215. With
our new funding and the extension to our experienced leadership team, we
hope to bring a much needed therapy to patients suffering from liver
diseases."

For further information please contact:

HepaRegeniX GmbH
Elias Papatheodorou
Chair of the Board
info@heparegenix.com

For media inquiries:

MC Services AG
Katja Arnold, Dr. Regina Lutz
+49 89 210 228-0
UK: Shaun Brown
M: +44 7867 515 918
heparegenix@mc-services.eu

About HepaRegeniX GmbH - www.heparegenix.com
Since 2017, HepaRegeniX has successfully discovered and developed several
drug candidates for the treatment of acute and chronic liver diseases based
on a novel proprietary molecular target Mitogen-Activated Protein (MAP)
Kinase
Kinase 4 (MKK4). The first MKK4 inhibitor HRX-215 recently completed Phase 1
clinical testing. MKK4 is a key regulator of liver regeneration and
suppression of MKK4 unlocks the regenerative capacity of hepatocytes even in
severely diseased livers. This new and unique therapeutic concept was
discovered by Prof. Lars Zender and his research group at the University
Hospital Tuebingen, Germany. Investors in HepaRegeniX include Vesalius
Biocapital IV, the Boehringer Ingelheim Venture Fund (BIVF), Novo Holdings
A/S, Coparion, High-Tech Gründerfonds (HTGF) and Ascenion GmbH.


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The issuer is solely responsible for the content of this announcement.

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