Promethera Biosciences raises €25.33 million ($31.4 million) in Series C financial round

Promethera Biosciences raises €25.33 million ($31.4 million) in Series C financial round

  • Promethera Biosciences raises €20.33 million in capital and €5 million in loans and subsidies from the Walloon region (Belgium)

  • This is one of the major life sciences financing rounds in Europe this year. The current Promethera Biosciences investors are joined by SFPI-FPIM and SMS Investments

  • The new round supports the clinical development of HepaStem

Mont-Saint-Guibert, Belgium, November 25, 2014 – Promethera Biosciences, a Belgian biotechnology company developing Promethera® HepaStem, a cell-based therapy for the treatment of in-born errors of metabolism and acquired liver diseases, today announces the completion of its Series C fundraising round. The company has raised €25.33 million ($31.4 million), including €20.33 million in capital.
The financing round is supported by existing Promethera Biosciences investors and two new investors: SFPI-FPIM, the Belgian Federal Holding and Investment Company, and SMS Investments, a Luxemburg based subsidiary office of the German SMS group.
The success of the Series-C fundraising is the result of the completion of the HepaStem phase I/II study, following a Series B fundraising in March 2012 when €17 million in equity was raised. Promethera Biosciences has attracted two new investors in this new round, securing a third capital increase of €20.33 million. SFPI-FPIM, the Belgian Federal Holding and Investment Company, and SMS Investments, a Luxemburg based subsidiary office of the German SMS group, have now acquired equity in Promethera Biosciences. They join the company's historical international investors: Vesalius Biocapital and Boehringer Ingelheim Venture Fund (the venture capital fund of the German pharmaceutical group) the lead investors; SRIW; Shire, a leading UK biopharmaceutical company; Mitsui Global Investment, the venture capital fund of Japanese industrial conglomerate Mitsui & Co Ltd. and Pall-ATMI LifeSciences; Vives-Louvain Technology Transfer Office Fund; as well as several business angels.
In addition, the Walloon region, which has backed the company since its inception, has granted loans and subsidies of €5 million to support the clinical development of HepaStem and the collaborative program with EMD-Millipore.
"We have made substantial progress and obtained significant achievements during the past three years, including the successful completion of our phase I/II clinical trial with Promethera® HepaStem in Urea Cycle Disorders and Crigler-Najjar disease. The study provided positive safety and preliminary efficacy data that enabled us to pursue the development of these indications. In addition, we have already obtained the first authorization for the HEP002 study, a phase IIb/III clinical trial in Urea Cycle Disorders," said Eric Halioua, chief executive officer of Promethera Biosciences.
"We are hopeful that Promethera's technology will shift the treatment paradigm for patients living with orphan liver diseases. We see a lot of interest from healthcare professionals who are eager to see this innovative therapy become a reality to support patients with high unmet medical needs," said Professor Etienne Sokal, chief scientific officer and founder of Promethera Biosciences, pediatric hepatologist at Cliniques Universitaires Saint-Luc (Belgium).
"We welcome the continued strong support of the Walloon region and the new funding by the existing and new investors Belgian SFPI-FPIM holding and SMS Investments. We hope to raise additional funds in the coming months in order to maximize the potential of the product and develop HepaStem in large acquired adult liver indications," said Alain Parthoens, partner at Vesalius Biocapital.
The major innovation of Promethera HepaStem, based on Heterologous Human Adult Liver Progenitor Cells (HHALPC), lies in its potential to treat a wide variety of congenital and acquired liver diseases.

About Promethera Biosciences
Promethera Biosciences is a clinical stage pharmaceutical company that develops innovative therapies for the treatment of liver diseases. In addition, it is currently developing two products based on human liver progenitor cells:
Promethera® HepaStem is a cell therapy product based on the use of allogeneic stem cells isolated from healthy adult human livers (Heterologous Human Adult Liver Progenitor Cells, HHALPC). These cells can be used to treat a wide variety of liver diseases, from rare inborn metabolic diseases (which can be classified as 'orphan diseases' and mainly affect children), to acquired deficiencies affecting adults, such as fulminant hepatitis or liver fibrosis. This treatment has already received the orphan drug designation from the European Medicines Agency for the treatment of two very debilitating pediatric pathologies and from the Food and Drug Administration (USA) for both indications.
Promethera® H2Screen & H3Screen is a non-therapeutic in vitro product, based on a recently discovered and patented liver progenitor cell type, isolated from healthy adult human livers. This novel biotechnology tool is designed for early preclinical pharmaco-toxicological evaluation of drug candidates and new chemical entities.
Promethera Biosciences is a spin-off of the Université Catholique de Louvain (UCL). Founded in 2009, it is located in Mont-Saint-Guibert, Belgium.
Since its creation in 2009, Promethera Biosciences has raised €65.5 million in three financial rounds; in capital, grants and loans from the Walloon region. The main investors are Vesalius Biocapital, Mitsui Global Investment, Boehringer Ingelheim Venture Fund, Shire and SRIW. Promethera Biosciences has 44 employees led by an experienced management team.
LinkedIn: Promethera Biosciences
About UCD and HEP002 study
Urea Cycle Disorders (UCD) are rare diseases, with an incidence between 1 in 8,000 and 1 in 44,000. Most patients have limited therapeutic options and may die at an early age. UCD are a group of enzyme deficiencies that affect the transfer of nitrogen into urea. Hyperammonemia and hyperglutaminemia are the common biochemical hallmarks of these disorders.
HEP002 is a prospective, open label, multicenter, efficacy and safety study with Promethera® HepaStem. The primary objective is to assess the efficacy of Promethera® HepaStem in patients with urea cycle deficiencies during the year following treatment. In the first clinical trial HEP001 Promethera® HepaStem demonstrated to be a safe treatment that can result in functional metabolic improvement in UCD patients.

About the Investors
Pall-ATMI LifeSciences Pall Corporation is providing filtration, separation and purification solutions for your fluid management needs. Pall Lifesciences Single-Use Technologies mission is to be the most trusted provider of cost effective single-use process solutions that meet quality and regulatory requirements from upstream to formulation and filling and are supported by comprehensive technical services.
Boehringer Ingelheim Venture Fund was formed in March 2010 to invest in biotechnology and start-up companies to help drive innovation in medical science. These may include – but are not limited to - novel technologies to address so far undruggable targets, new generation vaccines and new biological entities, such as antibody-dependent oncolysis. Novel therapeutic targets and disease-related biomarkers, as well as new approaches in regenerative medicine, are an additional focus.
Mitsui Global Investment (MGI) is a subsidiary of Mitsui & Co. Ltd., which invests in opportunities that have potential for growth. Headquartered in Tokyo, the company has offices in Silicon Valley, New York, Shanghai, Beijing, Mumbai and London (Alliance Team office) and its investments reach beyond these geographical barriers, reflecting a diversified global portfolio.
Sambrinvest is an actor in risk capital in the region of Charleroi in Belgium, based in the aeropole of Gosselies, with the objective of supporting the development of SMEs. Thanks to its expertise, it advises entrepreneurs at every development stage of their projects whilst respecting their management autonomy.
SFPI-FPIM, the Federal Holding and Investment Company, was created on 1 November 2006 as a result of a merger between the Federal Participation Company and the Federal Investment Company. The federal government is the sole shareholder of the Federal Holding and Investment Company. SFPI-FPIM centrally manages the federal government's shareholdings, cooperates with the government on specific projects and pursues its own investment policy in the interests of the Belgian economy. The core business of SFPI-FPIM is, as an investment company, to invest in companies with an attractive added value for the society in one of the SFPI-FPIM priority sectors, and, as a holding company, to acquire equity in companies that are of strategic importance as far as federal policy is concerned, either making use of its own funds or by using funds that the state provides per project.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
SMS Investments: SMS Investments is a Luxemburg based subsidiary of the German SMS group, a family-owned group of companies active in plant and machinery construction for the processing of steel and NF metals. Via its internal asset management activities SMS group invests into a diversified portfolio consisting of liquid assets as well as of private equity and venture capital.
Sopartec & Vives-Louvain Technology Fund Vives-Louvain Technology Fund is a multi-sectorial technology investment fund that invests in UCL spin-offs and start-ups in Belgium and neighboring countries. The objective of the fund is to invest in the development of start-ups from technological validation through to commercial maturity. The funds (Vives 1 of €15m and Vives 2 of €43m) are managed by Sopartec, the technology transfer company of the Université Catholique de Louvain (UCL). Sopartec, a member of the Louvain Technology Transfer Office (LTTO), together with the University´s Research Administration (ADRE) are in charge of the overall technology transfer process. This covers the financing of research contracts, the identification of inventions within the laboratories, the protection and management of intellectual property as well as the technological maturation. More specifically, Sopartec coordinates the management of licensing agreements and the technological maturation of UCL spin-offs. More than 50 spin-offs, which today generate more than 3,000 jobs, have been created in whole or part from the results of research conducted at the UCL. These include Ion Beam Application (IBA), I.R.I.S. Group, IbT, Telemis, Alterface, Cissoid, Viridaxis, Promethera, etc.
SRIW (Société Régionale d'Investissement de Wallonie/ the Wallonia Regional Investment Company) provides finance within and outside Belgium for businesses undertaking industrial projects or providing services that generate added value. For the last 30 years, the company has in this way been facilitating the Walloon Region of Belgium's economic development, contributing effectively and in real terms to the modernization, growth and restructuring of businesses that make up our industrial fabric
Vesalius Biocapital invests in companies active in human health through venture capital funds raised since 2007. It has contributed to developing twelve companies since inception, one of which was acquired through a trade sale. With over €120 million under management in two funds, Vesalius Biocapital Partners plays the role of lead investor in the large majority of its financing rounds. Vesalius Biocapital companies are based in Europe, allowing easy interaction with management. Investments are in all stages of development and do not shy away from relatively early-stage projects with a sound proprietary technology and corresponding IP, unique team skills and a clear competitive edge based on solid data. The investment strategy is focused on four areas: therapeutics, medical devices, diagnostics and novel food applications.