This new fundraising secures the financing of its Phase IIB study for HepaStem® in its flagship indication, Acute on Chronic Liver Failure (ACLF), a severe liver disease affecting more than 50000 patients each year in EU and USA , with a 40% to 70% mortality .
Mont-Saint-Guibert, Belgium, 30th June 2021 – Promethera Therapeutics SA, a pioneer in cell therapies for severe liver diseases, today announces a financing agreement for an amount of € 20M. This fundraising will allow the progress of the clinical development of HepaStem®, aimed to serve as alternative to liver transplant thanks to stem cell therapy restoring liver health. Belgian, German and Chinese investors contribute to this new fundraising. Through its affiliate Shang Ying International Holdings Limited, the Chinese company Tata Health International Holding Co., Ltd., a company listed on the Hong Kong Stock Exchange will invest an amount of € 10M in the Walloon company. At the same time, a license agreement will allow the clinical development of Hepastem® in China. Fund Plus (Leuven, Belgium), SMS Investments SA (Luxembourg), Sopartec (UCLouvain Technology Transfer Office, Louvain-la-Neuve, Belgium) and various private investors as well as Sofipôle, Invest.BW and Sambrinvest are part of the consortium of investors. The Walloon government has brought its support to the transaction.
Final closing will take place in the summer after approval of the transaction by the Hong Kong Stock Exchange.
This fundraising is intended to conduct Hepastem®'s Phase IIB clinical trial in the continuity of Phase IIA which has demonstrated safety and preliminary signs of efficacy in ACLF. It aims to demonstrate the effectiveness of Hepastem® in improving liver function and survival of ACLF patients.
Acute-on-chronic liver failure (ACLF) is an acute complication of chronic liver disease caused by toxic, viral or immune injuries of the liver. ACLF affects more than 50000 patients in the EU and USA every year and is associated to a very high short-term mortality of 40% to 70% depending on the stages of severity. In ACLF, the liver failure is complicated by that of one or more organs such as the heart, the lungs, the brain. ACLF reaches 30% of patients hospitalized for acute decompensation of liver cirrhosis. Strong systemic inflammation is one of the features in the pathophysiology of this syndrome and there is no treatment. At present, liver transplantation remains the only clearly identified option for ACLF, but the presence of uncontrolled comorbidities or infections, the shortage of organs to be transplanted, as well as other patient characteristics limit the eligibility of patients with ACLF for liver transplantation.
HepaStem® aims at bringing a therapeutic alternative. Liver stem cells are administered to the patient intravenously and are transported through the blood into the liver, in the intent to reduce the severe systemic and liver inflammation, and thereby, restoring liver health.
"We welcome our new investors and thank them for their trust. This new phase of our clinical development offers a great opportunity for growth for the company but also a therapeutic innovation for the hepatological community, that of participating in the development of a drug of a new kind, and which we hope will bring patients a real benefit in this lethal disease, without current therapeutic solution" declared Prof Etienne Sokal, historical Founder and Chairman of the Board of Promethera.
"Wallonia is once more demonstrating its solid biotechnology expertise and its attractiveness for investors in the field, as a recognition of the long-standing efforts to revamp the industrial landscape in high technology and life science sector" said Minister Willy Borsu, Vice President of Wallonia and Minister of Economy, Research & Innovation.
Mr. Yang Jun, Chairman of the Board of Directors of TATA Health International Holdings, said: "We are delighted and looking forward to the cooperation with Promethera® Therapeutics. We hope that with the technical expertise of Promethera® Therapeutics in liver cell therapy and the layout and resources of our group in domestic medical and big health industries, we can bring gospel to patients with liver diseases in China and Asia, and maximum value for shareholders."
"With this new fundraising, Promethera® accelerates its development after having recently recentered its activities on key and most promising indications. This roundtable is an important token of our investor’s trust in our renewed strategy, focusing on our key assets", says Etienne Sokal.
About Promethera® Therapeutics SA
Promethera® Therapeutics SA is a global innovator in the treatment of liver diseases, whose mission is to offer patients high technology treatments to increase the chances of survival and reduce the need for liver transplantation. Our main clinical program is derived from our patented HepaStem® cellular technology platform.
Promethera®, HepaStem®, H2Stem® are all registered trademarks of the PROMETHERA® Group.
HepaStem® is an advanced therapy medicinal product intended to bring an alternative to transplantation. HepaStem® is a drug manufactured from healthy human liver tissue and produced on a large scale under GMP (Good Manufacturing Practice) conditions. HepaStem® is administered by simple peripheral intravenous infusion and is transported through the bloodstream to the inflamed liver. Preclinical and clinical results suggest that HepaStem® may reduce inflammation and fibrosis through its ability to perform paracrine regenerative and immunomodulatory functions on CD4+ T cells and liver cells. These combined effects are expected to play a favorable role in the restoration of liver homeostasis. HepaStem® is currently being tested in ACLF (clinical Phase IIB). Additional liver diseases’ treatments are also under development pre-clinical stage.
Promethera® Therapeutics SA
About Tata Health International Holding Co., Ltd. (Stock code: HK 1255)
Tata Health International Holding Co., Ltd., formerly known as S.Culture International Holdings Limited (Stock Code: HK1255, hereinafter referred to as "Tata Health"), is an old local enterprise in Hong Kong listed on the main board of Hong Kong. As a distributor and retailer with stable business, Tata Health International Holding Co., Ltd. formerly acted as an agent for the distribution of fashion and comfortable footwear products of many international brands, including Clarks, Josef Seibel, Clarks The FlexX and Yokono.
Since 2017, the company has carried out diversification strategy. Following the acquisition of DSG, a local financial service company in Hong Kong, the company has begun to focus on the transformation to the big health strategy. Subsequently, it has established Zebra, a cross-border e-commerce platform for health care products, and sales channels for health care products in China through the acquisition of Six Avenue Plus Co. Ltd (SAP). In addition, through cooperation with Century Health Holdings Co., Ltd., a joint venture company, AXS, a brand of health care products, has been established, and a series of health care products have been developed, produced and sold.
In 2019, through the acquisition of Shangying Internet Medical Co., Ltd., the first and only one with internet medical license in Shanghai, China, the transformation of great health was successfully completed. Since then, the company has been actively seeking investment opportunities in the medical and health care business, including expanding into the biological science industry. Life science research is a part of the field of big health. The company believes that investment and participation in life science research will deepen and expand its development plan in the health care industry, so as to enhance the overall interests of the company and its shareholders.
About Invest.BW SA
Invest.BW is a Belgian regional evergreen investor with more than € 100M under management. Its strategy is to invest in all stages of company developments with the aim to support entrepreneurs in their long-term ambitions.
About Sambrinvest SA
With 35 years of experience alongside entrepreneurs, more than 270 companies in portfolio and € 160M under management, Sambrinvest is a major player in venture capital in the region of Charleroi Métropole, Wallonia, Belgium. More than an investor, Sambrinvest is the catalyst for local ecosystems development, such as Biotech, Digital and Engineering. Thanks to its expertise, it advises entrepreneurs at every development stage of their projects whilst respecting their management autonomy.
About Fund Plus SA
Fund plus is a Belgian Investment fund based in Leuven, Belgium, and was created in 2015 by the private foundation Désiré Collen and the nonprofit organization Life science Research Partners.
Fund+ invests in innovative life sciences companies primarily active in therapeutics, as well as companies developing diagnostics and medical devices.
As of today, Fund+ has raised € 200M of financing commitments. The investors are high net worth individuals, family offices and governmental agencies, which all share the same long-term vision and societal values of the founders. The intended investment size per company will be between 5 and 15M € spread over different milestones.