Amsterdam, The Netherlands, June 3, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma”, “Kiadis” or “the Company”), a clinical stage biopharmaceutical company developing innovative cellbased immunotherapy treatments, announces today its intention to raise new funds through an Initial Public Offering and listing of the entire share capital of a newly incorporated holding company on Euronext Amsterdam and Euronext Brussels.
Innovative cell-therapy for HSCT: Kiadis Pharma develops ATIR™, an innovative cell-therapy for allogeneic hematopoietic stem cell transplantation (HSCT). HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders, yet not a viable option for many patients given the risks and limitations of current HSCT treatments.
Meets significant unmet medical need: ATIR™ addresses the key risks and limitations of current HSCT treatments in blood cancers and inherited blood disorders, being: opportunistic infections, graft-versus-host-disease (GVHD), cancer relapse and limited donor availability. Consequently, ATIR™ enables the safer use of partially matched (haploidentical) family members as stem cell donors for those patients that would otherwise not find a matching donor in time, thereby meeting a significant unmet medical need.
Phase II trial for leukaemia: The Company’s lead product, ATIR™101, is currently in an international Phase II trial for leukaemia. The trial is being conducted in hospitals in Belgium, Canada, Germany and the UK. Trial results are expected at the beginning of 2016.
Obtained positive Phase II interim data: Positive interim data from the ongoing Phase II clinical trial for ATIR™101 were announced in December 2014, supporting the safety profile and showing efficacy of ATIR™101.
Market potential: Kiadis Pharma believes that ATIR™101 has the potential to provide a lifesaving therapy to approximately 19,000 patients in key countries worldwide, with a substantial expanding primary market and complementary product trends.
Second product for thalassemia: Kiadis Pharma’s second product, ATIR™201, is expected to be developed for inherited blood disorders with an initial focus on thalassemia.
Granted EMA manufacturing quality certificate: The Company has a robust, GMP-compliant manufacturing process in use in North America and Europe. It is one of five companies to have ever been issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA).
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “ATIR™ has the potential to make life-saving transplants available to a much larger group of patients, significantly improving success rates and lowering healthcare costs. As we seek to bring this product through clinical development and towards authorisation and commercialisation, we believe this initial public offering will support the strong momentum already established by Kiadis.”
Mark Wegter, Chairman of Kiadis Pharma, added: “Kiadis Pharma is operating in the very exciting immune-oncology space and has products in development that have the potential to make a huge impact on society. Thanks to Kiadis there are already many blood cancer patients still alive that would not have survived without the Company’s lead product, ATIR™101. Kiadis is in my view one of the most exciting biotech companies in the Netherlands and is now operating on a truly international stage due to its ongoing clinical trial and manufacturing activities in Europe and North America. The intended launch onto the public markets demonstrates the significant progress the experienced team at Kiadis has delivered. We are determined to develop our products through to commercialisation and build Kiadis into a worldclass
Clinical development plan
– Subject to the outcome of the ongoing Phase II trial, which is expected in the first quarter of 2016, the Company intends to file for conditional approval in the European Union and Canada for ATIR™101 in the fourth quarter of 2016.
– A Phase III trial for ATIR™101 is envisaged to start in the second quarter of 2016 which is expected to result in filing for marketing authorisation with EMA, FDA and Health Canada in 2019.
– ATIR™201 is expected to enter clinical development for thalassemia with a Phase I/II trial in the first quarter of 2016.
Kiadis Pharma intends to offer new ordinary shares in the IPO of a newly incorporated holding company and to seek admission to listing and trading of the entire share capital of such holding company on Euronext Amsterdam and Euronext Brussels. The Company intends to use the net proceeds of the Offering for the further clinical development of ATIR™101 and ATIR™201, production process optimisation and automation, working capital needs and general corporate purposes.
Kempen & Co is acting as Sole Global Coordinator and Kempen & Co and KBC Securities together act as Joint Bookrunners. Peel Hunt has been appointed as Co-Manager.