Amsterdam, The Netherlands, June 3, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma”, “Kiadis” or “the Company”), a clinical stage biopharmaceutical company developing innovative cell- based 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 ATIRTM, 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: ATIRTM 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, ATIRTM 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, ATIRTM101, 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 ATIRTM101 were announced in December 2014, supporting the safety profile and showing efficacy of ATIRTM101.
Market potential: Kiadis Pharma believes that ATIRTM101 has the potential to provide a life- saving 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, ATIRTM201, 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: “ATIRTM 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, ATIRTM101. 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 world- class biopharmaceutical leader.”
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 ATIRTM101 in the fourth quarter of 2016.
- A Phase III trial for ATIRTM101 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.
- ATIRTM201 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 ATIRTM101 and ATIRTM201, 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.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT). Although currently not a viable option for many patients, HSCT is generally regarded as the most effective curative approach to blood cancers and inherited blood disorders. The Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
Currently, ATIRTM101 is being tested in an open-label Phase II trial in patients with blood cancer who have not found a matching donor and where a partially matched (haploidentical) family member is used as donor for HSCT.
Kiadis Pharma is supported by a strong group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, The Netherlands. Further information can be found at: www.Kiadis.com
During HSCT treatment the bone marrow, harbouring the diseased cells, is completely destroyed and subsequently replaced by stem cells from a healthy donor. After an HSCT treatment it usually takes at least six to twelve months to recover to near-normal blood cell levels and immune cell functions in a patient that has received a transplant. During this period, the patient is highly susceptible and vulnerable to infections caused by bacteria, viruses and fungi. Immune cells in ATIRTM (Allodepleted T-cell ImmunotheRapeutics) will help fight these opportunistic infections and bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIRTM, T-cells that cause Graft-versus-Host-Disease (GVHD) are eliminated from the donor lymphocytes, which minimises the risk of GVHD and any related morbidity and mortality. At the same time, ATIRTM contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and avoid the return of the disease. ATIRTM allows the use of haploidentical grafts that are almost entirely depleted of T-cells, which eliminates the need for immune suppressive drugs. ATIRTM subsequently provides the patient with immune cells that do not cause GVHD. As a result, ATIRTM solves the problem of not finding a matched donor in time and has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible for, and who are in urgent need of, HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients. The use of haploidentical donor grafts without ATIRTM is only feasible in conjunction with severe immunosuppression which renders the patient highly vulnerable to infections with severe clinical complications, resulting potentially in death.
Manfred Ruediger, CEO Kiadis Pharma
Tel. +31 20 314 02 50 communication@Kiadis.com
International Media and Investor Contact:
Mary-Jane Elliott, Jessica Hodgson, Lindsey Neville, Hendrik Thys Consilium Strategic Communications
Tel: +44 (0) 203 709 5708
Ian Bickerton, Christa Nooitgedagt HuijskensBickerton
Tel. +31 (0) 20 685 5955 email@example.com
Important Legal Information
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This communication is not an offer to sell or a solicitation of any offer to buy the securities of Kiadis Pharma B.V. or any newly incorporated holding company of Kiadis Pharma B.V. (jointly the “Company”, and such securities jointly, the “Securities”) in the United States or in any other jurisdiction.
The Securities have not been and will not be registered under the US Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold in the United States unless registered under the Securities Act or an exemption from such registration is available. No public offering of
Securities of the Company is being made in the United States.
This announcement does not constitute a prospectus. The offer to acquire securities pursuant to the proposed offering will be made, and any investor should make his investment, solely on the basis of information that will be contained in the prospectus to be made generally available in the Netherlands and Belgium in connection with such offering.
When made generally available, copies of the prospectus may be obtained at no cost through the Company’s website.
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