Amsterdam, The Netherlands, April 15, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces its audited annual results for the year ended 31 December 2015, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Operating highlights (including post the period end)
– Strong progress was made in developing lead product ATIR101™ for blood cancer:
– full enrolment of the single dose Phase II clinical trial was completed;
– positive data was presented at the American Society of Hematology (ASH) Annual Meeting in December 2015;
– positive results on the primary endpoint were presented at the Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in April 2016;
– a further repeat-dosing Phase II clinical trial with ATIR101™ commenced patient enrolment in October 2015;
– a closed manufacturing process for ATIR101™ was established which allows for automation;
– preparations to initiate a randomised Phase III trial with ATIR101™ in the second half of 2016 are underway;
– ATIR101™ was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicinal Agency (EMA).
– Entered into a partnership with the U.S. Leukemia & Lymphoma Society, the world’s largest voluntary health agency dedicated to blood cancer in early 2016.
– Signed a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia for ATIR201™ in inherited blood disorders.
– Shares listed via an initial public offering (IPO) on Euronext Amsterdam and Euronext Brussels on 2 July 2015 raising gross proceeds of EUR34.7 million.
– The equity position of the Company improved significantly and increased to EUR25.7 million at year-end 2015 compared to EUR2.7 million at the end of 2014.
– With net proceeds of EUR31.2 million raised in the IPO, the Company’s cash position improved to EUR28.7 million at year-end 2015, which is an increase of EUR23 million compared to cash of EUR5.7 million at the end of 2014.
– Operating loss increased to EUR16 million in 2015 from a loss of EUR6.2 million in 2014.
– Operating expenses for 2015 included non-cash share-based payments of EUR7.8 million.
– Net loss increased from EUR7.8 million in 2014 to EUR16.5 million in 2015.
A full annual report for the year ended 31 December 2015 is available in the For Investors section of this website.
Commenting on the annual results, Manfred Rüdiger, CEO of Kiadis Pharma, said: “2015 has been a very successful year for Kiadis Pharma. We reached significant milestones in our clinical programmes and also successfully listed the Company on Euronext Amsterdam and Euronext Brussels. The financial results are fully in line with our guidance and projections and show that Kiadis Pharma has been conscious and diligent on expenses whilst progressing with the development of its lead product ATIR101™ for patients suffering from acute leukaemia towards its last phase of clinical development. With a healthy year-end cash position, we are well positioned to begin Phase I/II clinical development with ATIR201™ for thalassaemia, scale-up our manufacturing and begin enrolment into our pivotal Phase III trial with ATIR101™. I would like to thank our investors for their continued support and look forward to providing further updates in due course.”