Amsterdam, The Netherlands, August 24, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), will be announcing Financial Results for the six months ended June 30, 2018 at 7:00am CEST on Friday, August 31, 2018.
For more information, please contact:
Karl Hård, Head of IR & Communications
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
About Kiadis Pharma
Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD) and relapse. Single dose Phase 2 data with lead product candidate ATIR101 has demonstrated substantial and clinically relevant improvements over historical observational cohort data for a similar HSCT without ATIR101, and also shows an improvement over the Post-Transplant Cyclophosphamide (PTCy), or Baltimore protocol, data reported in scientific literature. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101 across the EU as an adjunctive treatment in HSCT for adult malignant disease. Kiadis Pharma submitted responses to the Day 120 List of Questions in March 2018 and received the Day 180 List of Issues in May 2018, and is on track to obtain a CHMP opinion for ATIR101 in the fourth quarter 2018 and, if positive, (conditional) approval from the European Commission in the first quarter of 2019, which would allow for a European launch in the second half of 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the PTCy/Baltimore protocol). The first patient was enrolled in December 2017.
In September 2017 the U.S. Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the U.S. and Europe.
The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.