Amsterdam, The Netherlands, August 28, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing a patient-specific T-cell product designed to be delivered following a haploidentical hematopoietic stem cell transplant, or HSCT, in order to support the patient’s newly transplanted immune system before it becomes fully functional, today announces that it is scheduled to attend the following investor conferences in September 2018.
Goldman Sachs 8th Annual Biotech Symposium
September 7, 2018, Goldman Sachs Offices, River Court, 120 Fleet Street, London, UK
Oppenheimer Fall Summit focused on Specialty Pharma and Rare Disease
September 26-27, 2018, The Langham, 400 5th Avenue, New York, USA
KBC Securities 6th Biotech and Healthcare Conference
September 27, 2018, Convene Grand Central, 101 Park Avenue, New York, USA
For more information, please contact:
Karl Hård, Head of IR & Communications
Tel. +31 611 096 298
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 714 1787
About Kiadis Pharma
Kiadis Pharma is initially developing its lead product candidate, ATIR101, for use in conjunction with haploidentical HSCT for adult blood cancers to address key limitations of haploidentical HSCT, without prophylactic immunosuppression and its associated morbidity and mortality. Based on the positive results from the single dose Phase II CR-AIR-007 study, the Company submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, in April 2017 for approval of ATIR101 as an adjunctive treatment in haploidentical HSCT for high risk adult hematological malignancies. Kiadis Pharma submitted responses to the EMA’s Day 120 List of Questions in March 2018 and received the Day 180 List of Issues in May 2018. The Company expects a Committee for Medicinal Products for Human Use, or CHMP, opinion in the fourth quarter of 2018 which, if positive, would enable it to receive a conditional marketing approval from the European Commission as early as in the first quarter of 2019. If then conditionally approved, Kiadis Pharma intends to launch ATIR101 in selected countries in Europe through its own commercial organization starting in the second half of 2019.
In December 2017, Kiadis Pharma commenced an international, multicenter, randomized and controlled Phase III clinical trial of ATIR101 against the Post-Transplant Cyclophosphamide, or PTCy protocol, the main protocol used to perform a haploidentical HSCT. The trial will be performed in 250 patients with acute leukemia and myelodysplastic syndrome, or MDS, at approximately 50 sites in the United States, Canada, Europe and certain additional countries. The trial’s primary endpoint is GVHD-Free and Relapse-Free Survival, or GRFS, which is defined as survival without acute GVHD grade III/IV, without chronic GVHD requiring systemic immunosuppression, and without relapse, and is a composite endpoint widely used in HSCT trials that captures survival, quality of life and future prognosis. The first patient was enrolled in December 2017. If successful, the Company intends to use data from this Phase III trial as a basis for the filing of a Biologics License Application, or BLA, with the U.S. Food and Drug Administration, or FDA. The Company also plans to use data from the Phase III trial to support the conversion of the anticipated conditional marketing approval of ATIR101 in Europe into a standard marketing approval. ATIR101 received regenerative medicine advanced therapy, or RMAT, designation from the FDA in September 2017, which provides benefits that are materially equivalent to a breakthrough designation from the FDA. In addition, ATIR101 has been granted multiple orphan drug designations both in the European Union and the United States.
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.