Amsterdam, The Netherlands, 30 April 2019 - Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its audited 2018 Annual Results for the year ended December 31, 2018, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Arthur Lahr, CEO of Kiadis Pharma, commented: "Kiadis made significant progress in 2018 as we continue on our journey to bring innovative cell therapies to patients. In 2018, we added commercial and medical affairs capabilities to support the potential launch of ATIR101 in the EU. Additionally, we have expanded our manufacturing and quality teams to ensure that we have adequate capacity to serve patients in the EU as well as patients enrolling in our global phase 3 study for ATIR101.
"As our company grows, we are all working to re-imagine medicine - leveraging the natural strengths of humanity and our collective immune system to source the best cells for life. Our uncompromising approach to serve patients, their families and caregivers aims to minimize harm and maximize help - delivering personalized treatments for every single patient to offer hope, reduce suffering and provide new life. We look forward to continuing this journey together to achieve our vision to improve the lives of patients suffering from life-threatening diseases."
Operating highlights (including post reporting period)
Financial highlights (including post reporting period)
(Amounts in EUR million, except per share data) | 2018 | 2017 | Change |
Total revenue and other income | -- | -- | -- |
Total operating expenses | (25.2) | (16.1) | (9.1) |
Research and development | (17.5) | (11.2) | (6.3) |
General and administrative | (7.7) | (4.9) | (2.8) |
Operating result | (25.2) | (16.1) | (9.1) |
Net financial result | (4.6) | (0.9) | (3.7) |
Net result | (29.8) | (17.0) | (12.8) |
Net operating cash flow | (24.2) | (15.9) | (8.3) |
Cash position at end of year | 60.3 | 29.9 | 30.4 |
Equity | 44.1 | 15.9 | 28.2 |
Earnings per share before dilution (EUR) | (1.46) | (1.14) | (0.32) |
Operating expenses
Operating results
Net financial result
Net result
Cash position
Equity
Earnings per share
Annual Report
The Annual Report 2018 is available on Kiadis Pharma's website April 30, 2019.
For more information, please contact:
Kiadis Pharma: Amy Sullivan, SVP, Corporate Affairs Tel. +1 508 479 3480 a.sullivan@kiadis.com | Optimum Strategic Communications: Mary Clark, Supriya Mathur, Hollie Vile Tel: +44 203 950 9144 David Brilleslijper (Amsterdam) Tel: +31 610 942 514 kiadis@optimumcomms.com |
About Kiadis Pharma
Kiadis Pharma is 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 to the European Medicines Agency in April 2017 for approval of ATIR101 as an adjunctive treatment in haploidentical HSCT for high risk adult hematological malignancies. If the product is 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 at approximately 50 sites in the United States, Canada, Europe and certain additional countries. ATIR101 received regenerative medicine advanced therapy 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.