- Significantly strengthened cash position; raised over EUR 60 million in equity and debt (gross, including raise in March 2018)
- Filed Marketing Authorization Application with the European Medicines Agency for ATIR101 in blood cancers
- Received Regenerative Medicine Advanced Therapy designation from the US FDA
- First patient enrolled in Phase 3 trial for ATIR101 in adult patients with blood cancer
- Leased existing commercial manufacturing facility in The Netherlands
- Strengthened Organization and Supervisory Board
Amsterdam, The Netherlands, April 13, 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), today announces its audited 2017 Annual Results for the year ended December 31, 2017, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Operating highlights (including post reporting period)
- In April 2017, based on the positive results from the Phase 2 ‘007’ trial, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of lead program ATIR101 as an adjunctive treatment in haploidentical (genetically half-matched) hematological stem-cell transplantations for adult patients with malignant disease.
- In September 2017, received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for ATIR101. The RMAT pathway is equivalent to the Breakthrough Therapy designation that allows companies, such as Kiadis Pharma, that are developing regenerative medicine therapies to interact with the US FDA more frequently. During 2017 only 12 companies obtained an RMAT designation.
- In December 2017, enrolled first patient in a Phase 3 trial of ATIR101 with participating sites in the US, Canada and Europe.
- In December 2017, secured access to build in-house manufacturing capabilities with an agreement to lease an existing state of the art commercial manufacturing facility. This includes process development and quality control laboratories, as well as office space.
- Strengthened Kiadis organization and Supervisory Board with key people who have a successful track record in developing and commercializing innovative products, including Mr. Arthur Lahr as CEO, Mr. Jan Feijen as COO, Dr. Andrew Sandler as CMO and Dr. Karl Hård as Head of Investor Relations. Dr. Otto Schwarz, former COO of Actelion and Mr. Subhanu Saxena, former Head of Global Product Strategy at Novartis and CEO of Cipla, are proposed as new Supervisory Board members.
- In March 2018, submitted responses to the EMA’s list of questions, potentially allowing to obtain an opinion from the EMA as early as the fourth quarter of 2018. If positive, this would enable a conditional marketing approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.
Financial highlights (including post reporting period)
- Significantly strengthened cash position, raised more than EUR 60 million in equity and debt since June 2017.
- The cash position increased to EUR 29.6 million at year-end 2017 compared to EUR 14.6 million at the end of 2016. This is mainly due to cash received from share offerings less the cash used in operating activities in 2017. Cash position was EUR 47.7 million at end of March 2018.
- Operating loss increased to EUR 16.1 million in 2017 from a loss of EUR 11.4 million in 2016.
- Operating expenses increased by EUR 4.7 million compared to last year as the number of employees increased from 39 at year-end 2016 to 61 at the end of 2017.
- Net loss for the year increased to EUR 17.0 million in 2017 from EUR 14.8 million in 2016.
Commenting on the financial results, Arthur Lahr, CEO of Kiadis Pharma, said: “We can look back at 2017 as a truly transformational year and are well on our way turning Kiadis Pharma into a Phase 3 clinical and commercial stage company. I am very proud of what the entire Kiadis Pharma team achieved. We are on track to obtain a CHMP opinion in the fourth quarter of 2018 for our lead program ATIR101. If positive, this would enable an approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.
“I wish to thank our employees, partners and shareholders for their support and confidence. ATIR101 has the potential to address a very significant unmet need in transplantation, reducing relapse and Graft versus Host Disease. We look forward to continue this journey together to achieve our vision to become a fully integrated biopharmaceutical company and improve the lives of patients suﬀering from