- 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.
|(Amounts in EUR million, except per share data)||2017||2016||Change|
|Total revenue and other income||–||–||–|
|Total operating expenses||(16.1)||(11.4)||(4.7)|
|– Research and development||(11.2)||(8.2)||(3.0)|
|– General and administrative||(4.9)||(3.2)||(1.7)|
|Net financial result||(0.9)||(3.4)||2.5|
|Net operating cash flow||(15.9)||(14.3)||(1.6)|
|Cash position at end of year||29.9||28.7||15.3|
|Earnings per share before dilution (EUR)||(1.14)||(1.36)||(0.06)|
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
Conference call and presentation
The Kiadis management will host a conference call for analysts and investors today, Friday April 13, 2018 at 2:00pm CEST / 1:00pm BST / 8:00am EDT. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:
Confirmation Code: 1711789
|Location||Phone Type||Phone Number|
|Netherlands||Local||+31 (0) 20 721 9251|
|United Kingdom||Tollfree/Freephone||0800 358 6377|
|United Kingdom||Local||+44 (0)330 336 9105|
|United States||Local||+1 646-828-8194|
A question and answer session will follow the presentation of the results. The presentation may be accessed by visiting http://www.kiadis.com/financial-news
For more information, please contact:
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
Optimum Strategic Communications:
London: Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1789
Amsterdam: David Brilleslijper
Tel: +31 (0) 610 942 514
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 is on track to obtain a CHMP opinion for ATIR101 in Q4 2018 and, if positive, (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 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 US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the US 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.