Amsterdam, The Netherlands, August 30, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces that Robbert van Heekeren is stepping down as Chief Financial Officer, or CFO, and as member of the Management Board. Scott A. Holmes has been appointed as new CFO. Mr. Holmes, who currently serves as Senior Vice President and CFO at Keryx Biopharmaceuticals, will join the Company following the completion of Nasdaq-listed Keryx Biopharmaceuticals’ recently announced merger with Akebia Therapeutics, which is expected to close by the end of 2018.
Mark Wegter, Chairman of the Supervisory Board of Kiadis Pharma, commented: “I respect Robbert’s decision to pursue his career in another direction and would like to express my sincere gratitude for his tremendous contributions and commitment to Kiadis Pharma during his 10 years with the Company, including the successful IPO on Euronext in 2015, and wish him every success in his future endeavors.”
Robbert van Heekeren, commented: “My decision to leave Kiadis was difficult, as I’ve been part of the journey from a small private entity to a public, near-commercial growth company. However, I feel confident I leave Kiadis in a great shape, with a strong successor to my role, and I wish Scott every success as new CFO.”
Arthur Lahr, CEO of Kiadis Pharma, commented: “I would like to thank Robbert for his support and contribution to the growth of Kiadis. Together with the Board, we have carried out a thorough search for a Chief Financial Officer and I’m delighted to welcome Scott to Kiadis. Scott’s experience with leading the finance functions in commercial-stage biotechnology companies, as well as his track record in raising significant capital for publicly listed companies will strengthen our leadership team, and allows us to further build our U.S. presence.”
Incoming Chief Financial Officer, Scott A. Holmes, commented: “I’m excited to join Kiadis Pharma at this crucial time in the Company’s evolution. As the Company approaches the potential approval and commercialization of its lead product candidate, ATIR101, I look forward to collaborating with Arthur, the management team and the Supervisory Board to build a leading fully-integrated biopharmaceutical company.”
Mr. Holmes brings nearly 20 years of life sciences and financial management expertise to Kiadis Pharma. Prior to Keryx, he was Senior Vice President of finance, investor relations and treasurer at AMAG Pharmaceuticals, during a period of high growth driven by acquisitions and public financings. Prior to this he held senior roles at Molecular Biometrics, On-Q-ity and Dynogen. Mr. Holmes started his career at Ernst & Young, in both the Assurance and Transaction Services practices, and while at Ernst & Young he earned his Certified Public Accountant certificate in the Commonwealth of Massachusetts. He holds a MS/MBA degree from Northeastern University and a BA in History from Middlebury College.
Mr. Holmes will be based in Boston and responsible for Kiadis Pharma’s finance and investor relations functions. He will join the Company’s management team, reporting to the Chief Executive Officer. Kiadis will propose to a future shareholders’ meeting that Mr. Holmes be appointed to the Management Board.
Transition arrangements have been made including hand over between the incoming and outgoing CFO and the interim appointment of Paul van Hagen to the Amsterdam-based finance functions. Mr. van Hagen has broad experience with publicly-listed companies. He was previously Senior Director of Finance & Control at Prosensa and BioMarin, Director Group Reporting and Financial Control at Crucell and Senior Manager Audit at Ernst & Young.
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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.