Amsterdam, The Netherlands, April 30, 2020 – Kiadis Pharma N.V. ( “Kiadis”, “Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its audited 2019 Annual Results for the year ended December 31, 2019, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Arthur Lahr, CEO of Kiadis commented, “2019 was a transformational year for Kiadis with the acquisition of CytoSen Therapeutics in the first half; the termination of the ATIR101 development program in the second half; and the restructuring and refocus of our organization solely on Kiadis’ natural killer (“K-NK”) cell therapies in the fourth quarter. We were faced with some difficult decisions during the year, but we were always guided by our core values of always doing what is right and putting our patients first. In the face of adversity, I am proud of the decisions that our team has made and believe that we have emerged in 2020 as a stronger organization.”
Key Developments (including post reporting period)
During the first quarter of 2019, Kiadis’ focus was on preparing for approval of the marketing authorization application (MAA) for ATIR101 in the EU; the Company’s regulatory team was engaged in discussions with the European Medicines Agency (EMA) to respond to day 180 questions and Kiadis’ commercial team was executing a launch plan to be ready to commercially treat the first patient with ATIR in the EU.
During the second quarter of 2019, Kiadis acquired CytoSen Therapeutics and its proprietary Natural Killer (NK) cell therapy platform, a transaction that had the potential to transform Kiadis into a leader in cell-based cancer immunotherapy for the treatment of both liquid and solid tumors.
During the third quarter of 2019, Kiadis learned that it did not expect a positive response from the EMA and its MAA for ATIR101 would be rejected. As such, Kiadis commenced a strategic review of its current operations and programs to determine the future focus of the company.
In the fourth quarter of 2019, Kiadis completed the strategic review and decided to terminate the ATIR program and focus solely on the development of K-NK-cell therapies. The Company restructured its organization, reducing staff by approximately 50 percent and shifting its focus and all resources toward the advancement of its K-NK-cell therapy platform and programs.
In 2020, Kiadis has already made progress advancing its K-NK-cell therapy programs. For the K-NK003 program, the Company is supporting a Phase 1/2 investigator sponsored study with The Ohio State University for the treatment of R/R AML with off-the-shelf K-NK cells from universal donors. Kiadis also filed the first investigational new drug application with the U.S. Food and Drug Administration (FDA) for its planned NK-REALM Phase 1/2 study, which will evaluate K-NK002 in 63 patients with blood cancer undergoing a haploidentical hematopoietic stem cell transplant (HSCT). Additionally, in April, Kiadis raised EUR17 million through two private placements with a US biotech investor and Life Sciences Partners to continue to fund the development of the Company’s K-NK-cell therapy programs.
Financial Highlights
(Amounts in EUR million, except per share data) 2019 2018 Change
Total revenue and other income
Total operating expenses
Research and development (43.0) (17.5) (25.5)
General and administrative (30.2) (7.7) (22.5)
Operating result (73.2) (25.2) (48.0)
Net financial result 20.7 (4.6) 25.3
Net result (52.6) (29.8) (22.8)
Net operating cash flow (48.3) (24.2) (24.1)
Cash position at end of year 29.5 60.3 (30.8)
Equity 34.3 44.1 (9.8)
Earnings per share before dilution (EUR) (1.92) (1.46) (0.46)
Revenue & Other Income
·The Group did not record revenue and/or other income in 2019 and 2018.
Operating Expenses
Operating expenses increased to EUR73.2 million from EUR25.2 million in 2018, an increase of EUR48.0 million which includes EUR19.0 million charges related to the termination of the ATIR platform development.
Research and Development expenses increased to EUR43.0 million from EUR17.5 million in 2018. Without the expenses for share-based compensation, Research and Development expenses increased to EUR41.4 million from EUR16.6 million in 2018, an increase of EUR24.8 million. The increase was primarily caused by the increased clinical trial costs related to the ramp up of the Phase 3 study of ATIR101, and the increase of the work force that the organization experienced prior to the discontinuation of the ATIR activities. Following the June 2019 acquisition of CytoSen, research and development expenses also include costs associated with the development of K-NK002 and the other NK-programs that we acquired. As a result of the termination of the ATIR platform development, Research and Development expenses include impairment charges of tangible assets for an amount of EUR0.7 million in addition to restructuring charges of EUR4.0 million.
General and Administrative expenses increased to EUR30.2 million from EUR7.7 million in 2018. Without the expenses for share-based compensation, General and Administrative expenses were EUR21.6 million higher at EUR28.6 million in 2019 compared to EUR7.0 million in 2018. General and Administrative expenses include impairment charges of intangible assets for an amount of EUR13.2 million and restructuring charges of EUR1.1 million. The increase was further due to increased headcount across all departments to support the continued growth of the company and consultancy expenses for business development, market access and the acquisition of CytoSen.