New strategic focus results in significant progress in cell based therapies Amsterdam, The Netherlands, April 7, 2021 - Kiadis Pharma N.V. ("Kiadis", "Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases, today announces its audited 2020 annual results 1. Arthur Lahr, CEO of Kiadis, commented, "2020 can be described as a year of transformation for Kiadis. Despite major and unforeseen world-wide challenges, I am extremely proud of the significant progress we made on advancing our cell based therapies to patients who desperately need them. At the start of 2020, we changed our strategic focus to our NK-cell-based immunotherapy platform, and today we have a broad pipeline consisting of clinical programs evaluating our product candidates as an adjunctive treatment for patients undergoing a haploidentical hematopoietic stem cell transplant (HSCT) and for treatment of AML R/R. Additionally, we have preclinical programs exploring the use of NK-cells for the treatment of a broad range of cancers and infectious diseases." Key Developments (including post reporting period) Over the course of 2020, Kiadis continued its work to maximize the value of its lead clinical programs, K-NK002 and K-NK003. The Company submitted an IND in April and received approval in May to start its NK-REALM Phase 2 clinical trial that will evaluate K-NK002 produced using Kiadis' proprietary PM21 technology platform. Enrolment for this trial is planned to start in 2021. For its K-NK003 program, the FDA approved a Phase 1 trial in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with off-the-shelf cells from universal donors and enrolment is ongoing. In July, as part of its K-NK004 program, Kiadis expanded application of its K-NK platform into multiple myeloma through a collaboration with Sanofi. Under this partnership, Sanofi licensed the Company's CD38 knock out K-NK therapeutic for development in combination with their approved antibody, Sarclisa®. Kiadis received a EUR17.5 million upfront payment with the potential to receive up to an additional EUR857.5 million upon Sanofi's achievement of preclinical, clinical, regulatory and commercial milestones. Additionally, Kiadis began to evaluate the potential application of NK cells for a broad range of other cancers and infectious diseases. In August, the Company initiated its K-NK-ID101 program that is focused on the development of NK cells as a treatment for COVID-19 and Kiadis received U.S. government funding to support the program. The significant progress achieved with the Company's K-NK programs was recognized by strategic partners and culminated in the proposed acquisition of Kiadis by Sanofi in November. Sanofi is offering to purchase the Kiadis shares at an offer price of EUR 5.45 in cash (cum dividend) for each issued and outstanding ordinary share. This represents a 272% premium to the closing share price on 30 October 2020. The transaction is expected to complete in the second quarter of 2021. Financial Highlights (Amounts in EUR million, except per share data) 2020 2019 Change Total Revenue and other income 21.1 - 21.1 Total operating expenses Research and development (31.2) (43.0) 11.8 General and administrative (24.0) (30.2) 6.2 Operating expenses (55.2) (73.2) 18.0 Operating Result (34.1) (73.2) 39.1 Net financial result (47.7) 20.7 (68.4) Net result (81.9) (52.6) (29.3) Net operating cash flow (24.1) (48.3) 24.2 Cash position at end of the year 13.7 29.5 (15.8) Equity (32.9) 34.3 (67.2) Earnings per share before dilution (EUR) (2.24) (1.92) (0.32) Financial Highlights Revenue & Other Income· Kiadis Pharma recorded a revenue of EUR17.5 million in 2020 relating to the exclusive license agreement with Sanofi signed on July 7, 2020 and other income related to grants of EUR3.6 million (2019: EUR 0). Operating Expenses Operating expenses decreased to EUR55.2 million from EUR73.2 million in 2019, a decrease of EUR18.0 million. Research and Development expenses decreased to EUR31.2 from EUR43.0 million in 2019. Without the expenses for share-based compensation, Research and Development expenses decreased to EUR28.3 million from EUR41.4 million in 2019, a decrease of EUR13.2 million. The decrease was primarily caused by the increased clinical trial costs in 2019 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 in 2019. In 2020 Kiadis Pharma fully focused on the development of K-NK002 and the other NK-programs which resulted in an increase in these program costs. General and Administrative expenses decreased to EUR24.0 million from EUR30.2 million in 2019. Without the expenses for share-based compensation, General and Administrative expenses decreased to EUR20.7 million from EUR28.6, a decrease of EUR7.9 million. This decrease was mainly due to a decreased headcount across all departments after the discontinuation of ATIR and higher consultancy expenses for business development activities, the preparation for market access in 2019, and the acquisition of CytoSen Therapeutics, Inc. in 2019. This decrease was offset by an increase caused by expenses related to the intended Sanofi acquisition. Operating Results· As a result of the overall decrease in total operating expenses and the revenue generated in 2020, the Company's operating loss decreased from EUR73.2 million in 2019 to EUR34.1 million in 2020. Net Financial Result Net financial income decreased EUR68.4 million to ...Full story available on Benzinga.com