argenx reports third quarter 2015 financial results and provides business update

November 17, 2015

Breda, the Netherlands / Ghent, Belgium – argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today provided development program updates and announced financial results for the third quarter ended 30 September 2015.

“We continue to be very pleased with the progress being made here at argenx as we continue to advance our clinical pipeline of four novel antibody compounds in oncology and inflammation, including the first human dosing this quarter of ARGX-113, a potential breakthrough therapy for the treatment of autoimmune crisis. This pipeline, developed in only six years, is based on our highly productive SIMPLE AntibodyTM platform,” commented Tim Van Hauwermeiren, chief executive officer of argenx.  “With key strategic alliances from prominent industry partners, including Shire, LEO and Bayer, as well as our strong cash position, premier technology suite and growing pipeline we are well-positioned to develop a premier biotechnology company based on truly novel and value added drugs.”

BUSINESS UPDATE AND OPERATIONAL HIGHLIGHTS

In the third quarter of 2015, the Company:

  • Entered into an exclusive license agreement with the Clinical Research Department of University of Bern, enabling argenx to develop and commercialize ARGX-110-based therapies to overcome treatment resistance mechanisms in hematologic tumors. The license agreement arose from a highly productive collaboration between the two groups, jointly announced in December 2014.
     
  • Announced the first human dosing by partner RuiYi, Inc. in a double-blind, placebo-controlled study of Gerilimzumab in healthy volunteers. Gerilimzumab is a novel monoclonal antibody neutralizing the IL-6 cytokine for the treatment of autoimmune disorders, including rheumatoid arthritis. argenx originally generated the antibody using its SIMPLE Antibody™ platform and in late 2012, licensed worldwide development and commercialization rights to RuiYi. Gerilimzumab has been further differentiated with argenx’ NHanceTM technology, which prolongs circulation time and improves tissue distribution of antibodies.

More recently, the Company:

  • Completed first human dosing of ARGX-113, a potential breakthrough therapy for the treatment of autoimmune crisis. ARGX-113 is argenx’ fourth drug candidate entering human trials in six years of operations.
     

FINANCIAL HIGHLIGHTS (as of 30 September 2015)

  • Operating income of EUR 7.3 million (Sept 30, 2014: EUR 3.6 million).
  • Net loss of EUR 10.1 million (Sept 30, 2014: EUR 6.3 million).
  • Net cash burn of EUR 9.3 million, resulting in a cash position of EUR 46.6 million (cash, cash-equivalents and financial assets) allowing the company to pursue the progress of its product portfolio as planned.