arGEN-X Announces Half-Year Results For 2015

August 25, 2015

Breda, the Netherlands / Ghent, Belgium – arGEN-X N.V. (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 a business update and announced its financial results for the first half of 2015 (six-month period ended June 30, 2015).

The results will be discussed during a webcast presentation tomorrow, August 26th, at 3:00 pm CET, 9:00 am EDT. The webcast is accessible on the arGEN-X website www.argen-x.com or by clicking here. To participate in the Q&A, please select your phone number here and use the confirmation code 89351549.

Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X commented: “During the quarter we made progress across our business. We were very pleased to have entered into our novel strategic partnership with LEO Pharma and to have continued making progress under our Shire and Bayer collaborations. In addition, we reported important pipeline progress in our Phase Ib study for ARGX-111 in MET amplified tumors with the opening of our expansion cohort. We also presented Phase I results on ARGX-110 in TCL patients and published a Science Translational Medicine paper on ARGX-115. We look forward to reporting data and further advances for our portfolio of highly differentiated antibody therapeutics, which have the potential to make a significant difference to patients with cancer and severe auto-immune diseases.”

BUSINESS UPDATE AND OPERATIONAL HIGHLIGHTS

In the first half of 2015, the Company:

  • Presented preliminary Phase I results of ARGX-110 in patients with T-cell lymphomas (TCL) at 13th International Conference on Malignant Lymphoma (ICML) (Lugano, June 18).
  • Presented preliminary efficacy and expanded safety data from Phase I trial of ARGX-111 at American Society of Clinical Oncology (ASCO) annual meeting (Chicago, May 29).
  • Entered into alliance with LEO Pharma to develop antibody-based treatments for skin conditions and receives pre-IND payments of EUR 4.5 million, including upfront payment. arGEN-X will also receive clinical, regulatory, and sales milestone payments that may total upward of EUR 100 million.
  • Awarded EUR 1.5 million grant from Institute for the Promotion of Innovation by Sciences and Technology in Flanders (IWT) to advance application of proprietary NHance® technology platform.

Events after the balance sheet date:

  • Entered into license agreement with University of Bern to develop ARGX-110-based combination therapies for treatment-resistant cancers.
  • Published preclinical data related to CD70 blockade in combination with imatinib in Science Translational Medicine, demonstrating potential of ARGX-110 to overcome therapy resistance in chronic myelogenous leukemia (CML).

FIRST HALF-YEAR FINANCIAL HIGHLIGHTS

  • Operating income of EUR 4.3 million (June 30, 2014: EUR 1.6 million).
  • Net loss for half-year of EUR 7.0 million (June 30, 2014: EUR 4.6 million).
  • Net cash burn of EUR 5.4 million, resulting in a strong cash position of EUR 50.5 million (cash, cash-equivalents and financial assets) allowing. The company to pursue the progress of the product portfolio as planned.

CHANGES TO THE BOARD OF DIRECTORS AND MANAGEMENT

  • Michael B. Sheffery, Non-executive Director representing OrbiMed Advisors, resigned from Board of Directors effective August 26th.
  • Dr. Alain Thibault, Chief Medical Officer, left the Company in pursuit of new career opportunities, in mutual agreement with the Company.