arGEN-X Reports Fourth Quarter Business Update And Full Year 2014 Financial Results

March 18, 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 announced its fourth quarter business update and the consolidated full year results for 2014, which have been prepared in accordance with IFRS as adopted by the European Union.

The FY results will be discussed during a conference call and webcast presentation today at 6 pm CET / 1 pm EDT. To participate in the conference call, please select your phone number here, and use the confirmation code 92395735. The webcast may be accessed on the homepage of the arGEN-X website at www.argen-x.com or by clicking here.

OPERATIONAL HIGHLIGHTS

  • Advancement of ARGX-110 into expansion cohorts as part of its Phase 1b study in CD70-positive cancer patients with either hematological or solid tumors to further evaluate safety and efficacy and to select indications for study in Phase 2 clinical development.
    • Enrolment completed of first cohort of 15 patients with CD70-positive hematological malignancies and 15 patients with CD70-positive solid tumors into a Phase 1b expansion trial.
    • Initiation of clinical efficacy evaluation of ARGX-110 in dedicated expansion cohort of patients with relapsed/refractory CD70-positive T-cell lymphomas, as part of broader Phase 1b study.
  • Acceptance of Investigational New Drug (IND) Application to evaluate ARGX-110 in Waldenström’s macroglobulinemia (a rare, incurable B-cell lymphoma).
  • Partnership with the Leukemia Lymphoma Society on the development of ARGX-110 for the treatment of Waldenström’s macroglobulinemia
  • Presentation of positive preclinical data on ARGX-110 in a chronic myelogenous leukemia (CML) model demonstrating potential of ARGX-110 in reversing resistance to tyrosine kinase inhibitors. Data were presented in December 2014 at ASH (American Society of Hematology).
  • Positive preclinical data for ARGX-113 supporting its use as a potential breakthrough concept for the treatment of severe autoimmune diseases.
  • Collaboration with Bayer, leveraging arGEN-X’ SIMPLE Antibody™ technology for the discovery and development of first-in-class antibodies addressing complex targets across multiple therapeutic areas.
  • Long-term strategic alliance with Shire Pharmaceuticals where arGEN-X focus its suite of human antibody discovery technologies on multiple targets aligned with Shire’s therapeutic focus.
  • Key patents relating to ARGX-110 and ARGX-111 granted in the US, providing patent protection for both until 2031-2032 and allowing up to five additional years of patent term extension.

FINANCIAL HIGHLIGHTS

  • Successful Initial Public Offering (“IPO”) on Euronext Brussels raising total gross proceeds of EUR 41.8 million.
  • Received two preclinical milestone payments under collaboration with Shire.
  • Operating loss totaled EUR 10.7 million in 2014 compared with EUR 6.2 million in 2013.
  • Net loss for 2014 increased to EUR 10.3 million compared with EUR 6.1 million in 2013, due to the costs of advancing the Group’s clinical pipeline.
  • On December 31, 2014 the Group’s cash, cash equivalents and financial assets amounted to EUR 56 million compared with EUR 23.2 million on December 31, 2013.

POST-PERIOD HIGHLIGHTS

  • Launch of Innovative Access Program (“IAP”), providing SIMPLE Antibody™ platform to academic centers of excellence and emerging biotech companies. First collaborations in cancer immunotherapy and dyslipidemia.
  • First program in-licensed from IAP for further development: ARGX-115, a first-in-class antibody targeting GARP for cancer immunotherapy.
  • Multi-product commercial license agreement with Lonza for the production of arGEN-X’ therapeutic antibodies.

Commenting on the 2014 results, Tim Van Hauwermeiren, CEO of arGEN-X, said: “2014 has been a transformational year for arGEN-X. We made significant progress within our clinical pipeline progressing ARGX-110 towards clinical proof-of-concept in important solid and hematological tumor indications including T-cell lymphoma and Waldenström’s macroglobulinemia. We also advanced and expanded our preclinical pipeline adding more depth to our development plan. Our business development activities were further validated the expected utility of our SIMPLE AntibodyTM platform with the deepening of partnerships as with Shire and the initiation of new ones as with Bayer and completed a successful IPO on Euronext Brussels,” comments Tim Van Hauwermeiren.

“With a well-balanced pipeline of wholly-owned and partnered clinical assets and several innovative early stage programs in oncology and auto-immune diseases, we feel we have positioned the Company for future success. We are entering a period of significant growth during which we intend to remain focused on our initial business strategy, on the execution of our pipeline programs, and on delivering added value to all our stakeholders.”