arGEN-X – Business Update and First Half 2014 Results

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 provides a business update and announces its financial results for the first half of 2014 (six-month period ended 30 June 2014).

BUSINESS HIGHLIGHTS

  • Completed successful Initial Public Offering (IPO) on Euronext Brussels (pricing on 8 July with overallotment option exercised on 11 August) raising total gross proceeds of EUR 41.8 million
  • Advanced ARGX-110 (anti-CD70 SIMPLE Antibody™) into the expansion part of its Phase Ib study. The objective is to further investigate the safety of ARGX-110 in CD70-positive cancer patients with either haematological or solid tumors, and to evaluate its biological activity in order to select the indications to be studied in Phase II clinical development (January)
  • Entered partnership with the Leukemia and Lymphoma Society (LLS) to develop ARGX-110 for the treatment of Waldenström’s macroglobulinemia, a rare B-cell lymphoma (June)
  • Presented clinical data from Phase 1b dose-escalation study with ARGX-110 at the American Society of Clinical Oncology (ASCO; May)
  • Announced positive preclinical data for ARGX-113 which supports its use as a potential breakthrough concept for the management of flares in severe autoimmune diseases (August)
  • Signed a long-term strategic alliance with Shire (June), which resulted in arGEN-X receiving a EUR 3 million upfront cash payment and a EUR 12 million equity investment. arGEN-X will bring its entire suite of human antibody discovery technologies to the alliance which is focused on multiple targets aligned with Shire’s therapeutic focus
  • Received two preclinical milestone payments from Shire under initial antibody discovery collaboration (January)
  • Initiated collaboration with Bayer to discover and develop therapeutic antibody candidates (May)
  • Initiated pilot research agreement with Boehringer Ingelheim (January)
  • Elected Werner Lanthaler, CEO of Evotec to the Board of Directors (April)
  • Appointed Eric Castaldi, former CFO of Nicox, as CFO (June). Mr Castaldi was elected to the Board of Directors (July)

FINANCIAL HIGHLIGHTS

  • Proceeds from IPO totalling EUR 41.8 million, including the overallotment, from high-quality corporate and institutional investors in Europe and the United States and retail investors in Belgium
  • Net loss for the period was EUR 4.6 million compared to EUR 4.8 million for the same period in 2013
  • Cash position as at 30 June 2014 was EUR 20.6 million. Cash position at the end of July, before the receipt of the proceeds from the exercise of the overallotment option, was EUR 58.1 million

Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X, said:We have made significant progress in 2014, delivering the key milestones in our strategic plan. Our successful IPO on Euronext Brussels has significantly strengthened our financial position and we are well positioned to generate important data for our lead therapeutic antibody candidates. Our clinical stage programs, ARGX-110 and ARGX-111, are on track and we are pleased with the initial safety and biological activity data observed for ARGX-110 and our recent clinical development partnership with LLS. We were delighted to expand our successful collaboration with Shire for the second time and to have signed new collaborations with Bayer and Boehringer Ingelheim to leverage the power of our SIMPLE Antibody™ platform against multiple, complex targets across a range of indications. We remain focused on executing our well thought out strategy, which we believe will deliver significant value for all of our stakeholders.