argenx reports fourth quarter business update and full year 2016 financial results

March 15, 2017

Breda, the Netherlands / Ghent, Belgium – argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced its fourth quarter business update and full year results for 2016, in accordance with IFRS as adopted by the European Union.

The full year results will be discussed during a conference call and webcast presentation today at 3 pm CET / 10 am EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 75576807. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

“The past year was one of significant growth for argenx, and we have seen the momentum maintained into the first months of 2017. We continued to build our proprietary pipeline and advanced both our lead programs, ARGX-113 and ARGX-110, through key safety and early efficacy inflection points. Our early studies guided us on the attributes of each drug and enabled us to choose the indications we believe were best-suited for Phase 2 study. By the end of the first quarter, we plan to launch four proof-of-concept Phase 2 studies: MG and ITP for ARGX-113, and AML and TCL for ARGX-110,” commented Tim Van Hauwermeiren, CEO of argenx. “We were also busy outside the clinic with the start of our collaboration with AbbVie for  our novel immuno-oncology product, ARGX-115, under which we received an upfront payment of $40 million and through the expansion of our shareholder base with blue-chip U.S. investors resulting in a €46 million investment over the course of 2016.”

 

FOURTH QUARTER 2016 AND RECENT HIGHLIGHTS

  • Dosed first patient with ARGX-113 in Phase 2 proof-of-concept study for treatment of myasthenia gravis (MG).
  • Hosted workshop in conjunction with American Society of Hematology (ASH) Annual Meeting and provided updates on clinical data from multiple ascending dose (MAD) Phase 1 study with ARGX-113 in healthy volunteers showing comparable pharmacodynamics (PD) and pharmacokinetic (PK) patterns between lower dose (10 mg/kg) and higher dose (25 mg/kg).
  • Initiated Phase 1/2 clinical trial in combination with standard of care, azacytidine, in newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) patients.
  • Published new preclinical data in Journal of Experimental Medicine on CD70/CD27 pathway that provide further biological rationale for ARGX-110 therapy for treatment of AML.
  • Presented further efficacy and safety data from ongoing Phase 1b study in relapsed/refractory T-cell lymphoma (TCL) patients at ASH workshop.
  • Announced that Staten Biotech exercised its exclusive option to license ARGX-116, an anti-ApoC3 SIMPLE AntibodyTM with therapeutic potential in dyslipidemia.
  • Announced the extension of our strategic partnership with Shire for a further year until May 30, 2018.

FINANCIAL HIGHLIGHTS (as on December 31, 2016) (compared to financial highlights as on December 31, 2015)

  • Operating income of €17.2 million (December 31, 2015: €10.0 million).
  • Net loss of €21.4 million (December 31, 2015: €15.3 million).
  • Cash position of €96.7 million (cash, cash-equivalents and current financial assets) allowing us to pursue development of our pipeline as planned.

See PDF version for all details

About argenx

argenx a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE AntibodyTM Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.  

www.argenx.com

 

 

For further information, please contact:

 

Joke Comijn, Corporate Communications Manager

+32 (0)477 77 29 44

+32 (0)9 310 34 19

info@argenx.com

 

Beth DelGiacco (US IR)

Stern Investor Relations

+1 212 362 1200

beth@sternir.com

 

Forward-looking Statements

 

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should,” and include statements argenx makes concerning the intended results of its strategy; its financial condition, results of operation and business outlook; the sufficiency of its cash, cash equivalents and current financial assets; and the momentum of its product candidate pipeline as well as the advancement of, and anticipated clinical development and regulatory milestones and plans related to, argenx’s product candidates and clinical trials. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.