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 financial results and provided a business update for the first quarter ended March 31, 2017.
We are pleased with our pipeline progress this past quarter having launched two clinical studies across our lead programs, as we set out to do at the start of the year. This leaves us very well-positioned with one ongoing Phase 1/2 and three Phase 2 trials to have several potential value creating events for the Company over the next year. Additionally, we have continued this quarter to expand our Innovative Access Program with new partnered programs with Broteio Pharma and Staten Biotechnology targeting severe autoimmune diseases and dyslipidemia and to validate our strategic collaborations with the extension of our Shire collaboration and our AbbVie partnership, through which we will receive our first preclinical milestone payment. These collaborations remain crucial to our goal of maximizing our pipeline value, commented Tim Van Hauwermeiren, CEO of argenx.
FIRST QUARTER 2017 AND RECENT HIGHLIGHTS
- Dosed first patients with ARGX-113 in two Phase 2 proof-of-concept studies for treatment of primary immune thrombocytopenia (ITP) and myasthenia gravis (MG).
- Launched Phase 2 study of ARGX-110 as a monotherapy in relapsed/refractory cutaneous T-cell lymphoma (CTCL) patients. This follows the initiation of a Phase 1/2 study of ARGX-110 in combination with azacitidine in newly diagnosed acute myeloid leukemia (AML) patients in December 2016.
- Announced that Staten Biotechnology exercised its exclusive option to license ARGX-116, an anti-ApoC3 SIMPLE AntibodyTM with therapeutic potential in dyslipidemia. This collaboration stems from our Innovative Access Program.
- Announced collaboration with Broteio Pharma to develop therapeutic antibody for severe autoimmune diseases, representing the latest success for our Innovative Access Program.
- Announced in April the first of two expected preclinical milestone payments from AbbVie collaboration before its filing of an investigational new drug (IND) application for ARGX-115, triggering a $10 million payment.
- Continued collaboration with Shire AG to discover and develop novel human therapeutic antibodies to address diverse rare and unmet diseases. Our strategic partnership with Shire was extended for a further year until May 30, 2018.
- Filed registration statement for a proposed public offering in the United States.
- Announced that Dr. J de Koning and E. Castaldi, who remains the CFO of argenx, have resigned from the Board of Directors and Msc. A.A. Rosenberg was appointed to the Board of Directors.
UPCOMING CLINICAL MILESTONES
ARGX-113
- Topline data from Phase 2 study in MG expected in 1Q 2018 and ITP expected in 2H 2018.
- Initiation of Phase 1 clinical trial of subcutaneous dosing in healthy volunteers expected in 2H 2017.
ARGX-110
- Interim data from Phase 1/2 study in AML and Phase 2 study in CTCL each expected by the end of 2017 and topline data from Phase 2 study in CTCL expected by the end of 2018.
ARGX-111
- Safety endpoints were met in the Phase 1 clinical trial; complete data set to be presented at the American Society of Clinical Oncology (ASCO) conference (Singapore) in July 2017.
FINANCIAL HIGHLIGHTS (as on March 31, 2017) (compared to financial highlights as of March 31, 2016)
- Operating income of €7.2 million (March 31, 2016: €2.8 million).
- Total comprehensive loss of €8.4 million (March 31, 2016: €3.0 million).
- Cash position of €85.0 million (cash, cash-equivalents and current financial assets) (March 31, 2016: €53.8 million) allowing the Company to pursue development of its product portfolio in line with its communicated business plan.
