UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 6-K

 


 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of November 2019

 

Commission File Number: 001-38097

 


 

ARGENX SE

(Translation of registrant’s name into English)

 


 

Willemstraat 5
4811 AH, Breda, the Netherlands

(Address of principal executive offices)

 


 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F  x     Form 40-F  o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 


 

argenx SE

 

On November 6, 2019, argenx SE (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

The information contained in this Current Report on Form 6-K, including Exhibit 99.1, is incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-225370) and S-8 (File No. 333-225375).

 

Exhibit

 

Description

 

 

 

99.1

 

Press Release dated November 6, 2019

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

ARGENX SE

 

 

Date: November 6, 2019

By:

/s/ Dirk Beeusaert

 

 

Dirk Beeusaert

 

 

General Counsel

 

3


Exhibit 99.1

 

 

argenx to Present Data at Upcoming 61st American Society of Hematology (ASH) Annual Meeting

 

November 6, 2019

 

Breda, the Netherlands / Ghent, Belgiumargenx (Euronext & Nasdaq: 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 three presentations at the the upcoming 61st American Society of Hematology (ASH) Annual Meeting being held from December 7-10, 2019 in Orlando, FL. The presentations will include preclinical translational data highlighting the multiple modes of action of cusatuzumab to target leukemic stem cells, potential synergies of cusatuzumab in combination with a BCL-2 antagonist, and previously announced data from the Company’s completed Phase 2 trial of efgartigimod for primary immune thrombocytopenia (ITP).

 

Details for the oral presentations are as follows:

 

Title: Targeting CD70 with Cusatuzumab Eliminates Acute Myeloid Leukemia Stem Cells in Humans

Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targets and Combinations

Date and Time: Saturday, December 7, 3:15 p.m. ET

Location: Orange County Convention Center, Chapin Theater, W320

Presenter: Dr. Adrian Ochsenbein, M.D., University of Bern

 

Title: Phase 2 Study of Efgartigimod, a Novel FcRn Antagonist, in Adult Patients with Primary Immune Thrombocytopenia

Oral Session: 311. Disorders of Platelet Number or Function: Advances in ITP Therapy

Date and Time: Monday, December 9, 6:15 p.m. ET

Location: Orange County Convention Center, W307

Presenter: Dr. Adrian Newland, M.D., The Royal London Hospital

 

Details for the poster presentation are as follows:

 

Title: The Combination of the BCL-2 Antagonist Venetoclax with the CD70-Targeting Antibody Cusatuzumab Synergistically Eliminates Primary Human Leukemia Stem Cells

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Date & Time: Monday, December 9, 2019, 6:00 p.m. - 8:00 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Dr. Carsten Riether, Ph.D., University of Bern

 

About argenx

 

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune diseases and cancer. The company is 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. argenx’s ability to execute on this focus is enabled by its suite of differentiated technologies. The SIMPLE Antibody™ Platform, based on the powerful llama immune

 


 

 

system, allows argenx to exploit novel and complex targets, and its three complementary Fc engineering technologies are designed to expand the therapeutic index of its product candidates.

 

 

www.argenx.com

 

 

For further information, please contact:

 

Beth DelGiacco, Vice President, Investor Relations

+1 518 424 4980

bdelgiacco@argenx.com

 

Joke Comijn, Director Corporate Communications & Investor Relations (EU)

+32 (0)477 77 29 44

+32 (0)9 310 34 19

info@argenx.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. 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 as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. 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.