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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549  

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): May 26, 2023

 

Y-MABS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38650   47-4619612

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

230 Park Avenue

Suite 3350

New York, New York 10169

(Address of principal executive offices) (Zip Code)

 

(646) 885-8505

(Registrant’s telephone number, include area code)

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:   Trading Symbol   Name of each exchange on which
registered:
Common Stock, $0.0001 par value   YMAB   Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On May 26, 2023, Y-mAbs Therapeutics, Inc. (the “Company”) issued two press releases. The first press release announced that the Company plans to present a poster presentation featuring interim clinical data on naxitamab, a recombinant, humanized anti-GD2 monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor, at the American Society of Clinical Oncology’s annual meeting to be held June 2, 2023 through June 6, 2023, in Chicago, Illinois (the “ASCO Meeting”). The second press release announced that the Company plans to present a poster featuring the design of its Phase 1 clinical trial evaluating the Company’s Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy at the ASCO Meeting.

 

Copies of the above-referenced press releases are attached hereto as Exhibits 99.1 and 99.2, respectively, and are hereby incorporated by reference.

 

The information in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release, Announcing Presentation of Naxitamab Data at the American Society of Clinical Oncology, dated May 26, 2023, issued by Y-mAbs Therapeutics, Inc.
     
99.2   Press Release, Announcing Presentation of GD2-SADA Study at the American Society of Clinical Oncology, dated May 26, 2023, issued by Y-mAbs Therapeutics, Inc.
     
104   Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

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

 

  Y-MABS THERAPEUTICS, INC.
     
Date: May 26, 2023 By: /s/ Thomas Gad
    Thomas Gad
    Founder, Chairman, President, Interim Chief Executive Officer and Head of Business Development & Strategy