UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| The |
||||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
The |
||
| (Address of principal executive offices) | (Zip Code) |
+
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communication 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-commencements 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 |
Name of each exchange on which registered | ||
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 December 10, 2024, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing positive topline data from the Company’s Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia, whose low-density lipoprotein cholesterol is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The Company is hosting a live webcast and conference call to discuss the positive topline results of the BROADWAY clinical trial on December 10, 2024 at 8:00 a.m., Eastern Time, and a live webcast of the call will be available through the Company’s website. A copy of the slide presentation to be used by the Company during the conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, is being “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 liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
EXHIBIT NUMBER |
EXHIBIT DESCRIPTION | |
| 99.1 | Press Release, dated December 10, 2024. | |
| 99.2 | NewAmsterdam Pharma Company N.V., December 10, 2024 BROADWAY Presentation. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
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 hereunto duly authorized.
| NewAmsterdam Pharma Company N.V. | ||
| By: | /s/ Michael Davidson | |
| Michael Davidson | ||
| Chief Executive Officer | ||
Dated: December 10, 2024