UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On November 20, 2024, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing positive topline data from its Phase 3 TANDEM clinical trial evaluating the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or atherosclerotic cardiovascular disease (“ASCVD”) or multiple ASCVD risk factors, whose low-density lipoprotein cholesterol (“LDL-C”) 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.
The Company is hosting a live webcast and conference call to discuss the positive topline results of the TANDEM clinical trial on November 20, 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 attached hereto as Exhibit 99.2 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 8.01 | Other Events. |
On November 20, 2024, the Company announced topline data from its TANDEM clinical trial, a Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluating the effect of 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including lipoprotein(a), non-high-density lipoprotein cholesterol and apolipoprotein B.
The TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. The observed reductions in the other co-primary endpoints are summarized below.
LDL-C percentage change:
| Ezetimibe (n=101) |
Obicetrapib (n=102) |
Obicetrapib and Ezetimibe FDC (n=102) |
||||||||||
Day 84 - from placebo |
||||||||||||
Mean % |
-23.3 | -35.5 | -52.2 | |||||||||
Median % |
-22.6 | -37.2 | -54.0 | |||||||||
LS mean % |
-20.7 | -31.9 | -48.6 | |||||||||
Comparison to pbo |
— | (p<0.0001) | (p<0.0001) | |||||||||
Comparison to eze 10 mg |
— | — | (p<0.0001) | |||||||||
Comparison to obi 10 mg |
— | — | (p=0.0007) | |||||||||
We also observed reductions in lipoprotein(a), with mean observed reduction compared of placebo of 16.2% in the ezetimibe monotherapy arm, 56.2% in the obicetrapib monotherapy arm and 62.9% in the fixed-dose combination arm.
Over 60% of patients in the fixed-dose combination group saw a greater than 50% decrease in LDL-C levels. In the fixed-dose combination group, approximately 71%, 80% and 90% of patients achieved LDL-C levels of less than 55 mg/dl, 70 mg/dl and 100 mg dl, respectively. Similar LDL-C levels were achieved by approximately 41%, 60% and 88% of patients in the obicetrapib 10 mg group, respectively, approximately 25%, 56% and 80% of patients in the ezetimibe group, respectively, and approximately 7%, 18% and 64% of patients in the placebo group, respectively.
In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to placebo. The below table summarizes study drug-related treatment emergent adverse events (“TEAEs”) and study drug-related treatment emergent serious adverse events (“TESAEs”).
| Placebo (n=102) |
Ezetimibe (n=101) |
Obicetrapib (n=102) |
Obicetrapib / Ezetimibe FDC (n=102) | |||||
Any study drug-related TEAEs |
4 (3.9%) | 3 (3.0%) | 7 (6.9%) | 3 (2.9%) | ||||
Any study drug-related TEAEs leading to discontinuation of study drug |
2 (2.0%) | 1 (1.0%) | 6 (5.9%) | 1 (1.0%) | ||||
Any study drug related TESAEs |
0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
The study was conducted at sites across the United States, and a total of 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who had a baseline LDL-C of at least 70 mg/dL, were randomized 1:1:1:1 to receive 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination, 10 mg obicetrapib, 10 mg ezetimibe or placebo for an 84-day treatment period. The mean baseline LDL-C for enrolled patients in the obicetrapib-ezetimibe arm was 97 mg/dL despite high intensity statin use reported by approximately 74% of patients during screening.
Forward-Looking Statements
Certain statements included in this Current Report on Form 8-K that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this Current Report on Form 8-K, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities and Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this Current Report on Form 8-K and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
EXHIBIT NUMBER |
EXHIBIT DESCRIPTION | |
| 99.1 | Press Release, dated November 20, 2024. | |
| 99.2 | NewAmsterdam Pharma Company N.V., November 20, 2024 TANDEM 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: November 20, 2024