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 May 2023
Commission File Number: 001-41562
NewAmsterdam Pharma Company N.V.
(Exact name of registrant as specified in its charter)
Gooimeer 2-35
1411 DC Naarden
The Netherlands
(Address of principal executive office)
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 ☒ Form 40-F ☐
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): ☐
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): ☐
On May 23, 2023, NewAmsterdam Pharma Company N.V. (the Company) issued a press release announcing that it is scheduled to present full data from its ROSE2 trial at the NLA Scientific Sessions on June 5, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Report on Form 6-K.
This Report on Form 6-K (including Exhibit 99.1) shall be deemed to be incorporated by reference into the registration statements on Form S-8 (File No. 333-271019).
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press Release, dated May 23, 2023. |
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, thereunto duly authorized.
NewAmsterdam Pharma Company N.V. | ||||||
May 23, 2023 | By: | /s/ Michael Davidson | ||||
Name: Michael Davidson Title: Chief Executive Officer |
Exhibit 99.1
NewAmsterdam to Present Full Data from ROSE2 at NLA Scientific Sessions 2023
NewAmsterdam to review data on webcast conference call on June 5, 2023 at 8:00 a.m. ET
Naarden, the Netherlands and Miami, USA; May 23, 2023 NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or NewAmsterdam or the Company), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today announced that it will present full data from ROSE2, a Phase 2 clinical trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, in a late-breaking presentation at the National Lipid Association (NLA) Scientific Sessions, being held June 1-4 in Atlanta, Georgia. NewAmsterdam is developing a fixed dose combination of obicetrapib 10 mg and ezetimibe 10 mg, and expects to select a formulation to advance into a definitive bioequivalence trial and a Phase 3 safety and efficacy trial in the second half of 2023.
Details of the presentation are as follows:
Presentation Title: The combination of Obicetrapib and Ezetimibe lowers LDL-C in Patients on High Intensity Statins: Results from the ROSE2 Trial (NCT05266586)
Session Title: Late-Breaker Session
Session Date and Time: Saturday, June 3, 2023, 12:00 P.M. ET
Location: Omni Atlanta Hotel at CNN Center
Investor and Analyst Conference Call and Live Webcast
NewAmsterdam will host a conference call for investors and analysts to review the full data from ROSE2. The live webcast will begin at 8:00 a.m. ET on Monday, June 5 and will include remarks by Robert Rosenson, M.D., a Professor of Medicine and Director of Cardiometabolic Disorders at the Icahn School of Medicine at Mount Sinai.
Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.
A live webcast of the call will also be available under Events & Presentations in the Investors & News section of the Companys website at https://ir.newamsterdampharma.com. The archived webcast will be available on NewAmsterdams website approximately two hours after the conference call and will be available for at least 30 days following the live event.
About NewAmsterdam
NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally-tolerated statin therapy for high-risk cardiovascular disease (CVD) patients. Results from NewAmsterdams ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10 mg experienced a median reduction in LDL-C of 51% versus baseline in patients on high-intensity statin therapy (vs. a 7% reduction in the placebo arm). In addition, topline results from NewAmsterdams ROSE2 trial evaluating the combination of 10 mg obicetrapib and 10 mg ezetimibe demonstrated a median reduction in LDL-C levels of 59% versus baseline in patients on high-intensity statin therapy (vs. a 6% reduction in the placebo arm). Based in the Netherlands, NewAmsterdam recently completed a business combination with FLAC, a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners. Proceeds from this transaction were approximately $328 million, prior to deducting transaction expenses. In June 2022, NewAmsterdam entered into an exclusive licensing agreement with the Menarini Group for the commercialization of obicetrapib in Europe, while retaining all rights to commercialize obicetrapib, if approved, in the rest of the world, as well as rights to develop certain forms of obicetrapib for other diseases such as Alzheimers disease. For more information, please visit: www.newamsterdampharma.com.
Forward-Looking Statements
Certain statements included in this document 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 Companys business and strategic plans, the Companys clinical trials and the timing for enrolling patients, the timing and forums for announcing data and the achievement and timing of regulatory approvals. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Companys 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 relating to the uncertainty of the projected financial information with respect to the Company; risks related to the approval of the Companys product candidate and the timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; the impact of COVID-19; global economic and political conditions, including the Russia-Ukraine conflict; the effects of competition on the Companys future business; and those factors described in the Companys public filings with the U.S. Securities and Exchange Commission. Additional risks related to the Companys business include, but are not limited to: uncertainty regarding outcomes of the Companys ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Companys efforts to commercialize a product candidate; the Companys ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Companys business; intellectual property related claims; the Companys 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 Companys 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 Companys expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Companys assessments to change. These forward-looking statements should not be relied upon as representing the Companys 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.
Company Contact
Matthew Philippe
P: 917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Bryan Blatstein
P: 917-714-2609
bblatstein@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1 212-362-1200
hannah.deresiewicz@sternir.com