00-0000000 false 0001936258 0001936258 2025-01-10 2025-01-10 0001936258 us-gaap:CommonStockMember 2025-01-10 2025-01-10 0001936258 us-gaap:WarrantMember 2025-01-10 2025-01-10

 

 

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): January 10, 2025

 

 

NewAmsterdam Pharma Company N.V.

(Exact name of registrant as specified in its charter)

 

 

 

The Netherlands   001-41562   N/A

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

Gooimeer 2-35  
Naarden  
The Netherlands   1411 DC
(Address of principal executive offices)   (Zip Code)

+31 (0) 35 206 2971

(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

Symbols

 

Name of each exchange

on which registered

Ordinary Shares, nominal value €0.12 per share   NAMS   The Nasdaq Stock Market LLC
Warrants to purchase Ordinary Shares   NAMSW   The Nasdaq Stock Market LLC

☐ 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).

 

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 January 10, 2025, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release highlighting milestones achieved in 2024 and its strategic priorities and anticipated milestones for 2025. 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.

On January 10, 2025, the Company posted an updated corporate investor presentation on its website (https://www.newamsterdampharma.com/). A copy of the corporate investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. The information contained on, or that can be accessed from, the Company’s website is not incorporated into, and does not constitute a part of, this Current Report on Form 8-K.

The information contained in this Item 7.01, including Exhibit 99.1 and Exhibit 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 Exhibit 99.1 and Exhibit 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 January 10, 2025
99.2    NewAmsterdam Pharma Company N.V. Corporate 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: January 10, 2025

Exhibit 99.1

NewAmsterdam Pharma Highlights 2024 Achievements and Outlines 2025 Strategic Priorities

— Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025; expected to support global regulatory filings for obicetrapib, including EMA submission in 2H25 by our partner Menarini –

— Data from Phase 2 VINCENT trial expected by 2H25, which explores effect of obicetrapib alone and in combination with a PCSK9i on Lp(a) –

— Focus on commercial readiness with manufacturing capacity establishment and inventory build-out

— Year end, unaudited, cash balance of $835 million following oversubscribed public offering in December 2024 —

Naarden, the Netherlands and Miami, USA; January 10, 2025 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2025.

NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. The Company’s global, pivotal Phase 3 clinical development program consists of four trials in over 12,250 patients.

“2024 was a landmark year for NewAmsterdam, underscored by exceptional clinical and operational execution. We announced positive topline results from three pivotal Phase 3 trials, BROOKLYN, TANDEM, and BROADWAY, which will form the foundation for our planned global regulatory filings for obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We were particularly excited to announce results from BROADWAY, which demonstrated greater than expected reduction in the exploratory outcome measure of major adverse cardiovascular events (“MACE”) after only one year of treatment with obicetrapib, with a safety profile that was comparable to placebo. These data not only reinforce obicetrapib’s potential to both lower LDL-C and address critical cardiovascular risks, but also support the approach we have taken for our ongoing PREVAIL Phase 3 cardiovascular outcomes trial (“CVOT”), which is designed to assess MACE benefit as its primary endpoint.”

“As we move into 2025, we are focused on sharing additional scientific findings on obicetrapib’s therapeutic potential through presentations at leading medical meetings and publications in high-impact journals, and on advancing PREVAIL toward a successful data readout. Importantly, following our recent financing, we are operating from a position of financial strength, with capital to support operations through the anticipated PREVAIL CVOT readout and, pending regulatory approval, the commercial launch of obicetrapib. We believe we are at the precipice of a major transformation for CVD care globally and remain steadfast in our mission to unlock the full potential of obicetrapib for the millions of people living with dyslipidemia and at heightened risk for CVD,” continued Dr. Davidson.

Key 2024 Achievements:

NewAmsterdam announced positive topline results for three Phase 3 clinical studies, each with safety comparable to placebo:

 

   

BROADWAY evaluated obicetrapib in 2,530 adult patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”), whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In December, NewAmsterdam reported positive topline data from the BROADWAY study. The primary endpoint was the least-squares mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001). Mean and median reductions in LDL-C at day 84 were 33% and 36%, respectively. As part of the safety analysis, the trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization, and in an exploratory analysis, a 21% reduction in MACE favoring obicetrapib was observed. NewAmsterdam expects to report additional data at an upcoming medical conference and to publish the data in a major medical journal.


   

TANDEM evaluated obicetrapib as part of a fixed-dose combination tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in 407 patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In November, NewAmsterdam reported that the TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 49% (p < 0.0001) compared to placebo at day 84. Mean and median reductions in LDL-C at day 84 were 52% and 54%, respectively. NewAmsterdam expects to report additional data at an upcoming medical conference and to publish the data in a major medical journal.

 

   

BROOKLYN evaluated obicetrapib in 354 patients with HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In July, NewAmsterdam reported that the BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36% (p < 0.0001) compared to placebo at day 84, with additional data presented at the American Heart Association Scientific Sessions 2024 in November. Mean and median reductions in LDL-C at day 84 were 36% and 39%, respectively.

 

   

PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024 and the trial continues in line with expectations.

In addition, NewAmsterdam announced that the United States Patent and Trademark Office (“USPTO”) issued a new patent covering the solid form that will be used in the Company’s products. The issuance of this composition of matter patent provides intellectual property protection for obicetrapib until July 2043 in the United States. The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses.

Key 2025 Milestones and Ongoing Trials:

Over the course of 2025, NewAmsterdam plans to announce additional data from its Phase 3 studies, including BROADWAY, TANDEM, and BROOKLYN. NewAmsterdam also plans to publish data on a significant number of topics that support the overall benefit and differentiation of obicetrapib and the fixed dose combination of obicetrapib plus ezetimibe, compared to other lipid lowering therapies.

In addition to PREVAIL, NewAmsterdam continues to enroll two studies of obicetrapib, including:

 

   

VINCENT, a Phase 2 clinical study to evaluate the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) (“Lp(a)”) in patients with mild dyslipidemia. The single arm study will treat patients with obicetrapib 10mg daily for 8 weeks followed by obicetrapib 10mg daily plus evolocumab 140 mg/dL every other week for 8 weeks. The study is expected to complete in the second half of 2025 and to enroll 30 patients with baseline Lp(a) levels above 50 mg/dL.

 

   

REMBRANDT, a Phase 3 cardiovascular computed tomography angiography imaging trial to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. The placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The study is expected to complete in 2027 and to enroll 300 patients.

An additional focus for the Company throughout 2025 will be on commercial manufacturing and readiness. The Company plans to scale up and build inventory sufficient for both the U.S. and European launches, if approved, which will be supported by the approximately $835 million of unaudited cash on hand at year-end 2024.


About Obicetrapib

Obicetrapib is a novel, oral, low-dose, and highly selective CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company is currently conducting the Phase 3 PREVAIL cardiovascular outcomes trial, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseases have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.

About Cardiovascular Disease

Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (LLTs). By 2050 more than 184 million US adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated US adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes.

About NewAmsterdam

NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.

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 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 document, 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; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the


final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, or whether projections regarding clinical outcomes will reflect actual results in future clinical trials or clinical use of our product candidate, if approved; 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 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; and ability to continue to source the raw materials for the Company’s 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 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 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.

Company Contact

Matthew Philippe

P: 1-917-882-7512

matthew.philippe@newamsterdampharma.com

Media Contact

Spectrum Science on behalf of NewAmsterdam

Jaryd Leady

P: 1-856-803-7855

jleady@spectrumscience.com

Investor Contact

Precision AQ on behalf of NewAmsterdam

Austin Murtagh

P: 1-212-698-8696

austin.murtagh@precisionaq.com

Exhibit 99.2 Corporate Presentation January 2025 Nasdaq: NAMS


Disclaimer This presentation (together with oral statements made in connection herewith, this “Presentation”) is for informational purposes only. This Presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful. Forward Looking Statements Certain statements included in this Presentation 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 by NewAmsterdam Pharma Company N.V. (“NewAmsterdam” or the “Company”) regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity; the Company's business and strategic plans; expectations and timing related to the success, cost and timing of product development activities, including timing of initiation, completion and data readouts for clinical trials and the potential approval of the Company’s product candidate; the timing for enrolling patients; the timing and forums for announcing data; the size and growth potential of the markets for the Company’s product candidate; the therapeutic and curative potential of the Company’s product candidate; financing and other business milestones; the Company’s expected cash runway; and the Company’s plans for commercialization. These statements are based on various assumptions, whether or not identified in this Presentation, 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 NewAmsterdam’s product candidate and the timing of expected regulatory and business milestones; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials; 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 conflict, and the war in Israel; the effects of competition on NewAmsterdam’s future business; and those factors discussed in documents filed by the Company with the SEC. Additional risks related to NewAmsterdam’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; and the Company’s ability to continue to source the raw materials for its product candidate, together with the risks described in the Company’s filings made with the U.S. Securities and Exchange Commission from time to time. If any of these risks materialize or NewAmsterdam’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that are presently unknown by the Company or that NewAmsterdam 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 NewAmsterdam’s expectations, plans, or forecasts of future events and views as of the date of this Presentation and are qualified in their entirety by reference to the cautionary statements herein. NewAmsterdam anticipates that subsequent events and developments will cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing NewAmsterdam’s assessments as of any date subsequent to the date of this Presentation. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither NewAmsterdam nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as required by law. Market Data Certain information contained in this Presentation relates to or is based on third-party studies, publications, surveys and NewAmsterdam’s own internal estimates and research. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while NewAmsterdam believes its internal research is reliable, such research has not been verified by any independent source and NewAmsterdam cannot guarantee and makes no representation or warranty, express or implied, as to its accuracy and completeness. Trademarks This Presentation contains trademarks, service marks, trade names, and copyrights of NewAmsterdam and other companies, which are the property of their respective owners. The use or display of third parties’ trademarks, service marks, trade name or products in this Presentation is not intended to, and does not imply, a relationship with NewAmsterdam or an endorsement or sponsorship by or of NewAmsterdam. Solely for convenience, the trademarks, service marks and trade names referred to in this Presentation may appear with the TM or SM symbols, but such references are not intended to indicate, in any way, that NewAmsterdam will not assert, to the 2 fullest extent permitted under applicable law, their rights or the right of the applicable licensor to these trademarks, service marks and trade names.


Obicetrapib and Obicetrapib plus Ezetimibe Could Address Significant Unmet Need in Cardiometabolic Diseases 30mm+ >3,500 pts Significant unmet need for oral LDL-C of favorable safety/tolerability patients in the US alone are not lowering therapy as adjunct to statins data comparable to placebo. achieving LDL-C lowering goals Blinded data in >9,500 patients Simple, once-daily, low-dose CETP inhibitor with statistically significant 35-40% 46-56% LDL-C lowering and effects beyond LDL-C lowering versus placebo as mean Lp(a) lowering versus LDL, observed across three Phase 3 + a monotherapy* placebo as a monotherapy trials and five Phase 2 trials Convenient oral format potentially 21% ~50% enables broad adoption and combinations to address unmet need, LDL-C lowering versus placebo in observed reduction in MACE ^ if approved combination** with ezetimibe favoring obicetrapib at 1-year Robust IP protection until mid 2043 Observed beneficial effects beyond LDL, on ApoB, non-HDL-C, LDL-P, HDL-C and other markers of glycemic control and renal function 3 Source: Company data for obicetrapib 10mg monotherapy, *Pooled data includes BROOKLYN, TANDEM, BROADWAY Phase 3 data sets. Reduction across ITT mean, median, and LS mean. ** ROSE2 and TANDEM data, Reduction across ITT mean, median, and LS mean +Pooled data from BROOKLYN and TANDEM. LS mean reduction placebo corrected ^Data from BROADWAY trial, MACE was an exploratory endpoint measure


Previous 18 Months Were a Time of Groundwork, Goals and Growth Doubled in size (~70) with Secured funding to support Building world-class Completed and announced new hires and offices in US Commercial launch, if commercial and MSL results for BROOKLYN, Amsterdam, NL, Miami, FL, approved, with cash at YE24 functions BROADWAY, and TANDEM and Philadelphia metro area of ~$835M Phase 3 studies 2024 2023 Presented Topline Japan Initial Completed Announced Announced Announced Selected formulation Composition of ROSE2 full Phase 2b Alzheimer’s enrollment for topline results topline results for topline results for for obi+eze Phase matter IP Granted data at NLA results Phase 2a data PREVAIL CVOT for BROOKLYN TANDEM Phase 3 BROADWAY 3 trial Phase 3 trial Phase 3 trial 4


Obicetrapib Designed to Address the ~30M Patients in US on Drug but not at Goal ~43 million ~18 million Treated primary prevention Not at goal of LDL-C patients <100mg/dl Of the ~30M treated patients not at goal, ~72 million ~19 million ~8 million ~18M were “far from Treated secondary High Risk ASCVD not at Adults in US diagnosed with goal” (greater than prevention patients goal of LDL-C <55 mg/dl hypercholesterolemia 20%) and 6M were not taking statins ~10 million ~5 million Diagnoses patients not ASCVD not at goal of LDL- treated with statin or LLT C <70 mg/dl US Branded Lipid Lowering Market Potential key factors limiting penetration include product limitations and market access hurdles: Low prescriber enthusiasm for existing TPPs Payors restrict access ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein-cholesterol; LLT=lipid lowering treatment. Source: ISPOR 2024 5


Lipid Lowering Therapy (LLT) Market is a Growing Opportunity 1 2 3 4 5 2 3 4 Patients on Lipid lowering Therapy Patients on Non-statin Treatment Patients on Branded Treatment Branded sales driving market 11.0% 1.3% 0.1% opportunity ($ millions) 56MM 4.0MM 700K 19.6% 31% 4.3% Growth Growth Growth 600K 5.4% Growth 26.3% 51MM 3.5MM 500K Growth 17.8% Growth 400K 87.6% 46MM 3.0MM 3.8MM 638K Generic - Statin Generic - non Statin 54MM 300K 51MM Branded - PCSK9 Branded - ACL Inhibitor 487K 49MM 3.2MM 200K 386K 41MM 2.5MM 2.7MM 100K 256M Prescriptions written 36MM 2.0MM 0K 1 Nov '20 to Nov '21 to Nov '22 to Nov '20 to Nov '21 to Nov '22 to Nov '20 to Nov '21 to Nov '22 to in past 12 months. Oct '21 Oct '22 Oct '23 Oct '21 Oct '22 Oct '23 Oct '21 Oct '22 Oct '23 Over 250 MM Market grew Non-statin market grew Branded market PCSK9 sales accelerated post launch miscalculations Rx’s annually 4% over 2 years at high double digits grew even faster Recent guideline and label changes driving renewed acceleration 5 2022: ACC updated guidelines to target LDL-C <55 mg/dl in high-risk patients in line with ESC/EAS 2024: FDA actions reflect need to reduce access restrictions for LLTs. Labels updated from “on top of maximally tolerated statins” to “treatment of primary 6 hyperlipidemia” for some LLTs 1. Source: IQVIA XPT - Data Period – 12 months of TRx from Dec ‘22 to Nov ’23 Source: IQVIA LAAD data from Nov ‘20 to Oct ’23 2. All Lipid Lowering therapies: Statins, Ezetimibe and combinations; PCSK9 a nd BPA 3. Non-Statins : Ezetimibe and 6 combinations; PCSK9 and BPA 4. Branded: PCSK9 and BPA 5. Lloyd-Jones DM, et al. J Am Coll Cardiol. 2022;80(14):1366-1418 6. Leqvio (inclisiran). Prescribing information. Novartis; 2023.; Nexletol (bempedoic acid). Prescribing information. Esperion Therapeutics Inc; 2023. Note: LTM=last 12 months ending 2Q24


Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets Primary prevention HeFH ASCVD patients with an Very high risk ASCVD patients with LDL-C target of LDL<70 or patients with an LDL-C 2 an LDL-C target <100 mg/dL <55 mg/dL (2017-2018) target <55 mg/dL (2020- 1 3 (2011-2017) 2021) LDL-C < 100 mg/dL LDL-C < 70 mg/dL LDL-C < 55 mg/dL 29% 24% 10% <1/3 achieved ~1/4 achieved 10% achieved LDL-C <100 mg/dL LDL-C <70 mg/dL LDL-C <55 mg/dL ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein-cholesterol. 1. Schreuder MM, et al. LDL cholesterol targets rarely achieved in familial hypercholesterolemia patients: A sex and gender-specific analysis. Atherosclerosis. 2023 2. Gao Y, Shah LM, Ding J, Martin SS. US trends in cholesterol screening, lipid levels, and lipid- lowering medication use in US adults, 1999 to 2018. J Am Heart Assoc. 2023;12(3):e028205; 3. Katzmann JL, et al. Simulation s tudy on LDL cholesterol target attainment, treatment costs, and ASCVD events with bempedoic acid in patients at high and very-high 7 cardiovascular risk. PLoS One. 2022;17(10):e0276898;


CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines in 2013 1 CVD Mortality Trends for US Males and Females, 1980 to 2020 Trends in Prevalence of High LDL-C in US Adults, 2 NHANES 1999-2018 with History of ASCVD 550 100 530 LDL-C Goals Removed In 75 510 2013 490 50 470 25 450 430 0 410 390 ~75% of ASCVD patients are NOT 370 at their risk-based LDL-C goal 350 1980 1985 1990 1995 2000 2005 2010 2015 2020 Year Males Females 1 Tsao, CW., et. al., Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association, Circulation. 2023;147:e00–e00. DOI: 10.1161/CIR.0000000000001123 2. Yumin Gao, Y., et.al., US Trends in Cholesterol Screening, Lipid 8 Levels, and Lipid-Lowering Medication Use in US Adults, 1999 to 2018, J Am Heart Assoc. 2023;12:e028205. DOI: 10.1161/JAHA.122.02820500 Deaths in Thousands LDL-C ≥70 mg/dL, %


Physicians have Limited Treatment Options to Meet Patients Needs (5) (5) (1) (2) (3) Obicetrapib Obi + Eze Ezetimibe Nexletol PCSK9i Approved Approved Approved Approval LDL-C data 2024 LDL-C data 2024 7% 13% 15% MACE Benefit 21%* TBD Observed LDL-C 49-54% 25% 17% 45-50% 35-40% Reduction Oral Oral Oral Oral Injectable Administration (small molecule) (small molecule) (small molecule) (small molecule) (mAb) 20mg Available and 10mg 10mg 180mg 140-150mg Dosing (10mg Obi + 10mg Eze) investigational treatment options No No No No No have limitations Food Effect Safety & Well-tolerated Well-tolerated Safe, Tendon rupture & gout Safe, injection site Tolerability well-tolerated warning on label reactions compared to placebo compared to placebo None 15-30% Lp(a) lowering None 63% 46-56% Note: The above data do not represent head-to-head comparisons. Actual results may differ from expectations. Obicetrapib mono and Ezetimibe combo, along with the Oral PCSK9 have not been approved by any regulatory authority. E= estimated dates. Red represents sub-optimal product charateristics. Sources: 1. PI Zetia table 7. refers to; Gagne, C et al. Am J Cardiol 2002. LDL-C measured only using Friedewald 2. PI Nexletol; study 2. refers to; Goldberg, A et al. JAMA 2019;322(18):1780-1788. LDL-C measured using Friedewald and direct assay for LDL-C <50 mg/dL. 3. multiple studies: Blom, D et al. N Engl J 9 Med 2014; Kereiakes, D et al. Am Heart J 2015.; Ray, K. N Engl J Med 2020. 4. Ballantyne, C et al. JACC 2023;81(16) 5. See slide 12 for LDL-C, *MACE benefit from exploratory analysis in BROADWAY at 1 year 6. MK0616 was observed to have adverse events comparable to pbo in Phase 2b trials


Limited New Therapies on the Horizon (3) (4) (1) (2) Obicetrapib Obi + Eze MK-0616 AZD0780 LDL-C data 2026E TBD LDL-C data 2024 Approval LDL-C data 2024 (CVOT data 2029E) Phase 2b Phase 3 Phase 3 Phase 3 Current Phase ongoing ongoing completed completed 50-59% Observed LDL-C 35-40% 49-54% 30%-38% Reduction (~20% with food) Oral Oral Oral Oral Administration (small molecule) (small molecule) (peptide) (small molecule) 20mg Available and 380mg 10mg 30mg-60mg Dosing (10mg Obi + 10mg Eze) (20mg API + 360mg SNAC) investigational treatment options Yes No No No have limitations Food Effect (8hr fast & 30min wait) SNAC technology has Well-tolerated Well-tolerated Safety & previously been observed Well-tolerated Tolerability to have compared to placebo compared to placebo (6) tolerability concerns 20-25% unkown 46-56% 63% Lp(a) lowering Note: The above data do not represent head-to-head comparisons. Actual results may differ from expectations. Obicetrapib mono and Ezetimibe combo, along with the Oral PCSK9 have not been approved by any regulatory authority. E= estimated dates.Red represents sub-optimal product charateristics. Sources:. 1. Ballantyne, C et al. JACC 2023;81(16) 2. EAS 2024 3. See slide 12 for LDL-C 6. MK0616 was observed to have adverse events comparable to pbo in Phase 2b trials 10


Obicetrapib Program Designed to Overcome Limitations of Prior CETP Inhibitors (3) (1) (2) (4) (5) Evacetrapib Torcetrapib Dalcetrapib Anacetrapib Obicetrapib (6) Observed LDL-C reduction 25% 7% 11-21% 17% 35-40% CETP inhibition 35% 30% 65% 80% 97% Dosing 60mg 600mg 100mg 100mg 10mg Blood pressure increase Yes No No No No Aldosterone increase Yes No No No No Lp(a) lowering unknown unknown 20-25% 20-25% 46%-56% ApoB lowering 15% None 15-20% 18% 22%-24% OUTCOMES STUDIES Name ILLUMINATE Dal-OUTCOMES ACCELERATE REVEAL PREVAIL Patients 15,067 15,871 12,092 30,449 9,541 Baseline LDL-C (mg/dl) 79.7 76.4 81.1 61 103 LDL-C reduction (mg/dl) 20 NS 25 11 TBD Median follow-up 18 mo 31 mo 26 mo 49 mo 42 mo (expected) Result (HR) 1.25 1.04 1.01 0.91 TBD Short follow-up but As expected, low Explanation Off target tox No LDL-C benefit mortality benefit (HR baseline and LDL TBD 0.84) reduction 11 Note: The above trials and data do not represent head-to-head comparisons. Actual results may differ from expectations. Sources: 1. Barter et al. NEJM.2007; 2. Schwartz et al. NEJM.2012; 3. Lincoff et al. NEJM.2017 4. Bowman et al. NEJM.2017 5. Company Data 6. Per PUC, if available


Consistent LDL-C Reduction Observed Across Our Phase 2 and Phase 3 Trials Obicetrapib 10 mg monotherapy Obicetrapib plus ezetimibe ROSE ROSE2 BROOKLYN TANDEM BROADWAY ROSE2 TANDEM 0.0% 0.0% -10.0% -10.0% -20.0% -20.0% -30.0% -30.0% -40.0% -40.0% -50.0% -50.0% -60.0% -60.0% On-treatment mean LS mean Median On-treatment mean LS mean Median Monotherapy reductions of 35-40% Combo reductions of 50-60% Note: ROSE at week 8, ROSE2, BROOKLYN, BROADWAY, and TANDEM as of week 12. 12 % change versus placebo % change versus placebo


Consistent LDL-C Reduction Observed Over One Year Trial Duration LS Mean % change vs. placebo LDL-C reduction over time (ITT population) 41.5% 38.2% 38.3% 36.3% * * Note: * = p<0.0001. Martin Hopkins mean changes at baseline, day 30, Day 180, Day 270 and LS mean by PUC at Day 84 and Day 36 5. 13


Consistent LDL-C Reduction Observed Over One Year Trial Duration LDL-C at day 84 and 365 Mean LDL-C reduction over time Day 84 (primary endpoint) Day 365 (secondary endpoint) 5% 0% 0% 1% -5% -1% -1% -1% -5% -3% -10% -10% -15% -15% -20% -20% -25% -25% -24% -30% -30% -29% -35% -33% -33% -34% -33% -33% -33% -35% -35% -40% -35% -36% -39% -37% -40% -45% Day 30 Day 84 Day 180 Day 270 Day 365 Obicetrapib 10 mg (LS mean) Obicetrapib 10 mg (on-treatment) Obicetrapib 10 mg (mean) Obicetrapib 10 mg (median) Placebo Obicetrapib 10 mg 14 Note: LDL-C at day 84 and 365 chart via PUC. Mean reduction over time chart via Martin/Hopkins. % change from placebo Mean % change from baseline


LDL-C Responder Analysis at day 84 34% of patients with >50% LDL-C reduction 33% of patients with >50% LDL-C reduction 100% 80% 60% 40% 20% 0% -20% -40% -60% -80% -100% 61% of patients with >50% LDL-C reduction 15 Note: each line represents a single patient in the obicetrapib 10 mg arm, five patients increase more than 100% in the BROADWAY study. TANDEM data for the FDC of obicetrapib and ezetimibe LDL-C % change versus baseline


Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal % of patients achieving LDL-C thresholds at Day 84 % of patients achieving LDL-C thresholds at Day 84 16


Over 70% of Patients on Obicetrapib+Ezetimbe Achieved Less than <55 mg/dL % of patients achieving LDL-C thresholds at Day 84 17


Exploratory Endpoint: Major Adverse Cardiovascular Events (MACE) (1) BROADWAY MACE Data Placebo Obicetrapib Hazard Ratio 95% CI N = 844 N= 1686 All-cause mortality – no. (%) 12 (1.4) 19 (1.1) 0.83 (0.40-1.71) Coronary heart death – no. (%) 5 (0.6) 8 (0.5) 0.80 (0.26-2.44) First 4-point MACE – no. (%) 44 (5.2) 70 (4.2) 0.79 (0.54-1.15) (1) BROADWAY + BROOKLYN Pooled MACE Data Placebo Obicetrapib Hazard Ratio 95% CI N = 962 N= 1920 All-cause mortality – no. (%) 14 (1.5) 20 (1.0) 0.78 (0.39-1.58) Coronary heart death – no. (%) 7 (0.7) 9 (0.5) 0.63 (0.24-1.70) First 4-point MACE – no. (%) 49 (5.1) 75 (3.9) 0.75 (0.53-1.08) 4-point MACE: CHD death, Non-fatal myocardial infarction, non-fatal stroke, coronary revascularization 18 1. MACE was evaluated in BROADWAY as an exploratory endpoint. There may be limitations on the interpretation of MACE data derived from both BROOKLYN and BROADWAY studies given they were not designed to assess MACE as the primary and secondary endpoints.


Kaplan-Meier Curve Separates at Day 200 HR=0.79 95% CI (0.54-1.15) 4-point MACE: CHD death, Non-fatal myocardial infarction, non-fatal stroke, coronary revascularization 19 Note: While not powered to detect a MACE benefit, we observed positive MACE data as part of our review of the exploratory endpoint. BROADWAY was not powered to measure MACE benefit and the MACE data presented below may not be predictive of the MACE data we observe in PREVAIL, which has been designed to measure MACE benefit.


Observed MACE Reduction in BROADWAY Suggests Potential Benefit Beyond LDL-C 30% CTT regression Line Observed MACE reduction 25% in BROADWAY •The CTT regression line (dotted lines) > 4 years of treatment represents the expected relationship 3 years of treatment between a mean absolute reduction in 20% LDL-C versus placebo and the predicted 2 years of treatment MACE benefit at different time points based on historical trials 15% 1 year of treatment •In BROADWAY, we observed a 21% 10% difference in MACE from placebo, after one year of treatment 5% 0% 0 5 10 15 20 25 30 35 40 45 50 Mean absolute LDL-C reduction between groups (mg/dL) Note: The 1-4 treatment lines in the chart above reflects the meta-analysis of 26 statin clinical trials conducted by the CTT collaboration which showed that there is a consistent, linear decrease in MACE for every absolute unit of non-HDL (which is primarily composed of LDL-C) cholesterol reduction. Actual results may differ materially as MACE was evaluated in BROADWAY as an exploratory endpoint. This is not a head-to-head analysis 20 Source: 1. JAMA. 2016;316(12):1289-1297 2. European Heart Journal (2018)39,2540–2545 Relative Risk Reduction of MACE


Obicetrapib Observed to Impact Multiple Factors Believed to be Associated with MACE LDL-C ↓ Non-HDL-C ↓ ApoB ↓ LDL-P ↓ sdLDL-C ↓ Small LDL-P ↓ Lp(a) ↓ Oxidized LDL-P ↓ HDL-C ↑ NODM ↓ MACE ApoA1 ↑ REDUCTION Note: NODM = New onset diabetes mellitus 21


Overview of Events of Special Interest Placebo N= 843 Obicetrapib N= 1685 n (%) n (%) AST or ALT > 3 x ULN 8 ( 0.9) 10 ( 0.6) Bilirubin > 2 x ULN 4 ( 0.5) 2 ( 0.1) CK > 5 x ULN 3 ( 0.4) 5 ( 0.3) (p = 0.015) NODM or worsening of glycemic control 338 ( 40.1) 592 ( 35.1) - AE indicating new/worse type 1 or 2 diabetes 30 ( 3.6) 58 ( 3.4) - Initiation of diabetes medication 104 ( 12.3) 186 ( 11.0) - HbA1c ≥ 6.5% (where baseline HbA1c < 6.5%) 55 ( 6.5) 84 ( 5.0) - Two consecutive glucose values > 126 mg/dL 248 ( 29.4) 459 ( 27.2) - HbA1c increase from baseline >0.5% 133 ( 15.8) 234 ( 13.9) - Worsening glycemic control 199 ( 23.6) 350 ( 20.8) Renal function worsening 77 (9.1) 127 (7.5) - eGFR < 30 mL/min/1.73m2 13 ( 1.5) 13 ( 0.8) - 25% decrease in eGFR from baseline: 70 ( 8.3) 115 ( 6.8) - Increase of Serum Creatinine ≥ 0.3 mg/dL from baseline 61 ( 7.2) 91 ( 5.4) Macular degeneration 0 ( 0.0) 1 ( 0.1) 22


Multiple Positive Data Readouts Provide Momentum into Next 12 Months 2022 2023 2024 2025E 2026E 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono Study BROADWAY Ph3 (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; LDL n=2,530) regulatory filing BROOKLYN Ph3 Phase 3 BROOKLYN Trial Lipid Mono Study (HeFH; LDL-C ≥ 70 mg/dL; n=354) Obicetrapib MACE Monotherapy PREVAIL CVOT regulatory Phase 3 CVOT PREVAIL Trial Product filing (ASCVD or HeFH; LDL-C ≥ 55 mg/dL; (obicetrapib 10mg) n=9,541) Phase 2 VINCENT Trial VINCENT Ph2 Lp(a) change in combo w/ Repatha (Lp(a) >50 mg/dL; LDL-C >70 mg/dL; n=30) LDL Phase 3 TANDEM Trial TANDEM Ph3 regulatory (LD L-C ≥ 70 mg/dL; n=407) filing Obi+Eze FDC Phase 3 REMBRANDT Trial Product Coronary plaque volume study REMBRANDT Ph 3 (obicetrapib 10mg + (LDL-C ≥ 70 mg/dL; Total coronary plaque > ezetimibe 10mg) 3 75mm ; n=300) LEGEND Initiation Phase 2b ROSE2 Trial ROSE2 Ph2b Enrollment (LD L-C ≥ 70 mg/dL; n=114) complete Ph3 readout Alzheimer’s Phase 2a Alzheimer’s Product Alzheimer’s Ph2a Disease Trial CVOT readout (proprietary (ApoE4 carrier; n=10–15) dose/formulation incorporating obicetrapib) Ph2 readout 23 Numerous catalysts expected throughout 2025-2026 Note: Other than as noted, the pipeline represents trials that are currently ongoing. Projections are subject to inherent limitations. Actual results may differ from expectations. Neuro- Cardiometabolic metabolic


Study Design and Baseline Characteristics of Phase 3 Trials 1º endpoint – week 12 N = 354 1º endpoint – week 12 N = 2530 LDL-C endpoint N = 9541 Obicetrapib 10 mg (2:1 randomization) Obicetrapib 10 mg 13 (2 -: m 1o r na thn sdomization) Obicetrapib 10 mg (1:1 randomization) Placebo Placebo Placebo 13-months 13-months 54-months Key Inclusion Criteria Key Inclusion Criteria Key Inclusion Criteria • HeFH • ASCVD or HeFH • ASCVD • LDL-C ≥70 mg/dL • LDL-C ≥55 mg/dL w/risk factors, or • LDL-C ≥55 mg/dL w/risk factors, or • Maximally tolerated lipid lowering therapy • LDL-C≥ 100 mg/dL • LDL-C≥ 100 mg/dL • Maximally tolerated lipid lowering therapy • Maximally tolerated lipid lowering therapy Baseline Lipids (obicetrapib 10mg mean) Baseline Lipids (blinded mean) Baseline Lipids (blinded mean) 142 200 150 200 125 155 148 136 133 98 150 150 92 123 100 107 103 97 100 100 50 48 52 50 50 50 0 0 0 LDL-C Non-HDL-C ApoB HDL-C TG LDL-C Non-HDL-C ApoB HDL-C TG LDL-C Non-HDL-C ApoB HDL-C TG Baseline Lipid Modifying Therapy Baseline Lipid Modifying Therapy Baseline Lipid Modifying Therapy • Any statin 91% • PCSK9i 4% • Any statin >90% • Any statin 89% • PCSK9i 14% • High intensity statin: 65% • Other 11% • High intensity statin: 70% • High intensity statin: 79% • Other 8% • Ezetimibe: 26% • Ezetimibe: 23% • Ezetimibe: 54% mg/dL mg/dL mg/dL


PREVAIL Designed to Apply Lessons Learned from Previous CVOTs to Reduce Risk and Demonstrate Obicetrapib’s Full Benefit Greater LDL-C lowering activity anticipated Higher absolute LDL-C reduction expected to lead Targeting higher baseline LDL-C patients to greater MACE benefit Longer duration of follow up Maximizes opportunity for MACE reduction Targeting higher-risk patient population Potentially enhanced Differentiated secondary endpoints commercial profile vs. other LDL-C lowering agents 25


2024 Achievements Pave the Way for Potential 2025 Value Inflection Milestones 4Q 2024 1Q 2024 3Q 2024 Complete enrollment for Initiate TANDEM BROOKLYN Phase 3 BROADWAY Phase 3 TANDEM Phase 3 BROADWAY Phase 3 topline PREVAIL CVOT Phase 3 trial topline topline topline 2024 2H 2025 1H 2025 EMA regulatory VINCENT Phase 2 BROADWAY full data TANDEM full data submission topline presentation and publication presentation and publication 2025 26 Note: Projections are subject to inherent limitations. Actual results may differ from expectations. The timing of regulatory submissions is subject to additional discussions with regulators.


Obicetrapib and Alzheimer’s Disease 27


CETP Knock-in Mice Observed to Increase Brain Cholesterol Levels and CETPi Observed to Rescue Cognition in Preclinical Models of CETP-induced AD ▪ Source: Felix Oestereich, et al., The Cholesteryl Ester Transfer Protein (CETP) raises Cholesterol Levels in the Brain and affects Presenilin-mediated Gene Regulation, Journal of Lipid Research, vol. 63, no.9, 2022. Control diet 1 % cholesterol diet p<0.05 p<0.05 1.6 1.2 CETPi 0.8 observed to increase brain 0.4 cholesterol levels 0.0 WT CEPT WT CEPT Control diet 1 % cholesterol diet p=0.0043 + HDL correlation - LDL correlation p=0.019 100 3 2.5 2 2 r =0.5837 r =-0.4042 Improvement in 80 2.0 p=0.015 p=0.0365 Correlation NOR scores 2 60 1.5 observed observed with between plasma 40 CETPi 1.0 lipoproteins and 1 (Evacetrapib) 0.5 NOR score 10 0 0 0 0 20 40 60 80 100 0 20 40 60 80 100 NOR score (%) NOR score (%) Positive correlation observed between Negative correlation observed between • Scores below the red line (50%) indicate cognitive impairment NOR score and HDL quantification in CETP NOR score and LDL quantification CETP • Evacetrapib had no observed effect on impairment in APP tg and APP/CETP expressing female mice and APP/CETP expressing female mice • Evacetrapib observed to inhibit memory impairment in CETPtg & APP/CETPtg 28 28 Novel object CETP WT discrimination ratio (%) Cholesterol intensity Plasma HDL (mmol/L) Plasma LDL (mmol/L)


CETP Loss-of-Function (LoF) Genotype may be Associated with Slower Memory Decline and Lower AD Risk • CETP’s potential involvement in CNS cholesterol homeostasis is supported by genetic data • CETP LoF genotype may be associated with lower CETP activity & a corresponding increase in HDL levels CETP CETP (Apo-A1) Lewy body dementia (LBD) LBD (ApoE-e4+) LBD (ApoE-e4-) Parkinson Dementia in Parkinson Lower CETP OR (95% CI) 2 LoF CETP genes 1 LoF CETP gene Normal CETP Source: JAMA, January 13, 2010—Vol 303, No. 2 29 29


Initial Data for Obicetrapib 10mg Observed to Decrease 24s- & 27-hydroxycholesterol (“OH”) in both Plasma and Cerebrospinal Fluid (“CSF”) • In separate trials with different protocols and endpoints, Simvastatin was observed to only reduce 24s- and 27-OH in plasma • Obicetrapib was observed to be well-tolerated. No serious adverse events were reported, nor were any adverse events Simvastatin Obicetrapib 6.2 considered to be related to the study drug. 1.2 -5.9 -8.6 -9.2 -11.0 -11.7 -20.1 Source: Alzheimer Dis Assoc Disord. 2010; 24(3): 220–226 and Company data 30 Note: The results shown above do not represent head-to-head comparisons. The data was obtained from clinical trials with different objectives, designs and patients. Actual results may differ from expectations. 30 % Change from BL % Change from BL


Clinical events and exclusivity timelines 31


Comprehensive Patent Portfolio with Composition of Matter IP into 2043 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 7/43 US (1) COM EU 7/43 Proprietary form (COM) patent family** PTE 2/34 9/39* US Species (2) Selection SPC 2 2/34 /34 9/39* EU 8/27 (U.S.); 4/25 (EU) Genus US approval 6 mo. US NCE exclusivity (5 years) 30 mo. stay pedi. Regulatory exclusivity 6 mo. EU approval Data exclusivity + market exclusivity (8 + 2 years) EU pedi. 32 Note: Regulatory exclusivity dates for information purposes only, Filled colors = granted patents & dotted lines = pending patents; one patent only to be selected for SPC/PTE; an earlier US approval leads to earlier regulatory expiry & shorter PTE; *including pediatric extension 6m; ** will be pending once a PCT application is filed; actual results may differ from expectations. 1. US 12,006,305 2. Low dose/ species selection patents US 10,653,692, US 11,013,742, US 11,642,344; statin combo patent US 10,300,059


Growing Team of Cardiometabolic Experts with Deep Experience Across Clinical Development and Commercialization Michael Davidson, M.D. John Kastelein, M.D. Douglas Kling William ‘BJ’ Jones Ian Somaiya Louise Kooij Juliette Audet CEO CSO COO CCO CFO CAO CBO Bob Rambo Annie Neild Matthew Philippe Chris Deluzio Sheng Cui Marc Ditmarsch, M.D. EVP, Marketing EVP, Head of Global EVP, Head of Investor EVP, Enterprise CMO CDO Regulatory Affairs Relations Operations 33


Thank You 34

v3.24.4
Document and Entity Information
Jan. 10, 2025
Document And Entity Information [Line Items]  
Document Type 8-K
Document Period End Date Jan. 10, 2025
Entity Registrant Name NewAmsterdam Pharma Company N.V.
Entity Incorporation State Country Code P7
Entity File Number 001-41562
Entity Tax Identification Number 00-0000000
Entity Address Address Line 1 Gooimeer 2-35
Entity Address City Or Town Naarden
Entity Address Country NL
Entity Address Postal Zip Code 1411 DC
Country Region 31
City Area Code (0) 35
Local Phone Number 206 2971
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001936258
Common Stock [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Ordinary Shares, nominal value €0.12 per share
Trading Symbol NAMS
Security Exchange Name NASDAQ
Warrant [Member]  
Document And Entity Information [Line Items]  
Security 12b Title Warrants to purchase Ordinary Shares
Trading Symbol NAMSW
Security Exchange Name NASDAQ

NewAmsterdam Pharma Comp... (NASDAQ:NAMSW)
Historical Stock Chart
Von Dez 2024 bis Jan 2025 Click Here for more NewAmsterdam Pharma Comp... Charts.
NewAmsterdam Pharma Comp... (NASDAQ:NAMSW)
Historical Stock Chart
Von Jan 2024 bis Jan 2025 Click Here for more NewAmsterdam Pharma Comp... Charts.