NewAmsterdam Pharma N.V.

– EMA submission expected in 2H25 by partner Menarini –

– PREVAIL Phase 3 CVOT remains on track –

-- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively --

-- Company to host R&D day on June 11th, 2025 in New York City --

–$808.5million in cash, cash equivalents and marketable securities at March 31, 2025 –

NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam,” “we,” 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 announced financial results for the quarter ended March 31, 2025 and provided a corporate update.

"Our first quarter was marked by continued clinical execution and investment in our commercial organization to support the potential launch of obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “With over $800 million in cash, cash equivalents and marketable securities on our balance sheet, we believe we are well positioned to drive near- and long-term value for our stakeholders, as we move closer to delivering novel, once-daily, low dose, oral therapies to address the significant global unmet need for safe and effective LDL-C lowering therapies.”

Dr. Davidson continued, “In addition, the data recently presented at EAS and published in the New England Journal of Medicine and The Lancet highlight obicetrapib’s differentiated product profile for the potential treatment of lipid management, and we are eager to continue to share additional data from our three pivotal Phase 3 trials, particularly regarding obicetrapib’s impact on major adverse cardiac events (“MACE”), at prominent medical conferences and journal publications. We are also progressing with regulatory interactions, including an expected EMA submission in the second half of the year by our partner Menarini. This commercial and clinical progress, combined with our financial strength provides a foundation for future growth as we look to address the needs of many more patients living with dyslipidemia.”

Clinical Development Updates

NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated. Additional data from BROADWAY, TANDEM, and BROOKLYN is expected to be presented and published over the next several months, highlighting what we believe to be obicetrapib’s differentiated product profile to lipid management.

Story Continues

Ongoing Trials:

Following the successful completion of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials NewAmsterdam plans to announce additional data over the course of 2025 relating to obicetrapib and the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe.

The following trials are currently ongoing:

PREVAIL Phase 3 trial. PREVAIL is a cardiovascular outcomes trial (“CVOT”) evaluating obicetrapib in patients with a history of atherosclerotic cardiovascular disease (“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. VINCENT Phase 2 trial. The trial will 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 10 mg daily for 8 weeks followed by obicetrapib 10 mg daily plus evolocumab 140 mg/dL every other week for 8 weeks. There will be two cohorts in the study. The first cohort will include 39 participants with Lp(a) levels greater than 125 nmol/L, and the second cohort will include 30 participants with Lp(a) levels greater than 50 nmol/L but less than 125 nmol/L. REMBRANDT Phase 3 trial. The trial will utilize coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. The placebo-controlled, double-blind, randomized, Phase 3 trial is being conducted in adult participants with high-risk ASCVD with evidence of coronary plaque who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The study is expected to enroll 300 patients.

Corporate Updates

In April 2025, NewAmsterdam appointed Adele Gulfo to the Company’s Board of Directors. Ms. Gulfo is an established pharmaceutical executive with over three decades of experience in the healthcare industry, distinguished by her expertise in global strategy, operations leadership, and commercialization of multiple blockbuster medicines.

Upcoming Investor Event

NewAmsterdam will host an R&D Day event on Wednesday, June 11, 2025, beginning at 9 a.m. ET in New York City.

A live webcast of the event will be available through the investor relations section of the NewAmsterdam website at ir.newamsterdampharma.com. Following the live webcast, an archived replay will be available on the Company’s website.

First Quarter Financial Results

Cash Position: As of March 31, 2025, NewAmsterdam recorded cash, cash equivalents and marketable securities of $808.5 million, compared to $834.2 million as of December 31, 2024. The decrease is primarily driven by ongoing operating expenditures, partially offset by the first of two development cost contributions from our partner Menarini and cash received from interest and the exercise of options. Revenue: NewAmsterdam recognized $3.0 million in revenue for the quarter ended March 31, 2025, compared to $1.4 million in the same period in 2024. The increase is primarily attributable to the increase in transaction price attributable to the R&D performance obligation as a result of the recognition in 2024 of the first of two annual development cost contributions pursuant to the terms of the license agreement with Menarini. Research and Development (“R&D”) Expenses: R&D expenses were $44.8 million in the quarter ended March 31, 2025, compared to $42.4 million for the same period in 2024. This increase was primarily due to an increase in personnel costs, including share-based compensation, non-clinical costs related to pipeline expansion and product lifecycle management and investments in commercial manufacturing capabilities, partially offset by a decrease in clinical expenses. Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $27.2 million in the quarter ended March 31, 2025, compared to $14.5 million for the same period in 2024. This increase was primarily due to an increase in personnel costs, including share-based compensation, and investments in capabilities to support the Company's planned commercial launch of obicetrapib, if approved and an increase in costs related to the Company's intellectual property primarily driven by worldwide patent filings. Net loss: Net loss for the quarter ended March 31, 2025 was $39.5 million, compared to net loss of $93.8 million for the same period in 2024. The individual components of the change are described above in addition to non-cash losses related to changes in the fair value of our derivative liabilities.

About Obicetrapib

Obicetrapib is a novel, oral, low-dose 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 commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company 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, 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 U.S. 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 by 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 70 mg/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 U.S. 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 conflicts; 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; 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
[email protected]

Media Contact
Spectrum Science on behalf of NewAmsterdam
Jaryd Leady
P: 1-856-803-7855
[email protected]

Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
[email protected]

NewAmsterdam Pharma Company N.V.
Condensed Consolidated Balance Sheet
(Unaudited)  March 31,
2025   December 31,
2024  (In thousands of USD)  Assets  Current assets:  Cash and cash equivalents  748,420    771,743  Prepayments and other receivables  8,827    24,272  Employee receivables  —    4,951  Marketable securities  60,057    62,447  Total current assets  817,304    863,413  Property, plant and equipment, net  238    242  Operating right of use asset  369    431  Intangible assets  502    534  Total assets  818,413    864,620  Liabilities and Shareholders' Equity  Current liabilities:  Accounts payable  6,087    4,744  Accrued expenses and other current liabilities  8,021    13,608  Deferred revenue, current  3,030    6,008  Lease liability, current  252    246  Derivative earnout liability, current  —    44,798  Derivative warrant liabilities  23,523    37,514  Total current liabilities  40,913    106,918  Lease liability, net of current portion  137    202  Total liabilities  41,050    107,120  Commitments and contingencies (Note 10)  Shareholders' Equity:  Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 112,169,291 and 108,064,340 shares issued and outstanding as at March 31, 2024 and December 31, 2023, respectively  13,968    13,444  Additional paid-in capital  1,357,059    1,298,160  Accumulated loss  (598,098 )   (558,571 ) Accumulated other comprehensive income  4,434    4,467  Total shareholders' equity  777,363    757,500  Total liabilities and shareholders' equity  818,413    864,620

NewAmsterdam Pharma Company N.V.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)  For the three months ended March 31,  2025   2024  (In thousands of USD, except per share amounts)  Revenue  2,978    1,401  Operating expenses:  Research and development expenses  44,751    42,430  Selling, general and administrative expenses  27,152    14,453  Total operating expenses  71,903    56,883  Operating loss  (68,925 )   (55,482 ) Other income (expense):  Interest income  7,351    3,083  Fair value change – earnout  3,992    (8,702 ) Fair value change – warrants  13,762    (30,248 ) Foreign exchange gains/(losses)  4,293    (2,418 ) Loss before tax  (39,527 )   (93,767 ) Income tax expense  —    —  Loss for the year  (39,527 )   (93,767 ) Other comprehensive income/(loss)  Unrealized gain/(loss) on available-for-sale securities, net of tax  (33 )   —  Total comprehensive loss for the year, net of tax  (39,560 )   (93,767 )

NewAmsterdam Pharma Company N.V.
Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit)
(Unaudited)  (In thousands of USD, except share amounts) Shares   Amount   Additional Paid-In Capital   Accumulated Loss   Accumulated Other Comprehensive Income   Total Shareholders' Equity  Balance at December 31, 2023  82,469,768    10,173    590,771    (316,973 )   4,422    288,393  Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs  5,871,909    759    189,207    —    —    189,966  Exercise of warrants  926,698    121    19,674    —    —    19,795  Exercise of stock options  452,461    60    (609 )   —    —    (549 ) Share-based compensation  —    —    7,965    —    —    7,965  Total loss and comprehensive loss for the period  —    —    —    (93,767 )   —    (93,767 ) As at March 31, 2024  89,720,836    11,113    807,008    (410,740 )   4,422    411,803   Balance at December 31, 2024  108,064,340    13,444    1,298,160    (558,571 )   4,467    757,500  Issuance of Earnout Shares  1,743,136    226    40,581    —    —    40,807  Exercise of Pre-Funded Warrants  1,293,938    162    (162 )   —    —    —  Exercise of warrants  15,942    2    410    —    —    412  Exercise of stock options  909,140    116    2,875    —    —    2,991  Vesting of RSUs  142,795    18    (18 )   —    —    —  Share-based compensation  —    —    15,213    —    —    15,213  Total loss and comprehensive loss for the period  —    —    —    (39,527 )   (33 )   (39,560 ) As at March 31, 2025  112,169,291    13,968    1,357,059    (598,098 )   4,434    777,363

NewAmsterdam Pharma Company N.V.
Condensed Consolidated Statements of Cash Flows
(Unaudited)  For the three months ended March 31,  2025   2024  (In thousands of USD)  Operating activities:  Loss for the period  (39,527 )   (93,767 ) Non-cash adjustments to reconcile loss for the period to net cash flows:  Depreciation and amortization  52    15  Non-cash rent expense  3    1  Fair value change - derivative earnout and warrants  (17,754 )   38,950  Foreign exchange (gains)/losses  (4,293 )   2,418  Amortization of premium/discount on available-for-sale debt securities  (513 )   —  Share-based compensation  15,213    7,918  Changes in working capital:  Changes in prepayments (current and non-current) and other receivables  16,031    956  Changes in accounts payable  2,251    (8,311 ) Changes in accrued expenses and other current liabilities  (4,953 )   (1,381 ) Changes in deferred revenue  (2,978 )   (1,401 ) Net cash used in operating activities  (36,468 )   (54,602 ) Investing activities:  Purchase of property, plant and equipment, including internal use software  (16 )   (385 ) Maturity of available-for-sale debt securities  12,500    —  Purchase of available-for-sale debt securities  (9,629 )   —  Net cash (used in)/provided by investing activities  2,855    (385 ) Financing activities:  Proceeds from February 2024 offering of Ordinary Shares and Pre-Funded Warrants  —    190,481  Transaction costs on February 2024 issue of Ordinary Shares and Pre-Funded Warrants  —    (515 ) Transaction costs on December 2024 issue of Ordinary Shares and Pre-Funded Warrants  (1,586 )   —  Proceeds from exercise of warrants  183    8,763  Proceeds from exercise of options  7,922    440  Payment of withholding taxes related to net share settlement of exercised options  —    (989 ) Net cash provided by financing activities  6,519    198,180  Net change in cash  (27,094 )   143,193  Foreign exchange differences  3,771    (2,496 ) Cash and cash equivalents at the beginning of the year  771,743    340,450  Cash and cash equivalents at the end of the year  748,420    481,147  Noncash financing and investing activities  Receivable related to exercise of warrants  —    1,271  Issuance of earnout shares  40,807    —

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