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NewAmsterdam Pharma Reports Full Year 2024 Financial Results and Provides Corporate Update
Globe Newswire 26-Feb-2025 8:00 AM
-- EMA submission expected in 2H25 by partner Menarini --
-- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025 --
-- Phase 3 PREVAIL CVOT remains on track --
-- $834.2 million in cash, cash equivalents and marketable securities at December 31, 2024 --
NAARDEN, the Netherlands and MIAMI, Feb. 26, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS), 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 full year ended December 31, 2024 and provided a corporate update.
"2024 was a transformative year for NewAmsterdam, marked by compelling data from three pivotal Phase 3 trials – BROOKLYN, TANDEM, and BROADWAY – where we observed durable LDL-C lowering by obicetrapib for CVD patients. In 2025, we look forward to sharing additional data and insights from these trials, including the impact of obicetrapib on the exploratory endpoint of major adverse cardiac events ("MACE"), at leading medical meetings and journal publications, as well as advancing regulatory interactions, including an anticipated EMA submission in the second half by our partner Menarini," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
"Additionally, we are increasing focus and efforts around launch readiness with plans to scale up and build inventory and commercial capabilities sufficient to support the launch of obicetrapib in both the U.S. and Europe, if approved. Following our successful $479 million upsized financing in December, we have the necessary capital to fund operations beyond the PREVAIL cardiovascular outcomes trial ("CVOT") readout and commercial launch of obicetrapib in the U.S., pending regulatory approval. We are excited to build on the strong momentum from the past year, as we work diligently to deliver a potentially transformative therapy to millions of CVD patients globally," continued Dr. Davidson.
Clinical Development Updates
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein ("CETP") inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, 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.
Throughout 2024, 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 ("LS") 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 LS mean LDL-C reduction of 33% (p<0.0001) compared to placebo at day 84. Mean and median reductions in LDL-C from placebo at day 84 were 33% and 36%, respectively. As part of the safety analysis, the trial adjudicated MACE, as an exploratory analysis, a 21% reduction in the composite of CHD death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization favoring obicetrapib was observed, after one year. 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 LDL-C reduction of 49% (p < 0.0001) compared to placebo at day 84. Mean and median reductions in LDL-C versus placebo 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 LDL-C 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 versus placebo at day 84 were 36% and 39%, respectively.
In addition, NewAmsterdam announced that the United States Patent and Trademark Office ("USPTO") issued a new patent covering the solid form of obicetrapib. 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 ten patents covering obicetrapib and its uses.
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. 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.
The following trials are currently ongoing:
PREVAIL Phase 3 trial. PREVAIL is a CVOT 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.
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 study 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 + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The study is expected to enroll 300 patients.
Full Year 2024 Financial Results
Cash Position: As of December 31, 2024, NewAmsterdam recorded cash and cash equivalents of $771.7 million and $62.5 million of marketable securities, compared to $340.5 million as of December 31, 2023. The increase in cash is primarily driven by the proceeds of the follow-on public equity offerings completed during the year, the achievement of a clinical development milestone, warrant exercises and option exercises, partially offset by cash outflows related to research and development costs as the Company continues development of obicetrapib and increased spending on selling, general and administrative expenses to support the Company's growing organization.
Revenue: NewAmsterdam recognized $45.6 million in revenue for the year ended December 31, 2024, compared to $14.1 million in the year ended December 31, 2023. This increase is primarily due to an increase in the revenue recognized related to the achievement of a clinical success milestone and the recognition of revenue related to a general development cost reimbursement.
Research and Development ("R&D") Expenses: R&D expenses were of $151.4 million for year ended December 31, 2024, compared to $159.4 million in the year ended December 31, 2023. This decrease is primarily due to a decrease in manufacturing and clinical costs due to clinical trials which are complete or nearing completion, partially offset by an increase in personnel and regulatory expenses.
Selling, General and Administrative ("SG&A") Expenses: SG&A expenses were $70.4 million for the year ended December 31, 2024, compared to $37.6 million in the year ended December 31, 2023. This increase is primarily due to increased personnel and marketing and communication costs as we begin to expand and build capabilities to support our planned commercial launch of obicetrapib, if approved.
Net loss: Net loss for the year ended December 31, 2024 was $241.6 million, compared to net loss of $176.9 million in the year ended December 31, 2023. 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 cardiovascular outcomes trial 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.
NewAmsterdam Pharma Company N.V. Consolidated Balance Sheet
As at December 31,
2024
2023
(In thousands of USD)
Assets
Current assets:
Cash and cash equivalents
771,743
340,450
Prepayments and other receivables
24,272
6,341
Employee receivables
4,951
—
Marketable securities
62,447
—
Total current assets
863,413
346,791
Property, plant and equipment, net
242
46
Operating right of use asset
431
55
Intangible assets
534
170
Long term prepaid expenses
—
35
Total assets
864,620
347,097
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
4,744
16,923
Accrued expenses and other current liabilities
13,608
11,398
Deferred revenue, current
6,008
8,942
Lease liability, current
246
60
Derivative earnout liability, current
44,798
—
Derivative warrant liabilities
37,514
12,574
Total current liabilities
106,918
49,897
Deferred revenue, net of current portion
—
1,019
Lease liability, net of current portion
202
—
Derivative earnout liability, net of current portion
—
7,788
Total liabilities
107,120
58,704
Commitments and contingencies (Note 13)
Shareholders' Equity:
Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 108,064,340 and 82,469,768 shares issued and outstanding at December 31, 2024 and 2023, respectively
13,444
10,173
Additional paid-in capital
1,298,160
590,771
Accumulated loss
(558,571
)
(316,973
)
Accumulated other comprehensive income
4,467
4,422
Total shareholders' equity
757,500
288,393
Total liabilities and shareholders' equity
864,620
347,097
NewAmsterdam Pharma Company N.V. Consolidated Statements of Operations and Comprehensive Income (Loss)
For the year ended December 31,
2024
2023
2022
(In thousands of USD, except per share amounts)
Revenue
45,563
14,090
102,694
Operating expenses:
Research and development expenses
151,406
159,424
86,744
Selling, general and administrative expenses
70,446
37,633
19,507
Total operating expenses
221,852
197,057
106,251
Operating loss
(176,289
)
(182,967
)
(3,557
)
Other income (expense):
Interest income
16,881
11,283
—
Interest expense
—
—
(287
)
Fair value change – earnout
(37,010
)
(266
)
(707
)
Fair value change – warrants
(38,583
)
(10,018
)
(334
)
Fair value change – profit rights
—
—
(12,390
)
Fair value change – tranche rights
—
—
4,388
Foreign exchange gains/(losses)
(6,598
)
5,058
(9,747
)
Loss before tax
(241,599
)
(176,910
)
(22,634
)
Income tax expense (benefit)
(1
)
27
—
Loss for the year
(241,598
)
(176,937
)
(22,634
)
Other comprehensive income/(loss)
Foreign currency translation adjustments
—
—
11,126
Unrealized gain on available-for-sale securities
45
—
—
Income tax effects of other comprehensive income/(loss)
—
—
—
Total comprehensive loss for the year, net of tax
(241,553
)
(176,937
)
(11,508
)
NewAmsterdam Pharma Company N.V. Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit)
Mezzanine Equity
Shareholders' Equity
(In thousands of USD, except share amounts)
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Loss
Accumulated other comprehensive income (loss)
Total Shareholders' Equity
Opening balance at January 1, 2022
6,039,728
84,541
5,285,714
58
3,417
(110,587
)
(6,704
)
(113,816
)
Equity contribution (Series A - Tranche II)
5,691,430
90,468
—
—
—
—
—
—
Repayment of loan (CEO Restricted Share Award)
—
—
—
—
747
—
—
747
Elimination of old shares (NewAmsterdam Pharma shareholders)
