NewAmsterdam Pharma Reports Full Year 2024 Financial Results and Provides Corporate Update
-- 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 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 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.
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