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 that
it will present new clinical and preclinical data highlighting the
potential for obicetrapib as a novel, oral, low-dose therapy for
hypercholesterolemia, at the European Atherosclerosis Society (EAS)
92nd Congress and the National Lipid Association (NLA) 2024
Scientific Sessions, taking place on May 26 – 29 in Lyon, France
and May 30 – June 2 in Las Vegas, Nevada, respectively.
Presentation details are as follows:
EAS 92nd Congress,
Lyon, France, May 26-29, 2024
Title: Obicetrapib Treatment Increases
Pre-Beta1 HDL and Lipophilic Antioxidants in the OCEAN and ROSE2
Studies Session Name: 0390 - SaaG Session: New
tricks of HDL Oral Presentation Session Date and
Time: Monday, May 27, 2024, 2:42 PM- 2:49 PM CET (8:42
AM-8:49 AM ET)Location: Station 7
Title: Obicetrapib Demonstrates Significant
Reductions of Lp(a) on Top of High-Intensity Statins
Session Name: 0601 - SaaG Session: Late-breaking
lipids Oral Presentation Session Date and Time:
Tuesday, May 28, 2024, 2:12 PM- 2:19 PM CET (8:12 AM-8:19 AM
ET)Location: Station 8
Title: Obicetrapib Alone and in Combination
with Ezetimibe Reduces Non-HDL-Cholesterol by Enhanced
LDL-Receptor-Mediated VLDL Clearance and Increased Net Fecal Sterol
Excretion in APOE*3-Leiden.CETP Mice Session Name:
0660- SaaG Session: Breaking updates in lipid-lowering
treatmentsOral Presentation Session Date and Time:
Tuesday, May 28, 2024, 3:17-3:24 CET (9:17 AM-9:24 AM
ET)Location: Station 3
Title: Obicetrapib Alone and in Combination
with Ezetimibe Reduces Atherosclerotic Lesion Size and Severity in
APOE*3-Leiden.CETP Mice Session Name: 0660- SaaG
Session: Breaking updates in lipid-lowering treatmentsOral
Presentation Session Date and Time: Tuesday, May 28, 2024,
3:24-3:31 CET (9:24 AM-9:31 AM ET)Location:
Station 3
Title: Obicetrapib does not Accumulate in
Adipose Tissue: Results from Studies in Man and Non-Human Primates
Flatboard Presentation Date: Monday, May 27 and
Tuesday, May 28, 2024
NLA 2024 Scientific Sessions, Las Vegas, Nevada, May
30-June 2, 2024
Title: Obicetrapib Demonstrates Significant
Reductions Of Lp(a) On Top Of High-intensity
StatinsAbstract/Poster #: 128Date and
Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30
PM-5:55 PM ET)Location: Poster Hall Monitor #
30
Title: Synergistic Effect of Obicetrapib and
Ezetimibe on Circulating LDL Particles Abstract/Poster
#: 138Date and Time: Friday, May 31,
2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM
ET)Location: Poster Hall Monitor # 22
Title: Obicetrapib Does Not Accumulate in
Adipose Tissue: Results from Studies in Man and Non-human Primates
Abstract/Poster #: 127Date and
Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30
PM-5:55 PM ET)Location: Poster Hall Monitor #
18
Title: Obicetrapib Treatment Increases
Pre-Beta1 HDL and Lipophilic Antioxidants in the OCEAN and ROSE2
Studies Abstract/Poster #: 140Date and
Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30
PM-5:55 PM ET)Location: Poster Hall Monitor #
15
Title: Assessment of Unmet Clinical Needs and
Healthcare Resource Use Among Statin-Treated Patients with or at
Risk of Developing ASCVD Abstract/Poster #:
139Date and Time: Friday, May 31, 2024, 2:30 PM-
2:55 PM PT (5:30 PM-5:55 PM ET)Location: Poster
Hall Monitor # 12
Presentation Title: Obicetrapib Alone and with
Ezetimibe Reduces Non-HDL-C by Enhanced LDL-Receptor-Mediated VLDL
Clearance and Increased Net Fecal Sterol Excretion
Abstract/Poster #: 141Oral Presentation
Session: Session V Date and Time:
Saturday, June 1, 2024, 11:05 AM- 11:55 AM PT (2:05-2:55 PM ET)
About ObicetrapibObicetrapib 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, 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
conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to
evaluate obicetrapib as a monotherapy used as an adjunct to
maximally tolerated lipid-lowering therapies to provide additional
LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib
and ezetimibe as a fixed-dose combination. The Company began
enrolling patients in BROADWAY in January 2022, in BROOKLYN in July
2022, and in TANDEM in March 2024; completing enrollment of
BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also
commenced the Phase 3 PREVAIL cardiovascular outcomes trial in
March 2022, 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.
About NewAmsterdamNewAmsterdam Pharma (Nasdaq:
NAMS) is a late-stage 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 studies, 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 StatementsCertain 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; 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; ability to continue to source the raw materials for its
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 ContactMatthew PhilippeP:
1-917-882-7512matthew.philippe@newamsterdampharma.com
Media ContactSpectrum Science on behalf of
NewAmsterdamJenn GordonP:
1-202-957-7795jgordon@spectrumscience.com
Investor ContactStern Investor Relations on
behalf of NewAmsterdamHannah DeresiewiczP:
1-212-362-1200hannah.deresiewicz@sternir.com
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