NewAmsterdam to Present Full Data from ROSE2 at NLA Scientific Sessions 2023
May 23 2023 - 7:00AM
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or
the “Company”), a clinical-stage company focused on the research
and development of transformative oral therapies for major
cardiometabolic diseases, today announced that it will present full
data from ROSE2, a Phase 2 clinical trial evaluating obicetrapib in
combination with ezetimibe as an adjunct to high-intensity statin
therapy, in a late-breaking presentation at the National Lipid
Association (“NLA”) Scientific Sessions, being held June 1-4 in
Atlanta, Georgia. NewAmsterdam is developing a fixed dose
combination of obicetrapib 10 mg and ezetimibe 10 mg, and expects
to select a formulation to advance into a definitive bioequivalence
trial and a Phase 3 safety and efficacy trial in the second half of
2023.
Details of the presentation are as follows:
Presentation Title: The combination of
Obicetrapib and Ezetimibe lowers LDL-C in Patients on High
Intensity Statins: Results from the ROSE2 Trial
(NCT05266586)Session Title: Late-Breaker
SessionSession Date and Time: Saturday, June 3,
2023, 12:00 P.M. ETLocation: Omni Atlanta Hotel at
CNN Center
Investor and Analyst Conference Call and Live
Webcast
NewAmsterdam will host a conference call for investors and
analysts to review the full data from ROSE2. The live webcast will
begin at 8:00 a.m. ET on Monday, June 5 and will include remarks by
Robert Rosenson, M.D., a Professor of Medicine, and Director of
Cardiometabolic Disorders at the Icahn School of Medicine at Mount
Sinai.
Participants may register for the conference call here. While
not required, it is recommended that participants join the call ten
minutes prior to the scheduled start.
A live webcast of the call will also be available under “Events
& Presentations” in the Investors & News section of the
Company’s website at https://ir.newamsterdampharma.com. The
archived webcast will be available on NewAmsterdam’s website
approximately two hours after the conference call and will be
available for at least 30 days following the live event.
About NewAmsterdam
NewAmsterdam (Nasdaq: NAMS) is a clinical-stage
biopharmaceutical company whose mission is to improve patient care
in populations with cardiometabolic diseases where currently
approved therapies have not been sufficiently successful or well
tolerated. NewAmsterdam is investigating obicetrapib, an oral,
low-dose and once-daily CETP inhibitor, as the preferred LDL-C
lowering therapy to be used as an adjunct to maximally-tolerated
statin therapy for high-risk cardiovascular disease (“CVD”)
patients. Results from NewAmsterdam’s ROSE Phase 2b trial
(presented at AHA Scientific Sessions in 2021) included
observations that patients receiving obicetrapib 10 mg experienced
a median reduction in LDL-C of 51% versus baseline in patients on
high-intensity statin therapy (vs. a 7% reduction in the placebo
arm). In addition, topline results from NewAmsterdam’s ROSE2 trial
evaluating the combination of 10 mg obicetrapib and 10 mg ezetimibe
demonstrated a median reduction in LDL-C levels of 59% versus
baseline in patients on high-intensity statin therapy (vs. a 6%
reduction in the placebo arm). Based in the Netherlands,
NewAmsterdam recently completed a business combination with FLAC, a
special purpose acquisition company sponsored by an affiliate of
Frazier Healthcare Partners. Proceeds from this transaction were
approximately $328 million, prior to deducting transaction
expenses. In June 2022, NewAmsterdam entered into an exclusive
licensing agreement with the Menarini Group for the
commercialization of obicetrapib in Europe, while retaining all
rights to commercialize obicetrapib, if approved, in the rest of
the world, as well as rights to develop certain forms of
obicetrapib for other diseases such as Alzheimer’s disease. For
more information, please visit: www.newamsterdampharma.com.
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 clinical trials and the timing for enrolling
patients, the timing and forums for announcing data and the
achievement and timing of regulatory approvals. 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 relating to the uncertainty of the projected
financial information with respect to the Company; risks related to
the approval of the Company’s product candidate and the timing of
expected regulatory and business milestones; ability to negotiate
definitive contractual arrangements with potential customers; the
impact of competitive product candidates; ability to obtain
sufficient supply of materials; the impact of COVID-19; global
economic and political conditions, including the Russia-Ukraine
conflict; the effects of competition on the Company’s future
business; and those factors described in the Company’s public
filings with the U.S. 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; 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:
917-882-7512matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdamBryan BlatsteinP:
917-714-2609bblatstein@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdamHannah
DeresiewiczP: 1 212-362-1200hannah.deresiewicz@sternir.com
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