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 provided a corporate update and
announced financial highlights for the first quarter ended March
31, 2023.
“We are pleased to report an exceptional start to the year,
marked by key accomplishments across our business,” said Michael
Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We
recently announced the early completion of enrollment in our Phase
3 BROOKLYN trial evaluating obicetrapib in patients with HeFH.
Likewise, enrollment in our Phase 3 BROADWAY trial and Phase 3
cardiovascular outcomes (“CVOT”) PREVAIL trial continues to be
strong. We have over 1,700 patients randomized in BROADWAY and over
3,400 patients randomized in PREVAIL and expect to complete
enrollment in the middle of 2023 and the first quarter of 2024,
respectively. We believe that the strong enrollment we have seen in
each clinical trial, at a time when patients and investigators have
the option of similar clinical trials using injectable drugs,
reflects the significant unmet need for a potent oral therapy that
can be used as an adjunct to maximally tolerated statin therapy to
help patients achieve target low-density lipoprotein cholesterol
(“LDL-C”) levels.”
Dr. Davidson continued, “In addition, we plan to announce data
from multiple Phase 2 trials in the coming months. We are eager to
share full data from the Phase 2 ROSE2 trial at the NLA Scientific
Sessions in June, as well as topline results from the Phase 2
dose-finding trial in Japanese patients with dyslipidemia and from
the Phase 2a trial in patients with early Alzheimer’s disease,
which we expect in the second half of 2023. We believe that, taken
together, these datasets can provide important information on the
potential of obicetrapib as a next-generation, oral, low-dose CETP
inhibitor with the potential to deliver a safe, convenient and
effective solution to patients living with some of the world’s most
prevalent and debilitating diseases.”
Clinical Development Updates:
NewAmsterdam is developing 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 patients. The Company is currently
conducting three pivotal Phase 3 clinical trials of obicetrapib:
BROOKLYN, evaluating the effect of obicetrapib on LDL-C levels in
patients with HeFH as an adjunct to maximally tolerated
lipid-lowering therapy; BROADWAY, evaluating the effect of
obicetrapib on top of maximally tolerated lipid-lowering therapy in
patients with HeFH and/or established atherosclerotic
cardiovascular disease (“ASCVD”); and PREVAIL, a CVOT in patients
with a history of ASCVD with inadequately controlled LDL-C despite
treatment with maximally tolerated lipid-modifying therapies.
In April 2023, NewAmsterdam announced the early completion of
enrollment of over 350 patients in the pivotal Phase 3 BROOKLYN
trial.
NewAmsterdam is also evaluating obicetrapib in a Phase 2a
clinical trial in patients with early Alzheimer’s disease and at
least one copy of the apolipoprotein E4 mutation. This study is
designed to assess pharmacodynamic and pharmacokinetic effects,
safety and tolerability, including whether CETP inhibition results
in increased ApoA1 levels in patient cerebrospinal fluid. There is
abundant pre-clinical data that suggests patients with the E4
variant of the ApoE protein are worse at transporting amyloid-beta
peptides out of the brain, and increasing ApoA1 levels in the brain
may rescue this loss-of-function by restoring appropriate
cholesterol clearance. Pre-clinical data suggests that cholesterol
accumulation in the brain may be a precursor to Alzheimer’s
disease; in pre-clinical animal studies, the Company observed a
statistically significant reduction in a biomarker of Alzheimer’s
disease.
Corporate Updates
- In April 2023, NewAmsterdam appointed Janneke van der Kamp to
its Board of Directors.
- In February 2023, NewAmsterdam appointed John W. Smither to its
Board of Directors. Mr. Smither also serves as chair of the
Company’s Audit Committee.
Upcoming Potential Milestones
NewAmsterdam currently expects to achieve the following upcoming
milestones:
- Present full data from the Phase 2 ROSE2 clinical trial testing
the combination of obicetrapib and ezetimibe at the NLA Scientific
Sessions, June 1-4, 2023 in Atlanta, GA.
- Complete enrollment of the Phase 3 BROADWAY trial for
obicetrapib monotherapy in mid-2023 and announce topline data in
the second half of 2024.
- Announce topline data from the Phase 2a trial evaluating
obicetrapib in ApoE4-carrying patients with early Alzheimer’s
disease in the second half of 2023.
- Announce topline results from the Phase 2 obicetrapib
monotherapy dose-finding trial in Japanese patients in the second
half of 2023.
- Select formulation for Phase 3 fixed-dose combination of
obicetrapib and ezetimibe in the second half of 2023.
- Complete enrollment in the Phase 3 PREVAIL trial for
obicetrapib monotherapy in the first quarter of 2024 and announce
topline data in the second half of 2026.
- Announce topline data from Phase 3 BROOKLYN trial for
obicetrapib monotherapy in the second half of 2024.
Financial Highlights
- Cash Position: As of March 31, 2023,
NewAmsterdam recorded cash of $441 million, compared to $468
million as of December 31, 2022 (equivalent to €439 million as was
reported in the company’s Full Year 2022 Financial Results). The
decrease reflects cash used to fund operating activities, partially
offset by the receipt of a milestone payment from Menarini pursuant
to the Company’s license agreement with Menarini.
- Financial Guidance: Based on its current
operating and development plans, NewAmsterdam believes that its
existing cash and cash equivalents will be sufficient to fund the
Company’s operations through 2026, beyond the anticipated readout
of its three ongoing Phase 3 trials, BROADWAY, BROOKLYN and
PREVAIL.
About NewAmsterdam
NewAmsterdam Pharma (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 Pharma’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 Pharma’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 Pharma 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 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,
cash runway, 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 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 Contact
Matthew 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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