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 the closing of its
business combination with Frazier Lifesciences Acquisition
Corporation (Nasdaq:FLAC), a special purpose acquisition company
sponsored by an affiliate of Frazier Healthcare Partners. The
ordinary shares and warrants of NewAmsterdam are expected to
commence trading on the Nasdaq Capital Market under the ticker
symbols “NAMS” and “NAMSW,” respectively, on November 23, 2022. The
shareholders of FLAC approved the transaction on November 15, 2022,
following approval by NewAmsterdam shareholders. NewAmsterdam’s
existing management team, including Chief Executive Officer,
Michael Davidson, M.D., will lead the combined company.
Proceeds from this transaction were approximately $328 million,
prior to deducting transaction expenses, comprising approximately
$93 million in funds from the former FLAC trust account and
approximately $235 million from the concurrent, oversubscribed PIPE
financing, which was co-led by Frazier Healthcare Partners and Bain
Capital Life Sciences. The Company’s cash balance, after the
transaction and excluding the transaction fees, is approximately
$490 million, which the Company believes will be sufficient to fund
operations through 2026, beyond the readout of its three ongoing
Phase 3 trials, BROADWAY, BROOKLYN and PREVAIL. BROADWAY is a Phase
3 trial designed to evaluate the effect of obicetrapib on top of
maximally tolerated lipid-lowering therapy in patients with
established atherosclerotic cardiovascular disease. BROOKLYN is a
Phase 3 trial designed to evaluate the effect of obicetrapib on
LDL-C levels in patients with heterozygous familial
hypercholesterolemia as an adjunct to maximally tolerated
lipid-lowering therapy. PREVAIL is a cardiovascular outcomes trial
in patients with a history of atherosclerotic cardiovascular
disease with inadequately controlled LDL-C despite treatment with
maximally tolerated lipid-modifying therapies. The Company expects
to announce data from both BROADWAY and BROOKLYN in 2024, and from
the PREVAIL CVOT study in 2026. NewAmsterdam is also evaluating
obicetrapib as a fixed-dose combination therapy with ezetimibe in a
secondary Phase 2 trial, ROSE2, from which data are expected in
2023.
“At NewAmsterdam, we are passionate about delivering
transformative oral therapies to people living with major
cardiometabolic diseases around the world,” said Dr. Davidson.
“Following the close of this transaction, we are well-positioned to
execute on this vision, with late-stage trials ongoing across the
globe, a leading pharmaceutical partner to support
commercialization efforts in Europe, if our product candidate is
approved, and what we believe to be sufficient capital to fund our
business through all expected key Phase 3 data readouts for
cardiovascular disease. I want to thank FLAC and its shareholders,
as well as our new and existing investors, for their confidence in
the NewAmsterdam team and in obicetrapib. I look forward to working
with my colleagues to deliver the promise of obicetrapib to the
millions of people in need of an effective and convenient LDL-C
lowering therapy that can be used as an adjunct to statin
therapy.”
“We believe NewAmsterdam is poised to significantly improve the
treatment of cardiovascular disease by providing an oral, low-dose
and once-daily CETP inhibitor with the potential to help many more
patients achieve their LDL-C goals and, ultimately, avoid major
adverse cardiac events,” said James Topper, M.D., Ph.D., Managing
Partner at Frazier Healthcare Partners, former Chairman of the
Board of Directors and Chief Executive Officer of FLAC and director
of the Company. “We are delighted to support NewAmsterdam as it
enters the public markets, and look forward to many more years of
productive collaboration as we partner with Michael and his team to
advance obicetrapib toward potential commercialization.”
Summary of TransactionOn July 25, 2022,
NewAmsterdam, a privately held biotechnology company, entered into
a definitive business combination agreement with FLAC, a special
purpose acquisition company sponsored by an affiliate of Frazier
Healthcare Partners, that was created with the purpose of merging
with a company that has the potential to both develop
transformative therapies for patients in need and deliver
significant returns to its investors.
In the transaction, the Company received gross proceeds of
approximately $328 million, prior to deducting transaction
expenses, consisting of approximately $93 million from the former
FLAC trust account (reflecting a final redemption rate of
approximately 32 percent) and approximately $235 million from PIPE
investors. The upsized and oversubscribed PIPE was co-led by
Frazier Healthcare Partners and Bain Capital Life Sciences, and
included new investors RA Capital Management, GMT Capital, Medicxi,
Panacea Venture and other institutional investors, in addition to
existing NewAmsterdam shareholders Forbion, LSP Dementia Fund and
Morningside Ventures.
AdvisorsCredit Suisse Securities (USA) LLC
acted as lead PIPE placement agent, financial advisor and capital
markets advisor to FLAC. Jefferies LLC, SVB Securities LLC and
William Blair & Company, L.L.C. also acted as PIPE placement
agents to FLAC and Jefferies LLC and William Blair & Company,
L.L.C. also acted as financial advisor and capital markets advisor
to FLAC. SVB Securities LLC acted as financial advisor and capital
markets advisor to NewAmsterdam. Covington & Burling LLP acted
as legal counsel to NewAmsterdam. Goodwin Procter LLP acted as
legal counsel to FLAC. Kirkland & Ellis LLP acted as legal
counsel to the PIPE placement agents.
About NewAmsterdam
NewAmsterdam (Nasdaq:NAMS) is a clinical-stage biopharmaceutical
company whose mission is to improve patient care in populations
with metabolic 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). Based in the Netherlands,
NewAmsterdam was founded in 2019 by the venture capital firm
Forbion and John Kastelein, Chief Scientific Officer of the
NewAmsterdam, and closed a $196 million (€160 million) Series A
financing in January 2021 led by Forbion, Morningside Ventures and
Ascendant BioCapital. 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 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 therapeutic and curative potential of the
Company’s product candidate; potential benefits of the
transactions; and expectations relating to the transactions,
including the Company’s expected cash runway. 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; failure to realize the anticipated benefits of the
transactions; 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 “Risk Factors” section
of the Company’s registration statement filed on Form F-4, as
amended (File No. 333-266510) in connection with the transactions
and other documents filed from time to time. 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 will 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 undertake
any obligation to update these forward-looking statements, except
as required by law.
Media Contact
Spectrum Science on behalf of NewAmsterdamCarmen LopezP: 1
773-306-6285clopez@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdamHannah
DeresiewiczP: 1 212-362-1200hannah.deresiewicz@sternir.com
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