– Leading institutional investors commit
approximately $235 million through an oversubscribed and
upsized private investment in public equity (“PIPE”) led by
Frazier Healthcare Partners and Bain Capital Life
Sciences –
– Total proceeds expected to bring pro forma
cash balance to at least $470 million; expected to extend
cash runway of NewAmsterdam through 2026, funding all
expected pre-approval milestones for lead candidate
obicetrapib, including readouts of Phase 3 PREVAIL study, a global
cardiovascular outcomes trial (“CVOT”) and two other pivotal Phase
3 studies –
– NewAmsterdam’s lead therapeutic candidate,
obicetrapib, is a next-generation oral, low-dose and once-daily
CETP inhibitor for which promising safety and >50% LDL-lowering
efficacy has been observed on top of high-intensity statins in
patients with dyslipidemia through Phase 2b, which could
potentially serve a global population of over 30 million patients
with unmet medical need in cardiovascular disease –
– NewAmsterdam shareholders, Frazier
Lifesciences Acquisition Corporation (Nasdaq: FLAC) shareholders
and PIPE investors will hold ordinary shares in a newly formed
company, NewAmsterdam Pharma Company N.V., which is expected to
list its ordinary shares on Nasdaq under the ticker “NAMS” –
– Merger expected to be completed in the second
half of 2022 –
NewAmsterdam Pharma Holding B.V. (“Company”), a late
clinical-stage company focused on the research and development of
transformative oral therapies for major cardiometabolic diseases,
and Frazier Lifesciences Acquisition Corporation (“FLAC”), a
special purpose acquisition company sponsored by an affiliate of
Frazier Healthcare Partners, today announced that they have entered
into a definitive business combination agreement. Upon closing of
the transaction, a newly formed holding company, NewAmsterdam
Pharma Company N.V. (“NewAmsterdam”) will be led by Michael
Davidson, M.D., Chief Executive Officer of the Company.
NewAmsterdam’s ordinary shares are expected to be listed on Nasdaq
under the ticker symbol “NAMS.”
NewAmsterdam is expected to receive approximately $235
million from an upsized and oversubscribed PIPE at $10.00 per share
plus funds held in FLAC’s trust account following any redemptions.
The PIPE was upsized from the initial target of $100 million due to
significant investor demand. The PIPE was co-led by Frazier
Healthcare Partners and Bain Capital Life Sciences, and
includes 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. The proceeds from this transaction, combined
with the upfront payment of $123 million (€115 million) received
from NewAmsterdam’s recently announced licensing agreement with the
Menarini Group and NewAmsterdam’s existing cash and cash
equivalents, would bring NewAmsterdam’s total pro forma cash
balance to at least $470 million, which the Company believes
would be sufficient to fund operations through 2026, beyond the
readout of NewAmsterdam’s Phase 3 PREVAIL CVOT study and two other
pivotal Phase 3 studies.
The transaction is expected to close in the second half of 2022,
subject to approval by FLAC’s shareholders and the satisfaction or
waiver of certain other customary closing conditions. The Boards of
Directors of both the Company and FLAC have unanimously approved
the transaction. Following the close of the transaction, James
Topper, M.D., Ph.D., Managing Partner at Frazier Healthcare
Partners and Chairman of the Board of Directors and Chief Executive
Officer of FLAC, and Nicholas Downing, M.D., Principal at Bain
Capital Life Sciences, will join the NewAmsterdam Board of
Directors.
“Today’s announcement marks a major milestone for NewAmsterdam.
We believe that the transaction, if consummated, would provide us
with the necessary capital to fund our business through 2026 and
beyond multiple Phase 3 data readouts for obicetrapib, including
our ongoing cardiovascular outcomes trial, and a potential global
product launch,” said Dr. Davidson. “Cardiovascular disease remains
a significant unmet need and is the number one cause of death in
western countries, with high LDL levels being the chief culprit
responsible for adverse outcomes and two-thirds of patients not
reaching LDL goals despite the wide availability of statins. Adding
a potential new convenient oral therapy that has been observed to
confer an additional 51% of LDL-lowering on top of high dose
statins could transform the treatment paradigm for this large
patient population. We are grateful to the FLAC team, as well as
our new and existing investors, for their support throughout this
transaction and look forward to a continued partnership as we
mature into a publicly traded company and pursue our mission of
improving patient care globally for this large patient population
with substantial unmet need despite existing therapies.”
“We founded FLAC in hopes of acquiring a therapeutics-focused
company with near-term inflection points, experienced and highly
credentialed leadership and sufficient capital to support planned
operations well into the future,” said James Topper, M.D., Ph.D.,
Managing Partner at Frazier Healthcare Partners and Chairman of the
Board of Directors and Chief Executive Officer of FLAC. “We have
found exactly this in NewAmsterdam. NewAmsterdam’s lead program,
obicetrapib, is a potentially first- and best-in-class once-daily,
oral CETP inhibitor, for which potent LDL-lowering activity on top
of high-intensity statins and a positive safety and tolerability
profile have been observed in clinical trials. We congratulate
NewAmsterdam on their recent success in securing a $1B+ partnership
with the Menarini Group for Europe and we are eager to support
NewAmsterdam’s world-class team as it advances obicetrapib through
Phase 3 development and aims to deliver a new transformative oral
therapy to the tens of millions of people worldwide who remain at
high-risk of experiencing a major adverse cardiac event, despite
the availability of statins and other prescription therapies.”
Proceeds from the transaction are expected to provide
NewAmsterdam with the capital needed to further develop obicetrapib
through several value-creating clinical and regulatory milestones,
including the following:
- Data from the ongoing Phase 3 BROADWAY trial of obicetrapib in
adults with heterozygous familial hypercholesterolemia (“HeFH”)
and/or established atherosclerotic cardiovascular disease (“ASCVD”)
who require additional lowering of low‑density lipoprotein
cholesterol (“LDL-C”) on top of high intensity statins in
2024;
- Data from the ongoing Phase 3 BROOKLYN trial of obicetrapib in
adults with HeFH, whose LDL-C is not adequately controlled despite
being on maximally tolerated lipid-modifying therapies in
2024;
- Data from the ongoing Phase 3 PREVAIL study, a global
cardiovascular outcomes trial, in patients with ASCVD who have
inadequate control of their LDL-C despite being on maximally
tolerated lipid-modifying therapies in 2026;
- Data from the ongoing Phase 2b ROSE2 trial, evaluating the
combination of obicetrapib with ezetimibe as an adjunct to
high-intensity statin therapy in 2023;
- Potential new drug application filings for obicetrapib in the
United States, Europe, Japan and China and potential commercial
launch.
Summary of Transaction
The closing of the business combination would bring
NewAmsterdam’s total pro forma cash balance to at least $470
million, in addition to a total enterprise value of $326
million.
Current Company shareholders are converting 100% of their
existing equity interests into ordinary shares of NewAmsterdam. In
addition to the funds held in FLAC’s trust account following any
redemptions, an additional group of premier healthcare investors
has committed to participate in the transaction through an
oversubscribed and upsized PIPE of approximately $235
million at $10.00 per share.
The Boards of Directors of both the Company and FLAC have
unanimously approved the proposed transaction, which is expected to
close in the second half of 2022, subject to the approval by FLAC’s
shareholders and the satisfaction or waiver of certain other
customary closing conditions.
The description of the business combination contained herein is
only a high-level summary. Additional information about the
transaction will be provided in a Current Report on Form 8-K to be
filed by FLAC with the Securities and Exchange Commission (“SEC”)
and will be available at www.sec.gov. In addition, NewAmsterdam
intends to file a registration statement on Form F-4 with the SEC,
which will include a proxy statement/prospectus, and will file
other documents regarding the proposed transaction with the
SEC.
Advisors
Credit Suisse Securities (USA) LLC is acting 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. are also acting as PIPE placement agents to FLAC
and Jefferies LLC and William Blair & Company, L.L.C. are also
acting as financial advisor and capital markets advisor to FLAC.
SVB Securities LLC is acting as financial advisor and capital
markets advisor to the Company. Moelis & Co. is also acting as
financial advisor to the Company. Covington & Burling LLP is
acting as legal counsel to the Company. Goodwin Procter LLP is
acting as legal counsel to FLAC. Kirkland & Ellis LLP is acting
as legal counsel to the PIPE placement agents.
About NewAmsterdam Pharma
NewAmsterdam Pharma is a private clinical-stage
biopharmaceutical company whose mission is to improve patient care
in populations with metabolic diseases where traditional therapies
have not been sufficiently successful or well-tolerated.
NewAmsterdam is investigating obicetrapib, a next-generation oral,
low-dose and once-daily CETP inhibitor, as the preferred
LDL-C-lowering 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 10mg experienced
reduced LDL-C by 51% versus baseline in patients on statin therapy
(vs. a 7% reduction in the placebo arm). Based in the Netherlands,
the Company was founded in 2019 by the venture capital firm Forbion
and John Kastelein, Chief Scientific Officer of the Company, and
closed a $196 million (€160 million) Series A financing in January
2021 led by Forbion, Morningside Ventures and Ascendant BioCapital.
In June 2022, the Company 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.
About Frazier Lifesciences Acquisition Corporation
FLAC is blank check company incorporated as a Cayman Islands
exempted company in October 2020 for the purpose of effecting a
merger, share exchange, asset acquisition, share purchase,
reorganization or similar business combination with one or more
businesses or entities. FLAC was formed to leverage the extensive
experience and track record of its management team with the goal of
financing a company that can both develop transformative therapies
for patients in need and deliver significant returns to its
investors. For more information, please visit:
www.frazierlifesciencesacquisition.com.
About Frazier Healthcare Partners
Founded in 1991, Frazier Healthcare Partners is a leading
provider of private equity capital to healthcare companies. With
more than $8.1 billion total capital raised, Frazier has invested
in more than 200 companies with transaction types ranging from
buyouts of profitable healthcare companies to venture capital and
company creation. Frazier has a philosophy of partnering with
strong management teams while leveraging its internal operating
resources and network to build exceptional companies. Frazier has
offices in Seattle, Washington, and Menlo Park, California, and
invests broadly across the U.S., Canada and Europe. For more
information, please visit: www.frazierhealthcare.com.
Important Information About the Merger and Where to Find
It
A full description of the terms of the transaction will be
provided in a registration statement on Form F-4 to be filed with
the SEC by NewAmsterdam that will include a prospectus with respect
to the NewAmsterdam securities to be issued in connection with the
business combination and a proxy statement with respect to the
shareholder meeting of FLAC to vote on the business combination.
FLAC, the Company and NewAmsterdam urge its investors,
shareholders and other interested persons to read, when available,
the preliminary proxy statement/prospectus, as well as other
documents filed with the SEC, because these documents will contain
important information about FLAC, the Company, NewAmsterdam and the
transaction. After the registration statement is declared
effective, the definitive proxy statement/prospectus to be included
in the registration statement will be mailed to shareholders of
FLAC as of a record date to be established for voting on the
proposed business combination. Once available, shareholders of FLAC
will also be able to obtain a copy of the Form F-4, including the
proxy statement/prospectus, and other documents filed with the SEC
without charge, by directing a request to: Frazier Lifesciences
Acquisition Corporation, Two Union Square, 601 Union St., Suite
3200, Seattle, WA 98101, Attn: Secretary. The preliminary and
definitive proxy statement/prospectus to be included in the
registration statement, once available, can also be obtained,
without charge, at the SEC’s website at www.sec.gov.
Participants in the Solicitation
FLAC, the Company and NewAmsterdam and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from FLAC’s shareholders in
connection with the proposed transaction. Information about the
directors and executive officers of FLAC is set forth in FLAC’s
annual report on Form 10-K filed with the SEC on March 25, 2022 and
is available free of charge at the SEC’s website at www.sec.gov or
by directing a request to: Frazier Lifesciences Acquisition
Corporation, Two Union Square, 601 Union St., Suite 3200, Seattle,
WA 98101, Attn: Secretary. Information regarding the persons who
may, under the rules of the SEC, be deemed participants in the
solicitation of FLAC’s shareholders in connection with the
potential transaction will be set forth in the registration
statement containing the preliminary proxy statement/prospectus
when it is filed with the SEC. These documents can be obtained free
of charge from the sources indicated above.
Non-Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
any securities nor shall there be any sale of securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act.
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 estimates and forecasts of other financial and
performance metrics and projections of market opportunity;
expectations and timing related to the success, cost and timing of
product development activities, including timing of initiation,
completion and data readouts for clinical trials and the potential
approval of NewAmsterdam’s product candidate; the size and growth
potential of the markets for NewAmsterdam’s product candidate; the
therapeutic and curative potential of NewAmsterdam’s product
candidate; financing and other business milestones; potential
benefits of the proposed transactions; and expectations relating to
the proposed transactions, including the proceeds of the business
combination and NewAmsterdam’s expected cash runway. These
statements are based on various assumptions, whether or not
identified in this document, and on the current expectations of
NewAmsterdam’s, the Company’s and FLAC’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 NewAmsterdam, the Company
and FLAC. 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; the inability of the parties to successfully or timely
enter into definitive agreements with respect to the proposed
transactions or consummate the proposed transactions, including the
risk that any regulatory approvals are not obtained, are delayed or
are subject to unanticipated conditions (such as any SEC statements
or enforcements or other actions relating to special purpose
acquisition companies) that could adversely affect NewAmsterdam or
the expected benefits of the proposed transactions, or the risk
that the approval of the shareholders of FLAC, the Company or
NewAmsterdam is not obtained; failure to realize the anticipated
benefits of the proposed transactions; matters discovered by FLAC,
the Company or NewAmsterdam as they complete their respective due
diligence investigations of each other; risks relating to the
uncertainty of the projected financial information with respect to
NewAmsterdam and the Company; risks related to the approval of
NewAmsterdam’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 NewAmsterdam’s future business; the amount of
redemption requests made by FLAC’s public shareholders; and those
factors discussed in documents FLAC has filed or will file with the
SEC, including the other risks and uncertainties described in the
“Risk Factors” section of FLAC’s registration statement on Form
S-1, as amended (File No. 333-250858), the registration statement
to be filed on Form F-4 in connection with the proposed
transactions and other documents filed from time to time.
Additional risks related to NewAmsterdam’s business include, but
are not limited to: uncertainty regarding outcomes of
NewAmsterdam’s ongoing clinical trials, particularly as they relate
to regulatory review and potential approval for its product
candidate; risks associated with NewAmsterdam’s efforts to
commercialize a product candidate; NewAmsterdam’s ability to
negotiate and enter into definitive agreements on favorable terms,
if at all; the impact of competing product candidates on
NewAmsterdam’s business; intellectual property related claims;
NewAmsterdam’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 FLAC’s, the
Company’s or NewAmsterdam’s assumptions prove incorrect, actual
results could differ materially from the results implied by these
forward-looking statements. There may be additional risks that
neither FLAC, the Company nor NewAmsterdam presently know or that
FLAC, the Company and NewAmsterdam currently believe are immaterial
that could also cause actual results to differ from those contained
in the forward-looking statements. In addition, forward-looking
statements reflect FLAC’s, the Company’s and NewAmsterdam’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. FLAC, the Company
and NewAmsterdam anticipate that subsequent events and developments
will cause FLAC’s, the Company’s and NewAmsterdam’s assessments to
change. These forward-looking statements should not be relied upon
as representing FLAC’s, the Company’s and NewAmsterdam’s
assessments as of any date subsequent to the date of this press
release. Accordingly, undue reliance should not be placed upon the
forward-looking statements. Neither FLAC, the Company, NewAmsterdam
nor any of their respective affiliates undertake any obligation to
update these forward-looking statements, except as required by
law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220725005427/en/
NewAmsterdam or Company Media Contact
Spectrum Science on behalf of NewAmsterdam Carmen Lopez P: 1
773-306-6285 clopez@spectrumscience.com
NewAmsterdam or Company Investor Contact
Stern Investor Relations on behalf of NewAmsterdam Hannah
Deresiewicz P: 1 212-362-1200 hannah.deresiewicz@sternir.com
FLAC Contacts:
James Topper P: 1 650-325-5156 james@frazierhealthcare.com
David Topper P: 1 650-325-5156
david.topper@frazierhealthcare.com
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