Nuvation Bio to receive $150 million in royalty
interest financing and $50 million in debt upon U.S. FDA approval
of taletrectinib, with access to additional $50 million in debt at
the Company’s option
Proceeds from the royalty interest financing
expected to fully fund U.S. commercial launch of taletrectinib
Pro forma cash balance expected to fully fund
development of current clinical-stage pipeline and create a path to
potential profitability without the need for additional
fundraising; improves flexibility for opportunistic capital
deployment
Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical
company tackling some of the greatest unmet needs in oncology,
today announced non-dilutive financings of up to $250 million with
Sagard Healthcare Partners (Sagard). The transaction comprises a
royalty interest financing of $150 million and a senior term loan
of up to $100 million. These financings strengthen Nuvation Bio’s
balance sheet to fully fund commercialization of taletrectinib in
the U.S., if approved, and development of the Company’s current
clinical-stage pipeline. The transaction also provides Nuvation Bio
with a path to potential profitability without the need to raise
additional capital.
“This transaction is a significant milestone for Nuvation Bio as
we prepare to bring taletrectinib to the U.S. market, subject to
FDA approval, in mid-2025,” said David Hung, M.D., Founder,
President, and Chief Executive Officer of Nuvation Bio. “With these
financings, we are well positioned to launch taletrectinib and
drive continued development of our clinical-stage pipeline—all
without the need for additional fundraising. This also improves our
flexibility to pursue strategic opportunities to deploy our
capital. We are thrilled to have support from Sagard and appreciate
their shared confidence in taletrectinib and Nuvation Bio as we
continue toward our goal of improving outcomes for patients with
cancer.”
Subject to the approval of taletrectinib by the U.S. Food and
Drug Administration (FDA) on or prior to September 30, 2025, Sagard
will provide Nuvation Bio with an upfront cash payment of $150
million. In return, Sagard will receive tiered royalties on U.S.
net sales of taletrectinib, including 5.5% of annual U.S. net sales
up to $600 million and 3.0% of annual U.S. net sales between $600
million and $1 billion. Nuvation Bio will retain all annual U.S.
net sales above $1 billion. Payments to Sagard will cease upon the
earliest occurrence of total royalties reaching 1.6 times its
investment by June 30, 2031, 1.75 times its investment by June 30,
2034, or 2.0 times its investment thereafter.
“We are excited to partner with Nuvation Bio, an organization
with deep oncology expertise and a commitment to delivering
transformative therapies,” said Raja Manchanda, Partner at Sagard
Healthcare Partners. “We believe taletrectinib has the potential to
redefine the treatment landscape for patients with ROS1-positive
non-small cell lung cancer, and we are pleased to provide a
structured financing that supports both potential near-term
commercialization and long-term growth.”
In addition to the royalty financing, Sagard has committed to a
5-year, senior secured term loan of up to $100 million, with $50
million to be funded upon U.S. FDA approval of taletrectinib on or
prior to September 30, 2025. The second tranche of $50 million is
available at Nuvation Bio's option until June 30, 2026, as long as
Nuvation Bio has achieved first U.S. commercial sale of
taletrectinib. The term loan will bear interest at SOFR + 6.00%,
subject to a 4.00% SOFR floor. There are no scheduled amortization
payments associated with the term loan, with all outstanding
principal due at maturity.
TD Cowen served as financial advisor and Cooley LLP served as
legal advisor to Nuvation Bio. Sidley Austin LLP served as legal
advisors to Sagard.
About Sagard
Sagard is a multi-strategy alternative asset management firm
with over US$25B under management, 150 portfolio companies, and 400
professionals. Sagard invests in venture capital, private equity,
private credit, and real estate. Sagard delivers flexible capital,
an entrepreneurial culture, and a global network of investors,
commercial partners, advisors, and value creation experts. Sagard’s
dynamic and supportive ecosystem gives its partners the advantage
they need to learn, grow and win at every stage. The firm has
offices in Canada, the United States, Europe and the Middle
East.
About Nuvation Bio
Nuvation Bio is a global biopharmaceutical company tackling some
of the greatest unmet needs in oncology by developing
differentiated and novel product candidates. Nuvation Bio’s
programs include taletrectinib (ROS1), safusidenib (mIDH1),
NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018
by biopharma industry veteran David Hung, M.D., who previously
founded Medivation, Inc., which brought to patients one of the
world’s leading prostate cancer medicines. Nuvation Bio has offices
in New York, San Francisco, Boston, and Shanghai. For more
information, please visit www.nuvationbio.com or follow the Company
on LinkedIn and X (@nuvationbioinc).
Forward Looking Statements
Certain statements included in this press release 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 are
sometimes 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,
our expectations regarding U.S. FDA approval and commercial launch
of taletrectinib, and the timing thereof, receipt and use of
proceeds from the financings to fully fund U.S. commercial launch
of taletrectinib and development of Nuvation Bio’s current
clinical-stage pipeline, the path to potential profitability
without need to raise additional capital, and the potential of
taletrectinib to redefine the treatment landscape for patients with
ROS1-positive non-small cell lung cancer. These statements are
based on various assumptions, whether or not identified in this
press release, and on the current expectations of the management
team of Nuvation Bio and are not predictions of actual performance.
These forward-looking statements are subject to a number of risks
and uncertainties that may cause actual results to differ from
those anticipated by the forward-looking statements, including but
not limited to the challenges associated with conducting drug
discovery and initiating or conducting clinical studies due to,
among other things, difficulties or delays in the regulatory
process, enrolling subjects or manufacturing or acquiring necessary
products; the emergence or worsening of adverse events or other
undesirable side effects; risks associated with preliminary and
interim data, which may not be representative of more mature data;
and competitive developments. Risks and uncertainties facing
Nuvation Bio are described more fully in its Form 10-Q filed with
the SEC on November 6, 2024, under the heading “Risk Factors,” and
other documents that Nuvation Bio has filed or will file with the
SEC. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
press release. Nuvation Bio disclaims any obligation or undertaking
to update, supplement or revise any forward-looking statements
contained in this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20250303777574/en/
Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact: media@nuvationbio.com
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