-
Financing to fund quarterly expenses related to the ATHENA first-line
maintenance clinical trial in ovarian cancer, beginning in Q2 2019
through study completion -
Repayment anticipated to begin 1H 2022, the approximate anticipated
timing of a potential Rubraca first-line maintenance approval in
advanced ovarian cancer -
The financing of ATHENA, Clovis’ largest study, extends Clovis’ cash
projected runway into 2022 -
Financing secured by Rubraca assets; Clovis maintains worldwide rights
to Rubraca
BOULDER, Colo.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24CLVS&src=ctag" target="_blank"gt;$CLVSlt;/agt;–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that it has entered
into an agreement for up to $175 million in non-dilutive clinical trial
financing with certain affiliates of TPG Sixth Street Partners to
reimburse Clovis’ costs and expenses related to the ATHENA clinical
trial. ATHENA is Clovis Oncology’s largest clinical trial, with a
planned target enrollment of 1000 patients across more than 270 sites in
at least 25 countries.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer is
the first-line maintenance treatment setting evaluating rucaparib
(Rubraca) plus nivolumab (PD-1 inhibitor), rucaparib, nivolumab and
placebo in newly-diagnosed patients who have completed platinum-based
chemotherapy. This study initiated in Q2 2018 and is currently enrolling
patients.
“The ATHENA study is a very important trial for us as we seek to
continue to expand the available therapeutic options for women with
ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “ATHENA is also our largest study, with a planned target
enrollment of approximately 1000 patients, which is expected to have a
meaningful impact on our cash flow over the next few years. We are
pleased to work with TPG Sixth Street Partners, which has provided us
with a financing option that we believe uniquely meets our need to
balance future investment in Rubraca with our anticipated cash flow
needs.”
Under the terms of the agreement, financing for ATHENA clinical trial
expenses will be paid quarterly, in arrears, beginning Q2 2019 generally
through 1H 2022 after a potential first-line ovarian cancer maintenance
approval for Rubraca. Clovis would begin to repay the loan beginning
with the approval by the FDA of an expansion of the Rubraca label
indication resulting from the ATHENA trial or in 1H 2022, or sooner in
the event the trial is terminated, or the Company determines that the
results of the ATHENA Trial are insufficient to achieve such an
expansion of the Rubraca label to cover an indication based on the
ATHENA trial. Payments are based on a certain percentage of the revenues
generated from the sales, and any future out-licensing, of Rubraca with
quarterly payment caps depending on trial outcome. The potential maximum
amount that could be required to be repaid under the agreement is two
times the aggregate borrowed amount. For a more detailed description of
the terms of the Financing, please see our Current Report on 8-K filed
with the SEC today.
Vijay Mohan, Partner, and Jeff Pootoolal, Managing Director, at TPG
Sixth Street Partners, said: “Rubraca represents a meaningful treatment
option for oncology patients and we are pleased to support Clovis as it
expands the potential use for this important medicine. Drawing on our
platform’s deep healthcare experience, we tailored this fully committed,
bespoke financing solution to provide Clovis with runway and flexibility
as it continues its mission to improve the lives of people living with
cancer.”
About Rubraca (rucaparib)
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3
being developed in multiple tumor types, including ovarian and
metastatic castration-resistant prostate cancers, as monotherapy, and in
combination with other anti-cancer agents. Exploratory studies in other
tumor types are also underway.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops, with partners, for those
indications that require them, diagnostic tools intended to direct a
compound in development to the population that is most likely to benefit
from its use. Clovis Oncology is headquartered in Boulder, Colorado;
please visit www.clovisoncology.com
for more information, including additional office locations in the U.S.
and Europe.
About TPG Sixth Street Partners
TPG Sixth Street Partners is a global finance and investment business
with over $30 billion in assets under management. Co-founded in 2009 by
Managing Partner Alan Waxman and TSSP’s management team, the firm’s
long-term oriented, highly flexible capital base allows it to invest
across industries, geographies, capital structures and asset classes.
TSSP focuses on partnering with businesses and management teams to
create fully committed financing solutions. The firm also makes
investments in both private and public companies and assets. TSSP is in
a strategic partnership with TPG, the global alternative asset firm. For
more information, visit www.tssp.com.
To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management. Words such as “believes,” “anticipates,”
“plans,” “expects,” “indicates,” “will,” “intends,” “potential,”
“suggests,” “assuming,” “designed,” and similar expressions are intended
to identify forward-looking statements. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our plans to continue to evaluate the potential for
rucaparib in the ATHENA Trial, our expectations regarding the cost of
the ATHENA Trial, the potential to out-license Rubraca outside the
United States, the expected timing of a potential approval of Rubraca in
first line maintenance treatment of ovarian cancer, the total amount of
funding that may be available to us under the agreement, our anticipated
cash needs and the amount by which the funding under the loan may extend
our cash runway, and the timing and amount of repayment of the amounts
funded under the loan. Such forward-looking statements involve
substantial risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from that expressed
or implied by the forward-looking statements. Such risks and
uncertainties include, among others, how our cash needs may be affected
by revenues, expenses and other the availability potential financing
sources, possible changes to our plans or priorities as we assess data,
whether future study results will be consistent with study findings to
date, factors affecting the pace of enrollment of ATHENA and the timing
of the trial, factors affecting the cost of the ATHENA trial, including
pace of enrollment, number of sites activated, length of the trial, how
amounts borrowed, future revenues and applicable percentage amounts of
quarterly payments affect the overall time for repayment, and whether
future study results will support continued development or regulatory
approval, and the initiation, enrollment, timing and results of our
planned clinical trials. Clovis Oncology does not undertake to update or
revise any forward-looking statements. A further description of risks
and uncertainties can be found in Clovis Oncology’s filings with the
Securities and Exchange Commission, including its Annual Report on Form
10-K and its reports on Form 10-Q and Form 8-K.
Contacts
Clovis Investor Contacts:
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com
Clovis Media Contacts: U.S.
Lisa Guiterman, 301-217-9353
clovismedia@sambrown.com
or
Christy
Curran, 615-414-8668
clovismedia@sambrown.com
TPG Sixth Street Partners Media Contact:
Patrick Clifford,
646-906-4339
pclifford@tssp.com