AVEO Oncology Announces Restructuring of Existing Term Loan with Closing of New Tranched, $35 Million Debt Facility
August 10 2020 - 4:05PM
Business Wire
AVEO Oncology (Nasdaq: AVEO) today announced the closing of a
tranched, $35 million debt facility with Hercules Capital, Inc.
(NYSE: HTGC) and its affiliates. The new facility has a maturity of
36 months, extendable up to 48 months, and an interest-only period
of 12 months, extendable up to 30 months upon the achievement of
performance milestones related to the approval and
commercialization of tivozanib.
Under the terms of the agreement, the initial tranche of $15
million fully refinanced AVEO’s existing Hercules term loan
facility, which had an outstanding principal amount of
approximately $9.7 million, providing net new proceeds of $5.3
million. A second $10 million tranche is contingent upon the
approval of the tivozanib New Drug Application (NDA) by the U.S.
Food and Drug Administration (FDA) as a treatment for renal cell
carcinoma (RCC), and certain other terms and conditions. An
additional two $5 million tranches will become available after that
time – one if product revenues from net sales of tivozanib reach
$20.0 million within a specified time frame, and the other at the
lender’s consent. As previously announced, the FDA has assigned
AVEO’s NDA a Prescription Drug User Fee Act target action date of
March 31, 2021.
“The refinancing of our debt facility with Hercules Capital is
expected to provide us with access to capital that funds planned
operations well into the anticipated launch of tivozanib,” said
Michael Bailey, president and chief executive officer of AVEO. “We
continue to work closely with the FDA in their review of our NDA,
as we build out our commercial organization, explore potentially
pivotal immunotherapy-combination studies for tivozanib, and
advance our pipeline.”
"We are excited and pleased to be extending and expanding our
financing partnership with AVEO as they prepare for the potential
approval and launch of tivozanib. Our relationship with AVEO spans
nearly 15 years and this most recent financing is another example
of our ability to support innovative life sciences companies at all
stages of development and through multiple value inflection
points," said Bryan Jadot, Senior Managing Director and Life
Sciences Group Head for Hercules.
About AVEO Pharmaceuticals, Inc.
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. AVEO’s strategy is to focus
its resources toward development and commercialization of its
product candidates in North America, while leveraging partnerships
to support development and commercialization in other geographies.
AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the
European Union and other countries by AVEO’s partner EUSA for the
treatment of adult patients with advanced renal cell carcinoma.
AVEO is working to develop and commercialize tivozanib in North
America as a treatment for renal cell carcinoma and hepatocellular
carcinoma. AVEO has previously reported promising early clinical
data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute
myeloid leukemia and pancreatic cancer and is conducting a
randomized Phase 2 confirmatory clinical trial of ficlatuzumab in
head and neck cancer. AVEO’s earlier-stage pipeline includes
several monoclonal antibodies in oncology development, including
AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353
(anti-Notch 3 mAb). AVEO is committed to creating an environment of
diversity and inclusion as a foundation for innovation.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements of AVEO
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve substantial risks and uncertainties. All
statements, other than statements of historical fact, contained in
this press release are forward-looking statements. The words
“anticipate,” “believe,” “expect,” “hope,” “intend,” “may,” “plan,”
“potential,” “could,” “should,” “would,” “seek,” “look forward,”
“advance,” “goal,” “strategy,” or the negative of these terms or
other similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among others, statements about: the potential for tivozanib as a
treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC, and following earlier TKI and
immunotherapy treatment; the potential efficacy, safety, and
tolerability of tivozanib, both as a stand-alone drug candidate and
in combination with other therapies in several indications; AVEO’s
execution of its clinical and regulatory strategy for tivozanib;
AVEO’s plans and strategies for current and future clinical trials
of tivozanib, ficlatuzumab and AV-380 and for commercialization of
tivozanib in the United States; the period in which AVEO expects to
have cash to fund its operations and the contingencies upon which
such guidance is dependent; and AVEO’s strategy, prospects, plans
and objectives for its product candidates and for the Company
generally. AVEO has based its expectations and estimates on
assumptions that may prove to be incorrect. As a result, readers
are cautioned not to place undue reliance on these expectations and
estimates. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the
forward-looking statements that AVEO makes due to a number of
important factors, including risks relating to: whether the results
of TIVO-3 are sufficient to obtain marketing approval for tivozanib
in the U.S., which turns on the ability of AVEO to demonstrate to
the satisfaction of the FDA the safety and efficacy of tivozanib
based upon the findings of tivozanib’s clinical trials, including
its data with respect to PFS, the rate of adverse events, OS and
other information that the FDA may determine to be relevant to
approvability; AVEO’s ability, and the ability of its licensees, to
demonstrate to the satisfaction of applicable regulatory agencies
such as the FDA the safety, efficacy and clinically meaningful
benefit of AVEO’s product candidates; and AVEO’s ability to enter
into and maintain its third party collaboration and license
agreements, and its ability, and the ability of its strategic
partners, to achieve development and commercialization objectives
under these arrangements. AVEO faces other risks relating to its
business as well, including risks relating to the timing and costs
of seeking and obtaining regulatory approval; AVEO’s and its
collaborators’ ability to successfully enroll and complete clinical
trials; AVEO’s ability to maintain compliance with regulatory
requirements applicable to its product candidates; AVEO’s ability
to obtain and maintain adequate protection for intellectual
property rights relating to its product candidates; AVEO’s ability
to successfully implement its strategic plans, including its
ability to successfully launch and commercialize tivozanib if it
may be approved for commercialization by the FDA; AVEO’s ability to
raise the substantial additional funds required to achieve its
goals, including those goals pertaining to the development and
commercialization of tivozanib; unplanned capital requirements;
AVEO’s ability to access up to $20.0 million of the Hercules loan
facility, which turns on the achievement of milestones related to
the approval and commercialization of tivozanib in the U.S., which
milestones may not be achieved; AVEO’s ability to comply with
various financial and operational covenants contained in its debt
facilities; adverse general economic and industry conditions; the
potential adverse effects of the COVID-19 pandemic on AVEO’s
business continuity, financial condition, results of operations,
liquidity and ability to successfully and timely enroll, complete
and read-out data from its clinical trials; competitive factors;
and those risks discussed in the sections titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Liquidity and Capital Resources” included in
AVEO’s quarterly and annual reports on file with the Securities and
Exchange Commission (SEC) and in other filings that AVEO makes with
the SEC. The forward-looking statements in this press release
represent AVEO’s views as of the date of this press release, and
subsequent events and developments may cause its views to change.
While AVEO may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO's views as of any date other than
the date of this press release.
Any reference to AVEO’s website address in this press release is
intended to be an inactive textual reference only and not an active
hyperlink.
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version on businesswire.com: https://www.businesswire.com/news/home/20200810005671/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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