AVEO Oncology Announces Extension of Debt Facility Interest Only Period
December 04 2018 - 4:05PM
Business Wire
Extends Cash Runway to Fund Planned Operations
into the Third Quarter of 2019
AVEO Oncology (NASDAQ:AVEO) today announced a six-month
extension to the interest only period under its existing amended
and restated loan and security agreement with Hercules Capital,
Inc. (Hercules). The extension was granted as a result of achieving
certain predefined requirements under the agreement, including
successfully meeting the primary endpoint of the Company’s Phase 3
TIVO-3 study of tivozanib in refractory advanced or metastatic
renal cell carcinoma (RCC), by demonstrating a significant
improvement in progression free survival.
The Company will begin making principal payments on the $20.0
million facility starting on August 1, 2019. AVEO believes that its
available cash, cash equivalents, and marketable securities,
together with the extension of the interest only period under the
Hercules loan agreement, which results in deferment of principal
payments, will allow it to fund planned operations into Q3 2019.
This estimate assumes no receipt of additional milestones from
AVEO’s partners, no additional funding from new partnership
agreements, no additional equity or debt financings, and no sales
of equity through the exercise of outstanding warrants issued in
connection with the 2016 private placement or outstanding warrants
issued in connection with the settlement of the securities class
action litigation.
“Extension of our cash runway takes us through several key
anticipated milestones, with the presentation of our TIVO-3 data,
including a planned update to the preliminary OS analysis which
will contain additional patient data recovered in the ongoing OS
sweep, and potential submission of a New Drug Application with the
FDA for tivozanib in RCC. Both milestones are expected in the first
half of 2019,” said Michael Bailey, president and chief executive
officer. “We also look forward to making important progress within
this period on our immunotherapy combination strategy, the third
pillar of our tivozanib strategy.”
About AVEO
AVEO Pharmaceuticals, Inc. is a biopharmaceutical company
dedicated to advancing a broad portfolio of targeted medicines for
oncology and other areas of unmet medical need. The Company’s
strategy is to retain North American rights to its oncology
portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking
to develop and commercialize its lead candidate tivozanib in North
America as a treatment for RCC. The Company has outlicensed
tivozanib (FOTIVDA®) for oncological indications in Europe and
other territories outside of North America. Tivozanib is approved
in the European Union, as well as Norway and Iceland, for the
first-line treatment of adult patients with RCC and for adult
patients who are vascular endothelial growth factor receptor and
mTOR pathway inhibitor-naïve following disease progression after
one prior treatment with cytokine therapy for RCC. The Company has
entered into partnerships for the development and commercialization
of AV-203 (CAN017) and ficlatuzumab, both clinical stage assets in
oncology. The Company is currently seeking a partner to develop the
AV-353 platform, a preclinical asset, worldwide for the potential
treatment of pulmonary arterial hypertension and oncology. In
addition, a new formulation of tivozanib is being explored in
ocular conditions. The Company has recently regained the rights to
its AV-380 program for the potential treatment of cachexia and is
considering a variety of options to advance the program’s
development.
For more information, please visit the Company’s website at
www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO
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,” “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: AVEO’s plans to present data from the
TIVO-3 study in the first half of 2019, including updated overall
survival data; AVEO’s plans and timing estimates regarding the
potential submission of a New Drug Application to the FDA for
tivozanib in the first half of 2019; AVEO’s plans and strategies
for commercialization of tivozanib in the United States and Europe;
the potential for tivozanib in RCC and other indications, such as
ocular conditions, and as either a monotherapy or combination
therapy; AVEO’s plan to seek a partner to develop the AV-353
platform; AVEO’s plans regarding AV-380; AVEO’s cash runway; and
AVEO’s strategy, prospects, plans and objectives, including its
plans to advance its portfolio of targeted medicines. 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 AVEO’s ability to enter into and maintain its third
party collaboration and license agreements, and its ability, and
the ability of its collaborators, licensees, and other strategic
partners, to achieve development and commercialization objectives
under these arrangements; and 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,
including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to the timing and costs
of any product candidate seeking and obtaining regulatory approval;
AVEO’s ability to file an NDA for tivozanib in the timeframe it
currently estimates or at all; AVEO’s and its collaborators’
ability to successfully enroll and complete clinical trials; AVEO’s
ability to achieve and 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 and
technologies; AVEO’s ability to successfully implement its
strategic plans; 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; adverse general economic and
industry conditions; 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 may make
with the SEC in the future. 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/20181204006041/en/
AVEO:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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