AVEO Oncology Announces Commitment for an Incremental $10 Million Loan in Addition to Current Tranched, $35 Million Debt Faci...
January 20 2021 - 7:00AM
Business Wire
– $20M Tranche Available on Approval of
Tivozanib –
AVEO Oncology (Nasdaq: AVEO) today announced that it has
received a commitment letter for an incremental $10 million loan
from Hercules Capital, Inc. (NYSE: HTGC, “Hercules”) and its
affiliates, to be added to the current tranched, $35 million debt
facility secured with Hercules in August 2020 through an amendment
to the amended and restated loan and security agreement (the “Loan
Agreement”). Terms of the facility would remain otherwise unchanged
from the Loan Agreement, with the loan bearing 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 Loan Agreement, an initial tranche of $15
million was drawn down at signing. Under the terms of the
commitment letter, a second tranche of $20 million would be
available contingent upon the approval of the tivozanib New Drug
Application (“NDA”) by the U.S. Food and Drug Administration
(“FDA”) as a treatment for relapsed or refractory renal cell
carcinoma (“RCC”). An additional $10 million will become available
if certain sales criteria are met. As previously announced, the FDA
has assigned AVEO’s NDA a Prescription Drug User Fee Act target
action date of March 31, 2021. The nonbinding commitment letter is
subject to AVEO and Hercules entering into a definitive amendment
of the Loan Agreement setting forth the terms of the additional
borrowing.
“The additional $10 million that would be made available from
Hercules Capital with execution of a definitive amendment and the
potential approval of tivozanib further supports what we believe
will be a robust launch of tivozanib in the U.S.,” said Michael
Bailey, president and chief executive officer of AVEO. “As we work
on expanding our commercial organization in preparation for this
potential launch, we also continue to progress our pipeline of
clinical programs, including our immunotherapy combination programs
for tivozanib, our Phase 2 study of ficlatuzumab and our recently
initiated Phase 1 study of AV-380. Throughout 2021, we look forward
to a number of milestones designed to enhance our long-term
value.”
“We are pleased to be expanding our financing partnership with
AVEO as they prepare for the potential approval and launch of
tivozanib. This amendment and the potential further additional
capital from Hercules represents another example of our unique
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 an oncology-focused biopharmaceutical company committed
to delivering medicines that provide a better life for cancer
patients. 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, is approved as FOTIVDA® in the European Union and other
countries in the territory of the AVEO’s partner, EUSA Pharma (UK)
Limited for the treatment of adult patients with advanced RCC.
Tivozanib is being studied in the TIVO-3 trial, which is supporting
a regulatory submission of tivozanib in the U.S. seeking marketing
approval as a treatment for relapsed or refractory RCC. 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,” “design,” “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: AVEO’s plan to
amend the Loan Agreement; the planned terms of the amendment to the
Loan Agreement; future borrowings available to AVEO pursuant to the
Loan Agreement, as amended by the 2021 Amendment; AVEO’s planned
timing for making tivozanib available to patients in the U.S.; the
potential for tivozanib as a treatment option for patients with
advanced HCC or relapsed/refractory or advanced RCC; 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 advancement of AVEO’s pipeline, including the advancement of
ficlatuzumab in multiple clinical studies; the potential efficacy,
safety and tolerability of ficlatuzumab, both as a stand-alone drug
candidate and in combination with other therapies; the potential
outcomes from studies of ficlatuzumab to provide AVEO with
opportunities to pursue regulatory strategies; the potential
clinical utility of ficlatuzumab in areas of unmet need; 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: uncertainties related to AVEO’s ability to access
future borrowings under 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; 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
TIVO-3, including its data with respect to PFS, the rate of adverse
events, OS and other information that the FDA may consider to be
relevant to an approval determination; 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 and to obtain and
maintain market and third party payor acceptance of 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 launch and
commercialization of tivozanib; 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
risks relating to the timing and costs of seeking and obtaining
regulatory approvals; 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’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; unplanned capital requirements; 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
“Cautionary Note Regarding Forward-Looking Statements” in AVEO’s
September 2020 press release regarding ficlatuzumab, and 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 (the
“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/20210120005170/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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