AVEO Oncology Announces $14M in Aggregate Gross Proceeds from Hercules Credit Facility and At-the-market Stock Offerings
June 27 2017 - 09:06AM
Business Wire
Additional Resources Sufficient to Fund
Planned Operations into the 4Q 2018
AVEO Oncology (NASDAQ:AVEO) today announced that it has secured
$14 million in aggregate gross proceeds through its credit facility
with Hercules Capital, Inc. (Hercules) and the sale of common stock
via its at-the-market issuance sales agreement with FBR & Co.
(FBR).
Pursuant to its 2010 loan and security agreement with Hercules,
as amended in 2016, AVEO intends to draw down an additional
$5 million in funding from Hercules and will defer the
commencement of principal payments on its aggregate loan balance by
six months from July 1, 2017 until January 1, 2018.
Pursuant to its February 2015 at-the-market issuance sales
agreement with FBR, AVEO has issued and sold shares of common stock
for gross proceeds of $9 million, effectively exhausting the
balance of its aggregate $17.9 million facility. Gross proceeds of
the common stock sales are subject to a commission of 2%. AVEO
believes that, with the addition of these resources to its existing
cash on hand, its planned operations will be funded into the fourth
quarter of 2018. This guidance excludes, among other things, any
potential revenues from or payments to EUSA or other portfolio
partnerships.
Pursuant to AVEO’s December 2015 agreement with EUSA Pharma, the
European licensee for lead candidate, tivozanib, AVEO is eligible
to receive a $4 million research and development reimbursement
payment from EUSA if the European Commission grants marketing
approval for tivozanib, in addition to up to $12 million in
additional milestones based on member state reimbursement and
regulatory approvals, as well as a tiered royalty ranging from a
low double-digit up to mid-twenty percent on net sales of tivozanib
in the agreement’s territories. On June 23, 2017, AVEO announced
that the Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency (EMA), has
recommended FOTIVDA™ (tivozanib) for approval as a treatment for
patients with advanced renal cell carcinoma (RCC).
“AVEO now has resources that we expect will take us well past
the anticipated first quarter 2018 readout of the TIVO-3 trial, our
U.S. pivotal trial in third-line RCC,” said Michael Bailey,
president and chief executive officer of AVEO. “With progress made
to date in all three pillars of our tivozanib strategy, including
European registration strategy, our North American clinical and
regulatory strategy (TIVO-3), and our immunotherapy combination
strategy (TiNivo), we look forward to a number of potential
transformative events in the coming months. We intend to continue
to maintain our streamlined operations, while leveraging external
resources and our prior investments in tivozanib’s commercial
launch preparation, to ensure that our resources are directed
toward maximizing the value of our pipeline for patients and our
shareholders.”
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma. AVEO is leveraging multiple
partnerships aimed at developing and commercializing tivozanib in
oncology indications outside of North America, and at progressing
its pipeline of novel therapeutic candidates in cancer, cachexia
(wasting syndrome) and pulmonary arterial hypertension (PAH). 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,” “will,” “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 cash balances and the period in
which it anticipates cash will be available to fund its operations;
the potential for tivozanib to be approved by the EC as a treatment
for RCC; the potential benefits of tivozanib both as a stand-alone
agent and in combination with other therapies; AVEO’s expectations
regarding the receipt of payments under its agreement with EUSA and
the potential for such payments, if received, to favorably impact
its financial condition; AVEO’s beliefs about the potential for
transformative events to occur in the coming months; AVEO’s plans
to continue to maintain its streamlined operations, leverage
external resources and investments, and direct its resources toward
maximizing value; timing of the anticipated readout of the TIVO-3
trial; AVEO’s and its collaborators’ future discovery, development
and commercialization plans and efforts, including without
limitation with respect to tivozanib, ficlatuzumab and AVEO’s other
programs and platforms; and AVEO’s strategy, prospects, plans and
objectives. 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 agreements,
and its ability, and the ability of its licensees and other
partners, to achieve development and commercialization objectives
under these arrangements; AVEO’s ability, and the ability of its
licensees, to demonstrate to the satisfaction of applicable
regulatory agencies the safety, efficacy and clinically meaningful
benefit of AVEO’s product candidates, including without limitation
risks relating to the ability of EUSA to successfully obtain
approval of tivozanib from the EC. AVEO faces other risks relating
to its business as well, including risks relating to its ability to
successfully enroll and complete clinical trials, including the
TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain
compliance with all 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; developments, expenses and outcomes
related to AVEO’s ongoing shareholder litigation; 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 section titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
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. AVEO anticipates
that 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170627005877/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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