AVEO Announces Milestone Payment from CANbridge for AV-203
April 03 2017 - 7:00AM
Business Wire
Company Provides Updated Financial
Guidance
AVEO Oncology (NASDAQ:AVEO) today announced receipt of a
$500,000 milestone payment from CANbridge Life Sciences Ltd., a
biopharmaceutical company focused on developing western drug
candidates in China and North Asia, related to a technology
transfer milestone for AV-203, AVEO’s clinical-stage ErbB3 (HER3)
inhibitory antibody candidate. AV-203 has demonstrated preclinical
activity in a number of different tumor models including breast,
head and neck, lung, ovarian and pancreatic cancers. CANbridge is
planning clinical development of AV-203 in squamous cell esophageal
cancer as its initial indication.
“Receipt of this milestone payment from CANbridge reflects
continued progress by our partner to engineer the manufacturing
process for AV-203 in an effort to develop an antibody
manufacturing process suitable for commercialization,” said Michael
Bailey, president and chief executive officer of AVEO. “We look
forward to continued progress in this program, and with the balance
of our partnered pipeline, including AV-380, a potentially disease
modifying treatment for cachexia which is partnered with Novartis,
and ficlatuzumab in development for squamous cell carcinoma of the
head and neck and acute myeloid leukemia, which is partnered with
Biodesix. With these programs advancing, we continue to focus on
tivozanib, including continuing our execution of the TIVO-3 and
TiNivo studies for our U.S. pivotal clinical strategy, and support
of our licensee, EUSA Pharma, in its response to European
regulators.”
In March 2016, AVEO announced an exclusive collaboration and
license agreement, granting CANbridge worldwide rights to AV-203,
excluding the United States, Canada, and Mexico. Under the terms of
the collaboration and license agreement, CANbridge paid AVEO an
upfront payment of $1 million, and AVEO is also eligible to receive
up to $133 million in reimbursement and milestone payments,
assuming the successful achievement of specified development,
regulatory and commercialization objectives. The transaction was
awarded the 2016 Deal of the Year by RNDer, a leading Chinese
publication providing value-added analysis for pharmaceutical and
biotechnology companies conducting business in China. AVEO has
retained North American rights to AV-203 and is also eligible for a
tiered royalty, with a percentage range in the low double digits,
on net sales of AV-203 in the partnered territories.
AVEO also announced today an update to its financial guidance.
The Company believes its recently completed underwritten public
offering, which yielded net proceeds of $15.5 million (on gross
proceeds of $17.3 million), together with its existing cash
resources, would be sufficient to fund its operations into the
second quarter of 2018. This guidance excludes any potential
partnership milestone payments to or from the Company, potential
debt or equity financings, acceleration of existing debt principal
payments under the term loan with Hercules which could result from
non-compliance with the cash covenant of that agreement, or
proceeds from any potential future partnership agreements.
As previously guided, top line data from the TIVO-3 trial,
AVEO’s ongoing Phase 3 clinical trial of tivozanib in the
third-line treatment of patients with refractory renal cell
carcinoma (RCC), is anticipated in the first quarter of 2018.
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 and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in non-oncologic indications worldwide
and oncology indications outside of North America, as well as to
progress its pipeline of novel therapeutic candidates in cancer and
cachexia (wasting syndrome). 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: the expected timelines for receiving top-line data readouts
in TIVO-3; AVEO’s guidance regarding the period in which it expects
to have cash to fund its operations and its expectations regarding
the assumptions and factors that may affect such timeframe; plans
and strategies of AVEO and its partners and the potential for
continued progress and achievement by AVEO and its partners of
clinical, regulatory, commercial, manufacturing and other
development goals and milestones for AV-203 and AVEO’s other
product candidates; the potential safety, efficacy, tolerability
and other benefits of tivozanib in the treatment of renal cell
carcinoma as a third line therapy, first line therapy, single agent
or in combination with other therapies. AVEO has based its
estimates, including its forecast for the period in which its cash
will be available to fund operations, on assumptions that may prove
to be incorrect. As a result, readers are cautioned not to place
undue reliance on these 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; AVEO’s 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 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/20170403005476/en/
For AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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