AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the first quarter ended March 31, 2017, and provided a business
update.
“We strengthened our balance sheet in the first quarter through
an underwritten public offering, giving us the resources to
potentially fund operations through the readout of our pivotal,
Phase 3 TIVO-3 study of tivozanib in renal cell cancer (RCC),
expected in the first quarter of 2018,” said Michael Bailey,
president and chief executive officer of AVEO. “TIVO-3, which is
designed to serve as the basis for a potential U.S. registration of
tivozanib as a first- and third-line treatment for RCC, remains on
track to complete enrollment and a pre-planned interim futility
analysis in June of this year. We also look forward to several
other potential key milestones this year, including completion of
the Phase 1 portion of the Phase 1/2 TiNivo trial a
tivozanib-nivolumab combination study in RCC, a regulatory decision
in Europe for marketing approval of tivozanib as a first line
treatment for RCC, and notable progress in our pipeline
programs.”
Mr. Bailey continued: “Among our pipeline programs, we look
forward to two planned ficlatuzumab data presentations from
investigator sponsored studies at ASCO, one in head and neck cancer
and the other in acute myeloid leukemia. Ficlatuzumab, which
targets Hepatocyte Growth Factor (HGF) with high affinity and
specificity to inhibit HGF/c-Met biological activities, continues
to attract investigator interest.”
Recent Updates
- Completion of the First Dose Cohort
of the Phase 1/2 TiNivo Study of Tivozanib in Combination with
Nivolumab in RCC. AVEO today announced completion of the first
dose cohort, and initiation of enrollment in the second and final
dose cohort, of the Phase 1 portion of the Company’s Phase 1/2
TiNivo trial evaluating tivozanib in combination with Opdivo®
(nivolumab), Bristol-Myers Squibb’s anti-PD-1 therapy, in advanced
RCC. The study, which is led by the Institut Gustave Roussy in
Paris, is under the direction of Professor Bernard Escudier, MD,
Chairman of the Genitourinary Oncology Committee. The Phase 1
portion of the study, which the Company expects to complete in the
first half of 2017, will primarily evaluate the safety of tivozanib
in combination with nivolumab at escalating doses of tivozanib. If
the Company receives favorable results, it expects to follow
immediately with an expansion Phase 2 trial at the established
combination dose.
- Presentation of Posters at Upcoming
2017 American Society of Clinical Oncology (ASCO) Annual
Meeting. In April 2017, AVEO announced that poster
presentations for three clinical studies will be presented at the
upcoming 2017 ASCO Annual Meeting, to be held June 2-6, 2017. Among
these are two presentations that highlight ficlatuzumab results
from Phase 1 investigator-sponsored studies, one in head and neck
squamous cell carcinoma and the other in acute myeloid leukemia. In
addition, a Trials in Progress presentation will highlight the
ongoing Phase 3, randomized, controlled, multi-center, open-label
TIVO-3 study comparing tivozanib, the Company’s potent, selective,
long half-life inhibitor of all three vascular endothelial growth
factor (VEGF) receptors, to sorafenib in subjects with refractory
advanced renal cell carcinoma.
- Submission of Response to Tivozanib
Marketing Authorization Application (MAA) Day 180 List of
Outstanding Issues (LOI). In April 2017, AVEO announced that
its European licensee for tivozanib, EUSA Pharma, submitted
responses to the European Medicines Agency (EMA) Day 180 LOI
related to the MAA for tivozanib as a first-line treatment for RCC.
With submission of the response complete, EUSA remains tentatively
scheduled to provide an oral explanation to the EMA’s Committee for
Medicinal Products for Human Use at its May 2017 meeting.
- Receipt of Milestone Payment from
CANbridge for AV-203. In April 2017, AVEO 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. CANbridge is planning clinical
development of AV-203 in squamous cell esophageal cancer as its
initial indication.
- Closing of Public Offering and Full
Exercise of Option to Purchase Additional Shares. In March
2017, AVEO announced the closing of an underwritten public offering
of 34,500,000 shares of common stock, including the exercise in
full by the underwriter of its option to purchase 4,500,000 shares
at the public offering price of $0.50 per share. The net proceeds
of the offering were approximately $15.5 million, and are expected
to be used for working capital and general corporate purposes
- TIVO-3 Enrolling Ahead of Schedule
and Passes First Safety Monitoring Committee Safety Review;
Pre-Planned Interim Futility Analysis Expected Midyear 2017. In
February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3
trial, a randomized, controlled, multi-center, open-label study to
compare tivozanib to sorafenib in subjects with refractory advanced
RCC, successfully completed the first safety review by the study’s
Safety Monitoring Committee (SMC). The SMC concluded that no safety
concern was observed for tivozanib and recommended that the study
replace the small number of patients who dropped out prior to
starting treatment. The Company announced just prior to the safety
review that the TIVO-3 trial is enrolling substantially ahead of
schedule. With the SMC recommendation to replace early dropouts,
the Company still expects to complete enrollment in June 2017,
ahead of its prior guidance of August 2017. A pre-planned futility
analysis of the trial is expected around midyear 2017, with topline
data expected in the first quarter of 2018. The TIVO-3 trial,
together with the previously completed TIVO-1 trial of tivozanib in
the first-line treatment of RCC, is designed to support potential
regulatory approval of tivozanib in the U.S. as a third- and first-
line treatment for RCC.
Personnel Updates
AVEO also announced today that Keith S. Ehrlich, the Company’s
Chief Financial Officer, will be retiring from the Company,
effective July 1, 2017. The Company has initiated a search for a
new chief financial officer. Michael Bailey, the Company’s
President and CEO, will assume certain of Mr. Ehrlich’s duties on
an interim basis, to the extent a new chief financial officer has
not been named by the time of Mr. Ehrlich’s retirement.
Mr. Bailey added: “We greatly appreciate Keith’s contributions
to AVEO and wish him well in his future endeavors. His leadership
and guidance through a period of turnaround for the Company have
been greatly valued. We look forward to a completing the search for
a new chief financial officer as expeditiously as possible.”
First Quarter 2017 Financial Highlights
- AVEO ended Q1 2017 with $33.4 million
in cash, cash equivalents and marketable securities as compared
with $23.3 million at December 31, 2016.
- Total collaboration revenue for Q1 2017
was approximately $2.5 million compared with $1.2 million for Q1
2016.
- Research and development expense for Q1
2017 was $8.0 million compared with $6.0 million for Q1 2016.
- General and administrative expenses for
Q1 2017 was $2.3 million compared with $2.5 for Q1 2016.
- Net loss for Q1 2017 was $8.8 million,
or a loss of $0.12 per basic and diluted share compared with net
loss of $7.7 million or a loss of $0.13 per basic and diluted share
for Q1 2016.
Updated Financial Guidance
We believe that our $33.4 million in cash resources would allow
us to fund our planned operations into the second 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 oncology indications outside of North
America, and at progressing 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, statements about 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; the timing of the
completion of enrollment and the data readout for the TIVO-3 trial;
the timing of the completion of the Phase 1 portion of the TiNivo
trial; and the Company’s cash runway. 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;
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, 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.
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of
Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months Ended
March 31,
2017 2016 Collaboration and licensing revenue $ 2,532
$ 1,203 Operating expenses: Research and development 7,956 5,972
General and administrative 2,331 2,463 10,287
8,435 Loss from operations (7,755 ) (7,232) Other
expense, net: Change in fair value of warrant liability (484) —
Other expense, net (551) (378 ) Other expense, net
(1,035) (378 ) Loss before provision for income taxes
(8,790 ) (7,610) Provision for income taxes (50) (100) Net loss $
(8,840 ) $ (7,710)
Basic and diluted net loss per share
$ (0.12 ) $ (0.13) Weighted average number of common shares
outstanding 76,246 58,166
Consolidated Balance Sheet Data (In thousands)
(Unaudited) March 31, December 31,
2017 2016 Assets Cash, cash equivalents
and marketable securities $ 33,411 $ 23,348 Accounts receivable 676
1,027 Prepaid expenses and other current assets 1,812 1,940 Other
assets 685 970 Total assets $ 36,584 $
27,285
Liabilities and stockholders’ equity
(deficit) Accounts payable and accrued expenses $ 9,689 $ 7,715
Loans payable 14,138 14,003 Deferred revenue 2,079 2,207 Warrant
liability 5,077 4,593 Other liabilities 690 690 Stockholder's
equity (deficit) 4,911 (1,923 ) Total
liabilities and stockholders’ equity (deficit) $ 36,584 $ 27,285
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version on businesswire.com: http://www.businesswire.com/news/home/20170504005457/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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