AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the full year ended December 31, 2016 and provided a business
update.
“TIVO-3, our lead clinical program designed to serve as the
basis for a potential U.S. registration for tivozanib as a first-
and third-line treatment for renal cell cancer, continues to enroll
ahead of schedule and has now completed its first safety review,”
said Michael Bailey, president and chief executive officer of AVEO.
“We look forward to the study’s pre-planned interim futility
analysis midyear 2017 and, potentially, to top line results in the
first quarter of 2018 and to initial data from our Phase 1 TiNivo
study of tivozanib in combination with Opdivo® in the first half of
2017. We also continue to support our partner EUSA Pharma in its
efforts to complete the European Marketing Authorization
Application review for tivozanib as a first-line treatment for
renal cell carcinoma. There remains a significant unmet need for
better tolerated therapies in this disease, particularly those that
enable combination treatment, and we look forward to receiving
tivozanib data and to potential regulatory milestones in the coming
quarters.”
Mr. Bailey continued: “We also look forward to several
milestones with the balance of our pipeline, including the
presentation of data from two investigator sponsored studies of
ficlatuzumab, a potential partnership for AV-353, and progress
toward the clinic for AV-380 and AV-203.”
Recent Updates
- 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
renal cell carcinoma (RCC), has 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.
- First Patient Dosed in Phase 1/2
TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers
Squibb’s Opdivo® (nivolumab) in Advanced RCC.
AVEO announced today that the first patient has been treated in the
Company’s Phase 1/2 TiNivo trial evaluating tivozanib in
combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo®
(nivolumab), 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, 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 at the
established combination dose.
- Ongoing Review of the Marketing
Authorization Application (MAA) in Europe for Approval of Tivozanib
as a First-Line RCC Treatment Option. In February 2017, AVEO
announced that its European licensee for tivozanib, EUSA Pharma, a
specialty pharmaceutical company with a focus on oncology and
oncology supportive care, has received the Day 180 List of
Outstanding Issues (LOI) from the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA). The
Day 180 LOI signifies that the MAA is not approvable at the present
time and outlines outstanding deficiencies, which are then required
to be satisfactorily addressed in an oral explanation and/or in
writing prior to a final application decision. EUSA has informed
AVEO that it expects to submit written responses to the Day 180 LOI
in April 2017, and the EMA has tentatively scheduled EUSA to
provide an oral explanation to the CHMP in May 2017.
- Submitted for Presentation Results
from Phase 1 Studies of Ficlatuzumab in Combination with Cetuximab
in Head and Neck Squamous Cell Cancer (HNSCC) and Cytarabine in
Acute Myeloid Leukemia (AML). The Company announced today that
results from two investigator sponsored Phase 1 studies of
ficlatuzumab were submitted for presentation at an upcoming major
medical meeting. The first study is designed to explore cetuximab
in combination with ascending doses of ficlatuzumab in patients
with cetuximab-refractory HNSCC patients. The second study is
designed to explore cytarabine in combination with ascending doses
of ficlatuzumab in relapsed/refractory AML. AVEO and Biodesix, Inc.
have a worldwide agreement to develop and commercialize
ficlatuzumab.
Full Year 2016 Financial Highlights
- AVEO ended 2016 with $23.3 million
in cash, cash equivalents and marketable securities as compared
with $34.1 million at December 31, 2015.
- Total collaboration revenue for 2016
was approximately $2.5 million compared with
$19.0 million for 2015.
- Research and development expense for
2016 was $23.7 million compared with $12.9 million for
2015.
- General and administrative expenses for
2016 were $8.2 million compared with $14.2 million for
2015.
- Net loss for 2016 was
$26.9 million, or a loss of $0.39 per basic and diluted share,
compared with net loss of $15.0 million for 2015, or a loss of
$0.27 per basic and diluted share.
Financial Guidance
We believe that our $23.3 million in existing cash, cash
equivalents and marketable securities as of December 31, 2016 could
allow us to fund our planned operations into the fourth quarter of
2017; however, additional funds will be needed to extend these
operations into 2018 and maintain compliance with our
$10.0 million financial covenant under our loan agreement with
Hercules.
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 RCC 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 completing enrollment,
undergoing a futility analysis and receiving top-line data readouts
in TIVO-3 and TiNivo; the potential for the design of the TIVO-3
and TIVO-1 trials to support regulatory approval for first- and
third-line indications in RCC in the U.S.; plans and strategies of
AVEO and its partners, including EUSA, and the potential
achievement by AVEO and its partners of clinical, regulatory,
commercial, manufacturing and other development goals and
milestones; the potential safety, efficacy, tolerability and other
benefits of tivozanib in the treatment of renal cell carcinoma as a
single agent or in combination with other therapies; and the period
in which AVEO expects that its existing cash, cash equivalents and
marketable securities will fund its operations. 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 trials; AVEO’s ability to maintain
compliance with the $10.0 million financial covenant under its
loan agreement with Hercules; 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 fund
its operating expenses beyond the beginning of the fourth quarter
of 2017 and to continue as a going concern; unplanned capital
requirements; adverse general economic and industry conditions;
competitive factors; and those risks discussed in the section
titled “Risk Factors” in AVEO’s most recent Annual Report on Form
10-K, its quarterly reports on Form 10-Q and its other filings with
the SEC. 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 EndedDecember 31, For
the Years EndedDecember 31, 2016
2015 2016
2015 Collaboration and licensing revenue $ 127 $
3,598 $ 2,515 $ 19,024 Operating expenses: Research and development
7,683 3,873 23,703 12,875 General and administrative 1,870 5,848
8,205 14,217 Restructuring and lease exit — —
— 4,358 9,553
9,721 31,908 31,450 Loss
from operations (9,426 ) (6,123 ) (29,393 ) (12,426 ) Other income
(expense), net: Change in fair value of warrant liability 4,569 —
4,751 — Other expense, net (748 ) (462 )
(2,144 ) (2,575 ) Other income (expense), net 3,821
(462 ) 2,607 (2,575 ) Loss
before provision for income taxes (5,605 ) (6,585 ) (26,786 )
(15,001 ) Provision for income taxes — —
(101 ) — Net loss $ (5,605 ) $ (6,585 )
$ (26,887 ) $ (15,001 ) Basic and diluted net loss per share $
(0.07 ) $ (0.11 ) $ (0.39 ) $ (0.27 ) Weighted average number of
common shares outstanding 75,863 58,136 69,268 55,701
Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
December 31, December 31, 2016
2015 Assets Cash, cash equivalents and marketable
securities $ 23,348 $ 34,135 Accounts receivable 1,027 4,641
Prepaid expenses and other current assets 1,940 1,600 Property and
equipment, net — 23 Other assets 970 143 Total
assets $ 27,285 $ 40,542
Liabilities and
stockholders’ (deficit) equity Accounts payable and accrued
expenses $ 7,715 $ 5,531 Total loans payable 14,003 9,471 Total
deferred revenue 2,207 3,695 Warrant liability 4,593 — Other
liabilities 690 4,618 Stockholder’s (deficit) equity (1,923
) 17,227 Total liabilities and stockholders’ (deficit)
equity $ 27,285 $ 40,542
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version on businesswire.com: http://www.businesswire.com/news/home/20170322006146/en/
AVEO:Argot PartnersDavid Pitts, 212-600-1902aveo@argotpartners.com
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