[November 04, 2016] |
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AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update
AVEO Oncology (NASDAQ:AVEO) today reported financial results for the
third quarter ended September 30, 2016.
"In the last 18 months, we have made important progress in moving
forward both elements of our strategy, including our oncology pipeline,
for which we have retained significant North American rights, and our
non-oncology pipeline, which is being advanced through partnerships with
disease-area experts," said Michael Bailey, president and chief
executive officer. "We anticipate a milestone rich calendar in the
months ahead, spanning both our proprietary and partnered programs, that
we expect will help define AVEO's long-term potential in multiple areas
of unmet medical need."
Mr. Bailey added: "For our lead oncology asset, tivozanib, we are well
underway in three simultaneous paths. We expect an approval decision in
first-line renal cell cancer (RCC) in Europe and initial results from
the Opdivo® combination TiNivo study in the first half of 2017, followed
by, in the first quarter of 2018, pivotal top-line data from our
U.S.-registration-directed Phase 3 TIVO-3 study in RCC. During 2017, we
also expect to see progress in our partnered pipeline, serving to
highlight the value-potential of these programs which are being
developed at little or no cost to AVEO."
Potential Corporate Milestones through the First Half of 2017
-
Regulatory decision for tivozanib in the European Union and associated
milestone payment by EUSA Pharma;
-
IND and proof-of-concept milestone payments for tivozanib in acute
macular degeneration by Ophthotech;
-
Partnership for AV-353, a first-in-class opportunity to address a
major unmet need in pulmonary arterial hypertension;
-
Initial safety results from the Phase 1 portion of the Phase 1/2
AVEO-sponsored TiNivo study of tivozanib in combination with
Bristol-Myers Squibb's Opdivo® (nivolumab);
-
Development progress and milestone payments for AV-380 in Cachexia by
Novartis;
-
Manufacturing tech transfer milestone payment for AV-203 by CANbridge.
Third Quarter and Recent Highlights
-
Initiation of Phase 1/2 TiNivo Trial Evaluating Tivozanib in
Combination with Bristol-Myers Squibb's Opdivo® (nivolumab) in
Advanced RCC. In August 2016, AVEO announced the initiation of a
Phase 1/2 clinical trial of AVEO's oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI),
tivozanib, in combination with Bristol-Myers Squibb's anti-PD-1
therapy, Opdivo® (nivolumab), in advanced RCC, named the TiNivo Trial.
The trial is being led by the Institut Gustave Roussy in Paris under
the direction of Professor Bernard Escudier, MD, Chairman of the
Genitourinary Oncology Committee. The Phase 1 trial is designed to
evaluate whether tivozanib's unique specificity and associated safety
profile can overcome the tolerability issues that have challenged
TKI-PD1 combinations to date. Initial safety results from the Phase 1
portion of the Phase 1/2 are expected to be available to the companies
in the first half of 2017.
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Ongoing Review of the Marketing Authorization Application (MAA) in
Europe for Approval of Tivozanib as a First-Line RCC Treatment Option. EUSA
Pharma, to which the Company licensed European and additional rights
outside North America, is working to submit responses to the European
Medicines Agency (EMA (News - Alert)) Day 120 List of Questions before year-end. The
MAA, which is based on tivozanib's existing dataset, including the
Phase 3 TIVO-1 study of tivozanib in first-line RCC, seeks approval
for tivozanib as a first-line treatment for advanced RCC under the
EMA's centralized review process. Following the response, EUSA Pharma
expects to receive the EMA Day 180 List of Outstanding Issues, the
last review stopping period prior to a recommendation from the
Committee for Medicinal Products for Human Use (CHMP) and the final
approval decision from EMA. If approved, tivozanib's distinct safety
profile has the potential to offer a new, well tolerated alternative
to currently approved VEGF TKIs, which, in clinical studies, have been
associated with challenging tolerability necessitating significant
dose reductions and interruptions.
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Continued Execution of the Pivotal Phase 3 TIVO-3 Study of
Tivozanib in RCC. In May 2016, AVEO announced the commencement of
enrollment and patient treatment for the Company's pivotal TIVO-3
trial, a randomized, controlled, multi-center, open-label study to
compare tivozanib to sorafenib in subjects with refractory advanced
RCC. The study continues to be on track to reach a top line readout in
the first quarter of 2018. The Phase 3 trial is expected to enroll
approximately 322 patients with recurrent or metastatic RCC who have
failed at least two prior regimens, including VEGF-TKI therapy (other
than sorafenib). Eligible patients may also have received checkpoint
inhibitor therapy in earlier lines of treatment. Patients will be
randomized 1:1 to receive either tivozanib or sorafenib, with no
crossover between arms.
The TIVO-3 trial, together with the
TIVO-1 trial, is designed to support a first- and third-line
indication for tivozanib in the U.S. TIVO-3 would also provide a
unique data set, in that it is expected to include the first
randomized Phase 3 results showing treatment with a VEGF TKI following
prior PD1 therapy, and is designed to support approval of the first
VEGF TKI specifically labeled for third-line treatment.
Third Quarter 2016 Financial Highlights
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AVEO ended Q3 2016 with $30.8 million in cash, cash equivalents and
marketable securities as compared with $34.1 million at December 31,
2015.
-
Total collaboration revenue in Q3 2016 was approximately $1.0 million
compared with $15.2 million Q3 2015.
-
Research and development expense was $4.4 million in Q3 2016 compared
with $4.5 million for Q3 2015.
-
General and administrative expense was $2.1 million in Q3 2016
compared with $2.2 million for Q3 2015.
-
Net loss for Q3 2016 was $5.0 million, or a loss of $0.07 per basic
and diluted share, compared with net income of $7.9 million, or income
of $0.14 per basic and diluted share for Q3 2015.
Financial Guidance
We believe that our $30.8 million in cash resources could allow us to
fund our planned operations into the fourth quarter of 2017.
Furthermore, we expect that these cash resources, together with certain
anticipated operational milestone payments from our collaboration
partners, could allow us to fund our U.S. tivozanib development strategy
through at least pivotal Phase 3 TIVO-3 top-line data as well as our
tivozanib-PD-1 inhibitor combination trial.
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 developing
and commercializing 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 to develop
and commercialize 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," "seek," 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: plans and strategies of AVEO and its
partners and the potential achievement by AVEO and its partners of
clinical, regulatory, manufacturing and other development goals and
milestones; AVEO's expectations regarding a registration decision in the
EU for tivozanib; the timing of enrollment and data readouts from the
TIVO-3 and TiNivo trials; the potential for the TIVO-3 trial to support
third line and first line indications in the U.S.; 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; the potential disease-modification capabilities and
partnership expectations for AV-353; and AVEO's cash and clinical trial
cost forecasts. 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, 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; 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 (News - Alert). 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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AVEO PHARMACEUTICALS, INC.
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Condensed Consolidated Statements of Operations
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(In thousands, except per share amounts)
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(Unaudited)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2016
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2015
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2016
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2015
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Collaboration and licensing revenue
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$
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992
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$
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15,158
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$
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2,388
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$
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15,426
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Operating expenses:
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|
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|
|
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Research and development
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4,444
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4,466
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16,020
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9,002
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General and administrative
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2,141
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2,225
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6,344
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|
|
|
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8,367
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Restructuring and lease exit
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|
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-
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|
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-
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|
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-
|
|
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4,358
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|
|
|
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6,585
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|
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6,691
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22,364
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21,727
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(Loss) income from operations
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(5,593
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)
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8,467
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(19,976
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)
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(6,301
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)
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Other income (expense), net:
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|
|
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Interest expense, net
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(551
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)
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(531
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)
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(1,388
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)
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(1,866
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)
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Change in fair value of warrant liability
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1,178
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|
|
|
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-
|
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182
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|
|
|
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-
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Other expense
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|
|
|
-
|
|
|
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(22
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)
|
|
|
|
-
|
|
|
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(245
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)
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Other income (expense), net
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627
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(553
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)
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(1,206
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)
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(2,111
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)
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Loss before provision for income taxes
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|
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(4,966
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)
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7,914
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(21,182
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)
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(8,412
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)
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Provision for income taxes
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-
|
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-
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(100
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)
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-
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Net (loss) income
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$
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(4,966
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)
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|
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$
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7,914
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$
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(21,282
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)
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|
|
$
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(8,412
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)
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Net (loss) income per share - basic
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|
|
$
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(0.07
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)
|
|
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$
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0.14
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|
|
|
$
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(0.32
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)
|
|
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$
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(0.15
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)
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Weighted average number of common shares outstanding
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75,861
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56,794
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67,046
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|
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54,880
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Net (loss) income per share - dilutive
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|
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$
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(0.07
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)
|
|
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$
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0.14
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$
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(0.32
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)
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$
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(0.15)
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Weighted average number of common shares outstanding
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75,861
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|
|
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57,016
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67,046
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|
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54,880
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Consolidated Balance Sheet Data
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(In thousands)
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(Unaudited)
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September 30,
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December 31,
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2016
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2015
|
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Assets
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Cash, cash equivalents and marketable securities
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$
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30,831
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$
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34,135
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Accounts receivable
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990
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4,641
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Prepaid expenses and other current assets
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2,203
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|
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1,600
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Property and equipment, net
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23
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|
|
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23
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Other assets
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|
|
|
1,071
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|
|
|
143
|
|
|
|
|
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Total assets
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|
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$
|
35,118
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$
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40,542
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|
|
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Liabilities and stockholders' equity
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|
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|
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Accounts payable and accrued expenses
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$
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5,528
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$
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5,531
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Total loans payable, net of discount
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13,869
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|
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9,471
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Total deferred revenue
|
|
|
|
2,334
|
|
|
|
3,695
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Warrant liability
|
|
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9,162
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|
|
|
-
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Other liabilities
|
|
|
|
690
|
|
|
|
4,618
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Stockholder's equity
|
|
|
|
3,535
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|
|
|
17,227
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|
|
|
|
|
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Total liabilities and stockholders' equity
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|
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$
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35,118
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$
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40,542
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View source version on businesswire.com: http://www.businesswire.com/news/home/20161104005133/en/
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