[August 04, 2016] |
|
AVEO Oncology Reports Second Quarter 2016 Financial Results and Provides Business Update
AVEO Oncology (NASDAQ:AVEO) today reported financial results for the
second quarter ended June 30, 2016.
"The second quarter of 2016 marked a defining moment for AVEO, with the
initiation of TIVO-3, our Phase 3 pivotal study of tivozanib in
refractory advanced renal cell cancer, and the closing of debt and
equity financings to support our North American first- and third-line
registration strategy for tivozanib as well as our planned PD-1
combination study," said Michael Bailey, president and chief executive
officer. "We are very pleased with investigator support for TIVO-3 to
date, and remain on track to complete enrollment in 2017 and see
top-line data in the first quarter of 2018. We expect to achieve several
milestones over the next 12 months, including the initiation of a
tivozanib PD-1 combination study, a decision on approval for tivozanib
in front-line RCC in Europe, meaningful progress in our partnered
pipeline programs as well as a potential partnership for AV-353. Along
with anticipated milestone payments from our partnered pipeline
programs, we believe that our resources will allow us to fully fund our
U.S. tivozanib development strategy through at least pivotal top-line
data for TIVO-3 in the first quarter of 2018."
Recent Highlights
-
Dosing of First Patient in Pivotal Phase 3 TIVO-3 Study of
Tivozanib in Renal Cell Carcinoma. In May 2016, AVEO announced
that the first patient was dosed in 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
renal cell carcinoma (RCC). Tivozanib is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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 VEGFR-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
primary endpoint of the study is progression free survival. Secondary
endpoints include overall survival, overall response rate, and safety
and tolerability. Top line readout of the study is currently projected
for 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 a first and third line
indication for tivozanib in the U.S. A marketing authorization
application seeking approval of tivozanib as a treatment for first
line renal cell cancer is currently pending in Europe based on an
application submitted by AVEO's partner EUSA Pharma.
-
Closing of Private Placement and Amended Term Loan. In May
2016, AVEO announced the closing of a private placement of 17,642,482
units, each consisting of one share of common stock and a warrant to
purchase one share of common stock, at a price of $0.965 per unit, for
gross proceeds of approximately $17 million. The transaction was led
by New Enterprise Associates and included New Leaf Venture
Partners and Perceptive Advisors, among other institutional investors.
Certain members of the Company's management team and Board of
Directors also participated in the financing. Piper Jaffray &
Co. served as the exclusive placement agent for the financing.
The
Company also announced that it entered into an amendment to its 2010
loan and security agreement with Hercules Capital, Inc. Pursuant to
the loan amendment, the Company borrowed an additional $5.0
million from Hercules. If specified conditions are met, AVEO may
borrow an additional tranche of $5.0 million from Hercules in the
first half of 2017, and repayment of principal on AVEO's loans may be
deferred to begin in 2018.
-
Filing of Provisional Patent Applications for AV-353, a Notch
3-Specific Inhibitor Antibody for PAH. In May 2016, AVEO
announced that it had filed provisional patent applications with the
United States Patent and Trademark Office covering composition of
matter claims for AV-353, the Company's potent inhibitory antibody
specific to Notch 3 for development in Pulmonary Arterial Hypertension
(PAH). These patent applications are the second set of applications
related to AV-353 and the Company's Notch 3 antibody program. Current
treatments in PAH focus only on controlling symptoms by avoiding
vasoconstriction and increasing vasodilation of vessels and do not
reverse the underlying cause of the disease. In contrast, with the
results of a recently concluded research study supported by AVEO,
AV-353 has generated a growing body of preclinical data that supports
AV-353's ability to potentially reverse the disease phenotype, which
would represent a potential disease-modifying approach to treatment.
Consistent with the Company's focus on developing oncology
therapeutics, AVEO is currently seeking an appropriate partner to
develop and commercialize AV-353 worldwide in PAH.
Second Quarter 2016 Financial Highlights
-
AVEO ended Q2 2016 with $39.5 million in cash, cash equivalents and
marketable securities as compared with $34.1 million at December 31,
2015. The increase was attributable to the net proceeds of our private
placement of securities and additional borrowings under our existing
loan and security agreement in the second quarter of 2016, net of the
use of cash to fund operations during 2016.
-
Total collaboration revenue in Q2 2016 was approximately $0.2 million
compared with $0.1 million Q2 2015. The increase was primarily due to
$0.1 million in revenue recognized in the second quarter of 2016 in
connection with the out-licensing agreement with EUSA, which was
executed in December 2015.
-
Research and development expense was $5.6 million in Q2 2016 compared
with $1.8 million for Q2 2015. The increase was primarily attributable
to an increase in tivozanib clinical trial costs in connection with
the preparation for, and conduct of, the TIVO-3 phase 3 trial in renal
cell carcinoma that commenced enrollment and patient treatment in May
2016.
-
General and administrative expense was $1.7 million in Q2 2016
compared with $2.9 million for Q2 2015. The decrease was primarily the
result of continued reduction of facilities and other operating
expenses after completing our restructuring in the first quarter of
2015.
-
Net loss for Q2 2016 was $8.6 million, or a loss of $0.13 per basic
and diluted share, compared with net loss of $5.5 million, or a loss
of $0.10 per basic and diluted share for Q2 2015.
Financial Guidance
We believe that our $39.5 million in cash resources could allow us to
fund our planned operations at least into the fourth quarter of 2017.
AVEO expects that its cash resources, its borrowing capacity under its
amended loan agreement, together with certain anticipated operational
milestone payments from its collaboration partners, could allow the
Company to fund its U.S. tivozanib development strategy through at least
pivotal Phase 3 TIVO-3 top-line data as well as a 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," "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: AVEO's plans with respect to the design and
execution of its TIVO-3 clinical trial and the timing of enrollment and
data readouts from the trial; the potential for the TIVO-3 trial to
support third line and first line indications in the U.S.; expectations
regarding the initiation of a tivozanib-PD-1 combination study; the
potential disease-modification capabilities and partnership expectations
for AV-353; AVEO's expectations regarding a registration decision in the
EU for tivozanib for first line renal cell cancer; the potential
benefits of tivozanib in the treatment of renal cell carcinoma as a
single agent or in combination with other therapies; AVEO's plans and
strategies and the potential achievement by AVEO and its partners of
milestones; 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 study; 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.
|
AVEO PHARMACEUTICALS, INC.
|
Condensed Consolidated Statements of Operations
|
(In thousands, except per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Collaboration and licensing revenue
|
|
$
|
193
|
|
|
$
|
134
|
|
|
$
|
1,396
|
|
|
$
|
268
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
5,604
|
|
|
|
1,841
|
|
|
|
11,576
|
|
|
|
4,536
|
|
General and administrative
|
|
|
1,731
|
|
|
|
2,889
|
|
|
|
4,203
|
|
|
|
6,144
|
|
Restructuring and lease exit
|
|
|
-
|
|
|
|
25
|
|
|
|
-
|
|
|
|
4,358
|
|
|
|
|
7,335
|
|
|
|
4,755
|
|
|
|
15,779
|
|
|
|
15,038
|
|
Loss from operations
|
|
|
(7,142
|
)
|
|
|
(4,621
|
)
|
|
|
(14,383
|
)
|
|
|
(14,770
|
)
|
Other expense, net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(468
|
)
|
|
|
(626
|
)
|
|
|
(837
|
)
|
|
|
(1,337
|
)
|
Change in fair value of warrant liability
|
|
|
(996
|
)
|
|
|
-
|
|
|
|
(996
|
)
|
|
|
-
|
|
Other expense
|
|
|
-
|
|
|
|
(209
|
)
|
|
|
-
|
|
|
|
(223
|
)
|
Other expense, net
|
|
|
(1,464
|
)
|
|
|
(835
|
)
|
|
|
(1,833
|
)
|
|
|
(1,560
|
)
|
Loss before provision for income taxes
|
|
|
(8,606
|
)
|
|
|
(5,456
|
)
|
|
|
(16,216
|
)
|
|
|
(16,330
|
)
|
Provision for income taxes
|
|
-
|
|
|
-
|
|
|
|
(100
|
)
|
|
-
|
|
Net loss
|
|
$
|
(8,606
|
)
|
|
$
|
(5,456
|
)
|
|
$
|
(16,316
|
)
|
|
$
|
(16,330
|
)
|
Net loss per share - basic and diluted
|
|
$
|
(0.13
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.30
|
)
|
Weighted average number of common shares outstanding
|
|
|
66,917
|
|
|
|
55,164
|
|
|
|
62,566
|
|
|
|
53,908
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet Data
|
(In thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
39,531
|
|
$
|
34,135
|
Accounts receivable
|
|
|
1,302
|
|
|
4,641
|
Prepaid expenses and other current assets
|
|
|
1,421
|
|
|
1,600
|
Property and equipment, net
|
|
|
22
|
|
|
23
|
Other assets
|
|
|
410
|
|
|
143
|
|
|
|
|
|
Total assets
|
|
$
|
42,686
|
|
$
|
40,542
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
6,304
|
|
$
|
5,531
|
Total loans payable
|
|
|
13,735
|
|
|
9,471
|
Total deferred revenue
|
|
|
3,326
|
|
|
3,695
|
Warrant liability
|
|
|
10,340
|
|
|
-
|
Other liabilities
|
|
|
690
|
|
|
4,618
|
Stockholder's equity
|
|
|
8,291
|
|
|
17,227
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
42,686
|
|
$
|
40,542
|
|
|
|
|
|
|
|
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