AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the third quarter ended September 30, 2017 and provided a business
update.
“The third quarter was a transformative period for AVEO, with
the achievement of significant milestones in each of the three
pillars of our global strategy for tivozanib. Notably, with the
European approval of tivozanib (FOTIVDA®) in advanced RCC, we have
transitioned from a development stage company to one with a
commercially approved product, a watershed achievement for any
emerging life sciences company,” said Michael Bailey, president and
chief executive officer of AVEO. “In addition, TIVO-3, our U.S.
registration study, successfully passed the interim futility
analysis with no changes to study protocol. Finally, we presented
promising Phase 1 immunotherapy combination data from the Phase 1/2
TiNivo study of tivozanib and nivolumab (OPDIVO®), and announced
that EUSA Pharma, our European licensee for tivozanib, has opted
into our combination development strategy.”
Mr. Bailey continued, “In addition, we expect the imminent
launch of tivozanib (FOTIVDA®) in Europe, the anticipated readout
of TIVO-3 in the first quarter of 2018 and Phase 2 data from TiNivo
in the first half of 2018. Supporting these efforts, we have a
balance sheet bolstered by recent milestone payments that could be
extended by additional potential payments from EUSA related to
reimbursement approval in EU5 countries, as well as double-digit
royalty payments on net sales for tivozanib in Europe.”
Recent Updates
- Tivozanib (FOTIVDA®)
Approved in the European Union for the Treatment of Advanced Renal
Cell Carcinoma (RCC). In August 2017, AVEO announced that the
European Commission (EC) approved tivozanib (FOTIVDA®) for the
treatment of adult patients with RCC in the European
Union plus Norway and Iceland. Tivozanib is
indicated for the first line treatment of adult patients with
advanced RCC and for adult patients who are vascular endothelial
growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve
following disease progression after one prior treatment with
cytokine therapy for advanced RCC.
- Successfully Passed the TIVO-3
Futility Analysis with No Changes to Study Protocol. In October
2017, AVEO announced the completion of a pre-planned interim
futility analysis of the Phase 3 TIVO-3 trial, the Company’s
randomized, controlled, multi-center, open-label study to compare
tivozanib (FOTIVDA®) to sorafenib (NEXAVAR®) in subjects with
advanced RCC. Based on the results of the futility analysis, which
were reviewed by an independent statistician, the study continued
as planned without modification. The analysis did not allow for
early stopping due to efficacy to assure adequate follow-up for the
key secondary endpoint of overall survival. The Company continues
to expect the TIVO-3 trial to read out 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 a potential regulatory
approval of tivozanib in the U.S. as a first and third line
treatment for RCC.
- Phase 1 Results from the TiNivo
Trial of Tivozanib and Nivolumab (OPDIVO®) in RCC -
Oral Presentation at the 16th International Kidney
Cancer Symposium. On November 3, 2017 AVEO presented results
from the Phase 1 portion of the Phase 1/2 TiNivo study at the 16th
International Kidney Cancer Symposium. The oral presentation,
titled “TiNivo: A Phase 1b Dose Escalation Trial of Tivozanib and
Nivolumab in Renal Cell Carcinoma,” was given by Laurence Albiges,
M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy,
and a lead investigator of the study. The TiNivo trial is a Phase
1/2 multicenter trial of tivozanib (FOTIVDA®) in combination with
Bristol-Myers Squibb’s nivolumab (OPDIVO®), an immune checkpoint,
or PD-1, inhibitor, for the treatment of advanced renal cell
carcinoma. The ongoing Phase 1 portion of the trial enrolled six
patients, and demonstrated that the combination of tivozanib and
nivolumab was well tolerated to the full dose and schedule of
single agent tivozanib, with no dose limiting toxicities. The
results also demonstrated promising early signs of potential
efficacy, with 67% of patients demonstrating a partial response
(PR), and a 100% disease control rate (PR + stable disease). Five
out of six patients remain on study therapy. Enrollment of
approximately 20 patients in the Phase 2 portion is ongoing. The
trial is being led by the Institut Gustave
Roussy in Paris under the direction of Bernard
Escudier, MD, Chairman of the Genitourinary Oncology
Committee.
- TiNivo Combination Study Opt-in.
In September 2017, AVEO announced that EUSA Pharma, under its
multi-territory licensing agreement with AVEO for
tivozanib (FOTIVDA®), opted in to co-develop the Phase 1/2 TiNivo
study and potential future combination studies in exchange for a
research and development reimbursement payment totaling $2.0
million. Under terms of the agreement, EUSA will fund up to half of
the Phase 1/2 TiNivo study, not to exceed $2.0 million, and may
utilize data from study for regulatory or commercial purposes.
- Receipt of Payments from EUSA Pharma
and CANbridge. In September 2017, AVEO announced the receipt of
a $4.0 million research and development reimbursement
payment from EUSA Pharma related to the approval of tivozanib
(FOTIVDA®) for the treatment of adult patients with advanced RCC
in Europe, and a $0.5 million milestone payment from
CANbridge related to manufacturing development activities for
AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody
candidate.
Third Quarter 2017 Financial Highlights
- AVEO ended Q3 2017 with $37.4 million
in cash, cash equivalents and marketable securities as compared
with $23.3 million at December 31, 2016.
- Total collaboration revenue was
approximately $4.6 million in Q3 2017 compared with $1.0 million
for Q3 2016.
- Research and development expense was
$4.7 million in Q3 2017 compared with $4.4 million for Q3
2016.
- General and administrative expense was
$2.1 million in Q3 2017 compared with $2.1 million for Q3
2016.
- Net loss for Q3 2017 was $26.4 million,
or a loss of $0.22 per basic and diluted share, compared with a net
loss of $5.0 million, or a loss of $0.07 per basic and diluted
share for Q3 2016. Approximately $23.5 million of the net
loss was a non-cash loss attributable to the increase in the fair
value of the warrant liability that was recorded in Q3 2017 that
principally resulted from the increase in the stock price that
occurred within the quarter. In Q3 2016, the non-cash gain
attributable to fair value of the warrant liability was $1.2
million.
Updated Financial Guidance
We believe that our $37.4 million in cash resources
would allow us to fund our planned operations into the fourth
quarter of 2018. This estimate assumes no receipt of additional
milestone or royalty payments from our partners or related payment
of potential licensing milestones to third parties, no additional
funding from new partnership agreements, no additional equity
financings, no debt financings and no further sales of equity under
our Sales Agreement with FBR or through the exercise of our
outstanding PIPE Warrants. This estimate also assumes no
acceleration in repayment of the term loan by Hercules in the event
of non-compliance with the $10.0 million financial
covenant.
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). Tivozanib
(FOTIVDA®) is approved by the European Commission for the treatment
of adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. 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: clinical, regulatory and commercial plans
of AVEO and its partner EUSA Pharma with respect to tivozanib
(FOTIVDA®); the expected timeline for reporting data from TIVO-3
and TiNivo; the role and expected benefits of tivozanib and other
TKIs on a stand-alone basis, or in combination with or following
immunotherapy; the expected enrollment of the TiNivo trial;
expectations about the potential for additional payments by EUSA
Pharma; the value of AVEO's partnerships in advancing its pipeline;
and AVEO’s strategy, prospects, plans and objectives, including as
they pertain specifically to tivozanib. 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,
including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to its 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 Nine Months Ended September 30,
September 30, 2017 2016 2017
2016 Collaboration and licensing revenue $ 4,614 $
992 $ 7,497 $ 2,388 Operating expenses: Research and development
4,666 4,444 19,503 16,020 General and administrative 2,101
2,141 6,734 6,344 6,767 6,585
26,237 22,364 Loss from operations (2,153 ) (5,593 )
(18,740 ) (19,976 ) Other expense, net: Interest expense, net (655
) (551 ) (1,736 ) (1,388 ) Change in fair value of warrant
liability (23,538 ) 1,178 (47,947 ) 182
Other expense, net (24,193 ) 627 (49,683 )
(1,206 ) Loss before provision for income taxes (26,346 )
(4,966 ) (68,423 ) (21,182 ) Provision for income taxes (51
) — (101 ) (100 ) Net loss $ (26,397 ) $
(4,966 ) $ (68,524 ) $ (21,282 ) Net loss per share — basic and
diluted $ (0.22 ) $ (0.07 ) $ (0.67 ) $ (0.32 ) Weighted average
number of common shares outstanding 118,006 75,861
101,754 67,046
Consolidated Balance
Sheet Data (In thousands) (Unaudited)
September 30, December 31, 2017
2016 Assets Cash, cash equivalents and
marketable securities $ 37,409 $ 23,348 Accounts receivable 2,375
1,027 Prepaid expenses and other current assets 1,744 1,940 Other
assets 183 970 Total assets $ 41,711 $ 27,285
Liabilities
and stockholders’ deficit Accounts payable and accrued expenses
$ 11,058 $ 7,715 Loans payable 19,244 14,003 Deferred revenue and
research and development reimbursements 3,190 2,207 Warrant
liability 51,953 4,593 Other liabilities 840 690 Stockholder’s
deficit (44,574 ) (1,923 ) Total liabilities and stockholders’
deficit $ 41,711 $ 27,285
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171107005521/en/
For AVEOArgot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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