AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the second quarter ended June 30, 2017, and provided a business
update.
“The second quarter was marked by validating events in each of
the three pillars of our global tivozanib strategy: a
recommendation for approval of tivozanib in advanced renal cell
carcinoma (RCC) by the CHMP, reaching our enrollment target for the
Phase 3 TIVO-3 trial in RCC, and the successful advancement to
Phase 2, at full dose, of the TiNivo trial, our Opdivo® combination
trial in RCC,” said Michael Bailey, president and chief executive
officer of AVEO. “We look forward to several key milestones in the
coming quarters, including a final determination from the European
Commission (EC) on marketing authorization for tivozanib for RCC,
as well as the expected presentation of TiNivo Phase 1 study
results this fall and the anticipated readout of TIVO-3 in the
first quarter of 2018. We believe that we now have the balance
sheet to take AVEO beyond these milestones and into the fourth
quarter of 2018. This runway could be extended by additional
potential payments of up to $16 million by our European tivozanib
partner, EUSA Pharma, related to European regulatory and
reimbursement approvals, and double-digit royalty payments on net
sales for tivozanib in Europe if the EC grants marketing approval
for tivozanib.”
Mr. Bailey added: “We also look forward to progress in our
earlier pipeline programs, including the initiation of an
investigator-sponsored, randomized Phase 2 trial of ficlatuzumab,
our potent HGF inhibitory antibody, in combination with cetuximab
in patients with cetuximab-resistant, metastatic head and neck
squamous cell carcinoma (HNSCC). As presented at the ASCO annual
meeting this past quarter, this combination demonstrated prolonged
progression free and overall survival compared to historical
controls in Phase 1.”
Recent Updates
- Enrollment Target Reached for
Pivotal Phase 3 TIVO-3 Study of Tivozanib in RCC. In June 2017,
AVEO announced that the Company’s pivotal TIVO-3 trial, a
randomized, controlled, multi-center, open-label study to compare
tivozanib to sorafenib in subjects with refractory RCC, reached its
enrollment target of 322 patients, more than two months ahead of
the Company’s initial guidance. A pre-planned futility analysis of
the TIVO-3 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 an application
seeking regulatory approval of tivozanib in the U.S. as a first and
third line treatment for RCC.
- $14M in Aggregate Gross Proceeds
Secured from Credit Facility and At-the-Market Stock Offerings.
In June 2017, AVEO announced that it secured gross proceeds of $14
million through two financing facilities: $5 million through a
drawdown of its credit facility with Hercules Capital, Inc. and $9
million from the sale of common stock under its at-the-market
issuance sales agreement with FBR & Co, effectively exhausting
the balance of that facility.
- Positive CHMP Opinion for Tivozanib
as a Treatment of Advanced RCC. On June 23, 2017, AVEO
announced that the Committee for Medicinal Products for Human Use
(CHMP), the scientific committee of the European Medicines Agency
(EMA), recommended tivozanib for approval as a treatment for
patients with advanced RCC. The CHMP's recommendation was referred
to the EC, which is expected to make its final decision about 67
days from the date of the CHMP’s recommendation. If approved by the
EC, marketing authorization for tivozanib will be granted in all 28
countries of the European Union, Norway, Iceland and Liechtenstein.
Approval would trigger a $4 million research and development
reimbursement payment to AVEO from EUSA Pharma, the European
licensee for tivozanib, and AVEO would also be eligible for up to
$12 million in additional milestones based on reimbursement
approvals.
- Phase 1/2 TiNivo Trial of Tivozanib
and Opdivo® (nivolumab) in RCC Successfully Advanced
to Phase 2 Portion. In June 2017, AVEO announced that its Phase
1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination
with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab),
in subjects with advanced RCC progressed to the Phase 2 portion of
the trial, following completion of the Phase 1 portion, which saw
no dose limiting toxicities, a good tolerability profile and
promising early signs of activity. The full dose tivozanib regimen
of 1.5 mg daily for 21 days, followed by a 7-day rest period, was
selected as the recommended Phase 2 dose (RP2D) for the expansion
portion of the trial, which is expected to enroll an additional 20
subjects.
- Results from Two
Investigator-Sponsored Phase 1 Studies of HGF Targeted Antibody
Ficlatuzumab Presented at the 2017 ASCO Annual Meeting. In June
2017, AVEO announced the presentation of results from two
investigator-sponsored Phase 1 studies of ficlatuzumab, a potent
hepatocyte growth factor (HGF) inhibitory antibody that binds to
the HGF ligand with high affinity and specificity to inhibit
HGF/c-Met biological activities, at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting. The first was a study of
ficlatuzumab in combination with the EGFR inhibitor cetuximab in
patients with cetuximab-resistant, metastatic HNSCC, which
demonstrated a disease control rate, prolonged progression free and
overall survival that compared favorably to historical controls, in
addition to being well tolerated. The Company announced that a
randomized, Phase 2, multicenter, investigator-initiated trial to
confirm these findings is expected to initiate in the second half
of 2017. The second, ongoing study explored ficlatuzumab in
combination with high-dose cytarabine in patients with high risk
relapsed or refractory AML, demonstrating early signs of
tolerability and activity, including a 50% complete response
rate.
- Matthew Dallas Appointed Chief
Financial Officer. In June 2017, Matthew Dallas joined AVEO as
its chief financial officer. In this role, Mr. Dallas is
responsible for the Company’s financial strategy and management,
and serves on the executive leadership team that governs corporate
strategy at AVEO. Mr. Dallas succeeds Keith Ehrlich, who retired
from the Company.
- Receipt of USPTO Notice of Allowance
Related to AV-353. In May 2017, AVEO announced receipt of a
Notice of Allowance from the United States Patent and Trademark
Office (USPTO) for U.S. patent application number 14/653,684,
entitled "notch binding agents and antagonists and methods of use
thereof." Allowed under the application are composition of matter
and method of use claims related to the Company's humanized
anti-Notch 3 antibodies, including AV-353, a potent inhibitory
antibody specific to Notch 3. The Notch 3 pathway is implicated in
multiple diseases, including Pulmonary Arterial Hypertension. The
U.S. patent scheduled to issue from this application will expire
December 19, 2032, with the potential for extension to December 19,
2037.
Second Quarter 2017 Financial Highlights
- AVEO ended Q2 2017 with $40.1 million
in cash, cash equivalents and marketable securities as compared
with $23.3 million at December 31, 2016.
- Total collaboration revenue was
approximately $0.4 million in Q2 2017 compared with $0.2 million
for Q2 2016.
- Research and development expense was
$6.9 million in Q2 2017 compared with $5.6 million for Q2
2016.
- General and administrative expense was
$2.3 million in Q2 2017 compared with $1.7 million for Q2
2016.
- Net loss for Q2 2017 was $33.3 million,
or a loss of $0.30 per basic and diluted share, compared with a net
loss of $8.6 million, or a loss of $0.13 per basic and diluted
share for Q2 2016. An approximate $23.9 million non-cash loss
attributable to the increase in the fair value of the warrant
liability was recorded in Q2 2017 that principally resulted from
the increase in the stock price that occurred within the quarter.
In Q2 2016 the non-cash loss attributable to fair value of the
warrant liability was $1.0 million.
Updated Financial Guidance
We believe that our $40.1 million in cash resources would allow
us to fund our planned operations into the fourth quarter of 2018.
This estimate assumes no receipt of milestone 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. 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. 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, cachexia
(wasting syndrome) and pulmonary arterial hypertension (PAH). 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: the expected decision on tivozanib by the
EC; the planned presentation of TiNivo Phase 1 study results in the
Fall; the anticipated readout of TIVO-3 in the first quarter of
2018; the period in which the Company expects to have cash to fund
its operations; expectations about the potential for additional
payments by EUSA Pharma; plans to progress pipeline programs,
including the initiation of a Phase 2 trial of ficlatuzumab; and
AVEO’s strategy, prospects, plans and objectives. 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 without limitation risks relating to the ability of EUSA
to successfully obtain approval of tivozanib from the EC. 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 EndedJune
30,
Six Months EndedJune 30,
2017 2016 2017
2016 Collaboration and licensing revenue $ 351 $ 193 $ 2,883
$ 1,396 Operating expenses: Research and development 6,881 5,604
14,837 11,576 General and administrative 2,302
1,731 4,633 4,203
9,183 7,335 19,470 15,779
Loss from operations (8,832
)
(7,142 ) (16,587
)
(14,383
)
Other expense, net: Interest expense, net (530
)
(468
)
(1,081
)
(837
)
Change in fair value of warrant liability (23,925 )
(996 ) (24,409 ) (996 ) Other expense, net
(24,455 ) (1,464
)
(25,490
)
(1,833
)
Loss before provision for income taxes (33,287
)
(8,606 ) (42,077
)
(16,216
)
Provision for income taxes — — (50
)
(100
) Net loss per share $ (33,287
)
$ (8,606 ) $ (42,127
)
$ (16,316
)
Net loss per share - basic
$ (0.30
)
$ (0.13 ) $ (0.45
)
$ (0.26
)
Weighted average number of common shares outstanding 110,550 66,917
93,493 62,566
Consolidated Balance Sheet Data
(In thousands) (Unaudited)
June 30, December 31, 2017 2016
Assets Cash, cash equivalents and marketable securities $
40,127 $ 23,348 Accounts receivable 445 1,027 Prepaid expenses and
other current assets 1,568 1,940 Other assets 352
970 Total assets $ 42,492 $ 27,285
Liabilities and stockholders’ deficit Accounts
payable and accrued expenses $ 10,964 $ 7,715 Loans payable 19,122
14,003 Deferred revenue 1,894 2,207 Warrant liability 29,002 4,593
Other liabilities 840 690 Stockholder's deficit (19,330 )
(1,923 ) Total liabilities and stockholders’ deficit
$ 42,492 $ 27,285
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170809005543/en/
For AVEO OncologyArgot PartnersDavid Pitts, (212)
600-1902aveo@argotpartners.com
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