AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the first quarter ended March 31, 2018 and provided a business
update.
“We continue to work toward reporting topline results from our
Phase 3 TIVO-3 Study, which we now anticipate will occur in the
third quarter of 2018. We are working closely with our contract
research organization (CRO) to shorten the time required to do the
data cleaning and analysis upon reaching the requisite number of
events. Together with the TIVO-1 study, the TIVO-3 study has been
designed to serve as the basis for a potential U.S. approval of
tivozanib as a first- and third-line treatment for advanced renal
cell carcinoma (aRCC),” said Michael Bailey, president and chief
executive officer of AVEO. “This important milestone, if achieved,
would add to the continued commercial progress of FOTIVDA® which is
approved in Europe, with launches currently underway in Germany,
the U.K. and Austria. We finished the quarter with $27 million in
cash, cash equivalents and investments as of March 31, 2018. Under
our agreement with our partner EUSA, we have double-digit
royalty payments due to us on net sales of FOTIVDA® in Europe,
potential milestone payments including $8 million related to
reimbursement approvals for France, Germany, Italy, and Spain, and
$20M in potential R&D reimbursement for access to TIVO-3 data
in the event of a positive study.”
Mr. Bailey added, “As we work toward our goal of
commercialization in the U.S., we also continue to aggressively
pursue the third pillar of our tivozanib strategy, combinations
with immunotherapy. We were pleased to present results from the
ongoing Phase 2 portion of the TiNivo study of tivozanib and
nivolumab (OPDIVO®) in aRCC at ASCO GU. These early results
demonstrated a combination of a favorable safety profile and
activity that we believe hold significant promise for patients with
aRCC and potentially other tumor types such as hepatocellular
carcinoma (HCC).”
Tivozanib TIVO-3 Study North America Update
Update on Anticipated Timeline to Topline
Data from Phase 3 TIVO-3 Study. AVEO today announced that the
pre-specified number of progression free survival (PFS) events
required to trigger data analysis of the Phase 3 TIVO-3 trial have
not been reached at this time and, as such, the Company is amending
its guidance for the anticipated topline data readout from the
second to the third quarter of 2018. In collaboration with the CRO
conducting the TIVO-3 study, AVEO has taken measures to shorten the
data cleaning and analysis period following the pre-specified
events trigger from 8-10 weeks down to 6-8 weeks. Together with the
previously completed TIVO-1 trial of tivozanib in the first line
treatment of aRCC, TIVO-3 is designed to support regulatory
approval of tivozanib in the U.S. as a first- and third-line
treatment for aRCC.
Tivozanib (FOTIVDA®) European Union
Updates
- Tivozanib (FOTIVDA®)
Launched in Austria for the Treatment of aRCC. In April 2018,
FOTIVDA® was launched in Austria for the treatment of adult
patients with aRCC. This follows the February 2018 publication by
the United Kingdom’s National Institute for Health and Care
Excellence (NICE) of a Final Appraisal Determination recommending
FOTIVDA® for the first line treatment of adult patients with aRCC,
which triggered the commercial launch in the UK as well as a $2M
milestone payment to AVEO from EUSA Pharma, the licensee for
tivozanib in Europe. FOTIVDA® is now available in the Germany, the
U.K., and Austria.FOTIVDA® was granted European Commission (EC)
approval in August 2017 for the treatment of adult patients with
aRCC in the European Union plus Norway and Iceland.
Additional Tivozanib Updates
- Long-term Follow-up Results from
TIVO-1 Extension Study (Study 902), Published in the European
Journal of Cancer. In March 2018, AVEO announced the
publication of long-term follow-up results from Study 902, where
patients were treated with tivozanib (FOTIVDA®) as second-line
treatment for aRCC, in the European Journal of Cancer. Findings
from the study underscore the activity of tivozanib in the
refractory setting, with evidence of encouraging clinical
responses, disease control and overall survival outcomes in
patients previously treated with a VEGFR TKI and support the
rationale for the ongoing Phase 3 TIVO-3 study. The
publication, titled “Efficacy of Tivozanib Treatment after
Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover
of a Phase 3 Study,” is available on our website at
www.aveooncology.com.
- Results from Phase 2 Portion of the
TiNivo Study of Tivozanib and Nivolumab (OPDIVO®) in
mRCC Presented at ASCO GU. In February 2018, Bernard Escudier,
M.D., from the Institute Gustav Roussy in Paris, France presented
results from the ongoing Phase 2 portion of the TiNivo study at the
2018 American Society of Clinical Oncology’s Genitourinary Cancers
Symposium (ASCO GU). TiNivo is a Phase 1b/2 multi-center trial of
oral tivozanib in combination with intravenous nivolumab (OPDIVO®,
Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor,
for the treatment of metastatic renal cell carcinoma (mRCC). The
presentation noted the favorable safety profile and promising
preliminary anti-tumor activity observed to date. These results
continue to support the potential advantages of using a
high-specificity VEGF inhibitor TKI in building upon the benefit of
immune checkpoint therapy in renal cancer. AVEO and EUSA Pharma
expect to present further updates to the TiNivo study at upcoming
medical meetings in the second half of 2018.
- Phase 1b/2 Study Results of
Tivozanib in Patients with Advanced Hepatocellular Carcinoma
Presented at ASCO GI. In January 2018, AVEO announced the
presentation of data from a multi-center, Phase 1b/2 study of
tivozanib in previously untreated patients with advanced,
unresectable HCC at the 2018 American Society of Clinical Oncology
Gastrointestinal Cancers Symposium (ASCO GI). Findings from the
study suggest that tivozanib has the potential to yield comparable
PFS and a favorable response rate when compared to current
first-line standards of care for HCC patients, and demonstrated a
favorable safety profile which may enable therapeutic combinations
with immunotherapy. The Phase 1b/2 study was led by Renuka Iyar,
M.D., from the Roswell Park Cancer Center and was one of several
studies funded by a grant provided to the National Comprehensive
Cancer Network by AVEO.
Ficlatuzumab Update
- Trials in Progress Poster for Phase
1b Study of Ficlatuzumab in Combination with Gemcitabine and
Nab-paclitaxel in Pancreatic Cancer to be Presented at the 2018
ASCO Annual Meeting. An ongoing, investigator-sponsored Phase
1b study to test the safety and tolerability of ficlatuzumab when
combined with Nab-paclitaxel and Gemcitabine in previously
untreated metastatic pancreatic ductal cancer (PDAC) will be
presented as a trials in progress poster (Poster Board: #330b,
Abstract TPS4152) at the 2018 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, IL. The study, which is being
conducted under the direction of Kimberly Perez, M.D. at the
Dana-Farber Cancer Institute, is currently enrolling, with an
expected total enrollment of approximately 30 patients.
Corporate Updates
- Refinanced Debt Facility, Extending
Cash Runway into 2019. In January 2018, AVEO announced that it
completed the refinancing of its existing $20.0 million debt
facility with Hercules Capital, Inc. and its affiliates, the terms
of which enable approximately an additional $12.1 million in cash
flow over 2018 and 2019, when compared to the prior loan. The new
$20.0 million facility has a 42-month maturity from closing, no
financial covenants, a lower interest rate and an interest-only
period of no less than 12 months, which could be extended up to a
maximum of 24 months, assuming the achievement of specified
milestones relating to the development of tivozanib. Extension of
the interest-only period is expected to enable the Company to
extend its cash runway into the first quarter of 2019. Proceeds of
the new facility were used to retire the Company’s previous $20.0
million of secured debt with Hercules.
- Strengthened Board of Directors.
In February 2018, AVEO announced the appointment of John H. Johnson
to the Company’s Board of Directors. Mr. Johnson brings to AVEO
over three decades of experience in the biotechnology and
pharmaceuticals industries, having held commercial and executive
management roles at leading global corporations that have a focus
on oncology.
First Quarter 2018 Financial Highlights
- AVEO ended Q1 2018 with $27.0
million in cash, cash equivalents and marketable securities as
compared with $33.5 million at December 31,
2017.
- Total revenue for Q1 2018 was
approximately $1.0 million compared
with $2.5 million for Q1 2017.
- Research and development expense for Q1
2018 was $5.4 million compared
with $8.0 million for Q1 2017.
- General and administrative expense for
Q1 2018 was $2.6 million compared with $2.3
million for Q1 2017.
- Net loss for Q1 2018
was $9.0 million, or a loss of $0.08 per basic
and diluted share, compared with net loss of $8.8 million
for Q1 2017, or a loss of $0.12 per basic and diluted
share. Approximately $1.5 million of the Q1 2018 net loss
was a non-cash loss attributable to the increase in the fair value
of the warrant liability that principally resulted from the
increase in the stock price that occurred within the quarter. In Q1
2017, the non-cash loss attributable to the increase in the fair
value of the warrant liability was $0.5 million.
Financial Guidance
We believe that our $27.0 million in cash resources
would allow us to fund our planned operations into the first
quarter of 2019. This estimate assumes no receipt of additional
milestones from our partners or related payment of potential
licensing milestones to third parties, no additional funding from
new partnership agreements, no additional equity or debt
financings, and no sales of equity through the exercise of our
outstanding warrants issued in connection with our 2016 private
placement.
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 other areas of unmet medical need.
Tivozanib (FOTIVDA®) is approved by the European Commission for the
treatment of adult patients with advanced renal cell carcinoma 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: the Company’s plans and prospects for
seeking and obtaining FDA approval of tivozanib as a first- and
third-line treatment for aRCC; the expected timeline for reporting
data from TIVO-3 and TiNivo clinical trials; advancement of AVEO’s
pipeline; potential payments under AVEO’s license agreement with
EUSA; the period in which AVEO anticipates that its existing cash
resources will fund its operations; 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 and license
agreements, and its ability, and the ability of its collaborators,
licensees and other strategic partners, to achieve development and
commercialization objectives under these arrangements; and AVEO’s
ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies such as the FDA 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
and its collaborators’ 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
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
quarterly and annual reports on file with the Securities and
Exchange Commission (SEC) 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 EndedMarch
31,
2018 2017 Revenues: Collaboration and
licensing revenue $ 980 $ 2,532 Partnership royalties 46
— 1,026 2,532
Operating expenses: Research and development 5,404 7,956 General
and administrative 2,610 2,331 Settlement costs 42
— 8,056 10,287 Loss from
operations (7,030 ) (7,755 ) Other expense, net: Interest expense,
net (493 ) (551 ) Change in fair value of PIPE warrant liability
(1,465 ) (484 ) Other expense, net (1,958 )
(1,035 ) Loss before provision for income taxes (8,988 )
(8,790 ) Provision for income taxes — (50 )
Net loss $ (8,988 ) $ (8,840 ) Net loss per share — basic and
diluted $ (0.08 ) $ (0.12 ) Weighted average number of common
shares outstanding 118,840 76,246
Consolidated Balance Sheet
Data(In thousands)
March 31,2018
December 31,2017
Assets Cash, cash equivalents and marketable securities $
26,995 $ 33,525 Accounts receivable 600 402 Prepaid expenses and
other current assets 1,007 1,256 Insurance recovery 15,000 15,000
Other assets 11 15 Total assets $
43,613 $ 50,198
Liabilities and
stockholders’ deficit Accounts payable and accrued expenses $
12,679 $ 13,215 Loans payable, net of discount 18,588 18,477
Deferred revenue and research and development reimbursements 6,276
2,820 PIPE warrant liability 38,110 37,746 Estimated settlement
liability 17,115 17,073 Other liabilities 1,090 1,630 Stockholder’s
deficit (50,245 ) (40,763 ) Total liabilities and
stockholders’ deficit $ 43,613 $ 50,198
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180508005542/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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