AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the full year ended December 31, 2017 and provided a business
update.
“Last year was one of major progress for AVEO, with highlights
including the first commercial launch of tivozanib (FOTIVDA®); the
completion of the enrollment for TIVO-3, our U.S. registration
study; the receipt of promising results from the Phase 1b/2 TiNivo
combination trial of tivozanib and nivolumab (OPDIVO®); and
progress across our earlier stage pipeline,” said Michael Bailey,
president and chief executive officer of AVEO. “These achievements
are only the beginning of our effort to unlock the value of
tivozanib through registration and development including
combination therapy. We also are excited by the potential of our
AVEO-developed pipeline candidates, including ficlatuzumab, AV-203,
AV-380 and AV-353. Supporting our multifaceted goals, we have
worked to strengthen our executive management team and Board with
the appointment of experienced leaders and to reinforce our balance
sheet through milestone payments, royalties, the renegotiation of
our debt agreement and careful financial stewardship.”
Tivozanib (FOTIVDA®) European Union
Update
- Tivozanib (FOTIVDA®)
Launched in Germany, Granted Positive NICE Final Appraisal
Determination for the Treatment of Advanced Renal Cell Carcinoma
(aRCC) in the UK. In November 2017, AVEO and EUSA Pharma, the
licensee for tivozanib in Europe, North and South Africa, Latin
America and Australasia, announced the first commercial launch of
FOTIVDA® with the initiation of product sales in Germany. In
February 2018, AVEO announced that the United Kingdom’s National
Institute for Health and Care Excellence (NICE) published a Final
Appraisal Determination recommending FOTIVDA® for the first line
treatment of adult patients with advanced renal cell carcinoma
(aRCC). The positive recommendation was followed by the launch of
FOTIVDA® in the United Kingdom and triggered a $2M milestone
payment to AVEO from EUSA Pharma. 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.
Tivozanib TIVO-3 Study North America Update
- Successfully Completed 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 to sorafenib (NEXAVAR®) in subjects with aRCC. 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. Based on the current rate of
progression-free survival (PFS) events, the Company expects
the TIVO-3 trial to read out in the second quarter of 2018.
The TIVO-3 trial, together with the previously
completed TIVO-1 trial of tivozanib in the first line
treatment of aRCC, is designed to support a potential regulatory
approval of tivozanib in the U.S. as a first- and third-line
treatment for aRCC.
TiNivo Combination Study Clinical Update
- Phase 1b/2 Results from the TiNivo
Trial of Tivozanib and Nivolumab (OPDIVO®) in aRCC
presented at International KCS and ASCO GU. In November 2017,
the results from the Phase 1b portion of the Phase 1b/2 TiNivo
study were presented at the 16th International Kidney Cancer
Symposium. In February 2018, Bernard Escudier, M.D., from the
Institute Gustav Roussy in Paris, France presented preliminary
results from the 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
Phase 1b/2 study has enrolled a total of 28 patients. The Phase 2
portion of the study (n=22) was designed to assess the safety,
tolerability, and anti-tumor activity of the full dose and schedule
of oral tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest
period), as established in the Phase 1b portion of the study (n=6),
in combination with intravenous nivolumab (240 mg every 2 weeks).
The combination was generally well tolerated. Treatment-related
Grade 3/4 adverse events occurred in 44% of patients, the most
common of which was hypertension. Preliminary efficacy was assessed
in 14 patients treated with the full dose and schedule of oral
tivozanib in combination with intravenous nivolumab and enrolled at
least 4 months prior to the data cutoff date. Of these, seven
patients had received at least one prior systemic therapy and seven
were treatment naive. A partial response was observed in 64% of
patients, and a disease control rate (partial response + stable
disease) was observed in 100% of patients. At the time of data
collection, 11 of 14 evaluable patients remained on study. The
Company and EUSA Pharma expect to present further updates to the
TiNivo study at upcoming medical meetings in the second half of
2018.
- TiNivo Combination Study Opt-in.
In September 2017, AVEO announced that EUSA Pharma, under its
multi-territory licensing agreement with AVEO for
tivozanib, opted in to co-develop the Phase 1b/2 TiNivo study and
potential future combination studies in exchange for research and
development reimbursement payments totaling $2.0 million.
Under terms of the agreement, EUSA will fund up to half of the
Phase 1b/2 TiNivo study, not to exceed $2.0 million, and may
utilize the data from the study for regulatory or commercial
purposes.
Tivozanib Clinical Development in Hepatocellular
Carcinoma
- 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 hepatocellular carcinoma (HCC) at the 2018 American
Society of Clinical Oncology Gastrointestinal Cancers Symposium
(ASCO GI). The study, designed to evaluate the safety and efficacy
of tivozanib in advanced HCC, enrolled a total of 21 patients at
three study sites. Tivozanib at 1.0 mg daily was selected in the
Phase 1b portion of the study as the dose for the Phase 2
expansion. Of 19 patients evaluable for efficacy, at a median
follow up of 16.9 months, the study’s primary endpoint of PFS and
PFS at week 24 were 5.5 months and 47%, respectively. A partial
response (PR) was seen in 21% (4/19) of patients and stable disease
(SD) was observed in 42% (8/19) of patients, for a disease control
rate (DCR) of 63%. Overall survival (OS) at 6 and 12 months was 58%
and 25%, respectively, with a median OS of 7.5 months. Notably, 4
patients have maintained SD for over two years. There were no
significant changes in hepatitis B or hepatitis C viral load during
study treatment. Tivozanib was generally well tolerated, with
adverse events consistent with those observed in previous tivozanib
trials. 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.
Pipeline Updates
- Phase 2 Study of Ficlatuzumab in
Combination with Cetuximab in HNSCC Initiated. In December
2017, AVEO announced the initiation of an investigator-sponsored
randomized, multi-center Phase 2 trial of ficlatuzumab and
cetuximab (ERBITUX®), an EGFR-targeted antibody, in patients with
cetuximab-resistant, metastatic head and neck squamous cell
carcinoma (HNSCC). AVEO has partnered with Biodesix, Inc. on the
development of ficlatuzumab, a humanized IgG1 antibody that binds
to the hepatocyte growth factor (HGF) ligand with high affinity and
specificity to inhibit the biological activities of the HGF/c-Met
pathway. The study will seek to confirm findings from a Phase 1
study where the addition of ficlatuzumab to cetuximab resulted in a
disease control rate of 67%, and prolonged progression free and
overall survival compared to historical controls, in addition to
being well tolerated. This Phase 2 multi-center study, which is
being conducted under the direction of Julie E. Bauman, M.D.,
M.P.H., Professor of Medicine, Chief, Division of
Hematology/Oncology, Associate Director of Translational Research,
University of Arizona Cancer Center, is expected to enroll
approximately 70 patients randomized to receive either ficlatuzumab
alone or ficlatuzumab and cetuximab.
- Phase 1b Study of Ficlatuzumab in
Combination with Gemcitabine and Nab-paclitaxel in Pancreatic
Cancer Initiated. In December 2017, AVEO announced the
initiation of an 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). The goal of the study, which is
based on preclinical findings demonstrating a synergistic effect of
these drugs in a preclinical model of PDAC, is designed to
determine the maximum tolerated dose of ficlatuzumab when combined
with gemcitabine and nab-paclitaxel. Secondary outcome measures
include response rate and progression free survival. The study,
which is being conducted under the direction of Kimberly Perez,
M.D. at the Dana-Farber Cancer Institute, is expected to enroll
approximately 30 patients.
- IND Application for CAN017 (AV-203)
Trial in Esophageal Squamous Cell Cancer (ESCC) Filed by CANbridge
In China. In December 2017, CANbridge Life Sciences, the
licensee for CAN017 (AV-203) outside of North America, announced
that it filed an Investigational New Drug application with the
China Food and Drug Administration for a Phase 1b/3 clinical study
of CAN017 in esophageal squamous cell cancer (ESCC). CAN017 is an
ErbB3 (HER3) inhibitory antibody candidate developed by AVEO.
CANbridge also announced that it entered into a strategic
partnership with Amoy Diagnostics Co., Ltd. to develop a CAN017
biomarker companion diagnostic.
Corporate Updates
- Strengthened Executive Team and
Board of Directors. In November 2017, AVEO announced the
appointment of Nikhil Mehta, Ph.D., as Senior Vice President of
Regulatory and Quality Assurance. In this role, Dr. Mehta oversees
all aspects of regulatory, quality and technical operations for the
Company’s portfolio. Dr. Mehta brings to AVEO more than 25 years of
experience in the biotechnology and pharmaceutical industries.AVEO
also recently appointed Mike Ferraresso as Vice President, Business
Analytics and Commercial Operations. Mr. Ferraresso brings more
than 20 years of pharmaceutical industry experience in commercial
strategy, sales operations and business analytics. He previously
worked at AVEO from 2011 to 2013 as Senior Director of Business
Analytics.AVEO also announced today that Karuna Rubin has been
named Senior Vice President and General Counsel, effective February
1, 2018. Ms. Rubin has more than 15 years of experience
representing public companies in a variety of industries in
securities, finance, mergers and acquisitions, litigation and other
matters and has served as AVEO’s lead counsel since 2015. She
received her J.D. from Columbia Law School and A.B. from Brown
University.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.
- 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.
Full Year 2017 Financial Highlights
- AVEO ended 2017 with $33.5
million in cash, cash equivalents and marketable securities as
compared with $23.3 million at December 31,
2016.
- Total collaboration revenue for 2017
was approximately $7.6 million compared
with $2.5 million for 2016.
- Research and development expense for
2017 was $25.2 million compared
with $23.7 million for 2016.
- General and administrative expense for
2017 was $9.1 million compared with $8.2
million for 2016.
- Net loss for 2017
was $65.0 million, or a loss of $0.61 per basic
and diluted share, compared with net loss
of $26.9 million for 2016, or a loss
of $0.39 per basic and diluted share.
Approximately $33.7 million of the 2017 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 year. In 2016, the
non-cash gain attributable to the decrease in the fair value of the
warrant liability was $4.8 million.
Updated Financial Guidance
We believe that our $33.5 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 RCC; 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 ended December
31,
For the Years Ended December
31,
2017 2016 2017 2016
Collaboration and licensing revenue $ 82 $ 127 $ 7,579 $ 2,515
Operating expenses: Research and development 5,676 7,683 25,179
23,703 General and administrative 2,404 1,870 9,138 8,205
Settlement costs 2,073 — 2,073 —
10,153 9,553 36,390 31,908 Loss from
operations (10,071 ) (9,426 ) (28,811 ) (29,393 ) Other income
(expense), net: Change in fair value of PIPE warrant liability
14,207 4,569 (33,740 ) 4,751 Other expense, net (637 )
(748 ) (2,373 ) (2,144 ) Other income
(expense), net 13,570 3,821 (36,113 )
2,607 Net loss before provision for income taxes 3,499 (5,605 )
(64,924 ) (26,786 ) Provision for income taxes — —
(101 ) (101 ) Net income (loss) $ 3,499 $ (5,605 ) $
(65,025 ) $ (26,887 ) Basic net income (loss) per share Net
income (loss) per share $ 0.03 $ (0.07 ) $ (0.61 ) $ (0.39 )
Weighted average number of common shares outstanding 118,323 75,863
105,930 69,268 Dilutive net income (loss) per share Net income
(loss) per share $ (0.08 ) $ (0.07 ) $ (0.61 ) $ (0.39 ) Weighted
average number of common shares and dilutive common share
equivalents outstanding 130,108 75,863 105,930 69,268
Consolidated Balance Sheet
Data(In thousands)
December 31,2017
December 31,2016
Assets Cash, cash equivalents and marketable
securities $ 33,525 $ 23,348 Accounts receivable 402 1,027 Prepaid
expenses and other current assets 1,256 1,940 Insurance recovery
15,000 — Other assets 15 970 Total assets $ 50,198 $ 27,285
Liabilities and stockholders’ deficit Accounts
payable and accrued expenses $ 13,215 $ 7,715 Loans payable 18,477
14,003 Deferred revenue and research and development reimbursements
2,820 2,207 PIPE warrant liability 37,746 4,593 Estimated
settlement liability 17,073 — Other liabilities 1,630 690
Stockholder’s deficit (40,763 ) (1,923 ) Total
liabilities and stockholders’ deficit $ 50,198 $ 27,285
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180313005468/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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