AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the full year ended December 31, 2018 and provided a business
update.
“The results of TIVO-3, presented in February at the 2019 ASCO
GU Symposium, underscore a unique activity and tolerability profile
among VEGF TKIs in the treatment of kidney cancer,” said Michael
Bailey, president and chief executive officer of AVEO. “We continue
to believe that there is a significant potential commercial
opportunity for an active and well tolerated therapy within the
third plus line of therapy, particularly one that demonstrated
activity in a highly refractory patient population that has
received prior PD-1 treatment. We are hopeful that the positive PFS
outcomes from TIVO-3 translate into an improved overall survival
hazard ratio and look forward to reporting a more mature interim OS
outcome in the fourth quarter of 2019.”
Recent Highlights
- Presented Topline Results from
TIVO-3 During an Oral Presentation at the 2019 ASCO Genitourinary
Cancers Symposium. In February 2019, AVEO presented topline
results from the TIVO-3 trial, AVEO’s Phase 3 randomized,
controlled, multi-center, open-label study to compare tivozanib to
sorafenib in 350 subjects with refractory advanced or metastatic
renal cell carcinoma (RCC) at the 2019 American Society of Clinical
Oncology (ASCO) Genitourinary (GU) Cancers Symposium held February
14-16, 2019 in San Francisco. The results were presented during an
oral presentation titled “TIVO-3: A Phase 3, Randomized,
Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to
Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma
(RCC).” A copy of the presentation is currently available in the
Publications & Presentation section of AVEO’s website.The
presentation noted that the TIVO-3 trial met its primary endpoint
of demonstrating a statistically significant benefit in median
progression-free survival (PFS). Median PFS for tivozanib was also
longer than sorafenib both in patients who received prior PD-1
therapy and those who received two prior VEGF TKI therapies. The
secondary endpoint of overall response rate also demonstrated a
statistically significant improvement for patients receiving
tivozanib compared to sorafenib.The analysis of the secondary
endpoint of overall survival (OS) was not mature at the time of the
final PFS analysis. As presented, the preliminary OS analysis
conducted at an October 4, 2018 data cutoff date, which included
additional patients previously lost to follow-up, showed a
non-statistically significant difference in OS favoring sorafenib
(hazard ratio: 1.12, p-value: 0.44).Tivozanib was generally
well-tolerated relative to sorafenib, with reported grade 3 or
higher adverse events consistent with those observed in previous
tivozanib trials. The improved tolerability of tivozanib was
evident in the lower rates of dose reductions and interruptions for
toxicity in patients receiving tivozanib compared to those
receiving sorafenib. The most common adverse event in patients
receiving tivozanib was hypertension, an adverse event known to
reflect effective VEGF pathway inhibition.
- Announced NDA Timing Update. In
January 2019, the U.S. Food and Drug Administration (FDA)
recommended that AVEO not submit a New Drug Application (NDA) for
tivozanib at this time using the preliminary OS results from the
TIVO-3 trial. The FDA indicated that these preliminary OS results
do not allay their concerns about the potential detriment in OS
outlined in the Complete Response Letter dated June 6, 2013. AVEO
now plans to make an NDA filing decision following the availability
of more mature OS results. AVEO intends to conduct an additional
interim OS analysis in August 2019, the results of which are
expected to be reported in the fourth quarter of 2019.
- Data from Phase 1b Expansion Cohort
of Ficlatuzumab and Cytarabine in Relapsed and Refractory AML to be
Presented at 2019 AACR Annual Meeting. Data from the
investigator-sponsored Phase 1b expansion cohort evaluating the
safety and tolerability of ficlatuzumab, AVEO’s potent hepatocyte
growth factor (HGF) inhibitory antibody, in combination with
cytarabine in patients with relapsed and refractory acute myeloid
leukemia (AML) will be presented during a poster session at the
2019 American Association for Cancer Research (AACR) Annual
Meeting. The presentation, titled, “Cyfi: Results from a Phase 1b
expansion cohort of anti-hepatocyte growth factor and cytarabine in
relapsed and refractory AML” (abstract CT078 / 2) will be featured
during a poster session (Session PO.CT03) on Monday, April 1, 2019
from 1:00-5:00pm Eastern Time.
- Entered Immuno-Oncology Clinical
Supply Agreement with AstraZeneca. In December 2018, AVEO
entered into a clinical supply agreement with AstraZeneca to
evaluate the safety and efficacy of AstraZeneca's IMFINZI®
(durvalumab), a human monoclonal antibody directed against
programmed death-ligand 1 (PD-L1), in combination with tivozanib in
first-line hepatocellular carcinoma, or liver cancer, in a Phase
1/2 study. AVEO will serve as the study sponsor; each party will
contribute the clinical supply of its study drug and study costs
will be otherwise shared equally. The Phase 1 portion of the study
is expected to commence this year.
- Earned $2 Million Milestone Payment
from EUSA Pharma. In November 2018, AVEO announced the
triggering of a $2 million milestone payment from EUSA Pharma
related to the reimbursement in Germany for FOTIVDA® as a first
line treatment of adult patients with advanced RCC.
- Extended Debt Facility Interest-Only
Period. In December 2018, AVEO announced a six-month extension
to the interest-only period under its existing amended and restated
loan and security agreement with Hercules Capital, Inc. The
extension was granted as a result of achieving certain predefined
requirements under the agreement, including successfully meeting
the primary endpoint of the TIVO-3 trial.
- Raised $7.5 Million Under the Sales
Agreement with SVB Leerink, Extending Financial Runway. In
February 2019, AVEO raised $7.5 million through its sales agreement
with SVB Leerink. Approximately $32 million of shares remain
available for future issuance and sale pursuant to the sales
agreement, which was originally entered into in February 2018. AVEO
believes that the proceeds generated in February 2019 through the
sales agreement, together with its available cash, cash
equivalents, and marketable securities at December 31, 2018, and
together with the extension of the interest-only period under the
Hercules loan agreement, which results in deferment of principal
payments, will allow it to fund planned operations into the first
quarter of 2020.
Full Year 2018 Financial Highlights
- AVEO ended 2018 with $24.4 million in
cash, cash equivalents and marketable securities as compared with
$33.5 million at December 31, 2017.
- Total revenue for 2018 was
approximately $5.4 million compared with $7.6 million for
2017.
- Research and development expense for
2018 was $20.7 million compared with $25.2 million for 2017.
- General and administrative expense for
2018 was $10.8 million compared with $9.1 million for 2017.
- Net loss for 2018 was $5.3 million, or
a loss of $0.04 and $0.19 per basic and diluted share,
respectively, compared with a net loss of $65.0 million for 2017,
or a loss of $0.61 per basic and diluted share.
- The 2018 net loss was partially offset
by an approximate $19.9 million non-cash gain attributable to the
decrease in the fair value of the 2016 private placement warrant
liability that principally resulted from the decrease in the stock
price that occurred within the fiscal year. In 2017, the non-cash
loss attributable to the increase in the fair value of such warrant
liability was $33.7 million.
Financial Guidance
AVEO believes that its $24.4 million in cash, cash equivalents,
and marketable securities at the end of 2018, together with the
additional $7.5 million raised from sales under its sales agreement
with SVB Leerink in February 2019 and together with the extension
of the interest-only period under the Hercules loan agreement,
which results in deferment of principal payments, would allow it to
fund planned operations into the first quarter of 2020. This
estimate assumes no receipt of additional milestones from AVEO’s
partners, no additional funding from new partnership agreements, no
additional equity or debt financings, and no sales of equity
through the exercise of outstanding warrants issued in connection
with the 2016 private placement or outstanding warrants issued in
connection with the recent settlement of the securities class
action litigation.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the
treatment of adult patients with advanced renal cell carcinoma
(RCC) in the European Union
plus Norway and Iceland. It is a potent, selective
and long half-life inhibitor of all three VEGF receptors and is
designed to optimize VEGF blockade while minimizing off-target
toxicities, potentially resulting in improved efficacy and minimal
dose modifications.1,2 Tivozanib has been shown to
significantly reduce regulatory T-cell production in preclinical
models3 and has demonstrated synergy in combination with nivolumab
(anti PD-1) in a Phase 2 study in RCC. Tivozanib has been
investigated in several tumor types, including renal cell,
hepatocellular, colorectal and breast cancers. In addition, a new
formulation of tivozanib is in pre-clinical development for the
treatment of age-related macular degeneration.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company seeking to advance targeted medicines for
oncology and other unmet medical needs. The Company is working to
develop and commercialize its lead candidate tivozanib in North
America as a treatment for RCC. The Company has sublicensed
tivozanib (FOTIVDA®) for oncological indications in Europe and
other territories outside of North America. Tivozanib is approved
in the European Union, as well as Norway and Iceland, for the
first-line treatment of adult patients with RCC and for adult
patients who are vascular endothelial growth factor receptor and
mTOR pathway inhibitor-naïve following disease progression after
one prior treatment with cytokine therapy for RCC. The Company also
has clinical collaborations to study tivozanib in combination with
immune checkpoint inhibitors in RCC and in hepatocellular
carcinoma. In addition, a new formulation of tivozanib is in
pre-clinical development for the treatment of age-related macular
degeneration. As part of the Company’s strategy, the Company has
also entered into partnerships to help fund the development and
commercialization of its other product candidates. Ficlatuzumab, a
hepatocyte growth factor inhibitory antibody, is currently being
tested in several investigator sponsored studies jointly funded by
the Company and one of its development partners for the potential
treatment of squamous cell carcinoma of the head and neck, AML, and
pancreatic cancer. The Company’s partner for AV-203, an anti-ErbB3
monoclonal antibody, is planning to initiate clinical studies in
China in 2019 in esophageal squamous cell carcinoma and has
committed to funding the development of AV-203 through
proof-of-concept. The Company has recently regained the rights to
AV-380, a humanized IgG1 inhibitory monoclonal antibody targeting
growth differentiation factor 15, a divergent member of the TGF-ß
family, for the potential treatment of cancer cachexia, and is
working to initiate preclinical toxicology studies mid-2019 to
support the potential filing of an investigational new drug
application with the FDA. The Company is evaluating options for the
development of its preclinical AV-353 platform which targets the
Notch 3 pathway.
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 potential commercial opportunity of
tivozanib; AVEO’s plans to make a NDA filing decision following the
availability of more mature OS results; AVEO’s plans to complete an
interim OS analysis for the TIVO-3 trial in August 2019 and to
report the results of this analysis in the fourth quarter; AVEO’s
expectation that the OS outcome will be more mature by August 2019;
the potential efficacy, safety, and tolerability of tivozanib, as a
single agent and in combination with other therapies in several
indications, such as RCC and liver cancer; timing for the
commencement of the Phase 1 portion of the IMFINZI and tivozanib
combination study; AVEO’s cash runway; AVEO’s plans and strategies
for commercialization of tivozanib in the United States and Europe;
AVEO’s plan to develop the AV-353 platform; AVEO’s plans regarding
AV-380 and AVEO’s other strategy, prospects, plans and objectives
for its product candidates and for the Company generally. 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, 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, in particular,
tivozanib; AVEO’s ability to successfully file an NDA for
tivozanib; and AVEO’s ability to enter into and maintain its third
party collaboration and license agreements, and its ability, and
the ability of its strategic partners, to achieve development and
commercialization objectives under these arrangements. AVEO faces
other risks relating to its business as well, including risks
relating to the timing and costs of seeking and obtaining
regulatory approval; AVEO’s and its collaborators’ ability to
successfully enroll and complete clinical trials; AVEO’s ability to
maintain compliance with 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; 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
sections 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 makes with the SEC. The
forward-looking statements in this press release represent AVEO’s
views as of the date of this press release, and 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. Any reference to AVEO’s website address in this
press release is intended to be an inactive textual reference only
and not an active hyperlink.
References
1. Fotivda (Tivozanib) SmPC August 2017
2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013;
31(30): 3791-9.
3. Pawlowski N et al. AACR 2013. Poster 3971.
AVEO PHARMACEUTICALS, INC. Condensed
Consolidated Statements of Operations (In thousands, except
per share amounts) (Unaudited) Three Months
Ended
December 31,
Year Ended
December 31,
2018 2017 2018 2017
Revenues: Collaboration and licensing revenue $ 1,296 $ 63 $ 4,947
$ 7,560 Partnership royalties 187 19 462
19 1,483 82 5,409 7,579
Operating expenses: Research and development 5,201 5,676 20,652
25,179 General and administrative 2,625 2,404 10,781 9,138
Settlement costs — 2,073 (667 ) 2,073
7,826 10,153 30,766 36,390 Loss from
operations (6,343 ) (10,071 ) (25,357 ) (28,811 ) Other income
(expense), net: Interest expense, net (570 ) (637 ) (2,191 ) (2,373
) Change in fair value of PIPE Warrant liability 26,431 14,207
19,919 (33,740 ) Other income (expense), net 2,300 —
2,300 — Other income (expense), net 28,161
13,570 20,028 (36,113 ) Net income (loss)
before provision for income taxes 21,818 3,499 (5,329 ) (64,924 )
Provision for income taxes — — — (101 )
Net income (loss) $ 21,818 $ 3,499 $ (5,329 ) $ (65,025 )
Basic net income (loss) per share Net income (loss) per share $
0.18 $ 0.03 $ (0.04 ) $ (0.61 ) Weighted average number of common
shares outstanding 124,395 118,323 120,592 105,930 Diluted net
income (loss) per share Net income (loss) per share $ (0.03 ) $
(0.08 ) $ (0.19 ) $ (0.61 ) Weighted average number of common
shares and dilutive common share equivalents outstanding 133,580
130,108 130,731 105,930
Consolidated
Balance Sheet Data (In thousands) (Unaudited)
December 31,
2018
December 31,
2017
Assets Cash, cash equivalents and marketable securities $
24,427 $ 33,525 Accounts receivable 3,026 402 Prepaid expenses and
other current assets 482 1,256 Insurance recovery — 15,000 Other
assets — 15 Total assets $ 27,935 $ 50,198
Liabilities and stockholders’ deficit Accounts payable and
accrued expenses $ 12,451 $ 13,215 Loans payable 19,033 18,477
Deferred revenue and research and development reimbursements 5,914
2,820 PIPE Warrant liability 16,674 37,746 Estimated settlement
liability — 17,073 Other liabilities 1,090 1,630 Stockholder’s
deficit (27,227 ) (40,763 ) Total liabilities and
stockholders’ deficit $ 27,935 $ 50,198
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190314005807/en/
AVEO:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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