AVEO Oncology (NASDAQ:AVEO) today reported financial results for
the second quarter ended June 30, 2018 and provided a business
update.
“Our U.S. registration strategy remains a key focus for AVEO,
with topline readout of the Phase 3 TIVO-3 study expected in the
fourth quarter of this year,” said Michael Bailey, president and
chief executive officer of AVEO. “TIVO-3 is the first randomized
Phase 3 study in advanced kidney cancer to stratify for prior
immunotherapy and, as a result, it has the potential to serve as a
benchmark study for the sequencing of therapies in advanced
disease.”
Mr. Bailey added: “The next two pillars of our tivozanib
strategy also continue to make progress. The recent launch of
FOTIVDA® in Scotland adds to ongoing commercial efforts in Germany,
the U.K., and Austria by our partner EUSA Pharma. We anticipate
additional potential reimbursement approvals for France, Germany,
Italy, and Spain in the coming months, triggering up to $8 million
in milestone payments due to AVEO in addition to double-digit
royalty payments on net sales of FOTIVDA® in Europe. EUSA has the
option to access TIVO-3 data in the event of a positive outcome in
exchange for a $20 million R&D reimbursement payment to AVEO.
Finally, we look forward to presenting additional data at the ESMO
meeting in October from the Phase 2 portion of the TiNivo study of
tivozanib and nivolumab (OPDIVO®) in aRCC, a study which to date
has demonstrated promising activity and a favorable safety
profile.”
Tivozanib TIVO-3 Study North America Update
- Topline Data from Phase 3 TIVO-3
Study Anticipated in the Fourth Quarter of 2018. As previously
announced, the Company expects to report topline results from the
TIVO-3 study, AVEO’s Phase 3 trial of tivozanib as a third-line
treatment for advanced renal cell carcinoma (aRCC), in the fourth
quarter of 2018, approximately 6-8 weeks after the trial records
255 progression free survival (PFS) events. AVEO plans to announce
when 255 PFS events have occurred and the topline data analysis for
the trial has been initiated. Together with the TIVO-1 study,
TIVO-3 is designed to serve as the basis for a potential U.S.
approval of tivozanib (FOTIVDA®) as a first- and third-line
treatment for aRCC.
Tivozanib (FOTIVDA®) European Union
Updates
- Tivozanib (FOTIVDA®)
Launched in Scotland for the Treatment of aRCC. In July 2018,
FOTIVDA® was launched in Scotland for the first-line treatment of
adult patients with aRCC after the Scottish Medicines Consortium
approved its use. FOTIVDA® is now available in Germany, Scotland,
the U.K., and Austria. FOTIVDA® was granted European Medicines
Association approval in August 2017 for the treatment of adult
patients with aRCC in the European Union plus Norway and
Iceland.
- Tivozanib (FOTIVDA®)
Expanded Access Program Launched in Italy. In July 2018, The
Program of Therapeutic Use Tivozanib (Expanded Access Program) for
renal cell carcinoma (RCC) was initiated, allowing patients in
Italy to have access to tivozanib as front-line therapy. In
addition, EUSA pharma is effecting the reimbursement procedure with
the Italian Drug Agency (AIFA), a process which is expected to be
finalized in the coming months.
Additional Tivozanib Updates
- Updated Phase 2 Results from the
TiNivo Trial of Tivozanib and Nivolumab (OPDIVO®) in
aRCC to be Presented at the 2018 ESMO Annual Meeting. Updated
Phase 2 data from the Phase 1b/2 TiNivo study of tivozanib in
combination with nivolumab (OPDIVO®, Bristol-Myers Squibb), an
immune checkpoint, or PD-1, inhibitor, will be presented at the
2018 European Society for Medical Oncology (ESMO) Annual Meeting in
Munich. The data will be presented during a poster presentation
titled, “TiNivo: Tivozanib combined with nivolumab: safety and
efficacy in patients with metastatic renal cell carcinoma (mRCC)”
(Presentation Number 878P). Previously presented results support
the potential advantages of a combination therapy using a
high-specificity VEGF inhibitor TKI in connection with an immune
checkpoint therapy in renal cancer.
Ficlatuzumab Update
- Trials in Progress Poster for Phase
2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC to
be Presented at the 2018 ESMO Annual Meeting. Data from an
ongoing, investigator-sponsored 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) will be presented as a trials in progress poster
at the 2018 ESMO Annual Meeting (Presentation Number 1124TiP). This
randomized multi-center study, which is being conducted under the
direction of Julie E. Bauman, MD, MPH, Professor of Medicine,
Chief, Division of Hematology/Oncology, Associate Director of
Translational Research, University of Arizona Cancer Center, is
expected to enroll approximately 60 patients randomized to receive
either ficlatuzumab alone or ficlatuzumab and cetuximab.
- Trials in Progress Poster for Phase
1b Study of Ficlatuzumab in Combination with Gemcitabine and
Nab-paclitaxel in Pancreatic Cancer Presented at the 2018 ASCO
Annual Meeting. Data from 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) was 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 in June 2018. The study, which is
being conducted under the direction of Kimberly Perez, MD at the
Dana-Farber Cancer Institute, is currently enrolling, with an
expected total enrollment of approximately 30 patients.
Corporate Update
- Added to the Russell 2000, Russell
3000, and Russell Microcap Indexes. In June 2018, AVEO
announced that it had been added to the Russell 2000®, Russell
3000®, and Russell Microcap® Indexes as part of FTSE’s annual
reconstitution. Russell U.S. Indexes are widely used by investment
managers and institutional investors as the basis for index funds
and as benchmarks for active investment strategies. Approximately
$9 trillion in assets are benchmarked against Russell U.S.
Indexes.
Second Quarter 2018 Financial Highlights
- AVEO ended Q2 2018 with $18.1 million
in cash, cash equivalents and marketable securities as compared
with $33.5 million at December 31, 2017.
- Total revenue for Q2 2018 was
approximately $0.4 million compared with $0.4 million for Q2
2017.
- Research and development expense for Q2
2018 was $4.9 million compared with $6.9 million for Q2 2017.
- General and administrative expense for
Q2 2018 was $2.8 million compared with $2.3 million for Q2
2017.
- Net income for Q2 2018 was $4.0
million, or income of $0.03 per basic share and a loss of $0.06 per
diluted share, compared with net loss of $33.3 million for Q2 2017,
or a loss of $0.30 per basic and diluted share. Approximately $11.1
million of Q2 2018 net income was a 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 quarter. In Q2 2017, the
non-cash loss attributable to the increase in the fair value of
such warrant liability was $23.9 million.
Financial Guidance
We believe that our $18.1 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, 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 or outstanding warrants
issued in connection with the recent settlement of our securities
class action litigation.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company”) is a
biopharmaceutical company dedicated to advancing a broad portfolio
of targeted medicines for oncology and other areas of unmet medical
need. The Company’s strategy is to retain North American rights to
its oncology portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking
to develop and commercialize its lead candidate tivozanib in North
America as a treatment for renal cell carcinoma (“RCC”). The
Company has outlicensed tivozanib (FOTIVDA®) for oncology 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 advanced RCC
(“aRCC”) 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
aRCC. The Company has entered into partnerships to fund the
development and commercialization of AV-203 and ficlatuzumab, both
clinical stage assets in oncology. The Company is currently seeking
a partner to develop the AV-353 platform, a preclinical asset,
worldwide for the potential treatment of pulmonary arterial
hypertension. The Company previously partnered with Novartis
International Pharmaceutical Ltd. (“Novartis”) to develop the
AV-380 program in cachexia and other indications. Effective August
28, 2018 the Company expects to regain the rights to AV-380 and is
considering a variety of options to continue the program’s
development.
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
advancing its lead development programs, including its expectations
regarding the timing for top line results from the Phase 3 TIVO-3
study of tivozanib in aRCC, and for providing an update to the
Phase 2 portion of the TiNivo Study of Tivozanib and Nivolumab
(OPDIVO®) in mRCC; the advancement of AVEO’s pipeline; AVEO’s cash
runway; and AVEO’s strategy, prospects, plans and objectives,
including as they pertain specifically to tivozanib and leveraging
partnerships. 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; 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. 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.
AVEO PHARMACEUTICALS, INC. Condensed Consolidated
Statements of Operations (In thousands, except per share
amounts) (Unaudited) Three Months
Ended Six Months Ended June 30, June
30, 2018 2017 2018
2017 Revenues: Collaboration and licensing revenue $ 336 $
351 $ 1,316 $ 2,883 Partnership royalties 97 —
143 — 433 351 1,459 2,883
Operating expenses: Research and development 4,887 6,881 10,291
14,837 General and administrative 2,827 2,302 5,437 4,633
Settlement costs (709 ) — (667 ) —
7,005 9,183 15,061 19,470 Loss from
operations (6,572 ) (8,832 ) (13,602 ) (16,587 ) Other income
(expense), net: Interest expense, net (549 ) (530 ) (1,042 ) (1,081
) Change in fair value of PIPE Warrant liability 11,125
(23,925 ) 9,660 (24,409 ) Other income
(expense), net 10,576 (24,455 ) 8,618
(25,490 ) Income (loss) before provision for income taxes 4,004
(33,287 ) (4,984 ) (42,077 ) Provision for income taxes —
— — (50 ) Net income (loss) $ 4,004 $ (33,287
) $ (4,984 ) $ (42,127 ) Basic net income (loss) per share
Net income (loss) per share $ 0.03 $ (0.30 ) $ (0.04 ) $ (0.45 )
Weighted average number of common shares
outstanding
118,940 110,550 118,891 93,493
Diluted net income (loss) per share Net income (loss) per share $
(0.06 ) $ (0.30 ) $ (0.11 ) $ (0.45 ) Weighted average number of
common shares and dilutive common share equivalents outstanding
128,692 110,550 129,372 93,493
Consolidated Balance Sheet Data (In thousands)
(Unaudited) June 30, December
31, 2018 2017 Assets
Cash, cash equivalents and marketable securities $ 18,089 $ 33,525
Accounts receivable 973 402 Prepaid expenses and other current
assets 937 1,256 Insurance recovery — 15,000 Other assets
7 15 Total assets $ 20,006 $
50,198
Liabilities and stockholders’ deficit Accounts
payable and accrued expenses $ 11,497 $ 13,215 Loans payable, net
of discount 18,730 18,477 Deferred revenue and research and
development reimbursements 5,743 2,820 PIPE Warrant liability
26,985 37,746 Estimated settlement liability 1,406 17,073 Other
liabilities 1,090 1,630 Stockholder’s deficit
(45,445 ) (40,763 ) Total liabilities and stockholders’
deficit $ 20,006 $ 50,198
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version on businesswire.com: https://www.businesswire.com/news/home/20180807005823/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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