AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the second quarter ended June 30, 2019 and provided a business
update.
“As we move toward reporting more mature interim overall
survival (OS) results from our TIVO-3 study of tivozanib in
advanced kidney cancer, AVEO continues to make meaningful clinical,
regulatory and strategic progress across our pipeline,” said
Michael Bailey, president and chief executive officer of AVEO.
“Notably, since the beginning of the second quarter, we presented
encouraging data from ongoing clinical studies of ficlatuzumab, our
HGF inhibitory antibody, closed a public offering in April, and saw
the approval of FOTIVDA® in New Zealand. In addition to these
events, we recently announced the amendment to our license
agreement with Kyowa Kirin for tivozanib non-oncology rights, which
is consistent with our strategy to develop and commercialize our
oncology-focused pipeline while retaining meaningful economic
interest and advancing our non-oncology pipeline through
partnerships. As a result of the license amendment with Kyowa Kirin
and the April financing, the Company’s cash runway is now
anticipated to extend into the third quarter of 2021. We expect
this progress will continue to build momentum as we look forward to
the next interim OS readout from our TIVO-3 study in the fourth
quarter of this year.”
Recent Highlights
- Announced Kyowa Kirin Buy Back of Tivozanib
Non-Oncology Rights from AVEO. In August 2019, AVEO and Kyowa
Kirin Co., Ltd. announced that the companies’ license agreement for
tivozanib has been amended to allow Kyowa Kirin to buy back the
non-oncology rights of tivozanib in AVEO’s territories, which
includes the U.S. and EU. Under the terms of the amended license
agreement, AVEO will receive a $25 million upfront payment and a
waiver of the $18 million milestone payment due to Kyowa Kirin upon
AVEO obtaining U.S. market approval for tivozanib. In addition,
AVEO will be eligible to receive up to $391 million in milestone
payments upon the successful achievement of certain development and
commercial objectives related to tivozanib formulations for the
treatment of non-oncology indications. AVEO is also eligible to
receive tiered royalty payments on net sales in these indications,
which range from a high single-digit to low double-digit
percent.
- FOTIVDA® (tivozanib) Approval in New Zealand for the
Treatment of Advanced RCC received by AVEO’s Partner, EUSA
Pharma. In July 2019, the New Zealand Medicines and Medical
Devices Safety Authority approved FOTIVDA® (tivozanib) for the
first line treatment of adult patients with advanced renal cell
carcinoma (RCC) and for adult patients who are vascular endothelial
growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve
following disease progression after one prior treatment with
cytokine therapy for advanced RCC.
- Presented Tivozanib Studies at the 2019 ASCO Annual
Meeting. In June 2019, two tivozanib poster presentations
reported encouraging data at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, Illinois. The
presentations, titled “Efficacy and safety of tivozanib in
recurrent, platinum-resistant ovarian, fallopian tube or primary
peritoneal cancer” (abstract 361) and “TIVO-3: Subgroup analysis of
progression-free survival of tivozanib compared to sorafenib in
subjects with refractory advanced renal cell carcinoma (RCC)”
(abstract 4572), are available in the Publications &
Presentations section of AVEO’s website.
- $2 Million Milestone Payment from EUSA Pharma Triggered.
In April 2019, AVEO announced the triggering of a $2 million
milestone payment from EUSA Pharma related to the reimbursement
approval and commercial launch of FOTIVDA® (tivozanib) in Spain as
a first-line treatment of adult patients with RCC.
- Closed Public Offering of Common Stock and Warrants. In
April 2019, AVEO completed an underwritten public offering of
21,739,131 shares of common stock and warrants to purchase
25,000,000 shares of common stock at the public offering price of
$1.14 per share and $0.01 per warrant. The warrants have a two-year
term and a strike price of $1.25 per share. Gross proceeds of the
offering were approximately $25.0 million and are expected to be
used for clinical and preclinical development of AVEO’s product
candidates, as well as for working capital and other general
corporate purposes.
- Announced Results from Phase 1b Ficlatuzumab-Cytarabine
Trial (CyFi) in Patients with Relapsed and Refractory AML. In
April 2019, AVEO announced the presentation of encouraging data
from an investigator-sponsored Phase 1b expansion cohort 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), at the
American Association for Cancer Research (AACR) Annual Meeting,
held March 29 - Apr 3, 2019 in Atlanta. Of 18 AML patients enrolled
in the study, all had disease that was refractory to initial
treatment, 17 were evaluable and 9 achieved a complete response.
The most frequent grade 3/4 treatment emergent adverse events
observed were febrile neutropenia, liver function test
abnormalities, and electrolyte disturbance. There was one death
from sepsis and multi-organ failure that was determined to be
disease related, and one patient withdrew from the study due to
grade 4 gastrointestinal bleed, determined to be likely
ficlatuzumab related. A copy of the presentation is currently
available in the Publications & Presentations section of AVEO’s
website. Based on these encouraging results, the Company is
planning potential next steps for this program in collaboration
with its ficlatuzumab development and commercialization partner,
Biodesix, Inc.
Second Quarter 2019 Financial Results
- AVEO ended Q2 2019 with $40.2 million in cash, cash equivalents
and marketable securities as compared with $24.4 million at
December 31, 2018.
- Total revenue for Q2 2019 was approximately $0.7 million
compared with $0.4 million for Q2 2018.
- Research and development expense for Q2 2019 was $2.6 million
compared with $4.9 million for Q2 2018.
- General and administrative expense for Q2 2019 was $3.0 million
compared with $2.8 million for Q2 2018.
- Net loss for Q2 2019 was $3.1 million, or net loss of $0.02 per
basic and diluted share, respectively, compared with net income of
$4.0 million for Q2 2018, or income of $0.03 per basic share and a
loss of $0.06 per diluted share.
Financial Guidance
AVEO believes that our approximate $40.2 million in cash, cash
equivalents and marketable securities at June 30, 2019 together
with the $25 million upfront payment from the Kyowa Kirin license
amendment to be received in the third quarter would allow us to
fund our planned operations into the third quarter of 2021. This
estimate excludes, subject to our decision whether to submit an New
Drug Application (NDA) for tivozanib to the U.S. Food and Drug
Administration (FDA) following the availability of more mature OS
results, remaining costs to prepare and filing fees in connection
with a possible NDA submission, and pre-commercialization
activities that we may undertake. This estimate also assumes no
receipt of additional milestone payments from our partners, no
funding from new partnership agreements, no additional equity
financings, no debt financings, no additional sales of equity under
our sales agreement with SVB Leerink and no additional sales of
equity through the exercise of our outstanding warrants.
Accordingly, the timing and nature of activities contemplated for
the remainder of 2019 and thereafter will be conducted subject to
the availability of sufficient financial resources.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma (RCC) in the European
Union plus Norway, New Zealand 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 RCC4. Tivozanib has been
investigated in several tumor types, including renal cell,
hepatocellular, ovarian, colorectal and breast cancers.
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is 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. AVEO and Biodesix, Inc. have a worldwide
agreement to develop and commercialize ficlatuzumab. Ficlatuzumab
is currently being evaluated in investigator-sponsored trials in
squamous cell carcinoma of the head and neck (SCCHN), metastatic
pancreatic ductal cancer (PDAC) and acute myeloid leukemia
(AML).
About AVEO
AVEO Pharmaceuticals is a biopharmaceutical company seeking to
advance targeted medicines for oncology and other unmet medical
needs. The Company’s lead candidate is tivozanib, a potent,
selective, long half-life inhibitor of vascular endothelial growth
factor 1, 2 and 3 receptors, which AVEO is working to develop and
commercialize in North America as a treatment for renal cell
carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers.
Tivozanib (FOTIVDA®) is approved by the European Commission for the
treatment of adult patients with advanced RCC in the European Union
plus Norway, New Zealand, and Iceland. AVEO is leveraging or seeks
to leverage partnerships to develop and commercialize its pipeline
of products and product candidates, including tivozanib in oncology
and other indications in various geographies, and ficlatuzumab (HGF
MAb) in head and neck cancer, pancreatic cancer and acute myeloid
leukemia. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3
MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) for various
oncology indications.
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
within the meaning of the Private Securities Litigation Reform Act
of 1995 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 report the results of an
interim OS analysis for the TIVO-3 trial in the fourth quarter and
make a NDA filing decision following such analysis; AVEO’s
expectation that the OS outcome will be more mature; 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; AVEO’s cash runway; AVEO’s plans and
strategies for commercialization of tivozanib in the United States
and Europe; and AVEO’s 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. 4. Barthelemy et al. ESMO 2018.
Poster 878P
AVEO PHARMACEUTICALS, INC. Condensed
Consolidated Statements of Operations (In thousands, except per
share amounts) (Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2019
2018
2019
2018
Revenues:
Collaboration and licensing revenue
$
493
$
336
$
1,947
$
1,316
Partnership royalties
210
97
367
143
703
433
2,314
1,459
Operating expenses:
Research and development
2,611
4,887
9,463
10,291
General and administrative
2,986
2,827
5,441
5,437
Settlement costs
—
(709
)
—
(667
)
5,597
7,005
14,904
15,061
Loss from operations
(4,894
)
(6,572
)
(12,590
)
(13,602
)
Other income (expense), net:
Interest expense, net
(451
)
(549
)
(1,015
)
(1,042
)
Change in fair value of PIPE Warrant
liability
2,210
11,125
11,025
9,660
Other income, net
1,759
10,576
10,010
8,618
Net income (loss)
$
(3,135
)
$
4,004
$
(2,580
)
$
(4,984
)
Basic net income (loss) per share
Net income (loss) per share
$
(0.02
)
$
0.03
$
(0.02
)
$
(0.04
)
Weighted average number of common shares
outstanding
159,020
118,940
145,736
118,891
Diluted net income (loss) per share
Net income (loss) per share
$
(0.02
)
$
(0.06
)
$
(0.02
)
$
(0.11
)
Weighted average number of common shares
and dilutive common share equivalents outstanding
159,020
128,692
145,736
129,372
Consolidated Balance Sheet Data (In
thousands) (Unaudited)
June 30,
2019
December 31,
2018
Assets
Cash, cash equivalents and marketable
securities
$
40,232
$
24,427
Accounts receivable
611
3,026
Prepaid expenses and other current
assets
819
482
Other assets
—
—
Total assets
$
41,662
$
27,935
Liabilities and stockholders’
equity (deficit)
Accounts payable and accrued expenses
$
8,226
$
12,451
Loans payable, net of discount
19,344
19,033
Deferred revenue and research and
development reimbursements
5,720
5,914
PIPE Warrant liability
5,649
16,674
Other liabilities
1,090
1,090
Stockholder’s equity (deficit)
1,633
(27,227
)
Total liabilities and stockholders’ equity
(deficit)
$
41,662
$
27,935
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190808005132/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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