AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the full year ended December 31, 2019 and provided a business
update.
“The coming months will be an important period for AVEO, with
filing of a New Drug Application (NDA) for tivozanib as a treatment
for relapsed or refractory renal cell carcinoma (RCC) planned for
the end of this quarter, and reporting of the final overall
survival (OS) update for the TIVO-3 trial expected by June,” said
Michael Bailey, president and chief executive officer of AVEO. “As
we work toward the potential FDA marketing approval of tivozanib,
our attention will turn increasingly to commercialization and
potential expanded clinical opportunities, while further advancing
the balance of our pipeline. We continue to believe that our
tivozanib dataset in RCC, which provides insights into the
sequencing of therapies, notably, following immunotherapy,
positions tivozanib well within this meaningful and growing
relapsed or refractory RCC patient population.”
Mr. Bailey added: “In addition, we look forward to continuing to
build on the clinical evaluation of tivozanib-immunotherapy (IO)
combinations, such as those studied in the TiNivo trial of
tivozanib and OPDIVO® (nivolumab) in RCC, for which we reported
encouraging final PFS data at last year’s ESMO Conference, and the
DEDUCTIVE trial of tivozanib and IMFINZI® (durvalumab) in
hepatocellular carcinoma (HCC). With a favorable tolerability
profile and results suggesting additive or synergistic activity in
both treatment naïve and previously treated RCC patients, our early
data support the potential for tivozanib to serve as a TKI
companion in combination with IO therapy. Beyond tivozanib,
building on promising results seen to date, we look forward to
continued progress in the evaluation of ficlatuzumab in multiple
clinical trials, including two ongoing randomized Phase 2 trials,
one in acute myeloid leukemia (AML) and one in head and neck
cancer, with the goal of identifying a pivotal trial design for
registration, assuming favorable trial outcomes.”
Phase 3 TIVO-3 Trial and North America Regulatory
Highlights
- Published Data from Phase 3 TIVO-3 Trial in Lancet
Oncology. In December 2019, AVEO announced that previously
reported data from its positive Phase 3 TIVO-3 trial were published
in The Lancet Oncology. The article, titled “Tivozanib versus
sorafenib in patients with advanced renal cell carcinoma (TIVO-3):
a phase 3, multicentre, randomised, controlled, open-label study”,
is available online via this link.
- Presented Updated OS and Subgroup Data from TIVO-3 Trial at
the 18th International Kidney Cancer Symposium. In November
2019, AVEO announced updated data from the Phase 3 TIVO-3 trial,
including two prespecified subgroup analyses of patients previously
treated with a checkpoint inhibitor and a VEGFR TKI, or two VEGFR
TKIs. Each of the prespecified subgroups showed superior
progression free survival (PFS) and overall response rate, as well
as an OS HR below 1, favoring tivozanib. Tivozanib was shown to
have lower overall rates of adverse events and fewer dose
interruptions and reductions versus sorafenib, indicating better
patient tolerability. A copy of the presentation, which was
presented at the 18th International Kidney Cancer Symposium, is
available in the Publications & Presentations section of AVEO’s
website.
- NDA Submission Expected This Month and Final OS Analysis
Report Expected by June. The Company continues to expect to
submit an NDA to the U.S. FDA in relapsed/refractory RCC by the end
of this month. As previously announced, a final OS analysis of the
study will be conducted in the second quarter based on a May 1,
2020 data cutoff date, at which point the Company estimates that
the study will have reached approximately 263 OS events. AVEO
expects to report results from the final OS analysis by June 2020.
The FDA and the Company agreed that if, during the review, the
final analysis yields an OS HR above 1.00, the Company will
withdraw its NDA. The FDA informed the Company that an Oncologic
Drugs Advisory Committee panel would likely be convened to review
the final tivozanib data package.
Additional Tivozanib Updates
- Announced Publication of Phase 1b/2 Trial of Tivozanib in
Advanced, Inoperable HCC in the British Journal of Cancer. In
February 2020, AVEO announced the publication of results from a
monotherapy trial of tivozanib in patients with advanced,
inoperable HCC in the British Journal of Cancer. 27 patients were
enrolled in the trial that sought to evaluate the safety, dosing,
pharmacokinetics, pharmacodynamics, and preliminary anti-tumor
activity of tivozanib in patients with advanced HCC. The
recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once
daily for 21 days followed by 7 days off treatment on a 28-day
cycle. Median PFS and OS were 24 weeks and 9 months, respectively,
for patients treated at the RP2D, with an overall response rate of
21%. A significant decrease in soluble plasma VEGFR-2 was also
observed, suggesting adequate target engagement. The link to this
publication is available on the Publications & Presentations
section of AVEO’s website.
- Announced Initiation of Enrollment in Phase 1b/2 DEDUCTIVE
Trial of Tivozanib in Combination with IMFINZI® (durvalumab) in
Previously Untreated Metastatic HCC. In September 2019, AVEO
announced the initiation of enrollment in the DEDUCTIVE trial, an
open-label, multi-center Phase 1b/2 clinical trial evaluating
tivozanib in combination with IMFINZI® (durvalumab), AstraZeneca’s
human monoclonal antibody directed against programmed death-ligand
1 (PD-L1), in patients with HCC who have not received prior
systemic therapy. The trial is being conducted as part of a
clinical collaboration between AVEO and AstraZeneca.
- Announced Kyowa Kirin Buy Back of Tivozanib
Non-Oncology Rights from AVEO. In August 2019, AVEO and Kyowa
Kirin Co., Ltd. amended the companies’ license agreement for
tivozanib 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 received a
$25 million upfront payment and a waiver of the $18 million
milestone payment that would have been due to Kyowa Kirin upon AVEO
obtaining U.S. marketing 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 percentage
of net sales.
Ficlatuzumab Update
- Presented Results from Phase 1b Trial of Ficlatuzumab,
Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer.
In January 2020, AVEO and Biodesix, Inc. announced the presentation
of results from an investigator-sponsored Phase 1b trial of
ficlatuzumab, AVEO’s potent hepatocyte growth factor inhibitory
antibody product candidate, in combination with nab-paclitaxel and
gemcitabine in patients with previously untreated metastatic
pancreatic ductal adenocarcinoma. The results were presented during
a poster session at the 2020 American Society of Clinical Oncology
(ASCO) Gastrointestinal (GI) Cancers Symposium. A total of 24
patients were enrolled. The average number of 28-day cycles
received was 7.5 (range 1-15), with 3 patients remaining on active
treatment at the end of the trial. The combination was associated
with a promising durable response rate relative to data observed
for gemcitabine and nab-paclitaxel alone. This included a 29%
partial response (PR) rate and 92% rate of disease control (PR +
stable disease). Treatment with this regimen was associated with
significant hypoalbuminemia and edema, and therefore a follow up
safety study is under consideration of ficlatuzumab in combination
with an alternate cytotoxic regimen. A copy of the presentation is
available in the Publications & Presentations section of AVEO’s
website.
- Initiated CyFi-2 Trial of Ficlatuzumab in Relapsed and
Refractory AML. In November 2019, AVEO and Biodesix, Inc.
announced the initiation of the CyFi-2 study, a randomized Phase 2
clinical trial evaluating ficlatuzumab, AVEO’s potent hepatocyte
growth factor (HGF) inhibitory antibody product candidate, in
combination with high-dose cytarabine vs. high-dose cytarabine
alone in patients with relapsed and refractory AML. AVEO will
sponsor the CyFi-2 study for patients with AML who failed induction
chemotherapy or who achieved a complete response but relapsed
within one year. The CyFi-2 study is being conducted as part of the
companies’ worldwide partnership to develop and commercialize
ficlatuzumab. Under the terms of this agreement, AVEO and Biodesix
equally share all development costs.
Recent Corporate Updates
- Effected 1-for-10 Reverse Stock Split. In February 2020,
the holders of a majority of AVEO’s outstanding shares of common
stock approved a reverse stock split and gave AVEO’s Board of
Directors authority to select a ratio for the split ranging from
1-for-5 to 1-for-15. The Board of Directors approved the reverse
stock split at a ratio of 1-for-10, and it became effective on
February 19, 2020. AVEO’s common stock began trading on the Nasdaq
Capital Market on a split-adjusted basis on February 20, 2020.
- Appointed Erick J. Lucera as Chief Financial Officer. In
January 2020, AVEO announced the appointment of Erick Lucera as
chief financial officer. Mr. Lucera brings to AVEO over twenty
years of financial, operational, and investment experience in the
biotechnology and medical device industries and will be responsible
for managing all aspects of the Company’s financial and accounting
functions.
- Added Scarlett Spring to Board of Directors. In November
2019, AVEO announced the appointment of Scarlett Spring to its
Board of Directors. Ms. Spring brings to AVEO extensive sales,
commercial, and leadership experience in the biopharmaceutical and
life sciences industries.
- Key Commercial and Medical Affairs Leadership
Appointments. AVEO appointed Jason Noto, Vice President of
Market Access; Kevin Peacock, Vice President of Marketing; and
Daniel Powers, D.O., Vice President of Medical Affairs.
Full Year 2019 Financial Highlights
- AVEO ended 2019 with $47.7 million in cash, cash equivalents
and marketable securities as compared with $24.4 million at
December 31, 2018.
- Total revenue for 2019 was approximately $28.8 million compared
with $5.4 million for 2018. In August 2019, AVEO earned a $25
million upfront payment in connection with Kyowa Kirin’s buy back
of tivozanib non-oncology rights.
- Research and development expense for 2019 was $18.0 million
compared with $20.7 million for 2018.
- General and administrative expense for 2019 was $11.2 million
compared with $10.8 million for 2018.
- Net income for 2019 was $9.4 million, or net income of $0.61
per basic and diluted share, compared with a net loss of $5.3
million for 2018, or a loss of $0.44 and $1.93 per basic and
diluted share, respectively (adjusted to reflect the 1-for-10
reverse stock split described above).
- Net income in 2019 reflects an approximate $11.6 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. The net loss in 2018 was partially offset by an
approximate $19.9 million non-cash gain attributable to the
decrease in the fair value of such warrant liability.
- On August 1, 2019, as scheduled and included in AVEO’s cash
guidance below, AVEO resumed principal payments of approximately
$0.8 million per month on the $20.0 million Hercules loan that
matures on July 1, 2021.
Financial Guidance
AVEO believes that its cash, cash equivalents and marketable
securities of approximately $47.7 million at December 31, 2019,
along with anticipated partnership payments from cost sharing
obligations and royalty revenues from sales of FOTIVDA® by EUSA,
would allow the Company to fund its planned operations into the
second quarter of 2021.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor receptor (VEGFR) 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, the United Kingdom, 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 is being studied in the TIVO-3 trial, which is intended
to support a regulatory submission of tivozanib in the U.S. seeking
marketing approval as a treatment for relapsed/refractory RCC.
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, colorectal, ovarian 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 squamous cell carcinoma of the head
and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC), and
acute myeloid leukemia (AML).
About AVEO
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. AVEO’s strategy is to focus
its resources toward development and commercialization of its
product candidates in North America, while leveraging partnerships
to support development and commercialization in other geographies.
AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the
European Union, the United Kingdom, Norway, New Zealand and Iceland
for the treatment of adult patients with advanced renal cell
carcinoma. AVEO is working to develop and commercialize tivozanib
in North America as a treatment for renal cell carcinoma,
hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb)
is in Phase 2 clinical trials in head and neck cancer and acute
myeloid leukemia and has reported early clinical data in pancreatic
cancer. AVEO’s earlier-stage pipeline includes several monoclonal
antibodies in oncology development, including AV-203 (anti-ErbB3
MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb). 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,” “designed to,” “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: AVEO’s plans to
submit an NDA for tivozanib at the end of the first quarter of
2020; AVEO’s plans to report the final OS data of the TIVO-3 trial
by June 2020; the potential marketing approval of tivozanib by the
FDA; the commercial and clinical opportunities of tivozanib; the
advancement of AVEO’s pipeline; the potential for tivozanib as a
treatment option for patients with relapsed/refractory or advanced
RCC; the growth of the relapsed/refractory RCC patient population;
the potential efficacy, safety, and tolerability of tivozanib, both
as a stand-alone drug candidate and in combination with other
therapies in several indications; AVEO’s plans to expand its
tivozanib-immunotherapy combination clinical strategy; the clinical
development of ficlatuzumab in multiple clinical studies to
identify a pivotal strategy, including two ongoing phase 2 studies
for the treatment of AML and HNSCC; 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 and ficlatuzumab; 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
impact of the novel coronavirus (COVID-19) outbreak on AVEO’s
clinical trials and other business operations; 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; the outcome of litigation;
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 or a third-party 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.
Consolidated Statements of
Operations
(In thousands, except per
share amounts)
(Unaudited)
Three Months Ended
December 31,
Year Ended December
31,
2019
2018
2019
2018
Revenues:
Collaboration and licensing revenue
$
493
$
1,296
$
27,934
$
4,947
Partnership royalties
271
187
861
462
764
1,483
28,795
5,409
Operating expenses:
Research and development
4,512
5,201
17,958
20,652
General and administrative
2,886
2,625
11,211
10,781
Settlement costs
—
—
—
(667
)
7,398
7,826
29,169
30,766
Loss from operations
(6,634
)
(6,343
)
(374
)
(25,357
)
Other income (expense), net:
Interest expense, net
(333
)
(570
)
(1,815
)
(2,191
)
Change in fair value of PIPE Warrant
liability
2,506
26,431
11,577
19,919
Other income
—
2,300
—
2,300
Other income (expense), net
2,173
28,161
9,762
20,028
Net income (loss)
$
(4,461
)
$
21,818
$
9,388
$
(5,329
)
Basic net income (loss) per share
Net income (loss) per share (1)
$
(0.28
)
$
1.75
$
0.61
$
(0.44
)
Weighted average number of common shares
outstanding (1)
16,077
12,439
15,331
12,059
Diluted net income (loss) per share
Net income (loss) per share (1)
$
(0.28
)
$
(0.35
)
$
0.61
$
(1.93
)
Weighted average number of common shares
and dilutive common share equivalents outstanding (1)
16,077
13,358
15,376
13,073
- All share amounts and per share amounts have been restated to
reflect the 1-for-10 reverse stock split on a retroactive
basis.
Condensed Consolidated Balance
Sheet Data
(In thousands)
(Unaudited)
December 31,
2019
December 31,
2018
Assets
Cash, cash equivalents and marketable
securities
$
47,745
$
24,427
Accounts receivable
1,631
3,026
Prepaid expenses and other current
assets
1,224
482
Other assets
—
—
Total assets
$
50,600
$
27,935
Liabilities and stockholders’
equity (deficit)
Accounts payable and accrued expenses
$
9,482
$
12,451
Loans payable, net of discount
15,766
19,033
Deferred revenue and research and
development reimbursements
4,619
5,914
PIPE Warrant liability
5,097
16,674
Other liabilities
790
1,090
Stockholder’s equity (deficit)
14,846
(27,227
)
Total liabilities and stockholders’ equity
(deficit)
$
50,600
$
27,935
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200316005671/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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