AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the third quarter ended September 30, 2019 and provided a
business update.
“This quarter we have made meaningful progress toward our goal
of bringing effective and better tolerated therapies to patients
battling kidney and other cancers,” said Michael Bailey, president
and chief executive officer of AVEO. “We are working to submit our
New Drug Application (NDA) in the first quarter of 2020 for
tivozanib as a treatment for relapsed/refractory renal cell
carcinoma (RCC) and to provide a final overall survival (OS) update
for the TIVO-3 study in June 2020. We also continue to make
progress in evaluating tivozanib-immunotherapy combinations, with
recently reported positive results from the TiNivo study of
tivozanib and OPDIVO® (nivolumab) in RCC and the initiation of the
Phase 1b/2 DEDUCTIVE study with IMFINZI® (durvalumab) in
hepatocellular carcinoma. Ficlatuzumab also continues to advance in
the clinic, with the initiation of CyFi-2, a Phase 2 randomized
study in patients with relapsed and refractory acute myeloid
leukemia (AML). Critical to this progress, we continue to maintain
a strong balance sheet that we believe provides us with a cash
runway into the second quarter of 2021.”
Tivozanib North America Regulatory and Phase 3 TIVO-3 Study
Updates
- Announced Plans for TIVO-3 Final OS Analysis and NDA
Submission for Tivozanib. Last week, AVEO provided a regulatory
update following a meeting with the U.S. Food and Drug
Administration (FDA) to discuss results from the August 2019 OS
analysis of the TIVO-3 trial and the Company’s proposal to proceed
with an NDA for tivozanib in relapsed/refractory RCC.
The Company intends to submit an update to
the TIVO-3 statistical analysis plan to the FDA allowing for the
final OS analysis to be conducted, followed by an NDA submission in
the first quarter of 2020, and expects to report results from the
final OS analysis of the TIVO-3 trial in June 2020. The FDA and the
Company agreed that if, during the review, the final analysis
yields an OS hazard ratio (HR) above 1.00, the Company will
withdraw its NDA application. The FDA informed the Company that an
Oncologic Drugs Advisory Committee panel would likely be convened
to review the final tivozanib data package.
TIVO-3 is the Company’s Phase 3 randomized,
controlled, multi-center, open-label study to compare tivozanib,
the Company’s vascular endothelial growth factor receptor tyrosine
kinase inhibitor (VEGFR-TKI), to sorafenib in 350 subjects with
highly refractory metastatic RCC.
- Announced Updated Overall Survival HR of 0.99 in Phase 3
TIVO-3 Trial of Tivozanib in RCC. In September 2019, AVEO
announced results from the second prespecified analysis of OS in
the TIVO-3 trial. These results included an OS HR, which assesses
the relative risk of death for the entirety of the dataset, that
was below 1.00 (HR=0.99; 95% CI: 0.76-1.29; p=0.95).
The data cutoff date for the second
prespecified analysis was August 15, 2019, two years from the last
patient enrolled and approximately ten months from the data cutoff
date for the first prespecified analysis. Between the two data
cutoff dates, 16 additional OS events were reported on the
tivozanib arm and 28 on the sorafenib arm, resulting in a total of
114 OS events on the tivozanib arm and 113 on the sorafenib arm.
Median OS, a point in time value of the OS when half of the
patients within each arm are still alive, was 16.4 months for
tivozanib (95% CI: 13.4-22.2) and 19.7 months for sorafenib (95%
CI: 15.0-24.2). As of the second data cutoff date, twenty patients
remained progression free on the tivozanib arm and two on the
sorafenib arm, with a median duration on study of 32.5 months.
- Updated Data from TIVO-3 Trial to be Presented at the 18th
International Kidney Cancer Symposium. Updated data from the
TIVO-3 trial will be presented during an oral session at the 18th
International Kidney Cancer Symposium being held November 15-16,
2019 in Miami. The presentation, titled “Overall Survival from
Phase 3 TIVO-3 Study in Advanced Renal Cell Carcinoma”, will be
presented on Saturday, November 16 at 9:42 a.m. Eastern Time. The
presentation will include the recently announced OS data, as well
as new data from important subgroups. A copy of the slides will be
available in the Publications & Presentations Section of AVEO’s
website following the presentation.
Additional Tivozanib Updates
- Announced Initiation of Enrollment in Phase 1b/2 DEDUCTIVE
Study 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. AVEO is
serving as the study sponsor, with study costs shared equally by
both parties and clinical drug supplied by each respective
company.
- Presented Final PFS Results from Phase 2 Portion of the
TiNivo Study of Tivozanib and OPDIVO® (nivolumab) in Advanced or
Metastatic RCC. In September 2019, AVEO and EUSA Pharma
announced the presentation of final progression free survival (PFS)
results from the Phase 2 portion of the TiNivo study, a Phase 1b/2
multicenter trial of tivozanib in combination with OPDIVO®
(nivolumab), Bristol-Myers Squibb’s immune checkpoint, or PD-1,
inhibitor, for the treatment of advanced or metastatic RCC. The
data were presented at the European Society of Medical Oncology
(ESMO) 2019 Annual Congress in Barcelona, Spain.
The combination required few dose reductions
and showed additive or synergistic activity for objective response
rate and PFS in both treatment naïve and previously treated
patients with metastatic RCC. Overall median PFS for the 25
patients treated at the study’s full dose and schedule was 18.9
months (95% CI: 16.4; NR). Median PFS for previously untreated
patients (n=12) was 18.5 months, while median PFS for previously
treated patients (n=13) had not yet been reached as of the August
27, 2019 data cutoff date. An objective response rate was observed
in 56% of patients (complete responses + partial responses),
including one treatment naïve patient (1/12) achieving a complete
response, and disease control (complete response + partial response
+ stable disease) was observed in 96% of patients. The most common
treatment-related Grade 3/4 adverse event was hypertension, and
only 17% of patients required a dose reduction.
A copy of the presentation is available in
the Publications & Presentations Section of AVEO’s website.
- 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 received 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.
Ficlatuzumab Update
- Initiation of the CyFi-2 Study of Ficlatuzumab in Relapsed
and Refractory AML. Last week, AVEO and Biodesix, Inc.
announced the initiation of the CyFi-2 study, a randomized Phase 2
clinical study 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, which is
expected to enroll approximately 60 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 Update
Appointment of Key Regulatory, Commercial and Medical Affairs
Leadership Roles. AVEO announced today the appointment of three
individuals to key leadership roles during the fourth quarter:
- Darlene Noci, Interim Head of Regulatory Affairs. Ms.
Noci brings to AVEO over 20 years of leadership experience in
global regulatory affairs and strategic drug development. She
received a Bachelor’s degree in Political Science from Adelphi
University and a Master’s degree in Government from Harvard
University.
- Kevin Peacock, Vice President of Marketing. Mr. Peacock
brings over 15 years of commercial leadership experience in
oncology marketing, strategic planning, and business analytics. He
received his Bachelor’s degree in Business Administration from
Temple University.
- Daniel Powers, D.O., Vice President of Medical Affairs.
Dr. Powers brings to AVEO over 20 years of clinical, academic, and
biopharmaceutical medical affairs experience. He received his
Bachelor’s degree in Chemistry from the University of Massachusetts
Boston and a Doctor of Osteopathic Medicine degree from Rowan
University. He completed his internship and residency in Internal
Medicine at Yale-New Haven Hospital and National Navy Medical
Center.
Third Quarter 2019 Financial Results
- AVEO ended Q3 2019 with approximately $57.7 million in cash,
cash equivalents and marketable securities as compared with $24.4
million at December 31, 2018.
- Total revenue for Q3 2019 was approximately $25.7 million
compared with $2.5 million for Q3 2018.
- Research and development expense for Q3 2019 was $4.0 million
compared with $5.2 million for Q3 2018.
- General and administrative expense for Q3 2019 was $2.9 million
compared with $2.7 million for Q3 2018.
- Net income for Q3 2019 was $16.4 million, or net income of
$0.10 per basic and diluted share, respectively, compared with a
net loss of $22.2 million for Q3 2018, or a loss of $0.18 per basic
and diluted share, respectively.
- On August 1, 2019, as scheduled and included in the Company’s
cash guidance below, the Company 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 $57.7 million at September 30, 2019
would allow the Company to fund its planned operations into the
second quarter of 2021. This estimate is a change from the
Company’s prior quarter guidance as a result of the Company’s plan
to file an NDA for tivozanib, reflecting additional costs related
to the NDA filing, as well as limited commercial launch-readiness
activities.
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, 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 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 seeking 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) drug candidates
being developed 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: AVEO’s plans to submit an NDA for
tivozanib, including the submission of an updated statistical
analysis plan and additional data to the FDA; the potential for
tivozanib as a treatment option for patients with
relapsed/refractory or advanced RCC; the advancement of AVEO’s
pipeline, including AVEO’s plans with respect to advancement of the
DEDUCTIVE trial and the CyFi-2 trial; the potential efficacy,
safety, and tolerability of tivozanib and ficlatuzumab, both as
stand-alone drug candidates and in combination with other therapies
in several indications, including without limitation, AVEO’s
expectations regarding the potential of tivozanib to successfully
meet endpoints in the TIVO-3 trial in RCC and the potential for
outcomes from studies of ficlatuzumab to provide AVEO with
opportunities to pursue regulatory strategies; expected costs of
AVEO’s clinical studies; 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 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
September 30,
Nine Months Ended
September 30,
2019
2018
2019
2018
Revenues:
Collaboration and licensing revenue
$
25,494
$
2,335
$
27,441
$
3,651
Partnership royalties
223
132
590
275
25,717
2,467
28,031
3,926
Operating expenses:
Research and development
3,983
5,160
13,446
15,451
General and administrative
2,884
2,719
8,325
8,156
Settlement costs
—
—
—
(667
)
6,867
7,879
21,771
22,940
Income (loss) from operations
18,850
(5,412
)
6,260
(19,014
)
Other income (expense), net:
Interest expense, net
(467
)
(579
)
(1,482
)
(1,621
)
Change in fair value of PIPE Warrant
liability
(1,954
)
(16,172
)
9,071
(6,512
)
Other income (expense), net
(2,421
)
(16,751
)
7,589
(8,133
)
Net income (loss)
$
16,429
$
(22,163
)
$
13,849
$
(27,147
)
Basic net income (loss) per share
Net income (loss) per share
$
0.10
$
(0.18
)
$
0.09
$
(0.23
)
Weighted average number of common shares
outstanding
160,744
120,138
150,794
119,311
Diluted net income (loss) per share
Net income (loss) per share
$
0.10
$
(0.18
)
$
0.09
$
(0.23
)
Weighted average number of common shares
and dilutive common share equivalents outstanding
160,826
120,138
151,294
119,311
Consolidated Balance Sheet
Data
(In thousands)
(Unaudited)
September 30, 2019
December 31, 2018
Assets
Cash, cash equivalents and marketable
securities
$
57,654
$
24,427
Accounts receivable
1,090
3,026
Prepaid expenses and other current
assets
1,016
482
Other assets
—
—
Total assets
$
59,760
$
27,935
Liabilities and stockholders’
equity (deficit)
Accounts payable and accrued expenses
$
9,087
$
12,451
Loans payable, net of discount
17,971
19,033
Deferred revenue and research and
development reimbursements
5,252
5,914
PIPE Warrant liability
7,603
16,674
Other liabilities
1,090
1,090
Stockholder’s equity (deficit)
18,757
(27,227
)
Total liabilities and stockholders’ equity
(deficit)
$
59,760
$
27,935
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191112005409/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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