- U.S. Commercial Launch Preparations Underway
Supporting the Tivozanib PDUFA Target Action Date of March 31, 2021
–
- Ficlatuzumab Worldwide Rights Regained; Final
Results from Open Label Randomized Phase 2 HNSCC Study and Plans
for Pivotal Program Expected in the Middle of 2021 –
- AV-380 IND Submission Expected by Year-end;
Phase 1 Clinical Study Planned for the First Quarter of 2021 –
AVEO Oncology (Nasdaq: AVEO) today reported financial results
for the third quarter ended September 30, 2020 and provided a
business update.
“In advance of the Food and Drug Administration’s (FDA) March
31, 2021 Prescription Drug User Fee Act (PDUFA) target action date
for our tivozanib New Drug Application, we are actively building
out AVEO’s U.S. commercial infrastructure to support the
FDA-pending U.S. launch of tivozanib in relapsed or refractory
renal cell carcinoma (RCC),” said Michael Bailey, president and
chief executive officer of AVEO. “Market data suggests that a
significant and growing demand exists for effective and better
tolerated treatment options for these patients. These data also
suggest that roughly half of patients currently forego treatment in
the third- and fourth-line of treatment.1 We believe tivozanib has
the potential to help address some of these challenges and provide
patients with a new option for continuing their fight against
cancer.”
Mr. Bailey added, “Beyond our ongoing development of tivozanib
as a potential monotherapy treatment, we are continuing our work in
the immunotherapy combination setting as a key area of focus, given
tivozanib’s tolerability profile and effects on reducing regulatory
T-cells2 to potentially enhance activity of the immune system. In
addition, we further enhanced our pipeline by regaining full global
rights to our second late-stage asset, ficlatuzumab, and have
secured additional manufacturing capacity to enable a potential
registrational Phase 3 trial in head and neck squamous cell cancer
(HNSCC) in 2022. Finally, we remain on track to file an
Investigational New Drug (IND) application by the end of the year
for AV-380 for the treatment of cancer cachexia, with a potential
Phase 1 study in the first quarter of 2021, following the IND safe
to proceed letter.”
Tivozanib Updates
- Announced Publication of Results from Phase 1b/2 TiNivo
Study of Tivozanib in Combination with OPDIVO® (nivolumab) in RCC
in Annals of Oncology. In November 2020, AVEO announced that
previously reported results from the Phase 1b/2 TiNivo study of
oral (PO) tivozanib (FOTIVDA®), AVEO’s next-generation vascular
endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor
(TKI) drug candidate, in combination with intravenous (IV)
nivolumab (OPDIVO®, Bristol-Myers Squibb), an immune checkpoint, or
PD-1, inhibitor, for the treatment of advanced RCC, were published
in Annals of Oncology. The article, titled “TiNivo: Safety and
Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients
with Metastatic Renal Cell Carcinoma”, is available online first
via this link. AVEO is also studying tivozanib in combination with
IMFINZI® (durvalumab), AstraZeneca’s human monoclonal antibody
directed against programmed death-ligand 1 (PD-L1), in patients
with first-line metastatic hepatocellular carcinoma (HCC) in the
Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase
2.
- Published Final Overall Survival Results from Phase 3 TIVO-3
Study of Tivozanib in RCC in European Urology. In September
2020, AVEO announced that final overall survival (OS) results from
its pivotal Phase 3 TIVO-3 study comparing tivozanib to sorafenib
in third- and fourth-line RCC were published in the journal
European Urology. The article, titled “Final Overall Survival
Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as
Third- or Fourth-line Therapy in Subjects with Metastatic Renal
Cell Carcinoma,” is available online via this link.
- Preparations Ongoing to Support Commercial Launch of
Tivozanib in the U.S. Following the PDUFA Date (March 31,
2021). In preparation for the potential commercial launch of
tivozanib in the U.S., the Company continues to expand its sales,
marketing, market access and medical affairs teams, and is working
to put in place its U.S. distribution capabilities by the end of
the year. In connection with these preparations, in October 2020,
AVEO announced the appointment of David W. Crist as vice president
of sales. Mr. Crist, who brings to AVEO over twenty years of
oncology sales experience in both launch-stage and late-stage
companies, will be responsible for building out AVEO’s sales force
in anticipation of the potential marketing approval and launch of
tivozanib in the U.S.
Tivozanib Non-Oncology Partnership Update
- $2.8 Million Development Milestone from Kyowa Kirin Co.,
Ltd. In August 2020, the Company announced that it earned a
$2.8 million development milestone payment from partner Kyowa
Kirin. The milestone relates to acceptance by the Japanese
Pharmaceuticals and Medical Devices Agency of an IND application
for a new formulation of tivozanib in a non-oncology indication
being developed by Kyowa Kirin. Under the terms of AVEO’s agreement
with Kyowa Kirin, in addition to the 2019 upfront payment of $25
million to AVEO, waiver of AVEO’s obligation to make an $18 million
milestone payment upon AVEO gaining U.S. marketing approval of
tivozanib for RCC, and the $2.8 million IND development milestone,
Kyowa Kirin has also agreed to pay AVEO up to an additional $388
million in potential milestone payments upon the successful
achievement of certain development, regulatory, and commercial
objectives in non-oncology indications of tivozanib. Kyowa Kirin
will also be obligated to make tiered royalty payments on the net
sales of a product for these indications, ranging from a high
single-digit to low double-digit percent.
Ficlatuzumab Update
- Regained Full Global Rights to Ficlatuzumab. In
September 2020, AVEO regained full global rights to ficlatuzumab,
the Company’s potent hepatocyte growth factor (HGF) inhibitor
antibody which binds to the HGF ligand with high affinity and
specificity to inhibit HGF/c-Met biological activities. The Company
announced plans to fund the clinical manufacture of ficlatuzumab to
enable a potential registrational Phase 3 clinical trial in HNSCC,
as well as additional potential development in Phase 2 studies in
pancreatic cancer and acute myeloid leukemia. Ficlatuzumab is being
studied in an ongoing randomized confirmatory Phase 2 study in
combination with cetuximab, an EGFR-targeted antibody, in
metastatic HNSCC, which is expected to conclude enrollment in the
fourth quarter of 2020, with results from the study expected in the
middle of 2021. In that timeframe, the Company plans to provide an
update on its pivotal program for ficlatuzumab.
AV-380 Update
- Company on Track for IND Application Submission by Year-end,
with Phase 1 Clinical Study Planned for the First Quarter of
2021. AVEO plans to submit an IND application to the FDA for
AV-380, its first-in-class, potent, humanized inhibitory antibody
targeting GDF15, for the treatment of cancer cachexia by year-end.
Cachexia, a common complication in patients with advanced cancer
and other chronic diseases, is a complex metabolic syndrome
characterized by malnutrition and severe involuntary weight loss
due to the loss of muscle and fat tissue, as well as the clinical
manifestation of anemia, inflammation and suppression of immune
functions. Preparations for a Phase 1 trial are currently
underway.
Corporate Updates
- Announced Restructuring of Existing Term Loan with Closing
of New Tranched, $35 Million Debt Facility, Potentially Providing
for Working Capital into 2022. In August 2020, The Company
announced the closing of a tranched, $35 million debt facility with
Hercules Capital, Inc. and its affiliates. Under the terms of the
agreement, the initial tranche of $15 million fully refinanced
AVEO’s existing Hercules term loan facility, which had an
outstanding principal amount of approximately $9.7 million,
providing net new proceeds of $5.3 million. A second $10 million
tranche is contingent upon the approval of the tivozanib New Drug
Application by the FDA as a treatment for RCC, and certain other
terms and conditions. An additional two $5 million tranches would
potentially become available after that time – one if net product
revenues of tivozanib reach $20.0 million within a specified time
frame, and the other upon the lender’s consent.
A current summary of the Company’s activities and corporate
updates is available in AVEO’s corporate presentation available on
the investor relations portion of the Company’s website at
investor.aveooncology.com.
Third Quarter 2020 Financial Results
- AVEO ended Q3 2020 with $68.8 million in cash, cash equivalents
and marketable securities as compared with $47.7 million at
December 31, 2019.
- Total revenue was approximately $3.6 million for Q3 2020
compared with $25.7 million for Q3 2019. The third quarter of 2019
included the $25.0 million upfront payment pursuant to AVEO’s
agreement with Kyowa Kirin for non-oncology indications of
tivozanib.
- Research and development expense for Q3 2020 was $5.9 million
compared with $4.0 million for Q3 2019.
- General and administrative expense for Q3 2020 was $5.8 million
compared with $2.9 million for Q3 2019.
- Net loss for Q3 2020 was $8.4 million, or net loss of $0.33 per
basic and diluted share, compared with net income of $16.4 million
for Q3 2019, or net income of $1.02 per basic and diluted share,
respectively.
Financial Guidance
AVEO believes that its $68.8 million in cash, cash equivalents
and marketable securities as of September 30, 2020, along with
anticipated partnership cost sharing reimbursements, royalties from
EUSA’s FOTIVDA sales and, if the pending marketing application for
FOTIVDA is approved by the FDA, resulting product revenues upon
commercial launch and the potential additional $20 million in
credit under the Hercules loan, would allow the Company to fund
planned operations into 2022.
In accordance with Accounting Standards Update No. 2014-15,
Disclosure of Uncertainties about an Entity’s Ability to Continue
as a Going Concern (Accounting Standards Codification Subtopic
205-40), cash flows that are contingent on FDA approval, such as
product revenues, cannot be reflected in the going concern
assessment. As a result, Hercules loan funding contingent on such
approval and revenue is also excluded from the Company’s going
concern assessment. Accordingly, the Company continues to have a
going concern opinion.
About Tivozanib (FOTIVDA®)
Tivozanib is an oral, once-daily, next-generation vascular
endothelial growth factor receptor (VEGFR) tyrosine kinase
inhibitor (TKI) discovered by Kyowa Kirin and approved as FOTIVDA®
for the treatment of adult patients with advanced renal cell
carcinoma (RCC) in the European Union and other countries in the
EUSA territory. 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.3,4
Tivozanib is being studied in the TIVO-3 trial, which is supporting
a regulatory submission of tivozanib in the U.S. seeking marketing
approval as a treatment for adult patients with relapsed or
refractory advanced RCC. Tivozanib has been shown to significantly
reduce regulatory T-cell production in preclinical models2 and has
demonstrated synergy in combination with nivolumab (anti PD-1) in a
Phase 2 study in RCC.5 Tivozanib has been investigated in several
tumor types, including renal cell, hepatocellular, colorectal,
ovarian and breast cancers. Tivozanib is also being studied by
partner Kyowa Kirin in non-oncology indications.
About AVEO Pharmaceuticals, Inc.
AVEO is an oncology-focused biopharmaceutical company committed
to delivering medicines that provide a better life for cancer
patients. 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, is approved as FOTIVDA® in the European Union and other
countries in the EUSA territory for the treatment of adult patients
with advanced renal cell carcinoma. AVEO is working to develop and
potentially commercialize tivozanib in the U.S. as a treatment for
renal cell carcinoma and hepatocellular carcinoma. AVEO has
previously reported promising early clinical data on ficlatuzumab
(anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and
pancreatic cancer and is conducting a randomized Phase 2
confirmatory clinical trial of ficlatuzumab in head and neck
cancer. AVEO’s earlier-stage pipeline includes several monoclonal
antibodies in oncology development, including AV-203 (anti-ErbB3
mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO
is committed to creating an environment of diversity and inclusion
as a foundation for innovation.
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,” “hope,” “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 advancement of AVEO’s pipeline,
including the advancement of ficlatuzumab in multiple clinical
studies; the potential efficacy, safety and tolerability of
ficlatuzumab, both as a stand-alone drug candidate and in
combination with other therapies; the potential outcomes from
studies of ficlatuzumab to provide AVEO with opportunities to
pursue regulatory strategies; the potential clinical utility of
ficlatuzumab in areas of unmet need; the potential for tivozanib as
a treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC; 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 execution of its clinical and regulatory
strategy for tivozanib; AVEO’s plans and strategies for current and
future clinical trials of tivozanib, ficlatuzumab and AV-380 and
for commercialization of tivozanib in the United States; AVEO’s
expectations about its cash runway and its cash runway guidance;
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: whether the results of TIVO-3 are sufficient to obtain
marketing approval for tivozanib in the U.S., which turns on the
ability of AVEO to demonstrate to the satisfaction of the FDA the
safety and efficacy of tivozanib based upon the findings of TIVO-3,
including its data with respect to PFS, the rate of adverse events,
OS and other information that the FDA may consider to be relevant
to an approval determination; 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; 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,
including its ability to successfully launch and commercialize
tivozanib if it may be approved for commercialization by the FDA;
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; AVEO’s ability to access future borrowings under the
Hercules loan facility, which turns on the achievement of
milestones related to the approval and commercialization of
tivozanib in the U.S., which milestones may not be achieved;
adverse general economic and industry conditions; the potential
adverse effects of the COVID-19 pandemic on AVEO’s business
continuity, financial condition, results of operations, liquidity
and ability to successfully and timely enroll, complete and
read-out data from its clinical trials; 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
- Decision Resources, 2019
- Pawlowski N et al. AACR 2013. Poster 3971
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9
- 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,
2020
2019
2020
2019
Revenues:
Collaboration and licensing revenue
$
3,293
$
25,494
$
4,280
$
27,441
Partnership royalties
307
223
853
590
3,600
25,717
5,133
28,031
Operating expenses:
Research and development
5,860
3,983
18,105
13,446
Selling, general and administrative
5,800
2,884
13,209
8,325
11,660
6,867
31,314
21,771
Income (loss) from operations
(8,060
)
18,850
(26,181
)
6,260
Other income (expense), net:
Interest expense, net
(419
)
(467
)
(1,083
)
(1,482
)
Change in fair value of PIPE Warrant
liability
86
(1,954
)
3,184
9,071
Other income (expense), net
(333
)
(2,421
)
2,101
7,589
Net income (loss)
$
(8,393
)
$
16,429
$
(24,080
)
$
13,849
Basic net income (loss) per share
Net income (loss) per share
$
(0.33
)
$
1.02
$
(1.22
)
$
0.92
Weighted average number of common shares
outstanding
25,808
16,074
19,773
15,079
Diluted net income (loss) per share
Net income (loss) per share
$
(0.33
)
$
1.02
$
(1.22
)
$
0.92
Weighted average number of common shares
and dilutive common share equivalents outstanding
25,808
16,083
19,773
15,129
Consolidated Balance Sheet
Data
(In thousands)
(Unaudited)
September 30,
2020
December 31,
2019
Assets
Cash, cash equivalents and marketable
securities
$
68,844
$
47,745
Accounts receivable
1,052
1,631
Prepaid expenses and other current
assets
1,746
1,224
Property and equipment, net
210
—
Operating lease right-of-use asset
1,012
—
Other assets
158
—
Total assets
$
73,022
$
50,600
Liabilities and stockholders’
equity
Accounts payable and accrued expenses
$
11,335
$
9,482
Loans payable, net of discount
13,617
15,766
Deferred revenue and research and
development reimbursements
3,286
4,619
PIPE Warrant liability
1,913
5,097
Operating lease liability
815
—
Other liabilities
1,833
790
Stockholder’s equity
40,223
14,846
Total liabilities and stockholders’
equity
$
73,022
$
50,600
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109006084/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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