AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the first quarter ended March 31, 2020 and provided a business
update.
“Our recent submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) seeking marketing approval
for tivozanib as a treatment for relapsed or refractory renal cell
carcinoma (R/R RCC) is both an important milestone and a
significant achievement for AVEO,” said Michael Bailey, president
and chief executive officer of AVEO. “There is no current standard
of care for the third+ line R/R RCC population and, prior to
TIVO-3, there was no robust clinical dataset to support treatment
choice. If approved, we believe tivozanib has the opportunity to
address this meaningful and growing segment of treatment. We look
forward to the presentation of results from the final TIVO-3
overall survival (OS) analysis as we continue to build on our
foundation for commercial readiness.”
“In addition, our clinical and business development teams’
attention is turning toward opportunities to expand
tivozanib-immunotherapy combination studies that build on the
TiNivo and DEDUCTIVE trials in RCC and HCC, where we believe
tivozanib’s safety and activity profile could make it a companion
TKI of choice. We also remain committed to advancing the balance of
our pipeline, which includes ficlatuzumab, currently in an ongoing
randomized Phase 2 trial in head and neck cancer (HNSCC) which,
with a favorable outcome, could characterize a potential
registration path, and AV-380, for which we look forward to filing
an IND in the second half of 2020,” continued Mr. Bailey.
Tivozanib Updates
- Final Overall Survival Analysis from the Phase 3 TIVO-3
Trial of Tivozanib in RCC to be Presented at the ASCO 2020 Virtual
Scientific Program. Data from the final OS analysis from AVEO’s
pivotal Phase 3 TIVO-3 trial comparing tivozanib, the Company’s
vascular endothelial growth factor receptor tyrosine kinase
inhibitor, to sorafenib in 3rd and 4th line renal cell carcinoma,
will be presented at the ASCO 2020 Virtual Scientific Program. The
presentation, titled, “TIVO-3: Final OS analysis of a phase III,
randomized, controlled, multicenter, open-label study to compare
tivozanib to sorafenib in subjects with metastatic renal cell
carcinoma (RCC)” (abstract 5062) will be featured during a poster
session (Genitourinary Cancer – Kidney and Bladder). A copy of the
poster will be available at the ASCO virtual meeting and on the
AVEO website Friday, May 29, 2020, at 8:00 AM ET.
- Submitted an NDA to U.S. FDA for Tivozanib in Patients with
Relapsed or Refractory RCC and Results of Final TIVO-3 OS Analysis
Expected by June. In March 2020, AVEO announced the submission
of an NDA to the U.S. FDA seeking marketing approval for tivozanib
as a treatment for relapsed or refractory RCC. 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. 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.
- Announced Publication of Phase 1b/2 Trial of Tivozanib in
Advanced, Inoperable Hepatocellular Carcinoma (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.
Ficlatuzumab Updates
- 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.
- CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML
Discontinued. In March 2020, AVEO and Biodesix, Inc. announced
the discontinuation of their Phase 2 CyFi-2 study of ficlatuzumab
in combination with high-dose cytarabine in relapsed and refractory
AML. The decision was made due to the urgent shift among clinical
sites toward efforts to combat the COVID-19 pandemic, which has
impacted the feasibility of completing the study within the
shelf-life of the current ficlatuzumab clinical trial supply.
Recent Corporate Updates
- Announced New Corporate Headquarters. AVEO today
announced that it recently relocated its headquarters from
Cambridge, Massachusetts to Boston. The new headquarters will lower
overall costs and support further growth as the Company continues
to execute on its tivozanib development strategy and advance the
balance of its pipeline.
- Building out Foundation for Commercial Readiness. As
part of the build-out of its commercial organization ahead of the
potential launch of tivozanib in R/R RCC, AVEO recently announced
the appointment of key commercial and medical affairs leadership,
including Jason Noto, Vice President of Market Access; Kevin
Peacock, Vice President of Marketing; and Daniel Powers, D.O., Vice
President of Medical Affairs. The commercial organization has begun
additional recruitment efforts in medical affairs, market access
and patient access contingent on the near-term OS update from the
TIVO-3 trial.
First Quarter 2020 Financial Results
- AVEO ended Q1 2020 with $33.6 million in cash, cash equivalents
and marketable securities as compared with $47.7 million at
December 31, 2019.
- Total revenue for Q1 2020 was approximately $0.8 million
compared with $1.6 million for Q1 2019.
- Research and development expense for Q1 2020 was $7.8 million
compared with $6.8 million for Q1 2019. Research and development
expense for Q1 2020 includes the $2.9 million application user fee
pursuant to the FDA’s Prescription Drug User Fee Act that was paid
upon the submission of the tivozanib NDA to the U.S. FDA in March
2020.
- General and administrative expense for Q1 2020 was $3.7 million
compared with $2.5 million for Q1 2019.
- Net loss for Q1 2020 was $8.4 million, or net loss of $0.52 per
basic and diluted share, compared with net income of $0.6 million
for Q1 2019, or net income of $0.04 and net loss of $0.62 per basic
and diluted share, respectively.
- The Company recognized approximately $2.6 million and $8.8
million in non-cash gains in Q1 2020 and Q1 2019, respectively,
that were attributable to the decrease in fair value of the 2016
private placement warrant liability that principally resulted from
decreases in the stock price that occurred within each of the
periods.
Financial Guidance
AVEO believes that its cash, cash equivalents and marketable
securities of approximately $33.6 million at March 31, 2020, 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 supporting
a regulatory submission of tivozanib in the U.S. seeking marketing
approval as a treatment for relapsed or 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 a clinical study of patients with
squamous cell carcinoma of the head and neck (HNSCC).
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 a Phase 2 clinical trial in head and neck cancer 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,” “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 potential for tivozanib as a
treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC, and following earlier TKI and
immunotherapy treatment; AVEO’s plan to conduct a final OS analysis
in the second quarter based on a May 1, 2020 data cutoff date and
to report results by June 2020; 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 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: the potential for
unfavorable final OS data from the TIVO-3 trial; the potential for
the FDA to not accept AVEO’s NDA for filing; 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 determine to be relevant to approvability; 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; 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;
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
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9
- Pawlowski N et al. AACR 2013. Poster 3971
- 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 March
31,
2020
2019
Revenues:
Collaboration and licensing revenue
$
493
$
1,454
Partnership royalties
291
157
784
1,611
Operating expenses:
Research and development
7,826
6,852
General and administrative
3,672
2,455
11,498
9,307
Loss from operations
(10,714
)
(7,696
)
Other income, net:
Interest expense, net
(315
)
(564
)
Change in fair value of PIPE Warrant
liability
2,648
8,815
Other income, net
2,333
8,251
Net income (loss)
$
(8,381
)
$
555
Basic net income (loss) per share
Net income (loss) per share
$
(0.52
)
$
0.04
Weighted average number of common shares
outstanding
16,081
13,230
Diluted net income (loss) per share
Net income (loss) per share
$
(0.52
)
$
(0.62
)
Weighted average number of common shares
and dilutive
common share equivalents outstanding
16,081
13,283
Consolidated Balance Sheet
Data (In thousands) (Unaudited)
March 31, 2020
December 31, 2019
Assets
Cash, cash equivalents and marketable
securities
$
33,620
$
47,745
Accounts receivable
2,779
1,631
Prepaid expenses and other current
assets
665
1,224
Property and equipment, net
100
—
Operating lease right-of-use asset
1,225
—
Other assets
158
—
Total assets
$
38,547
$
50,600
Liabilities and stockholders’
equity
Accounts payable and accrued expenses
$
9,541
$
9,482
Loans payable, net of discount
13,486
15,766
Deferred revenue and research and
development reimbursements
4,243
4,619
PIPE Warrant liability
2,449
5,097
Operating lease liability
1,030
—
Other liabilities
790
790
Stockholder’s equity
7,008
14,846
Total liabilities and stockholders’
equity
$
38,547
$
50,600
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200430005254/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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