AVEO Oncology (NASDAQ: AVEO) today reported financial results
for the first quarter ended March 31, 2019 and provided a business
update.
“With a successful recent equity offering, together with the
triggering of a FOTIVDA® (tivozanib) milestone from EUSA, AVEO’s
strengthened balance sheet provides us with a cash runway that we
expect will take us into the fourth quarter of 2020,”
said Michael Bailey, president and chief executive officer
of AVEO. “We remain committed to our goal of improving
outcomes and patient experience in renal cell carcinoma (RCC), and
look forward to reporting more mature interim OS results from our
TIVO-3 study in advanced or metastatic RCC, which we expect will
occur in the fourth quarter of 2019, as well as the subsequent
decision regarding a potential NDA filing in the U.S. We also
continue to make progress with the balance of our programs and
pipeline, most notably the ongoing clinical collaborations
combining FOTIVDA® with Bristol Myers Squibb’s OPDIVO® (nivolumab)
for the TiNivo study in RCC and with AstraZeneca’s IMFINZI®
(durvalumab) in first-line hepatocellular carcinoma, ongoing
studies of ficlatuzumab in multiple oncology indications, and the
emerging potential of a new ocular formulation of tivozanib for the
treatment of age-related macular degeneration.”
Recent Highlights
- $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 February 2019 reimbursement approval and subsequent
commercial launch of FOTIVDA® (tivozanib) in Spain as a first-line
treatment of adult patients with RCC.
- Closing of 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 25,000,000 warrants to purchase 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 ongoing clinical and
preclinical development of AVEO’s product candidates, as well as
for working capital and other general corporate purposes.
- Announced Positive Results from
Phase 1b Ficlatuzumab-Cytarabine Trial (CyFi) in Patients with
Relapsed and Refractory AML. In April 2019, AVEO announced the
presentation of positive 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, LFT
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 & Presentation section of AVEO’s
website.Based on these results, the Company is evaluating potential
next steps for this program in collaboration with its ficlatuzumab
development and commercialization partner, Biodesix, Inc.
- Appointed Gregory T. Mayes to Board
of Directors. In February 2019, the Company announced the
appointment of Gregory T. Mayes to its Board of Directors. Mr.
Mayes brings to the AVEO Board over 20 years of experience as a
biopharmaceutical executive with deep expertise in public company
governance, business strategy and the commercialization of life
sciences products.
- Presented Topline Results from
TIVO-3 in an Oral Presentation at the 2019 ASCO Genitourinary
Cancers Symposium and Announced Updated NDA Timing. In February
2019, AVEO presented topline results from the TIVO-3 trial, AVEO’s
Phase 3 randomized, controlled, multi-center, open-label study to
compare tivozanib to sorafenib in 350 subjects with refractory
advanced or metastatic RCC at the 2019 American Society of Clinical
Oncology (ASCO) Genitourinary (GU) Cancers Symposium held February
14-16, 2019 in San Francisco. The results were presented during an
oral presentation titled “TIVO-3: A Phase 3, Randomized,
Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to
Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma
(RCC).” A copy of the presentation is currently available in the
Publications & Presentation section of AVEO’s website.The
presentation noted that the TIVO-3 trial met its primary endpoint
of demonstrating a statistically significant benefit in
progression-free survival (PFS) versus sorafenib. There was also a
significant PFS improvement demonstrated for tivozanib both in the
subgroups of patients who received prior PD-1 therapy and those who
received two prior VEGF TKI therapies. The secondary endpoint of
overall response rate demonstrated a statistically significant
improvement for patients receiving tivozanib compared to sorafenib.
The analysis of the secondary endpoint of overall survival (OS) was
not mature at the time of the final PFS analysis, but the hazard
ratio at the time of the analysis favored sorafenib. Tivozanib was
generally well-tolerated, with grade 3 or higher adverse events
consistent with those observed in previous tivozanib trials.
Infrequent but severe adverse events reported in greater number in
the tivozanib arm were thrombotic events similar to those observed
in previous tivozanib studies. The most common adverse event in
patients receiving tivozanib was hypertension, an adverse event
known to reflect effective VEGF pathway
inhibition.AVEO intends to initiate an additional interim OS
analysis in August 2019, the results of which are expected to
be reported in the fourth quarter of 2019 and would be the first
planned update since the prior OS analysis was initiated in the
fourth quarter of 2018. At the recommendation of the U.S. Food and
Drug Administration, AVEO plans to make a New Drug Application
(NDA) filing decision following the availability of more mature OS
results.
First Quarter 2019 Financial Results
- AVEO ended Q1 2019 with $23.5 million
in cash, cash equivalents and marketable securities as compared
with $24.4 million at December 31, 2018.
- Total revenue for Q1 2019 was
approximately $1.6 million compared with $1.0 million for Q1
2018.
- Research and development expense for Q1
2019 was $6.9 million compared with $5.4 million for Q1 2018.
- General and administrative expense for
Q1 2019 was $2.5 million compared with $2.6 million for Q1
2018.
- Net income for Q1 2019 was $0.6
million, or net income of $0.01 and net loss of $0.06 per basic and
diluted share, respectively, compared with a net loss of $9.0
million for Q1 2018, or net loss of $0.08 per basic and diluted
share.
- The Q1 2019 net income was driven by an
approximate $8.8 million non-cash gain attributable to the decrease
in the fair value of the 2016 PIPE warrant liability that
principally resulted from the decrease in the stock price that
occurred during the fiscal quarter. In Q1 2018, the non-cash loss
attributable to the increase in the fair value of such warrant
liability was $1.5 million.
Financial Guidance
AVEO believes that our approximate $23.5 million in cash, cash
equivalents and marketable securities at March 31, 2019, along with
approximately $24.2 million in additional net funding received in
the second quarter of 2019 to-date, as described above, would allow
us to fund our planned operations into the fourth quarter of 2020.
This estimate excludes possible additional clinical trials we may
sponsor and, subject to our decision whether to submit an NDA for
tivozanib to the FDA following the availability of more mature OS
results, remaining costs to prepare and filing fees in connection
with a possible NDA submission, any related drug manufacturing and
drug supply distribution, 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 Leerink
Sales Agreement 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 Hakko Kirin and approved for the
treatment of adult patients with advanced renal cell carcinoma
(RCC) in the European Union
plus Norway 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 RCC. Tivozanib has been
investigated in several tumor types, including renal cell,
hepatocellular, colorectal and breast cancers. In addition, a new
formulation of tivozanib is in pre-clinical development for the
treatment of age-related macular degeneration.
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 (HNSCC), metastatic pancreatic ductal cancer (PDAC),
and acute myeloid leukemia (AML).
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company seeking to advance targeted medicines for
oncology and other unmet medical needs. The Company is working to
develop and commercialize its lead candidate tivozanib in North
America as a treatment for RCC. The Company has sublicensed
tivozanib (FOTIVDA®) for oncological indications in Europe and
other territories outside of North America. Tivozanib is approved
in the European Union, as well as Norway and Iceland, for the
first-line treatment of adult patients with RCC and for adult
patients who are vascular endothelial growth factor receptor and
mTOR pathway inhibitor-naïve following disease progression after
one prior treatment with cytokine therapy for RCC. The Company also
has clinical collaborations to study tivozanib in combination with
immune checkpoint inhibitors in RCC and in hepatocellular
carcinoma. In addition, a new formulation of tivozanib is in
pre-clinical development for the treatment of age-related macular
degeneration. As part of the Company’s strategy, the Company has
also entered into partnerships to help fund the development and
commercialization of its other product candidates. Ficlatuzumab, a
hepatocyte growth factor inhibitory antibody, is currently being
tested in several investigator sponsored studies jointly funded by
the Company and one of its development partners for the potential
treatment of HNSCC, AML, and PDAC. The Company’s partner for
AV-203, an anti-ErbB3 monoclonal antibody, is planning to initiate
clinical studies in China in 2019 in esophageal squamous cell
carcinoma and has committed to funding the development of AV-203
through proof-of-concept. The Company has recently regained the
rights to AV-380, a humanized IgG1 inhibitory monoclonal antibody
targeting growth differentiation factor 15, a divergent member of
the TGF-ß family, for the potential treatment of cancer cachexia,
and is working to initiate preclinical toxicology studies in 2019
to support the potential filing of an investigational new drug
application with the FDA. The Company is evaluating options for the
development of AV-353, a preclinical asset which targets the Notch
3 pathway.
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 initiate an interim OS
analysis for the TIVO-3 trial in August 2019 and to report the
results of this analysis in the fourth quarter and make a NDA
filing decision following such analysis; AVEO’s expectation that
the OS outcome will be more mature by August 2019; 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; timing for the commencement of the
Phase 1 portion of the IMFINZI and tivozanib combination study;
AVEO’s cash runway; AVEO’s plans and strategies for
commercialization of tivozanib in the United States and Europe;
AVEO’s plan to develop the AV-353 platform; AVEO’s plans regarding
AV-380 and AVEO’s other 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 20172. 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.
Condensed Consolidated Statements of
Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months EndedMarch
31,
2019
2018 Revenues: Collaboration and licensing revenue $
1,454
$ 980 Partnership royalties 157 46 1,611
1,026 Operating expenses: Research and development 6,852
5,404 General and administrative 2,455 2,610
Settlement costs
— 42 9,307 8,056 Loss from operations
(7,696 ) (7,030) Other income (expense), net: Interest expense, net
(564 ) (493) Change in fair value of PIPE Warrant liability
8,815 (1,465) Other income (expense), net 8,251
(1,958) Net income (loss) $ 555 $ (8,988) Basic net
income (loss) per share Net income (loss) per share $ 0.01 $ (0.08)
Weighted average number of common shares outstanding 132,304
118,840 Diluted net income (loss) per share Net
income (loss) per share $ (0.06 ) $ (0.08) Weighted average number
of common shares and dilutive common share
equivalents outstanding
132,831 118,840
Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
March 31,2019
December 31,2018
Assets
Cash, cash equivalents and marketable securities $ 23,483 $
24,427 Accounts receivable 2,571 3,026 Prepaid expenses and other
current assets 241 482 Other assets 212 — Total
assets $ 26,507 $ 27,935
Liabilities and stockholders’
deficit
Accounts payable and accrued expenses $ 10,593 $ 12,451 Loans
payable, net of discount 19,199 19,033 Deferred revenue and
research and development reimbursements 6,342 5,914 PIPE Warrant
liability 7,859 16,674 Other liabilities 1,090 1,090 Stockholder’s
deficit (18,576 ) (27,227 ) Total liabilities and
stockholders’ deficit $ 26,507 $ 27,935
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190509005222/en/
AVEO:David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
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