AVEO Reports First Quarter 2019 Financial Results and Provides Business Update

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 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.

Contacts

AVEO:
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com