AVEO Reports Full Year 2016 Financial Results and Provides Business Update
“TIVO-3, our lead clinical program designed to serve as the basis for a
potential U.S. registration for tivozanib as a first- and third-line
treatment for renal cell cancer, continues to enroll ahead of schedule
and has now completed its first safety review,” said
Mr. Bailey continued: “We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203.”
TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEOannounced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first-line treatment for RCC.
First Patient Dosed in Phase 1/2 TiNivo Trial Evaluating Tivozanib
in Combination with Bristol-Myers Squibb’s Opdivo®
(nivolumab) in Advanced RCC.
AVEOannounced today that the first patient has been treated in the Company’s Phase 1/2 TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab), in advanced RCC. The study, which is led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1, which the Company expects to complete in the first half of 2017, will primarily evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib. If the Company receives favorable results, it expects to follow immediately with an expansion Phase 2 at the established combination dose.
Ongoing Review of the Marketing Authorization Application (MAA) in
Europefor Approval of Tivozanib as a First-Line RCC Treatment Option. In February 2017, AVEOannounced that its European licensee for tivozanib, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has received the Day 180 List of Outstanding Issues (LOI) from the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency(EMA). The Day 180 LOI signifies that the MAA is not approvable at the present time and outlines outstanding deficiencies, which are then required to be satisfactorily addressed in an oral explanation and/or in writing prior to a final application decision. EUSA has informed AVEOthat it expects to submit written responses to the Day 180 LOI in April 2017, and the EMA has tentatively scheduled EUSA to provide an oral explanation to the CHMP in May 2017.
Submitted for Presentation Results from Phase 1 Studies of
Ficlatuzumab in Combination with Cetuximab in Head and Neck Squamous
Cell Cancer (HNSCC) and Cytarabine in Acute Myeloid Leukemia (AML). The
Company announced today that results from two investigator sponsored
Phase 1 studies of ficlatuzumab were submitted for presentation at an
upcoming major medical meeting. The first study is designed to explore
cetuximab in combination with ascending doses of ficlatuzumab in
patients with cetuximab-refractory HNSCC patients. The second study is
designed to explore cytarabine in combination with ascending doses of
ficlatuzumab in relapsed/refractory AML.
AVEOand Biodesix, Inc.have a worldwide agreement to develop and commercialize ficlatuzumab.
Full Year 2016 Financial Highlights
AVEOended 2016 with $23.3 million in cash, cash equivalents and marketable securities as compared with $34.1 million at December 31, 2015.
Total collaboration revenue for 2016 was approximately
$2.5 million compared with $19.0 million for 2015.
Research and development expense for 2016 was
$23.7 million compared with $12.9 million for 2015.
General and administrative expenses for 2016 were
$8.2 million compared with $14.2 millionfor 2015.
Net loss for 2016 was
$26.9 million, or a loss of $0.39per basic and diluted share, compared with net loss of $15.0 million for 2015, or a loss of $0.27per basic and diluted share.
We believe that our
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
For the Years Ended
|Collaboration and licensing revenue||$||127||$||3,598||$||2,515||$||19,024|
|Research and development||7,683||3,873||23,703||12,875|
|General and administrative||1,870||5,848||8,205||14,217|
|Restructuring and lease exit||—||—||—||4,358|
|Loss from operations||(9,426||)||(6,123||)||(29,393||)||(12,426||)|
|Other income (expense), net:|
|Change in fair value of warrant liability||4,569||—||4,751||—|
|Other expense, net||(748||)||(462||)||(2,144||)||(2,575||)|
|Other income (expense), net||3,821||(462||)||2,607||(2,575||)|
|Loss before provision for income taxes||(5,605||)||(6,585||)||(26,786||)||(15,001||)|
|Provision for income taxes||—||—||(101||)||—|
|Basic and diluted net loss per share||$||(0.07||)||$||(0.11||)||$||(0.39||)||$||(0.27||)|
|Weighted average number of common shares outstanding||75,863||58,136||69,268||55,701|
Consolidated Balance Sheet Data
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||23,348||$||34,135|
|Prepaid expenses and other current assets||1,940||1,600|
|Property and equipment, net||—||23|
|Liabilities and stockholders’ (deficit) equity|
|Accounts payable and accrued expenses||$||7,715||$||5,531|
|Total loans payable||14,003||9,471|
|Total deferred revenue||2,207||3,695|
|Stockholder’s (deficit) equity||(1,923||)||17,227|
|Total liabilities and stockholders’ (deficit) equity||$||27,285||$||40,542|
Source: AVEO Oncology
David Pitts, 212-600-1902