AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update
“In the last 18 months, we have made important progress in moving
forward both elements of our strategy, including our oncology pipeline,
for which we have retained significant North American rights, and our
non-oncology pipeline, which is being advanced through partnerships with
disease-area experts,” said
Mr. Bailey added: “For our lead oncology asset, tivozanib, we are well
underway in three simultaneous paths. We expect an approval decision in
first-line renal cell cancer (RCC) in
Potential Corporate Milestones through the First Half of 2017
Regulatory decision for tivozanib in the
European Unionand associated milestone payment by EUSA Pharma;
IND and proof-of-concept milestone payments for tivozanib in acute
macular degeneration by
- Partnership for AV-353, a first-in-class opportunity to address a major unmet need in pulmonary arterial hypertension;
Initial safety results from the Phase 1 portion of the Phase 1/2
AVEO-sponsored TiNivo study of tivozanib in combination with Bristol-Myers Squibb’s Opdivo® (nivolumab);
Development progress and milestone payments for AV-380 in Cachexia by
- Manufacturing tech transfer milestone payment for AV-203 by CANbridge.
Third Quarter and Recent Highlights
Initiation of Phase 1/2 TiNivo Trial Evaluating Tivozanib in
Combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in
Advanced RCC. In
August 2016, AVEOannounced the initiation of a Phase 1/2 clinical trial of AVEO’s oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), tivozanib, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab), in advanced RCC, named the TiNivo Trial. The trial is being led by the Institut Gustave Roussy in Paris under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial is designed to evaluate whether tivozanib’s unique specificity and associated safety profile can overcome the tolerability issues that have challenged TKI-PD1 combinations to date. Initial safety results from the Phase 1 portion of the Phase 1/2 are expected to be available to the companies in the first half of 2017.
Ongoing Review of the Marketing Authorization Application (MAA) in
Europefor Approval of Tivozanib as a First-Line RCC Treatment Option. EUSA Pharma, to which the Company licensed European and additional rights outside North America, is working to submit responses to the European Medicines Agency(EMA) Day 120 List of Questions before year-end. The MAA, which is based on tivozanib’s existing dataset, including the Phase 3 TIVO-1 study of tivozanib in first-line RCC, seeks approval for tivozanib as a first-line treatment for advanced RCC under the EMA’s centralized review process. Following the response, EUSA Pharma expects to receive the EMA Day 180 List of Outstanding Issues, the last review stopping period prior to a recommendation from the Committee for Medicinal Products for Human Use(CHMP) and the final approval decision from EMA. If approved, tivozanib’s distinct safety profile has the potential to offer a new, well tolerated alternative to currently approved VEGF TKIs, which, in clinical studies, have been associated with challenging tolerability necessitating significant dose reductions and interruptions.
Continued Execution of the Pivotal Phase 3
TIVO-3 Study of Tivozanib in RCC. In May 2016, AVEOannounced the commencement of enrollment and patient treatment for the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. The study continues to be on track to reach a top line readout in the first quarter of 2018. The Phase 3 trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGF-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms.
TIVO-3 trial, together with the TIVO-1 trial, is designed to support a first- and third-line indication for tivozanib in the U.S. TIVO-3 would also provide a unique data set, in that it is expected to include the first randomized Phase 3 results showing treatment with a VEGF TKI following prior PD1 therapy, and is designed to support approval of the first VEGF TKI specifically labeled for third-line treatment.
Third Quarter 2016 Financial Highlights
AVEOended Q3 2016 with $30.8 millionin cash, cash equivalents and marketable securities as compared with $34.1 millionat December 31, 2015.
Total collaboration revenue in Q3 2016 was approximately
$1.0 millioncompared with $15.2 millionQ3 2015.
Research and development expense was
$4.4 million in Q3 2016 compared with $4.5 millionfor Q3 2015.
General and administrative expense was
$2.1 millionin Q3 2016 compared with $2.2 millionfor Q3 2015.
Net loss for Q3 2016 was
$5.0 million, or a loss of $0.07per basic and diluted share, compared with net income of $7.9 million, or income of $0.14per basic and diluted share for Q3 2015.
We believe that our
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
Nine Months Ended
|Collaboration and licensing revenue||$||992||$||15,158||$||2,388||$||15,426|
|Research and development||4,444||4,466||16,020||9,002|
|General and administrative||2,141||2,225||6,344||8,367|
|Restructuring and lease exit||—||—||—||4,358|
|(Loss) income from operations||(5,593||)||8,467||(19,976||)||(6,301||)|
|Other income (expense), net:|
|Interest expense, net||(551||)||(531||)||(1,388||)||(1,866||)|
|Change in fair value of warrant liability||1,178||—||182||—|
|Other income (expense), net||627||(553||)||(1,206||)||(2,111||)|
|Loss before provision for income taxes||(4,966||)||7,914||(21,182||)||(8,412||)|
|Provision for income taxes||—||—||(100||)||—|
|Net (loss) income||$||(4,966||)||$||7,914||$||(21,282||)||$||(8,412||)|
Net (loss) income per share - basic
|Weighted average number of common shares outstanding||75,861||56,794||67,046||54,880|
Net (loss) income per share - dilutive
|Weighted average number of common shares outstanding||75,861||57,016||67,046||54,880|
|Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||30,831||$||34,135|
|Prepaid expenses and other current assets||2,203||1,600|
|Property and equipment, net||23||23|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||5,528||$||5,531|
|Total loans payable, net of discount||13,869||9,471|
|Total deferred revenue||2,334||3,695|
|Total liabilities and stockholders’ equity||$||35,118||$||40,542|
Source: AVEO Oncology
Media and Investors:
David Pitts, 212-600-1902