AVEO Oncology Reports Second Quarter 2016 Financial Results and Provides Business Update
“The second quarter of 2016 marked a defining moment for
Dosing of First Patient in Pivotal Phase 3
TIVO-3 Study of Tivozanib in Renal Cell Carcinoma. In May 2016, AVEOannounced that the first patient was dosed in 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 renal cell carcinoma (RCC). Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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 VEGFR-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.
The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. Top line readout of the study is currently projected for 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 a first and third line indication for tivozanib in the U.S. A marketing authorization application seeking approval of tivozanib as a treatment for first line renal cell cancer is currently pending in Europe based on an application submitted by AVEO’s partner EUSA Pharma.
Closing of Private Placement and Amended Term Loan. In
May 2016, AVEOannounced the closing of a private placement of 17,642,482 units, each consisting of one share of common stock and a warrant to purchase one share of common stock, at a price of $0.965 per unit, for gross proceeds of approximately $17 million. The transaction was led by New Enterprise Associates and included New Leaf Venture Partners and Perceptive Advisors, among other institutional investors. Certain members of the Company’s management team and Board of Directors also participated in the financing. Piper Jaffray& Co. served as the exclusive placement agent for the financing.
The Company also announced that it entered into an amendment to its 2010 loan and security agreement with Hercules Capital, Inc. Pursuant to the loan amendment, the Company borrowed an additional $5.0 million from Hercules. If specified conditions are met, AVEO may borrow an additional tranche of $5.0 million from Hercules in the first half of 2017, and repayment of principal on AVEO’s loans may be deferred to begin in 2018.
Filing of Provisional Patent Applications for AV-353, a Notch
3-Specific Inhibitor Antibody for PAH. In
May 2016, AVEOannounced that it had filed provisional patent applications with the United States Patent and Trademark Office covering composition of matter claims for AV-353, the Company’s potent inhibitory antibody specific to Notch 3 for development in Pulmonary Arterial Hypertension (PAH). These patent applications are the second set of applications related to AV-353 and the Company’s Notch 3 antibody program. Current treatments in PAH focus only on controlling symptoms by avoiding vasoconstriction and increasing vasodilation of vessels and do not reverse the underlying cause of the disease. In contrast, with the results of a recently concluded research study supported by AVEO, AV-353 has generated a growing body of preclinical data that supports AV-353’s ability to potentially reverse the disease phenotype, which would represent a potential disease-modifying approach to treatment. Consistent with the Company’s focus on developing oncology therapeutics, AVEO is currently seeking an appropriate partner to develop and commercialize AV-353 worldwide in PAH.
Second Quarter 2016 Financial Highlights
AVEOended Q2 2016 with $39.5 millionin cash, cash equivalents and marketable securities as compared with $34.1 millionat December 31, 2015. The increase was attributable to the net proceeds of our private placement of securities and additional borrowings under our existing loan and security agreement in the second quarter of 2016, net of the use of cash to fund operations during 2016.
Total collaboration revenue in Q2 2016 was approximately
$0.2 millioncompared with $0.1 millionQ2 2015. The increase was primarily due to $0.1 millionin revenue recognized in the second quarter of 2016 in connection with the out-licensing agreement with EUSA, which was executed in December 2015.
Research and development expense was
$5.6 million in Q2 2016 compared with $1.8 millionfor Q2 2015. The increase was primarily attributable to an increase in tivozanib clinical trial costs in connection with the preparation for, and conduct of, the TIVO-3 phase 3 trial in renal cell carcinoma that commenced enrollment and patient treatment in May 2016.
General and administrative expense was
$1.7 millionin Q2 2016 compared with $2.9 millionfor Q2 2015. The decrease was primarily the result of continued reduction of facilities and other operating expenses after completing our restructuring in the first quarter of 2015.
Net loss for Q2 2016 was
$8.6 million, or a loss of $0.13per basic and diluted share, compared with net loss of $5.5 million, or a loss of $0.10per basic and diluted share for Q2 2015.
We believe that our
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO that
involve substantial risks and uncertainties. All statements, other than
statements of historical fact, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,” “expect,”
“intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of
these terms or other similar expressions, are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements
include, among others: AVEO’s plans with respect to the design and
execution of its TIVO-3 clinical trial and the timing of enrollment and
data readouts from the trial; the potential for the TIVO-3 trial to
support third line and first line indications in the U.S.; expectations
regarding the initiation of a tivozanib-PD-1 combination study; the
potential disease-modification capabilities and partnership expectations
for AV-353; AVEO’s expectations regarding a registration decision in the
EU for tivozanib for first line renal cell cancer; the potential
benefits of tivozanib in the treatment of renal cell carcinoma as a
single agent or in combination with other therapies; AVEO’s plans and
strategies and the potential achievement by
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
Six Months Ended
|Collaboration and licensing revenue||$||193||$||134||$||1,396||$||268|
|Research and development||5,604||1,841||11,576||4,536|
|General and administrative||1,731||2,889||4,203||6,144|
|Restructuring and lease exit||
|Loss from operations||(7,142||)||(4,621||)||(14,383||)||(14,770||)|
|Other expense, net:|
|Interest expense, net||(468||)||(626||)||(837||)||(1,337||)|
|Change in fair value of warrant liability||(996||)||
|Other expense, net||(1,464||)||(835||)||(1,833||)||(1,560||)|
|Loss before provision for income taxes||(8,606||)||(5,456||)||(16,216||)||(16,330||)|
|Provision for income taxes||
|Net loss per share ─ basic and diluted||$||(0.13||)||$||(0.10||)||$||(0.26||)||$||(0.30||)|
|Weighted average number of common shares outstanding||66,917||55,164||62,566||53,908|
|Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||39,531||$||34,135|
|Prepaid expenses and other current assets||1,421||1,600|
|Property and equipment, net||22||23|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||6,304||$||5,531|
|Total loans payable||13,735||9,471|
|Total deferred revenue||3,326||3,695|
|Total liabilities and stockholders’ equity||$||42,686||$||40,542|
Source: AVEO Oncology
Company, Media and Investor Contact:
David Pitts, 212-600-1902