AVEO Oncology Reports First Quarter 2016 Financial Results and Provides Business Update
“We achieved several important goals in the first quarter critical to
advancing the corporate strategy we outlined early in 2015. This
includes the submission and validation of an MAA filing in
Mr. Bailey concluded: “Our next steps in the development of tivozanib in
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.
Exclusive Licensing Agreement for
AV-203 Outside of North Americawith CANbridge Life Sciences. In March 2016 AVEOand CANbridge Life Sciences announced an exclusive collaboration and license agreement in which AVEOhas granted CANbridge worldwide rights, excluding the United States, Canada, and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate. CANbridge plans to develop AV-203 first in esophageal squamous cell cancer (ESCC). Under the terms of the agreement, CANbridge is obligated to pay AVEOan upfront payment of $1 millionplus up to $133 millionin potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. AVEOis also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in CANbridge’s territories. CANbridge will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as pre-clinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for ESCC, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria. Following completion of the proof-of-concept studies, AVEOand CANbridge will negotiate a possible agreement under which the parties may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights.
- Submission and validation of a European Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma. In February 2016, AVEO and its European partner, EUSA Pharma announced that EUSA Pharma submitted and received a validation notice for the Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for tivozanib as a first line treatment for renal cell carcinoma (RCC).
Acceptance of Registration Dossier for Tivozanib in RCC by
the Ministry of Health of the Russian Federation. In February
2016, AVEO announced that a registration dossier seeking to obtain
marketing authorization of tivozanib as a first line treatment of
advanced RCC has been accepted by the Ministry of Health of the
Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, AVEO’s licensing partner in Russia, Ukraineand CIS.
- Receipt of $3.5 Million AV-380 Inventory Reimbursement Payment from Novartis. AVEO previously announced that Novartis exercised its right under its license agreement for AV-380, AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), to acquire AVEO’s inventory of clinical quality drug substance. This reimbursement payment of approximately $3.5 million was received in the first quarter of 2016.
First Quarter 2016 Financial Highlights
AVEOended Q1 2016 with $23.8 millionin cash, cash equivalents and marketable securities. The reduction in cash over base operations was primarily attributable to clinical trial startup costs related to the TIVO-3 study and a significant pay down in accounts payable quarter over quarter.
Total collaboration revenue in Q1 2016 was approximately
$1.2 millioncompared with $0.1 millionfor Q1 2015. The increase was primarily due to an additional $1.0 millionin revenue recognized in the first quarter of 2016 in connection with our out-licensing agreement with CANbridge, which was executed in March 2016.
Research and development (R&D) expense was
$6.0 millionin Q1 2016 compared with $2.7 millionfor Q1 2015. The increase was primarily attributable to an increase in tivozanib clinical trial costs associated with our preparation for a planned Phase 3 trial.
General and administrative (G&A) expense was
$2.5 millionin Q1 2016 compared with $3.3 millionfor Q1 2015. The decrease was primarily the result of a decrease in external legal costs associated with various ongoing legal matters, and a decrease in employee compensation, consulting, facilities and IT costs as a result of our decreased headcount and the reduction of our utilized facility space following our January 2015restructuring.
There was no restructuring and lease exit expense in Q1 2016, compared
$4.3 millionfor Q1 2015. The expenses incurred during the three months ended March 31, 2015 related to the January 2015restructuring, which was substantially completed in March 2015.
Net loss for Q1 2016 was
$7.7 million, or a loss of $0.13per basic and diluted share, compared with net loss of $10.9 million, or a loss of $0.21per basic and diluted share for Q1 2015.
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
For the Three Months
Ended March 31,
|Research and development||5,972||2,695|
|General and administrative||2,463||3,255|
|Restructuring and lease exit||-||4,333|
|Loss from operations||(7,232||)||(10,149||)|
|Other income and expense:|
|Other expense), net||(9||)||(14||)|
|Other expense, net||(378||)||(725||)|
|Provision for income taxes||(100||)||-|
|Net loss per share - basic and diluted||$||(0.13||)||$||(0.21||)|
|Weighted average number of common shares outstanding||58,166||52,638|
|Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||23,805||$||34,135|
|Prepaid expenses and other current assets||5,123||1,600|
|Property and equipment, net||18||23|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||3,183||$||5,531|
|Total loans payable||9,556||9,471|
|Total deferred revenue||3,492||3,695|
|Total liabilities and stockholders’ equity||$||30,806||$||40,542|
Source: AVEO Oncology
Company, Media and Investor Contact:
David Pitts, 212-600-1902