AVEO Oncology Reports First Quarter 2014 Financial Results
“We made solid progress executing on a key component of our recently
announced corporate strategy, which is to advance our clinical-stage
assets through collaborations while retaining substantial value,” said
Recent Operational Highlights
Re-acquired rights to AV-203, AVEO’s ErbB3 inhibitor, from
Biogen Idecin March 2014. By re-acquiring these rights, AVEOwill be able to seek a partner with established oncology capabilities to accelerate and financially support the clinical development of this asset.
Executed an agreement with Biodesix in
April 2014under which AVEOplans to conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced non-small cell lung cancer using Biodesix’s VeriStrat® test to select for a patient population which did not respond well to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy, but responded to the combination therapy in an exploratory analysis of AVEO’s Phase 2 trial data. Biodesix will fund up to $15 millionof the cost of the study. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally between AVEOand Biodesix, as will any potential profits.
AVEOand Astellas announced the termination of their tivozanib collaboration pursuant to which Astellas will return all rights for tivozanib to AVEOin August 2014. At that time AVEOplans to explore potential partnership opportunities to support the further clinical development of tivozanib.
Q1 2014 Financial Highlights
“We remain on target to end 2014 with a cash balance of between
Ended Q1 2014 with
$88.3 millionin cash, cash equivalents and marketable securities.
Total collaboration revenue was approximately
$15.3 millioncompared with $0.3 millionfor Q1 2013. The increase was primarily due to an additional one-time recognition of $14.1 millionof previously deferred revenue as a result of the modification of the company’s arrangement with Biogen Idec.
Research and development (R&D) expense was
$11.8 millioncompared with $21.0 millionfor Q1 2013. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013strategic restructuring as well as a decrease in external clinical trial, consulting, and manufacturing costs associated with development and pre-commercialization activities for tivozanib.
General and administrative (G&A) expense was
$5.6 millioncompared with $12.4 millionfor Q1 2013. The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following the company’s June 2013strategic restructuring and a decrease in marketing and consulting costs for tivozanib related to pre-commercialization activities.
Net loss for Q1 2014 was
$6.5 millionor a loss of $0.12per basic and diluted net loss per share compared with net loss of $34.1 millionor a loss of $0.69per basic and diluted net loss per share for Q1 2013.
2014 Financial Guidance
Based on current operating plans,
Upcoming Q2 Events
AVEO’s Phase 1 dose-escalation study of AV-203 has been accepted for a
poster presentation at the 2014 Annual Meeting of the
Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,”
“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, statements about AVEO’s plans to initiate a proof of concept
study of ficlatuzumab, AVEO’s advancement of its business strategy,
including entering into new strategic partnerships, and AVEO’s estimates
for its 2014 year-end cash balance. Actual results or events
could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that
|AVEO Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$88,322||$118,506|
Prepaid expenses and other current assets
Property and equipment, net
Liabilities and stockholders’ equity
|Accounts payable and accrued expenses||$16,382||$17,501|
Total loans payable
Total deferred revenue
Total deferred rent
|Total liabilities and stockholders’ equity||$127,805||$146,346|
AVEO Pharmaceuticals, Inc.
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|For the Three Months|
|Ended March 31,|
Research and development
General and administrative
Restructuring and lease exit
|Loss from operations||(5,892)||(33,155)|
|Other income and expense:|
|Other income (expense), net||7||(101)|
|Other expense, net||(558)||(930)|
Net loss per share - basic and diluted
Weighted average number of common shares outstanding
Source: AVEO Oncology
AVEO Investor Relations
Rob Kloppenburg, 617-299-5990