AVEO Oncology Reports First Quarter 2015 Financial Results
“We continue to execute on our strategy of leveraging biomarker insights
and exploring partnership opportunities to advance our pipeline, while
continuing to streamline AVEO’s operations to align with our needs,”
Announced Presentation of AV-380 Preclinical Data in Cancer
Associated Cachexia – In April,
AVEOannounced the presentation of results from a preclinical study of AV-380, the Company’s potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), in a cachectic human tumor xenograft model with significantly increased plasma GDF15 levels. The data were presented in a poster titled “Effective treatment of cancer associated cachexia by AV-380, a GDF15 inhibitory antibody” at the 2015 Annual Meeting of the American Association of Cancer Research in Philadelphia.
Announced Presentation of Phase 2 Study Analysis Showing Longer PFS
with Tivozanib versus Bevacizumab in Low Serum NRP-1 Patients with
Advanced CRC – In March,
AVEOannounced the presentation of final results, including a predefined biomarker analysis of 162 patients with NRP-1 samples from the BATON-CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in CRC. The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” was presented in a poster session at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conferencein Orlando.
Received Confirmation of Eligibility for Submission of a MAA for
Tivozanib in RCC to the
European Medicines Agencyand Announced Completion of Rapporteur Meetings – In January, AVEOannounced that, in response to submission of a letter of intent, it has received written confirmation from the European Medicine Agency(EMA) that tivozanib is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. The Company announced today that, in late April 2015, its representatives met with the assigned Rapporteur and co-Rapporteur regarding the potential submission of a MAA for tivozanib for the treatment of RCC based on clinical trials conducted to date. The Company continues to evaluate the clinical, regulatory and economic feasibility of a submission to the EMA. Confirmation of eligibility for submission is not predictive of the EMA’s approval of a MAA.
Announced Several Key Executive Appointments – In January,
AVEOannounced that its board of directors appointed Michael P. Baileyas the Company’s president and chief executive officer and has elected Mr. Bailey as a director. Also in January, AVEOannounced the appointment of Michael N. Needle, M.D., to the position of chief medical officer. In April, AVEOannounced the appointment of Keith S. Ehrlich as the Company’s chief financial officer.
Announced Corporate Restructuring – In January,
AVEOannounced the elimination of its internal research function, as well as certain corporate support positions, to align its resources with the Company’s future strategic plans, focusing on advancement of its pipeline in the clinical setting and reducing corporate expenses. The Company expects to exit its current facility by the end of May 2015with no further obligations to its landlord and to relocate to an appropriately-sized office facility in Cambridge, MAunder flexible lease terms.
First Quarter 2015 Financial Highlights
AVEOended Q1 2015 with $39.1 millionin cash, cash equivalents and marketable securities.
Total collaboration revenue was approximately
$0.1 millioncompared with $15.3 millionfor Q1 2014. The decrease 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 in Q1 2014.
Research and development (R&D) expense was
$2.7 millioncompared with $11.8 millionfor Q1 2014. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following AVEO’s January 2015strategic restructuring, the reduction of its leased facilities as well as a decrease in external clinical trial and consulting costs associated with decreased tivozanib clinical development activity.
General and administrative (G&A) expense was
$3.3 millioncompared with $5.6 millionfor Q1 2014. The decrease in G&A expense was primarily due to a reduction in external legal costs associated with various ongoing legal matters and a decrease in employee compensation, facilities and IT costs following the Company’s January 2015restructuring and the reduction of its leased facilities.
Restructuring and lease exit expense was
$4.3 millioncompared with $3.9 millionfor Q1 2014. The expense incurred during Q1 2014 relates to space that the Company ceased using during the quarter, while the Q1 2015 expenses relates to the elimination of its internal research function and the associated reduction in workforce in January 2015, which was substantially completed in March 2015.
Net loss for Q1 2015 was
$10.9 million, or a loss of $0.21per basic and diluted share compared with a net loss of $6.5 millionor a loss of $0.12per basic and diluted share for Q1 2014. The increase in the net loss is primarily driven by the additional one-time recognition of previously deferred revenue during Q1 2014, partially offset by the decrease in R&D and G&A expense.
Updated Financial Guidance
Based on its current operating plan, the Company expects its
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
For the Three Months
|Ended March 31,|
|Research and development||2,695||11,767|
|General and administrative||3,255||5,555|
|Restructuring and lease exit||4,333||3,859|
|Loss from operations||(10,149||)||(5,892||)|
|Other income and expense:|
|Other (expense) income, net||(14||)||7|
|Other expense, net||(725||)||(558||)|
|Net loss per share - basic and diluted||$||(0.21||)||$||(0.12||)|
|Weighted average number of common shares outstanding||52,638||51,634|
|AVEO Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||39,069||$||52,306|
|Prepaid expenses and other current assets||4,400||4,481|
|Property and equipment, net||5,372||11,295|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||10,847||$||17,527|
|Total loans payable||18,017||20,652|
|Total deferred rent||5,369||10,569|
|Total liabilities and stockholders’ equity||$||50,001||$||70,662|
Source: AVEO Oncology
Company, Media and Investor Contact:
David Pitts, 212-600-1902