AVEO Oncology Reports Second Quarter 2014 Financial Results and Updates Progress on Strategic Plan
Ficlatuzumab Phase 2 NSCLC Data and Tivozanib Phase
AV-380 Preclinical Data to Be Presented at 2nd
“Our strategy for building value remains focused on our AV-380 program
in cachexia and in leveraging partner resources to advance the
development of our clinical pipeline,” said
Recent Program Updates
AVEOannounced today that worldwide rights to tivozanib, the Company’s inhibitor of vascular endothelial growth factor (VEGF) 1, 2, and 3 receptors, were regained from Astellas Pharma, Inc. AVEOand Astellas were developing tivozanib for the treatment of renal cell carcinoma, colorectal cancer and breast cancer pursuant to a worldwide collaboration and license agreement. Subsequent to the receipt of a complete response letter, Astellas elected to terminate the license agreement, which became effective today. AVEOwill actively pursue other partnerships to advance the development of tivozanib.
The Company also announced today that clinical results from two Phase 2 studies of tivozanib in colorectal cancer, which were discontinued after an interim analysis, and renal cell cancer were accepted for poster presentation at the
European Society for Medical Oncology(ESMO) 2014 Congresstaking place September 25–30, 2014, in Madrid, Spain. The date and time of the presentations will be provided once they become available.
Ficlatuzumab – In
April 2014, AVEOexecuted an agreement with Biodesix under which AVEOplans to conduct a Phase 2 clinical trial of ficlatuzumab, the Company’s hepatocyte growth factor (HGF) inhibitory antibody, in combination with erlotinib in advanced non-small cell lung cancer. The study will use Biodesix’s VeriStrat® test to select for a patient population which, in an exploratory analysis of AVEO’s Phase 2 trial data, showed a progression free survival and overall survival benefit from the addition of ficlatuzumab to an EGFR TKI. The Company announced today that results from this exploratory analysis have been accepted for poster presentation at the ESMO 2014 Congress. The date and time of the presentation will be provided once they become available.
As part of the agreement between
AVEOand Biodesix, Biodesix will fund up to $15 millionof the cost of the new Phase 2 trial as well as the further development and registration of VeriStrat as a potential companion diagnostic. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the Phase 2 trial will be shared equally between AVEOand Biodesix, as will any potential profits.
AV-203 – In
June 2014, AVEOpresented results from a first-in-human Phase 1 study of AV-203, the Company’s potent, high-affinity ErbB3 (HER3) monoclonal antibody, in patients with metastatic or advanced solid tumors, at the American Society of Clinical Oncology( ASCO) 2014 Annual Meeting. The study established a recommended Phase 2 dose of AV-203, demonstrated good tolerability and reached the maximum planned dose of AV-203 monotherapy. The data also showed promising early signs of activity and provide a rationale for further investigation of AV-203 as novel anticancer therapy. AVEOis actively pursuing partnerships to further advance the development of AV-203.
AV-380 – During the second quarter,
AVEOinitiated non-GMP manufacturing and animal toxicology studies for AV-380, the Company’s potent, humanized GDF15 inhibitory antibody, in preparation for the initiation of clinical trials planned for the 4th quarter of 2015. The Company announced today that results from four preclinical studies of AV-380 in various in vivo cachexia models and in vitro assays have been accepted as poster presentations, and preclinical work leading to the identification of GDF15 as an important driver of cancer cachexia has been accepted for an oral presentation at the 2nd Cancer Cachexia Conferencetaking place September 26-28in Montreal, Canada. AVEOis actively pursuing partnerships to realize the full potential of AV-380 within and beyond cancer cachexia.
Second Quarter 2014 Financial Highlights
Ended Q2 2014 with
$64.9 millionin cash, cash equivalents and marketable securities.
Research and development (R&D) expense was
$9.3 millionfor Q2 2014 compared with $16.2 millionfor Q2 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 expense (G&A) expense was
$4.8 millionfor Q2 2014 compared with $7.3 millionfor Q2 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.
Restructuring and lease exit expense was
$5.2 millionfor Q2 2014 compared with $7.9 millionfor Q2 2013. The expense incurred during Q2 2014 relates to space that the Company ceased using during the quarter, while the Q2 2013 expense relates to severance and employee benefits incurred as part of the June 2013strategic restructuring.
Net loss for Q2 2014 was
$18.0 million, or $0.35per basic and diluted net loss per share, compared with net loss of $31.9 million, or $0.62per basic and diluted net loss per share, for Q2 2013.
Financial Comparison of First and Second Quarters 2014
The Company had net cash outflows of approximately
$23 millionin Q2 2014, compared to $30 millionin Q1 2014.
R&D expense was
$9.3 millionfor Q2 2014 compared to $11.8 millionin Q1 2014. The decrease in R&D expenses was primarily due to a reduction in clinical study costs and allocated overhead. The components of R&D expense are as follows:
|Research & Development Expense||
|Headcount and Programs||$||8,251||$||9,132||$||(881||)|
|Reimbursable Partnership Expenses||$||(1,218||)||$||(1,153||)||$||(65||)|
|Stock-Based Compensation Expense||$||197||$||318||$||(121||)|
|Sub Total Non-Program R&D Expense||$||2,267||$||3,788||$||(1,521||)|
|Total R&D Expense||$||9,300||$||11,767||$||(2,467||)|
G&A expense was
$4.8 millionfor Q2 2014 compared to $5.6 millionin Q1 2014. The decrease in G&A expense was primarily due to a reduction in legal expenses and allocated overhead.
The Company’s construction related capital expenditures in Q2 2014
$4.0 million, down from $7.8 millionin Q1 2014. These construction-related capital expenditures are associated with AVEO’s corporate headquarters at 650 E. Kendall St., Cambridge, MA.
With respect to the Company’s loan facility with Hercules Technology,
the Company made payments toward loan principal and interest in Q2
$4.3 millioncompared to $3.1 millionin Q1 2014. The increase was due to a $1.2 millionone-time payment made in June 2014pursuant to the terms of AVEO’s loan agreement.
The Company anticipates cash inflows of approximately
$15 millionin the second half of 2014 associated with landlord reimbursement of construction-related capital expenditures in accordance with AVEO’s lease arrangement at 650 E. Kendall St., Cambridge, MA.
Based on its current operating plan, the Company expects to remain on
target to end 2014 with approximately
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
AVEO Pharmaceuticals, Inc.
|For the Three Months||For the Six Months|
|Ended June 30,||Ended June 30,|
|Research and development||9,300||16,203||21,067||37,165|
|General and administrative||4,846||7,324||10,400||19,773|
|Restructuring and lease exit||5,165||7,869||9,025||7,936|
|Loss from operations||(17,465||)||(31,072||)||(23,357||)||(64,227||)|
|Other income and expense:|
|Other income (expense), net||(2||)||(51||)||5||(152||)|
|Other expense, net||(494||)||(841||)||(1,052||)||(1,771||)|
|Net loss per share - basic and diluted||$||(0.35||)||$||(0.62||)||$||(0.47||)||$||(1.31||)|
Weighted average number of common
|AVEO Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||64,937||$||118,506|
|Prepaid expenses and other current assets||19,252||9,429|
|Property and equipment, net||15,863||14,140|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||19,693||$||17,501|
|Total loans payable||14,184||19,205|
|Total deferred revenue||1,256||18,392|
|Total deferred rent||14,510||20,072|
|Total liabilities and stockholders’ equity||$||104,247||$||146,346|
Source: AVEO Oncology
Company, Media and Investor:
David Pitts, 212-600-1902