AVEO Oncology Reports Full Year 2013 Financial Results and Outlines 2014 Strategic Plan
- Company ends 2013 with
- Focuses internal R&D investment on AV-380 in cachexia -
- Intends to advance clinical-stage assets through strategic partnering –
“With the cost-containment measures implemented in the second half of
Cachexia is a serious and common syndrome in patients with advanced cancer and other chronic diseases, characterized by symptoms of unintentional weight loss, progressive muscle wasting and loss of appetite (anorexia). Cachexia is associated with increased mortality and 50% of patients with cancer die with cachexia present.
Development Programs Update
AVEOsuccessfully completed a Phase 1 safety study showing no dose limiting toxicities at maximum dose of 20mg/kg and Clinical Laboratory Improvements Amendment (CLIA) validation has been completed for a biomarker for potential patient selection. Results from this study are expected to be presented at a scientific meeting in 2014. AVEOwill seek a partner to support further clinical development of AV-203, subject to regaining certain rights from Biogen Idec, who currently has the option to develop AV-203 in territories outside of the U.S. The single agent expansion cohort in a biomarker-positive patient population has been terminated pending a development partnership agreement.
Ficlatuzumab – In 2013, an exploratory analysis using a
serum-based molecular diagnostic test identified a patient
sub-population that experienced a statistically significant
progression-free survival and overall survival benefit on the
combination therapy in the Phase 2 trial of ficlatuzumab in
combination with gefitinib compared to gefitinib monotherapy in first
line non-small cell lung cancer. These results are expected to be
presented at a scientific meeting later in 2014.
AVEOis actively seeking collaboration opportunities to support the clinical development of ficlatuzumab in this patient group with the goal of initiating a confirmatory Phase 2 study.
Tivozanib – On
February 14, 2014, AVEOand Astellas announced their decision to terminate their collaboration for the development and commercialization of tivozanib. Costs for ongoing tivozanib-related expenses will be shared by the parties. AVEOestimates that AVEO’s share of costs for these activities will be approximately $12 millionin 2014. Based on the terms of the agreement, all rights for tivozanib will revert to AVEOin August 2014, six months after Astellas notified AVEOof its intention to terminate the agreement. AVEOplans to explore potential partnership opportunities for the further clinical development of tivozanib.
AV-380 (GDF-15 Program) - AV-380, a potential first-in-class
GDF-15 inhibitor, was discovered using AVEO’s proprietary Human
Response Platform™, that provides the company unique insights into
cancer and related disease biology. The clinical program will be
designed to obtain rapid proof of clinical activity with
first-in-human clinical trials planned for the second half of 2015.
Initial clinical development is expected to be for the treatment of
AVEOplans to evaluate opportunities for partnerships to expand the development of AV-380 for the treatment of cachexia associated with other indications such as chronic kidney disease, congestive heart failure and chronic obstructive pulmonary disease.
Full Year 2013 Financial Results
AVEOended 2013 with cash, cash equivalents and marketable securities of $118.5 million.
Total collaboration revenue for 2013 was approximately
$1.3 millioncompared with $19.3 millionfor 2012. The decrease was primarily due to revenue recognized during 2012 that did not recur during 2013, including a $15.0 millionmilestone payment earned under AVEO’s collaboration agreement with Astellas related to the FDA’s acceptance of the NDA filing for tivozanib and revenue earned under AVEO’s agreements with OSI Pharmaceuticals, Inc.and Centocor Ortho Biotech Inc.Revenue recognized during 2013 consisted of the amortization of previously deferred amounts related to AVEO’s collaboration agreements with Biogen Idec International GmbHand Astellas.
Research and development (R&D) expense for 2013 was
$68.5 millioncompared with $91.4 millionfor 2012. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following the strategic restructurings announced in October 2012and June 2013, and a decrease in clinical trial and regulatory costs for tivozanib and ficlatuzumab, offset by additional development costs for ficlatuzumab relating to the manufacture of clinical material and by additional facilities costs due to additional leased space at 650 East Kendall Street.
General and administrative (G&A) expense for 2013 was
$28.7 millioncompared with $36.9 millionfor 2012. The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following our strategic restructuring announced in June 2013and a reduction in pre-commercialization costs associated with tivozanib.
Restructuring expense for 2013 was
$8.0 millioncompared with $2.6 millionfor 2012. The increase is primarily the result of the additional costs incurred in connection with our June 2013strategic restructuring.
Net loss for 2013 was
$107.0 million, or basic and diluted net loss per share of $2.10, compared with net loss of $114.4 million, or basic and diluted net loss per share of $2.64for 2012.
2014 Financial Guidance
Based on current operating plans,
“I would like to thank Bill for his service and commitment to AVEO,” said Mr. Ha-Ngoc. “His unwavering dedication to patients has guided and inspired our efforts in AVEO’s clinical programs. We wish him well in his future endeavors.”
Today’s Conference Call and Webcast Reminder
The live webcast of the conference call can be accessed by visiting the
investors section of the
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
1 Includes cash, cash equivalents and marketable securities.
AVEO Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
|For the Three Months||For the Years|
|Ended December 31,||Ended December 31,|
|Research and development||11,889||24,033||68,468||91,358|
|General and administrative||4,499||9,463||28,712||36,932|
|Loss from operations||(16,069||)||(20,598||)||(103,904||)||(111,637||)|
|Other income and expense:|
|Other (expense) income, net||(3||)||(32||)||(123||)||247|
|Other expense, net||(656||)||(882||)||(3,125||)||(2,757||)|
|Basic net loss per share|
|Weighted average number of common shares outstanding||51,546||43,486||50,928||43,374|
|Diluted net loss per share|
Weighted average number of common shares and dilutive
AVEO Pharmaceuticals, Inc.
Consolidated Balance Sheet Data
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||118,506||$||160,602|
|Prepaid expenses and other current assets||9,429||9,430|
|Property and equipment, net||14,140||12,867|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||17,501||$||30,171|
|Total loans payable||19,205||26,037|
|Total deferred revenue||18,392||19,685|
|Total deferred rent||20,072||11,400|
|Total liabilities and stockholders’ equity||$||146,346||$||207,469|
Source: AVEO Oncology
AVEO Oncology Investor Relations
Caton Morris, 910-232-7166