AVEO Reports First Quarter 2012 Financial Results and Recent Developments
“Since the achievement of the primary endpoint in our
First Quarter 2012 Financial Results
• Total collaboration revenues for the first quarter ended
• Research and development (R&D) expense for the first quarter of 2012
• General and administrative (G&A) expense for the first quarter of 2012
• Net loss for the first quarter of 2012 was
• AVEO ended the first quarter of 2012 with cash, cash equivalents and
marketable securities of
AVEO is maintaining its financial guidance and continues to expect
year-end 2012 cash, cash equivalents and marketable securities of at
Successful achievement of primary endpoint and positive top-line
results reported from
TIVO-1: In January 2012, AVEO announced top-line data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line RCC), a global, randomized, Phase 3, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma (RCC), which showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1. In TIVO-1, tivozanib also demonstrated a well-tolerated safety profile generally consistent with the Phase 2 experience in RCC.
TIVO-1 data accepted for presentation at ASCO2012: The detailed TIVO-1 data have been selected for an oral presentation at the American Society of Clinical Oncology( ASCO) Annual Meeting to be held June 1-5, 2012in Chicago.
Positive tivozanib Phase 2 data published in
Journal of Clinical Oncology: In April 2012, AVEO announced that previously reported results from a successful Phase 2 clinical trial evaluating the efficacy and safety of tivozanib in 272 patients with advanced RCC were published in the Journal of Clinical Oncology. Results demonstrated improved median PFS among patients treated with tivozanib compared to placebo combined with a well-tolerated safety profile with minimal off-target toxicities.
- Announced preliminary results of exploratory Phase 2 study evaluating ficlatuzumab in first-line patients with advanced lung cancer: The open-label, randomized exploratory Phase 2 study was designed to compare the combination of ficlatuzumab and gefitinib versus gefitinib monotherapy, in Asian subjects with previously untreated advanced NSCLC, a population with a high occurrence of EGFR sensitizing mutations. The ficlatuzumab/gefitinib combination was well-tolerated and the trend of clinical activity favored this arm; however, study results in the overall population did not reach statistical significance. Encouraging signals of activity were observed in unique subsets of patients based on EGFR mutation status and c-Met expression level.
- Implemented organizational updates: As AVEO continues its evolution into an integrated oncology company, the following appointments were made:
Henri Termeerhas been named chairman of the Board of Directors;
- Elan Ezickson has been promoted to executive vice president and chief operating officer;
Jeno Gyuris, Ph.D., has been promoted to senior vice president, chief scientific officer;
Joseph Vittiglio, Esq., has been promoted to vice president, chief corporate counsel;
Nell Joneswas appointed as senior vice president, human resources; and
Rob Kloppenburgwas appointed as vice president, corporate communications and public affairs.
AVEO expects to present at the following investor conferences:
Deutsche Bank37th Annual Health Care Conference, May 7-9, 2012 in Boston.
Jefferies2012 Global Healthcare Conference, June 4-7, 2012in New York City.
Goldman Sachs33rd Annual Global Healthcare Conference, June 5-7, 2012, Ranchos Palos Verdes, Calif.
AVEO expects to have a presence at the following oncology medical meeting:
American Society of Clinical Oncology( ASCO) 2012 Annual Meeting, June 1-5, 2012in Chicago.
Today’s Conference Call and Webcast Reminder
The AVEO management team will host a conference call at
A webcast of the conference call can also be accessed by visiting the investors section of the AVEO website at investor.aveopharma.com. A replay of the webcast will be archived on the company's website for two weeks following the call.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO that
involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements, within the meaning 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||24,776||38,017|
|General and administrative||8,983||9,228|
|Income (loss) from operations||(32,899)||86,369|
|Other income and expense:|
|Other income (expense), net||299||(56)|
|Other expense, net||(347)||(1,003)|
|Net income (loss)||(33,246)||$||85,366|
|Basic net income (loss) per share|
|Net income (loss)||$||(0.77)||$||2.38|
|Weighted average number of common shares outstanding||43,254||35,781|
|Diluted net income (loss) per share|
|Net income (loss)||$||(0.77)||$||2.28|
|Weighted average number of common shares and dilutive common share equivalents outstanding||43,254||37,483|
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|(in thousands, except par value amounts)|
|March 31,||December 31,|
|Cash and cash equivalents||$||73,065||$||43,506|
|Prepaid expenses and other current assets||3,487||6,057|
|Total current assets||237,303||234,395|
|Property and equipment, net||6,032||5,471|
|Liabilities and stockholders’ equity|
|Loans payable, net of discount||-||8,551|
|Total current liabilities||25,049||34,609|
|Loans payable, net of current portion and discount||25,800||15,619|
|Deferred revenue, net of current portion||19,361||19,684|
|Deferred rent, net of current portion||334||359|
|Preferred Stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding at March 31, 2012 and December 31, 2011, respectively||-||-|
|Common stock, $.001 par value: 100,000 shares authorized; 43,560 and 43,254 shares issued and outstanding at March 31, 2012 and December 31, 2011, respectively||44||43|
|Additional paid-in capital||431,915||429,531|
|Accumulated other comprehensive income (loss)||60||(167||)|
|Total stockholders’ equity||192,907||223,541|
|Total liabilities and stockholders’ equity||$||264,689||$||295,050|
Monique Allaire, 617-299-5810
Rob Kloppenburg, 617-930-5595
Dan Budwick, 973-271-6085