AVEO Reports Second Quarter 2012 Financial Results
“The last six months have been very productive for AVEO Oncology, as
highlighted by the presentation of the positive results from the
Second Quarter 2012 Financial Results
• Total collaboration revenues for the second quarter of 2012 were
• Research and development (R&D) expense for the second quarter of 2012
• General and administrative (G&A) expense for the second quarter of
• Net loss for the second quarter of 2012 was
• AVEO ended the second 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
TIVO-1: AVEO and Astellas reported detailed 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 were presented at the 2012 Annual Meeting of the American Society of Clinical Oncology( ASCO). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, and tivozanib demonstrated favorable tolerability as evidenced by a significantly lower rate of dose interruptions and reductions as compared to sorafenib. Key data reported from TIVO-1 based on independent radiological reviews include:
- Tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall (Intent To Treat) study population (HR=0.797, 95% CI 0.639–0.993; P=0.042). Objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (p=0.014). The efficacy advantage of tivozanib over sorafenib was consistent across subgroups in the study.
In patients who were treatment naïve for advanced RCC (70% of
total study population), tivozanib demonstrated a statistically
significant improvement in PFS with a median PFS of 12.7 months
compared to a median PFS of 9.1 months for sorafenib (HR 0.756,
95% CI 0.580–0.985; P=0.037). This is the longest median PFS
reported to date in treatment naïve advanced RCC patients in a
- In the subpopulation of patients who were pretreated with systemic therapy including cytokines (30% of total study population), tivozanib demonstrated an improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib.
Study results demonstrated favorable tolerability as evidenced by
a distinctively low rate of dose interruptions and reductions. The
most common adverse event (all grades/≥grade 3) for tivozanib was
hypertension (T: 44%/25% vs S: 34%/17%) and for sorafenib was
hand-foot syndrome (T: 13%/2% vs S: 54%/17%). Other adverse events
included diarrhea (T: 22%/2% vs S: 32%/6%), fatigue (T: 18%/5% vs
S: 16%/4%), and neutropenia (T: 10%/2% vs S: 9%/2%).
- The rate of dose interruptions due to adverse events was 18% for tivozanib compared to 35% for sorafenib (p<0.001).
- The rate of dose reductions was 14% for tivozanib compared to 44% for sorafenib (p<0.001).
Overall survival (OS) data from
TIVO-1 are not yet mature and medians have not been reached. Estimated OS rate at one year was 81% among patients randomized to the sorafenib arm and 77% among patients randomized to tivozanib. However, as reported at ASCO, 53% of patients randomized to the sorafenib arm of the trial went on to receive subsequent therapy, nearly all of whom received tivozanib after sorafenib. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy.
Regulatory Update: The
FDAhas expressed concern regarding the OS trend in the TIVO-1 trial and has said that it will review these findings at the time of the NDA filing as well as during the review of the NDA. AVEO is conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy; analyses that the company believes will directly address this issue. AVEO is continuing to work toward submitting the NDA by end of the third quarter; however, there is a chance that the additional OS analyses may cause the submission to move into the fourth quarter.
TAURUS patient preference clinical study: In
June 2012, AVEO and Astellas announced plans to initiate a new clinical study, TAURUS (TivozAnib Use veRsUs Sutent in advanced RCC: Patient Preference), to establish additional data regarding tivozanib when used as first-line therapy in patients with advanced RCC. The TAURUS study will enroll patients at sites throughout the United Statesand Western Europe, and the primary objective of the study is designed as a superiority comparison of tivozanib versus sunitinib with respect to patient preference. Secondary objectives are to evaluate the incidence of treatment emergent Grade 3/4 adverse events and serious adverse events; frequency of dose modifications; and quality of life in patients treated with tivozanib versus sunitinib.
- Preliminary results from ficlatuzumab exploratory Phase 2 study: 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 non-small cell lung cancer, 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. Detailed findings from this study have been accepted for a presentation at ESMO in September. AVEO expects to provide additional information regarding its plans in support of further development of ficlatuzumab at that time.
- Phase 1 study of AV-203: AVEO announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, and was developed through AVEO’s Human Response Platform™. This advancement marked the third AVEO product candidate to enter clinical development.
AVEO expects to present at the following investor conferences:
Canaccord Genuity 32nd Annual Growth Conference,
August 14-16, 2012in Boston.
Morgan Stanley Global Healthcare Conference, September 10-12, 2012in New York City.
AVEO expects to have a presence at the following oncology medical meeting:
European Society for Medical Oncology(ESMO) 2012 Congress, September 28-October 2, 2012in Vienna.
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.aveooncology.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||For the Six Months|
|Ended June 30,||Ended June 30,|
|Research and development||21,450||25,078||46,226||63,095|
|General and administrative||9,186||6,371||18,169||15,599|
|Income (loss) from operations||(28,759||)||(4,895||)||(61,658||)||81,474|
|Other income and expense:|
|Other income (expense), net||(66||)||11||233||(45||)|
|Other expense, net||(787||)||(836||)||(1,134||)||(1,839||)|
|Net income (loss)||(29,546||)||$||(5,731||)||(62,792||)||$||79,635|
|Basic net income (loss) per share|
|Net income (loss)||$||(0.68||)||$||(0.16||)||$||(1.45||)||$||2.19|
|Weighted average number of common shares outstanding||43,322||36,849||43,288||36,318|
|Diluted net income (loss) per share|
|Net income (loss)||$||(0.68||)||$||(0.16||)||$||(1.45||)||$||2.09|
|Weighted average number of common shares and dilutive common share equivalents outstanding||43,322||36,849||43,288||38,120|
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|(in thousands, except par value amounts)|
|June 30,||December 31,|
|Cash and cash equivalents||$||85,789||$||43,506|
|Prepaid expenses and other current assets||5,208||6,057|
|Total current assets||230,284||234,395|
|Property and equipment, net||6,626||5,471|
|Liabilities and stockholders’ equity|
|Loans payable, net of discount||1,946||8,551|
|Total current liabilities||29,131||34,609|
|Loans payable, net of current portion and discount||23,933||15,619|
|Deferred revenue, net of current portion||19,037||19,684|
|Deferred rent, net of current portion||1,695||359|
|Preferred Stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively||-||-|
|Common stock, $.001 par value: 100,000 shares authorized; 43,642 and 43,254 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively||44||43|
|Additional paid-in capital||434,437||429,531|
|Accumulated other comprehensive income (loss)||9||(167||)|
|Total stockholders’ equity||165,832||223,541|
|Total liabilities and stockholders’ equity||$||240,866||$||295,050|
Source: AVEO Oncology
Monique Allaire, 617-299-5810
Rob Kloppenburg, 617-930-5595
Dan Budwick, 973-271-6085