• General and administrative (G&A) expense for the first quarter of 2012 was $9.0 million compared with $9.2 million for the first quarter of 2011.
• Net loss for the first quarter of 2012 was $33.2 million, or basic and diluted net loss per share of $0.77, compared with net income of $85.4 million, or basic and diluted net income per share of $2.38 and $2.28, respectively, for the first quarter of 2011.
• AVEO ended the first quarter of 2012 with cash, cash equivalents and marketable securities of $244.8 million.
Financial GuidanceAVEO is maintaining its financial guidance and continues to expect year-end 2012 cash, cash equivalents and marketable securities of at least $120 million, with R&D spending, net of cost sharing with Astellas, of approximately $130 million. AVEO anticipates that this capital is sufficient to fund its operations into the second half of 2013 based on its current operating plans. Recent Developments
- 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 S orafenib in 1 st 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 ASCO 2012: 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, 2012 in 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 Termeer has 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 Jones was appointed as senior vice president, human resources; and
- Rob Kloppenburg was appointed as vice president, corporate communications and public affairs.
- Deutsche Bank 37 th Annual Health Care Conference, May 7-9, 2012 in Boston.
- Jefferies 2012 Global Healthcare Conference, June 4-7, 2012 in New York City.
- Goldman Sachs 33 rd Annual Global Healthcare Conference, June 5-7, 2012, Ranchos Palos Verdes, Calif.
- American Society of Clinical Oncology (ASCO) 2012 Annual Meeting, June 1-5, 2012 in Chicago.
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