- Phase 2 study of tivozanib in colorectal cancer fully enrolled since first half of 2013: AVEO, and its partner Astellas Pharma, Inc., continue to evaluate tivozanib in a Phase 2 BATON ( Biomarker Assessment of Tivozanib in ONcology) study in patients with advanced metastatic colorectal cancer (CRC). BATON is a series of clinical trials assessing biomarkers in solid tumors that may be predictive of clinical response to tivozanib. Enrollment was completed in the Phase 2 study in patients with CRC earlier this year, and data are anticipated in 2014.
- Enrollment slower than anticipated in Phase 2 study of tivozanib in breast cancer: AVEO and Astellas continue to evaluate tivozanib in a Phase 2 BATON study in patients with locally recurrent or metastatic triple negative breast cancer (TNBC). Enrollment in this study has been slower than anticipated. AVEO has undertaken additional patient recruitment efforts in support of this study and expects to reassess enrollment rates and the impact on its plans in TNBC in the coming months.
- Dose-escalation portion of AV-203 Phase 1 study completed: AV-203, AVEO’s antibody targeting the ErbB3 (HER3) receptor, has demonstrated tolerability in the dose-escalation portion of the ongoing Phase 1 study in patients with solid tumors, and the recommended dose for further evaluation has been established. AV-203 is now being evaluated in an expansion cohort in a biomarker-defined patient population.
- AV-380 nominated the clinical candidate for cachexia program: AVEO has nominated AV-380 as the development candidate for its program focusing on cachexia. AV-380 is an antibody discovered using AVEO’s proprietary Human Response Platform™ that addresses a target believed to be involved in cachexia in patients with cancer and other chronic diseases. Appropriate IND-enabling efforts, including cell line development, have been initiated to begin to prepare AV-380 for future clinical development.
- Total collaboration revenue for the third quarter of 2013 was approximately $0.3 million compared with $1.0 million for the third quarter of 2012. The decrease was due to revenue recognized for research funding in the third quarter of 2012 under a collaboration agreement with Centocor Ortho Biotech Inc., which was terminated in December 2012. Revenue recognized during the third quarter of 2013 consisted of the amortization of previously deferred amounts related to AVEO’s collaboration agreements with Biogen Idec International GmbH and Astellas.
- Research and development (R&D) expense for the third quarter of 2013 was $19.4 million compared with $21.1 million for the third quarter of 2012. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following the strategic restructurings announced in October 2012 and June 2013 and a decrease in clinical trial and regulatory costs for tivozanib and ficlatuzumab, offset by development costs relating to the manufacture of ficlatuzumab.
- General and administrative (G&A) expense for the third quarter of 2013 was $4.4 million compared with $9.3 million for the third quarter of 2012. The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following our strategic restructuring announced in June 2013 and a reduction in pre-commercialization costs associated with tivozanib.
- Net loss for the third quarter of 2013 was $24.3 million, or basic and diluted net loss per share of $0.47, compared with a net loss of $30.1 million, or basic and diluted net loss per share of $0.69 for the third quarter of 2012.
- AVEO ended the third quarter of 2013 with cash, cash equivalents and marketable securities of $130.4 million.
About AVEOAVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering and developing targeted therapies designed to provide substantial impact in patients’ lives by addressing unmet medical needs. AVEO’s proprietary Human Response Platform provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveooncology.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO’s plans to leverage its Human Response Platform to develop targeted agents for specific patient populations; AVEO’s plans to advance its preclinical and clinical development programs, including its plans to assess its TNBC program and its plans to develop AV-380; and AVEO’s estimates for its 2013 year-end cash balance and its estimate with respect to the availability of cash to fund its operating plans through at least the second quarter of 2015. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to execute on its revised business plan and manage the impact of unplanned operating expenses; AVEO’s ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO’s ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; adverse general economic and industry conditions; competitive factors; AVEO’s ability to maintain its strategic partnerships and relationships, including its collaboration with Astellas; and those risks discussed in the section titled “Risk Factors” included in AVEO’s most recent Quarterly Report on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|For the Three Months||For the Nine Months|
|Ended September 30,||Ended September 30,|
|Research and development||19,414||21,099||56,579||67,325|
|General and administrative||4,440||9,300||24,213||27,469|
|Loss from operations||(23,608||)||(29,381||)||(87,835||)||(91,039||)|
|Other income and expense:|
|Other income (expense), net||32||46||(120||)||279|
|Other expense, net||(698||)||(741||)||(2,469||)||(1,875||)|
|Net loss per share - basic and diluted||$||(0.47||)||$||(0.69||)||$||(1.78||)||$||(2.14||)|
|Weighted average number of common shares outstanding||51,443||43,430||50,719||43,336|
|AVEO Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||130,362||$||160,602|
|Prepaid expenses and other current assets||7,232||9,430|
|Property and equipment, net||12,766||12,867|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||18,291||$||30,171|
|Total loans payable||21,592||26,037|
|Total deferred revenue||18,715||19,685|
|Total deferred rent||17,468||11,400|
|Total liabilities and stockholders’ equity||$||163,114||$||207,469|