We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
AVEO Pharmaceuticals Inc | NASDAQ:AVEO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 15.00 | 14.99 | 15.00 | 0 | 01:00:00 |
AVEO Oncology (NASDAQ:AVEO) today reported financial results for the full year ended December 31, 2016 and provided a business update.
“TIVO-3, our lead clinical program designed to serve as the basis for a potential U.S. registration for tivozanib as a first- and third-line treatment for renal cell cancer, continues to enroll ahead of schedule and has now completed its first safety review,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to the study’s pre-planned interim futility analysis midyear 2017 and, potentially, to top line results in the first quarter of 2018 and to initial data from our Phase 1 TiNivo study of tivozanib in combination with Opdivo® in the first half of 2017. We also continue to support our partner EUSA Pharma in its efforts to complete the European Marketing Authorization Application review for tivozanib as a first-line treatment for renal cell carcinoma. There remains a significant unmet need for better tolerated therapies in this disease, particularly those that enable combination treatment, and we look forward to receiving tivozanib data and to potential regulatory milestones in the coming quarters.”
Mr. Bailey continued: “We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203.”
Recent Updates
Full Year 2016 Financial Highlights
Financial Guidance
We believe that our $23.3 million in existing cash, cash equivalents and marketable securities as of December 31, 2016 could allow us to fund our planned operations into the fourth quarter of 2017; however, additional funds will be needed to extend these operations into 2018 and maintain compliance with our $10.0 million financial covenant under our loan agreement with Hercules.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for RCC and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). 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 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential”, “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” 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: the expected timelines for completing enrollment, undergoing a futility analysis and receiving top-line data readouts in TIVO-3 and TiNivo; the potential for the design of the TIVO-3 and TIVO-1 trials to support regulatory approval for first- and third-line indications in RCC in the U.S.; plans and strategies of AVEO and its partners, including EUSA, and the potential achievement by AVEO and its partners of clinical, regulatory, commercial, manufacturing and other development goals and milestones; the potential safety, efficacy, tolerability and other benefits of tivozanib in the treatment of renal cell carcinoma as a single agent or in combination with other therapies; and the period in which AVEO expects that its existing cash, cash equivalents and marketable securities will fund its operations. 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 enter into and maintain its third party collaboration agreements, and its ability, and the ability of its licensees and other partners, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo trials; AVEO’s ability to maintain compliance with the $10.0 million financial covenant under its loan agreement with Hercules; 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, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to fund its operating expenses beyond the beginning of the fourth quarter of 2017 and to continue as a going concern; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and 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 may cause its views to change. 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 other than the date of this press release.
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months EndedDecember 31, For the Years EndedDecember 31, 2016 2015 2016 2015 Collaboration and licensing revenue $ 127 $ 3,598 $ 2,515 $ 19,024 Operating expenses: Research and development 7,683 3,873 23,703 12,875 General and administrative 1,870 5,848 8,205 14,217 Restructuring and lease exit — — — 4,358 9,553 9,721 31,908 31,450 Loss from operations (9,426 ) (6,123 ) (29,393 ) (12,426 ) Other income (expense), net: Change in fair value of warrant liability 4,569 — 4,751 — Other expense, net (748 ) (462 ) (2,144 ) (2,575 ) Other income (expense), net 3,821 (462 ) 2,607 (2,575 ) Loss before provision for income taxes (5,605 ) (6,585 ) (26,786 ) (15,001 ) Provision for income taxes — — (101 ) — Net loss $ (5,605 ) $ (6,585 ) $ (26,887 ) $ (15,001 ) Basic and diluted net loss per share $ (0.07 ) $ (0.11 ) $ (0.39 ) $ (0.27 ) Weighted average number of common shares outstanding 75,863 58,136 69,268 55,701Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
December 31, December 31, 2016 2015 Assets Cash, cash equivalents and marketable securities $ 23,348 $ 34,135 Accounts receivable 1,027 4,641 Prepaid expenses and other current assets 1,940 1,600 Property and equipment, net — 23 Other assets 970 143 Total assets $ 27,285 $ 40,542 Liabilities and stockholders’ (deficit) equity Accounts payable and accrued expenses $ 7,715 $ 5,531 Total loans payable 14,003 9,471 Total deferred revenue 2,207 3,695 Warrant liability 4,593 — Other liabilities 690 4,618 Stockholder’s (deficit) equity (1,923 ) 17,227 Total liabilities and stockholders’ (deficit) equity $ 27,285 $ 40,542
View source version on businesswire.com: http://www.businesswire.com/news/home/20170322006146/en/
AVEO:Argot PartnersDavid Pitts, 212-600-1902aveo@argotpartners.com
1 Year AVEO Pharmaceuticals Chart |
1 Month AVEO Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions