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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 second quarter ended June 30, 2017, and provided a business update.
“The second quarter was marked by validating events in each of the three pillars of our global tivozanib strategy: a recommendation for approval of tivozanib in advanced renal cell carcinoma (RCC) by the CHMP, reaching our enrollment target for the Phase 3 TIVO-3 trial in RCC, and the successful advancement to Phase 2, at full dose, of the TiNivo trial, our Opdivo® combination trial in RCC,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to several key milestones in the coming quarters, including a final determination from the European Commission (EC) on marketing authorization for tivozanib for RCC, as well as the expected presentation of TiNivo Phase 1 study results this fall and the anticipated readout of TIVO-3 in the first quarter of 2018. We believe that we now have the balance sheet to take AVEO beyond these milestones and into the fourth quarter of 2018. This runway could be extended by additional potential payments of up to $16 million by our European tivozanib partner, EUSA Pharma, related to European regulatory and reimbursement approvals, and double-digit royalty payments on net sales for tivozanib in Europe if the EC grants marketing approval for tivozanib.”
Mr. Bailey added: “We also look forward to progress in our earlier pipeline programs, including the initiation of an investigator-sponsored, randomized Phase 2 trial of ficlatuzumab, our potent HGF inhibitory antibody, in combination with cetuximab in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC). As presented at the ASCO annual meeting this past quarter, this combination demonstrated prolonged progression free and overall survival compared to historical controls in Phase 1.”
Recent Updates
Second Quarter 2017 Financial Highlights
Updated Financial Guidance
We believe that our $40.1 million in cash resources would allow us to fund our planned operations into the fourth quarter of 2018. This estimate assumes no receipt of milestone payments from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity financings, no debt financings and no further sales of equity under our Sales Agreement with FBR. This estimate also assumes no acceleration in repayment of the term loan by Hercules in the event of non-compliance with the $10.0 million financial covenant.
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 renal cell carcinoma. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer, cachexia (wasting syndrome) and pulmonary arterial hypertension (PAH). 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, statements about: the expected decision on tivozanib by the EC; the planned presentation of TiNivo Phase 1 study results in the Fall; the anticipated readout of TIVO-3 in the first quarter of 2018; the period in which the Company expects to have cash to fund its operations; expectations about the potential for additional payments by EUSA Pharma; plans to progress pipeline programs, including the initiation of a Phase 2 trial of ficlatuzumab; and AVEO’s strategy, prospects, plans and objectives. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. 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, including without limitation risks relating to the ability of EUSA to successfully obtain approval of tivozanib from the EC. AVEO faces other risks relating to its business as well, including risks relating to its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; 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 achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016, its quarterly reports on Form 10-Q and in other filings that AVEO may make with the SEC in the future. 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 EndedJune 30,
Six Months EndedJune 30,
2017 2016 2017 2016 Collaboration and licensing revenue $ 351 $ 193 $ 2,883 $ 1,396 Operating expenses: Research and development 6,881 5,604 14,837 11,576 General and administrative 2,302 1,731 4,633 4,203 9,183 7,335 19,470 15,779 Loss from operations (8,832)
(7,142 ) (16,587
)
(14,383
)
Other expense, net: Interest expense, net (530
)
(468
)
(1,081
)
(837
)
Change in fair value of warrant liability (23,925 ) (996 ) (24,409 ) (996 ) Other expense, net (24,455 ) (1,464
)
(25,490
)
(1,833
)
Loss before provision for income taxes (33,287
)
(8,606 ) (42,077
)
(16,216
)
Provision for income taxes — — (50
)
(100
) Net loss per share $ (33,287)
$ (8,606 ) $ (42,127
)
$ (16,316
)
Net loss per share - basic
$ (0.30)
$ (0.13 ) $ (0.45
)
$ (0.26
)
Weighted average number of common shares outstanding 110,550 66,917 93,493 62,566 Consolidated Balance Sheet Data (In thousands) (Unaudited) June 30, December 31, 2017 2016 Assets Cash, cash equivalents and marketable securities $ 40,127 $ 23,348 Accounts receivable 445 1,027 Prepaid expenses and other current assets 1,568 1,940 Other assets 352 970 Total assets $ 42,492 $ 27,285 Liabilities and stockholders’ deficit Accounts payable and accrued expenses $ 10,964 $ 7,715 Loans payable 19,122 14,003 Deferred revenue 1,894 2,207 Warrant liability 29,002 4,593 Other liabilities 840 690 Stockholder's deficit (19,330 ) (1,923 ) Total liabilities and stockholders’ deficit $ 42,492 $ 27,285
View source version on businesswire.com: http://www.businesswire.com/news/home/20170809005543/en/
For AVEO OncologyArgot PartnersDavid Pitts, (212) 600-1902aveo@argotpartners.com
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