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Business Wire 9-Nov-2018 7:00 AM
AVEO Oncology (NASDAQ:AVEO) today reported financial results for the third quarter ended September 30, 2018 and provided a business update.
"The recent announcement of positive topline results from the Phase 3 TIVO-3 study in renal cell carcinoma is transformative for AVEO, and the next step of an ongoing, multi-year effort to ensure tivozanib (FOTIVDA®) is available to patients for whom it could deliver its differentiated combination of efficacy and tolerability relative to other commercially available TKIs in RCC," said Michael Bailey, president and chief executive officer of AVEO. "We remain committed to our three-pillar strategy for tivozanib, which includes potential registration in the U.S., the ongoing commercialization of FOTIVDA® in Europe with partner EUSA Pharma, and a broad exploration of tivozanib's potential in combination with immunotherapies in cancer. Our recent achievements with TIVO-3 also provides a strong foundation to realize the potential of our pipeline, which includes two oncology-focused product candidates and three non-oncology product candidates."
Tivozanib TIVO-3 Study North America Update
Tivozanib TiNivo Study Update
The data demonstrated that the tivozanib-nivolumab combination continued to exhibit synergistic efficacy and favorable tolerability. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension. Preliminary efficacy was assessed in all 25 patients, who were treated with the full dose and schedule of oral tivozanib in combination with intravenous nivolumab. Of these patients, 13 (52%) had received at least one prior systemic therapy, including 2 (8%) that had received prior PD-1 therapy, and 12 (48%) were treatment naïve. An overall response rate was observed in 14 patients (56%) (complete response plus partial response), including 1 patient (4%) achieving a complete response, and a disease control rate (complete response plus partial response plus stable disease) was observed in 24 patients (96%). The 2 patients (8%) who received prior PD-1 therapy both achieved a partial response. At the time of data collection, 13 patients (52%) remained on study and 18 patients (72%) had tumor shrinkage of at least 25%, with a majority of patients having disease control for at least 48 weeks.
Tivozanib (FOTIVDA®) European Union Updates
Ficlatuzumab Update
CAN017 (AV-203) Update
Financial Update
Third Quarter 2018 Financial Highlights
Financial Guidance
AVEO believes that its $20.4 million in cash, cash equivalents, and marketable securities at the end of Q3 2018 and the additional $8.4 million raised from sales under its sales agreement with Leerink in October and November 2018 would allow it to fund planned operations into the second quarter of 2019. This estimate assumes no receipt of additional milestones from AVEO's partners, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of outstanding warrants issued in connection with the 2016 private placement or outstanding warrants issued in connection with the recent settlement of the securities class action litigation.
About AVEO
AVEO Pharmaceuticals, Inc. (the "Company" or "AVEO") is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need. The Company's strategy is to retain North American rights to its oncology portfolio while securing partners in development and commercialization outside of North America. The Company is seeking to develop and commercialize its lead candidate tivozanib in North America as a treatment for advanced or metastatic renal cell carcinoma ("RCC"). The Company has outlicensed tivozanib (FOTIVDA®) for oncological indications in Europe and other territories outside of North America. Tivozanib is approved in the European Union, as well as Norway and Iceland, for the first-line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC. The Company has entered into partnerships for the development and commercialization of AV-203 (CAN017) and ficlatuzumab, both clinical stage assets in oncology. The Company is currently seeking a partner to develop the AV-353 platform, a preclinical asset, worldwide for the potential treatment of pulmonary arterial hypertension and oncology. In addition, a new formulation of tivozanib is being explored in ocular conditions. The Company has recently regained the rights to its AV-380 program for the potential treatment of cachexia and is considering a variety of options to advance the program's development.
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 Company's plans and prospects for advancing its lead development programs, including its expectations regarding the presentation for detailed top line results from the Phase 3 TIVO-3 study of tivozanib in RCC, and for providing an update to the Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO®) in mRCC; the Company's plans to submit an NDA to the FDA for tivozanib for RCC and the timing of such submission; the potential efficacy, safety, and tolerability profile of tivozanib; the Company's plans and strategies for commercialization of tivozanib in the United States and Europe; the potential for tivozanib in other indications, as either a monotherapy or combination therapy; the Company's plan to seek a partner to develop the AV-353 platform; the Company's plans regarding AV-380; the Company's cash runway; 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 and license agreements, and its ability, and the ability of its collaborators, licensees and other strategic partners, to achieve development and commercialization objectives under these arrangements; and AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO's product candidates, including tivozanib. AVEO faces other risks relating to its business as well, including risks relating to the timing and costs of any product candidate that receives regulatory approval; its ability to file an NDA for tivozanib in the timeframe it currently estimates; its and its collaborators' 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; 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 sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO's quarterly and annual reports on file with the Securities and Exchange Commission (SEC) 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. Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.
AVEO PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) |
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Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
Collaboration and licensing revenue | $ | 2,335 | $ | 4,614 | $ | 3,651 | $ | 7,497 | ||||||||||||
Partnership royalties | 132 | — | 275 | — | ||||||||||||||||
2,467 | 4,614 | 3,926 | 7,497 | |||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 5,160 | 4,666 | 15,451 | 19,503 | ||||||||||||||||
General and administrative | 2,719 | 2,101 | 8,156 | 6,734 | ||||||||||||||||
Settlement costs | — | — | (667 | ) | — | |||||||||||||||
7,879 | 6,767 | 22,940 | 26,237 | |||||||||||||||||
Loss from operations | (5,412 | ) | (2,153 | ) | (19,014 | ) | (18,740 | ) | ||||||||||||
Other expense, net: | ||||||||||||||||||||
Interest expense, net | (579 | ) | (655 | ) | (1,621 | ) | (1,736 | ) | ||||||||||||
Change in fair value of PIPE Warrant liability | (16,172 | ) | (23,538 | ) | (6,512 | ) | (47,947 | ) | ||||||||||||
Other expense, net | (16,751 | ) | (24,193 | ) | (8,133 | ) | (49,683 | ) | ||||||||||||
Loss before provision for income taxes | (22,163 | ) | (26,346 | ) | (27,147 | ) | (68,423 | ) | ||||||||||||
Provision for income taxes | — | (51 | ) | — | (101 | ) | ||||||||||||||
Net loss | $ | (22,163 | ) | $ | (26,397 | ) | $ | (27,147 | ) | $ | (68,524 | ) | ||||||||
Net loss per share - basic and diluted | $ | (0.18 | ) | $ | (0.22 | ) | $ | (0.23 | ) | $ | (0.67 | ) | ||||||||
Weighted average number of common shares outstanding | 120,138 | 118,006 | 119,311 | 101,754 |
Consolidated Balance Sheet Data (In thousands) (Unaudited) |
||||||||||
September 30,
2018 |
December 31,
2017 |
|||||||||
Assets | ||||||||||
Cash, cash equivalents and marketable securities | $ | 20,408 | $ | 33,525 | ||||||
Accounts receivable | 344 | 402 | ||||||||
Prepaid expenses and other current assets | 686 | 1,256 | ||||||||
Insurance recovery | — | 15,000 | ||||||||
Other assets | 4 | 15 | ||||||||
Total assets | $ | 21,442 | $ | 50,198 | ||||||
Liabilities and stockholders' deficit | ||||||||||
Accounts payable and accrued expenses | $ | 13,426 | $ | 13,215 | ||||||
Loans payable, net of discount | 18,877 | 18,477 | ||||||||
Deferred revenue and research and development reimbursements | 5,284 | 2,820 | ||||||||
PIPE Warrant liability | 43,157 | 37,746 | ||||||||
Estimated settlement liability | - | 17,073 | ||||||||
Other liabilities | 1,090 | 1,630 | ||||||||
Stockholder's deficit | (60,392 | ) | (40,763 | ) | ||||||
Total liabilities and stockholders' deficit | $ | 21,442 | $ | 50,198 |
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