May 7, 2014
AVEO Oncology Reports First Quarter 2014 Financial Results
CAMBRIDGE, Mass.–(BUSINESS WIRE)–May 7, 2014– AVEO Oncology (NASDAQ:AVEO) today reported its first quarter 2014 financial results and provided an update on its progress toward achieving its strategic plan.
“We made solid progress executing on a key component of our recently announced corporate strategy, which is to advance our clinical-stage assets through collaborations while retaining substantial value,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “In March we re-acquired worldwide commercial rights to AV-203, our ErbB3 inhibitor, from Biogen Idec, which will allow us to find a partner to support further clinical development of AV-203. In addition, in April we announced an innovative partnership with Biodesix, a private diagnostic company, to advance the clinical development of ficlatuzumab, our HGF inhibitory antibody. We expect to initiate a proof-of-concept clinical trial of ficlatuzumab in non-small cell lung cancer by the end of the year, subject to discussions with the Food and Drug Administration.”
Recent Operational Highlights
- Re-acquired rights to AV-203, AVEO’s ErbB3 inhibitor, from Biogen Idec in March 2014. By re-acquiring these rights, AVEO will be able to seek a partner with established oncology capabilities to accelerate and financially support the clinical development of this asset.
- Executed an agreement with Biodesix in April 2014 under which AVEO plans to conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced non-small cell lung cancer using Biodesix’s VeriStrat® test to select for a patient population which did not respond well to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy, but responded to the combination therapy in an exploratory analysis of AVEO’s Phase 2 trial data. Biodesix will fund up to $15 million of the cost of the study. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally between AVEO and Biodesix, as will any potential profits.
- AVEO and Astellas announced the termination of their tivozanib collaboration pursuant to which Astellas will return all rights for tivozanib to AVEO in August 2014. At that time AVEO plans to explore potential partnership opportunities to support the further clinical development of tivozanib.
Q1 2014 Financial Highlights
“We remain on target to end 2014 with a cash balance of between $50 and $55 million,” said Tuan Ha-Ngoc. “In the first quarter AVEO reported cash expenditures of $30 million, approximately half of which are related to facilities and site costs. The majority of these site costs are reimbursable through our lease arrangement and were incurred as construction nears completion on our 650 Kendall offices and labs where our operations will be consolidated.”
- Ended Q1 2014 with $88.3 million in cash, cash equivalents and marketable securities.
- Total collaboration revenue was approximately $15.3 million compared with $0.3 million for Q1 2013. The increase was primarily due to an additional one-time recognition of $14.1 million of previously deferred revenue as a result of the modification of the company’s arrangement with Biogen Idec.
- Research and development (R&D) expense was $11.8 million compared with $21.0 million for Q1 2013. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013 strategic restructuring as well as a decrease in external clinical trial, consulting, and manufacturing costs associated with development and pre-commercialization activities for tivozanib.
- General and administrative (G&A) expense was $5.6 million compared with $12.4 million for Q1 2013. The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following the company’s June 2013 strategic restructuring and a decrease in marketing and consulting costs for tivozanib related to pre-commercialization activities.
- Net loss for Q1 2014 was $6.5 million or a loss of $0.12 per basic and diluted net loss per share compared with net loss of $34.1 million or a loss of $0.69 per basic and diluted net loss per share for Q1 2013.
2014 Financial Guidance
Based on current operating plans, AVEO continues to expect to end 2014 with approximately $50-$55 million in cash, cash equivalents and marketable securities.
Upcoming Q2 Events
AVEO’s Phase 1 dose-escalation study of AV-203 has been accepted for a poster presentation at the 2014 Annual Meeting of the American Society for Clinical Oncology in June.
AVEO expects to present at the 2014 Jefferies Healthcare Conference, June 2-5 in New York City.
AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to discovering and developing targeted therapies designed to provide substantial impact in the lives of people with cancer by addressing unmet medical needs. AVEO’s proprietary Human Response PlatformTM provides the company with unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.
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 initiate a proof of concept study of ficlatuzumab, AVEO’s advancement of its business strategy, including entering into new strategic partnerships, and AVEO’s estimates for its 2014 year-end cash balance. 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 business plan and re-align its resources behind key development opportunities; 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, such as the collaboration with Biodesix described in this press release; 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.|
|Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$88,322||$118,506|
|Prepaid expenses and other current assets||16,001||9,429|
|Property and equipment, net||19,011||14,140|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$16,382||$17,501|
|Total loans payable||16,731||19,205|
|Total deferred revenue||3,101||18,392|
|Total deferred rent||22,595||20,072|
|Total liabilities and stockholders’ equity||$127,805||$146,346|
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|For the Three Months|
|Ended March 31,|
|Research and development||11,767||20,962|
|General and administrative||5,555||12,449|
|Restructuring and lease exit||3,859||67|
|Loss from operations||(5,892)||(33,155)|
|Other income and expense:|
|Other income (expense), net||7||(101)|
|Other expense, net||(558)||(930)|
|Net loss per share – basic and diluted||$(0.12)||$(0.69)|
|Weighted average number of common shares outstanding||51,634||49,380|
Source: AVEO Oncology
AVEO Investor Relations
Rob Kloppenburg, 617-299-5990