SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 4, 2010
AVEO Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction
75 Sidney Street
|(Address of Principal Executive Offices)||(Zip Code)|
Registrants telephone number, including area code: (617) 299-5000
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Item 2.02||Results of Operations and Financial Condition.|
On November 4, 2010, we issued a press release announcing our results for the quarter ended September 30, 2010 and will conduct a previously-announced, publicly-available conference call to discuss those results. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K and Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
|Item 9.01||Financial Statements and Exhibits.|
(d) The following exhibit is included in this report and shall be deemed to be furnished, and not filed:
|99.1||Press release issued by the Company on November 4, 2010|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|AVEO Pharmaceuticals, Inc.|
Date: November 4, 2010
Chief Executive Officer
|99.1||Press release issued by the Company on November 4, 2010|
FOR IMMEDIATE RELEASE
AVEO Pharmaceuticals, Inc.
AVEO Reports Third Quarter 2010 Financial Results and Recent Developments
Current Financial Position Supports Expanding and Accelerating Clinical Development Plans for Tivozanib
CAMBRIDGE, Mass., November 4, 2010 AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced updated financial guidance and third quarter financial results, as well as recent developments.
During the third quarter, we achieved two significant developments - completing enrollment of TIVO-1, our Phase 3 clinical trial of tivozanib in patients with advanced kidney cancer, which advances the expected timeline for top-line data for TIVO-1 by six months to mid-2011, and regaining worldwide rights to AV-299, our internally-discovered anti-HGF antibody, said Tuan Ha-Ngoc, president and chief executive officer of AVEO. We now have two late-stage, unencumbered assets with potential to advance toward commercialization. We believe that these events, coupled with the proceeds from our recently-completed private placement, position AVEO well for achieving our vision of becoming a fully integrated cancer therapeutics company and making a meaningful contribution to the treatment of patients with cancer.
Financing and Financial Guidance
On October 29, 2010, the company announced that it had entered into a definitive agreement with respect to the private placement of 4.5 million shares of its unregistered common stock at $13.50 per share to a group of institutional and accredited investors. AVEO completed the private placement on November 3, 2010, resulting in approximately $57 million in net proceeds to AVEO.
With the net proceeds from the private placement financing, AVEO expects to end 2010 with at least $100 million in cash and marketable securities.
Third Quarter 2010 Financial Results
AVEO ended the third quarter of 2010 with cash and marketable securities of $87.0 million.
Total collaboration revenues for the third quarter of 2010 were $6.2 million compared with $5.9 million for the third quarter of 2009.
Research and development (R&D) expense for the third quarter of 2010 was $20.3 million compared with $16.5 million for the same period of 2009. The increase in R&D spending was primarily driven by clinical
costs associated with TIVO-1, AVEOs global Phase 3 clinical trial of tivozanib in patients with advanced RCC, which commenced enrollment in February 2010.
General and administrative expense was $3.6 million for the third quarter of 2010 compared with $2.5 million for the third quarter of 2009. The primary driver of the increase in spending was personnel-related expenses.
Net loss for the third quarter of 2010 was $18.6 million, or $0.60 per common share (based on 30.9 million weighted average shares outstanding), compared with $13.8 million, or $8.56 per common share, for the third quarter of 2009 (based on 1.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from AVEOs initial public offering in March 2010, as well as the conversion of all preferred stock to common stock.
Completed Enrollment of TIVO-1: In August, AVEO announced that it achieved its enrollment target for TIVO-1 in patients with advanced renal cell carcinoma (RCC). AVEO initiated patient enrollment in TIVO-1 in February of this year and successfully reached the target enrollment of 500 patients six months ahead of schedule. The company expects top-line data from this trial in mid-2011.
Presented Previously Announced Phase 2 Tivozanib Data at IKCS and ESMO: AVEO presented previously announced data from the Phase 2 randomized discontinuation trial with tivozanib showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy was 14.8 months. This is the same patient population being studied in the TIVO-1 Phase 3 trial. Median PFS among all 272 patients in the Phase 2 trial was 11.8 months. Off-target toxicities commonly associated with other VEGF-directed targeted therapies, such as mucositis, fatigue and hand-foot syndrome, were notably low during treatment with tivozanib in the Phase 2 trial.
Regained Worldwide Rights to AV-299: In September, AVEO announced that it regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299, AVEOs anti-hepatocyte growth factor (HGF) antibody candidate, effective as of December 27, 2010. AV-299 is a potent, anti-HGF antibody that was discovered by AVEO through its Human Response Platform. Data from Phase 1 clinical trials of AV-299 indicate the potential for a favorable tolerability profile and good combinability with EGFR inhibitors, erlotinib (Tarceva®) and gefitinib (Iressa®). In June 2010, AVEO initiated a Phase 2 clinical trial evaluating AV-299 in combination with gefitinib versus gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). In conjunction with the Phase 2 trial initiation, AVEO received an $8.5 million milestone payment from Merck under the terms of the collaboration agreement. As of the effective date of the return of right from Merck, the company will be responsible for future development, manufacturing and commercialization funding for the AV-299 program. Top-line efficacy data from the AV-299 Phase 2 trial are expected in 2012.
Awarded approximately $733,000 in Grants under Patient Protection and Affordable Care Act: In November, AVEO was informed that it has been awarded three separate grants totaling approximately $733,000 under the Patient Protection and Affordable Care Act of 2010. These grants support both clinical and pre-clinical development activities related to tivozanib, AV-299, as well as AVEOs discovery stage programs and proprietary Human Response Platform.
AVEO expects to present at the following investor conferences:
22nd Annual Piper Jaffray Health Care Conference, New York City, November 30-December 1, 2010
J.P. Morgan SMid Cap Conference, New York City, December 2-3, 2010
Deutsche Banks 2010 BioFEST, Boston, December 14-15, 2010
AVEO expects to have a presence at the following oncology meetings:
28th Annual Chemotherapy Foundation Symposium (CFS), New York City, November 9-13, 2010
22nd Annual Symposium of the European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR), Berlin, Germany, November 16-19, 2010
33rd Annual San Antonio Breast Cancer Symposium (SABCS), San Antonio, Texas, December 8-12, 2010
Todays Conference Call and Webcast Reminder
The AVEO management team will host a conference call discussing the companys third quarter financial results, recent developments and 2010 financial guidance today at 10:00 a.m. (EDT). The call can be accessed by dialing 1-866-713-8563 (domestic) or 1-617-597-5311 (international) five minutes prior to the start of the call and providing the passcode 21275874. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 75499695. The replay of the call will be available for two weeks from the date of the live call.
A live, listen-only webcast of the conference call can also be accessed by visiting the investors section of the AVEO website at investor.aveopharma.com. A replay of the webcast will be archived on the companys website for two weeks following the call.
AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The companys lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEOs second product candidate, AV-299, is a potent, functional anti-HGF antibody that is currently in Phase 2 development. AVEOs proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the companys website at www.aveopharma.com.
Statements in this press release about AVEOs future expectations, plans and prospects, including statements about AVEO becoming a fully integrated cancer therapeutics company and making a meaningful contribution to the treatment of patients living with cancer, AVEOs estimates for its 2010 financial performance (including its expected year-end cash balance), the expected timing of TIVO-1 trial results, the expected timing of data from the AV-299 Phase 2 trial, AVEOs proprietary, integrated cancer biology platform offering AVEO a unique advantage in oncology drug development, and other statements containing the words believes, anticipates, plans, expects, will, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including risks relating to: AVEOs ability to successfully research, develop, obtain and maintain regulatory approvals for tivozanib, AV-299 and its other product candidates; AVEOs inability to obtain and maintain adequate protection for intellectual property rights relating to AVEOs product candidates and technologies; AVEOs ability to maintain its strategic partnerships and risks related to the failure of AVEOs strategic partners to meet their obligations under their agreements with AVEO; AVEOs ability to consummate additional strategic partnerships on favorable terms; unplanned operating expenses; AVEOs inability to raise substantial additional funds to achieve its goals; general economic and industry conditions; and other factors discussed in the Risk Factors section of AVEOs most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that AVEO periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent AVEOs views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause AVEOs views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, AVEO specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing AVEOs views as of any date subsequent to the date of this press release.