- Completion of the First Dose Cohort of the Phase 1/2 TiNivo Study of Tivozanib in Combination with Nivolumab in RCC. AVEO today announced completion of the first dose cohort, and initiation of enrollment in the second and final dose cohort, of the Phase 1 portion of the Company's Phase 1/2 TiNivo trial evaluating tivozanib in combination with Opdivo ® (nivolumab), Bristol-Myers Squibb's anti-PD-1 therapy, in advanced RCC. The study, which is led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 portion of the study, which the Company expects to complete in the first half of 2017, will primarily evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib. If the Company receives favorable results, it expects to follow immediately with an expansion Phase 2 trial at the established combination dose.
- Presentation of Posters at Upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. In April 2017, AVEO announced that poster presentations for three clinical studies will be presented at the upcoming 2017 ASCO Annual Meeting, to be held June 2-6, 2017. Among these are two presentations that highlight ficlatuzumab results from Phase 1 investigator-sponsored studies, one in head and neck squamous cell carcinoma and the other in acute myeloid leukemia. In addition, a Trials in Progress presentation will highlight the ongoing Phase 3, randomized, controlled, multi-center, open-label TIVO-3 study comparing tivozanib, the Company's potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, to sorafenib in subjects with refractory advanced renal cell carcinoma.
- Submission of Response to Tivozanib Marketing Authorization Application (MAA) Day 180 List of Outstanding Issues (LOI). In April 2017, AVEO announced that its European licensee for tivozanib, EUSA Pharma, submitted responses to the European Medicines Agency (EMA) Day 180 LOI related to the MAA for tivozanib as a first-line treatment for RCC. With submission of the response complete, EUSA remains tentatively scheduled to provide an oral explanation to the EMA's Committee for Medicinal Products for Human Use at its May 2017 meeting.
- Receipt of Milestone Payment from CANbridge for AV-203. In April 2017, AVEO announced receipt of a $500,000 milestone payment from CANbridge Life Sciences Ltd., a biopharmaceutical company focused on developing western drug candidates in China and North Asia, related to a technology transfer milestone for AV-203, AVEO's clinical-stage ErbB3 (HER3) inhibitory antibody candidate. CANbridge is planning clinical development of AV-203 in squamous cell esophageal cancer as its initial indication.
- Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares. In March 2017, AVEO announced the closing of an underwritten public offering of 34,500,000 shares of common stock, including the exercise in full by the underwriter of its option to purchase 4,500,000 shares at the public offering price of $0.50 per share. The net proceeds of the offering were approximately $15.5 million, and are expected to be used for working capital and general corporate purposes
- TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC, successfully completed the first safety review by the study's Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first- line treatment for RCC.
Mr. Bailey added: "We greatly appreciate Keith's contributions to AVEO and wish him well in his future endeavors. His leadership and guidance through a period of turnaround for the Company have been greatly valued. We look forward to a completing the search for a new chief financial officer as expeditiously as possible."First Quarter 2017 Financial Highlights
- AVEO ended Q1 2017 with $33.4 million in cash, cash equivalents and marketable securities as compared with $23.3 million at December 31, 2016.
- Total collaboration revenue for Q1 2017 was approximately $2.5 million compared with $1.2 million for Q1 2016.
- Research and development expense for Q1 2017 was $8.0 million compared with $6.0 million for Q1 2016.
- General and administrative expenses for Q1 2017 was $2.3 million compared with $2.5 for Q1 2016.
- Net loss for Q1 2017 was $8.8 million, or a loss of $0.12 per basic and diluted share compared with net loss of $7.7 million or a loss of $0.13 per basic and diluted share for Q1 2016.
|AVEO PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited)|
|Three Months Ended March 31,|
|Collaboration and licensing revenue||$||2,532||$||1,203|
|Research and development||7,956||5,972|
|General and administrative||2,331||2,463|
|Loss from operations||(7,755||)||(7,232)|
|Other expense, net:|
|Change in fair value of warrant liability||(484)||—|
|Other expense, net||(551)||(378||)|
|Other expense, net||(1,035)||(378||)|
|Loss before provision for income taxes||(8,790||)||(7,610)|
|Provision for income taxes||(50)||(100)|
|Basic and diluted net loss per share||$||(0.12||)||$||(0.13)|
|Weighted average number of common shares outstanding||76,246||58,166|
|Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||33,411||$||23,348|
|Prepaid expenses and other current assets||1,812||1,940|
|Liabilities and stockholders' equity (deficit)|
|Accounts payable and accrued expenses||$||9,689||$||7,715|
|Stockholder's equity (deficit)||4,911||(1,923||)|
|Total liabilities and stockholders' equity (deficit)||$||36,584||$||27,285|