On August 7, 2018 AVEO Oncology (NASDAQ: AVEO) reported financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, AVEO, AUG 7, 2018, View Source [SID1234528477]).

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"Our U.S. registration strategy remains a key focus for AVEO, with topline readout of the Phase 3 TIVO-3 study expected in the fourth quarter of this year," said Michael Bailey, president and chief executive officer of AVEO. "TIVO-3 is the first randomized Phase 3 study in advanced kidney cancer to stratify for prior immunotherapy and, as a result, it has the potential to serve as a benchmark study for the sequencing of therapies in advanced disease."

Mr. Bailey added: "The next two pillars of our tivozanib strategy also continue to make progress. The recent launch of FOTIVDA in Scotland adds to ongoing commercial efforts in Germany, the U.K., and Austria by our partner EUSA Pharma. We anticipate additional potential reimbursement approvals for France, Germany, Italy, and Spain in the coming months, triggering up to $8 million in milestone payments due to AVEO in addition to double-digit royalty payments on net sales of FOTIVDA in Europe. EUSA has the option to access TIVO-3 data in the event of a positive outcome in exchange for a $20 million R&D reimbursement payment to AVEO. Finally, we look forward to presenting additional data at the ESMO (Free ESMO Whitepaper) meeting in October from the Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO) in aRCC, a study which to date has demonstrated promising activity and a favorable safety profile."

Tivozanib TIVO-3 Study North America Update

Topline Data from Phase 3 TIVO-3 Study Anticipated in the Fourth Quarter of 2018. As previously announced, the Company expects to report topline results from the TIVO-3 study, AVEO’s Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma (aRCC), in the fourth quarter of 2018, approximately 6-8 weeks after the trial records 255 progression free survival (PFS) events. AVEO plans to announce when 255 PFS events have occurred and the topline data analysis for the trial has been initiated. Together with the TIVO-1 study, TIVO-3 is designed to serve as the basis for a potential U.S. approval of tivozanib (FOTIVDA) as a first- and third-line treatment for aRCC.

Tivozanib (FOTIVDA) European Union Updates

Tivozanib (FOTIVDA) Launched in Scotland for the Treatment of aRCC. In July 2018, FOTIVDA was launched in Scotland for the first-line treatment of adult patients with aRCC after the Scottish Medicines Consortium approved its use. FOTIVDA is now available in Germany, Scotland, the U.K., and Austria. FOTIVDA was granted European

Medicines Association approval in August 2017 for the treatment of adult patients with aRCC in the European Union plus Norway and Iceland.

Tivozanib (FOTIVDA) Expanded Access Program Launched in Italy. In July 2018, The Program of Therapeutic Use Tivozanib (Expanded Access Program) for renal cell carcinoma (RCC) was initiated, allowing patients in Italy to have access to tivozanib as front-line therapy. In addition, EUSA pharma is effecting the reimbursement procedure with the Italian Drug Agency (AIFA), a process which is expected to be finalized in the coming months.

Additional Tivozanib Updates

Updated Phase 2 Results from the TiNivo Trial of Tivozanib and Nivolumab (OPDIVO) in aRCC to be Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. Updated Phase 2 data from the Phase 1b/2 TiNivo study of tivozanib in combination with nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, will be presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Munich. The data will be presented during a poster presentation titled, "TiNivo: Tivozanib combined with nivolumab: safety and efficacy in patients with metastatic renal cell carcinoma (mRCC)" (Presentation Number 878P). Previously presented results support the potential advantages of a combination therapy using a high-specificity VEGF inhibitor TKI in connection with an immune checkpoint therapy in renal cancer.

Ficlatuzumab Update

Trials in Progress Poster for Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC to be Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. Data from an ongoing, investigator-sponsored Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC) will be presented as a trials in progress poster at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting (Presentation Number 1124TiP). This randomized multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.

Trials in Progress Poster for Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. Data from an ongoing, investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with nab-paclitaxel and gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC) was presented as a trials in progress poster (Poster Board: #330b, Abstract TPS4152) at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL in June 2018. The study, which is being conducted under the direction of Kimberly Perez,

MD at the Dana-Farber Cancer Institute, is currently enrolling, with an expected total enrollment of approximately 30 patients.

Corporate Update

Added to the Russell 2000, Russell 3000, and Russell Microcap Indexes. In June 2018, AVEO announced that it had been added to the Russell 2000, Russell 3000, and Russell Microcap Indexes as part of FTSE’s annual reconstitution. Russell U.S. Indexes are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell U.S. Indexes.

Second Quarter 2018 Financial Highlights

AVEO ended Q2 2018 with $18.1 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.

Total revenue for Q2 2018 was approximately $0.4 million compared with $0.4 million for Q2 2017.

Research and development expense for Q2 2018 was $4.9 million compared with $6.9 million for Q2 2017.

General and administrative expense for Q2 2018 was $2.8 million compared with $2.3 million for Q2 2017.

Net income for Q2 2018 was $4.0 million, or income of $0.03 per basic share and a loss of $0.06 per diluted share, compared with net loss of $33.3 million for Q2 2017, or a loss of $0.30 per basic and diluted share. Approximately $11.1 million of Q2 2018 net income was a non-cash gain attributable to the decrease in the fair value of the 2016 private placement warrant liability that principally resulted from the decrease in the stock price that occurred within the quarter. In Q2 2017, the non-cash loss attributable to the increase in the fair value of such warrant liability was $23.9 million.

Financial Guidance

We believe that our $18.1 million in cash resources would allow us to fund our planned operations into the first quarter of 2019. This estimate assumes no receipt of additional milestones from our partners, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of our outstanding warrants issued in connection with our 2016 private placement or outstanding warrants issued in connection with the recent settlement of our securities class action litigation.