AVEO Reports Second Quarter 2018 Financial Results and Provides Business Update
“Our U.S. registration strategy remains a key focus for
Mr. Bailey added: “The next two pillars of our tivozanib strategy also
continue to make progress. The recent launch of FOTIVDA® in
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. AVEOplans 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
Scotlandfor the Treatment of aRCC. In July 2018, FOTIVDA® was launched in Scotlandfor the first-line treatment of adult patients with aRCC after the Scottish Medicines Consortiumapproved its use. FOTIVDA® is now available in Germany, Scotland, the U.K., and Austria. FOTIVDA® was granted European Medicines Associationapproval in August 2017for the treatment of adult patients with aRCC in the European Unionplus Norwayand 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 Italyto 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 Annual Meeting. Updated Phase 2 data from the
Phase 1b/2 TiNivo study of tivozanib in combination with nivolumab
Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, will be presented at the 2018 European Society for Medical Oncology( ESMO) 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.
Trials in Progress Poster for Phase 2 Study of Ficlatuzumab in
Combination with Cetuximab in HNSCC to be Presented at the 2018
ESMOAnnual 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 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 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) Annual Meeting in Chicago, ILin 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.
Added to the Russell 2000, Russell 3000, and Russell Microcap
June 2018, AVEOannounced 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 trillionin assets are benchmarked against Russell U.S. Indexes.
Second Quarter 2018 Financial Highlights
AVEOended Q2 2018 with $18.1 millionin cash, cash equivalents and marketable securities as compared with $33.5 millionat December 31, 2017.
Total revenue for Q2 2018 was approximately
$0.4 millioncompared with $0.4 millionfor Q2 2017.
Research and development expense for Q2 2018 was
$4.9 millioncompared with $6.9 millionfor Q2 2017.
General and administrative expense for Q2 2018 was
$2.8 millioncompared with $2.3 millionfor Q2 2017.
Net income for Q2 2018 was
$4.0 million, or income of $0.03per basic share and a loss of $0.06per diluted share, compared with net loss of $33.3 millionfor Q2 2017, or a loss of $0.30per basic and diluted share. Approximately $11.1 millionof 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 $23.9 million.
We believe that our
For more information, please visit the Company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|AVEO PHARMACEUTICALS, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and licensing revenue||$||336||$||351||$||1,316||$||2,883|
|Research and development||4,887||6,881||10,291||14,837|
|General and administrative||2,827||2,302||5,437||4,633|
|Loss from operations||(6,572||)||(8,832||)||(13,602||)||(16,587||)|
|Other income (expense), net:|
|Interest expense, net||(549||)||(530||)||(1,042||)||(1,081||)|
|Change in fair value of PIPE Warrant liability||11,125||(23,925||)||9,660||(24,409||)|
|Other income (expense), net||10,576||(24,455||)||8,618||(25,490||)|
|Income (loss) before provision for income taxes||4,004||(33,287||)||(4,984||)||(42,077||)|
|Provision for income taxes||—||—||—||(50||)|
|Net income (loss)||$||4,004||$||(33,287||)||$||(4,984||)||$||(42,127||)|
|Basic net income (loss) per share|
|Net income (loss) per share||$||0.03||$||(0.30||)||$||(0.04||)||$||(0.45||)|
Weighted average number of common shares outstanding
|Diluted net income (loss) per share|
|Net income (loss) per share||$||(0.06||)||$||(0.30||)||$||(0.11||)||$||(0.45||)|
|Weighted average number of common shares and dilutive common share equivalents outstanding||128,692||110,550||129,372||93,493|
|Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||18,089||$||33,525|
|Prepaid expenses and other current assets||937||1,256|
|Liabilities and stockholders’ deficit|
|Accounts payable and accrued expenses||$||11,497||$||13,215|
|Loans payable, net of discount||18,730||18,477|
|Deferred revenue and research and development reimbursements||5,743||2,820|
|PIPE Warrant liability||26,985||37,746|
|Estimated settlement liability||1,406||17,073|
|Total liabilities and stockholders’ deficit||$||20,006||$||50,198|
Source: AVEO Oncology
David Pitts, 212-600-1902