AVEO Reports First Quarter 2018 Financial Results and Provides Business Update
“We continue to work toward reporting topline results from our Phase 3
Mr. Bailey added, “As we work toward our goal of commercialization in the U.S., we also continue to aggressively pursue the third pillar of our tivozanib strategy, combinations with immunotherapy. We were pleased to present results from the ongoing Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO®) in aRCC at ASCO GU. These early results demonstrated a combination of a favorable safety profile and activity that we believe hold significant promise for patients with aRCC and potentially other tumor types such as hepatocellular carcinoma (HCC).”
Tivozanib TIVO-3 Study North America Update
Update on Anticipated Timeline to Topline Data from Phase 3
Tivozanib (FOTIVDA®) European Union Updates
Tivozanib (FOTIVDA®) Launched in
Austriafor the Treatment of aRCC. In April 2018, FOTIVDA® was launched in Austriafor the treatment of adult patients with aRCC. This follows the February 2018publication by the United Kingdom’s National Institute for Health and Care Excellence(NICE) of a Final Appraisal Determination recommending FOTIVDA® for the first line treatment of adult patients with aRCC, which triggered the commercial launch in the UKas well as a $2Mmilestone payment to AVEOfrom EUSA Pharma, the licensee for tivozanib in Europe. FOTIVDA® is now available in the Germany, the U.K., and Austria.
FOTIVDA® was granted
European Commission(EC) approval in August 2017for the treatment of adult patients with aRCC in the European Unionplus Norwayand Iceland.
Additional Tivozanib Updates
Long-term Follow-up Results from
TIVO-1 Extension Study (Study 902), Published in the European Journal of Cancer. In March 2018, AVEOannounced the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA®) as second-line treatment for aRCC, in the European Journal of Cancer. Findings from the study underscore the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI and support the rationale for the ongoing Phase 3 TIVO-3 study. The publication, titled “Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study,” is available on our website at www.aveooncology.com.
Results from Phase 2 Portion of the TiNivo Study of Tivozanib and
Nivolumab (OPDIVO®) in mRCC Presented at
ASCOGU. In February 2018, Bernard Escudier, M.D., from the Institute Gustav Roussyin Paris, Francepresented results from the ongoing Phase 2 portion of the TiNivo study at the 2018 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU). TiNivo is a Phase 1b/2 multi-center trial of oral tivozanib in combination with intravenous nivolumab (OPDIVO®, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of metastatic renal cell carcinoma (mRCC). The presentation noted the favorable safety profile and promising preliminary anti-tumor activity observed to date. These results continue to support the potential advantages of using a high-specificity VEGF inhibitor TKI in building upon the benefit of immune checkpoint therapy in renal cancer. AVEOand EUSA Pharma expect to present further updates to the TiNivo study at upcoming medical meetings in the second half of 2018.
Phase 1b/2 Study Results of Tivozanib in Patients with Advanced
Hepatocellular Carcinoma Presented at ASCO GI. In
January 2018, AVEOannounced the presentation of data from a multi-center, Phase 1b/2 study of tivozanib in previously untreated patients with advanced, unresectable HCC at the 2018 American Society of Clinical Oncology Gastrointestinal Cancers Symposium(ASCO GI). Findings from the study suggest that tivozanib has the potential to yield comparable PFS and a favorable response rate when compared to current first-line standards of care for HCC patients, and demonstrated a favorable safety profile which may enable therapeutic combinations with immunotherapy. The Phase 1b/2 study was led by Renuka Iyar, M.D., from the Roswell Park Cancer Centerand was one of several studies funded by a grant provided to the National Comprehensive Cancer Network by AVEO.
Trials in Progress Poster for Phase 1b Study of Ficlatuzumab in
Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer
to be Presented at the 2018 ASCO Annual Meeting. 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) will be 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, IL.The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is currently enrolling, with an expected total enrollment of approximately 30 patients.
Refinanced Debt Facility, Extending Cash Runway into 2019. In
January 2018, AVEOannounced that it completed the refinancing of its existing $20.0 milliondebt facility with Hercules Capital, Inc.and its affiliates, the terms of which enable approximately an additional $12.1 millionin cash flow over 2018 and 2019, when compared to the prior loan. The new $20.0 millionfacility has a 42-month maturity from closing, no financial covenants, a lower interest rate and an interest-only period of no less than 12 months, which could be extended up to a maximum of 24 months, assuming the achievement of specified milestones relating to the development of tivozanib. Extension of the interest-only period is expected to enable the Company to extend its cash runway into the first quarter of 2019. Proceeds of the new facility were used to retire the Company’s previous $20.0 millionof secured debt with Hercules.
Strengthened Board of Directors. In
February 2018, AVEOannounced the appointment of John H. Johnsonto the Company’s Board of Directors. Mr. Johnson brings to AVEOover three decades of experience in the biotechnology and pharmaceuticals industries, having held commercial and executive management roles at leading global corporations that have a focus on oncology.
First Quarter 2018 Financial Highlights
- AVEO ended Q1 2018 with $27.0 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.
- Total revenue for Q1 2018 was approximately $1.0 million compared with $2.5 million for Q1 2017.
- Research and development expense for Q1 2018 was $5.4 million compared with $8.0 million for Q1 2017.
- General and administrative expense for Q1 2018 was $2.6 million compared with $2.3 million for Q1 2017.
- Net loss for Q1 2018 was $9.0 million, or a loss of $0.08 per basic and diluted share, compared with net loss of $8.8 million for Q1 2017, or a loss of $0.12 per basic and diluted share. Approximately $1.5 million of the Q1 2018 net loss was a non-cash loss attributable to the increase in the fair value of the warrant liability that principally resulted from the increase in the stock price that occurred within the quarter. In Q1 2017, the non-cash loss attributable to the increase in the fair value of the warrant liability was $0.5 million.
We believe that our $27.0 million in cash resources would allow us to fund our planned operations into the first quarter of 2019. This estimate assumes no receipt of additional milestones from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of our outstanding warrants issued in connection with our 2016 private placement.
AVEO Oncology (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
AVEO PHARMACEUTICALS, INC.
Three Months Ended
|Collaboration and licensing revenue||$||980||$||2,532|
|Research and development||5,404||7,956|
|General and administrative||2,610||2,331|
|Loss from operations||(7,030||)||(7,755||)|
|Other expense, net:|
|Interest expense, net||(493||)||(551||)|
|Change in fair value of PIPE warrant liability||(1,465||)||(484||)|
|Other expense, net||(1,958||)||(1,035||)|
|Loss before provision for income taxes||(8,988||)||(8,790||)|
|Provision for income taxes||—||(50||)|
|Net loss per share — basic and diluted||$||(0.08||)||$||(0.12||)|
|Weighted average number of common shares outstanding||118,840||76,246|
Consolidated Balance Sheet Data
|Cash, cash equivalents and marketable securities||$||26,995||$||33,525|
|Prepaid expenses and other current assets||1,007||1,256|
|Liabilities and stockholders’ deficit|
|Accounts payable and accrued expenses||$||12,679||$||13,215|
|Loans payable, net of discount||18,588||18,477|
|Deferred revenue and research and development reimbursements||6,276||2,820|
|PIPE warrant liability||38,110||37,746|
|Estimated settlement liability||17,115||17,073|
|Total liabilities and stockholders’ deficit||$||43,613||$||50,198|
Source: AVEO Oncology
David Pitts, 212-600-1902