AVEO Reports Full Year 2018 Financial Results and Provides Business Update
“The results of
- Presented Topline Results from
TIVO-3 During an Oral Presentation at the 2019 ASCO Genitourinary Cancers Symposium. In February 2019, AVEOpresented topline results from the TIVO-3 trial, AVEO’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in 350 subjects with refractory advanced or metastatic renal cell carcinoma (RCC) at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposiumheld February 14-16, 2019in San Francisco. The results were presented during an oral presentation titled “TIVO-3: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma (RCC).” A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.
The presentation noted that the
TIVO-3 trial met its primary endpoint of demonstrating a statistically significant benefit in median progression-free survival (PFS). Median PFS for tivozanib was also longer than sorafenib both in patients who received prior PD-1 therapy and those who received two prior VEGF TKI therapies. The secondary endpoint of overall response rate also demonstrated a statistically significant improvement for patients receiving tivozanib compared to sorafenib.
The analysis of the secondary endpoint of overall survival (OS) was not mature at the time of the final PFS analysis. As presented, the preliminary OS analysis conducted at an
October 4, 2018data cutoff date, which included additional patients previously lost to follow-up, showed a non-statistically significant difference in OS favoring sorafenib (hazard ratio: 1.12, p-value: 0.44).
Tivozanib was generally well-tolerated relative to sorafenib, with reported grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. The improved tolerability of tivozanib was evident in the lower rates of dose reductions and interruptions for toxicity in patients receiving tivozanib compared to those receiving sorafenib. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.
- Announced NDA Timing Update. In
January 2019, the U.S. Food and Drug Administration( FDA) recommended that AVEOnot submit a New Drug Application (NDA) for tivozanib at this time using the preliminary OS results from the TIVO-3 trial. The FDAindicated that these preliminary OS results do not allay their concerns about the potential detriment in OS outlined in the Complete Response Letter dated June 6, 2013. AVEOnow plans to make an NDA filing decision following the availability of more mature OS results. AVEOintends to conduct an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019.
- Data from Phase 1b Expansion Cohort of Ficlatuzumab and Cytarabine
in Relapsed and Refractory AML to be Presented at 2019 AACR Annual
Meeting. Data from the investigator-sponsored Phase 1b expansion
cohort evaluating the safety and tolerability of ficlatuzumab, AVEO’s
potent hepatocyte growth factor (HGF) inhibitory antibody, in
combination with cytarabine in patients with relapsed and refractory
acute myeloid leukemia (AML) will be presented during a poster session
at the 2019
American Associationfor Cancer Research (AACR) Annual Meeting. The presentation, titled, “Cyfi: Results from a Phase 1b expansion cohort of anti-hepatocyte growth factor and cytarabine in relapsed and refractory AML” (abstract CT078 / 2) will be featured during a poster session (Session PO.CT03) on Monday, April 1, 2019from 1:00-5:00pm Eastern Time.
- Entered Immuno-Oncology Clinical Supply Agreement with
AstraZeneca. In December 2018, AVEOentered into a clinical supply agreement with AstraZenecato evaluate the safety and efficacy of AstraZeneca'sIMFINZI® (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with tivozanib in first-line hepatocellular carcinoma, or liver cancer, in a Phase 1/2 study. AVEOwill serve as the study sponsor; each party will contribute the clinical supply of its study drug and study costs will be otherwise shared equally. The Phase 1 portion of the study is expected to commence this year.
$2 MillionMilestone Payment from EUSA Pharma. In November 2018, AVEOannounced the triggering of a $2 millionmilestone payment from EUSA Pharma related to the reimbursement in Germanyfor FOTIVDA® as a first line treatment of adult patients with advanced RCC.
- Extended Debt Facility Interest-Only Period. In
December 2018, AVEOannounced a six-month extension to the interest-only period under its existing amended and restated loan and security agreement with Hercules Capital, Inc.The extension was granted as a result of achieving certain predefined requirements under the agreement, including successfully meeting the primary endpoint of the TIVO-3 trial.
$7.5 MillionUnder the Sales Agreement with SVB Leerink, Extending Financial Runway. In February 2019, AVEOraised $7.5 millionthrough its sales agreement with SVB Leerink. Approximately $32 millionof shares remain available for future issuance and sale pursuant to the sales agreement, which was originally entered into in February 2018. AVEObelieves that the proceeds generated in February 2019through the sales agreement, together with its available cash, cash equivalents, and marketable securities at December 31, 2018, and together with the extension of the interest-only period under the Hercules loan agreement, which results in deferment of principal payments, will allow it to fund planned operations into the first quarter of 2020.
Full Year 2018 Financial Highlights
AVEOended 2018 with $24.4 millionin cash, cash equivalents and marketable securities as compared with $33.5 millionat December 31, 2017.
Total revenue for 2018 was approximately
$5.4 millioncompared with $7.6 millionfor 2017.
Research and development expense for 2018 was
$20.7 millioncompared with $25.2 millionfor 2017.
General and administrative expense for 2018 was
$10.8 millioncompared with $9.1 millionfor 2017.
Net loss for 2018 was
$5.3 million, or a loss of $0.04and $0.19per basic and diluted share, respectively, compared with a net loss of $65.0 millionfor 2017, or a loss of $0.61per basic and diluted share.
The 2018 net loss was partially offset by an approximate
$19.9 millionnon-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 fiscal year. In 2017, the non-cash loss attributable to the increase in the fair value of such warrant liability was $33.7 million.
- The 2018 net loss was partially offset by an approximate
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma (RCC) in the
For more information, please visit the Company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
1. Fotivda (Tivozanib) SmPC
2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
3. Pawlowski N et al. AACR 2013. Poster 3971.
|AVEO PHARMACEUTICALS, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|Three Months Ended
|Collaboration and licensing revenue||$||1,296||$||63||$||4,947||$||7,560|
|Research and development||5,201||5,676||20,652||25,179|
|General and administrative||2,625||2,404||10,781||9,138|
|Loss from operations||(6,343||)||(10,071||)||(25,357||)||(28,811||)|
|Other income (expense), net:|
|Interest expense, net||(570||)||(637||)||(2,191||)||(2,373||)|
|Change in fair value of PIPE Warrant liability||26,431||14,207||19,919||(33,740||)|
|Other income (expense), net||2,300||—||2,300||—|
|Other income (expense), net||28,161||13,570||20,028||(36,113||)|
|Net income (loss) before provision for income taxes||21,818||3,499||(5,329||)||(64,924||)|
|Provision for income taxes||—||—||—||(101||)|
|Net income (loss)||$||21,818||$||3,499||$||(5,329||)||$||(65,025||)|
|Basic net income (loss) per share|
|Net income (loss) per share||$||0.18||$||0.03||$||(0.04||)||$||(0.61||)|
|Weighted average number of common shares outstanding||124,395||118,323||120,592||105,930|
|Diluted net income (loss) per share|
|Net income (loss) per share||$||(0.03||)||$||(0.08||)||$||(0.19||)||$||(0.61||)|
|Weighted average number of common shares and dilutive common share equivalents outstanding||133,580||130,108||130,731||105,930|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and marketable securities||$||24,427||$||33,525|
|Prepaid expenses and other current assets||482||1,256|
|Liabilities and stockholders’ deficit|
|Accounts payable and accrued expenses||$||12,451||$||13,215|
|Deferred revenue and research and development reimbursements||5,914||2,820|
|PIPE Warrant liability||16,674||37,746|
|Estimated settlement liability||—||17,073|
|Total liabilities and stockholders’ deficit||$||27,935||$||50,198|
David Pitts, Argot Partners