AVEO Reports First Quarter 2019 Financial Results and Provides Business Update
“With a successful recent equity offering, together with the triggering
of a FOTIVDA® (tivozanib) milestone from EUSA, AVEO’s
strengthened balance sheet provides us with a cash runway that we expect
will take us into the fourth quarter of 2020,” said Michael Bailey,
president and chief executive officer of AVEO. “We remain committed to
our goal of improving outcomes and patient experience in renal cell
carcinoma (RCC), and look forward to reporting more mature interim OS
results from our
$2 MillionMilestone Payment from EUSA Pharma Triggered. In April 2019, AVEOannounced the triggering of a $2 millionmilestone payment from EUSA Pharma related to the February 2019reimbursement approval and subsequent commercial launch of FOTIVDA® (tivozanib) in Spainas a first-line treatment of adult patients with RCC.
- Closing of Public Offering of Common Stock and Warrants. In
April 2019, AVEOcompleted an underwritten public offering of 21,739,131 shares of common stock and 25,000,000 warrants to purchase common stock at the public offering price of $1.14per share and $0.01per warrant. The warrants have a two-year term and a strike price of $1.25per share. Gross proceeds of the offering were approximately $25.0 millionand are expected to be used for ongoing clinical and preclinical development of AVEO’s product candidates, as well as for working capital and other general corporate purposes.
- Announced Positive Results from Phase 1b Ficlatuzumab-Cytarabine
Trial (CyFi) in Patients with Relapsed and Refractory AML. In
April 2019, AVEOannounced the presentation of positive data from an investigator-sponsored Phase 1b expansion cohort 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), at the American Association for Cancer Research(AACR) Annual Meeting, held March 29 - Apr 3, 2019in Atlanta. Of 18 AML patients enrolled in the study, all had disease that was refractory to initial treatment, 17 were evaluable and 9 achieved a complete response. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, LFT abnormalities, and electrolyte disturbance. There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. A copy of the presentation is currently available in the Publications & Presentation section of AVEO’s website.
Based on these results, the Company is evaluating potential next steps for this program in collaboration with its ficlatuzumab development and commercialization partner,
Gregory T. Mayesto Board of Directors. In February 2019, the Company announced the appointment of Gregory T. Mayesto its Board of Directors. Mr. Mayes brings to the AVEO Board over 20 years of experience as a biopharmaceutical executive with deep expertise in public company governance, business strategy and the commercialization of life sciences products.
- Presented Topline Results from
TIVO-3 in an Oral Presentation at the 2019 ASCO Genitourinary Cancers Symposium and Announced Updated NDA Timing. 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 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 progression-free survival (PFS) versus sorafenib. There was also a significant PFS improvement demonstrated for tivozanib both in the subgroups of patients who received prior PD-1 therapy and those who received two prior VEGF TKI therapies. The secondary endpoint of overall response rate 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, but the hazard ratio at the time of the analysis favored sorafenib. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.
AVEO intends to initiate an additional interim OS analysis in
August 2019, the results of which are expected to be reported in the fourth quarter of 2019 and would be the first planned update since the prior OS analysis was initiated in the fourth quarter of 2018. At the recommendation of the U.S. Food and Drug Administration, AVEO plans to make a New Drug Application (NDA) filing decision following the availability of more mature OS results.
First Quarter 2019 Financial Results
AVEOended Q1 2019 with $23.5 millionin cash, cash equivalents and marketable securities as compared with $24.4 millionat December 31, 2018.
Total revenue for Q1 2019 was approximately
$1.6 millioncompared with $1.0 millionfor Q1 2018.
Research and development expense for Q1 2019 was
$6.9 millioncompared with $5.4 millionfor Q1 2018.
General and administrative expense for Q1 2019 was
$2.5 millioncompared with $2.6 millionfor Q1 2018.
Net income for Q1 2019 was
$0.6 million, or net income of $0.01and net loss of $0.06per basic and diluted share, respectively, compared with a net loss of $9.0 millionfor Q1 2018, or net loss of $0.08per basic and diluted share.
The Q1 2019 net income was driven by an approximate
$8.8 millionnon-cash gain attributable to the decrease in the fair value of the 2016 PIPE warrant liability that principally resulted from the decrease in the stock price that occurred during the fiscal quarter. In Q1 2018, the non-cash loss attributable to the increase in the fair value of such warrant liability was $1.5 million.
- The Q1 2019 net income was driven by an approximate
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma (RCC) in the
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth
factor (HGF) inhibitory antibody that binds to the HGF ligand with high
affinity and specificity to inhibit HGF/c-Met biological
For more information, please visit the Company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
1. Fotivda (Tivozanib) SmPC
2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
3. Pawlowski N et al. AACR 2013. Poster 3971.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
|Collaboration and licensing revenue||$||
|Research and development||6,852||5,404|
|General and administrative||2,455||2,610|
|Loss from operations||(7,696||)||(7,030)|
|Other income (expense), net:|
|Interest expense, net||(564||)||(493)|
|Change in fair value of PIPE Warrant liability||8,815||(1,465)|
|Other income (expense), net||8,251||(1,958)|
|Net income (loss)||$||555||$||(8,988)|
|Basic net income (loss) per share|
|Net income (loss) per share||$||0.01||$||(0.08)|
|Weighted average number of common shares outstanding||132,304||118,840|
|Diluted net income (loss) per share|
|Net income (loss) per share||$||(0.06||)||$||(0.08)|
Weighted average number of common shares and dilutive common share
Consolidated Balance Sheet Data
|Cash, cash equivalents and marketable securities||$||23,483||$||24,427|
|Prepaid expenses and other current assets||241||482|
Liabilities and stockholders’ deficit
|Accounts payable and accrued expenses||$||10,593||$||12,451|
|Loans payable, net of discount||19,199||19,033|
|Deferred revenue and research and development reimbursements||6,342||5,914|
|PIPE Warrant liability||7,859||16,674|
|Total liabilities and stockholders’ deficit||$||26,507||$||27,935|
Source: AVEO Oncology
David Pitts, Argot Partners