Looking At AVEO With Fresh Eyes
Stephen Simpson, CFA
Stephen Simpson, CFA
Thu, May 26, 7:31 AM
- The first patient has been dosed in AVEO Oncology's (NASDAQ:AVEO) Phase 3 clinical trial, called TIVO-3, assessing lead product candidate tivozanib compared to sorafenib [Bayer's (OTCPK:BAYRY) Nexavar] in patients with refractory advanced renal cell carcinoma (RCC) who have failed at least two prior regimens including vascular endothelial growth factor tyrosine kinase inhibitor (VEGFR-TKI) therapy (other than sorafenib).
- The 322-subject trial will randomize participants 1:1 to receive either tivozanib or sorafenib with no crossover between arms. The primary endpoint is progression-free survival at month 24. Top-line data are expected in Q1 2018.
- Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is designed to optimize VEGF blockade while minimizing toxic side effects. Sorafenib is a kinase inhibitor.
Fri, May 13, 9:15 AM
- AVEO Oncology (NASDAQ:AVEO) inks a private placement of 17,642,482 units at $0.95 per unit to institutional investors yielding gross proceeds of ~$17M. Each unit consists of one share of common stock and one five-year warrant to purchase one share of common at $1.00. Closing date is May 18.
- Net proceeds will fund the U.S. Phase 3 study of lead product candidate tivozanib, a combination trial of tivozanib and a PD-1 inhibitor and general corporate purposes.
- Yesterday's close was $0.84.
- Update: The private placement closed on May 18. Concurrently, the company amended its 2010 loan and security agreement with Hercules Capital which enabled it to borrow an additional $5M. Another $5M tranche may be borrowed in H1 2017 if certain conditions are met.
Tue, Mar. 15, 9:48 AM
- AVEO Pharmaceuticals (AVEO -10.4%) Q4 results: Revenues: $3.6M (+999%); R&D Expense: $3.9M (-55.2%); SG&A: $5.8M (+87.1%); Operating Loss: ($6.1M) (+53.1%); Net Loss: ($6.6M) (+52.5%); Loss Per Share: ($0.11) (+59.3%).
- FY2015 results: Revenues: $19M (+5.0%); R&D Expense: $12.9M (-66.2%); SG&A: $14.2M (-23.7%); Operating Loss: ($12.4M) (+75.4%); Net Loss: ($15M) (+71.5%); Loss Per Share: ($0.27) (+73.3%); Quick Assets: $34.1M (-34.8%).
- No guidance given.
Tue, Mar. 15, 7:35 AM
Dec. 21, 2015, 12:45 PM
Dec. 21, 2015, 10:29 AM
- Nano cap AVEO Pharmaceuticals (AVEO +31.1%) enters into an exclusive license agreement with EUSA Pharma for the European rights to lead product candidate tivozanib for the treatment of advanced renal cell carcinoma (RCC). The deal also includes South Africa and additional countries in South America as well as additional potential indications.
- Under the terms of the agreement, AVEO will receive an upfront payment of $2.5M, up to $394M in milestones and tiered royalties ranging from low double-digit to mid-20%. A portion of the milestones and royalties will be payable to Kyowa Hakko Kirin under a sublicensing deal.
- EUSA plans to submit a Marketing Authorization Application (MAA) for tivozanib for the first-line treatment of advanced RCC in Q1.
- Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is designed to optimize VEGF blockade while minimizing toxic side effects.
Dec. 21, 2015, 9:18 AM
Nov. 9, 2015, 9:14 AM
Nov. 9, 2015, 6:43 AM
- AVEO Pharmaceuticals (NASDAQ:AVEO): Q3 EPS of $0.14 beats by $0.23.
- Revenue of $15.16M (+1642.5% Y/Y) beats by $14.96M.
Aug. 24, 2015, 9:19 AM
- Gainers: GAS +29%.
- Losers: VTL -79%. ACI -31%. BZUN -25%. WBAI -23%. JMEI -20%. BTU -17%. MDR -17%. CSIQ -17%. VIPS -16%. FIT -16%. SFUN -15%. LC -15%. PLUG -15%. EXXI -15%. QIHU -14%. MACK -14%. ACHN -14%. KNDI -13%. CYBR -13%. OHGI -13%. Z -13%. TCK -13%. JKS -13%. AVEO -12%. OAS -12%. WLL -12%. MCUR -12%.
Aug. 17, 2015, 12:44 PM
Aug. 17, 2015, 9:15 AM
Aug. 17, 2015, 6:58 AM
- Nano cap AVEO Oncology (NASDAQ:AVEO) enters into an exclusive worldwide license agreement with Novartis (NYSE:NVS) for the development and commercialization of AV-380, AVEO's humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), and related antibodies.
- GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been associated with cachexia (weakness and wasting of the body) in cachectic cancer patients. Preclinical data show that inhibiting GDF15 may reverse the effects of cachexia by switching from catabolism (destructive metabolism) to anabolism (constructive metabolism).
- Under the terms of the agreement, AVEO will receive an upfront payment of $15M, potential milestones totaling $311M and tiered royalties from high single-digit to low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs.
- Cachexia, a serious complication in advanced cancers and other chronic diseases, affects ~5M Americans.
- Shares are up 126% premarket on robust volume.
Aug. 10, 2015, 10:01 AM
- AVEO Pharmaceuticals (AVEO +4.2%) Q2 results: Revenues: $0.1M (-94.4%); R&D Expense: $1.8M (-80.6%); SG&A: $2.9M (-39.6%); Operating Loss: ($4.6M) (+73.7%); Net Loss: ($5.5M) (+69.4%); Loss Per Share: ($0.10) (+71.4%); Quick Assets: $26.8M (-48.8%).
- 2015 Guidance: The company believes that cash resources will be sufficient to fund current operations at least through 3Q16.
Aug. 10, 2015, 7:24 AM
- AVEO Pharmaceuticals (NASDAQ:AVEO): Q2 EPS of -$0.10 beats by $0.10.
- Revenue of $0.13M (-93.0% Y/Y) misses by $0.07M.
Jun. 17, 2015, 12:45 PM
AVEO Pharmaceuticals, Inc. is a biopharmaceutical company, which is discovering, developing and commercializing targeted therapies to treat patients with cancer. Its proprietary human response platform provides the company unique insights into cancer and related disease biology and is being... More
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