Please wait while we load the requested 10-K report or click the link below:
https://last10k.com/sec-filings/report/1325879/000156459017005015/aveo-10k_20161231.htm
August 2022
August 2022
June 2022
May 2022
May 2022
April 2022
March 2022
March 2022
December 2021
November 2021
Exhibit 99.1
AVEO Reports Full Year 2016 Financial Results and Provides Business Update
CAMBRIDGE, Mass. March 22, 2017 AVEO Oncology (NASDAQ: AVEO) today reported financial results for the full year ended December 31, 2016 and provided a business update.
TIVO-3, our lead clinical program designed to serve as the basis for a potential U.S. registration for tivozanib as a first- and third-line treatment for renal cell cancer, continues to enroll ahead of schedule and has now completed its first safety review, said Michael Bailey, president and chief executive officer of AVEO. We look forward to the studys pre-planned interim futility analysis midyear 2017 and, potentially, to top line results in the first quarter of 2018 and to initial data from our Phase 1 TiNivo study of tivozanib in combination with Opdivo® in the first half of 2017. We also continue to support our partner EUSA Pharma in its efforts to complete the European Marketing Authorization Application review for tivozanib as a first-line treatment for renal cell carcinoma. There remains a significant unmet need for better tolerated therapies in this disease, particularly those that enable combination treatment, and we look forward to receiving tivozanib data and to potential regulatory milestones in the coming quarters.
Mr. Bailey continued: We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203.
Recent Updates
| TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the studys Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first-line treatment for RCC. |
| First Patient Dosed in Phase 1/2 TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers Squibbs Opdivo® (nivolumab) in Advanced RCC. AVEO announced today that the first patient has been treated in the Companys Phase 1/2 TiNivo |
Please wait while we load the requested 10-K report or click the link below:
https://last10k.com/sec-filings/report/1325879/000156459017005015/aveo-10k_20161231.htm
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Aveo Pharmaceuticals Inc.
Aveo Pharmaceuticals Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2017 10-K Annual Report includes:
Rating
Learn More![]()
This decrease was partially offset by the $1.0 million upfront payment received in connection with our collaboration and license agreement with CANbridge entered into in March 2016 and $0.8 million in the acceleration of deferred revenue that was recognized upon the effective termination of our licensing agreement with Pharmstandard in September 2016 that otherwise would have been recognized over the performance period through April 2022.
We are obligated to pay Biogen Idec a percentage of milestone payments we receive under the CANbridge agreement and single-digit royalty payments on net sales related to the sale of AV-203, up to cumulative maximum amount of $50.0 million.
There can be no assurance, however, that we will receive cash proceeds from any of these potential resources or, to the extent cash proceeds are received, those proceeds would be sufficient to support our operations and allow us to maintain compliance with our financial covenant for at least the next twelve months from the date of filing this Annual Report on Form 10-K. We have concluded the likelihood that our plan to obtain sufficient funding from one or more of these sources will be successful, while reasonably possible, is less than probable.
In accordance with the sublicensing provisions of our KHK agreement, in 2011 we made a $22.5 million payment to KHK related to the upfront license payment received under a collaboration and license agreement we entered into with Astellas Pharmaceuticals, Inc., the termination of which became effective on August 11, 2014.
Pursuant to the 2016 Amendment, we received additional loan proceeds from Hercules in the amount of $5.0 million, which increased the aggregate outstanding principal balance under the Loan Agreement to $15.0 million.
In 2015 as compared to...Read more
These amounts were partially offset...Read more
We are also eligible to...Read more
The periods over which revenue...Read more
In August 2015, in connection...Read more
the costs involved in preparing,...Read more
In 2015 as compared to...Read more
In 2016 as compared to...Read more
The 2016 Amendment includes a...Read more
Payments or reimbursements resulting from...Read more
The 2015 Shelf covers the...Read more
On May 7, 2015, we...Read more
Raise funding of up to...Read more
CANbridge also agreed to reimburse...Read more
We do not expect to...Read more
Such a change could have...Read more
In 2016 as compared to...Read more
agreement effective September 9, 2016....Read more
In March 2016, which we...Read more
Pursuant to the amendment, we...Read more
With respect to financial reporting...Read more
We cannot currently predict the...Read more
As of December 31, 2016,...Read more
The net offering proceeds to...Read more
We anticipate that we will...Read more
The license agreements required us...Read more
In 2015 as compared to...Read more
As a result of the...Read more
If we sublicense any of...Read more
In May 2016, we entered...Read more
We have determined that the...Read more
Other awards, such as performance-based...Read more
the costs of preparing, filing...Read more
Tivozanib is a potent, selective...Read more
In 2016 as compared to...Read more
our ability to establish and...Read more
The royalty rate escalates within...Read more
Cash used by investing activities...Read more
In 2015 as compared to...Read more
In addition to the amounts...Read more
Development timelines, probability of success...Read more
Due to the unpredictable nature...Read more
We expect the total estimated...Read more
Under the amendment, we agreed...Read more
the scope, progress, results and...Read more
Under the 2016 Amendment, from...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Material Contracts, Statements, Certifications & more
Aveo Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits
Ticker: AVEO
CIK: 1325879
Form Type: 10-K Annual Report
Accession Number: 0001564590-17-005015
Submitted to the SEC: Wed Mar 22 2017 4:17:45 PM EST
Accepted by the SEC: Wed Mar 22 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations