Health and Healthcare

How to Evaluate a 50% Move in AVEO

When investors see stocks run up 50% or more on a news release, they probably just assume the company is being acquired. AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) saw its shares rise by more than 50% on Thursday after release of details of its study regarding advanced renal cell carcinoma — kidney cancer. On top of the move being enormous, even with three hours until the close some 65 million shares had traded hands.

This is one of those situations when small cap and speculative investors will have very little guidance. In fact, AVEO investors and speculators may be entirely their own here.

AVEO announced Thursday that final results from Study 902 will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. This was in patients with advanced renal cell carcinoma (RCC) who received tivozanib as a second-line treatment subsequent to disease progression on sorafenib in the company’s Phase 3 TIVO-1 first-line RCC study.

The big driver here is that AVEO’s prior report of interim median progression free survival (PFS) results of 8.4 months among the 163 patients enrolled in Study 902 was too low. AVEO’s final results have now indicated that there is a median PFS in this setting of 11.0 months. Even better, the median overall survival was 21.6 months.

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The study design shared with the U.S. Food and Drug Administration (FDA) includes 314 subjects randomized one-to-one to receive either tivozanib or sorafenib. Efficacy results from Study 902 and final results from the TIVO-1 trial will be presented at the 2015 ASCO Annual Meeting being held May 29 to June 2.

On top of just having positive study data, AVEO also said in its press release that it received a written response from the FDA on its Phase 3 study: “… may support AVEO’s proposed indication for tivozanib in the 3rd line setting.” In response to whether the study, together with the TIVO-1 study, would be sufficient to support licensure of tivozanib as a treatment for advanced RCC, the FDA indicated: “[W]hether the results from this [third line] study can support AVEO’s proposal for tivozanib in the first line setting is a review issue.”

The primary objective of the study would be progression-free survival. Michael Bailey, president and chief executive officer of AVEO, said:

Based on TIVO-1, where tivozanib led to a longer progression free survival than sorafenib in the first line, combined with the activity tivozanib demonstrated in patients who have progressed on a VEGF therapy, we are optimistic about the probability of a successful clinical outcome in a third line RCC study. We are also encouraged by the FDA’s willingness to consider whether a refractory study can serve as a confirmatory study for TIVO-1 in first line RCC. Prior to committing to a new study, we will continue to evaluate all options, including partnerships, for the clinical and regulatory advancement for tivozanib in RCC as well as colorectal cancer.

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If a gain of over 50% to $2.50 on close to 40 times normal trading volume sounds big (or sounds too big), just consider that AVEO shares were as high as $3.50 earlier in the day. This stock was trading at $1.60 Wednesday, and the market cap is $140 million or so after this move.

AVEO shares had climbed marginally above $2.00 in March and in April, but they had been under $2.00 ever since February of 2014, prior to those moves. Does it matter that AVEO was a $20 stock in June and July of 2011?

When investors see news of this sort followed by gains of 50% or more, the more aggressive and risk-averse wonder if they should participate. It turns out that AVEO has hardly any analyst coverage. Suddenly, investors have very little to hang their hat on here, other than momentum trading and the hopes (or doubts) of having the next great cancer drug.

AVEO also been has burning through cash, ending the March quarter with almost $42 million in cash and short-term investments, down from $55.3 million at the end of 2014 and from $66.3 million last September. AVEO said with its last loss report:

Based on its current operating plan, the Company expects its $39.1 million in cash resources as of March 31, 2015 will be sufficient to fund operations into the third quarter of 2016.

Again, this is one of those situations in which most investors will feel very alone when it comes to how they wish to evaluate AVEO.

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