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Genocea Biosciences Inc (NASDAQ:GNCA) Is A Discount Opportunity

Genocea Biosciences Inc (NASDAQ:GNCA) Is A Discount Opportunity
Written by
Chris Sandburg
Published on
January 12, 2017
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Genocea Biosciences Inc (NASDAQ:GNCA) found itself on the wrong side of an Adam Feuerstein Tweet back in March, 2016, when the latter highlighted an interim release as being baseless from an efficacy perspective, rooted in the fact that the company didn't offer any comparison placebo data. Genocea essentially collapsed on the Tweet, and failed to recover throughout the remainder of the year.Fast forward to January, 2017, and the company just put out the exact data that Feuerstein highlighted as absent in the initial release. Of course, Feuerstein has – as yet – remained quiet, and indeed, there is some discussion among shareholders suggesting he is denying the initial output. Whatever is going on, however, markets don't seem to have responded to the news, and this could present something of an opportunity to get in ahead of a market realignment.For those not familiar with the company, Genocea is a development stage biotechnology company, and its lead candidate is called GEN-003. The drug is targeting genital herpes, and it is currently under investigation as part of a phase 2b clinical trial. The data that just hit press relates to six-month results from this study.By way of a brief introduction to the science, the drug is based in T cell immunity, a process that many believe is critical in the development and symptom prevalence of genital herpes. The drug is a vaccine, and as such, it is designed to induce a T cell response (or in other words, an immune response) that targets the herpes post administration. Currently, patients need to take oral daily administration pills in order to stay on top of the condition. This treatment is designed to reduce this administration burden, and thus essentially – offer what could amount to be the only cure in the market for the condition.So what did the data show? Well, as mentioned, the trial pitched GEN-003 against placebo, targeting a host of endpoints including reduction in viral shedding, genital lesion rates, time to first outbreak, time to next outbreak, percent reduction free at 6 and 12 months and total number of outbreaks. The data just released fell in line with an efficacy thesis when measured against these endpoints. According to the report, GEN-003 significantly reduced the rate of genital lesions during the six months following dosing compared to placebo (4.5 percent of days vs. 7.9 percent, respectively; 41% reduction vs. placebo, p<0.05).The drug also hit on a host of secondary endpoints (many of which are listed above), demonstrating a statistically significant improvement over the placebo arm when measured against these criteria. Basically, GEN-003 looks as though it is performing exceptionally.The trial isn't over yet; there is an extension under which all patients are followed for 12 months after dosing. This means that we won't see full top line until some point later this year. However, with the 12-month data being rooted in extension, Genocea has the opportunity to undertake a pivotal based on the interim, and the hitting of the primary endpoint (which the company announced back in September).As such, the next major catalyst is an end of phase 2 meeting with the FDA, during which the company will sit down with the agency and discuss the protocol for a pivotal trial. According to company reports, this meeting should take place during the first quarter of this year. That slates the next six or seven weeks as a potential period to watch for some market moving news. Beyond that, the initiation of the pivotal will be the next big release, aside from the 12-month data from the phase 2. Chances are these catalysts will hit press around the same time, with maybe the 12-month data hitting slightly earlier than the pivotal initiation. Either way, the pivotal is slated to kick off sometime during the fourth quarter of 2017.At last count, the company had a little over $26 million cash on hand, a healthy sum for a company of its size, and just short of $17 million debt. Near term dilution, therefore, shouldn't be too much of an issue.We will be updating our subscribers as soon as we know more. For the latest updates on GNCA, sign up below!Disclosure: We have no position in GNCA and have not been compensated for this article.

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