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Here's What We Want From Eleven Biotherapeutics Inc (NASDAQ:EBIO) On Earnings Day

Here's What We Want From Eleven Biotherapeutics Inc (NASDAQ:EBIO) On Earnings Day
Written by
Chris Sandburg
Published on
May 3, 2017
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Earnings season is in full swing in the biotechnology sector right now, and next in line is Eleven Biotherapeutics Inc (NASDAQ:EBIO). The company is set to put out its first quarter 2017 numbers on May 4 (Thursday morning) and will accompany the release with a conference call designed to bring markets up to speed with what's going on behind the scenes.We've highlighted this one as well worth keeping an eye on in the past, with our last coverage coming back in November last year. The company has dipped a bit since then (it's currently trading at around $1.85) but we expect the upcoming update to attract some speculative volume towards the company.This is dev-stage biotech, so in all honesty, the numbers don't mean much. Cash and burn are all we're really looking at from a quant perspective, and we've got a pretty good idea how things stand in that arena already.What we will be looking at, however, and what we think is going to draw the speculative volume alluded to above, is the smooth progress (and the on-track timing) of Eleven's lead asset trial – a phase III oncology study. Ahead of the event, then, here's a look at what the study involves and what we are looking for from both the upcoming conference call and the trial's maturation as indicative of potential upside going forward.The drug in question is called Vicinium and it's one of the two assets that Eleven picked up as part of the acquisition of Viventia last year. The primary indication is non-muscle invasive bladder cancer (NMIBC), which accounts for 70-80% of all bladder cancers in the US, and for which there have been no major developments on the treatment side of things for the last 40 years.The drug is protein synthesis blocker. Basically, it locates the cancer cells by seeking out (and binding to) an antigen called EpCAM, which is expressed to a high degree by bladder cancer cells. Once bound, the cancer cell internalizes the Vicinium, and the drug gets to work cleaving parts of the cell that are necessary for protein synthesis. No protein synthesis means no replication, which means cell death.The drug has put out some solid results on the back of both phase I and phase II studies along its development pathway. In the former, a safety study primarily, no dose limiting toxicities were reported, the drug was well tolerated at these doses and there was some initial evidence of clinical benefit (dose correlated) against a complete response metric. In phase II, the drug hit its endpoint of complete response at three months and managed to maintain the clean safety profile that sets it apart from current SOC.So the phase III is in place and management expects that – if it succeeds – it will serve as sufficient for an NDA submission and a green light from the FDA.So what are we looking for from the call?Enrollment is set to complete mid-2017, so we want to see management serve up some indication that the company (and the trial) is set to meet this pre-slated target. If we get confirmation on this, then it puts the end of 2018 as the target for trial completion.As we noted last time, this one's a bit of a slow burner, with data likely not to hit press until a couple of months' post-completion.As an interim catalyst driver, then, we're looking to the company's secondary program, a drug called Proxinium. It's under investigation as a potential therapy for Squamous Cell Carcinoma of the Head and Neck (SCCHN) cancer, and there's a phase II study set to start during the second half of this year that will see it combined with checkpoint inhibitors (likely Opdivo and Keytruda) and pitched against a control arm in the cancer in question. These sorts of combo trials bring with them the potential for interim readouts, so this one should tide markets over until we get topline from the bladder cancer program.As we've said, keep an eye on cash tomorrow. The company had around $25 million at the end of last year and expects this will fund through early 2018. We want confirmation that it's still on track for this so as to negate any near-term dilution risk.We will be updating our subscribers as soon as we know more. For the latest updates on EBIO, sign up below!Disclosure: We have no position in EBIO and have not been compensated for this article.

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