Heat Biologics Inc (NASDAQ:HTBX): Delving Into The Upcoming Catalysts

Heat Biologics Inc (NASDAQ:HTBX) is running up this week. The company is set to report some key data at two major meetings near term, and both have the potential to shift an asset in its pipeline into what could be a game changing late stage trial. Markets are loading up ahead of the potential for positive data, and even given the more than 120% gains seen over the last week, there's plenty of further upside on offer if the data hits.Ahead of both reports, here's a look at what's important in the numbers.Before we get going, it's worth noting that the company has published its presentation abstracts at the respective meeting publication sites, and as such, we can gain some insight into the quality of the data from these abstracts. That said, relying on abstracts for bottom line inference is notoriously inaccurate, so we're not basing our final bias on their conclusions. We'll have to see what the presentations say for that.That out of the way, here's what's coming up.The first major presentation comes at the Society of Urology Annual Meeting, in San Antonio, TX, on Wednesday, Nov 30, and will focus on Heat's lead bladder cancer asset, HS-410. The drug just completed a phase II trial, and it is top line from this trial that Heat will address in its presentation. The trial was looking at HS-410 in combination with a drug called BCG, a standard of care treatment, in non-muscle invasive bladder cancer (NMIBC). The trial was randomized, blinded, and looked at impact in a total of 78 patients. The primary endpoint, and the figure we're focusing on, is what’s called recurrence free survival (RFS).In the abstract, the company put out a composite RFS figure, which looked at the unblended data. This figure pointed to an RFS across all arms of 84.6%. With no adverse events in the active arms (there were two dosing regimens) outside of those experienced in the placebo arm, we think this number points to some positive results when the company puts out the unblended figure. Basically, on this one, we're looking for an RFS in the active arms that is higher than the placebo. With safety proving no issue, it's this number that markets will be looking at. More specifically, a number higher than the composite – so higher than 84.6% - with the more disparity the better.The second major presentation will address a Phase Ib study evaluating HS-110, in combination with Opdivo, Bristol-Myers Squibb Co (NYSE:BMY)'s PD1 asset, for the treatment of non-small cell lung cancer (NSCLC). This one's a bit more complicated. Basically, HS-110 is designed to inflame tumors so that Opdivo has a more prominent effect on their degradation. The trial was primarily a safety trial, so the presentation will likely cover that initially, but its any sign of complementary efficacy we're looking for as the presentation digs into the secondary endpoints. We know (by way of the abstract) that safety wasn’t an issue, and we also know that there was some injection site reactions and maculopapular rashes, both of which are consistent with HS-110 mechanism of action. From the abstract, it looks like the trial fell down on the suitability of patients (it was only an 8 patient trial) so whether this plays into the conclusion will be another key focus point.This one is set to take place at the International Society for the Study of Lung Cancer Annual Meeting on December 6, 2016.So that's where things stand. The company has two major events scheduled, and if the presentations can support the seemingly sound conclusions of the abstracts, we expect a run up in market capitalization on the back of both.Check out the abstracts here:Lung cancerBladder cancerWe will be updating our subscribers as soon as we know more. For the latest updates on HTBX, sign up below!Disclosure: We have no position in HTBX and have not been compensated for this article.