Biopharmx Corp (NYSEMKT:BPMX) Is Heating Up: Data Soon?

Back in February, we highlighted Biopharmx Corp (NYSEMKT:BPMX) at $0.45 as being a stock to watch throughout the first half of 2017. We featured it again as part of this coverage, at $0.69. Markets were loading up on the stock in the absence of any clear fundamental developments, and we hypothesized that traders were getting in ahead of some upcoming phase II data.Since that date, Biopharmx has confirmed the release of this data as set for the first half of May. The company has also closed on a $5 million registered direct offering (RDO), and we think this serves as indicative of the strength of the upcoming data and the asset in question's subsequent advance into a pivotal study.At last close, Biopharmx went for $0.83 a piece – that's an 85% run since we first covered this one. There remains plenty of potential for continued advance, however.The offering closed late Friday and there's a chance that the data could hit press as early as today. If this is the case, the company could really run. With this noted, here's a look at what's we want to see from the data and what's up for grabs.The drug is called BPX-01 and it's under development as an acne drug. It's a reformulation of a drug called minocycline that's already pretty well established for a host of indications, dermatology and otherwise. Biopharmx has taken minocycline and turned it into a non-oil based topical gel, designed for delivery direct to the skin as a cream-type admin.The trial is a phase IIb study and it's set up to investigate the safety and efficacy of BPX-01 across the acne population. The case for approval is straightforward – many of the currently used drugs in this population are steroid based, and steroid based drugs bring with them some pretty nasty (and often prohibitive to chronic dosing) side effects.As we pointed out last time, there's a potential $450 million in annual sales up for grabs if the company can score a moderately successful commercialization strategy. Given its current market capitalization of just $55 million, there's plenty of upside on offer if BPX-01 clears its forward regulatory hurdles.So what are we looking for from the data?There are three arms, two doses (low and high) and one placebo. The study has recruited 225 individuals, aged 9-40, all of which suffer from moderate to severe form of the condition. Patients were dosed once daily for twelve weeks, with either placebo, low or high dose.The primary endpoint is efficacy across the period (active versus control) as measured by the absolute mean change from baseline in inflammatory lesion counts at Week 12. A secondary endpoint will seek to identify the proportion of subjects with at least a two-grade reduction in IGA at Week 12. IGA just refers to the investigator's global assessment scale, which in this indication is a five-point spread, with low to high correlating with the numerical advance.We want to see the drug hit on the primary initially, with (ideally) a correlation between dose concentration and impact. That is, if the high dose doesn’t bring about any severe side effects (we expect that it won't, as minocycline is generally well established as safe). If we do see side effects, then a comparative efficacy between low and high dose would be a bonus. Most importantly, the drug has to beat out on the placebo arm. Lesion count is priority, but we'd love to see some degree of IGA reduction (and in particular, a two-grade reduction) as reinforcing this drug's potential.As mentioned, this is seeking to offer an alternative to patients that aren’t dealing well with steroidal SOC, so even modest efficacy would be enough to support an advance into phase III.The recent raise removes any near-term dilution risk (and does so through being minimally dilutive in itself) so this one's all about the drug for the next couple of quarters.We will be updating our subscribers as soon as we know more. For the latest updates on BPMX, sign up below!Disclosure: We have no position in BPMX and have not been compensated for this article.