Tuesday was an incredibly busy day in the biotechnology space, with more than 50 companies at just the small-cap end of the arena reporting first quarter financials. Of course, the action wasn’t just limited to the numbers. Alongside the financials, and in some instances, without financials attached, small-cap biotechnology companies put out operational updates that translated to market action. Here is a look at three of the biggest movers on operational developments so far this week, with a look at what has driven action in each.
The three companies in question are SCYNEXIS Inc (NASDAQ:SCYX), Array BioPharma (NASDAQ:ARRY) and Sage Therapeutics, Inc. (NASDAQ:SAGE).
Okay then, let’s kick things off with SCYNEXIS.
For this company, and its shareholders, Tuesday was not a good day. At market open, SCYNEXIS put out some news related to one of its lead development assets, an intravenous formulation of a drug called SCY-078. The drug was under investigation as part of a phase I study in patients with severe fungal infections – a population that desperately needs new assets hitting shelves, but that is notoriously difficult to navigate successfully for a development asset. SCYNEXIS experienced this difficulty firsthand, when the agency slapped the trial with a clinical hold based on three mild to moderate thrombotic events in healthy volunteers that arose as part of the above mentioned phase 1. Alongside its earnings release, the company noted that it intends to kickoff a phase 2 trial at some point in 2018, once the hold is lifted. Markets were hoping that said trial would initiate sooner (with expectations initially set at late third quarter early fourth quarter 2017), and therein lies the root of the company’s decline throughout the session on Tuesday. At market open, SCYNEXIS went for a little over $2.54 a share. By the close of the session, this had declined to $1.62 – a 36% decline across the period.
At first glance, this looks like something of an overreaction. So long as the hold is lifted (and all signs suggest that it will be) the program should get back on track. Sure, it is going to cost some money, and shareholders are likely going to have to bear the cost of this through dilution, but the development is far from terminal.
Moving on, let’s look at Array.
This one is a little simpler. The company put out data from one of its lead trials during the session on Tuesday, and – simply put – the data looks good. The trial relates to a drug called binimetinib, and was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. It is phase 3 data and it’s investigating comparable (between arm) efficacy in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. As per the latest data, which derives from the second part of the phase 3 study, median progression free survival (PFS) for patients treated with the combination came in at 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with an HR of 0.77, a 95% CI 0.61-0.97, and a p=0.029. A stat sig improvement and a good result all round. Markets are taking the data for what it is, and trading up on the company as a result. Not dramatically, but up nonetheless. At last count, Array traded for $7.80 per share – gains of little over 11%, all having come during the after hours trading on Tuesday.
This one is relatively straightforward, so we won’t spend too much time on it. The company is developing a drug called brexanalone in a target indication of super-refractory status epilepticus (SRSE). It’s in a phase 3 investigation right now, and the initial target for data release was set at the second quarter of 2017 (i.e., before the end of this quarter). Alongside its latest financials, Sage announced that it’s not going to meet this initial data release target, and that the report should happen at some point during the third quarter of this year. Markets are trading down a bit on the company on the back the news, with Sage currently trading at a little over $66 a share – down 3% or so on its pre-announcement numbers.