Tuesday was another big day in the biotechnology sector. Here are some of the biggest movers with an analysis of what happened and what’s next for each.
The first big mover that made the cut for today’s biotechnology list is Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX). The company put out some data from one of its lead development programs after hours on Tuesday and – on the back of the news – has picked up a considerable amount of strength.
Specifically, the data derives from two separate trials, one phase I and one phase 2, both of which were set up to investigate the safety and efficacy of a combination of drugs in a cystic fibrosis (CF) indication. The company has spent the last few year developing four separate assets, each of which falls into a category of drugs named next generation correctors. They are designed to target the underlying genetic defect that causes CF and – in doing so – could become the next major standard of care therapy in the space, as the majority of already approved assets only target symptoms and don’t correct the underlying disease. There are 35,000 sufferers of CF in North America, Europe and Australia, meaning if Vertz can get this regimen past the FDA, it could be looking at a Blockbuster asset hitting shelves.
So what did the data show?
From the phase 2 trial, a combination of two drugs called VX-152 and VX-440 translated to an improvement in the ability of patients to expel air over the course of one second by 9.7 and 12% respectively for the combination. In the phase 1 trial, the same metric hit 9.6% on the back of treatment with a drug called VX 659.
Safety and tolerability came in as relatively sound, with the majority of adverse events reported across the trials (and across the patient population involved) coming in as mild to moderate.
So what is next?
Well, it is important to remember that this is an early-stage trial and – while the data is extremely positive – the company is still going to have to conduct at least a couple of mid stage trials before it can submit for approval in the US. With that said, however, this is a dramatic unmet need and one that – as we have already mentioned – doesn’t really have many options for patients as far as treating the underlying condition is concerned.
With this in mind, we expect that the FDA will be willing to try and streamline the process as much as possible (of course, while remaining within its own regulatory parameters) and this bodes well for a relatively speedy program. It is this potential that has driven the company to its current highs (which are all-time highs for Vertex), with the company currently trading at more than $163 a share (having reached this level during after-hours trading) – a more than 40% appreciation on the back the news.
Moving on, let’s quickly address a second big mover on Tuesday, Inovio Pharmaceuticals, Inc. (NASDAQ:INO).
This one is a little different and – for shareholders – nowhere near as positive. The company announced during the session on Tuesday that it is set to conduct an offering that will see it sell around $75 million worth of its shares at market in order to raise capital to fund ongoing operational expense and drug development.
This sort of raise is relatively standard in the biotechnology space, with the majority of companies requiring shareholder capital in order to get to the point at which they have enough drugs in their portfolio (and on shelves) to allow for cash flow positivity. Even though it’s common, however, it is still unpopular. Why? Because offerings like this add a large amount of shares to the outstanding balance, and with more shares in the base, the current shareholders are diluted. When shareholders get diluted, the portion of the overall company (in this instance, Inovio, that their individual holding represents declines.
If Inovio can use the capital to push forward to a major catalyst (one that will drive share price higher) then chances are shareholders will forgive this dilution longer-term. The company has a relatively strong pipeline, and so this is far from out of the question, but right now Inovio is trading down on the news somewhere in region of 10%. Chances are we will see a continuation of this dip near term as markets digest, and adjust to accommodate, the dilution.