The end of the week last week brought with it a number of updates from various companies in the biotechnology space and – with these updates – came quite a bit of volatility for the market capitalization of the companies in question. Here is a look at two of the biggest movers, what drove the action in each, and how we expect things to play out going forward as a fresh week kicks off in the sector.
The two companies that we are focusing on for the session today are Celsion Corporation (NASDAQ:CLSN) and Neos Therapeutics Inc (NASDAQ:NEOS).
We will kick things off with Celsion.
This one is a bit of a strange situation. The company recently announced that it was set to undertake a share offering and – as is relatively standard in this space – took a hit on the announcement. Shareholders view a company raising capital through equity issue as negative because the added shares will almost always dilute the outstanding base and reduce the proportionate value of their holdings of existing shares of a company. In this instance, Celsion filed an S-1 (a registration filing necessary before executing an offering) with the Securities and Exchange Commission (SEC) in the US back in April, and, as recently as the middle of last week, amended the filing to account for the sale of 2.45 million common shares and pre-funded and base warrants to buy over 4 million shares.
Everything changed, however, at the end of last week, when the company announced that he no longer intends to carry out the offering and withdrew from execution. As to why management decided not to raise cash in this way, only they really know. We did get a brief statement from Celsion on the back of the update, as follows:
“(The company has decided to withdraw from the offering because…) it does not intend to pursue the contemplated offering at this time.”
Of course, companies like this aren’t obligated to carry out offerings, and will often register shares by way of the above noted S-1 filing just in case. However, it is unusual for a company to amend a filing just a couple days before announcing its intention to withdraw.
Anyway, whatever the reason, markets are viewing the development as positive for the exact opposite reasons to those described above as to why equity issues are generally viewed as negative. The company gained 156% in market capitalization on Friday and – as this week kicks off – we expect Celsion will appreciate further as markets reposition ahead of some near-term catalysts.
Moving on, let’s look at Neos.
This one is a more standard move. Today, Neos has a PDUFA for its lead development product, and asset called Cotempla XR-ODT, which it is trying to get approved in a target indication of attention deficit hyperactivity disorder (ADHD). The current standard of care treatment in this indication is a once-daily pill, commonly known as Ritalin. Many of those who need to take it, however, have problems doing so. These are children, and many can’t swallow tablets whole or don’t want to. Neos is attempting to overcome this problem with Cotempla XR-ODT, which is – for all intents and purposes – a reformulation of Ritalin into what is called an orally disintegrable tablet, or ODT. Patients just put it in their mouths and it breaks down on its own, making it easier to swallow.
it has not had an easy ride so far, however.
The company received a Complete Response Letter (CRL) from the FDA in 2015 and had to carry out some additional studies in order to meet the agencies request for additional bioequivalence data. The fact that the FDA has accepted a resubmission suggests that – at a high level, at least – the company has met the requirements, but this doesn’t mean that the drug is a shoo-in for approval when the agency makes its decision.
With that said, markets seem to be leaning towards optimism, and this is what is moving Neos right now. The company gained 10% towards the end of last week on nothing more than speculative volume loading up the head of the FDA decision day (which, again, is today). If the decision goes Neos’ way, expect this one to really run throughout the remainder of the week.