We’re midway through the week in the biotechnology sector and a number of companies are moving on a variety of entity-specific inputs. Here’s a look at who’s moving, what’s moving them and where we expect things to go next based on the inputs in question. The two companies in focus for the session today are Kite Pharma Inc (NASDAQ:KITE) and Galena Biopharma, Inc. (NASDAQ:GALE).
First up, Kite.
This one just put out second quarter 2017 financials and alongside the numbers (and as in generally customary, especially at this end of the biotechnology sector) we got a conference call to update markets on the progress of Kite’s development pipeline. This time around, it’s the latter of these two inputs that is causing the move in Kite’s market capitalization; specifically, an update related to one of the company’s development stage assets – a drug called Axi-cel.
The asset is a type of immuno-oncology drug (and specifically one that employs a CART-T MOA) and Kite is trying to get the drug approved in the US for the treatment of Non-Hodgkin’s Lymphoma (NHL). The company submitted a New Drug Application (NDA) for Axi-cel earlier this year and the Food and Drug Administration (FDA) in the US quickly accepted the application for review. At the time, many expected that the drug would have to go in front of an advisory committee panel (and by proxy, become subject to the voting system employed at such meetings) at some point before PDUFA.
According to the latest release, however, and as reinforced by the conference call that accompanied the financials, the FDA has advised Kite that an adcom panel will not be required and that the drug has a clean run through to PDUFA at the end of the year (scheduled for November 29, 2017).
Markets are responding positively to the news and Kite currently trades for a close to 6% premium to its pre-announcement (and pre-earnings) market capitalization.
It’s important to keep in mind that this removal of the necessity for a panel review doesn’t imply that the drug will be approved come PDUFA – at least not outright. There are many reasons why the FDA may not require a review and the reason that Kite is trading up right now is rooted in the fact that markets generally see the non-requirement as positive.
To quickly address the numbers, Kite reported revenues for the second quarter of the year at $10.1 million and that research and development expenses were $70.9 million for the period. R&D costs generally account for the lion’s share of outgoings for a company like this (development heavy biotech) and, when combined with a little over $40 million in gen and admin costs), translated to a net loss for the period of $109.8 million. At first glance, that seems high. When considered against the $781.1 million cash on hand reported at the end of the quarter in question, however, it’s a close to two-year runway, removing a large portion of the (dilutive) risk associated with picking up an exposure to Kite right now.
Moving on, then, let’s look at the second biotech mover to make today’s list – Galena. This one’s a different sort of move altogether and, unfortunately for Galena and its shareholders, hasn’t resulted in a move in line with that of Kite.
Galena announced this week that the company has entered into a merger agreement with a privately held biotech company called SELLAS Life Sciences Group Ltd. As per the terms of the agreement, the combined entity will change its name to SELLAS Life Science Group and current Galena shareholders will account for a 32.5% holding of the new company.
Initial reports suggest that SELLAS will be focusing on all elements of the two companies’ combined pipelines, but there’s a good chance that resource allocation will weight towards the SELLAS assets initially. Investors should look at this as more of a reverse merger than anything else – SELLAS wanted access to public market capital, Galena was trading for pennies and didn’t have much cash, SELLAS merges with Galena to bolster pipeline of the latter and to allow it to pick up an exposure to a shareholder infusion of volume.
Only time will tell how this one will play out – markets are initially selling off on the news, with Galena set to open the session on Wednesday at a 27% discount to its pre-merger capitalization.