Biota has announced it corporate update and 2014 year results. And board and management changes. And some guidance on strategy.
Very cheeky of Biota to seek an extension to the Relenza patent. Hopefully it succeeds, but both GSK and the USPTO will make it very difficult. This company finds it hard to catch a break, so on form it shouldn't be expected.
The generally positive sub-outcomes reported on the Igloo trial are interesting. Even the positive data on the smaller studies, including asthmatics. The combination data approach is worth taking. But the news on discussions with FDA on the Igloo trial and the future of LANI are no guarantee of anything. Problem for the FDA is that there is already pressure on the regulators about the quality of data behind registration of NIs. My reading is that Daiichi, who have suddenly become our partner again, are the only buyer for LANI. The comments about uncertainty around the ROW contract if the marketer is not a third party were initially referenced to Biota being the marketer, and now its clearly (in my view) directed at DS's role. DS have an interest in protecting LANI's reputation. All this would have been better avoided by using the same outcome instruments used by relenza and tamiflu.
Vapendavir has tested its new formulation, but has decided to proceed with the original formulation for the current Phase 2 trial. The new tab formulation will be used for subsequent trials after some enhancement to get more than 60% bioavailability of the original. The new formulation gives them a fresher patent, and thus a longer patent life.
Large institutions seem to have obtained the resignation or demotion of Mr. Fox and Mr. Plumb, as well as the withdrawal of some stock options, and renewed vigour for M&A. It's not clear what executive function Mr. Plumb will retain, but he is the Executive Chairman. Mr. Fox seems to have been given charge of finalising the BARDA extraction. We wonder which institutions were at that meeting.
Mr. Patti is talking up M&A. I guess the company has its cash reserves, unclaimed tax credits in Australia and UK, vapendavir in Phase 2, possibly RSV in IND, and a small residual on LANI (and an even smaller residual on relenza). M&A is the only method to recoup share value. I and other shareholders at our drinks event yesterday thought that it was not likely that the company would seriously pursue VAP as it's reason to continue as a stand alone company. His comments were, to our ears, fairly pointed about M&A.
It's hard to speculate where the merger interest will come from. However, a lot of cash poor speculative companies would love the cash pile. We'd prefer bigger companies with a good record.
Possibly after finalisation of a merger, Mr. Plumb and Fox and many of the rest of the Board will resign. There are, by my count, still 8 board members, if I assume Joe Patti will be on the board to replace Mr. Hill. That's quite a lot, for a company soon to have 20 employees on the direct payroll.
These things will take some time to pan out. No merger will be finalised until the FDA says something about LANI (determining how much DS will throw in the hat), BARDA is finalised, and Melbourne is completely shut down. So, another long wait until mid 2015, I guess.
It still causes us to shake our heads over a beer, while we count our losses. Right now though, our interests are shackled to the larger holders, because there is no market for us to sell into, much less them.
Thanks to those of you there last night.
