I'll try to answer at least some of these to the best of my ability:
1. What are the measuring parameters for the May/15 presentation of results?....what will be considered good/bad/excellent news?
In my opinion, Biomira suffers more from being "undiscovered" than from any real uncertainties involving the phase 3 trial of Theratope. To some extent, if this conference merely generated positive PR for what already is seen as a "great" product, that would be some measure of success. On the "excellent" side, any amount of mass exposure resulting from the conference - such as a NY Times article featuring "cancer vaccines" (the CEO was interviewed 3 weeks ago, incidentally) - would put Biomira in it's rightful spot along side IMCL and ENMD, along with the much higher valuations.
On the technical side, we have 3 major studies to evaluate. Theratope used after stem cell replacement for breast and ovarian cancers, and the bridging study results. In the first two studies, we already know Theratope created a significant immunological response - how significant is what we hope to hear. With the bridging study we have perhaps one of the last opportunities to see how well the "new formulation" of Theratope, currently in a double-blind phase 3, works in comparison to the phase 2 formulation prior to completion of phase 3. The interim data released last year showed a hundred fold increase in immunological response, which directly correlated to life expectancy in other studies.
Which of these studies will be the "breakthrough news" we all want? Your guess is as good as mine. But there is certainly potential for all of them.
2. Assuming very good news, can we assume a wild run ?...or a gentle slop going north
That all depends on the amount of media exposure. A NY Time article in conjunction with mediocre results would generate a huge spike compared to fantastic data and no media exposure at all. Remember, Entremed went from $10 to $80 on a NY Times article that described rudimentary pre-clinical mouse data for a treatement that to this day has never been tested on a human. When you consider that Biomira's BLP-25 super vaccine produced virtually the same results in mice last year, you realize that the mass media has more to do with valuations than the science. Let me take that one step further - BLP-25 produced better results than endostatin because it not only eliminated all the tumors (like the anti-angiogenesis drug), but also worked as a 100% preventative. Just consider that for a moment when evaluating cancer treatments - and imagine the NY Times or WSJ article that could - and will eventually - be written about this little company.
3. Sale on the news syndrome....do we expect a sale out on the news if news are not that conclusive
Could go either way. Entremed dropped from $80 down do the 30's. But it later made it back to $50, and is about $29 today. (All pretty amazing considering the company has never conducted a single clinical trial). SUGN had that so-so 60 Minutes exposure, and definately sold off big time (I think it had too hard of a run-up, and the news was inconclusive).
IMCL is what I would hope for. It ran up, sold off a little, and then kept on trucking (really pissed off the shorts too). If the BIOM results are excellent, perhaps we could pick up some good analyst coverage. Or perhaps an investment opinion similar to the one IMCL got (showing a valuation based on future sales of $150/share in 2001). IMCL is a great comparison company, since both companies are at similiar stages, and future valuations based on sales are virtually identical. Up until the recent exposure for IMCL, both also shares very similar market caps (IMCL has since doubled their cap).
4. What is the float?
44 Million. Approximately 15% institutional holdings (last I heard). Nice pool of dedicated longs that are holding out for phase 3.
How long will the phase III last?.....when do you expect that there will be a green line to market (if succeed of course)?
The phase 3 trial is designed for 4 years, although it is also designed to produce results in 18 months for possible fast track approval. If the FDA approves fast track, it can be marketed immediately, even though the trial continues to completion. You'll hear a lot of different dates from different people, but that's somewhere between 2000-2001.
At sometime prior to this, we can also assume Chiron will pay a milestone payment - I guess at phase 3 full enrollment, which would be soon. That's always nice press for a small biotech. I'd expect it to be in the $30-60 million range.
SM |
