Greetings! Finally had a few minutes to sit around and read the transcript of the call. I listened in, but always like to read the exact wording/language they used, before I say anything too dumb.
A few thoughts. Yep trial results coming in slowly is a pain, but I really didn't expect much different. A company this new and this small, even with ligand, I would have been shocked if everything was quick. I actually didnt (and still don't) think it would be difficult to find hips, I knew the Nash stuff would be a pain. The slower hip fracture enrollment leads me to suspect that they are either working diligently keep the trial cost reasonable and not pushing the budget, or that they are recruiting in a very selective fashion. Hopefully the second. Especially with it being so new, they seem smart enough to do the trial 'intelligently' and with a decent population, which would probably give them maximum chance of a smaller enroll or shorter phase 3. Either way, I don't think the slower enroll is worrisome. If you grab every grandma off the street with a hip, you're going to get scraps. If they are doing what I suspect, my guess is that the mortality rate will be low, all around. I don't think it will affect the data validity though, as it's not going to be a long enough trial where you could start to wonder if the population is reflective. Finding better patients will also reduce the chance of recorded side effects, possibly. More frail, more problems, all around. All just guesses and conspiracy theories. Pharma stuff all goes the same. Only the fools rush in.
I suppose the best thing they said, was what they didn't say. No significant dilution, no unforeseen problems, all pipelines moving, partnering interest. The cash burn is incredibly reasonable for a company with two phase twos in full swing, and other irons in the fire. The 9 months of cash burn time will get them well past hip data, and maybe lipid data. I would hope they partner if hip data is good, but it may not be necessary. I could easily foresee a situation where ligand doubles down on their stake when they are allowed, and the easiest way to do that is an arrangement giving the company capital in some form, and a clear win win. Burning cash this slowly really gives them the opportunity to partner wisely and without desperation, especially with ligand in the wings. If they dilute, they would all only be harming themselves.
The request to lower the LDL on the other lipid trial is incredibly wise. Quicker enroll, healthier patients, again possibly less side effect population, etc.
Regarding my last posts, I feel that side effect profile will be the main factor in how quickly the hip or lipid drugs could reach other populations. Docs are much quicker to go off label when drugs aren't clearly harmful. The side effect profiles are way more important to me than primary endpoint showing phenomenal results. As long as the primary is statistically significant, the rest of the secondary stuff and side effect profile will matter way more in the long run. The quality of life stuff, if good for hip study, would hopefully imply that longer phase 3 studies will really start to show that the treatment arm moving away. Happier people, better core strength, they get off the couch more, and don't continue to wither and get the predictable stuff that takes people out, blood clots, utis, etc. It would also make it more likely to make it a longer term drug for dosing, possibly.
The lean muscle endpoint seems very reasonable. 2 pounds of muscle, that's a gift. They are basically asking it to do something, not everything.
I like the common shares much more than the warrants at these levels. This seems like a great time to add, and I picked up some more shares the other day. 1.20's is a gift. The market is not patient, I love situations like this. The same people selling now will be coming back in a few months when data nears again, or if we get an earlier gift from one of their early phase trials.
Bottom line, no trials halted, no unforeseen side effects disclosed now that a lot of patients should be complete... not a bad waiting game.
I've done ok on a few other things lately, I'm keeping some cash in case market pressure arises, maybe I could get some 1.1's shares if so.
I doubt earlier phase news will do much for share price, long term at least. most people know that it is going to be feast or slaughter when hip data comes. I don't think earlier phase stuff will make anyone want to hold this through hip data that otherwise isn't holding already, so any gains on earlier phase stuff will be transient if it occurs. I will start selling my common if we get earlier phase updates that give us a boost, if they come very soon.
Another thing to consider. Yeah it's undervalued, hugely. And totally unknown, which is fine by me. I was nervous for how to play this when I originally thought that we'd get hip data in march. Holding on good hip data that came in march would be tricky, that's a long time to wait for lipid news, a lot of people would jump ship and take gains. If we get hip data in august, or even better... September, we could pop on good data, and day traders would be very likely to hold into oct/nov, waiting to sell before lipid phase two. That would create a phenomenal 1-2 punch. It's an absolute best case scenario in my book. I would sell some in late oct before the data dip, and buy back when it dips just before lipid data. unless the hip data is phenomenal... then I'd ride it as close to the wire as possible before selling some. I honestly can't remember the last time a company was set to report two phase 2's in that short of time frame, at least one that wasn't monster cap and insanely overvalued.
So yeah, I'm bored waiting, but much more excited for later this year.
Hope that helps.
Have a good one!
Waffles
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