Yup it appears it took a bit longer than expected to kick off enrollment. I've been involved in pharma and biotech for 15 years and in my eyes, taking the time to do things right is always the best way forward. And delays are part of the this field, fairly typical.
From their website, the n = 180 allows is powered at 90% and I believe they have the opportunity to make adjustments if needed during the course of the trial. They need 125 events showing benefit of 6.5 months vs 3.5 for salvage treatment (a 3 month benefit). On the plus side, the FDA might approve early if it shows efficacy (and safety mimics what was seen in phase 2).
Financing is tricky. From my understanding, their last round of financing gets them through quite a bit of this trial if not all. They raised about 8+ million. And warrants provide them extra if needed. But the market cap is at $20 million so even if they doubled their shares it would still only be 27 million on the market. Waaaaay lower than most biotechs. But doubling never happens. Say its 25% which is still high. That's about 3.5 million more which only puts them at 16 million. Success at phase 3 can EASILY put it at a 300 million dollar valuation which would equal an $18.75 share price at 25% dilution.
So personally, I am confident in the management. They do what they say.
I am comfortable with financing.
I am positive on the trial design and probability of success (especially vs. salvage).
And extremely positive about the opportunities in first line and second line treatment.
And am also extremely positive about efficacy within additional indications.
Seems like a solid bet to me, even though the price is way low. Low volume makes it easy to short.
We shall see.
It took almost a year to kick off the phase III.
Also, the total cohort size is 180? What kind of stat power will that bring?
Will they have enough funding to get to finishline? I see another funding before they finish the phase III. So, I guess it is not a buy just yet.
