Hi everyone,
So Talphera (previously AcelRx) is currently testing Nafamostat, a regional anticoagulant medication used during CRRT, whereas no medication has this ability (citrate is not FDA approved for CRRT). They need 70 patients total, and the last quarter they announced about 61% patients signed up. They did push the date from finishing trial around july/August to end of year (with FDA approval now in early next year).
There was a ton of insider purchasing lately despite them having the ability to grant shares. Yes there was some dilution last year, but they now have enough cash to last until the end of the trial.
Nafamostat/Niyad has been used in Japan for about 4 decades, and is actually preferred by doctors there (and South Korea for a shorter amount of time) over Heparin. So the medication itself has been shown to be effective, which to me reduces the risk a bit.
The FDA gave Nafamostat a breakthrough device Designation status so that once the trial is done the approval period is sped up. Nafamostat also already has a billing code for it (XY0YX37), by CMS, which means it can be billed to insurance when its approved, a process that usually takes 6 months to a year.
Enter CorMedix deal, who now owns 19% of TLPH (CorMedix only holding) with the option to buy 100% of the company within 60 days of trial completion. So TLPH is a buyout candidate. I think (and analysts agree) that this company is worth at least $3-$4 a share, once trial is completed. So far they've had good results with it, just recruiting is hard due to a limited population of those who are heparin resistant or at risk of bleeding too much on heparin. Even if it gets de-listed, it wont matter if they're bought out.
I'm in for 3700 shares at $0.96 average. Just want to hear your thoughts or shit all over my thesis.