Newer to Investing (11 months in) and insider buying back in February and March for TLPH caught my eye at first. Seth Klarman, Hilary Kramer, and Joel Greenblatt describe pre-revenue biotechs like buying an option.
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 (CEO bought 300,000 between feb/march, CFO, CMO, and chief engineering officer bought 115,000 in Feb) despite also getting grants. 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. (This part in parenthesis added by claude ai- \*\*Multiple independent studies back this up: Korean RCTs comparing nafamostat to no anticoagulant in high-bleeding-risk CRRT patients found significantly longer filter survival and less clotting, and a separate Japanese nationwide registry of over 3,000 sepsis patients found nafamostat use was associated with significantly lower mortality versus heparin/conventional therapy, with no increase in bleeding complications. Across these studies and others, nafamostat has been tested in well over 1,000 patients combined in Japan and Korea without ever underperforming the standard of care it was compared against.\*\*)
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 exclusive rights to negotiate for 100% of the company within 60 days of trial completion. So TLPH is a buyout candidate. I think (and analysts including westpark capital and HC Wainwright & co, 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.
All was written by me except part added about trials.