Talphera is developing Niyad, a form of nafamostat that keeps blood from clotting in the filter circuit during kidney replacement therapy in intensive care; it is not approved.
Talphera's case rests on Niyad, a nafamostat formulation that keeps blood from clotting in the filter circuit during continuous renal replacement therapy. The registrational NEPHRO CRRT study was 75% enrolled in August, and Talphera expects it to be complete this year. Its primary endpoint compares post-filter clotting time with Niyad versus placebo. Cash was $17.1 million at June 30, and the 10-Q says more capital is needed within twelve months. A positive result could trigger a $12 million second closing.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: NEPHRO CRRT meets its primary endpoint
Does Niyad significantly prolong post-filter clotting time versus placebo over the first 24 hours?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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Talphera expects to finish NEPHRO CRRT enrollment this year while funding stays tight
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Disease areas: Kidney diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
vs. direct competitors
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.