Talphera, Inc.

Talphera did not report revenue, EPS, or gross margin on this call. Cash balance at June 30, 2026 was $17.1 million. Cash operating expenses, or combined R&D and SG&A, were $3.9 million in Q2 2026 versus $3.7 million in Q2 2025; excluding stock-based compensation, they were $3.7 million versus $3.5 million. Management said the $0.2 million increase was mainly due to higher Niyad development spending from increased enrollment and some SG&A tied to initial market research. Forward guidance: the company expects NEPHRO enrollment to finish later this year, top-line data about 4 to 5 weeks later, and a PMA filing in the first half of next year. Management also said the current cash plus about $16 million of remaining conditional financing tranches should fund operations through at least a potential 2027 PMA approval.

CEO Vince Angotti framed the quarter around execution and commercialization readiness. He said the company is on track to finish enrollment later this year, has reached 75% enrollment, and is increasingly turning attention to the commercial opportunity for nafamostat. He emphasized the significance of the KDIGO guideline update, said the market opportunity appears larger than previously estimated, and described the likely launch approach as highly targeted rather than a broad traditional sales rollout.

CFO Raffi Asadorian focused on liquidity, timing, and spending. He said cash was $17.1 million at June 30, 2026, and that this plus two conditional financing tranches totaling about $16 million should provide sufficient capital through at least potential Niyad PMA approval expected in 2027. He also reported cash operating expenses of $3.9 million in Q2 2026 versus $3.7 million a year ago, or $3.7 million versus $3.5 million excluding stock-based compensation, and attributed the increase mainly to higher development costs from enrollment and early market research spending.

Analysts asked about launch preparation, hiring, rollout strategy, timing from enrollment to data and PMA, investigator feedback, titration behavior, and the KDIGO guideline process and adoption. Management said hiring would likely begin once the PMA is submitted in the first half of next year, with only a small initial team focused on education; they also said launch planning is concentrated on a relatively small number of institutions that drive most CRRT procedures. On the study, management said titration has been straightforward, most patients are therapeutic at the starting dose or after only minor adjustment, and the DSMB identified no new safety issues. On KDIGO, they said the guideline appears likely to finalize in roughly 3 to 6 months and that its inclusion of nafamostat should help validate and support institutional adoption, though actual uptake varies by hospital.