Talphera (TLPH) Q1 2026 earnings summary

Executive summary

• Achieved over 50% enrollment in the NEPHRO CRRT study for nafamostat, with completion and top-line data expected in 2026 and PMA filing targeted for 2026, aiming for FDA approval in 2027.

• All resources are focused on Niyad, with other candidates under evaluation for discontinuation.

• Strong engagement and positive feedback from principal investigators and site staff regarding the study protocol's ease and stability.

• Clinical data presented at a major nephrology conference, highlighting unmet needs in CRRT anticoagulation.

• Net loss for Q1 2026 was $2.6 million, consistent with Q1 2025; accumulated deficit reached $474.1 million.

Financial highlights

• Cash and investments totaled $21.1 million as of March 31, 2026.

• Closed a $4.1 million financing tranche in Q1 2026; two conditional tranches totaling $16 million remain, contingent on study milestones.

• Combined R&D and SG&A expenses were $3.9 million in Q1 2026, up from $2.9 million in Q1 2025, mainly due to increased Niyad development and G&A costs.

• Excluding non-cash stock-based compensation, Q1 2026 expenses were $3.7 million versus $2.7 million in Q1 2025.

• Revenue for Q1 2026 was $27,000, compared to $0 in Q1 2025.

Outlook and guidance

• Guidance maintained for NEPHRO study completion and top-line data release in the second half of 2026.

• Sufficient capital expected through potential Niyad PMA approval in 2027, assuming conditional tranches close; however, management expects to need additional capital before the 12-month anniversary of the filing date.

• Plans to raise capital through equity, debt, or strategic transactions, but these are not guaranteed.

• Top-line data expected within a month after last patient out, with rapid data cleansing due to short study endpoints.

• Ongoing focus on completing the Niyad NEPHRO CRRT trial and preparing for regulatory submissions.