Pulse Biosciences (PLSE) Q1 2026 earnings summary

Executive summary

• Achieved a major inflection point with three milestones: landmark European feasibility data, strategic realignment to focus on the nPulse cardiac catheter for AF, and commencement of U.S. pivotal IDE study enrollment, with accelerated enrollment timeline now expecting completion in early Q4 2026.

• Expanded leadership team with new Chief Medical Officer and Chief Operating Officer to accelerate clinical and commercial execution.

• Presented outstanding clinical results at major medical meetings, reinforcing the differentiated profile of nsPFA technology and continued progress in surgical AF ablation and soft tissue ablation clinical programs.

Financial highlights

• Q1 2026 revenue was $401,000, primarily from nPulse Vybrance systems and electrodes.

• GAAP net loss was $18.6 million, up from $16.8 million year-over-year; non-GAAP net loss was $16.4 million, up from $11.4 million.

• Cash and cash equivalents totaled $68.3 million as of March 31, 2026, down from $80.7 million at year-end 2025 and $119.3 million a year earlier.

• Cash used in operating activities was $14.6 million, compared to $13.5 million in the prior year period.

• $200 million shelf registration and $60 million ATM program available for future financing.

Outlook and guidance

• Enrollment for the pivotal IDE study expected to complete in early Q4 2026, ahead of previous guidance.

• European CE mark submission for the nPulse cardiac catheter planned for H2 2026, with potential approval by mid-2027.

• NANOCLAMP AF surgical study enrollment expected to complete by mid-2027.

• Vybrance PRECISE-BTN study expanded to 100 patients; PTMC feasibility study enrollment to complete by year-end 2026.