Pulse Biosciences (PLSE) Q1 2026 earnings summary

Executive summary

• Achieved a major inflection point with accelerated U.S. pivotal IDE study enrollment, strategic realignment to focus on the nPulse cardiac catheter for AF, and positive European feasibility data.

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

• Presented strong clinical results at major medical meetings, reinforcing the differentiated profile of nsPFA technology.

• Continued progress in surgical AF ablation and soft tissue ablation clinical programs, with positive data presented at conferences.

• Limited commercial revenue began in late 2025 with the Vybrance System; continued investment in R&D and clinical trials.

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.

• 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.

• Existing financial resources and recent equity raise are expected to fund operations for at least the next 12 months.