Pulse Biosciences (PLSE) Q3 2024 earnings summary

Executive summary

• Advanced three core nano-PFA device programs: soft tissue ablation, cardiac surgical ablation for AF, and endocardial catheter ablation for AF, with positive early clinical results and regulatory progress, including FDA 510(k) clearance and Breakthrough Device Designation.

• Placed nsPFA Percutaneous Electrode Systems at seven U.S. sites for pilot clinical assessment, with commercial use expected in coming quarters.

• Completed a $60 million rights offering in July 2024, with majority participation from the Co-Chairman, strengthening liquidity for ongoing R&D and commercialization.

• Expanded leadership team with key hires in clinical, commercial, and medical roles, including a new Chief Medical Officer and advisory board members.

• No product revenues reported; company remains in development stage and relies on external financing.

Financial highlights

• GAAP costs and expenses for Q3 2024 were $13.7 million, up from $11.3 million year-over-year, mainly due to higher stock-based compensation and organizational growth.

• Non-GAAP costs and expenses increased to $10.4 million from $9.2 million year-over-year.

• GAAP net loss was $12.7 million for Q3 2024, compared to $10.6 million in Q3 2023; non-GAAP net loss was $9.4 million, up from $8.5 million year-over-year.

• Cash and cash equivalents totaled $79 million as of September 30, 2024, up from $44.4 million at year-end 2023, including $60 million from the rights offering.

• Net cash used in operating activities was $27.2 million for the nine months ended September 30, 2024.

Outlook and guidance

• Commercial use of the nsPFA Percutaneous Electrode System expected to begin in the coming quarters.

• Plans to initiate pivotal U.S. clinical trials for all three device programs in mid-2025.

• Existing cash is expected to fund operations for at least the next twelve months; additional capital will be sought for future needs.