PLSE

Business Context and Reporting Period

Pulse Biosciences, Inc. (PLSE) is a novel ablation company developing Nano-pulse Stimulation (NPS) technology for medical applications, primarily focusing on the treatment of atrial fibrillation (AF) and soft tissue ablation. This Form 10-Q covers the quarterly period ended March 31, 2026. The Company is classified as a non-accelerated filer and a smaller reporting company.

Key Financial Metrics

Material Changes vs. Prior Period

• Revenue Generation: The Company recorded $0.4 million in product revenue for Q1 2026, compared to zero in Q1 2025, driven by the limited market release of the Vybrance Percutaneous Electrode System.
• Operating Loss: Net loss increased by $1.8 million year-over-year, primarily due to higher R&D expenses ($2.3 million increase) partially offset by lower SG&A expenses ($1.1 million decrease).
• Expense Drivers: R&D increases were driven by higher paid services and compensation. SG&A decreases were largely due to a $2.8 million reduction in stock-based compensation resulting from executive departures.
• Liquidity: Cash and cash equivalents decreased by $12.4 million during the quarter, reflecting a net cash burn of $14.6 million from operations, partially offset by $2.2 million in financing activities.
• Stock-Based Compensation: Total stock-based compensation expense dropped significantly to $1.9 million from $5.7 million in the prior year quarter.

Guidance, Outlook, and Risks

• Strategic Realignment: In March 2026, the Company announced a strategic realignment to prioritize the development of nsPFA electrophysiology catheters and cardiac devices for AF treatment, reducing short-term investments in cardiac surgery and Vybrance sales/marketing.
• Clinical Progress:
  • nPulse Cardiac Catheter: FDA approved an Investigational Device Exemption (IDE) in December 2025; first patients treated in April 2026. Positive 1-year follow-up data (96% procedural success) was presented in February 2026.
  • nPulse Cardiac Surgical Clamp: Received FDA Breakthrough Device Designation and IDE approval in September 2025; pivotal trial enrollment commenced.
  • Vybrance System: Commenced the PRECISE BTN clinical trial in September 2025 to generate evidence for benign thyroid nodule treatment.
• Capital Resources: Management believes existing cash ($68.3 million) combined with proceeds from a subsequent May 2026 stock sale ($12.9 million) is sufficient for operations for at least 12 months. However, the Company expects to incur additional losses and will require further capital.
• Risks: Key risks include the need for additional financing, potential dilution, regulatory approval uncertainties for cardiac devices, and intense competition from established thermal ablation and micro-PFA technologies.

Investor Verification Checklist

• Cash Runway: Verify the sufficiency of the $68.3 million cash balance against the projected burn rate of ~$14.6 million per quarter.
• Subsequent Financing: Confirm the details and impact of the May 11, 2026, at-the-market offering which raised approximately $12.9 million.
• Clinical Milestones: Monitor enrollment and data readouts for the newly initiated IDE studies for the Cardiac Catheter and Surgical Clamp.
• Revenue Sustainability: Assess whether the $0.4 million in Q1 revenue from the Vybrance System is sustainable given the strategic shift to prioritize cardiac development.
• Majority Shareholder Influence: Note that Co-Chairman Robert W. Duggan owns approximately 72% of voting power and participated significantly in recent financing.