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 June 30, 2026. The company operates as a single segment and is classified as a non-accelerated filer and a smaller reporting company.

Key Financial Metrics

Material Changes vs. Prior Period

• Revenue Growth: The company generated $0.4 million in product revenue for the quarter ended June 30, 2026, compared to zero revenue in the same period in 2025. This revenue stems from the limited market release of the Vybrance Percutaneous Electrode System.
• Increased Operating Loss: Net loss increased by $5.5 million (29%) for the quarter and $7.3 million (20%) for the six-month period compared to the prior year. This was driven primarily by higher R&D expenses ($4.9 million increase for the quarter) due to clinical research, professional services, and compensation costs.
• Financing Activity: During the six months ended June 30, 2026, the company raised approximately $46.8 million in net proceeds through an at-the-market (ATM) offering program, compared to $14.1 million in warrant exercises in the prior year period. This significantly improved liquidity.
• Strategic Realignment: In March 2026, the company announced a strategic realignment to prioritize electrophysiology catheters for AF treatment, resulting in $0.6 million in severance and termination expenses.

Outlook, Risks, and Management Commentary

• Liquidity: Management believes existing cash resources ($101.6 million) are sufficient to fund operations for at least the next 12 months. However, the company expects to continue incurring losses and plans to raise additional capital in the near future.
• Clinical Progress:
  • nPulse Cardiac Catheter: Pivotal IDE study enrollment is underway (over 50% of 164 evaluable patients enrolled). Positive 1-year follow-up data from the first-in-human study showed 96% procedural success.
  • nPulse Cardiac Surgical Clamp: Pivotal IDE study enrollment has commenced. The device received Breakthrough Device Designation and is enrolled in the FDA's Total Product Life Cycle Advisory Program.
  • Vybrance System: The company is conducting the PRECISE BTN clinical trial to generate evidence for benign thyroid nodule treatment.
• Risks:
  • Capital Needs: Failure to secure additional financing could force the company to delay or discontinue product development programs.
  • Regulatory Uncertainty: No assurance that clinical trials will succeed or that FDA PMA approval will be granted for cardiac devices.
  • Concentration of Ownership: Co-Chairman Robert W. Duggan owns approximately 70% of the outstanding common stock, limiting other stockholders' influence.
  • Competition: Intense competition from established medical device companies with greater resources in both cardiology and soft tissue ablation markets.

Key Facts for Investor Verification

• Verify the enrollment rates and interim data from the pivotal IDE studies for the nPulse Cardiac Catheter and Surgical Clamp, as these are critical for future PMA approval.
• Monitor the remaining capacity of the February 2026 ATM program (approx. $1.0 million remaining) and the status of the newly established August 2026 ATM program ($75 million capacity).
• Assess the timeline for the PRECISE BTN clinical trial results for the Vybrance System, which supports the company's only current revenue stream.
• Review the impact of the March 2026 strategic realignment on future R&D burn rates and headcount.
• Confirm the status of the 2024 Rights Offering warrants, noting that the second tranche was redeemed in July 2026 and no such warrants remain outstanding as of July 31, 2026.