Pulse Biosciences (PLSE 10.40%), a medical device innovator focused on nanosecond pulsed field ablation (nsPFA) for treating various conditions, released its second-quarter 2025 results on August 12, 2025. The company reported another pre-commercial quarter, with no revenue. Operating expenses increased substantially amid ongoing clinical trial expansion and commercialization preparations. Cash and cash equivalents totaled $106.3 million as of June 30, 2025, up from $26.2 million a year earlier. Overall, the results show the company’s rapid advance through clinical and regulatory milestones while highlighting the sustained financial investment needed ahead of first product revenue.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.28) | N/A | $(0.20) | (40.0%) |
| Revenue (GAAP) | $0 | $0 | $0 | 0% |
| Total Operating Expenses (Non-GAAP) | $14.8 million | $9.4 million | 57.4% | |
| Cash and Cash Equivalents | $106.3 million | $26.2 million | 306.1% |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Areas of Focus
Pulse Biosciences is developing the CellFX System, a device that uses ultrafast electrical pulses to treat unwanted or problematic tissue while sparing healthy cells. The underlying nsPFA technology is being tested for uses in soft tissue tumor removal, treatment of benign thyroid nodules, and cardiac ablation for atrial fibrillation (AF), a type of heart rhythm disorder.
The company’s recent strategy has been to drive clinical evidence for three main product types: the Percutaneous Electrode for soft tissue ablation, the Cardiac Surgery System for surgical AF ablation, and the 360° Catheter for endocardial ablation. Success depends on generating positive clinical outcomes, building a robust regulatory dossier, scaling up for various indications, and protecting intellectual property to defend its competitive position.
Quarter in Review: Clinical, Regulatory, and Financial Progress
During Q2 2025, Pulse Biosciences expanded its pilot program for the nsPFA Percutaneous Electrode, a device for treating benign thyroid nodules, enrolling over 140 patients—up from 90 in the prior quarter. Five U.S. study centers were also identified for a planned post-market study, setting the stage for expanded clinical evidence and future commercialization in soft tissue indications.
In its cardiac programs, the company submitted investigational device exemption (IDE) requests to the U.S. Food and Drug Administration for both the Cardiac Surgery System (surgical clamp) and the 360° Catheter, staying on schedule for pivotal trials. In Europe, the feasibility trial with the Cardiac Surgery System enrolled 40 patients as of Q2 2025, 10 more than in the prior quarter, with the company highlighting “positive clinical outcomes, as indicated by follow up remapping procedures.” For the 360° Catheter, European clinical sites have now treated more than 140 patients as of Q2 2025, advancing clinical expertise and operational efficiency, as demonstrated by improved procedure times presented at the Heart Rhythm Society Meeting in April.
No product or service revenue was reported for the quarter, consistent with its pre-commercial phase. While this absence of revenue matched expectations, it underscores the company’s current focus on investing in clinical validation and regulatory progress. Non-GAAP costs and expenses for the three months ended June 30, 2025, increased 57.4% year over year. The primary cost drivers were high levels of investment needed to advance clinical programs and grow the organizational infrastructure, including a material increase in non-cash stock-based compensation.
Net loss widened on both a GAAP and non-GAAP basis in Q2 2025 as expenditures increased for clinical trials and early commercialization preparation. At the same time, the company’s cash and cash equivalents (GAAP) increased by $80.1 million in Q2 2025 compared to Q2 2024. The available cash provides a cushion for ongoing development and the expected push into commercialization, though the pace of spending means future fundraising or a swift move to revenue generation may be necessary in the future.
Inventory levels, while still small, rose to $51,000 as of June 30, 2025, hinting at initial production activities ahead of commercial launch. The quarter also saw an interest income boost driven by a larger cash balance. No one-time settlement costs were incurred during the period—a contrast to several earlier quarters. As of quarter-end, there was no preferred stock outstanding, and common shares increased modestly as funding was raised through warrant exercises earlier in the year.
Pulse Biosciences does not currently pay a dividend.
Looking Ahead
Management did not provide any quantitative revenue or earnings guidance for the remainder of fiscal 2025 or beyond.
For investors, key points to watch in upcoming quarters include the pace of patient enrollment in both U.S. and European trials, progress in securing IDE approvals and launching pivotal studies, and signs of initial commercial adoption for the nsPFA Percutaneous Electrode in benign thyroid nodule treatments. The company’s ability to bring a first product to market, manage costs, and extend its cash runway will remain central to its story as it attempts to move from clinical-stage to commercial-stage operations.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
