What Pulse Biosciences (PLSE) Said on Its Q3 Earnings Call

Key Points

• Cardiac catheter trial enrollment finished ahead of schedule: Pulse enrolled 169 evaluable patients in its pivotal U.S. study, with results expected in Q3 2027. The company is preparing for a potential early-2028 launch and expects a European CE Mark in Q4 2027.
• Other programs reported progress: In a 100-patient thyroid study, preliminary results showed an 86% rate of nodules shrinking by more than 50% after one treatment, with no serious adverse events reported. Further follow-up data are expected in 2027.
• Spending is set to increase: Q3 revenue rose to $395,000, while net loss widened to $23.1 million. Pulse had $189.2 million in cash and marketable securities at quarter-end, which management said represented about two years of runway, and expects quarterly non-GAAP expenses to rise 15%–25%.

Pulse Biosciences NASDAQ: PLSE said it completed enrollment ahead of schedule in the pivotal U.S. study of its nPulse Cardiac Catheter, setting up a data readout expected in the third quarter of 2027 as the company increases spending on clinical development and launch preparations.

On its Nov. 5 third-quarter earnings call, the company reported revenue of $395,000, up from $86,000 a year earlier, while its net loss widened to $23.1 million from $19.4 million. Cash and marketable securities totaled $189.2 million at Sept. 30, which CEO Paul LaViolette said provides approximately two years of runway.

Pulse Biosciences is developing devices based on its nanosecond pulsed field ablation, or nsPFA, technology for applications including atrial fibrillation and thyroid disease. Its cardiac catheter is designed to isolate pulmonary veins, a common target in atrial fibrillation ablation.

Cardiac catheter study moves into follow-up

The NANOPULSE-AF study reached its enrollment target in early October, completing the process in less than six months, about three months ahead of the original schedule. The study enrolled 169 evaluable patients and 20 roll-in patients across 15 sites, LaViolette said. All patients are now in follow-up.

The study’s efficacy endpoint measures freedom from treatment failure through 12 months, using a combination of six- and 12-month follow-up data. Pulse expects final patient data in the third quarter of 2027 and plans to incorporate the results into the final clinical module of its U.S. premarket approval submission.

LaViolette said the company has begun modular regulatory submissions and expects a European CE Mark for the catheter in the fourth quarter of 2027. It is preparing to support a launch beginning in early 2028.

The company also plans to submit an investigational device exemption application in the fourth quarter of 2026 for a study in persistent atrial fibrillation. Its existing pivotal trial focuses on paroxysmal, or intermittent, atrial fibrillation.

In Europe, the company’s feasibility study has enrolled more than 190 patients, including more than 155 in a five-second ablation cohort. Pulse plans to submit data for presentation at the AF Symposium in early 2027, including more than 100 patients with 12-month follow-up.

Earlier results presented in April covered 53 patients in the five-second cohort with one-year follow-up. Freedom from atrial fibrillation measured by a 24-hour Holter monitor was 96%, while estimated freedom from recurrent atrial fibrillation, flutter or tachycardia was 90%. LaViolette said the European data could help inform expectations for the U.S. trial, although the company has not released the pivotal study’s results.

Manufacturing and partnership planning

Pulse is preparing to increase manufacturing capacity for the catheter and its console. LaViolette said the company uses more than one contract manufacturer for catheter supply and plans to manufacture consoles internally. It is also working on training, mapping-system integration and customer segmentation.

The preparations are intended to support either a direct launch or a partnership. Co-Chair Bob Duggan said a partnership with a larger company could help Pulse gain market share, but potential partners are looking for additional evidence. He said terms would be addressed later as appropriate.

Asked about safety, LaViolette said patients in the U.S. pivotal study received fluids before their procedures as a step to mitigate hemolysis, or red blood cell breakdown. He declined to disclose specific pivotal-study safety data. He also said the company plans a clinical comparison using biomarkers to investigate differences between nanosecond and microsecond PFA, without taking tissue samples from patients.

Surgical and thyroid programs advance

Pulse continues to enroll patients in NANOCLAMP-AF, a study of its surgical clamp for treating atrial fibrillation during cardiac surgery. LaViolette said the company remains on track to finish enrollment by the end of the first half of 2027 and expects a CE Mark for the clamp in the fourth quarter of that year.

The company also completed enrollment in its PRECISE-BTN study of Vybrance for symptomatic benign thyroid nodules. The study enrolled 100 patients, twice its original design. Preliminary data presented at the American Thyroid Association showed that 86% of patients achieved the primary endpoint of a greater than 50% reduction in nodule volume after a single treatment, LaViolette said. He also reported an average 78% improvement in the overall quality-of-life score at six months and no serious adverse events.

Additional results are expected in 2027 as patients complete follow-up. Pulse plans to use the study data to support a 510(k) submission for an on-label benign thyroid nodule indication. The Vybrance percutaneous electrode already has FDA clearance, according to the company.

Spending expected to rise

CFO Jon Skinner said third-quarter GAAP costs and expenses increased to $24.7 million from $20.5 million a year earlier, driven primarily by clinical investments and employee-related spending. The non-GAAP net loss rose to $17.5 million from $13.5 million.

Pulse raised $95.8 million through its at-the-market equity program during the quarter and more than $150 million in net proceeds since May. Skinner said approximately $64 million of capacity remained under the program, with cumulative 2026 dilution of less than 6%.

Operating cash use was $15.3 million in the third quarter, down from $18.7 million in the second quarter, primarily because of the timing of clinical-study payments. Skinner expects quarterly non-GAAP costs and expenses in coming quarters to run 15% to 25% above the approximately $20 million average for the second and third quarters, as Pulse funds further studies, manufacturing and pre-commercial work.

About Pulse Biosciences (NASDAQ:PLSE)

Pulse Biosciences, Inc NASDAQ: PLSE is a medical technology company developing bioelectric therapies based on its Nano-Pulse Stimulation (NPS) technology. The technology uses short, high-voltage electrical pulses to create temporary openings in cell membranes, with the goal of selectively affecting targeted cells while limiting thermal damage to surrounding tissue.

The company's principal product is the CellFX System, a device designed to deliver NPS treatments for certain dermatologic conditions.

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