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Pulse Biosciences, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 19 February 2026: press release. Guidance figures: 3 new. The quarter’s numbers.

Key takeaways

  • Q4 revenue rose to $264 thousand: Revenue was $264 thousand in the fourth quarter, including nPulse capital and Vybrance disposables sales, compared with $86 thousand in the third quarter of 2025. Source
  • Full-year GAAP net loss widened: The GAAP net loss for 2025 was $72.8 million, against $53.6 million in 2024. Net loss per share was $(1.08), against $(0.92). Source
  • Full-year costs rose on build-out: GAAP costs and expenses were $77.3 million for 2025, up $21.0 million, driven by the expanding organization for nsPFA clinical trials and commercialization. Source
  • Pivotal endocardial AF study approved: The FDA approved a pivotal IDE study for paroxysmal AF using the nPulse Cardiac Catheter System in Q4 2025. Source
  • Feasibility procedural success reported: In the first-in-human feasibility study, evaluable patients showed 100% procedural success at six months and 96% at one year, freedom from AF, per the company. Source
  • Cash fell to $80.7 million: Cash and cash equivalents were $80.7 million at December 31, 2025, down from $118.0 million a year earlier and $95.2 million at September 30, 2025. Source

“2025 was a highly productive year for Pulse Biosciences as we achieved notable milestones in each of our market development programs.”

Paul LaViolette, CEO of Pulse Biosciences

Guidance

AreaPeriodFigureAgainst last quarter
Endocardial pivotal study enrollment SourceNext few months to Q4 2026First patient in the next few months; last patient in Q4 2026New
Thyroid nodule study (PRECISE-BTN) enrollment SourceNext few months, then the two quarters after50 patients, then 100 patientsNew
Surgical AF pivotal study (NANOCLAMP AF) enrollment Source2026Enrollment completion in 2026New

What changed from last quarter

  • New: FDA approval for the endocardial pivotal study was received in Q4 2025. The prior release reported the IDE application as submitted, with a study start planned for Q1 2026. Source
  • New: The company initiated a research collaboration with the University of Texas MD Anderson Cancer Center on nsPFA for benign and malignant thyroid tumors. The prior release did not mention it. Source
  • New guidance: A target of 50 enrolled patients, then 100, was given for the PRECISE-BTN thyroid study. The prior release gave no such enrollment target. Source

Revenue and net loss

  • Q4 revenue rose to $264 thousand: Revenue was $264 thousand in the fourth quarter, including nPulse capital and Vybrance disposables sales, compared with $86 thousand in the third quarter of 2025. Source
  • Full-year revenue reached $350 thousand: Full-year 2025 revenue was $350 thousand, with cost of product revenue of $539 thousand for the year. Source
  • Full-year GAAP net loss widened: The GAAP net loss for 2025 was $72.8 million, against $53.6 million in 2024. Net loss per share was $(1.08), against $(0.92). Source
  • Fourth-quarter net loss narrowed: The GAAP net loss for the fourth quarter was $17.4 million, against $19.4 million a year earlier. The non-GAAP net loss was $12.2 million, against $10.4 million. Source

Operating costs

  • Full-year costs rose on build-out: GAAP costs and expenses were $77.3 million for 2025, up $21.0 million, driven by the expanding organization for nsPFA clinical trials and commercialization. Source
  • Fourth-quarter costs fell on prior-year items: Fourth-quarter GAAP costs were $18.5 million, down $1.7 million, as prior-year legal and severance costs did not recur, partly offset by organization expansion. Source
  • Non-GAAP quarterly costs rose: Non-GAAP costs and expenses for the fourth quarter were $13.3 million, up $2.0 million from $11.3 million a year earlier. Source

“I am thrilled in particular with the compelling clinical evidence being developed by our programs, especially the best-in-class procedural success rates treating paroxysmal AF from our large feasibility study.”

Paul LaViolette, CEO of Pulse Biosciences

Endocardial AF program

  • Pivotal endocardial AF study approved: The FDA approved a pivotal IDE study for paroxysmal AF using the nPulse Cardiac Catheter System in Q4 2025. Source
  • Feasibility procedural success reported: In the first-in-human feasibility study, evaluable patients showed 100% procedural success at six months and 96% at one year, freedom from AF, per the company. Source
  • Pivotal first patient expected soon: The first pivotal patient is expected to be enrolled in the next few months, and the last in Q4 2026. Source

Surgical AF program

  • NANOCLAMP AF enrollment continues: Enrollment continues in the NANOCLAMP AF pivotal study, described as the first PFA study approved by the FDA for a surgical cardiac ablation device in concomitant procedures. Source
  • Site activation expanding for 2026: The company is expanding and accelerating IDE site activation to support completion of enrollment in 2026. Source
  • European surgical feasibility treated 44 patients: As of the third-quarter release, the European surgical feasibility study had treated 44 patients, with follow-up remapping procedures reported as indicating positive clinical outcomes.

“Our focus in 2026 is on clinical trial execution, including completing pivotal enrollment in both cardiac programs.”

Paul LaViolette, CEO of Pulse Biosciences

Soft tissue and thyroid

  • Soft tissue launch generated $264 thousand: Soft tissue ablation generated $264 thousand of revenue in what the company described as a highly controlled commercial launch. Source
  • PRECISE-BTN enrollment continuing: Enrollment continues in PRECISE-BTN, a study of benign thyroid nodules treated with the nPulse Vybrance percutaneous electrode system. Source
  • MD Anderson thyroid collaboration started: The company initiated a research collaboration with MD Anderson Cancer Center to evaluate nsPFA for benign and malignant thyroid tumors. Source

Cash and share count

  • Cash fell to $80.7 million: Cash and cash equivalents were $80.7 million at December 31, 2025, down from $118.0 million a year earlier and $95.2 million at September 30, 2025. Source
  • Operating cash use rose in quarter: Cash used in operating activities was $14.8 million in the fourth quarter, against $9.1 million a year earlier and $13.0 million in the third quarter. Source
  • Shares outstanding rose year over year: Shares issued and outstanding were 67,839,689 at December 31, 2025, up from 65,925,503 a year earlier. Source

Coming up, as management said on 19 February 2026

  • First endocardial pivotal patient enrolled: The first patient in the paroxysmal AF pivotal study is expected to be enrolled in the next few months, with the last patient expected in Q4 2026. Source
  • PRECISE-BTN enrollment milestones: The company plans to complete enrollment of 50 patients in the next few months, then expand enrollment to 100 patients over the following two quarters. Source
  • Surgical enrollment completion in 2026: The company expects to complete enrollment in the NANOCLAMP AF surgical pivotal study in 2026, through expanded IDE site activation. Source

Earlier plans management reported on

  • Not stated: The prior release planned to commence the IDE study in Q1 2026. The current release reports FDA approval received in Q4 2025, without a status against the earlier plan.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.