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Pulse Biosciences, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 lowered, 4 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose to $0.4 million: The company reported third quarter revenue of $0.4 million, compared with $0.1 million in the prior year period, with Vybrance accounting for the revenue. Source
  • GAAP net loss was $23.1 million: GAAP net loss for the quarter was $23.1 million, compared with $19.4 million a year earlier. Source
  • NANOPULSE-AF enrollment completed: Enrollment in the U.S. pivotal NANOPULSE-AF study of the nPulse Cardiac Catheter System was completed with 169 evaluable patients at 15 sites and 36 investigators. Source
  • Vybrance controlled launch continues: The company remains in a controlled commercial launch of Vybrance, directing efforts toward market development and clinical use within a limited customer base. Source
  • GAAP costs rose $4.2 million: GAAP costs and expenses rose on higher clinical program and employee-related spend, per management. Source
  • Cash position rose to $189.2M: Cash, cash equivalents and marketable securities totaled $189.2 million at September 30, 2026, up from $101.6 million at June 30, 2026. Source
  • ATM programs raised $95.8 million: The company raised $95.8 million net through its ATM programs in the quarter, more than $150 million since May, with under 6% dilution. Source
  • CE Mark approval now Q4 2027: Anticipated CE Mark approval is Q4 2027. The prior release had said approval was anticipated by the middle of 2027. Source

“led by completing enrollment in our U.S. pivotal IDE study in just six months, three months ahead of plan,”

Paul LaViolette, CEO and Co Chairman of Pulse Biosciences

Guidance

AreaPeriodFigureAgainst last quarter
Vybrance commercial launch SourceThrough Q4 2027continue into Q4 2027New
CE Mark approval, nPulse Cardiac Catheter System SourceQ4 2027Q4 2027Lowered from middle of 2027
EU feasibility study, 12-month data SourceQ1 2027Q1 2027New
Persistent AF IDE application SourceQ4 2026fourth quarter of 2026New
NANOCLAMP-AF enrollment completion SourceEnd of first half of 2027end of the first half of 2027Kept
Interest income on cash and securities SourceAnnual, at current balanceover $7.5 millionNew

What changed from last quarter

  • Guidance lowered: CE Mark approval timing moved from the middle of 2027 to Q4 2027. Source
  • New guidance: Controlled Vybrance launch phase now given an end point of Q4 2027. Source
  • New guidance: Twelve-month EU feasibility data timing given as Q1 2027. Source
  • New: Plan to file an IDE application for a persistent AF study, extending the catheter to larger and more complex patient groups. Source
  • Ended: NANOPULSE-AF enrollment phase closed; the prior release had targeted early Q4 2026 completion. Source
  • Guidance kept: NANOCLAMP-AF enrollment completion target of end of first half 2027 is unchanged. Source

Results and revenue

  • Revenue rose to $0.4 million: The company reported third quarter revenue of $0.4 million, compared with $0.1 million in the prior year period, with Vybrance accounting for the revenue. Source
  • GAAP net loss was $23.1 million: GAAP net loss for the quarter was $23.1 million, compared with $19.4 million a year earlier. Source
  • Non-GAAP net loss was $17.5 million: Non-GAAP net loss was $17.5 million, compared with $13.5 million a year earlier. Non-GAAP figures exclude stock-based compensation, depreciation and amortization. Source

Clinical programs and enrollment

  • NANOPULSE-AF enrollment completed: Enrollment in the U.S. pivotal NANOPULSE-AF study of the nPulse Cardiac Catheter System was completed with 169 evaluable patients at 15 sites and 36 investigators. Source
  • NANOCLAMP-AF enrollment continues: Enrollment in NANOCLAMP-AF, the surgical AF ablation pivotal study, continues. The first enrolled patient has reached one-year follow-up. Source
  • PRECISE-BTN enrollment completed: PRECISE-BTN completed enrollment in September with 100 patients. Preliminary data are being presented at the American Thyroid Association annual meeting. Source
  • Thyroid readouts follow patient follow-up: Further PRECISE-BTN data readouts are expected after all patients reach six-month and twelve-month follow-up. Source

“That speed reflects the growing enthusiasm physicians have shown for the nPulse catheter since their very first cases.”

Paul LaViolette, CEO and Co Chairman of Pulse Biosciences

Vybrance commercial launch

  • Vybrance controlled launch continues: The company remains in a controlled commercial launch of Vybrance, directing efforts toward market development and clinical use within a limited customer base. Source
  • Case volume rose from prior quarters: Management said Vybrance commercial case volume increased from prior quarters, and that milestones focused on developing existing accounts were achieved. Source
  • Launch phase expected into 2027: Management expects the current launch phase to continue into Q4 2027. Source

Costs and losses

  • GAAP costs rose $4.2 million: GAAP costs and expenses rose on higher clinical program and employee-related spend, per management. Source
  • Non-GAAP costs rose $4.5 million: Non-GAAP costs and expenses were $19.1 million, up from $14.6 million, also driven by clinical program and employee-related spend. Source
  • GAAP costs totaled $24.7 million: Total GAAP costs and expenses for the quarter were $24.7 million, against $20.5 million a year earlier. Source

“With NANOPULSE-AF fully enrolled, and the capital to execute, we are now focused on preparations for launch readiness, additional data readouts, and regulatory submissions.”

Paul LaViolette, CEO and Co Chairman of Pulse Biosciences

Cash, financing and dilution

  • Cash position rose to $189.2M: Cash, cash equivalents and marketable securities totaled $189.2 million at September 30, 2026, up from $101.6 million at June 30, 2026. Source
  • ATM programs raised $95.8 million: The company raised $95.8 million net through its ATM programs in the quarter, more than $150 million since May, with under 6% dilution. Source
  • Operating cash use was $15.3 million: Cash used in operating activities was $15.3 million, compared with $13.0 million a year earlier and $18.7 million in the second quarter of 2026. Source
  • About $64 million ATM capacity left: Approximately $64 million of ATM capacity remains available, according to the release. Source
  • Interest income cited at $7.5M: Based on current yields and the current balance, the company cites over $7.5 million of annual interest income. Source

Regulatory timing and new studies

  • CE Mark approval now Q4 2027: Anticipated CE Mark approval is Q4 2027. The prior release had said approval was anticipated by the middle of 2027. Source
  • Persistent AF IDE planned for Q4: Management plans an IDE application for a persistent AF study in Q4 2026, extending the platform to more complex patient groups. Source
  • EU 12-month data planned for Q1 2027: Twelve-month follow-up data on 100 patients from the EU feasibility study are planned for presentation in Q1 2027. Source

Coming up, as management said on 5 November 2026

  • Persistent AF IDE application: Management plans to submit an IDE application for a persistent AF study in Q4 2026. Source
  • EU 12-month data presentation: Twelve-month follow-up data on 100 EU feasibility patients are planned for presentation in Q1 2027. Source
  • CE Mark approval anticipated: Anticipated CE Mark approval for the endocardial catheter is Q4 2027. Source
  • NANOCLAMP-AF enrollment completion: NANOCLAMP-AF enrollment is expected to complete by the end of the first half of 2027. Source
  • Vybrance launch phase continues: The current Vybrance controlled launch phase is expected to continue into Q4 2027. Source
  • PRECISE-BTN further readouts: Further PRECISE-BTN data readouts are expected after six-month and twelve-month follow-up of all patients. Source

Figures management reported

FigureReported
NANOPULSE-AF evaluable patients enrolled Source169 at 15 sites with 36 investigators
PRECISE-BTN patients enrolled Source100
Vybrance revenue, third quarter Source$0.4 million

Earlier plans management reported on

  • Ahead: Enrollment completed three months faster than the timeline originally communicated, against the prior early Q4 2026 target. Source
  • On track: Management states the NANOCLAMP-AF study remains on track for enrollment completion by the end of the first half of 2027. Source
  • Not stated: Prior release anticipated approval by the middle of 2027; this release gives Q4 2027 without a status term. Source
  • Not stated: Prior release expected enrollment completion within the month; this release reports completion in September with 100 patients. Source

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.