Pulse Biosciences, Inc.: Q2 FY2026 earnings call
What management said about Q2 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 1 raised, 1 new, 3 kept. The quarter’s numbers.
Key takeaways
- Revenue small in controlled launch: Total revenue was $0.4 million. The company remains in a controlled commercial launch focused on market development. Source
- Net loss widened year over year: GAAP net loss was $24.7 million, against $19.2 million a year earlier. Non-GAAP net loss was $19.4 million, against $13.7 million. Source
- Enrollment passed halfway point: NANOPULSE-AF, the US IDE pivotal study of the nPulse Cardiac Catheter System, passed the halfway point of enrollment. Source
- Protocol widened to all AAD classes: Protocol amendment lifts the prior restriction on AAD class of failure. Patients on all four AAD classes now qualify, reflecting real-world patient management. Source
- GAAP costs rose on clinical spend: GAAP costs and expenses were $25.7 million, up $5.4 million from $20.3 million a year earlier. Source
- Cash rose to $101.6 million: Cash and equivalents were $101.6 million at June 30, up $33.3 million from March 31, which management attributes to ATM net proceeds. Source
- ATM raised $46.8 million in quarter: $46.8 million in net ATM proceeds were raised in the quarter, about $13 million from insiders, plus $10.7 million after quarter end. Source
- New $75 million ATM facility: A new $75 million ATM facility was put in place, with an effective shelf for up to a further $125 million, providing flexibility through milestones ahead. Source
“This was a highly productive quarter for Pulse Biosciences, defined by exceptional momentum in our cardiac catheter program,”
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| NANOPULSE-AF evaluable patient target Source | NANOPULSE-AF enrollment | 164 evaluable patients | Raised |
| NANOPULSE-AF enrollment completion Source | Q4 2026 | early Q4 | Kept |
| CE Mark submission, endocardial catheter Source | second half of 2026, approval mid-2027 | submission in second half of 2026; potential approval by middle of 2027 | |
| CE Mark filing, surgical system Source | before end of 2026, approval mid-2027 | filing before the end of 2026; potential approval by middle of 2027 | |
| NANOCLAMP-AF enrollment completion Source | end of first half of 2027 | end of the first half of 2027 | Kept |
| PTMC feasibility enrollment Source | year-end 2026 | up to 30 patients; enrollment completed by year-end 2026 | Kept |
| Clayman partnership progress Source | Q4 2026 | Q4 | New |
What changed from last quarter
- Guidance raised: Evaluable patient target for NANOPULSE-AF raised by 19 patients to 164 following the protocol amendment. Source
- New: NANOPULSE-AF protocol amended to lift the prior restriction on the class of anti-arrhythmic drug failure required for qualification. Source
- New: Partnership announced with the Clayman Thyroid Center in Tampa, Florida, to demonstrate Vybrance therapy for benign thyroid nodules. Source
- New: New $75 million ATM facility put in place after quarter end. Source
Results and revenue launch
- Revenue small in controlled launch: Total revenue was $0.4 million. The company remains in a controlled commercial launch focused on market development. Source
- Product revenue grew sequentially: Second-quarter product revenue of $434 thousand grew sequentially over the first quarter, which reported $401 thousand. Source
- Focus on procedural use: Management said the company is focused on growing procedural utilization within a limited customer base. Source
- Net loss widened year over year: GAAP net loss was $24.7 million, against $19.2 million a year earlier. Non-GAAP net loss was $19.4 million, against $13.7 million. Source
Endocardial AF catheter program
- Enrollment passed halfway point: NANOPULSE-AF, the US IDE pivotal study of the nPulse Cardiac Catheter System, passed the halfway point of enrollment. Source
- Protocol widened to all AAD classes: Protocol amendment lifts the prior restriction on AAD class of failure. Patients on all four AAD classes now qualify, reflecting real-world patient management. Source
- Rapid procedures reported across operators: Management observed rapid, efficient procedures; several sites performed five or more cases in a day, and some physicians reached 7 - 8 minute ablation times early. Source
- CE Mark submission targeted 2026: CE Mark submission for the cardiac catheter is targeted for second half of 2026, supported by six-month European feasibility data. Source
“Together with a meaningfully strengthened balance sheet, we are well positioned to advance the clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally.”
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences
Surgical AF ablation program
- NANOCLAMP-AF enrolling toward 2027: Enrollment continues in the US IDE pivotal study for concomitant surgical AF ablation, expected to complete by end of first half of 2027. Source
- European feasibility passes 70 patients: Over 70 patients treated across six sites in the first-in-human European feasibility study, up from over 60 across three sites earlier. Source
- Surgical CE Mark filing on schedule: Management said it remains on schedule to file for CE Mark for the surgical system before end of 2026, with approval potentially by mid-2027. Source
Soft tissue ablation programs
- Thyroid partnership with Clayman Center: Partnership with the Clayman Thyroid Center in Tampa aims to demonstrate Vybrance therapy for symptomatic benign thyroid nodules. Source
- Benign nodule study nearing enrollment end: PRECISE-BTN enrollment expected to complete within the month, after expansion from 50 to 100 patients. Trial completion projected across three sites in under one year. Source
- PTMC study about half enrolled: The nsPFA feasibility study for papillary thyroid microcarcinoma, run with MD Anderson, is about half enrolled; physicians remain enthusiastic. Source
“The catheter’s ease of use, seamless workflow integration and its demonstrated safety and durability outcomes are driving rapid progress in the study.”
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences
Costs and loss per share
- GAAP costs rose on clinical spend: GAAP costs and expenses were $25.7 million, up $5.4 million from $20.3 million a year earlier. Source
- Clinical and compensation drove increase: Management attributed the increase mainly to clinical program investment and compensation-related spend supporting clinical and product development. Source
- Non-GAAP research spend higher: Non-GAAP research and development was $14.4 million, against $9.7 million a year earlier. Non-GAAP SG&A was $5.8 million, against $5.1 million. Source
- Loss per share rose to $0.36: Net loss per share, basic and diluted, was $0.36 against $0.28 a year earlier. Weighted average shares rose to 69.2 million from 67.3 million. Source
Cash, financing and share count
- Cash rose to $101.6 million: Cash and equivalents were $101.6 million at June 30, up $33.3 million from March 31, which management attributes to ATM net proceeds. Source
- ATM raised $46.8 million in quarter: $46.8 million in net ATM proceeds were raised in the quarter, about $13 million from insiders, plus $10.7 million after quarter end. Source
- Warrant exercises added after quarter: After quarter end, warrant exercises brought $1.8 million in gross proceeds, in addition to the ATM proceeds. Source
- Operating cash use $18.7 million: Cash used in operating activities was $18.7 million in the quarter, against $12.8 million a year earlier and $14.6 million in the first quarter. Source
- New $75 million ATM facility: A new $75 million ATM facility was put in place, with an effective shelf for up to a further $125 million, providing flexibility through milestones ahead. Source
- Shares outstanding rose: Shares outstanding were 70,799,962 at June 30, 2026, against 67,839,689 at December 31, 2025. Source
Management view and strategic focus
- CEO cites cardiac catheter momentum: CEO Paul LaViolette described the quarter as highly productive, defined by momentum in the cardiac catheter program. Source
- Balance sheet tied to milestones: CEO linked the strengthened balance sheet to upcoming clinical and regulatory milestones. Source
- Ease of use cited for study pace: CEO attributed progress in the pivotal study to the catheter’s ease of use, workflow integration, and safety and durability outcomes. Source
Coming up, as management said on 6 August 2026
- NANOPULSE-AF enrollment completion: Enrollment completion targeted for early Q4 2026, three months earlier than the original timeline. Source
- Cardiac CE Mark submission: CE Mark submission for the cardiac catheter targeted for second half of 2026. Source
- Surgical CE Mark filing: CE Mark filing for the surgical system before end of 2026. Source
- PRECISE-BTN enrollment completion: Enrollment in the benign thyroid nodule study expected to complete within the month. Source
- NANOCLAMP-AF enrollment completion: Enrollment in the surgical pivotal study expected to complete by end of first half of 2027. Source
- PTMC enrollment completion: Enrollment in the papillary thyroid microcarcinoma study expected to complete by year-end 2026. Source
- Clayman partnership progress report: Management plans to report progress on partnership objectives in Q4. Source
Figures management reported
| Figure | Reported |
|---|---|
| NANOPULSE-AF evaluable patients enrolled Source | exceeding 82 |
| Active investigational sites Source | 12 |
| Patients treated, surgical feasibility study Source | over 70 across six sites |
Earlier plans management reported on
- Ahead: Management reiterated the early Q4 enrollment target, which it describes as three months earlier than the original timeline. Source
- On track: Management said the company remains on schedule to file for CE Mark for the surgical system before end of 2026. Source
- Not stated: Management said it continues to progress toward CE Mark submission for the cardiac catheter in second half of 2026. 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.