PULSE BIOSCIENCES, INC. (PLSE): Results of Operations and Financial Condition
PULSE BIOSCIENCES, INC. (PLSE) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Pulse Biosciences Reports Business Updates and Second Quarter 2026 Financial Results HAYWARD, California [Business Wire] — August 6, 2026. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-P
How this was made
The 30-second read
Why it matters
Key disclosed items include cash raised under an ATM, updated enrollment status and protocol amendment for the NANOPULSE-AF pivotal trial, and progress toward CE Mark submissions. These details affect near-term financing expectations and the perceived probability of hitting clinical and regulatory milestones.
Market read
Traders get fresh, decision-relevant updates on pivotal trial enrollment pace, protocol qualification expansion, and cash runway via ATM financing, alongside updated loss and revenue figures.
What to watch
Cash balance rose via ATM, but the company also increased operating investment and remains loss-making, so future dilution risk could cap rallies even with clinical progress.
Pulse Biosciences reported $0.4 million of second-quarter revenue, advanced cardiac and soft-tissue clinical programs, and strengthened cash through ATM financing while operating losses and cash use increased.
Clinical enrollment and regulatory milestones advanced and the company raised capital, but revenue remained $0.4 million in a controlled commercial launch while GAAP costs and expenses, net loss, and operating cash use increased from the prior-year period.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenueGAAP | $0.4 million | – | – |
| Total GAAP costs and expensesGAAP | $25.7 million | – | an increase of $5.4 million |
| Non-GAAP costs and expensesnon-GAAP | $20.5 million | – | an increase of $5.7 million |
| Net lossGAAP | ($24.7) million | – | – |
| Net lossnon-GAAP | ($19.4) million | – | – |
| Cash used in operating activitiesGAAP | $18.7 million | – | – |
| Cash and cash equivalentsGAAP | $101.6 million | The sequential increase of $33.3 million | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| Soft Tissue AblationThe company remained in a controlled commercial launch focused on market development and growing procedural utilization within a limited customer base. | $434 thousand | sequential growth over the first quarter | – |
Second half of 2026 and 2027 outlook
- NoteNANOPULSE-AF enrollment completion target of early Q4.
- NoteProgress toward a CE Mark submission in the second half of 2026 for the nPulse Cardiac Catheter System, with potential approval anticipated by the middle of 2027.
- NoteNANOCLAMP-AF enrollment expected to be completed by the end of the first half of 2027.
- NoteCE Mark filing for the nPulse Cardiac Surgical System before the end of 2026, with potential approval anticipated by the middle of 2027.
- NotePRECISE-Benign Thyroid Nodule study expected to complete enrollment within the month.
- NotePTMC feasibility-study enrollment expected to be completed by year-end 2026.
- NoteProgress toward Clayman Thyroid Center partnership objectives to be reported in Q4.
What drove it
- NANOPULSE-AF exceeded 82 evaluable patients and surpassed the halfway point of enrollment.
- The NANOPULSE-AF protocol amendment expanded the total evaluable patient target by 19 patients to 164 and broadened qualification to patients on all four classes of anti-arrhythmic drugs.
- The nPulse Cardiac Catheter System study had 12 active investigational sites.
- Multiple sites performed five or more cases in a single day, and multiple physicians completed cases with ablation times of 7–8 minutes or faster within their first several cases.
- NANOCLAMP-AF enrollment continued, while the European first-in-human feasibility study had treated over 70 patients to date across six sites.
- PRECISE-BTN expanded from its original 50-patient design to 100 patients.
Concerns
- The company remained in a controlled commercial launch and reported total revenue of $0.4 million.
- GAAP costs and expenses increased to $25.7 million from $20.3 million in the prior-year period, primarily due to clinical-program investment and compensation-related spending.
- GAAP net loss was ($24.7) million, compared with ($19.2) million in the prior-year period.
- Cash used in operating activities was $18.7 million, compared with $12.8 million in the same period in the prior year and $14.6 million in the first quarter of 2026.
- Key commercial, clinical, and regulatory milestones remain forward-looking, including CE Mark submissions and potential approvals.
What to watch
- Completion of NANOPULSE-AF enrollment targeted for early Q4.
- Progress toward the second-half 2026 CE Mark submission for the nPulse Cardiac Catheter System.
- Completion of PRECISE-BTN enrollment expected within the month and the company’s planned Q4 update on its Clayman Thyroid Center partnership objectives.
- CE Mark filing for the nPulse Cardiac Surgical System before the end of 2026.
- PTMC feasibility-study enrollment completion expected by year-end 2026.
- Use of the new $75 million ATM facility and the effective shelf registration statement for up to an additional $125 million.
Balance sheet and cash flow
- Cash and cash equivalents totaled $101.6 million as of June 30, 2026.
- During Q2 the Company raised $46.8 million in net proceeds through an at-the-market (ATM) program.
- Subsequent to the close of Q2, the Company raised an additional $10.7 million in net proceeds through the ATM and $1.8 million in gross proceeds from the exercise of warrants.
- Cash used in operating activities in the second quarter of 2026 totaled $18.7 million.
- The Company has since put a new $75 million ATM facility in place and continues to maintain an effective shelf registration statement for up to an additional $125 million.
Analysis
Pulse Biosciences reported $0.4 million of total revenue for the three months ended June 30, 2026, while remaining in a controlled commercial launch focused on market development. Soft Tissue Ablation generated $434 thousand of second-quarter revenue, which the company said represented sequential growth over the first quarter. The company is concentrating on growing procedural utilization within a limited customer base based on strong clinical results.
The principal operating progress was in the endocardial catheter program. NANOPULSE-AF exceeded 82 evaluable patients, surpassing the halfway point of enrollment. The protocol amendment broadened eligibility across all four classes of anti-arrhythmic drugs and increased the evaluable-patient target by 19 patients to 164, while management reiterated its early-Q4 enrollment-completion target. The program had 12 active investigational sites, and the company described rapid procedure throughput and ablation times of 7–8 minutes or faster at multiple physicians' initial cases.
Expenses and losses rose as the company invested in clinical and product-development programs. Total GAAP costs and expenses were $25.7 million, compared with $20.3 million in the prior-year period, and non-GAAP costs and expenses were $20.5 million, compared with $14.8 million. GAAP net loss was ($24.7) million versus ($19.2) million, while non-GAAP net loss was ($19.4) million versus ($13.7) million. Cash used in operating activities increased to $18.7 million from $12.8 million in the prior-year period and $14.6 million in the first quarter of 2026.
The balance sheet was reinforced through financing. Cash and cash equivalents were $101.6 million at June 30, 2026, compared with $68.3 million at March 31, 2026, and the company attributed the sequential increase of $33.3 million to ATM-program net proceeds raised during the quarter. It raised $46.8 million in net proceeds under the ATM during the quarter, followed by $10.7 million in net proceeds after quarter-end and $1.8 million in gross warrant-exercise proceeds. The company also established a new $75 million ATM facility and retained an effective shelf registration statement for up to an additional $125 million.
Forward milestones center on clinical enrollment and CE Mark activity rather than financial guidance. The company targets a catheter-system CE Mark submission in the second half of 2026 and potential approval by the middle of 2027. It expects a surgical-system CE Mark filing before the end of 2026, NANOCLAMP-AF enrollment completion by the end of the first half of 2027, PRECISE-BTN enrollment completion within the month, and PTMC-study enrollment completion by year-end 2026. These milestones, together with commercial utilization in the limited Soft Tissue Ablation launch and continuing cash consumption, are the key reported items for the next periods.
Management, verbatim
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
We have recently surpassed the halfway point of enrollment in our U.S. pivotal NANOPULSE-AF study, and even after expanding the enrollment target by 19 patients, we continue to anticipate completing enrollment by early Q4.
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences
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
Not in the filing
stated, not guessed- Revenue prior-year comparison
- Revenue prior-quarter comparison
- Revenue year-over-year change
- Revenue quarter-over-quarter percentage change
- Gross profit
- Gross margin
- Operating income or loss
- Research and development expense
- Selling, general and administrative expense
- Cost of product revenue
- GAAP earnings or loss per share
- Non-GAAP earnings or loss per share
- Weighted-average shares outstanding
- Free cash flow
- Debt balance
- Repurchases
- Dividends
- Financial revenue guidance
- Gross-margin guidance
- Operating-expense guidance
- Tax-rate guidance
- Prior outlook for comparison
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
This is an SEC 8-K with an attached press release covering Q2 2026 business updates and financial results for Pulse Biosciences.
Ticker impact
Pulse Biosciences reported Q2 2026 results and said NANOPULSE-AF enrollment is past 82 evaluable patients, targeting early Q4 completion.
Near-term bias modestly positive, with volatility tied to ongoing enrollment pace and future financing needs.
The filing discloses concrete enrollment metrics, protocol amendment expanding qualifying AAD classes, and cash raised under an ATM, all of which can move biotech risk perception. However, it also reiterates ongoing GAAP and non-GAAP net losses, limiting upside conviction.
Market effects
Reinforces investor focus on procedural adoption and regulatory timelines for cardiac ablation platforms using pulsed field ablation.
Limited direct regional impact; primarily US clinical execution with CE Mark pathway.
CE Mark submission and potential mid-2027 approval timing keep European regulatory milestones in traders’ radar.
Counterpoint
Enrollment momentum may not translate into faster regulatory approval; protocol changes and expanded targets can also increase variability in outcomes.
Key entities
- issuerPulse Biosciences, Inc.
Nasdaq-listed company developing nanosecond pulsed field ablation systems; subject of the 8-K and press release.
- clinical_programNANOPULSE-AF
U.S. IDE pivotal study for the nPulse Cardiac Catheter System; enrollment and protocol qualification criteria were updated.
- partnerClayman Thyroid Center
Named partnership site for demonstrating Vybrance system therapy viability for benign thyroid nodules.
- collaboratorMD Anderson Cancer Center
Named collaboration for first-in-human feasibility in papillary thyroid microcarcinoma.
