Summary of Pulse Biosciences FY Conference Call Company Overview - **Company**: Pulse Biosciences (NasdaqCM:PLSE) - **Industry**: Medical Devices, specifically focusing on electrophysiology (EP) and atrial fibrillation (AF) treatment Key Points and Arguments Clinical Data and Product Efficacy - Pulse Biosciences presented data on the NS 360 catheter, achieving 100% efficacy in rhythm control at 6 months and 96% at 12 months, with 90% freedom from all atrial arrhythmias at 12 months [4][5][6] - The company attributes its success to the use of nanosecond pulsed field ablation (PFA), which allows for a more efficient energy delivery and a contiguous lesion creation, leading to deeper and higher quality lesions compared to traditional methods [6][7][10] - The total energy delivered by Pulse's system is lower than that of competitors, yet it achieves better outcomes due to the efficiency of energy penetration into tissue [10][11][12] Integration with Mapping Systems - The integration of mapping systems in the EFS study was noted as suboptimal, but improvements are expected in future studies with higher fidelity registration [13][19][20] - The company anticipates that better integration with mapping systems will enhance procedural efficiency and potentially improve outcomes, although achieving higher efficacy than 96% may be challenging [20][21] IDE Study and Enrollment - Pulse Biosciences has received IDE approval for a study involving 155 patients, targeting paroxysmal AF, with enrollment expected to begin in Q2 2026 [23][24] - The study is designed to be efficient, with the potential for multiple patients to be enrolled per site per day, which is expected to accelerate the enrollment process [25][30] Strategic Direction and Market Position - The company is focusing on the EP market, which is seen as highly attractive due to its growth potential [35][36] - Pulse Biosciences plans to pursue partnerships rather than building a complete organization independently, as this is viewed as a more efficient strategy to leverage their disruptive technology [37][38] - The company is positioned to combine its unique energy technology with mapping systems to capture significant market share in the coming years [38][39] Financial Outlook and Cash Management - As of the end of 2025, Pulse Biosciences had $80 million in cash, with additional funding options available through a $60 million ATM and a $200 million shelf registration [45] - The company expects an increase in cash burn throughout 2026, primarily due to the costs associated with the IDE studies [47][48] Conclusion - Pulse Biosciences is poised for significant advancements in the EP market with its innovative catheter technology and strong clinical data. The focus on strategic partnerships and efficient enrollment in clinical studies is expected to drive growth and enhance shareholder value moving forward [41][42][46]

Summary of Pulse Biosciences FY Conference Call (March 04, 2026) Company Overview - **Company**: Pulse Biosciences (NasdaqCM:PLSE) - **CEO**: Paul LaViolette, with over 45 years in med tech, joined Pulse Biosciences after being impressed by its technology [2][3] Key Industry Insights - **Technology Focus**: Pulse Biosciences is centered on Nanosecond Pulsed Field Ablation (NSPFA), a novel technology aimed at improving clinical outcomes in various applications, particularly in electrophysiology (EP) [4][10] - **Market Potential**: The ablation catheter market is estimated at $3 billion to $3.5 billion, growing at 15%-20% annually, with significant opportunities in treating atrial fibrillation (AFib) [27] Financial Highlights - **Cash Position**: The company ended the previous year with $80 million in cash, sufficient to fund clinical trials through 2026 and into 2027 [6] - **Quarterly Burn Rate**: Currently at approximately $15 million, expected to increase as clinical trials ramp up [7] Clinical Developments - **Atrial Fibrillation (AFib)**: AFib is the most common arrhythmia, with nearly 2 million patients diagnosed annually. The company aims to revolutionize AFib treatment with its NSPFA technology [12][13] - **Clinical Data**: Recent studies show 100% clinical success at 6 months and 96% at 12 months for patients treated with NSPFA, which is unprecedented in the field [18][19] - **Workflow Efficiency**: The NSPFA procedure can achieve full pulmonary vein isolation in as little as 5 minutes, significantly faster than current methods [14][17] Technology and Innovation - **Unique Mechanism**: NSPFA operates with pulse durations in billionths of a second, which is 1,000-fold shorter than conventional systems, leading to more efficient energy delivery and reduced thermal damage [9][10] - **Intellectual Property**: The company holds a robust patent portfolio of 250 patents, covering various aspects of NSPFA technology, creating significant barriers for competitors [11][26] Future Plans - **Clinical Trials**: The company is set to commence IDE enrollment for its EP catheter in the U.S. and is also advancing a cardiac surgery program that has received FDA Breakthrough designation [22][25] - **Expansion into Oncology**: Plans to initiate clinical studies for treating papillary thyroid microcarcinoma, showcasing the versatility of NSPFA technology [24] Additional Insights - **Regulatory Focus**: The company is investing in data, regulatory approvals, and reimbursement strategies to support market development [23] - **Investigator Enthusiasm**: Positive feedback from the electrophysiology community following recent data presentations indicates growing interest and optimism about the technology [42][43] Conclusion - **Strategic Vision**: Pulse Biosciences is positioned to lead in the NSPFA market with a strong focus on clinical evidence, regulatory advancements, and innovative technology development, aiming to significantly impact the treatment landscape for AFib and beyond [26][27]

Financial Performance - Pulse Biosciences reported a quarterly loss of $0.26 per share, better than the Zacks Consensus Estimate of a loss of $0.32, representing an earnings surprise of +18.75% [1] - The company posted revenues of $0.26 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 5.60%, compared to zero revenues a year ago [2] - The current consensus EPS estimate for the upcoming quarter is -$0.37 on $0.5 million in revenues, and for the current fiscal year, it is -$1.66 on $3.75 million in revenues [7] Stock Performance - Pulse Biosciences shares have increased by approximately 85.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 0.5% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Instruments industry, to which Pulse Biosciences belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor decisions [5]

Pulse Biosciences (NasdaqCM:PLSE) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Company ParticipantsAnthony Petrone - Managing Director Equity ResearchJon Skinner - CFOPaul LaViolette - Co-Chair and CEORobert Duggan - Co-ChairTrip Taylor - Principal of Investor RelationsNone - ShareholderConference Call ParticipantsJosh Jennings - Managing Director and Senior AnalystSuraj Kalia - Managing Director and Senior AnalystOperatorLadies and gentlemen, thank you for standing by. My name is Colby, and I'll be ...

Financial Data and Key Metrics Changes - In Q4 2025, total revenue was $264,000, up from $86,000 in Q3 2025, driven by both capital and disposable devices [24] - GAAP net loss in Q4 2025 was $17.4 million, compared to $19.4 million in the prior year period [25] - Cash and cash equivalents totaled $80.7 million as of December 31, 2025, down from $118 million as of December 31, 2024 [26] Business Line Data and Key Metrics Changes - The nPulse cardiac catheter achieved a 96% procedural success rate at 1 year and 90% freedom from atrial arrhythmia at 12 months [38][40] - Revenue from Vibrance systems and electrodes in Q4 was $264,000, an increase compared to Q3 [19] Market Data and Key Metrics Changes - The company is focused on expanding its presence in the European market, generating robust datasets from clinical studies [8] - The annual incidence of symptomatic benign thyroid nodules in the U.S. is approximately 250,000, translating to 150,000 surgeries annually, highlighting a significant market opportunity [19] Company Strategy and Development Direction - The company aims to transition the medical field towards nanosecond pulsed field ablation (nsPFA) technology, which offers precision and efficiency in treating diseases [4][5] - Plans for 2026 include completing enrollment in pivotal trials for the nPulse Cardiac Catheter and expanding the IDE program for the nPulse Cardiac Clamp [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical and commercial progress made in 2025 and early 2026, emphasizing the importance of data in driving future growth [7][9] - The company anticipates that achieving FDA therapeutic clearances will be essential for significant revenue growth [23] Other Important Information - The company added 67 issued and 77 pending patents in 2025, totaling 250 granted patents and 180 pending [5] - A research collaboration with the University of Texas MD Anderson Cancer Center aims to evaluate nsPFA for treating thyroid tumors, expanding the potential indications for the technology [21][22] Q&A Session Summary Question: Transition from limited release to broader release for Vibrance - Management indicated that the current focus is on market development and quality outcomes before scaling up commercialization [32][33] Question: Updated timelines for IDE study enrollment - Enrollment is expected to be completed in the next 1-2 months, with plans to expand the study for more robust data [36][37] Question: Reception of nPulse data from the AF Symposium - The reception has been exceptionally positive, with significant interest from physicians and stakeholders in the cardiovascular space [39][40] Question: Integration of nPulse with mapping systems - Management confirmed that improved software integration is expected in the IDE, which could enhance procedural accuracy and outcomes [50][51] Question: Spillover benefits from nClamp - There are expected synergies between nPulse and nClamp, with both technologies demonstrating strong safety and efficacy data [55][56]

Financial Data and Key Metrics Changes - In Q4 2025, total revenue was $264,000, up from $86,000 in Q3 2025, driven by both capital and disposable devices [23] - GAAP net loss for Q4 2025 was $17.4 million, compared to $19.4 million in the prior year period [24] - Cash and cash equivalents totaled $80.7 million as of December 31, 2025, down from $118 million as of December 31, 2024 [25] Business Line Data and Key Metrics Changes - The nPulse cardiac catheter achieved a 96% procedural success rate at 1 year and 90% freedom from atrial arrhythmia at 12 months [11][39] - Revenue from the Vibrance system and electrodes in Q4 was $264,000, an increase compared to Q3 [17] Market Data and Key Metrics Changes - The company is focused on expanding its presence in the electrophysiology market, particularly for atrial fibrillation, which is the most common arrhythmia [39] - The nPulse Vibrance system is being used to treat symptomatic benign thyroid nodules, with a significant annual incidence of 250,000 new diagnoses in the U.S. [17] Company Strategy and Development Direction - The company aims to transition the medical field towards nanosecond pulsed field ablation (nsPFA) technology, which offers precision and efficiency in treating diseases [4][5] - Plans for 2026 include completing enrollment in pivotal trials for the nPulse cardiac catheter and expanding the IDE program for the NanoClamp-AF surgical device [8][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical and commercial progress made in 2025 and early 2026, emphasizing the importance of data in driving future growth [6][32] - The company anticipates that achieving FDA therapeutic clearances will be essential for significant revenue growth [22] Other Important Information - The company added 67 issued and 77 pending patents in 2025, totaling 250 granted patents and 180 pending [5] - A research collaboration with the University of Texas MD Anderson Cancer Center is underway to evaluate the use of nsPFA for treating thyroid tumors [20] Q&A Session Summary Question: Transition from limited release to broader release for Vibrance - Management indicated that the current focus is on market development and quality outcomes before scaling up commercialization [31][33] Question: Enrollment timelines for the post-market surveillance study for thyroid - Enrollment is on track to be completed in the next few months, with plans to expand the study [34] Question: Reception of nPulse data from the AF Symposium - The reception has been exceptionally positive, with significant interest from physicians and stakeholders in the cardiovascular space [39] Question: Integration of nPulse with mapping systems - Management confirmed that improved software integration is expected in the IDE, which could enhance procedural accuracy [50] Question: Update on next-gen nPulse - The next-generation nPulse system is still in development, intended to integrate multiple ablation capabilities into one device [52] Question: Spillover benefits from nClamp - There are expected synergies between the nPulse and nClamp systems, reinforcing the potency of the ablation energy [53]

Revenue Performance - Total revenue for Q4 2025 was $264 thousand, a significant increase from $86 thousand in Q3 2025[3] - Full year 2025 total revenue reached $350 thousand, reflecting the company's ongoing commercial launch efforts[7] - Product revenue for Q4 2025 was $264 million, while total revenue for the year was $350 million[21] Net Loss and Financial Performance - GAAP net loss for Q4 2025 was ($17.4) million, an improvement from ($19.4) million in Q4 2024[5] - Full year 2025 GAAP net loss was ($72.8) million, compared to ($53.6) million in 2024, indicating increased investment in clinical trials and commercialization[9] - Net loss for Q4 2025 was $17,433 million, compared to a net loss of $19,385 million in Q4 2024, with a total net loss for the year of $72,781 million versus $53,585 million[21] - Non-GAAP net loss for Q4 2025 was $12,204 million, compared to $10,410 million in Q4 2024, with a total non-GAAP net loss for the year of $50,843 million versus $36,925 million[24] Costs and Expenses - Total GAAP costs and expenses for Q4 2025 were $18.5 million, down from $20.3 million in the prior year, primarily due to non-recurring costs[4] - Non-GAAP costs and expenses for Q4 2025 were $13.3 million, an increase of $2.0 million compared to $11.3 million in Q4 2024[4] - Total cost and expenses for Q4 2025 were $18,517 million, an increase from $20,261 million in Q4 2024, and for the year, it rose to $77,289 million from $56,257 million[21] - Research and development expenses for Q4 2025 were $10,927 million, up from $10,662 million in Q4 2024, and for the year, it increased to $44,721 million from $32,336 million[21] - Selling, general and administrative expenses for Q4 2025 were $7,330 million, down from $9,599 million in Q4 2024, with total expenses for the year at $32,029 million compared to $23,921 million[21] - Stock-based compensation expense for Q4 2025 was $4,970 million, a decrease from $6,793 million in Q4 2024, and for the year, it rose to $21,457 million from $13,586 million[21] Cash Position - Cash and cash equivalents totaled $80.7 million as of December 31, 2025, down from $118.0 million a year earlier[10] Clinical and Regulatory Developments - The company achieved 100% procedural success at 6 months and 96% at one year for patients treated with the nPulse Cardiac Catheter System[6] - FDA approved the initiation of pivotal studies for the nPulse Cardiac Catheter System in Q4 2025, with patient enrollment expected to begin shortly[6] - The company plans to expand enrollment in the PRECISE-BTN study to 100 patients over the next two quarters[6] Interest Income - Interest income for Q4 2025 was $825 million, slightly down from $886 million in Q4 2024, with total interest income for the year at $4,210 million compared to $2,690 million[21] Comprehensive Loss - The company reported a comprehensive loss of $17,433 million for Q4 2025, compared to a comprehensive loss of $19,385 million in Q4 2024[21] Shares Outstanding - Weighted average common shares outstanding for Q4 2025 were 67,788,877, compared to 62,055,927 in Q4 2024[21]

Product Development and Clinical Trials - The company has developed the nPulse System, utilizing Nano-pulse Stimulation (NPS) technology, targeting a $3.0 billion market in atrial fibrillation treatment with an annual diagnosis of approximately 1.9 million patients in the U.S.[230] - In June 2023, the company initiated a first-in-human study for the Vybrance Percutaneous Electrode System, treating 30 subjects with no serious side effects reported, and showing significant resorption of benign thyroid nodules[232] - The company received FDA 510(k) clearance for the Vybrance system in March 2024, and a second electrode size was cleared in August 2024, enhancing treatment options for customers[233] - A clinical trial (PRECISE BTN) commenced in September 2025 to evaluate the safety and effectiveness of the Vybrance system, with over 300 patient procedures completed to date[235] - The company’s cardiac surgical clamp has achieved transmural ablations in less than three seconds, demonstrating significant advantages over thermal modalities[239] - In July 2024, the company received Breakthrough Device Designation from the FDA for its nsPFA Cardiac Surgery System, aimed at expediting development and patient access[241] - The company has initiated a pivotal clinical trial for the cardiac surgical clamp, planning to enroll up to 136 patients across 20 sites, with initial patient treatments already underway[242] - The nPulse Cardiac Catheter System is designed for circumferential ablation in a single treatment cycle, potentially enabling faster treatment times compared to current thermal modalities[243] - The first-in-human study for the nPulse Cardiac Catheter System has enrolled over 165 patients, with a reported 96% procedural success rate at one year[245] - The company submitted an Investigational Device Exemption (IDE) application for the nsPFA Cardiac Catheter System in July 2025, which was approved by the FDA in December 2025, allowing for a study to enroll up to 155 patients across 30 sites[246] Financial Performance - Product revenue for the year ended December 31, 2025, was $0.4 million, with no revenue reported for the previous year, marking the first commercial sale of the Vybrance Percutaneous Electrode System in Q3 2025[267] - Research and development expenses increased by $12.4 million to $44.7 million for the year ended December 31, 2025, compared to $32.3 million in 2024, driven by increases in paid services, stock-based compensation, and employee-related expenses[270] - Selling, general and administrative expenses rose by $8.1 million to $32.0 million for the year ended December 31, 2025, compared to $23.9 million in 2024, primarily due to increases in stock-based compensation and employee-related expenses[272] - Interest income increased by $1.5 million to $4.2 million for the year ended December 31, 2025, compared to $2.7 million in 2024, attributed to higher cash balances from the 2024 Rights Offering[273] - The total cost and expenses for the year ended December 31, 2025, were $77.3 million, an increase of $21.0 million from $56.3 million in 2024[266] - The company reported a net loss of $72.8 million for the year ended December 31, 2025, compared to a net loss of $53.6 million in 2024, reflecting an increase in losses of $19.2 million[266] - The cost of product revenue was $0.5 million for the year ended December 31, 2025, with no cost reported for the previous year[268] Strategic Focus and Market Position - The company has shifted its focus from dermatology to cardiology and soft tissue ablation, ceasing all commercial sales efforts in dermatology as of September 2022[247] - The company continues to explore partnership opportunities to develop additional applications for nsPFA ablation and NPS technology[248] Cash Flow and Financing - As of December 31, 2025, the company had cash and cash equivalents of $80.7 million, expected to fund projected operating requirements for at least the next twelve months[275] - For the year ended December 31, 2025, net cash used in operating activities was $54.1 million, consisting of a net loss of $72.8 million and a net change of $5.0 million in net operating assets and liabilities[279] - The company raised $60 million from the 2024 Rights Offering, selling six million units at $10.00 each, with approximately 88% purchased by majority stockholder Robert W. Duggan[276] - Cash provided from financing activities for the year ended December 31, 2025, was $17.1 million, primarily from $14.1 million in proceeds from the exercise of common stock warrants[282] - The company plans to raise additional capital in the near future, with a shelf registration statement allowing for the sale of up to $50 million in securities[277] - For the year ended December 31, 2024, cash provided from financing activities was $110.1 million, mainly due to $59.6 million from the 2024 Rights Offering[283] Operational Challenges and Risks - The company incurred significant operating losses each year since inception, with expectations to continue incurring additional losses for the next several years due to ongoing investments in product development[274] - As of December 31, 2025, there were 405,624 outstanding 2024 Rights Offering Warrants subject to the 200% redemption feature, allowing for the purchase of approximately 202,812 shares of common stock[276] - The company has a lease obligation for approximately 50,300 square feet in Hayward, California, through October 2029, and an additional lease in Miami, Florida, through April 2030[284] - The company is exposed to market risks, including interest rate and foreign exchange risks, but does not currently hedge interest rate exposure[293][294]

Core Insights - Pulse Biosciences (PLSE) announced promising results from its first-in-human feasibility study of the nPulse Cardiac Catheter System, demonstrating effective treatment for atrial fibrillation in 150 patients with high procedural success rates and minimal adverse effects [1][4][7] Company Developments - The study reported a 100% procedural success rate at six months and 96% at one year, with an average procedure time of 65 minutes and a low incidence of serious adverse events at 1.3% [8][10] - Management emphasized the significance of these findings, highlighting the system's efficiency and clinical outcomes, and plans to initiate pivotal IDE studies in Europe and the U.S. to expand patient treatment [2][4] Market Performance - Following the announcement, PLSE shares increased by 51.6%, with a 39.5% rise over the past six months, contrasting with a 0.4% decline in the industry [3] Clinical and Commercial Outlook - The positive results from the feasibility study are expected to enhance the company's clinical and commercial prospects, with high success rates and short procedure times supporting its competitive position in the pulsed field ablation market [4][12] - The planned pivotal IDE study in the U.S. is seen as a crucial milestone for regulatory approval and market entry, potentially boosting investor sentiment and long-term revenue opportunities [4][9] Industry Context - The pulsed field ablation market is projected to grow from $1.6 billion in 2026 at a CAGR of 33.2% through 2033, driven by increasing arrhythmia prevalence and demand for minimally invasive procedures [12]

Core Viewpoint - Pulse Biosciences Inc. is experiencing a stock surge driven by positive clinical data from its nPulse Cardiac Catheter feasibility study, despite a slight decline in the broader market [1]. Group 1: Clinical Data and Study Results - The nPulse Cardiac Catheter demonstrated successful treatment outcomes for atrial fibrillation in 150 patients, with rapid procedure times and minimal adverse effects, positioning the technology as a leading market option [2]. - Findings were presented at the Annual AF Symposium 2026 in Boston, highlighting the potential of the nPulse technology to advance atrial fibrillation treatment, with plans to initiate a pivotal IDE study for additional patient treatment [3]. Group 2: Stock Performance and Technical Analysis - The stock is trading 49% above its 20-day simple moving average (SMA) and 39.4% above its 100-day SMA, indicating strong short-term momentum, although shares have decreased by 7.20% over the past 12 months [4]. - The Relative Strength Index (RSI) is at 75.62, indicating overbought territory, while the MACD is above its signal line, reflecting bullish momentum, suggesting mixed signals regarding stock performance [5]. - Benzinga Edge ranks Pulse Biosciences' stock with a strong momentum score of 68.22, indicating outperformance relative to the broader market, but caution is advised due to the overbought RSI condition [6]. Group 3: Current Stock Price Action - Pulse Biosciences shares were up 4.05% at $21.59 during premarket trading, with key resistance identified at $24.50 and key support at $20.00 [7].