HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulseâ"¢ technology using its proprietary Nanosecond Pulsed Field Ablationâ"¢ (nanosecond PFA or nsPFAâ"¢) energy, today announced late-breaking clinical study results from the nPulseâ"¢ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The feasibility study is intended to assess the initial s. ...

Core Insights - Pulse Biosciences Inc (PLSE) shares have crossed above their 200-day moving average of $17.14, reaching a high of $18.10 per share, indicating a positive trading day with an increase of approximately 11.2% [2] Price Performance - The 52-week low for PLSE shares is $13.7658, while the 52-week high is $25, with the last trade recorded at $18.01 [2]

Company Overview - Pulse Biosciences (PLSE) received FDA approval for its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, which evaluates its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF) [1][8] - The IDE approval is a significant growth catalyst for the company, validating its technology and enhancing its potential for broader clinical adoption in the cardiac ablation market [2][4] Market Position and Financials - PLSE currently has a market capitalization of $1.01 billion [6] - Following the announcement of the IDE approval, PLSE shares closed flat, with a year-to-date decline of 15.2%, compared to the industry's decline of 10.9% and the S&P 500's gain of 11.9% [3] Study Details - The NANOCLAMP AF study will involve up to 136 patients across 20 global sites, including two outside the United States, to evaluate the effectiveness of the nsPFA Cardiac Surgical System during concomitant cardiac surgeries [9][10] - Early clinical data from the EU indicate rapid and consistent ablation, with the device designed to minimize collateral tissue damage due to its nonthermal mechanism [10][11] Industry Prospects - The global atrial fibrillation market was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.44% from 2025 to 2033 [12]

Summary of Pulse Biosciences (PLSE) FY Conference Call - August 13, 2025 Company Overview - **Company**: Pulse Biosciences - **CEO**: Paul Le Violette - **CFO**: John Skinner - **Industry**: Medical Technology, specifically focusing on pulsed electric field (PFA) therapies Core Points and Arguments - **Therapeutic Platform**: Pulse Biosciences is focused on a life-changing therapeutic platform utilizing nanosecond PFA technology to treat various diseases, including atrial fibrillation (AFib) and benign thyroid nodules [4][5][6] - **Market Potential**: The company targets multiple markets, including thyroid interventions, cardiac surgery, and electrophysiology (EP) ablation, with a total addressable market of approximately $6 billion, expected to double over time [19][20] - **PFA Technology**: The unique aspect of Pulse's PFA technology is its ability to deliver shorter pulse durations (in billionths of a second), which allows for non-thermal tissue ablation, reducing the risk of thermal damage and improving clinical outcomes [8][9][17] - **Clinical Applications**: The company has multiple FDA clearances and breakthrough designations for its technologies, indicating strong clinical validation and potential for market entry [10][11] Key Market Segments 1. **Thyroid Interventions**: - Targeting benign thyroid nodules, with 250,000 patients diagnosed annually in the U.S. and 150,000 leading to surgical removal [25][26] - Aims to convert surgical procedures into less invasive alternatives, preserving thyroid function and reducing recovery time [27][28] - Currently in a pilot program with plans for a limited launch across 10 centers [29][30] 2. **Cardiac Ablation**: - Focused on patients undergoing open-heart surgery who also have preoperative AFib, with only 25-30% currently receiving ablation therapy [32] - The technology aims to improve the efficiency and effectiveness of existing radiofrequency ablation methods [33] 3. **Electrophysiology (EP) Market**: - The largest market segment, with significant potential for NSPFA to enhance treatment speed and safety compared to first-generation PFA technologies [36][39] Financial Position - **Strong Balance Sheet**: The company reported over $100 million in cash at the end of the quarter, enabling execution of its strategic plans [14][40] Strategic Approach - **Hybrid Market Entry Strategy**: The company plans to pursue a combination of direct market entry and partnerships, focusing on capital-efficient approaches to maximize market penetration [20][21] Challenges and Considerations - **Clinical Data and Reimbursement**: The company acknowledges the importance of clinical data to drive adoption and is actively working on reimbursement strategies to facilitate market entry [43][47] - **Existing Codes**: There are existing codes for irreversible electroporation that could be leveraged for reimbursement, although thyroid is not currently an approved indication [47][48] Conclusion - **Future Outlook**: Pulse Biosciences is positioned for growth with its innovative PFA technology, targeting significant unmet needs in the medical market, and is optimistic about its potential to transform treatment paradigms in multiple therapeutic areas [39][41]

Financial Data and Key Metrics Changes - Total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period [20] - GAAP net loss in 2025 was $19.2 million compared to $11.4 million in the prior year period [21] - Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 [21] Business Line Data and Key Metrics Changes - The NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue, with over 140 patients treated in the pilot program to date [9][12] - Surgeons are transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR) for better patient and surgeon experience [10] - The company expects to generate initial revenue from the percutaneous electrode in the second half of the year [23] Market Data and Key Metrics Changes - The market potential for the NSPFA device in benign thyroid disease is significant, with hundreds of thousands of patients in the US alone [7] - The prevalence of thyroid nodules is estimated to be 50% or greater in the population, increasing with age [28] - Approximately 250,000 patients are diagnosed with thyroid issues annually, with 150,000 undergoing thyroidectomy [32] Company Strategy and Development Direction - The company is focused on advancing its NSPFA technology and expanding its market presence through pilot programs and clinical studies [5][19] - A strategic partnership in the electrophysiology space is being pursued to enhance market opportunities [19][39] - The company aims to demonstrate that NSPFA may be a better treatment than surgery for many patients suffering from benign thyroid disease [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value proposition of NSPFA technology and its potential to transform treatment options [16] - The company anticipates increased cash usage as it invests in commercial infrastructure and clinical studies [22] - Management highlighted the importance of generating high-quality clinical data to support technology adoption and regulatory filings [17] Other Important Information - The company is engaged in a multicenter prospective clinical study to generate additional clinical data for the NSPFA technology [11] - The FDA awarded Breakthrough Device Designation for the Cardiac Surgical Clamp Ablation Device, which is under review for IDE submission [13][14] Q&A Session Summary Question: Can you share some patient baseline characteristics driving the pull through for NSPFA? - Management noted that symptomatic patients with benign nodules often seek therapy due to discomfort and the risks associated with thyroidectomy [28][30] Question: Is the expectation still for a single-arm study for catheter ablation? - Management confirmed it would be a single-arm study for electrophysiology [35] Question: Is Pulse collaborating with a market leader in cardiac ablation? - Management affirmed ongoing partnership discussions with a market leader in cardiac ablation [38][39] Question: How does the ASC opportunity position the NSPFA platform? - Management highlighted that the NSPFA system is well-suited for ASCs due to rapid procedure times and low neuromuscular stimulation [44][46] Question: Will the data collected overseas play into the PMA application for the clamp? - Management confirmed that human data collected will be included in IDE submissions, which is beneficial for FDA approval [53][55]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, operations, and cash flows [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Details the company's assets, liabilities, and stockholders' equity at the end of the reporting periods Key Balance Sheet Data | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :------------------------------- | | Total Assets | $120,251 | $132,460 | | Cash and Cash Equivalents | $106,349 | $118,038 | | Total Liabilities | $15,764 | $17,598 | | Total Stockholders' Equity | $104,487 | $114,862 | | Accumulated Deficit | $(426,463) | $(390,500) | - Total assets **decreased by $12,209 thousand** from December 31, 2024, to June 30, 2025, primarily due to a reduction in cash and cash equivalents[13](index=13&type=chunk) - Total stockholders' equity **decreased by $10,375 thousand**, largely influenced by the accumulated deficit increasing by $35,963 thousand[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three-%20and%20Six-Month%20Periods%20Ended%20June%2030%2C%202025%20and%202024) Summarizes revenues, expenses, and net loss for the three- and six-month periods Key Operational Results | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $— | $— | $— | $— | | Research and Development | $12,088 | $7,230 | $22,401 | $13,971 | | General and Administrative | $8,187 | $4,496 | $15,918 | $8,370 | | Total Cost and Expenses | $20,275 | $11,726 | $38,319 | $22,341 | | Net Loss | $(19,168) | $(11,383) | $(35,963) | $(21,520) | | Basic and Diluted Net Loss Per Share | $(0.28) | $(0.20) | $(0.54) | $(0.38) | - **Net loss increased significantly** for both the three-month period (from $(11,383) thousand in 2024 to $(19,168) thousand in 2025) and the six-month period (from $(21,520) thousand in 2024 to $(35,963) thousand in 2025)[15](index=15&type=chunk) - Research and development expenses **rose by $8,430 thousand** for the six-month period, and general and administrative expenses increased by $7,548 thousand, contributing to the higher net loss[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six-Month%20Periods%20Ended%20June%2030%2C%202025%20and%202024) Outlines the sources and uses of cash from operating, investing, and financing activities Cash Flow Summary | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | | Net Cash Used in Operating Activities | $(26,328) | $(18,175) | | Net Cash Used in Investing Activities | $(168) | $(34) | | Net Cash Provided by Financing Activities | $14,807 | $40 | | Net Decrease in Cash and Cash Equivalents | $(11,689) | $(18,169) | | Cash and Cash Equivalents at End of Period | $106,349 | $26,196 | - Net cash used in operating activities **increased by $8,153 thousand**, reflecting higher operational expenditures[18](index=18&type=chunk) - Net cash provided by financing activities saw a **substantial increase of $14,767 thousand**, primarily driven by proceeds from the exercise of warrants[18](index=18&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three-%20and%20Six-Month%20Periods%20Ended%20June%2030%2C%202025%20and%202024) Details the changes in the company's equity accounts over the reporting periods Stockholders' Equity Changes | Metric (in thousands) | Balance, December 31, 2024 | Balance, June 30, 2025 | | :-------------------- | :------------------------- | :--------------------- | | Common Stock Amount | $66 | $67 | | Additional Paid-in Capital | $505,296 | $530,883 | | Accumulated Deficit | $(390,500) | $(426,463) | | Total Stockholders' Equity | $114,862 | $104,487 | - Total stockholders' equity **decreased by $10,375 thousand** from December 31, 2024, to June 30, 2025, primarily due to the net loss incurred during the period[21](index=21&type=chunk) - Additional paid-in capital **increased by $25,587 thousand**, largely from stock-based compensation expense ($10,870 thousand) and proceeds from warrant exercises ($13,973 thousand)[21](index=21&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides supplementary information and disclosures related to the financial statements [1. Description of the Business](index=9&type=section&id=1.%20Description%20of%20the%20Business) Pulse Biosciences is a novel ablation company focused on Nano-pulse Stimulation technology - In 2022, the company **shifted its primary focus from dermatology to atrial fibrillation ("AF")** and surgical soft tissue ablation, leveraging its CellFX System[25](index=25&type=chunk) - The company **currently generates no revenue** and requires additional capital to finance its operations, with no assurance of obtaining necessary financing on acceptable terms[27](index=27&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and estimates used in preparing the financial statements - The unaudited condensed consolidated financial statements are prepared consistent with the December 31, 2024, audited statements, omitting certain U.S. GAAP footnote disclosures[28](index=28&type=chunk) - Key estimates include **stock-based compensation valuation**, equity-classified subscription rights, inventory valuation, income taxes, and useful lives of long-lived assets[31](index=31&type=chunk) - The company **began capitalizing inventory in the first six months of 2025** in preparation for early pilot commercialization of percutaneous electrodes for its nsPFA Percutaneous Electrode System[39](index=39&type=chunk) [3. Fair Value of Financial Instruments](index=12&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) Discloses the fair value hierarchy for financial assets and liabilities Fair Value of Financial Instruments | Asset (in thousands) | Classification | Level 1 | Level 2 | Level 3 | Total | | :------------------- | :---------------------- | :----------- | :------ | :------ | :----------- | | **June 30, 2025** | | | | | | | Money market funds | Cash and cash equivalents | $103,606 | $— | $— | $103,606 | | **December 31, 2024**| | | | | | | Money market funds | Cash and cash equivalents | $113,776 | $— | $— | $113,776 | - All financial instruments measured at fair value on a recurring basis are **classified as Level 1**, consisting solely of money market funds[50](index=50&type=chunk) [4. Balance Sheet Components](index=13&type=section&id=4.%20Balance%20Sheet%20Components) Provides detailed breakdowns of specific balance sheet accounts Selected Balance Sheet Components | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Property and equipment, net | $1,109 | $1,160 | | Intangible assets, net | $907 | $1,220 | | Accrued expenses | $4,777 | $7,027 | - Intangible assets, net, **decreased by $313 thousand** due to accumulated amortization, with $332 thousand remaining for amortization in the latter half of 2025[53](index=53&type=chunk) - Accrued expenses **decreased by $2,250 thousand**, primarily due to the resolution of a legal settlement and severance expenses by December 31, 2024[54](index=54&type=chunk) [5. Goodwill](index=14&type=section&id=5.%20Goodwill) Details the carrying amount of goodwill and the results of impairment testing - Goodwill of **$2.8 million** was recorded in connection with 2014 acquisitions[55](index=55&type=chunk) - As of June 30, 2025, the company reviewed goodwill for impairment and determined that **no impairment existed**[56](index=56&type=chunk) [6. Stockholders' Equity and Stock-Based Compensation](index=15&type=section&id=6.%20Stockholders'%20Equity%20and%20Stock-Based%20Compensation) Describes equity transactions and the accounting for stock-based compensation - The 2024 Rights Offering closed on July 3, 2024, generating **$60 million in gross proceeds**, with Robert W. Duggan, the majority stockholder, purchasing approximately 88% of the units[58](index=58&type=chunk) - During the six months ended June 30, 2025, the company received **$14.0 million in gross proceeds** from exercises of the 2024 Rights Offering Warrants[59](index=59&type=chunk) - Total stock-based compensation expense **increased significantly to $10,870 thousand** for the six months ended June 30, 2025, from $3,811 thousand in the prior year, primarily driven by time-based and market-based options[81](index=81&type=chunk)[82](index=82&type=chunk) - **No expense was recognized for performance-based and market and performance-based options** during the three-month and six-month periods ended June 30, 2025, as their performance conditions were not deemed probable of achievement[76](index=76&type=chunk)[81](index=81&type=chunk) Stock-Based Compensation Expense | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Stock-Based Compensation Expense | $5,189 | $2,052 | $10,870 | $3,811 | | Time-based options | $3,579 | $1,315 | $7,686 | $2,478 | | Market-based options | $1,535 | $683 | $3,004 | $1,190 | | Performance-based options | $— | $14 | $— | $22 | [7. Commitments and Contingencies](index=23&type=section&id=7.%20Commitments%20and%20Contingencies) Discloses contractual obligations, lease liabilities, and potential legal contingencies - The company is not currently a party to any legal proceedings that management believes could have a **material adverse effect** on its results of operations or financial condition[87](index=87&type=chunk) Operating Lease Liabilities | Metric (in thousands) | June 30, 2025 | | :-------------------- | :------------ | | Total Lease Liabilities | $8,245 | | Current Operating Lease Liabilities | $1,459 | | Non-Current Operating Lease Liabilities | $6,786 | Future Lease Payments | Year Ending December 31 (in thousands) | Lease Payments | | :------------------------------------- | :------------- | | 2025 (remaining 6 months) | $1,083 | | 2026 | $2,225 | | 2027 | $2,302 | | 2028 | $2,381 | | 2029 | $2,080 | | Thereafter | $73 | | Total Lease Payments | $10,144 | [8. Segment Reporting](index=25&type=section&id=8.%20Segment%20Reporting) Confirms the company operates as a single reportable segment - The company operates as a **single operating and reportable segment** focused on the research and development of its NPS technology[88](index=88&type=chunk) - The Chief Operating Decision-Maker (CODM) reviews consolidated net loss and detailed expense categories to monitor performance and allocate resources[88](index=88&type=chunk)[94](index=94&type=chunk) - All of the company's long-lived assets are located in the **United States** as of June 30, 2025[92](index=92&type=chunk) [9. Related Party Transactions](index=25&type=section&id=9.%20Related%20Party%20Transactions) Details transactions with the company's majority stockholder - Robert W. Duggan, the company's majority stockholder and Co-Chairman, purchased approximately **88% of the units offered through the 2024 Rights Offering**, contributing significantly to the $60 million gross proceeds[93](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes financial performance, liquidity, capital resources, and operational results for the reporting period [Overview](index=27&type=section&id=Overview) Provides an overview of the company's business, technology, and strategic focus [CellFX nsPFA Percutaneous Electrode System](index=27&type=section&id=CellFX%20nsPFA%20Percutaneous%20Electrode%20System) Details the progress and commercialization plans for the soft tissue ablation system - The company received **FDA 510(k) clearance** in March 2024 for its nsPFA Percutaneous Electrode System for soft tissue ablation, with a second size cleared in August 2024[103](index=103&type=chunk) - The CellFX System is in **early pilot commercialization**, with nine sites in the U.S. performing over 140 patient procedures under evaluation agreements[104](index=104&type=chunk) - A clinical trial is expected to commence in **Q3 2025** to support planned commercialization of the system for benign thyroid nodules in H2 2025[104](index=104&type=chunk) [Our Cardiac Surgical Program](index=29&type=section&id=Our%20Cardiac%20Surgical%20Program) Describes the development of nsPFA technology for treating Atrial Fibrillation - The program focuses on treating Atrial Fibrillation (AF) using nsPFA technology, which offers advantages over thermal ablation, such as **faster ablations and sparing of acellular tissue**[106](index=106&type=chunk)[109](index=109&type=chunk) - The CellFX nsPFA Cardiac Clamp received **FDA Breakthrough Device Designation** and is enrolled in the TPLC Advisory Program, with a pivotal clinical trial for AF expected to begin in the next few months[110](index=110&type=chunk)[111](index=111&type=chunk) - The CellFX nsPFA Cardiac Catheter, designed for circumferential ablation, has shown **promising acute and remapping data** from clinical studies in Prague and Rome, with a U.S. IDE pivotal clinical study anticipated soon[112](index=112&type=chunk)[114](index=114&type=chunk) [The CellFX Console](index=31&type=section&id=The%20CellFX%20Console) Explains the role of the core platform technology - The CellFX Console is a **tunable, software-enabled platform** designed to accommodate various disposable applicators across clinical applications[116](index=116&type=chunk) - The company **ceased commercial sales and marketing operations in dermatology** in September 2022 to focus on cardiology and soft tissue ablation, while continuing to support existing commercial users[116](index=116&type=chunk) [Financing Our Business](index=31&type=section&id=Financing%20Our%20Business) Discusses historical funding sources and future capital requirements - The company has historically funded its business through equity securities and debt, with **significant investments from Robert Duggan**, its majority stockholder and Co-Chairman[118](index=118&type=chunk) - The 2024 Rights Offering raised **$60.0 million**, with Mr. Duggan purchasing approximately 88% of the units[118](index=118&type=chunk) - The company has incurred **substantial operating losses** and will need to raise additional capital, with no assurance that financing will be available on acceptable terms, potentially leading to curtailed operations or product development[119](index=119&type=chunk)[120](index=120&type=chunk) [Critical Accounting Policies and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Highlights significant judgments and estimates affecting the financial statements - The preparation of financial statements requires significant estimates and judgments, particularly concerning the **valuation and recognition of stock-based compensation**[121](index=121&type=chunk) - Fair value of market-based and performance-based stock options is estimated using a **Monte Carlo simulation model**, requiring assumptions about expected volatility, risk-free interest rate, cost of equity, and expected term[122](index=122&type=chunk)[124](index=124&type=chunk) - As of June 30, 2025, **no stock-based compensation expense was recognized** for market and performance-based options because the achievement of performance conditions was not deemed probable[76](index=76&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Compares operating results for the three- and six-month periods ended June 30, 2025 and 2024 [Comparison of the three-month periods ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20three-month%20periods%20ended%20June%2030%2C%202025%20and%202024) Analyzes the changes in revenues, expenses, and net loss for the second quarter Q2 2025 vs Q2 2024 Performance | Metric (in thousands) | Q2 2025 | Q2 2024 | $ Change | | :-------------------- | :----------- | :----------- | :----------- | | Revenues | $— | $— | $— | | Net Loss | $(19,168) | $(11,383) | $(7,785) | | Research and Development | $12,088 | $7,230 | $4,858 | | General and Administrative | $8,187 | $4,496 | $3,691 | | Interest Income, net | $1,107 | $343 | $764 | - **Net loss increased by $7.8 million**, primarily due to a $4.9 million increase in R&D expenses and a $3.7 million increase in G&A expenses, partially offset by a $0.8 million rise in interest income[127](index=127&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) [Comparison of the six-month periods ended June 30, 2025 and 2024](index=34&type=section&id=Comparison%20of%20the%20six-month%20periods%20ended%20June%2030%2C%202025%20and%202024) Analyzes the changes in revenues, expenses, and net loss for the first half of the year H1 2025 vs H1 2024 Performance | Metric (in thousands) | H1 2025 | H1 2024 | $ Change | | :-------------------- | :----------- | :----------- | :----------- | | Revenues | $— | $— | $— | | Net Loss | $(35,963) | $(21,520) | $(14,443) | | Research and Development | $22,401 | $13,971 | $8,430 | | General and Administrative | $15,918 | $8,370 | $7,548 | | Interest Income, net | $2,356 | $821 | $1,535 | - **Net loss increased by $14.4 million**, driven by an $8.4 million increase in R&D expenses and a $7.5 million increase in G&A expenses, partially offset by a $1.5 million rise in interest income[132](index=132&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its short-term and long-term obligations - As of June 30, 2025, the company had **$106.3 million in cash and cash equivalents**, which is believed to be sufficient to fund projected operating requirements for at least the next twelve months[139](index=139&type=chunk) - The company will need to **raise additional capital in the future** through equity offerings, debt financings, or collaborations, with no assurance of availability on acceptable terms[139](index=139&type=chunk)[140](index=140&type=chunk) - Proceeds from the exercise of warrants contributed **$14.1 million to financing activities** during the six months ended June 30, 2025[145](index=145&type=chunk) Cash Flow Activity Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net Cash Used in Operating Activities | $(26,328) | $(18,175) | | Net Cash Provided by Financing Activities | $14,807 | $40 | [Contractual Obligations](index=37&type=section&id=Contractual%20Obligations) Confirms no material changes to contractual obligations - There have been **no material changes** to the company's contractual obligations outside the ordinary course of business since the Annual Report on Form 10-K for the year ended December 31, 2024[147](index=147&type=chunk) [Off-Balance-Sheet Arrangements](index=37&type=section&id=Off-Balance-Sheet%20Arrangements) States the company has no off-balance-sheet arrangements - As of June 30, 2025, the company **did not have any transactions, obligations, or relationships** that constitute off-balance sheet arrangements[148](index=148&type=chunk) - The company enters into standard indemnification arrangements with third parties, directors, and officers, but the maximum potential amount of future payments is **not determinable**[149](index=149&type=chunk)[150](index=150&type=chunk) [Trends, Events and Uncertainties](index=37&type=section&id=Trends%2C%20Events%20and%20Uncertainties) Discusses key factors that could impact future results - Research and development of new technologies are **inherently unpredictable**, and there is no assurance that financing will be sufficient to generate future sales or sustain operations[151](index=151&type=chunk) - The company **cannot assure investors that its technology will be adopted** or that it will achieve sustainable revenues, profitability, or positive operating cash flows[153](index=153&type=chunk) - **Insufficient funds could lead to delays**, scaling back activities, headcount reductions, discontinuing clinical trials, stopping manufacturing, deferring capital expenditures, or licensing technologies on unfavorable terms, potentially curtailing or discontinuing operations entirely[153](index=153&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discloses the company's exposure to market risks, primarily interest rate fluctuations - There have been **no material changes in market risk** from the information provided in the Annual Report on Form 10-K for the year ended December 31, 2024[156](index=156&type=chunk) - The company's primary market risk exposure is a result of **fluctuations in interest rates**[156](index=156&type=chunk) - The company **does not hold financial instruments for trading purposes**[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Confirms the effectiveness of disclosure controls and procedures and notes no material changes in internal controls [Evaluation of Disclosure Controls and Procedures](index=39&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective - Management, under the supervision of the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of June 30, 2025[157](index=157&type=chunk) [Changes in Internal Control Over Financial Reporting](index=39&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) No material changes in internal control over financial reporting were identified - **No changes in internal control over financial reporting** occurred during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[158](index=158&type=chunk) [Inherent Limitations on Effectiveness of Controls](index=39&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) Acknowledges that control systems provide reasonable, not absolute, assurance - Management acknowledges that disclosure controls and internal control over financial reporting can only provide **reasonable, not absolute, assurance** against errors and fraud[159](index=159&type=chunk) - Inherent limitations include **faulty judgments, simple errors, circumvention by individuals or collusion, and management override**[159](index=159&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not presently a party to any legal proceedings that, in management's opinion, could have a **material adverse effect** on its results of operations or financial condition[161](index=161&type=chunk) - Any litigation, regardless of outcome, could adversely impact the company due to **defense and settlement costs, diversion of management resources, negative publicity, and reputational harm**[161](index=161&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Outlines the significant risks and uncertainties associated with the company's business and stock [Summary](index=40&type=section&id=Summary) Summarizes key risks related to financial position, product development, IP, and corporate governance - The company faces risks related to its **financial position and need for additional capital**, including dependence on NPS technology success, limited commercialization experience, and potential for further dilution or debt[165](index=165&type=chunk) - Product development and commercialization risks include the **complex, expensive, and high-failure-rate process**, uncertainty of regulatory approval for AF treatments, limited sales/marketing experience, and intense competition[165](index=165&type=chunk) - Intellectual property, cybersecurity, and data privacy risks involve **reliance on patents, potential infringement claims**, inability to protect IP globally, and vulnerability to cyber threats and data breaches[168](index=168&type=chunk)[170](index=170&type=chunk) - Corporate governance and common stock risks include dependence on key personnel, **concentrated ownership by the Co-Chairman (72% voting power)** limiting other investors' influence, and stock price volatility[169](index=169&type=chunk)[170](index=170&type=chunk) [Risks Relating to Our Business, Industry and Financial Condition](index=42&type=section&id=Risks%20Relating%20to%20Our%20Business%2C%20Industry%20and%20Financial%20Condition) Details risks from limited operating history, lack of revenue, and need for capital - The company has a **limited operating history and no significant revenue**, making future business evaluation difficult and anticipating continued operating losses for several years[172](index=172&type=chunk)[173](index=173&type=chunk) - **Insufficient funding could lead to curtailment of operations**, delays in R&D, discontinuation of clinical trials, or cessation of business, as additional financing may not be available on commercially reasonable terms[175](index=175&type=chunk)[176](index=176&type=chunk)[181](index=181&type=chunk) - Future profitability is **entirely dependent on the CellFX System and Nano-pulse Stimulation platform**, making the business vulnerable to product obsolescence or lack of market adoption[184](index=184&type=chunk)[185](index=185&type=chunk) - Operating results may **fluctuate significantly** due to factors like R&D timing, regulatory approvals, clinical trial enrollment, reimbursement policies, manufacturing costs, and litigation, making future results difficult to predict[188](index=188&type=chunk)[191](index=191&type=chunk) - The company faces **intense competition** from well-established medical technology manufacturers with greater financial, technical, and marketing resources[192](index=192&type=chunk) [Risks Related to Product Development and Product-Related Risks](index=54&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Product-Related%20Risks) Highlights uncertainties in clinical development, regulatory approval, and product safety - The CellFX System or future products may cause **serious adverse side effects**, potentially delaying or preventing regulatory approval, limiting commercial desirability, or resulting in negative consequences[221](index=221&type=chunk)[222](index=222&type=chunk) - **Clinical development is lengthy, expensive, and uncertain**; early study results may not predict future trial outcomes, and limited human experience in AF and thyroid nodules exists[223](index=223&type=chunk) - Long-term growth depends on developing marketable products for AF, tumors, and nodules, but **rapid technological changes** in the medical device industry could render products obsolete[225](index=225&type=chunk) - Failure to maintain or obtain necessary **regulatory clearances or approvals** for products or new indications could significantly harm commercial prospects[229](index=229&type=chunk)[233](index=233&type=chunk) - The exact **mechanism of action of NPS technology is not fully understood**, which could make obtaining regulatory approvals or partnerships more challenging[236](index=236&type=chunk) - **Difficulties in enrolling sufficient eligible patients** in clinical trials could delay or prevent product development[237](index=237&type=chunk) - The safety and effectiveness of products may depend on the **user's technique**, and laboratory results may not be replicable in commercial or field conditions[238](index=238&type=chunk)[240](index=240&type=chunk) - Issues with proprietary firmware and software, including **malfunctions or security vulnerabilities**, could negatively affect device function, harm patients, or lead to unauthorized data release[241](index=241&type=chunk) [Risks Related to Intellectual Property, Cybersecurity, Data Privacy, & Litigation](index=59&type=section&id=Risks%20Related%20to%20Intellectual%20Property%2C%20Cybersecurity%2C%20Data%20Privacy%2C%20%26%20Litigation) Covers risks of protecting IP, infringement claims, data breaches, and product liability - **Inability to protect intellectual property** (patents, trade secrets) could adversely affect the company's financial condition, results of operations, and competitive position, as patents may be challenged, invalidated, or circumvented[242](index=242&type=chunk)[245](index=245&type=chunk) - Litigation or third-party claims of **intellectual property infringement** could result in substantial expenses, diversion of resources, or prevent the development, regulatory approval, or commercialization of product candidates[243](index=243&type=chunk) - Failure to protect confidential proprietary information and know-how could **enable competitors to duplicate technological achievements**, eroding the company's competitive position[248](index=248&type=chunk) - The company's intellectual property rights **may not be protected throughout the world**, as filing patents globally is expensive and foreign laws may offer less extensive protection[250](index=250&type=chunk) - **Compromised information technology systems or data**, or those of third parties, could lead to regulatory investigations, litigation, fines, business disruptions (including clinical trials), reputational harm, and financial losses[251](index=251&type=chunk)[255](index=255&type=chunk) - **Product liability lawsuits** could cause substantial liabilities and limit commercialization, even if claims are successfully defended, due to defense costs, reputational harm, and potential regulatory actions[257](index=257&type=chunk)[258](index=258&type=chunk) [Risks Related to Government Regulation](index=64&type=section&id=Risks%20Related%20to%20Government%20Regulation) Discusses risks from extensive regulation, healthcare policy changes, and compliance failures - The company is subject to **extensive and rigorous domestic and foreign regulation** (e.g., FDA), which governs device development, testing, manufacturing, labeling, marketing, and safety, and can be costly, lengthy, and unpredictable[261](index=261&type=chunk)[263](index=263&type=chunk) - **Changes in healthcare policy**, such as those related to the Affordable Care Act or cost-reduction proposals, could increase costs, decrease revenues, and impact product sales and reimbursement[264](index=264&type=chunk) - **Disruptions at government agencies** (e.g., FDA) due to funding shortages, government shutdowns, or global health concerns could hinder timely review and approval of new product candidates[265](index=265&type=chunk)[267](index=267&type=chunk) - Dependence on strong working relationships with physicians for product development and marketing exposes the company to scrutiny by government agencies (OIG, DOJ) regarding **compliance with laws governing these relationships**[272](index=272&type=chunk) - The company is subject to various federal and state healthcare laws and regulations, including **anti-kickback, false claims, HIPAA, Sunshine Act, and consumer privacy laws**, with non-compliance potentially leading to substantial penalties[273](index=273&type=chunk) - Even if cleared or approved, products may only receive **narrow indications**, limiting commercial viability and making it difficult to achieve desired revenues[279](index=279&type=chunk) - Ongoing compliance with **quality system regulations** and other requirements is strictly enforced, and failure to comply could result in sanctions, product recalls, or withdrawal of approvals[280](index=280&type=chunk) - The company is exposed to the risk of **fraud or misconduct by employees and collaborators**, violating regulatory standards or healthcare fraud laws, which could lead to significant fines or sanctions[281](index=281&type=chunk) - Compliance with **environmental regulations and anti-corruption laws** (e.g., FCPA) is required, and violations could lead to significant liabilities, criminal/civil penalties, and reputational harm[285](index=285&type=chunk)[287](index=287&type=chunk)[289](index=289&type=chunk) [Risks Related to Owning Our Common Stock](index=70&type=section&id=Risks%20Related%20to%20Owning%20Our%20Common%20Stock) Addresses stock price volatility, concentrated ownership, and corporate governance issues - The price of the company's common stock has been, and is expected to remain, **highly volatile** due to factors such as clinical trial results, regulatory actions, financial fluctuations, competition, IP disputes, financing efforts, and general market conditions[290](index=290&type=chunk)[291](index=291&type=chunk) - Sales or purchases of common stock by the company or its stockholders, particularly **Robert W. Duggan (majority stockholder)**, may adversely affect the market price[293](index=293&type=chunk) - An **active, liquid, and orderly trading market** for common stock may not exist, making it difficult for investors to sell shares quickly or at a desired price[294](index=294&type=chunk) - Robert W. Duggan's **controlling ownership (approximately 72% of voting power)** limits the ability of other stockholders to influence corporate actions and creates potential for conflicts of interest[295](index=295&type=chunk)[296](index=296&type=chunk) - As a **"controlled company"** under Nasdaq rules, the company may elect not to comply with certain corporate governance requirements, potentially reducing protections for other stockholders[297](index=297&type=chunk)[299](index=299&type=chunk) - **Anti-takeover provisions** in charter documents and Delaware law could delay or prevent a change of control or management, which may be beneficial to stockholders[309](index=309&type=chunk)[310](index=310&type=chunk) [General Risk Factors](index=76&type=section&id=General%20Risk%20Factors) Covers broad risks from economic conditions, internal controls, and natural disasters - **Unfavorable global economic or political conditions**, including armed conflicts, health epidemics, and trade tariffs, could adversely affect the company's business, financial condition, or results of operations[312](index=312&type=chunk)[314](index=314&type=chunk) - Future **material weaknesses in internal control over financial reporting** could adversely affect investor confidence in financial data and the value of common stock[315](index=315&type=chunk) - **Incorrect interpretations, estimates, or judgments** used in preparing financial statements could lead to a loss of investor confidence and a decline in stock price[317](index=317&type=chunk) - Involvement in litigation (securities, product liability, patent infringement, etc.) can be **time-consuming, costly, and divert management's attention**, potentially having a material adverse effect[318](index=318&type=chunk) - The company's facilities in Hayward, California, are located near known earthquake faults, making them **vulnerable to damage from natural disasters**, which could seriously impair business operations[319](index=319&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Confirms no unregistered sales of equity securities occurred during the period - The company completed **no unregistered sales of its securities** during the three-month period ended June 30, 2025[321](index=321&type=chunk) [Item 3. Default Upon Senior Securities](index=78&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) The company reported no default upon senior securities during the period - The company reported **no default upon senior securities**[322](index=322&type=chunk) [Item 4. Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are **not applicable** to the company[323](index=323&type=chunk) [Item 5. Other Information](index=78&type=section&id=Item%205.%20Other%20Information) Reports no adoption or termination of Rule 10b5-1 trading arrangements by directors or officers - None of the company's directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement" during the three-month period ended June 30, 2025[324](index=324&type=chunk) [Item 6. Exhibits](index=78&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including certifications and XBRL documents - The exhibits include certifications of the Chief Executive Officer and Chief Financial Officer pursuant to **Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002**[325](index=325&type=chunk) - **Inline XBRL Instance Document** and Taxonomy Extension documents are provided for financial data[325](index=325&type=chunk) - The certifications under Section 906 (Exhibit 32.1 and 32.2) are deemed **furnished and not filed** with the SEC[325](index=325&type=chunk) [Signatures](index=79&type=section&id=Signatures) The report is duly signed on behalf of the company by its President and CEO - The report was signed by **Paul A. LaViolette, President and Chief Executive Officer** (Principal Executive Officer)[330](index=330&type=chunk) - The signing date of the report is **August 12, 2025**[330](index=330&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) Pulse Biosciences announced its second quarter 2025 financial results and provided business updates, emphasizing progress in its Nanosecond Pulsed Field Ablation (nsPFA) technology programs, including expanded pilot studies and regulatory submissions, alongside increased operational costs and net losses [Introduction and Key Highlights](index=1&type=section&id=Introduction%20and%20Key%20Highlights) Pulse Biosciences announced its second quarter 2025 financial results and provided business updates, emphasizing progress in its Nanosecond Pulsed Field Ablation (nsPFA) technology programs, including expanded pilot studies and regulatory submissions, alongside increased operational costs and net losses - Pulse Biosciences is advancing top priorities for its three market development programs, expanding the Percutaneous Electrode pilot program, submitting IDEs for cardiac surgical clamp and nsPFA 360° catheter, and generating **positive clinical outcomes** in European feasibility studies[2](index=2&type=chunk) Q2 2025 Financial Snapshot (GAAP) | Metric | Q2 2025 (in $M) | Q2 2024 (in $M) | Change (in $M) | | :----- | :-------------- | :-------------- | :------------- | | Total Costs & Expenses | 20.3 | 11.7 | +8.5 | | Net Loss | (19.2) | (11.4) | +(7.8) | | Cash & Cash Equivalents | 106.3 | 26.2 | +80.1 | | Cash Used in Operations | 12.8 | 8.4 | +4.4 | [Business Updates](index=1&type=section&id=Business%20Updates) The company provides updates on its soft tissue and cardiac AF ablation programs, highlighting clinical progress and regulatory submissions [Soft Tissue Ablation Program](index=1&type=section&id=Soft%20Tissue%20Ablation%20Program) The company expanded its pilot program for the nsPFA Percutaneous Electrode for soft tissue ablation, successfully treating over 140 benign thyroid nodule patients and planning a post-market study - Expanded the pilot program for the **nsPFA Percutaneous Electrode for soft tissue ablation**[7](index=7&type=chunk) - Treated over **140 Benign Thyroid Nodule patients** to date across multiple pilot program centers[7](index=7&type=chunk) - Identified **five sites** to participate in a post-market study of benign thyroid disease, with enrollment planned for **Q3** upon IRB approvals[7](index=7&type=chunk) [Cardiac AF Ablation Programs](index=1&type=section&id=Cardiac%20AF%20Ablation%20Programs) Pulse Biosciences made significant strides in its cardiac AF ablation programs, submitting FDA IDE applications for both surgical and endocardial catheter systems and reporting positive clinical outcomes and improved procedure times in European feasibility studies [Surgical AF Ablation](index=1&type=section&id=Surgical%20AF%20Ablation) FDA IDE for nsPFA Cardiac Surgery System submitted, pivotal study planned, with positive European feasibility outcomes - The company submitted its **FDA IDE application**, including the pivotal study protocol, for the **nsPFA Cardiac Surgery System** and remains on track to commence the pivotal study soon. European feasibility studies have treated **40 patients** with **positive clinical outcomes**[7](index=7&type=chunk) - Submitted **FDA IDE application**, including the pivotal study protocol, to support a premarket approval (PMA) application for atrial fibrillation (AF) treatment, remaining on track to commence the **IDE pivotal study** in the next few months[7](index=7&type=chunk) - Treated **40 patients** to date and generated **positive clinical outcomes**, as indicated by follow-up remapping procedures, as part of the **nsPFA Cardiac Surgery System** multi-center, first-in-human AF feasibility study in Europe[7](index=7&type=chunk) [Endocardial Catheter AF Ablation](index=1&type=section&id=Endocardial%20Catheter%20AF%20Ablation) FDA IDE for nsPFA 360° catheter submitted, pivotal study expected, European studies show improved procedure times - The **FDA IDE application** for the **nsPFA 360° catheter** has been submitted, with the pivotal study expected to commence in the coming months. Over **140 patients** have been treated in European studies, showing **improved procedure times**[7](index=7&type=chunk) - Observed **improved procedure times** since last presented at the Heart Rhythm Society 2025 Meeting in April[7](index=7&type=chunk) - Treated over **140 total patients** with the **nsPFA 360° catheter** to date as part of the multi-center, first-in-human AF study in Europe[7](index=7&type=chunk) [Second Quarter 2025 Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Q2 2025 financial performance shows increased operational costs, net losses, and significant cash and cash equivalents growth [GAAP Financial Results](index=1&type=section&id=GAAP%20Financial%20Results) Total GAAP costs and expenses for Q2 2025 increased significantly year-over-year, primarily due to organizational expansion and higher stock-based compensation, resulting in a larger GAAP net loss GAAP Costs and Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in $M) | Q2 2024 (in $M) | YoY Change (in $M) | | :---------------------- | :-------------- | :-------------- | :----------------- | | Research and development | 12.088 | 7.230 | +4.858 | | General and administrative | 8.187 | 4.496 | +3.691 | | **Total Costs and Expenses** | **20.275** | **11.726** | **+8.549** | GAAP Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in $M) | Q2 2024 (in $M) | YoY Change (in $M) | | :------- | :-------------- | :-------------- | :----------------- | | Net Loss | (19.168) | (11.383) | +(7.785) | | Basic and Diluted Net Loss Per Share | (0.28) | (0.20) | +(0.08) | - The increase in costs was primarily driven by **administrative expenses** related to expanding the organization to support **nsPFA device clinical trials and commercialization**, and **non-cash stock-based compensation** and other compensation[3](index=3&type=chunk) [Non-GAAP Financial Results](index=1&type=section&id=Non-GAAP%20Financial%20Results) Non-GAAP costs and expenses and net loss for Q2 2025 also increased year-over-year, reflecting the underlying operational growth when excluding non-cash and certain non-recurring items Non-GAAP Costs and Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in $M) | Q2 2024 (in $M) | YoY Change (in $M) | | :---------------------- | :-------------- | :-------------- | :----------------- | | Non-GAAP Research and development | 9.709 | 6.177 | +3.532 | | Non-GAAP General and administrative | 5.104 | 3.199 | +1.905 | | **Non-GAAP Cost and expenses** | **14.813** | **9.376** | **+5.437** | Non-GAAP Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in $M) | Q2 2024 (in $M) | YoY Change (in $M) | | :---------- | :-------------- | :-------------- | :----------------- | | Non-GAAP Net loss | (13.706) | (9.033) | +(4.673) | [Balance Sheet and Liquidity](index=1&type=section&id=Balance%20Sheet%20and%20Liquidity) Cash and cash equivalents significantly increased year-over-year, reaching $106.3 million as of June 30, 2025, despite an increase in cash used in operating activities. Total assets and stockholders' equity decreased from year-end 2024 Cash and Cash Equivalents | Date | Amount (in $M) | | :---------- | :------------- | | June 30, 2025 | 106.3 | | March 31, 2025 | 119.3 | | June 30, 2024 | 26.2 | Cash Used in Operating Activities | Period | Amount (in $M) | | :------------------ | :------------- | | Q2 2025 | 12.8 | | Q1 2025 | 13.5 | | Q2 2024 | 8.4 | Selected Balance Sheet Items (in $M) | Metric | June 30, 2025 | Dec 31, 2024 | Change | | :---------------------- | :------------ | :----------- | :----- | | Total Assets | 120.251 | 132.460 | (12.209) | | Total Liabilities | 15.764 | 17.598 | (1.834) | | Total Stockholders' Equity | 104.487 | 114.862 | (10.375) | [Non-GAAP Financial Measures Explanation](index=2&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) Non-GAAP financial measures clarify operational performance by excluding non-cash and non-recurring items, complementing GAAP results [Non-GAAP Financial Measures](index=2&type=section&id=Non-GAAP%20Financial%20Measures) Pulse Biosciences utilizes non-GAAP financial measures to complement its GAAP results, believing they offer a clearer view of ongoing operations by excluding non-cash expenses and certain non-recurring items, though investors are cautioned about their limitations - Company management uses these measurements as aids in monitoring the Company's **ongoing financial performance** from quarter to quarter and year to year, and for **financial and operational decision-making**[10](index=10&type=chunk) - **Non-GAAP adjustments** include **stock-based compensation**, **depreciation and amortization**, **restructuring**, **severance**, and a **legal settlement**[10](index=10&type=chunk) - Investors are cautioned that there are a number of **limitations** associated with the use of **non-GAAP financial measures** as analytical tools[10](index=10&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) Forward-looking statements are subject to inherent risks and uncertainties, with actual results potentially differing materially from projections [Forward-Looking Statements Disclaimer](index=2&type=section&id=Forward-Looking%20Statements%20Disclaimer) This section provides a standard disclaimer, highlighting that all non-historical statements are forward-looking and subject to risks and uncertainties, and actual results may differ materially. The company disclaims any obligation to update these statements - All non-historical statements in this press release are **forward-looking statements**, including those related to the **effectiveness of nsPFA technology**, **future commercialization and product development**, **early clinical successes**, and **future clinical and regulatory initiatives**[12](index=12&type=chunk) - Do not place undue reliance on forward-looking statements, as they involve **known and unknown risks, uncertainties, and assumptions** that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences' control[12](index=12&type=chunk) [Contacts](index=2&type=section&id=Contacts) Investor relations contact information for Pulse Biosciences and its external partner is provided [Investor Relations](index=2&type=section&id=Investor%20Relations) Contact information for investor inquiries is provided for Pulse Biosciences directly and through Gilmartin Group - Investors: **Pulse Biosciences, Inc. Jon Skinner, CFO** IR@pulsebiosciences.com[13](index=13&type=chunk) - **Gilmartin Group Philip Trip Taylor** 415.937.5406 philip@gilmartinir.com[14](index=14&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed consolidated financial statements detail the company's financial position and performance, including balance sheets and operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows a decrease in total assets and stockholders' equity compared to December 31, 2024, primarily driven by a reduction in cash and cash equivalents Condensed Consolidated Balance Sheets (Selected Items, in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $106,349 | $118,038 | | Total current assets | $108,160 | $119,449 | | Total assets | $120,251 | $132,460 | | Total current liabilities | $8,978 | $10,055 | | Total liabilities | $15,764 | $17,598 | | Total stockholders' equity | $104,487 | $114,862 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2025, Pulse Biosciences reported no product revenues, with significant increases in research and development and general and administrative expenses leading to higher net losses compared to the prior year periods Statements of Operations (3-Month Periods, in thousands) | Metric | June 30, 2025 | June 30, 2024 | YoY Change | | :---------------------- | :------------ | :------------ | :--------- | | Product revenues | $— | $— | $— | | Research and development | $12,088 | $7,230 | +$4,858 | | General and administrative | $8,187 | $4,496 | +$3,691 | | Total cost and expenses | $20,275 | $11,726 | +$8,549 | | Net loss | $(19,168) | $(11,383) | $(7,785) | | Basic and diluted net loss per share | $(0.28) | $(0.20) | $(0.08) | Statements of Operations (6-Month Periods, in thousands) | Metric | June 30, 2025 | June 30, 2023 | YoY Change | | :---------------------- | :------------ | :------------ | :--------- | | Product revenues | $— | $— | $— | | Research and development | $22,401 | $13,971 | +$8,430 | | General and administrative | $15,918 | $8,370 | +$7,548 | | Total cost and expenses | $38,319 | $22,341 | +$15,978 | | Net loss | $(35,963) | $(21,520) | $(14,443) | | Basic and diluted net loss per share | $(0.54) | $(0.38) | $(0.16) | Stock-Based Compensation Expense (3-Month Periods, in thousands) | Metric | June 30, 2025 | June 30, 2024 | YoY Change | | :-------------------------------- | :------------ | :------------ | :--------- | | Research and development | $2,335 | $1,001 | +$1,334 | | General and administrative | $2,854 | $1,051 | +$1,803 | | **Total stock-based compensation expense** | **$5,189** | **$2,052** | **+$3,137** | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) This section details the adjustments made to GAAP figures, primarily for stock-based compensation, depreciation, amortization, and legal settlements, to derive non-GAAP research and development, general and administrative expenses, total costs and expenses, and net loss for both quarterly and year-to-date periods Reconciliation of GAAP to Non-GAAP Costs and Expenses (3-Month Periods, in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | GAAP Cost and expenses | $20,275 | $11,726 | | Less: Stock-based compensation expense | $(5,189) | $(2,052) | | Less: Depreciation and amortization | $(273) | $(298) | | Add: Legal settlement | $— | $— | | **Non-GAAP Cost and expenses** | **$14,813** | **$9,376** | Reconciliation of GAAP to Non-GAAP Net Loss (3-Month Periods, in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | GAAP Net loss | $(19,168) | $(11,383) | | Add: Stock-based compensation expense | $5,189 | $2,052 | | Add: Depreciation and amortization | $273 | $298 | | Less: Legal settlement | $— | $— | | **Non-GAAP Net loss** | **$(13,706)** | **$(9,033)** | - **Non-GAAP adjustments** include **stock-based compensation**, **depreciation and amortization**, **restructuring**, **severance**, and a **legal settlement**[10](index=10&type=chunk)

Financial Data and Key Metrics Changes - In Q1 2025, total GAAP costs and expenses increased by $7.4 million to $18 million compared to $10.6 million in the prior year period [25] - GAAP net loss in Q1 2025 was $16.8 million compared to $10.1 million in the prior year period [26] - Cash and cash equivalents totaled $119.3 million as of March 31, 2025, compared to $34.9 million as of March 31, 2024, representing an increase of $1.2 million versus year-end 2024 [26] Business Line Data and Key Metrics Changes - The company has achieved seven FDA clearances and treated over 6,000 patients, validating its proprietary mechanism of action and therapeutic potential [7] - The percutaneous electrode for soft tissue ablation has shown an average of 83% volume reduction in benign thyroid nodules at one year [13] - The three sixty catheter system for AF ablation has treated 100 patients in a feasibility study, demonstrating a 94.2% success rate for pulmonary vein isolation [22] Market Data and Key Metrics Changes - The company is expanding its direct commercial resources for the launch of its soft tissue ablation product in the U.S. [10] - Clinical data presented at various medical symposiums have increased awareness of the NSPFA technology among clinicians [11][24] Company Strategy and Development Direction - The company aims to initiate commercialization of the percutaneous electrode for soft tissue ablation and IDE pivotal studies for its cardiac devices in 2025 [8] - The focus is on building commercial infrastructure and generating revenue in the second half of 2025 [16] - The company is actively engaged with the FDA regarding the design of its IDE pivotal clinical study [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential benefits of NSPFA technology and its ability to transform care across multiple large markets [7] - The company is encouraged by the performance of its devices and expects to share preliminary results of its trials in late 2025 [18] Other Important Information - The increase in GAAP costs was primarily driven by a rise in non-cash stock-based compensation, which was $5.7 million in Q1 2025 compared to $1.8 million in the prior year [25] - Cash used in operating activities during Q1 2025 was $13.5 million, offset by $14.1 million in proceeds from the exercise of warrants [27] Q&A Session Summary - There were no questions during the Q&A session, and the call concluded with closing remarks from management [28][29]

Financial Data and Key Metrics Changes - In Q1 2025, total GAAP costs and expenses increased by $7.4 million to $18 million compared to $10.6 million in the prior year period [26] - GAAP net loss in Q1 2025 was $16.8 million compared to $10.1 million in the prior year period [27] - Cash and cash equivalents totaled $119.3 million as of March 31, 2025, compared to $34.9 million as of March 31, 2024, representing an increase of $1.2 million versus year-end 2024 [27] Business Line Data and Key Metrics Changes - The company has achieved seven FDA clearances and treated over 6,000 patients, validating its proprietary mechanism of action and therapeutic potential [7] - The percutaneous electrode for soft tissue ablation has shown an average of 83% volume reduction in benign thyroid nodules at one year [13] - The three sixty catheter system for AF ablation has treated 100 patients in a feasibility study, demonstrating a 94.2% success rate for pulmonary vein isolation [22] Market Data and Key Metrics Changes - The company is expanding its direct commercial resources for the launch of its soft tissue ablation product in the U.S. [10] - Clinical data on the catheter-based treatment of atrial fibrillation were presented at major medical symposiums, indicating strong interest and potential for the technology [8][21] Company Strategy and Development Direction - The company aims to initiate commercialization of the percutaneous electrode for soft tissue ablation and IDE pivotal studies for its cardiac devices in 2025 [8] - The focus is on advancing therapies that can transform care across multiple large markets, particularly in cardiac and soft tissue applications [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential benefits of nanosecond pulse field ablation technology and its ability to disrupt existing treatment modalities [7] - The company anticipates generating revenue in the second half of 2025 as it continues to build its commercial infrastructure [16] Other Important Information - The company raised $14 million through the exercise of warrants during Q1 to maintain its cash position [10] - The FDA awarded breakthrough designation for the cardiac surgical clamp device, which is expected to enhance its regulatory process [18] Q&A Session Summary - There were no questions during the Q&A session, and the call concluded with closing remarks from management [29][30]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201%2E%20Financial%20Statements) Unaudited Q1 2025 financials show no revenue, a **$16.8 million net loss**, and **$119.3 million** cash, boosted by financing activities [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets slightly increased to **$133.4 million**, liabilities decreased to **$14.9 million**, and stockholders' equity rose to **$118.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $119,279 | $118,038 | | Total current assets | $120,909 | $119,449 | | Total assets | $133,383 | $132,460 | | **Liabilities & Equity** | | | | Total current liabilities | $7,760 | $10,055 | | Total liabilities | $14,931 | $17,598 | | Total stockholders' equity | $118,452 | $114,862 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 saw no revenue, with net loss widening to **$16.8 million** from **$10.1 million** due to increased operating expenses, notably R&D and G&A Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenues | $0 | $0 | | Research and development | $10,313 | $6,741 | | General and administrative | $7,731 | $3,874 | | Loss from operations | $(18,044) | $(10,615) | | Net loss | $(16,795) | $(10,137) | | Net loss per share | $(0.25) | $(0.18) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 operating cash use was **$13.5 million**, offset by **$14.8 million** from financing, primarily warrant exercises, leading to a **$1.2 million** cash increase and **$119.3 million** ending balance Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,521) | $(9,780) | | Net cash used in investing activities | $(45) | $(5) | | Net cash provided by financing activities | $14,807 | $305 | | **Net increase (decrease) in cash** | **$1,241** | **$(9,480)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's NPS technology focus, complex stock-based compensation valuation, the **$60 million** 2024 Rights Offering, and confirm single-segment operations - The company's primary focus is on using its nsPFA energy and CellFX platform for treating atrial fibrillation (AF) and for surgical soft tissue ablation[23](index=23&type=chunk) - In Q1 2025, the company issued stock options with both market-based (market capitalization targets) and performance-based (revenue and margin metrics) vesting conditions, valued using a Monte Carlo simulation model[33](index=33&type=chunk) - The 2024 Rights Offering raised gross proceeds of **$60 million**. The company's majority stockholder and Co-Chairman, Robert W. Duggan, purchased approximately **88%** of the units offered[54](index=54&type=chunk)[86](index=86&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $2,762 | $949 | | General and administrative | $2,919 | $810 | | **Total** | **$5,681** | **$1,759** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses nsPFA technology, FDA clearance, and clinical progress, highlighting increased operating expenses and net loss, while confirming sufficient cash for 12 months but anticipating future financing [Overview](index=23&type=section&id=Overview) The company focuses on NPS/nsPFA technology for AF and soft tissue ablation, with FDA 510(k) clearance and Breakthrough Device Designation, expecting pivotal cardiac clinical trials in mid-2025 - Received FDA 510(k) clearance in March 2024 for the nsPFA Percutaneous Electrode System for soft tissue ablation[95](index=95&type=chunk) - The company plans to pursue a PMA application for its cardiac clamp to treat AF and expects to begin a pivotal clinical trial in mid-2025[101](index=101&type=chunk) - Received Breakthrough Device Designation from the FDA in July 2024 for its nsPFA Cardiac Surgery System for the treatment of AF[102](index=102&type=chunk) - Following promising data from an initial clinical study, the company expects to commence a U.S. IDE pivotal clinical study of its 360° Cardiac Catheter in mid-2025[106](index=106&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Q1 2025 saw no revenue, with R&D expenses up **$3.6 million** to **$10.3 million** and G&A up **$3.9 million** to **$7.7 million**, widening net loss to **$16.8 million** Comparison of Operations (in thousands) | Item | Q1 2025 | Q1 2024 | $ Change | | :--- | :--- | :--- | :--- | | Total revenues | $0 | $0 | $0 | | Research and development | $10,313 | $6,741 | $3,572 | | General and administrative | $7,731 | $3,874 | $3,857 | | **Net loss** | **$(16,795)** | **$(10,137)** | **$(6,658)** | - The increase in R&D expenses was primarily due to rises of **$1.8 million** in stock-based compensation and **$0.9 million** in compensation and other employee-related expenses[119](index=119&type=chunk) - The increase in G&A expenses was primarily due to rises of **$2.1 million** in stock-based compensation and **$1.5 million** in compensation and other employee-related expenses[120](index=120&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash was **$119.3 million**, with **$13.5 million** used in operations and **$14.8 million** provided by financing, deemed sufficient for 12 months, but future capital raises are planned - The company had cash and cash equivalents of **$119.3 million** as of March 31, 2025, and believes this is sufficient to fund operations for at least the next twelve months[124](index=124&type=chunk) - In Q1 2025, financing activities provided **$14.8 million**, mainly from **$14.1 million** in proceeds from the exercise of warrants[130](index=130&type=chunk) - Cumulatively, as of March 31, 2025, the company has received a total of **$63.5 million** in gross proceeds from exercises of the 2024 Rights Offering Warrants[123](index=123&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes in market risk from year-end 2024; primary exposure is interest rate fluctuations, with no financial instruments used for trading - There have been no material changes in market risk. The primary exposure is from fluctuations in interest rates[140](index=140&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[141](index=141&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[142](index=142&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=25&type=section&id=Item%201%2E%20Legal%20Proceedings) The company is not a party to any legal proceedings expected to materially adversely affect its financial condition or results of operations - The company is not presently a party to any legal proceedings expected to have a material adverse effect on its results or financial condition[145](index=145&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A%2E%20Risk%20Factors) This section details substantial investment risks, including financial position, capital needs, high development and commercialization risks for its single NPS technology, IP, cybersecurity, and significant ownership concentration [Risks Related to Financial Position and Need for Additional Capital](index=34&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) As a development-stage company with no significant revenue and a history of losses, the company requires additional capital; failure to secure funding could force program delays or elimination - The company has incurred significant operating losses each year since inception and expects to continue incurring losses for the next several years[156](index=156&type=chunk)[157](index=157&type=chunk) - The company will need to raise additional capital to execute its business plan, and if unable to do so, may need to scale back operations[160](index=160&type=chunk)[162](index=162&type=chunk) [Risks Related to Development and Commercialization](index=34&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20our%20Medical%20Products) Success depends on its single NPS technology, facing high clinical development risks, intense competition, limited sales experience, and uncertainty in obtaining adequate third-party reimbursement - The company's revenues and future profitability are entirely dependent upon the CellFX System and the NPS platform technology[168](index=168&type=chunk) - The company faces intense competition from well-established manufacturers like Abbott, Boston Scientific, and Medtronic, which have significantly greater resources[176](index=176&type=chunk) - Commercial viability may be impacted if products fail to obtain an adequate level of reimbursement from Medicare and other third-party payers[197](index=197&type=chunk) [Risks Related to Intellectual Property, Cybersecurity, and Data Privacy](index=35&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%2C%20Cybersecurity%20and%20Data%20Privacy) Competitive position relies on protecting NPS technology patents, facing risks of challenges and infringement, alongside cybersecurity threats and data breaches - The company's ability to compete depends on the proprietary nature of its technologies, and it may be unable to adequately protect its intellectual property rights[226](index=226&type=chunk) - The company is exposed to risks from cybersecurity and data privacy threats, which could lead to regulatory investigations, litigation, and disruptions to business operations[235](index=235&type=chunk) [Risks Related to Corporate Governance and Owning Our Common Stock](index=35&type=section&id=Risks%20Related%20to%20Corporate%20Governance%20and%20Owning%20Our%20Common%20Stock) Significant stockholder risk stems from Co-Chairman Robert W. Duggan's **72%** ownership, controlling corporate actions, classifying the company as 'controlled,' and contributing to high stock price volatility - Co-Chairman Robert W. Duggan beneficially owns approximately **72%** of the company's common stock, giving him control over corporate actions requiring stockholder approval[278](index=278&type=chunk) - The company is considered a "controlled company" under Nasdaq rules, which may exempt it from certain corporate governance requirements[280](index=280&type=chunk) - The market price of the company's common stock has been and is expected to continue to be highly volatile[273](index=273&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the three-month period ended March 31, 2025 - During the three-month period ended March 31, 2025, the company completed no unregistered sale of its securities[304](index=304&type=chunk) [Default Upon Senior Securities](index=47&type=section&id=Item%203%2E%20Default%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[305](index=305&type=chunk) [Mine Safety Disclosures](index=47&type=section&id=Item%204%2E%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[306](index=306&type=chunk) [Other Information](index=47&type=section&id=Item%205%2E%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - During Q1 2025, none of the company's directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement"[307](index=307&type=chunk) [Exhibits](index=47&type=section&id=Item%206%2E%20Exhibits) This section lists Form 10-Q exhibits, including CEO/CFO certifications and Inline XBRL financial data files - The report includes required CEO and CFO certifications (Exhibits 31.1, 31.2, 32.1, 32.2) and Inline XBRL data files[308](index=308&type=chunk)