Pulse Biosciences(PLSE) - 2025 Q2 - Quarterly Results

Executive Summary 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 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] 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 The company provides updates on its soft tissue and cardiac AF ablation programs, highlighting clinical progress and regulatory submissions Soft Tissue Ablation Program 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] - Treated over 140 Benign Thyroid Nodule patients to date across multiple pilot program centers[7] - Identified five sites to participate in a post-market study of benign thyroid disease, with enrollment planned for Q3 upon IRB approvals[7] Cardiac AF Ablation Programs 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 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] - 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] - 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] Endocardial Catheter AF Ablation 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] - Observed improved procedure times since last presented at the Heart Rhythm Society 2025 Meeting in April[7] - 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] Second Quarter 2025 Financial Performance Q2 2025 financial performance shows increased operational costs, net losses, and significant cash and cash equivalents growth GAAP Financial Results 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] Non-GAAP Financial Results 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 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 Non-GAAP financial measures clarify operational performance by excluding non-cash and non-recurring items, complementing GAAP results Non-GAAP Financial Measures 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] - Non-GAAP adjustments include stock-based compensation, depreciation and amortization, restructuring, severance, and a legal settlement[10] - Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools[10] Forward-Looking Statements Forward-looking statements are subject to inherent risks and uncertainties, with actual results potentially differing materially from projections Forward-Looking Statements Disclaimer 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] - 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] Contacts Investor relations contact information for Pulse Biosciences and its external partner is provided Investor Relations 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] - Gilmartin Group Philip Trip Taylor 415.937.5406 philip@gilmartinir.com[14] Condensed Consolidated Financial Statements Condensed consolidated financial statements detail the company's financial position and performance, including balance sheets and operations Condensed Consolidated Balance Sheets 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 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 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]