Pulse Biosciences(PLSE) - 2025 Q1 - Quarterly Results

Recent Business Highlights Pulse Biosciences reports significant progress in Q1 2025, with growing clinical evidence supporting its nsPFA technology across three key device areas: soft tissue ablation, surgical AF ablation, and endocardial catheter AF ablation. The company is preparing for the commercial launch of its nsPFA Percutaneous Electrode System in H2 2025 and plans to initiate pivotal U.S. clinical trials for its cardiac systems in mid-2025 - CEO Paul LaViolette highlighted mounting clinical evidence for nsPFA technology and significant progress in early 2025, positioning the company for commercial expansion and pivotal trial initiations in mid-2025[2] - Key strategic advancements include: - Expanded commercial resources for the nsPFA Percutaneous Electrode launch in H2 2025 - Planned U.S. clinical trial for benign thyroid nodules in mid-2025 - Received EU approval to expand the patient cohort for the nsPFA Cardiac Surgery System's first-in-human AF study - On track to commence a pivotal U.S. trial for the nsPFA Cardiac Surgery System in mid-2025 - Presented positive clinical data for the nsPFA 360° catheter at the Heart Rhythm Society 2025 Meeting - Completed treatment of 100 patients in the European first-in-human study for the nsPFA 360° catheter - Expects to start a U.S. IDE pivotal study for the nsPFA 360° catheter in mid-2025[7] First Quarter 2025 Financial Results In Q1 2025, Pulse Biosciences reported no revenue. Total GAAP costs and expenses increased to $18.0 million, and the GAAP net loss widened to ($16.8) million from ($10.1) million year-over-year, primarily due to higher non-cash stock-based compensation and expenses related to organizational expansion for clinical trials and commercialization. The company maintained a strong cash position of $119.3 million, bolstered by $14.1 million in net proceeds from warrant exercises Q1 2025 vs Q1 2024 Key Financial Metrics | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | GAAP Costs & Expenses | $18.0 | $10.6 | +$7.4 | | Non-GAAP Costs & Expenses | $12.7 | $8.6 | +$4.1 | | GAAP Net Loss | ($16.8) | ($10.1) | +$6.7 | | Non-GAAP Net Loss | ($11.4) | ($8.1) | +$3.3 | - The increase in costs was primarily driven by non-cash stock-based compensation and other expenses related to expanding the organization to support clinical trials and commercialization[3][4] Cash Position and Usage | Metric | As of Mar 31, 2025 (in millions) | As of Mar 31, 2024 (in millions) | As of Dec 31, 2024 (in millions) | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $119.3M | $34.9M | $118.0M | | Cash Used in Operations (Q1) | $13.5M | $9.8M | $9.1M (Q4 2024) | - The cash balance as of March 31, 2025, included $14.1 million in net proceeds from the exercise of warrants during the first quarter[5] Financial Statements This section presents the unaudited condensed consolidated financial statements as of March 31, 2025, and for the three months then ended. It includes the Balance Sheets, showing an increase in total assets and stockholders' equity, and the Statements of Operations, detailing the components of the net loss for the quarter Condensed Consolidated Balance Sheets As of March 31, 2025, Pulse Biosciences' total assets were $133.4 million, a slight increase from $132.5 million at year-end 2024. Total liabilities decreased to $14.9 million from $17.6 million, primarily due to a reduction in accrued expenses. Consequently, total stockholders' equity increased to $118.5 million from $114.9 million Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $119,279 | $118,038 | | Total current assets | $120,909 | $119,449 | | Total assets | $133,383 | $132,460 | | 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 For the first quarter of 2025, the company reported no revenue. The net loss was ($16.8) million, or ($0.25) per share, compared to a net loss of ($10.1) million, or ($0.18) per share, in Q1 2024. The increased loss was driven by higher operating expenses, with R&D costs rising to $10.3 million and G&A costs to $7.7 million, both significantly impacted by increased stock-based compensation Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenues | $— | $— | | 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) | | Basic and diluted net loss per share | ($0.25) | ($0.18) | 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 | Reconciliation of GAAP to Non-GAAP Financial Measures This section provides a detailed reconciliation of GAAP to non-GAAP financial measures for Q1 2025 and Q1 2024. The company adjusts for non-cash expenses like stock-based compensation and depreciation/amortization, as well as a legal settlement, to offer what it believes is a clearer view of its ongoing operational performance. Non-GAAP net loss for Q1 2025 was ($11.4) million, compared to the GAAP net loss of ($16.8) million - Management uses non-GAAP measures to supplement GAAP results, believing it aids in monitoring ongoing financial performance by excluding items like stock-based compensation, depreciation, amortization, and legal settlements[10] Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP Net loss | ($16,795) | ($10,137) | | Add: Stock-based compensation expense | $5,681 | $1,759 | | Add: Depreciation and amortization | $282 | $300 | | Less: Legal settlement | ($590) | $— | | Non-GAAP Net loss | ($11,422) | ($8,078) | Reconciliation of GAAP to Non-GAAP Costs and Expenses (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP Cost and expenses | $18,044 | $10,615 | | Less: Stock-based compensation expense | ($5,681) | ($1,759) | | Less: Depreciation and amortization | ($282) | ($300) | | Add: Legal settlement | $590 | $— | | Non-GAAP Cost and expenses | $12,671 | $8,556 |