CeriBell, Inc.(CBLL) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section provides CeriBell, Inc.'s unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements (Unaudited) This section presents CeriBell, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, redeemable convertible preferred stock and stockholders' deficit, and cash flows, along with detailed notes explaining significant accounting policies, revenue recognition, fair value measurements, balance sheet details, employee benefits, commitments, leases, debt, warrants, stockholders' equity, net loss per share, and income taxes for the periods ended June 30, 2025, and December 31, 2024 Condensed Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Balance Sheet Summary (in millions) | Assets/Liabilities | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :----------------- | :-------------------------- | :------------------------------ | | Total assets | $207.7 | $225.4 | | Total liabilities | $35.5 | $34.2 | | Total stockholders' equity | $172.2 | $191.2 | - Total assets decreased by $17.7 million from December 31, 2024, to June 30, 2025, primarily due to a significant reduction in cash and cash equivalents, partially offset by the introduction of marketable securities[19] - Cash and cash equivalents decreased from $194.4 million at December 31, 2024, to $40.1 million at June 30, 2025, while marketable securities increased from zero to $137.3 million[19] Condensed Statements of Operations and Comprehensive Loss This section details the company's financial performance over specific periods, including revenue, gross profit, operating loss, and net loss Operations and Comprehensive Loss Summary (in millions, except per share data) | Metric (in millions) | 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 revenue | $21.2 | $15.3 | $41.7 | $29.7 | | Gross profit | $18.7 | $13.2 | $36.7 | $25.5 | | Loss from operations | $(15.0) | $(8.4) | $(29.2) | $(16.9) | | Net loss | $(13.6) | $(8.9) | $(26.4) | $(17.5) | | Basic and diluted net loss per share | $(0.38) | $(1.61) | $(0.73) | $(3.17) | - Total revenue increased by 38% for the three months and 40% for the six months ended June 30, 2025, compared to the same periods in 2024[21] - Net loss increased by 53% for the three months and 51% for the six months ended June 30, 2025, compared to the same periods in 2024, primarily due to higher operating expenses[21] Condensed Statements of Stockholders' Equity This section outlines changes in the company's equity over time, reflecting net income/loss, stock issuances, and other equity transactions Stockholders' Equity Summary (in millions) | Metric (in millions) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total Stockholders' Equity | $191.2 | $172.2 | | Accumulated Deficit | $(166.9) | $(193.4) | | Additional Paid-in Capital | $358.1 | $365.5 | - Stockholders' equity decreased by $19.0 million from December 31, 2024, to June 30, 2025, mainly due to a net loss of $26.4 million, partially offset by stock-based compensation and common stock issuances[24] Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit This section details the company's redeemable convertible preferred stock and the accumulated deficit, reflecting historical losses Redeemable Convertible Preferred Stock and Stockholders' Deficit Summary (in millions) | Metric (in millions) | December 31, 2023 | June 30, 2024 | | :-------------------- | :---------------- | :------------ | | Redeemable Convertible Preferred Stock Amount | $147.4 | $147.4 | | Total Stockholders' Deficit | $(112.3) | $(127.3) | | Accumulated Deficit | $(126.5) | $(144.0) | - The accumulated deficit increased from $126.5 million at December 31, 2023, to $144.0 million at June 30, 2024, primarily due to net losses incurred during the period[26] Condensed Statements of Cash Flows This section presents the cash inflows and outflows from operating, investing, and financing activities over specific periods Cash Flow Summary (in millions) | Cash Flow Activity (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(18.9) | $(16.5) | | Net cash used in investing activities | $(137.3) | $(1.3) | | Net cash provided by financing activities | $2.0 | $7.7 | | Net decrease in cash and cash equivalents | $(154.2) | $(10.1) | | Cash and cash equivalents, end of period | $40.1 | $24.4 | - Net cash used in investing activities significantly increased in 2025 due to substantial purchases of marketable securities[29] - Net cash provided by financing activities decreased in 2025 compared to 2024, as 2024 included proceeds from debt issuance[29] Notes to Condensed Financial Statements This section provides detailed explanations and additional information supporting the condensed financial statements, including accounting policies and specific account breakdowns 1. The Company This note describes CeriBell, Inc.'s business, its financial position, and the inherent risks associated with its operations in the medical technology industry - CeriBell, Inc. is a commercial-stage medical technology company focused on neurological conditions, utilizing its Ceribell System, an AI-powered EEG platform for rapid diagnosis and continuous monitoring in acute care settings[31][32][115] - As of June 30, 2025, the Company had $177.4 million in cash and cash equivalents and marketable securities, and an accumulated deficit of $193.4 million, expecting to incur near-term losses due to product development and sales/marketing[33][34][121] - The Company faces risks common to the medical device industry, including technological innovations, third-party payer dependence, supply chain pressures, and adverse economic conditions, which could impact financial results[37][38][39] 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the financial statements, ensuring consistency and comparability - The financial statements are prepared in accordance with GAAP and SEC rules, reflecting normal recurring adjustments[43][44] - A 1-for-2.57 reverse stock split was effected on October 4, 2024, retroactively adjusting all share and per-share amounts[45] - The Company operates as one reportable segment, with all revenue generated in the United States[52][53] - The Company extended the exclusivity of licensed patents from Stanford University to May 2036 for a $0.25 million fee, amortized to cost of revenue[54] 3. Revenue This note disaggregates revenue by type, detailing product and subscription revenue, and explains related accounting policies like contract costs Revenue by Type (in millions) | Revenue Type (in millions) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | EEG headbands | $15.9 | $11.6 | $31.5 | $22.6 | | EEG portal and Clarity subscriptions | $5.3 | $3.7 | $10.2 | $7.1 | | Total Revenue | $21.2 | $15.3 | $41.7 | $29.7 | - Product revenue increased by 38% and subscription revenue by 41% for the three months ended June 30, 2025, compared to the prior year[58] - Capitalized contract costs (sales commissions) increased to $3.7 million as of June 30, 2025, from $2.9 million as of June 30, 2024, amortized over an estimated three-year customer life[61] 4. Fair Value Measurements This note provides information on assets and liabilities measured at fair value, categorized by valuation inputs (Level 1, 2, or 3) Fair Value of Assets (in millions) | Asset Type (in millions) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------ | :------------------------- | :----------------------------- | | Money market funds (Level 1) | $36.2 | $178.9 | | U.S. Treasury Bills (Level 1/2) | $66.7 | — | | U.S. Notes and Bonds (Level 1/2) | $70.6 | — | | Total assets, at fair value | $173.5 | $178.9 | - The Company diversified its cash equivalents into marketable securities (U.S. Treasury Bills and Notes/Bonds) by June 30, 2025, which were not present at December 31, 2024[68][70] 5. Balance Sheet Details This note provides a detailed breakdown of specific balance sheet accounts, including inventory, property and equipment, and accrued liabilities Selected Balance Sheet Items (in millions) | Item (in millions) | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Inventory | $6.0 | $6.9 | | Property and Equipment, Net | $2.1 | $2.3 | | Other Non-Current Assets | $2.5 | $2.2 | | Accrued Liabilities | $10.4 | $10.1 | - Inventory decreased by $0.9 million, primarily in finished goods, from December 31, 2024, to June 30, 2025[71] - Accrued liabilities increased by $0.4 million, driven by higher professional fees and employee stock purchase plan liability, partially offset by lower accrued bonuses and commissions[75] 6. Employee Benefit Plan This note describes the company's employee benefit plan, including 401(k) contributions and related expenses - The Company began providing a 50% match for employee 401(k) contributions starting March 1, 2025, contributing $0.3 million for the three months and $0.5 million for the six months ended June 30, 2025[76] 7. Commitments and Contingencies This note discloses the company's commitments and potential liabilities arising from legal proceedings or other contractual obligations - As of June 30, 2025, and December 31, 2024, there were no litigation liabilities recorded[77] 8. Leases This note provides details on the company's operating leases, including right-of-use assets, lease liabilities, and lease expenses Lease Metrics (in millions, except years) | Lease Metric (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Operating lease right-of-use asset | $1.7 | $2.1 | | Total operating lease liabilities | $1.9 | $2.4 | | Weighted average remaining lease term (years) | 1.6 | 2.1 | | Total lease expense (six months) | $0.7 | $0.6 | - Total operating lease liabilities decreased by $0.53 million from December 31, 2024, to June 30, 2025, with a weighted average remaining lease term of 1.6 years[78] 9. Term Loan This note details the company's term loan and revolving facility, including terms, interest rates, and collateral - The Company refinanced its existing term loan in February 2024 with a new Venture Loan and Security Agreement (VLSA) for $20.0 million, maturing in March 2029, and secured by all Company assets excluding intellectual property[80][81][82] - The VLSA includes variable interest rates (Prime Rate for SVB Loan, Prime Rate + 2.75% for Horizon Loan) and end-of-term fees of 4.0% per tranche[83] - A Senior Revolving Facility of up to $10.0 million was also executed, maturing in February 2026, with no amounts drawn as of June 30, 2025[86][91] Notes Payable (in millions) | Notes Payable (in millions) | June 30, 2025 | December 31, 2024 | | :--------------------------- | :------------ | :---------------- | | Principal of notes payable | $20.0 | $20.0 | | Carrying value of Notes Payable | $19.7 | $19.6 | 10. Warrants This note provides information on warrants issued, their exercise price, and their conversion to common stock warrants - Warrants to purchase 41,345 shares of Series C-1 Preferred Stock were issued in February 2024 as part of a $60.0 million financing commitment, with an exercise price of $11.49 per share[93] - All warrants converted to common stock warrants immediately prior to the IPO on October 15, 2024, and are included in Additional paid-in capital[95][94] Warrants Outstanding (shares) | Warrants (shares) | December 31, 2024 | June 30, 2025 | | :---------------- | :---------------- | :------------ | | Total warrants | 102,299 | 102,299 | 11. Stockholders' Equity This note details the company's common stock authorization, shares reserved for equity plans, and stock-based compensation expense - The Company is authorized to issue 500 million shares of $0.001 par value common stock[97] Reserved Common Stock (shares) | Reserved Common Stock (shares) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Conversion of outstanding warrants | 102,299 | 102,299 | | Outstanding options | 4,907,780 | 5,708,070 | | Outstanding RSUs | 1,328,240 | 335,511 | | Shares reserved for future issuance under equity plans | 5,625,849 | 3,964,620 | | Total | 11,964,168 | 10,110,500 | - Total stock-based compensation expense for the six months ended June 30, 2025, was $5.5 million, a significant increase from $1.8 million in the prior year, reflecting increased headcount and public company costs[105] - The Company adopted an Employee Stock Purchase Plan (ESPP) in February 2025, with 810,195 shares available for purchase as of June 30, 2025[106][107] 12. Net loss attributable to common stockholders This note presents the calculation of net loss per share, basic and diluted, for common stockholders Net Loss Attributable to Common Stockholders (in millions, except per share and share data) | Metric (in millions, except per share) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(13.6) | $(8.9) | $(26.4) | $(17.5) | | Weighted-average shares outstanding | 36,294 | 5,560 | 36,088 | 5,507 | | Net loss per share, basic and diluted | $(0.38) | $(1.61) | $(0.73) | $(3.17) | - Diluted net loss per share is the same as basic net loss per share due to the Company's net loss position, making potentially dilutive items anti-dilutive[108] 13. Income Taxes This note explains the company's income tax position, including its effective tax rate, valuation allowance, and the impact of recent tax legislation - The Company had an effective tax rate of 0.0% for the three and six months ended June 30, 2025 and 2024, due to incurring operating losses[110] - A full valuation allowance is maintained against net deferred tax assets due to uncertainties surrounding their realization[111] - The recently enacted One Big Beautiful Bill Act (OBBB Act) on July 4, 2025, will introduce U.S. tax law amendments, the financial impact of which is currently being assessed[112] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on CeriBell, Inc.'s financial condition and operational results, highlighting the company's focus on its AI-powered Ceribell System for neurological conditions, key factors influencing performance, and a detailed comparison of financial results for the three and six months ended June 30, 2025 and 2024. It also discusses liquidity, funding requirements, contractual obligations, and critical accounting estimates Overview This overview introduces CeriBell, Inc.'s core business, its Ceribell System, market adoption, and financial outlook including accumulated deficit and expected future losses - CeriBell, Inc. is a medical technology company transforming neurological diagnosis and management with its Ceribell System, a point-of-care EEG platform integrating portable hardware and AI-powered algorithms[115][117] - The Ceribell System is adopted by over 550 active accounts and has been used for over 200,000 patients, primarily focused on seizure detection in acute care settings[116] - The Company had an accumulated deficit of $193.4 million as of June 30, 2025, and expects continued losses due to investments in R&D, sales & marketing, and public company infrastructure[121][122] Our Business Model This section describes the key drivers of the company's financial performance, including market adoption, utilization, R&D investment, and expansion strategies - Key factors affecting results include adoption of the Ceribell System in new accounts (over 550 active accounts as of June 30, 2025), utilization within the existing customer base, and investment in R&D for innovation and market expansion[123] - The Company aims to expand its direct sales organization in the U.S. and pursue international market access, targeting approximately 6,000 acute care facilities in the U.S.[118][123] - R&D efforts focus on enhancing the Ceribell System and expanding its application to other neurological conditions beyond seizures[123] Components of our Results of Operations This section breaks down the revenue streams and expense categories that constitute the company's financial results, outlining their nature and expected trends - Revenue is generated from disposable headband sales (product revenue, recognized at point of time) and monthly subscription fees for Clarity, recorders, and the portal (subscription revenue, recognized ratably)[124] - Cost of revenue includes materials, labor for headbands, recorder depreciation, third-party hosting fees, and personnel expenses[126] - Operating expenses (R&D, Sales & Marketing, G&A) are expected to increase due to continued product development, commercial expansion, and public company operating costs[130][132][134] Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024 This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025 and 2024, detailing revenue, gross profit, and net loss Three Months Ended June 30 (in millions) | Metric (in millions) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :-------------------- | :------------------------------- | :------------------------------- | :------------- | | Total revenue | $21.2 | $15.3 | 38% | | Product revenue | $15.9 | $11.6 | 38% | | Subscription revenue | $5.3 | $3.7 | 41% | | Gross profit | $18.7 | $13.2 | 42% | | Gross margin | 88% | 86% | 2% pts | | Loss from operations | $(15.0) | $(8.4) | 77% | | Net loss | $(13.6) | $(8.9) | 53% | Six Months Ended June 30 (in millions) | Metric (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | % Change (YoY) | | :-------------------- | :----------------------------- | :----------------------------- | :------------- | | Total revenue | $41.7 | $29.7 | 40% | | Product revenue | $31.5 | $22.6 | 39% | | Subscription revenue | $10.2 | $7.1 | 43% | | Gross profit | $36.7 | $25.5 | 44% | | Gross margin | 88% | 86% | 2% pts | | Loss from operations | $(29.2) | $(16.9) | 73% | | Net loss | $(26.4) | $(17.5) | 51% | - Sales and marketing expenses increased by 63% for the three months and 67% for the six months ended June 30, 2025, primarily due to increased headcount[146][147] - General and administrative expenses rose by 49% for the three months and 43% for the six months, driven by increased personnel costs and professional fees related to public company operations and intellectual property enforcement[148][149] - Interest and other income, net, significantly increased due to higher cash equivalents and marketable securities balances from IPO proceeds[150][151] Cash Flows This section analyzes the company's cash generation and usage across operating, investing, and financing activities for the reported periods Cash Flow Activities (in millions) | Cash Flow Activity (in millions) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(18.9) | $(16.5) | | Net cash used in investing activities | $(137.3) | $(1.3) | | Net cash provided by financing activities | $2.0 | $7.7 | - Net cash used in operating activities increased to $18.9 million in 2025, primarily due to the net loss, partially offset by non-cash charges[153] - Net cash used in investing activities surged to $137.3 million in 2025, mainly due to purchases of marketable securities[155] - Net cash provided by financing activities decreased to $2.0 million in 2025, compared to $7.7 million in 2024, which included significant debt issuance proceeds[156] Liquidity and Capital Resources This section discusses the company's ability to meet its short-term and long-term financial obligations, including available cash, debt, and future funding needs - As of June 30, 2025, principal liquidity sources included $177.4 million in cash, cash equivalents, and marketable securities, and $20.0 million in term loans[160] - The Company believes existing cash and IPO proceeds will fund operations and capital expenditures for at least the next 12 months, but may need additional capital for growth, R&D, or acquisitions[163] - Contractual obligations at June 30, 2025, included $20.0 million in long-term debt principal payments and $2.0 million in operating lease payments due within 19 months[165] Critical Accounting Estimates This section highlights accounting estimates that require significant judgment and could materially impact the financial statements - The Company's financial statements rely on estimates and judgments, with no material changes to significant accounting policies or estimates during the six months ended June 30, 2025[166][167] Recently Issued Accounting Pronouncements This section refers to the notes to financial statements for details on new accounting standards and their potential impact on the company - Refer to Note 2 of the financial statements for details on recently issued accounting pronouncements applicable to the Company[168] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no quantitative and qualitative disclosures about market risk applicable to the Company for the reporting period - The Company has no applicable quantitative and qualitative disclosures about market risk for this reporting period[169] Item 4. Controls and Procedures Management, with CEO and CFO participation, evaluated the effectiveness of disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of June 30, 2025. No material changes in internal control over financial reporting were identified, though the inherent limitations of control systems are acknowledged - Disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of June 30, 2025[170] - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025[171] - The effectiveness of internal controls is subject to inherent limitations, including judgment, human error, and potential for circumvention[172][174] PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures Item 1. Legal Proceedings CeriBell, Inc. initiated patent infringement complaints against Natus Medical Incorporated on July 7, 2025, alleging infringement of six patents related to the Ceribell EEG headband and electrode design, and unfair competition. The Company seeks an exclusion order from the USITC and damages from the U.S. District Court - On July 7, 2025, CeriBell, Inc. filed patent infringement complaints against Natus Medical Incorporated with the USITC and the U.S. District Court for the District of Delaware[176] - The complaints allege infringement of six patents related to the Ceribell EEG headband and electrode design and unfair competition, seeking an exclusion order and damages[176] - The Company is not currently a party to any other litigation that would materially and adversely affect its business, but acknowledges that legal proceedings are costly and unpredictable[177] Item 1A. Risk Factors This section outlines significant risks that could materially and adversely affect CeriBell, Inc.'s business, financial condition, results of operations, and prospects. These risks span business and industry challenges, regulatory compliance, reliance on third parties, data privacy, AI technology, intellectual property protection, financial and accounting matters, and common stock ownership Business and Industry Risk Factors This section details risks related to the company's limited operating history, market acceptance, competitive landscape, supply chain, and macroeconomic conditions - The Company has a limited operating history and expects to incur substantial losses in the foreseeable future, with an accumulated deficit of $193.4 million as of June 30, 2025[179][183] - Dependence on sales from the Ceribell System means failure to achieve substantial market acceptance or diminished confidence in products would harm the business[186] - The Company operates in a highly competitive industry, facing larger, more established conventional EEG providers and other rapid EEG system developers[190] - Reliance on international manufacturers and suppliers, particularly in China, exposes the Company to foreign operational risks, trade risks (e.g., tariffs, political instability), and supply chain disruptions[194][195][197][202] - Inability to innovate at the pace of competitors, attract and retain key personnel, or manage rapid growth could adversely affect the business[205][210][223] - Macroeconomic conditions, including inflation and high interest rates, could negatively impact demand, increase costs, and affect hospital spending on equipment[227][229][230] Risk Related to Regulatory Matters This section covers risks associated with healthcare reimbursement, fraud and abuse laws, FDA regulations, product safety, and international regulatory compliance - Adequate reimbursement for diagnostic tests using Ceribell System is critical; changes in coverage or reimbursement rates could diminish sales or profitability[232][236] - The Company is subject to extensive federal and state fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), and non-compliance could lead to substantial penalties, investigations, and reputational harm[241][247] - Healthcare policy changes, including the Affordable Care Act and other cost-containment measures, could limit coverage or lower reimbursement for products[249][252] - Failure to maintain marketing authorizations or timely obtain new ones for future products, or non-compliance with FDA regulations (e.g., QSR), could harm the business and lead to enforcement actions or product recalls[257][275] - Products may cause adverse medical events (e.g., false alarms, skin irritation, infection hazards) requiring FDA reporting, and misuse or off-label use could lead to product liability suits and regulatory sanctions[276][279][283][284] - Future international expansion will subject the Company to foreign regulatory requirements, which are complex and vary widely, potentially delaying market entry and increasing costs[289] Risks Related to Our Reliance on Third Parties This section addresses risks stemming from dependence on third-party manufacturers, suppliers, clinical investigators, and service providers for critical aspects of the business - Manufacturing of the Ceribell System relies on third-party manufacturers in China and various component suppliers, exposing the Company to risks of supply chain disruptions, quality control issues, and increased costs[293][294][296] - Dependence on a limited number of single-source suppliers for critical components makes the Company vulnerable to supply shortages, price fluctuations, and delays in qualifying alternative sources[298][299][300] - Reliance on independent investigators and collaborators for preclinical studies and clinical trials means less direct control over conduct, timing, and data quality, potentially delaying marketing authorization[301][302][307] - The Company relies on contracted physicians for remote EEG reading services, and termination of these contracts could impact service provision to customers[309] Data Privacy Risk Factors This section highlights risks related to evolving global data privacy laws, cybersecurity threats, data breaches, and the adequacy of insurance coverage - The Company is subject to evolving global data privacy and security laws (e.g., HIPAA, CCPA, EU GDPR, UK GDPR), and non-compliance could lead to significant penalties, reputational damage, and operational changes[310][313][314][315] - Cybersecurity threats, information technology system failures, and data breaches could disrupt operations, lead to data loss, incur substantial costs for investigation and remediation, and harm reputation[329][330][332][335] - Existing insurance policies may not fully cover potential claims related to security breaches, potentially exposing the Company to significant liabilities[336] Risks Associated with AI and Machine Learning Models This section addresses risks inherent in the company's reliance on AI and machine learning models, including design flaws, data quality issues, misuse, and evolving regulatory frameworks - The Company's reliance on AI and machine learning models (e.g., Clarity algorithm) carries risks if models are incorrectly designed, trained on poor quality data, misused, or suffer unforeseen defects, potentially impacting product performance and reputation[319][321][322] - An earlier version of the Clarity algorithm failed to detect seizures in certain ICU patients, highlighting performance limitations[323] - The regulatory framework for AI Technologies is rapidly evolving, with potential new laws and interpretations that could limit the Company's use of AI, increase operating expenses, and require significant resources for compliance[324][328] Risks Related to Our Intellectual Property This section details risks concerning the company's ability to obtain, maintain, enforce, and protect its intellectual property, including patents, trade secrets, and licensed technology - Success depends on obtaining, maintaining, enforcing, and protecting intellectual property (patents, trademarks, trade secrets); failure could erode competitive advantage and harm the business[337][338][340] - Patent prosecution is expensive and uncertain; issued patents may be challenged, invalidated, or circumvented, and pending applications may not result in broad protection[339][340][345] - Changes in U.S. or foreign patent laws or their interpretations could diminish patent value and increase prosecution/enforcement costs[349][352] - Enforcing intellectual property rights globally is challenging and expensive, as foreign laws may offer less protection, and proceedings can divert resources[357][359][361] - The Company may face intellectual property litigation or administrative proceedings, which are costly, time-consuming, and could result in substantial damages, injunctions, or invalidation of rights[362][364][365][371] - Reliance on licensed intellectual property (e.g., from Stanford University) means rights are subject to license terms and potential termination, impacting product development and commercialization[378][379] - Failure to protect trade secrets and confidential information through contracts and security measures could harm competitive position if disclosed or independently developed by competitors[383][384][387] - Use of third-party open source software components could require public disclosure of proprietary code or lead to litigation if license terms are not met[390][391] - Licensed technology developed with U.S. government grants is subject to the Bayh-Dole Act, which includes domestic manufacturing requirements and potential 'march-in rights' that could limit exploitation[392][393] Risks Relating to Financial and Accounting Matters This section covers financial risks including limitations on NOL carryforwards, tax rate volatility, restrictive debt covenants, and exposure to uninsured cash deposits - The Company's ability to use its net operating loss (NOL) carryforwards (approximately $127.1 million federal, $126.9 million state as of December 31, 2024) may be limited by ownership changes under Sections 382 and 383 of the Internal Revenue Code[394][396] - The effective tax rate may vary significantly due to changes in tax laws, regulations, accounting pronouncements, and the market price of common stock affecting share-based compensation tax benefits[397][398] - Changes in tax laws, such as the Inflation Reduction Act and the OBBB Act, could adversely affect effective tax rates and financial condition[399][400] - The venture loan and security agreement (VLSA) and revolving facility contain restrictive covenants that limit operational flexibility, and a breach could trigger immediate debt repayment[401][402] - Cash deposits exceeding insured limits with financial institutions pose a risk of loss or delayed access to funds in case of institutional failure[403] Risks Relating to Ownership of Our Common Stock This section addresses risks for common stockholders, including market price volatility, dilution from future issuances, control by principal stockholders, and anti-takeover provisions - As an emerging growth company and smaller reporting company, reduced reporting requirements may make common stock less attractive to investors, potentially affecting market price and volatility[404][406] - Operating as a public company incurs increased legal, accounting, and compliance costs, potentially lowering profits[409] - Failure to maintain effective internal control over financial reporting could erode investor confidence and lead to a decline in stock price[410] - The Company does not intend to pay dividends in the foreseeable future, meaning investor returns will depend on stock price appreciation[411] - Future securities issuances could significantly dilute existing stockholders' ownership and depress the market price of common stock[414] - Principal stockholders and management own approximately 60% of common stock, enabling them to exert significant control over stockholder approval matters[416] - Provisions in charter documents and Delaware law could discourage takeovers and entrench management[417][418] - The market price of common stock may be volatile due to various factors, including financial performance, competitor announcements, and general economic conditions[426] General Risk Factors This section covers broad risks such as those related to acquisitions, natural disasters, and the costs and unpredictability of legal and arbitration proceedings - Acquisitions or strategic partnerships could increase capital requirements, dilute stockholders, incur debt, and introduce integration risks[431][432] - Natural disasters and catastrophic events, especially given facilities near earthquake faults in California, could severely disrupt operations and supply chains, with limited disaster recovery plans and no earthquake insurance[433][437][438] - Legal and arbitration proceedings may prevent business activities or incur significant costs, and insurance may not cover all potential losses[439][440][443] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports no unregistered sales of equity securities. It details the use of proceeds from the October 15, 2024 IPO, which generated $188.2 million net, allocated to sales and marketing, R&D (including delirium and ischemic stroke indications), and general corporate purposes, with no material change in intended use - No unregistered sales of equity securities occurred during the period[444] - The IPO on October 15, 2024, generated approximately $188.2 million in net proceeds[445] - IPO proceeds are used to fund sales and marketing, research and product development (including delirium and ischemic stroke indications), and general corporate purposes[446] - There has been no material change in the intended use of IPO proceeds[447] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities during the reporting period[448] Item 4. Mine Safety Disclosures This section indicates that mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to the Company[449] Item 5. Other Information This section discloses Rule 10b5-1 trading plans adopted by certain officers. Dr. Josef Parvizi adopted and subsequently terminated a plan due to a clerical error, with no trades executed. Raymond Woo, Ph.D., adopted a plan for 120,008 shares Rule 10b5-1 Trading Plans | Name | Action | Date | Trading Arrangement | Total Shares to be Sold | Expiration Date | | :------------------------ | :---------- | :----------- | :------------------ | :---------------------- | :-------------- | | Josef Parvizi, M.D., Ph.D. | Adopt | May 22, 2025 | Rule 10b5-1 | 180,000 | April 30, 2026 | | Josef Parvizi, M.D., Ph.D. | Terminate | June 25, 2025| Rule 10b5-1 | 180,000 | April 30, 2026 | | Raymond Woo, Ph.D. | Adopt | May 28, 2025 | Rule 10b5-1 | 120,008 | May 19, 2026 | - Dr. Josef Parvizi's Rule 10b5-1 trading plan, adopted on May 22, 2025, was terminated on June 25, 2025, due to a clerical error, with no trades executed[450][451] - Raymond Woo, Ph.D., Chief Technology Officer, adopted a Rule 10b5-1 trading plan on May 28, 2025, for 120,008 shares[450] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including organizational documents, certifications, and XBRL-related documents. It notes that certain portions of Exhibit 10.1 have been omitted as non-material and confidential - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Form of Common Stock Certificate, and an Amendment to the Exclusive (Equity) Agreement with Stanford University[452][453] - Certifications from the Principal Executive Officer and Principal Financial Officer are included pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[453][454] - XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are provided[453] Signatures This section contains the required signatures for the Quarterly Report on Form 10-Q, affirming its submission on behalf of CeriBell, Inc. by its President and Chief Executive Officer, Xingjuan (Jane) Chao, Ph.D., and Chief Financial Officer, Scott Blumberg, on August 5, 2025 - The report is signed by Xingjuan (Jane) Chao, Ph.D., President and Chief Executive Officer, and Scott Blumberg, Chief Financial Officer, on August 5, 2025[458][459]