Alector(ALEC) - 2025 Q2 - Quarterly Report

FORM 10-Q Cover Page This section provides key filing details for Alector, Inc.'s Quarterly Report on Form 10-Q for the period ended June 30, 2025 - Alector, Inc. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025, as a Delaware corporation and accelerated filer[2][3][4] Common Stock Listing Details | Title of each class | Trading Symbol | Name of each exchange on which registered | | :------------------ | :------------- | :---------------------------------------- | | Common Stock | ALEC | The Nasdaq Stock Market LLC | - As of August 1, 2025, 101,212,329 shares of common stock were outstanding[4] Table of Contents This section outlines the report's structure, divided into PART I. FINANCIAL INFORMATION and PART II. OTHER INFORMATION, covering financial statements, management's discussion, and other disclosures - The report is structured into PART I. FINANCIAL INFORMATION and PART II. OTHER INFORMATION, covering financial statements, management's discussion, market risk, controls, legal proceedings, risk factors, and exhibits[6] SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This section highlights that the report contains forward-looking statements subject to risks and uncertainties, with no obligation for public updates unless legally required - This report contains forward-looking statements concerning future results, business strategy, product candidates, clinical trials, and regulatory approvals, which inherently involve known and unknown risks and uncertainties[8][9] - The company does not plan to publicly update or revise any forward-looking statements herein, except as required by applicable law[10] PART I. FINANCIAL INFORMATION This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period Item 1. Financial Statements. This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, statements of cash flows, and accompanying notes, providing a detailed view of its financial position and performance Condensed Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time, highlighting changes in financial position Condensed Consolidated Balance Sheet Summary (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Total assets | $356,422 | $468,303 | $(111,881) | | Total liabilities | $285,247 | $341,503 | $(56,256) | | Total stockholders' equity | $71,175 | $126,800 | $(55,625) | | Accumulated deficit | $(900,122) | $(829,127) | $(70,995) | - Current assets decreased by $105.6 million, primarily due to a reduction in marketable securities[15] - Current liabilities decreased by $40.7 million, mainly driven by a reduction in accrued liabilities and the current portion of refund liability to collaboration partner[15] Condensed Consolidated Statements of Operations and Comprehensive Loss This statement details the company's revenues, expenses, and net loss over specific periods, reflecting its operational performance and comprehensive loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | 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 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $7,874 | $15,083 | $11,548 | $30,976 | | Research and development | $27,611 | $46,314 | $61,252 | $91,481 | | General and administrative | $14,401 | $14,375 | $29,129 | $28,809 | | Total operating expenses | $42,012 | $60,689 | $90,381 | $120,290 | | Loss from operations | $(34,138) | $(45,606) | $(78,833) | $(89,314) | | Other income, net | $3,614 | $7,003 | $7,838 | $14,639 | | Net loss | $(30,524) | $(38,676) | $(70,995) | $(74,755) | | Net loss per share, basic and diluted | $(0.30) | $(0.40) | $(0.71) | $(0.78) | - Net loss decreased by $8.152 million for the three months ended June 30, 2025, and by $3.760 million for the six months ended June 30, 2025, compared to the prior year periods[18] - Collaboration revenue decreased significantly year-over-year for both the three-month and six-month periods[18] Condensed Consolidated Statements of Stockholders' Equity This statement tracks changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, over specific reporting periods Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric (in thousands) | Balance Dec 31, 2024 | March 31, 2025 | June 30, 2025 | | :-------------------- | :------------------- | :------------- | :------------ | | Common Stock (Amount) | $9 | $9 | $9 | | Additional Paid-In Capital | $955,657 | $964,008 | $971,192 | | Accumulated Other Comprehensive Income (Loss) | $261 | $191 | $96 | | Accumulated Deficit | $(829,127) | $(869,598) | $(900,122) | | Total Stockholders' Equity | $126,800 | $94,610 | $71,175 | - Total stockholders' equity decreased from $126.8 million at December 31, 2024, to $71.2 million at June 30, 2025, primarily due to net losses[22] - Stock-based compensation added $15.4 million to additional paid-in capital for the six months ended June 30, 2025[22][67] Condensed Consolidated Statements of Cash Flows This statement summarizes the cash inflows and outflows from operating, investing, and financing activities, illustrating changes in the company's cash position Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash used in operating activities | $(109,829) | $(124,143) | | Cash provided by investing activities | $121,457 | $25,381 | | Cash provided by financing activities | $122 | $71,752 | - Net cash used in operating activities decreased by $14.3 million for the six months ended June 30, 2025, compared to the same period in 2024[29] - Net cash provided by investing activities significantly increased by $96.1 million, primarily due to higher maturities of marketable securities[29] Notes to Condensed Consolidated Financial Statements This section provides additional information and explanations for the figures presented in the financial statements, detailing accounting policies, significant estimates, and other disclosures 1. The Company and Liquidity This note describes Alector, Inc.'s business as a late-stage clinical biotechnology company and details its recent capital-raising activities to support operations - Alector, Inc. is a late-stage clinical biotechnology company focused on developing therapies for neurodegeneration[31] - The company completed a public offering on January 19, 2024, raising $71.1 million in net proceeds from the sale of 10,869,566 shares of common stock[32] 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements, including revenue recognition and fair value measurements - The condensed consolidated financial statements are prepared in conformity with GAAP and include all normal, recurring adjustments necessary for fair presentation of interim results[33] - Marketable securities are classified as 'available-for-sale' and carried at fair value, with unrealized gains/losses excluded from earnings and included in other comprehensive income[40] - Revenue from collaboration agreements is recognized when control of promised goods or services is transferred, either at a point in time or over time based on costs incurred for research and development services[46][47] 3. Fair Value Measurements This note details the fair value hierarchy and measurements for the company's financial assets, primarily marketable securities, as of the reporting dates Fair Value Measurements of Financial Assets (in thousands) | Asset Type (in thousands) | June 30, 2025 Fair Market Value | December 31, 2024 Fair Market Value | | :------------------------ | :------------------------------ | :---------------------------------- | | Money market funds | $41,106 | $31,310 | | U.S. government treasury securities | $28,326 | $72,360 | | Certificates of deposit | $15,999 | $15,958 | | Commercial paper | $107,556 | $81,780 | | Corporate bonds | $113,366 | $210,278 | | Total cash equivalents and marketable securities | $306,353 | $411,686 | - The company's financial assets measured at fair value, primarily marketable securities, decreased by $105.3 million from December 31, 2024, to June 30, 2025[55] - The majority of investments are in Level 1 (money market funds, U.S. government treasury securities) and Level 2 (certificates of deposit, commercial paper, corporate bonds) of the fair value hierarchy[55] 4. Commitments and Contingencies This note addresses potential future obligations and legal matters, including indemnification arrangements, that could impact the company's financial position - The company does not believe any current legal matters will have a material adverse effect on its financial position, results of operations, or cash flows[56] - Customary indemnification arrangements are in place with vendors, clinical trial sites, and other parties, with maximum potential future payments not determinable[57] 5. Collaboration Agreement with GSK This note details the strategic collaboration with GSK for developing progranulin-elevating monoclonal antibodies, including financial terms and revenue recognition impacts - Alector and GSK collaborate on global development and commercialization of progranulin-elevating monoclonal antibodies, including latozinemab and AL101, under an agreement effective August 17, 2021[58] - Alector received $700 million in upfront payments and is eligible for up to an additional $1.5 billion in clinical development, regulatory, and commercial launch-related milestone payments[59] - Collaboration revenue for the three and six months ended June 30, 2025, was $7.9 million and $11.5 million, respectively, representing a decrease from the prior year due to estimated refund liabilities and program modifications[63][64] 6. Stock-based Compensation This note provides details on the company's stock-based compensation expenses, categorized by function, and their impact on financial results Stock-based Compensation Expense (in thousands) | Expense Category (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 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,838 | $4,990 | $6,500 | $10,385 | | General and administrative | $4,224 | $4,919 | $8,913 | $9,831 | | Total stock-based compensation | $7,062 | $9,909 | $15,413 | $20,216 | - Total stock-based compensation decreased by $2.8 million for the three months and $4.8 million for the six months ended June 30, 2025, compared to the prior year[67] 7. Income Taxes This note explains the company's income tax position, including its effective tax rate and the anticipated impact of new tax legislation - The company's effective tax rate was 0% for the three and six months ended June 30, 2025, primarily due to a full valuation allowance on its net deferred tax asset[68] - New U.S. tax legislation, the 'One Big Beautiful Bill Act' (OBBBA), signed July 4, 2025, is not anticipated to have a material impact on results of operations until 2026[69] 8. Net Loss Per Share This note details the calculation of net loss per share and identifies potentially dilutive shares excluded due to their anti-dilutive effect Potentially Dilutive Shares Excluded from EPS Calculation | Potentially Dilutive Shares | June 30, 2025 | June 30, 2024 | | :-------------------------- | :------------ | :------------ | | Restricted stock units subject to future vesting | 5,399,351 | 5,374,701 | | Options to purchase common stock | 10,177,305 | 11,346,095 | | Shares committed under 2019 ESPP | 103,326 | 171,412 | | Total | 15,679,982 | 16,892,208 | - Approximately 15.7 million potentially dilutive shares were excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2025, due to their anti-dilutive effect[70] 9. Restructuring This note describes the company's workforce reduction plan initiated in March 2025 and the associated one-time restructuring charges incurred - On March 7, 2025, the company committed to a plan to reduce its workforce by approximately 13% (25 employees) as part of cost reduction initiatives[71] - One-time restructuring charges are expected to be approximately $2.4 million, primarily for personnel expenses, with $2.3 million incurred for the six months ended June 30, 2025[71] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, including an overview of its business, detailed analysis of revenue and expenses, liquidity, capital resources, and critical accounting policies Overview This overview introduces Alector as a late-stage clinical biotechnology company, highlights its key clinical and preclinical programs, and summarizes its recent financial performance and liquidity position - Alector is a late-stage clinical biotechnology company focused on developing therapies for neurodegenerative diseases, leveraging proprietary protein engineering, antibody discovery, and Alector Brain Carrier (ABC) technology[73][74] - The clinical pipeline includes latozinemab (Phase 3 for FTD-GRN, topline data by mid-Q4 2025) and AL101/GSK4527226 (Phase 2 for early AD, enrollment completed April 2025)[76][79][83] - Preclinical programs include ADP037-ABC (anti-Aβ for AD), ADP050-ABC (GCase replacement for PD/LBD), and ADP064-ABC (anti-tau siRNA for AD)[86][87][88] - The company reported net losses of $30.5 million for Q2 2025 and $71.0 million for H1 2025, with an accumulated deficit of $900.1 million as of June 30, 2025[90] - Cash, cash equivalents, and marketable securities totaled $307.3 million as of June 30, 2025, providing anticipated runway into the second half of 2027, following a 13% workforce reduction in March 2025[91] Components of Results of Operations This section breaks down the key financial components contributing to the company's operating results, including revenue, research and development expenses, general and administrative expenses, and other income Revenue This subsection explains the sources of the company's revenue, primarily from collaboration agreements, and details deferred revenue related to the GSK Agreement - Revenue is primarily derived from collaboration agreements, specifically the GSK Agreement, with no product sales to date[92] - The GSK Agreement included $700 million in upfront payments and potential milestone payments of up to $1.5 billion[93] - Deferred revenue related to the GSK Agreement was $182.3 million as of June 30, 2025, expected to be recognized over the research and development period through completion of initial Phase 2 clinical trials[96] Research and Development Expenses This subsection details the significant costs associated with the company's R&D activities, including third-party services, clinical materials, personnel, and regulatory submissions - R&D expenses are a significant portion of operating expenses, recorded as incurred, and include costs for third-party contract organizations, clinical materials, lab/vendor expenses, personnel, and regulatory submissions[97][101] - Specific program expenses include latozinemab (Phase 3) and AL101 (Phase 2), with expectations for substantial increases in R&D expenses as product candidates advance[98][100] General and Administrative Expenses This subsection outlines the costs associated with the company's administrative functions, including personnel, legal, accounting, and facility expenses - G&A expenses primarily consist of personnel-related costs (including stock-based compensation) for executive, legal, finance, IT, human resources, and other administrative functions[101] - These expenses also include legal fees, professional fees for accounting, auditing, consulting, and tax services, insurance costs, and facility costs[102] Other Income, Net This subsection describes the primary source of other income, which is interest earned on cash equivalents and marketable securities - Other income, net, primarily consists of interest earned on cash equivalents and marketable securities[103] Income Tax Expense This subsection identifies the components of the company's income tax expense, comprising federal and state provisions - Income tax expense consists of federal and state income tax provisions[104] Results of Operations This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025, versus the prior year Comparison of the Three Months Ended June 30, 2025 and 2024 This subsection compares the company's financial performance, including revenue, expenses, and net loss, for the second quarter of 2025 against the same period in 2024 Three Months Ended June 30, 2025 vs 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Dollar Change | | :-------------------- | :------------ | :------------ | :------------ | | Collaboration revenue | $7,874 | $15,083 | $(7,209) | | Research and development | $27,611 | $46,314 | $(18,703) | | General and administrative | $14,401 | $14,375 | $26 | | Other income, net | $3,614 | $7,003 | $(3,389) | | Net loss | $(30,524) | $(38,676) | $8,152 | - Collaboration revenue decreased by $7.2 million, mainly due to the satisfaction of performance obligations for the AL002 program and latozinemab FTD-C9orf72 Phase 2 trial in Q4 2024[106] - Research and development expenses decreased by $18.7 million, driven by reduced program costs for AL002 and latozinemab, and lower personnel-related costs from workforce reductions[107] Comparison of the Six Months Ended June 30, 2025 and 2024 This subsection compares the company's financial performance, including revenue, expenses, and net loss, for the first half of 2025 against the same period in 2024 Six Months Ended June 30, 2025 vs 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Dollar Change | | :-------------------- | :------------ | :------------ | :------------ | | Collaboration revenue | $11,548 | $30,976 | $(19,428) | | Research and development | $61,252 | $91,481 | $(30,229) | | General and administrative | $29,129 | $28,809 | $320 | | Other income, net | $7,838 | $14,639 | $(6,801) | | Net loss | $(70,995) | $(74,755) | $3,760 | - Collaboration revenue decreased by $19.4 million, primarily due to the completion of performance obligations for the AL002 program and latozinemab FTD-C9orf72 Phase 2 trial[113] - Research and development expenses decreased by $30.2 million, mainly due to reduced costs for the AL002 and latozinemab programs and lower personnel expenses from workforce reductions[114] Liquidity and Capital Resources This section assesses the company's ability to meet its financial obligations, detailing its cash position, future funding needs, and potential sources of additional capital - As of June 30, 2025, the company had $307.3 million in cash, cash equivalents, and marketable securities, anticipated to fund operations into the second half of 2027[119][121] - Future funding requirements are substantial and depend on the progress of R&D activities, clinical trials, regulatory approvals, and commercialization efforts[120][123] - The company may seek additional capital through public equity or debt financings, license agreements, or other arrangements, and has access to up to $50 million in Term Loans under a November 2024 agreement[121][122] Cash Flows This section analyzes the company's cash movements from operating, investing, and financing activities, highlighting significant changes between reporting periods Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash used in operating activities | $(109,829) | $(124,143) | | Cash provided by investing activities | $121,457 | $25,381 | | Cash provided by financing activities | $122 | $71,752 | - Net cash used in operating activities decreased to $109.8 million in H1 2025, primarily due to a lower net loss and changes in operating assets and liabilities[126] - Net cash provided by investing activities significantly increased to $121.5 million in H1 2025, mainly driven by maturities of marketable securities[128] Critical Accounting Policies and Estimates This section discusses the significant judgments and assumptions management makes in applying accounting policies, particularly for revenue recognition and accruals - The preparation of financial statements requires management to make estimates and assumptions, particularly in areas like revenue recognition, manufacturing and clinical accruals, and fair value measurements[130][131] - Revenue recognition involves identifying performance obligations, determining transaction price, allocating it, and recognizing revenue as control is transferred or costs are incurred, with re-evaluation of expected costs each period[132][133] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section describes the company's exposure to market risks, primarily interest rate risk on its investment portfolio and foreign currency risk from international transactions - The company's primary market risk is interest rate sensitivity on its $307.3 million in cash, cash equivalents, and marketable securities[135] - An immediate 100 basis point increase or decrease in interest rates would cause an approximate $1.1 million change in the fair value of these investments[135] - Foreign currency risk from contracts denominated in foreign currencies is not material, and the company does not have a formal hedging program[137] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, and reported no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[138] - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[139] PART II. OTHER INFORMATION This part provides additional disclosures beyond financial statements, covering legal proceedings, risk factors, equity sales, defaults, and exhibits Item 1. Legal Proceedings The company is not currently involved in any litigation or legal proceedings that management believes would have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings likely to have a material adverse effect on its business[142] - Regardless of outcome, litigation can have an adverse impact due to legal fees, settlement costs, and diversion of management resources[142] Item 1A. Risk Factors This section details various risks that could significantly impact the company's business, financial condition, results of operations, and growth prospects, categorized into business, financial, development, regulatory, third-party reliance, intellectual property, and general operational risks Summary of Risk Factors This summary outlines the principal risks, including limited operating history, significant net losses, drug development uncertainties, reliance on third parties, and the need for substantial additional financing - Key risks include a limited operating history, significant net losses, the highly uncertain nature of drug development, reliance on third-party service providers, and the need for substantial additional financing[144] - The company must prioritize development of certain product candidates due to resource constraints and faces risks related to clinical trial delays, adverse events, and intense competition in neurodegenerative diseases[144] Risks Related to Our Business, Financial Condition, and Capital Requirements This section details risks associated with the company's operational history, ongoing financial losses, substantial funding needs, and the implications of its loan agreements - The company has a limited operating history since May 2013, no products approved for commercial sale, and has terminated several product candidates, making future success difficult to predict[145][147] - Alector has incurred significant net losses ($30.5 million for Q2 2025, $71.0 million for H1 2025) and expects continued losses, with an accumulated deficit of $900.1 million as of June 30, 2025[149] - Substantial additional funding will be required to complete development and commercialization of product candidates, despite current cash, cash equivalents, and marketable securities of $307.3 million providing runway into H2 2027[159][160] - The Loan Agreement for up to $50 million in Term Loans includes operating covenants and grants a first priority security interest on assets, which could limit financial flexibility[166][167] Risks Related to the Discovery, Development, and Commercialization of Our Product Candidates This section outlines the inherent uncertainties and challenges in drug development, including clinical trial failures, regulatory hurdles, competition, and manufacturing complexities - Drug development is inherently risky; there is no assurance that any product candidates will receive regulatory approval or be successfully commercialized[170][178] - Clinical trials are expensive, time-consuming, and uncertain, with potential for delays, suspensions, or terminations due to factors like insufficient patient enrollment or adverse events[186][191] - AL002 failed its primary endpoint in the INVOKE-2 Phase 2 clinical trial, leading to the termination of the program and the AbbVie Agreement[174][195] - Treatment-emergent MRI findings resembling ARIA were observed in the INVOKE-2 trial, posing risks for future clinical trials and regulatory approval[196][241] - The company faces significant competition from major pharmaceutical and biotechnology companies, some with greater resources and approved products for neurodegenerative diseases (e.g., donanemab, lecanemab for AD)[201][202] - Manufacturing product candidates is complex, expensive, and highly regulated, with reliance on CDMOs carrying risks of production difficulties, quality issues, and non-compliance with cGMP regulations[207][209] Risks Related to Regulatory Approval and Other Legal Compliance Matters This section covers the extensive and unpredictable regulatory processes, potential adverse events, post-marketing requirements, healthcare legislation impacts, and compliance risks with fraud and abuse laws - The regulatory approval processes of the FDA, EMA, and comparable foreign authorities are lengthy, unpredictable, and may result in delays or denial of approval for product candidates[230][234] - Undesirable side effects or adverse events caused by product candidates could halt clinical development, prevent regulatory approval, or limit commercial potential[239][242] - Data from clinical trials conducted outside the United States may not be accepted by the FDA or other regulatory authorities, requiring additional costly and time-consuming trials[243][245] - Approved products will be subject to extensive post-marketing requirements and regulatory scrutiny, including compliance with cGMP, labeling, promotion, and adverse event reporting[248][250] - Healthcare legislative and executive measures, such as the Inflation Reduction Act and executive orders on drug pricing, could adversely affect the company's ability to set adequate pricing, obtain reimbursement, and commercialize products[261][263] - The company is exposed to risks of fraud, misconduct, and non-compliance with healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), which could result in substantial penalties[270][273][274] Risks Related to Our Reliance on Third Parties This section details the risks associated with the company's dependence on external collaborators, contract research organizations, and contract development and manufacturing organizations for critical operations - The company relies heavily on collaborations with third parties (e.g., GSK) for research, development, and commercialization, and the termination of such agreements (like the AbbVie Agreement) could significantly impact its programs[283][290] - Reliance on third parties like CROs, clinical data management organizations, and medical institutions to conduct clinical trials reduces control and carries risks of performance failures, missed deadlines, or non-compliance with regulatory requirements[291][293] - Dependence on CDMOs for manufacturing materials introduces risks such as breach of agreement, termination, site closure, and inability to meet quality standards or required volumes[296][297] - The company and its CDMO partners depend on third-party suppliers for key raw materials, facing risks of supply chain disruptions, limited control over pricing, and quality issues, which could delay development[301][303] Risks Related to Our Intellectual Property This section addresses the challenges of obtaining and maintaining patent protection, the potential for intellectual property disputes, and the impact of evolving patent laws on the company's competitive position - The company's success depends on obtaining and maintaining patent protection for its product candidates and technologies, but patent applications may not issue or provide sufficient protection against competitors[304][308] - Patents may be challenged, narrowed, circumvented, or invalidated by third parties through litigation or administrative proceedings, leading to loss of exclusivity or increased costs[309][310] - Rights to intellectual property are subject to collaboration agreements, which may not grant exclusive rights or control over patent prosecution, and the U.S. government may have rights to federally funded inventions[313][315][317] - Changes in U.S. patent law (e.g., America Invents Act, Supreme Court rulings) could diminish the value of patents and increase the uncertainties and costs of patent prosecution and enforcement[330][332] - Failure to protect trade secrets or successfully defend against claims of intellectual property infringement or misappropriation could harm the company's business and competitive position[336][341] Risks Related to Our Operations This section addresses operational risks including dependence on key personnel, cybersecurity threats, business disruptions, international operational complexities, and limitations on net operating loss carryforwards - The company is highly dependent on key personnel and its ability to attract, motivate, and retain qualified staff, with recent workforce reductions impacting approximately 13% of employees[352][356] - Cyberattacks, information security breaches, or system failures could disrupt operations, compromise sensitive data, and harm the company's reputation[364][368] - Business disruptions from geopolitical events, natural disasters, pandemics, or other unforeseen events could seriously harm future revenue and financial condition[370] - International operations are subject to economic, political, and regulatory risks, including trade tariffs, currency exchange rates, and differing regulatory requirements[372][373] - The ability to use net operating loss (NOL) carryforwards may be limited by ownership changes under IRC Sections 382 and 383, and state tax suspensions[374] General Risk Factors This section addresses broader risks such as stock price volatility, potential dilution from future capital raises, influence of principal stockholders, public company compliance costs, and anti-takeover provisions - The market price of the company's common stock is highly volatile and can fluctuate significantly due to various factors, including clinical trial results, regulatory developments, and general economic conditions[378] - Raising additional capital through equity or debt offerings may dilute existing stockholders, impose restrictive covenants, or require relinquishing rights to technologies[385][386] - Principal stockholders and management beneficially own 45.9% of outstanding common stock, allowing them to significantly influence matters requiring stockholder approval[388] - Operating as a public company incurs significant legal, accounting, and compliance costs, and failure to maintain effective internal controls could adversely affect the business[389][390] - Delaware law and provisions in the company's charter documents could discourage, delay, or prevent a change in control or changes in management[396][397] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports that there were no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds were reported for the period[403] Item 3. Defaults Upon Senior Securities This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[404] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the registrant[405] Item 5. Other Information This section discloses Rule 10b5-1 trading plans adopted or terminated by a director and a former officer during the last fiscal quarter - On May 27, 2025, Director Paula Hammond adopted a Rule 10b5-1 trading plan to sell up to 14,000 shares of common stock[406] - On June 20, 2025, former CFO Marc Grasso terminated a Rule 10b5-1 trading plan that included the exercise of options for up to 75,501 shares and the sale of up to 84,357 shares[407] Item 6. Exhibits This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL data - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, certifications from the Principal Executive and Financial Officers, and Inline XBRL documents[410][412] SIGNATURES This section provides the official signatures of the company's executive officers, certifying the accuracy and completeness of the Quarterly Report on Form 10-Q - The report was signed on August 7, 2025, by Arnon Rosenthal, Ph.D. (Co-founder and Chief Executive Officer), Neil Berkley (Chief Business Officer and Interim CFO), and Grace Wong-Sarad (Vice President, Accounting)[418]