IDEAYA Biosciences(IDYA) - 2025 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION Presents the unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements (Unaudited) Presents the unaudited condensed financial statements, including key financial statements and detailed accounting notes Condensed Balance Sheets Details the company's financial position, presenting assets, liabilities, and stockholders' equity at specific dates | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | % Change | | :--------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $114,645 | $84,378 | $30,267 | 35.87% | | Short-term marketable securities | $555,093 | $591,941 | $(36,848) | -6.22% | | Total current assets | $685,602 | $689,713 | $(4,111) | -0.60% | | Total assets | $1,041,270 | $1,124,091 | $(82,821) | -7.37% | | Total current liabilities | $55,338 | $46,071 | $9,267 | 20.11% | | Total liabilities | $81,617 | $64,944 | $16,673 | 25.67% | | Total stockholders' equity | $959,653 | $1,059,147 | $(99,494) | -9.39% | Condensed Statements of Operations and Comprehensive Loss Details the company's financial performance, including revenues, expenses, net loss, and comprehensive loss over periods | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (3M) | % Change (3M) | | :-------------------- | :------------------------------- | :------------------------------- | :---------- | :-------------- | | Research and development | $74,226 | $54,533 | $19,693 | 36.11% | | General and administrative | $14,580 | $10,394 | $4,186 | 40.27% | | Total operating expenses | $88,806 | $64,927 | $23,879 | 36.78% | | Loss from operations | $(88,806) | $(64,927) | $(23,879) | 36.78% | | Interest income and other income, net | $11,315 | $12,155 | $(840) | -6.91% | | Net loss | $(77,491) | $(52,772) | $(24,719) | 46.84% | | Comprehensive loss | $(77,555) | $(53,265) | $(24,290) | 45.60% | | Net loss per common share, basic and diluted | $(0.88) | $(0.68) | $(0.20) | 29.41% | | Weighted-average common shares outstanding | 88,472,197 | 77,962,730 | 10,509,467 | 13.48% | | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (6M) | % Change (6M) | | :-------------------- | :----------------------------- | :----------------------------- | :---------- | :-------------- | | Research and development | $145,112 | $97,338 | $47,774 | 49.08% | | General and administrative | $28,083 | $18,606 | $9,477 | 50.94% | | Total operating expenses | $173,195 | $115,944 | $57,251 | 49.38% | | Loss from operations | $(173,195) | $(115,944) | $(57,251) | 49.38% | | Interest income and other income, net | $23,526 | $23,600 | $(74) | -0.31% | | Net loss | $(149,669) | $(92,344) | $(57,325) | 62.08% | | Comprehensive loss | $(148,960) | $(94,322) | $(54,638) | 57.93% | | Net loss per common share, basic and diluted | $(1.69) | $(1.21) | $(0.48) | 39.67% | | Weighted-average common shares outstanding | 88,414,586 | 76,535,607 | 11,878,979 | 15.52% | Condensed Statements of Stockholders' Equity Outlines changes in stockholders' equity, reflecting net loss, stock issuances, and stock-based compensation - Total stockholders' equity decreased from $1.06 billion as of December 31, 2024, to $959.7 million as of June 30, 2025, primarily due to a net loss of $149.7 million, partially offset by proceeds from at-the-market offerings, stock option exercises, ESPP purchases, and stock-based compensation[16][24] | Item (in thousands) | Six Months Ended June 30, 2025 | | :------------------ | :----------------------------- | | Net loss | $(149,669) | | Issuance of common stock (ATM) | $24,997 | | Stock-based compensation | $22,105 | | Other comprehensive income | $709 | | Total Stockholders' Equity (June 30, 2025) | $959,653 | Condensed Statements of Cash Flows Summarizes cash inflows and outflows from operating, investing, and financing activities over specific periods | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(122,816) | $(76,695) | $(46,121) | | Net cash provided by (used in) investing activities | $125,735 | $(285,414) | $411,149 | | Net cash provided by financing activities | $27,348 | $388,294 | $(360,946) | | Net increase in cash, cash equivalents and restricted cash | $30,267 | $26,185 | $4,082 | | Cash, cash equivalents and restricted cash, at end of period | $115,450 | $183,960 | $(68,510) | - Net cash used in operating activities increased by $46.1 million, primarily due to a higher net loss. Investing activities shifted from a net use of $285.4 million in H1 2024 to a net provision of $125.7 million in H1 2025, driven by a significant increase in maturities of marketable securities. Financing activities saw a substantial decrease in cash provided, from $388.3 million in H1 2024 to $27.3 million in H1 2025, mainly due to lower net proceeds from at-the-market offerings[27][209][211][213] Notes to Condensed Financial Statements (Unaudited) Offers detailed explanations and additional information supporting the condensed financial statements and accounting policies 1. Organization Describes the company's business, incorporation details, recent financing activities, and financial position - IDEAYA Biosciences, Inc. is a precision medicine oncology company focused on discovery, development, and commercialization of cancer therapies, incorporated in Delaware in June 2015[29] - The Company completed an underwritten public follow-on offering on July 11, 2024, raising approximately $283.8 million in net proceeds from 8,355,714 shares and pre-funded warrants[30] - Under an at-the-market offering program (January 2024 Sales Agreement), the Company sold 984,000 shares for $25.0 million net proceeds during the six months ended June 30, 2025, with $156.6 million remaining available[31][32] - The Company has an accumulated deficit of $772.5 million as of June 30, 2025, and expects continued operating losses. Cash, cash equivalents, and marketable securities totaled approximately $991.9 million as of June 30, 2025, believed to be sufficient for at least 12 months of planned operations[34][35][36] 2. Summary of Significant Accounting Policies Outlines key accounting principles and methods used in financial statement preparation, including estimates and new pronouncements - The condensed financial statements are prepared in accordance with GAAP and SEC rules for interim reporting, with certain disclosures condensed or omitted compared to annual statements[37][38] - Management makes estimates and assumptions affecting reported amounts, including useful lives of assets, lease discount rates, R&D accruals, revenue recognition, stock-based compensation, and income taxes[40] - The Company operates in a highly competitive, dynamic biotechnology industry, facing risks related to product development, regulatory approval, intellectual property, key personnel, and the need for additional financing[41][42][43][44] - The Company adopted ASU 2023-07 (Segment Reporting) for the annual report beginning January 1, 2024, and interim periods beginning January 1, 2025, resulting in additional disclosures in Note 13[50] - New accounting pronouncements not yet adopted include ASU 2023-06 (Disclosure Improvements), ASU 2023-09 (Income Tax Disclosures), and ASU 2024-03/2025-01 (Expense Disaggregation Disclosures), which are currently being evaluated for their impact[52][53][54][55] 3. Fair Value Measurement and Marketable Securities Details valuation methods for financial instruments and the composition of marketable securities, including fair values and maturities - The Company applies fair value accounting using a three-tier hierarchy (Level 1, 2, 3) based on observable inputs, with Level 2 inputs primarily used for U.S. government securities, corporate bonds, and commercial paper, and Level 1 for money market funds[56][57][58][59] | Asset Type (in thousands) | Fair Value as of June 30, 2025 | | :------------------------ | :----------------------------- | | U.S. government securities | $511,057 | | Corporate bonds | $348,227 | | Commercial paper | $37,582 | | Money market funds | $76,261 | | Cash | $18,742 | | Total fair value of assets | $991,869 | | Asset Type (in thousands) | Fair Value as of December 31, 2024 | | :------------------------ | :--------------------------------- | | U.S. government securities | $552,869 | | Corporate bonds | $363,135 | | Commercial paper | $89,122 | | Money market funds | $57,626 | | Cash | $19,399 | | Total fair value of assets | $1,082,151 | - All marketable securities as of June 30, 2025, and December 31, 2024, had a remaining maturity of less than three years. The Company determined that unrealized losses were not credit-related and does not intend to sell these securities before maturity[64][65] 4. Balance Sheet Components Breaks down key components of the balance sheet, including property and equipment, and accrued liabilities | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Laboratory equipment | $14,637 | $13,513 | | Total property and equipment | $21,826 | $20,677 | | Less: Accumulated depreciation and amortization | $(13,007) | $(11,711) | | Property and equipment, net | $8,819 | $8,966 | - Depreciation and amortization expense for property and equipment was $0.7 million for Q2 2025 (vs $0.6 million in Q2 2024) and $1.3 million for H1 2025 (vs $1.2 million in H1 2024)[66] | Accrued Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Accrued research and development expenses | $28,116 | $19,956 | | Accrued salaries and benefits | $6,860 | $8,233 | | Legal and professional fees | $2,146 | $1,213 | | Total accrued liabilities | $37,750 | $30,352 | 5. Operating Leases Details the company's operating lease agreements, including new leases, future payment obligations, and associated costs - The Company entered into a 120-month lease for 44,000 sq ft of lab/office space in South San Francisco in June 2023, commencing August 2024, with an option to extend for two five-year periods[68] - In May 2024, the South San Francisco lease was amended to add 11,321 sq ft, commencing January 2025. A separate lease for 5,700 sq ft in San Diego commenced December 2023 and expires March 2028[69][70] | Operating Lease Liabilities (in thousands) | As of June 30, 2025 | | :--------------------------------------- | :------------------ | | Total future minimum lease payments | $46,552 | | Less: imputed interest | $(19,955) | | Total operating lease liabilities | $26,597 | - Operating lease costs were $1.2 million for Q2 2025 (vs $0.5 million in Q2 2024) and $2.5 million for H1 2025 (vs $1.0 million in H1 2024). Variable lease costs were $0.6 million for Q2 2025 (vs $0.4 million in Q2 2024) and $1.2 million for H1 2025 (vs $0.8 million in H1 2024)[72][73] 6. Commitments and Contingencies Addresses potential future obligations and legal matters, including litigation and indemnification arrangements - The Company may be involved in litigation but does not believe any current matters will materially adversely affect its financial position, results of operations, or cash flows as of June 30, 2025[75] - The Company enters into standard indemnification arrangements with vendors and clinical trial sites, but the maximum potential future payments are not determinable, and no related liability has been recorded[76] 7. Income Taxes Explains the company's income tax position, including tax provision absence due to losses and new tax legislation impact - No federal or state income tax provision was recorded for the three and six months ended June 30, 2025 and 2024, due to recurring net losses. A full valuation allowance is maintained against net deferred tax assets[77] - A California audit for 2020-2021 concluded with no proposed adjustments. Management is evaluating the impact of the 'One Big Beautiful Bill Act' (Tax Act) enacted in Q3 2025, but does not expect a material impact on tax expense or effective tax rate for the year[78][79] 8. Common Stock Details common stock structure, outstanding shares, recent offerings, and shares reserved for future issuance - As of June 30, 2025, the Company had 87,641,776 shares of common stock issued and outstanding, with 300,000,000 shares authorized. No dividends have been declared[16][80] - The July 11, 2024, follow-on offering generated approximately $283.8 million in net proceeds from 8,355,714 common shares and 285,715 pre-funded warrants[81] | Issue Date | Expiration Date | Exercise Price per Share | Number of Shares subject to Outstanding Warrants | | :--------- | :-------------- | :----------------------- | :--------------------------------------------- | | July 11, 2024 | None | $0.0001 | 285,715 | | October 27, 2023 | None | $0.0001 | 319,150 | | April 27, 2023 | None | $0.0001 | 270,270 | - Warrants are classified as a component of Stockholders' Equity within Additional Paid-in-Capital, are immediately exercisable, and do not expire until fully exercised[83] | Reserved Common Stock for Future Issuance | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Exercise of outstanding options | 11,255,169 | 7,737,595 | | Shares available for grant (2019 Plan) | 2,774,703 | 1,910,589 | | Shares available for grant (2023 Inducement Plan) | 1,566,267 | 593,592 | | Shares available (ESPP) | 2,727,556 | 1,911,011 | | Pre-funded warrants outstanding | 875,135 | 875,135 | | Total | 19,198,830 | 13,027,922 | 9. Stock-Based Compensation Explains stock-based compensation plans, including share availability, expense recognition, and stock option activity - The 2023 Inducement Plan, amended in June 2024 and May 2025, increased shares available for issuance by 1,000,000 and 2,000,000 respectively, with 1,566,267 shares available as of June 30, 2025[85][86][87] - The 2019 Incentive Award Plan, with 2,774,703 shares available as of June 30, 2025, allows for annual increases and governs ISOs and NSOs for employees, directors, and consultants[88][89][90][91] - The 2019 Employee Stock Purchase Plan (ESPP) allows eligible employees to purchase common stock via payroll deductions, with 2,727,556 shares available as of June 30, 2025. ESPP compensation expense was $0.2 million for Q2 2025 and $0.4 million for H1 2025[93][94][95] | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $7,131 | $5,900 | $13,152 | $9,683 | | General and administrative | $4,737 | $3,834 | $8,953 | $6,363 | | Total stock-based compensation expense | $11,868 | $9,734 | $22,105 | $16,046 | | Stock Options Activity | Shares (June 30, 2025) | Weighted Average Exercise Price | | :--------------------- | :--------------------- | :------------------------------ | | Balance, January 1, 2025 | 7,737,595 | $26.06 | | Options granted | 3,836,758 | $20.30 | | Options exercised | (105,777) | $14.60 | | Options canceled | (178,812) | $27.31 | | Options expired | (34,595) | $28.95 | | Balance, June 30, 2025 | 11,255,169 | $24.18 | | Exercisable as of June 30, 2025 | 4,374,507 | $21.36 | - The weighted-average grant-date fair value of options granted was $14.02 per share for H1 2025 (vs $31.85 for H1 2024). Unrecognized stock-based compensation expense for stock options was $118.8 million as of June 30, 2025, to be recognized over a weighted-average period of 2.89 years[98][99] 10. Significant Agreements Summarizes key collaboration, license, and clinical trial agreements, detailing terms, milestones, and financial implications - GSK Collaboration Agreement (June 2020): Collaboration on MAT2A, Pol Theta, and Werner Helicase programs. GSK paid $100.0 million upfront and $20.0 million in development/regulatory milestones as of June 30, 2025[105][106] - Pol Theta Program (GSK): GSK leads clinical development of IDE705 (GSK101) and is responsible for all R&D costs. The Company earned $7.0 million in August 2023 for IND acceptance and has potential for $10.0 million upon Phase 1 dose expansion, up to $465.0 million in late-stage milestones, $475.0 million in commercial milestones, and tiered royalties[107][108][109][110] - Werner Helicase Program (GSK): GSK leads clinical development of IDE275 (GSK959), with IDEAYA responsible for 20% of R&D costs. The Company earned $7.0 million in October 2024 for IND acceptance and has potential for $10.0 million upon Phase 1 dose expansion, up to $465.0 million in late-stage milestones, $475.0 million in commercial milestones, 50% of U.S. net profits, and tiered royalties on global non-U.S. net sales[111][112][113][114] - Novartis License Agreement (September 2018): Exclusive worldwide license for darovasertib (PKC inhibitor) for GNAQ/GNA11 mutated cancers. FDA granted Breakthrough Therapy designation for darovasertib in primary uveal melanoma in March 2025, triggering a $1.0 million milestone payment to Novartis in April 2025. Potential for up to $8.0 million in additional clinical/regulatory milestones and $20.0 million in commercial milestones, plus mid to high single-digit tiered royalties[115][116][117][118][119] - Pfizer Clinical Trial Collaboration and Supply Agreements (multiple): Agreements for Pfizer to supply binimetinib and crizotinib for combination studies with darovasertib in GNAQ/GNA11 mutated tumors and MUM. The Company is the sponsor and pays for studies, while Pfizer provides compounds at no cost (or lump-sum cost for additional crizotinib). Joint ownership of clinical data and inventions[120][121][122][123][124][125] - Cancer Research UK and University of Manchester License Agreement: Exclusive worldwide license for PARG inhibitors. The Company paid a £250,000 option exercise fee in January 2022 and incurred £750,000 in milestone payments in April 2023 for IDE161 Phase 1/2 clinical trial. Potential for up to £18.75 million in additional development/regulatory milestones and low single-digit tiered royalties[126][127][128][129][130] - Amgen Clinical Trial Collaboration and Supply Agreement (July 2022): Evaluated IDE397 with AMG 193 (PRMT5 inhibitor) in MTAP-null solid tumors. Mutually agreed to wind down the combination study in February 2025[131] - Gilead Clinical Study Collaboration and Supply Agreement (November 2023 & February 2025): Evaluates IDE397 in combination with Trodelvy (Trop-2 ADC) in MTAP-deletion urothelial cancer and NSCLC. The Company is the sponsor and bears study costs, while Gilead supplies Trodelvy. Each party retains commercial rights to its compounds[132][133][134] - Merck Clinical Trial Collaboration and Supply Agreement (March 2024): Evaluates IDE161 with KEYTRUDA (anti-PD-1 therapy) in MSI-High and MSS endometrial cancer. The Company sponsors and pays for the study, Merck provides KEYTRUDA at no cost. Joint ownership of clinical data, each party retains commercial rights[135][136] - Biocytogen Option and License Agreement (July 2024): Option for exclusive worldwide license for B7H3/PTK7 TOP1i-payload BsADC program. Paid $6.5 million upfront/exercise fee. Targeting IND submission for IDE034 in H2 2025. Potential for $400.0 million in total milestones (up to $100.0 million development/regulatory) and low to mid single-digit royalties[138][139] - Hengrui Pharma License Agreement (December 2024): Exclusive worldwide license (outside Greater China) for IDE849 (DLL3 TOP1i ADC). Received U.S. IND clearance in April 2025 for Phase 1 trial in solid tumors. Hengrui Pharma eligible for $1.045 billion in total payments ($75.0 million upfront, up to $200.0 million development/regulatory milestones) and mid-single to low-double digit royalties[140][141] 11. Revenue Recognition Explains the company's revenue recognition policies, particularly for collaboration agreements and milestone payments - The Company recognized no revenue for the three and six months ended June 30, 2025 and 2024[144] - All performance obligations related to the upfront payment under the GSK Collaboration Agreement were completed as of December 31, 2023. Future collaboration revenue is contingent on additional milestone payments as they are earned[145][171] - Development and regulatory milestones from the GSK Collaboration Agreement were fully constrained at inception due to uncertainty, and are recognized only when earned. The Company earned $7.0 million from GSK in August 2023 for IDE705 IND acceptance and $7.0 million in October 2024 for IDE275 IND acceptance[146][147][150] 12. Net Loss Per Share Attributable to Common Stockholders Presents the calculation of net loss per common share, including basic and diluted figures, and treatment of dilutive securities | Metric | 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 (in thousands) | $(77,491) | $(52,772) | $(149,669) | $(92,344) | | Weighted-average common shares outstanding, basic and diluted | 88,472,197 | 77,962,730 | 88,414,586 | 76,535,607 | | Net loss per share, basic and diluted | $(0.88) | $(0.68) | $(1.69) | $(1.21) | - Potentially dilutive securities, including 11,255,169 options to purchase common stock as of June 30, 2025, were excluded from diluted net loss per share computation because their inclusion would have been antidilutive[154] 13. Segment Information Describes the company's operating segments and provides disaggregated research and development expenses by program - The Company operates as a single operating and reportable segment focused on oncology-focused precision medicine research and development. The President and CEO serves as the chief operating decision maker (CODM)[155] | Disaggregated R&D Expenses (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 | | :---------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Darovasertib | $25,091 | $14,895 | $48,109 | $25,764 | | IDE397 | $3,790 | $4,064 | $7,531 | $6,991 | | IDE161 | $1,568 | $2,059 | $4,016 | $4,754 | | Personnel related and stock-based compensation | $17,201 | $14,534 | $33,015 | $26,789 | | Other research and development expenses | $26,576 | $18,981 | $52,441 | $33,040 | | Total research and development expenses | $74,226 | $54,533 | $145,112 | $97,338 | 14. Subsequent Events Reports on events occurring after the balance sheet date but before financial statements were issued, requiring disclosure - The Company evaluated all subsequent events from June 30, 2025, through the filing date of this Quarterly Report on Form 10-Q and found no significant events requiring recognition or disclosure[158] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Provides management's perspective on financial condition and results, focusing on pipeline, operating expenses, liquidity, and capital Overview Introduces the company's business model, clinical pipeline, upcoming milestones, and overall financial position - IDEAYA Biosciences is a precision medicine oncology company focused on discovering, developing, and commercializing transformative therapies for cancer, utilizing small-molecule drug discovery, structural biology, and bioinformatics[160] - The clinical pipeline includes six potential first-in-class product candidates: Darovasertib (PKC inhibitor for uveal melanoma), IDE397 (MAT2A inhibitor for MTAP-deletion solid tumors), and IDE849 (DLL3 TOP1i ADC for SCLC, NETs, and other DLL3 expressing tumors)[161][162] - Key upcoming data readouts include median PFS data for darovasertib in 1L metastatic UM by end of 2025, initial safety and visual benefit data for neoadjuvant darovasertib in primary UM at R&D Day (Sept 8th), and clinical efficacy/safety data for IDE849 in SCLC at IASLC 2025 (Sept 6-9)[161] - Three preclinical programs are advancing towards IND submissions: IDE892 (MTA-cooperative PRMT5 inhibitor) in mid-2025, IDE034 (B7H3/PTK7 bispecific TOP1i ADC) in Q4 2025, and IDE574 (KAT6/7 dual inhibitor) in Q4 2025[168] - The Company had $991.9 million in cash, cash equivalents, and marketable securities as of June 30, 2025, expected to fund operations for at least 12 months[164][169] - Net losses were $149.7 million for H1 2025 (vs $92.3 million for H1 2024), with an accumulated deficit of $772.5 million as of June 30, 2025. Significant operating losses are expected to continue and increase[165][166] Components of Operating Results Defines the key revenue and expense categories that constitute the company's operating results, including R&D and G&A - The Company has not generated product sales revenue and does not expect to until regulatory approval and commercialization of product candidates. Revenue consists exclusively of collaboration revenue from the GSK Collaboration Agreement, which fluctuates based on milestone payments[171] - Research and development expenses include payroll, personnel-related costs, stock-based compensation, fees to CMOs/CROs for manufacturing and clinical activities (darovasertib, IDE397, IDE849, IDE161, IDE275/GSK959, IDE705/GSK101), laboratory supplies, product licenses, and allocated overhead[172] - General and administrative expenses primarily cover payroll, personnel-related costs, stock-based compensation, professional fees (legal, patent, consulting, accounting, tax), allocated overhead, and other operating expenses[179] - Interest income and other income, net, primarily consists of interest earned on cash, cash equivalents, and marketable securities[181] Results of Operations Analyzes financial performance over specific periods, detailing changes in R&D, G&A expenses, and net loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended March 31, 2025 | Change | % Change | | :-------------------- | :------------------------------- | :-------------------------------- | :----- | :------- | | Research and development | $74,226 | $70,886 | $3,340 | 5% | | General and administrative | $14,580 | $13,503 | $1,077 | 8% | | Loss from operations | $(88,806) | $(84,389) | $(4,417) | 5% | | Interest income and other income, net | $11,315 | $12,211 | $(896) | -7% | | Net loss | $(77,491) | $(72,178) | $(5,313) | 7% | - Research and development expenses increased by $3.3 million (5%) in Q2 2025 compared to Q1 2025, driven by personnel-related expenses and fees to CROs, CMOs, and consultants[184] - General and administrative expenses increased by $1.1 million (8%) in Q2 2025 compared to Q1 2025, primarily due to personnel-related expenses[185] | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | % Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | :------- | | Research and development | $145,112 | $97,338 | $47,774 | 49% | | General and administrative | $28,083 | $18,606 | $9,477 | 51% | | Loss from operations | $(173,195) | $(115,944) | $(57,251) | 49% | | Interest income and other income, net | $23,526 | $23,600 | $(74) | -0% | | Net loss | $(149,669) | $(92,344) | $(57,325) | 62% | - Research and development expenses increased by $47.8 million (49%) in H1 2025 compared to H1 2024, mainly due to increased fees to CROs, CMOs, and consultants ($37.4 million), personnel-related expenses ($6.2 million), and laboratory supplies/facilities costs ($4.2 million)[188] - General and administrative expenses increased by $9.5 million (51%) in H1 2025 compared to H1 2024, primarily due to personnel-related expenses ($5.2 million) and consulting/legal patent expenses ($4.3 million)[189] Liquidity and Capital Resources; Plan of Operations Discusses the company's financial resources, funding sources, future capital needs, and cash flow activities - The Company's operations are funded primarily by common stock sales and GSK collaboration payments. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled approximately $991.9 million[191] - During H1 2025, the Company sold 984,000 shares for $25.0 million net proceeds under its at-the-market offering program, with $156.6 million remaining available[193] - The Company had net losses of $149.7 million for H1 2025 and an accumulated deficit of $772.5 million as of June 30, 2025. Existing capital is expected to fund operations for at least the next 12 months[195] - Additional capital will be required for future development and commercialization, potentially through equity/debt financings or collaborations. Failure to raise capital could lead to delays or termination of development programs[197][199] - Material cash requirements include operating lease obligations, with total future minimum lease payments of $46.6 million as of June 30, 2025[71][201][202][203] | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(122,816) | $(76,695) | | Net cash provided by (used in) investing activities | $125,735 | $(285,414) | | Net cash provided by financing activities | $27,348 | $388,294 | | Net increase in cash, cash equivalents and restricted cash | $30,267 | $26,185 | Critical Accounting Policies Highlights accounting policies requiring significant management judgment and estimates, crucial to financial statements - The financial statements are prepared under U.S. GAAP, requiring management estimates and assumptions for assets, liabilities, revenue, and expenses. No material changes to critical accounting policies were reported for H1 2025 compared to the 2024 Annual Report on Form 10-K[215][216] Item 3. Quantitative and Qualitative Disclosures About Market Risk Assesses market risk exposure, primarily interest rate sensitivity, concluding risks are not significant due to investment characteristics - As of June 30, 2025, the Company held approximately $991.9 million in cash, cash equivalents, and marketable securities, primarily in bank deposits, money market funds, U.S. government securities, commercial paper, and corporate bonds[217] - The primary objective of investment activities is capital preservation. Due to the short-term duration of investments and the maturity of U.S. government treasury bonds prior to liquidity needs, the Company believes its exposure to interest rate risk is not significant[218] - Inflation and exchange rate fluctuations have not had a significant impact on the Company's results of operations for the periods presented[219] Item 4. Controls and Procedures Evaluates disclosure controls and procedures effectiveness, concluding they were effective with no material changes to internal control - Management acknowledges that controls and procedures provide only reasonable assurance and require judgment in evaluating benefits versus costs[220] - The Principal Executive Officer and Principal Financial Officer concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[221] - No changes in internal control over financial reporting occurred during the period that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[222] PART II—OTHER INFORMATION Presents additional information not covered in financial statements, including legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings States that the company is not currently involved in any litigation or legal proceedings expected to have a material adverse effect - The Company is not currently involved in any litigation or legal proceedings deemed to have a material adverse effect on its business[224] - Litigation, regardless of outcome, can negatively impact the business due to defense/settlement costs and diversion of management resources[224] Item 1A. Risk Factors Refers to risk factors detailed in the Annual Report on Form 10-K, confirming no material changes as of the current report date - Readers should consider the risk factors detailed in the Annual Report on Form 10-K filed February 18, 2025[225] - As of the date of this 10-Q, there have been no material changes to the previously disclosed risk factors[225] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Reports no unregistered sales of equity securities, no applicable use of proceeds from registered securities, and no issuer purchases - No unregistered sales of equity securities occurred[227] - The section on 'Use of Proceeds from the Sale of Registered Securities' is not applicable[228] - No issuer purchases of equity securities were made[228] Item 3. Defaults Upon Senior Securities Indicates that there were no defaults upon senior securities during the reporting period - This item is not applicable, indicating no defaults upon senior securities[229] Item 4. Mine Safety Disclosures States that there are no mine safety disclosures applicable to the company - This item is not applicable, indicating no mine safety disclosures[230] Item 5. Other information Reports that no Section 16 officers or directors adopted or terminated trading plans for company securities during the period - No Section 16 officers or directors adopted or terminated trading plans for Company securities during Q2 2025[231] Item 6. Exhibits Provides a comprehensive list of exhibits filed with the Quarterly Report, including organizational documents, agreements, and certifications - The exhibit index lists various documents, including the Amended and Restated Certificate of Incorporation and Bylaws, forms of Common Stock Certificate and Pre-funded Warrants, Non-Employee Director Compensation Program, Employment Agreement, and certifications (31.1, 31.2, 32.1)[234] - XBRL Instance Document, Taxonomy Extension Schema, and Cover Page Interactive Data File are included[234] - Certification Exhibit 32.1 is not deemed filed with the SEC and is not incorporated by reference into other filings[235] SIGNATURES Contains the required signatures for the Quarterly Report on Form 10-Q, confirming its submission by the Principal Executive and Financial Officers - The report is signed by Yujiro Hata, President and Chief Executive Officer (Principal Executive Officer), and Joshua Bleharski, Ph.D., Chief Financial Officer (Principal Financial Officer), on August 5, 2025[238][239][240][241]