Celcuity Inc. 10-K

ITEM 8. Financial Statements and Supplementary Data REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of Celcuity Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Celcuity Inc. (the Company) as of December 31, 2025 and 2024, and the related statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2025, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters. We have served as the Company’s auditor since 2017. Boulay LLP Minneapolis, Minnesota March 26, 2026 PCAOB ID: 542 65 Celcuity Inc. Balance Sheets (in thousands, except share and par value amounts) December 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 165,703 $ 22,515 Investments 275,794 212,589 Prepaid clinical trial costs 18,896 6,769 Other current assets 5,266 2,698 Total current assets 465,659 244,571 Property and equipment, net 499 336 Operating lease right-of-use assets 51 216 Other non-current assets 349 — Total assets $ 466,558 $ 245,123 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 6,407 $ 9,366 Accrued clinical trial costs 16,826 16,708 Other accrued expenses 20,865 5,477 Operating lease liabilities, current 54 172 Total current liabilities 44,152 31,723 Operating lease liabilities, non-current — 54 Convertible debt 195,324 — Note payable, non-current 126,527 97,727 Total liabilities 366,003 129,504 Commitments and contingencies (Note 7) - - Stockholders’ equity: Preferred stock, $ 0.001 par value: 2,500,000 shares authorized as of December 31, 2025 and 2024; 0 and 317,577 shares issued and outstanding as of December 31, 2025 and 2024, respectively — — Common stock, $ 0.001 par value: 95,000,000 shares authorized as of December 31, 2025 and 2024; 48,244,960 and 37,143,242 shares issued and outstanding as of December 31, 2025 and 2024, respectively 48 37 Additional paid-in capital 549,404 387,437 Accumulated deficit ( 448,897 ) ( 271,855 ) Total stockholders’ equity 100,555 115,619 Total liabilities and stockholders’ equity $ 466,558 $ 245,123 See accompanying notes to the financial statements. 66 Celcuity Inc. Statements of Operations (in thousands, except share and per share amounts) 2025 2024 Year Ended December 31, 2025 2024 Operating expenses: Research and development $ 144,995 $ 104,203 General and administrative 27,197 9,064 Total operating expenses 172,192 113,267 Loss from operations ( 172,192 ) ( 113,267 ) Other (expense) income: Interest expense ( 17,148 ) ( 10,280 ) Interest income 12,298 11,768 Other (expense) income, net ( 4,850 ) 1,488 Net loss before income taxes ( 177,042 ) ( 111,779 ) Income taxes — — Net loss $ ( 177,042 ) $ ( 111,779 ) Net loss per share, basic and diluted $ ( 3.79 ) $ ( 2.83 ) Weighted average common shares outstanding, basic and diluted 46,757,691 39,449,393 See accompanying notes to the financial statements. 67 Celcuity Inc. Statements of Changes in Stockholders’ Equity (in thousands, except share amounts) Shares Amount Shares Amount Capital Deficit Total Common Stock Preferred Stock Additional Paid-In Accumulated Total Stockholders’ Shares Amount Shares Amount Capital Deficit Equity Balance as of December 31, 2023 25,506,012 $ 26 854,134 $ 1 $ 299,818 $ ( 160,076 ) $ 139,769 Stock-based compensation 1,429 — — — 6,988 — 6,988 Conversion of preferred stock to common stock 5,365,570 5 ( 536,557 ) ( 1 ) ( 4 ) — — Employee stock purchases 33,215 — — — 276 — 276 Exercise of common stock options, net of shares withheld for exercise price 103,245 — — — 770 — 770 Exercise of common stock warrants, net of shares withheld for exercise price 1,827,357 2 — — 14,734 — 14,736 Issuance of common stock in an ATM offering, net of issuance costs 435,414 — — — 7,378 — 7,378 Issuance of common stock upon closing of follow-on offering, net of underwriting discounts and offering costs 3,871,000 4 — — 56,248 — 56,252 Issuance of common stock warrants, note payable — — — — 1,229 — 1,229 Net loss — — — — — ( 111,779 ) ( 111,779 ) Balance as of December 31, 2024 37,143,242 37 317,577 — 387,437 ( 271,855 ) 115,619 Balance 37,143,242 37 317,577 — 387,437 ( 271,855 ) 115,619 Stock-based compensation 1,029 — — — 21,383 — 21,383 Conversion of preferred stock to common stock 3,175,770 3 ( 317,577 ) — ( 3 ) — — Employee stock purchases 77,090 — — — 711 — 711 Exercise of common stock options, net of shares withheld for exercise price 393,086 — — — 3,485 — 3,485 Exercise of common stock warrants, net of shares withheld for exercise price 5,282,375 6 — — 42,055 — 42,061 Issuance of common stock warrants in connection with note agreement — — — — 2,786 — 2,786 Issuance of common stock upon closing of equity offering, net of underwriting discounts and offering costs 2,172,368 2 — — 91,550 — 91,552 Net loss — — — — — ( 177,042 ) ( 177,042 ) Balance as of December 31, 2025 48,244,960 $ 48 — $ — $ 549,404 $ ( 448,897 ) $ 100,555 Balance 48,244,960 $ 48 — $ — $ 549,404 $ ( 448,897 ) $ 100,555 See accompanying notes to the financial statements. 68 Celcuity Inc. Statements of Cash Flows (in thousands) 2025 2024 Year Ended December 31, 2025 2024 Cash flows from operating activities: Net loss $ ( 177,042 ) $ ( 111,779 ) Adjustments to reconcile net loss to net cash and cash equivalents used in operations: Depreciation 167 130 Stock-based compensation 21,383 6,988 Amortization of debt issuance costs and discount 3,137 1,331 Payment-in-kind interest 1,104 1,364 Non-cash operating lease expense ( 7 ) — Change in accrued interest income 630 150 Changes in operating assets and liabilities: Prepaid clinical trial costs ( 12,127 ) ( 1,994 ) Other current and non-current assets ( 2,991 ) 2,770 Accounts payable ( 3,040 ) 4,316 Accrued clinical trial costs 118 10,244 Other accrued expenses 15,388 3,013 Net cash used in operating activities ( 153,280 ) ( 83,467 ) Cash flows from investing activities: Proceeds from maturities of investments 332,507 642,346 Purchases of investments ( 396,342 ) ( 705,165 ) Purchases of property and equipment ( 249 ) ( 250 ) Net cash used in investing activities ( 64,084 ) ( 63,069 ) Cash flows from financing activities: Proceeds from employee stock purchases 711 276 Proceeds from exercise of common stock options 3,485 770 Proceeds from exercise of common stock warrants 42,061 14,736 Proceeds from convertible debt, net of debt issuance costs of $ 6,246 and $ 0 during the years ended December 31, 2025 and 2024, respectively 195,004 — Proceeds from note payable, net of debt issuance costs of $ 2,255 and $ 2,438 during the years ended December 31, 2025 and 2024, respectively 27,745 59,226 Proceeds from equity offering, net of underwriting discounts and offering costs 91,592 56,252 Proceeds from an ATM offering, net of issuance costs — 7,356 Payments for secondary registration statement costs ( 46 ) ( 228 ) Net cash provided by financing activities 360,552 138,388 Net change in cash and cash equivalents 143,188 ( 8,148 ) Cash and cash equivalents: Beginning of period 22,515 30,663 End of period $ 165,703 $ 22,515 Supplemental disclosure of cash flow information: Cash paid for interest $ 10,348 $ 7,586 Cash paid for operating leases $ 220 $ 325 Supplemental disclosures of non-cash investing and financing activities: Common stock warrants issued with the note payable transaction $ 2,786 $ 1,229 Property and equipment included in accounts payable $ 82 $ 1 Deferred financing, offering and registration statement costs included in accounts payable $ — $ 42 See accompanying notes to the financial statements. 69 CELCUITY INC. NOTES TO FINANCIAL STATEMENTS 1. Organization and Liquidity Organization Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer (“ABC”) has completed enrollment and reported detailed results for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients with PIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- ABC is ongoing. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota. The Company has not generated any revenue to date. Liquidity Since inception, the Company has not generated any revenue from product sales or other sources and has incurred operating losses and negative cash flows from operations. The Company’s primary uses of cash, cash equivalents, and investments to date have been funding clinical trials and research and development activities, the scaling of commercial launch related activities such as marketing, supply chain, distribution, market access and other commercial operations, business planning, establishing and maintaining the Company’s intellectual property portfolio, hiring personnel, leasing premises and associated capital expenditures, raising capital, and providing general and administrative support for these operations. As of December 31, 2025, the Company had an accumulated deficit of $ 448.9 million. To date, the Company has funded operations primarily through private placements, registered offerings of its equity securities, convertible notes, and borrowings under loan agreements. As of December 31, 2025, the Company had $ 441.5 million in cash, cash equivalents and short-term investments. The Company believes its existing cash, cash equivalents and short-term investments will be sufficient to fund planned operations for at least one year from the issuance of these financial statements. The Company is subject to risks common to companies in the development stage including, but not limited to, the clinical and commercial success of its initial drug product, gedatolisib, the regulatory approval of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition. 2. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Operating results during the year ended December 31, 2025, are not necessarily indicative of results to be expected for any future year. 70 Accounting Estimates Management uses estimates and assumptions in preparing these financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenue and expenses. Actual results could differ from those estimates and the difference could be material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and prepaid or accrued clinical trial costs. Cash and Cash Equivalents The Company maintains its accounts at two financial institutions. As of December 31, 2025 and 2024, the Company had $ 165.7 million and $ 22.5 million, respectively, in business checking accounts and money market funds that are considered cash equivalents. Cash and cash equivalents are classified as Level 1 assets under the fair value hierarchy. Investments The Company maintains its investments in U.S. treasury securities and has classified them as held-to-maturity at the time of purchase. Held-to-maturity purchases are those investments which the Company has the ability and intent to hold until maturity. Held-to-maturity investments are recorded at amortized cost, adjusted for the amortization or accretion of premiums and discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity investment using the straight-line method. The difference between the carrying value, which is based on cost, and the aggregate fair value of the held-to-maturity investments, was immaterial as of December 31, 2025. As of December 31, 2025 and 2024, the Company had $ 275.8 million and $ 212.6 million, respectively, of short-term investments. Fair Value of Financial Instruments The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: ● Level 1: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date. ● Level 2: Other than quoted prices included in Level 1, inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. ● Level 3: Unobservable inputs that are significant to the fair value measurement and supported by little or no market activity. The level in the fair value hierarchy within which a fair value measurement in its entirety falls, is based on the lowest level input that is significant to the fair value measurement in its entirety. The carrying values of cash equivalents, accounts payable, accrued expenses and other financial working capital items approximate fair value as of each of December 31, 2025 and 2024, due to the short maturity nature of these items. Refer to Note 10 for disclosures around the Company’s 2.750 % Senior Notes due 2031 (the “Notes”) and note payable. Concentration of Credit Risk Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash, cash equivalents, and investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. 71 Allowance for Credit Losses For investments in an unrealized loss position, the Company first assesses whether it intends to sell, or it is more likely than not that it will be required to sell, the investment before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the investment’s amortized cost basis is written down to fair value through earnings. For investments that do not meet the aforementioned criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes in interest rates, and any changes to the rating of the security by a rating agency, among other factors. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost basis of the investment. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded, limited by the amount that the fair value is less than the amortized cost basis. Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive loss. Property and Equipment Property and equipment are stated at cost. Depreciation is provided over estimated useful lives using the straight-line method. Maintenance and repairs are expensed as incurred; major improvements and betterments are capitalized. Estimated useful lives of property and equipment are as follows for the major classes of assets: Schedule of Estimated Useful Lives of Property and Equipment Asset description Estimated useful life Furniture and equipment 4 years Leasehold improvements Shorter of remaining lease term or estimated useful life Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances presented in the arrangement, including whether the Company controls the use of identified assets. The Company classifies leases with a term greater than one year as either operating or finance leases at the lease commencement date and records a right-of-use asset and current and non-current lease liabilities, as applicable, on the balance sheets. The Company has elected not to recognize on the balance sheets leases with terms of one year or less, but payments are recognized as expense on a straight-line basis over the lease term. The Company’s leases may include options to extend or terminate the leases. Periods covered by an option to extend the lease are included in the lease term when it is reasonably certain that the Company will exercise that option. Periods covered by an option to terminate the lease are included in the lease term when it is reasonably certain that the Company will not exercise that option. The Company monitors its plans to renew or terminate its material leases each reporting period. If a lease includes provisions for leasehold improvements for which the Company has an obligation to pay, the Company determines if the improvements should be considered lessor or lessee assets. If the improvements are considered lessor assets, the Company records the payments in the calculation of the lease liability and corresponding right-of-use asset. Lease liabilities and the corresponding right-of-use assets are recorded based on the present value of lease payments over the remaining lease term. The present value of future lease payments is discounted using the interest rate implicit in the lease contracts if that rate is readily determinable; otherwise, the Company utilizes information available at the commencement of the lease to calculate the incremental borrowing rate, which reflects the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and in a similar economic environment. Lease cost is recognized on a straight-line basis over the lease term and variable lease payments are recognized as operating expenses in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company. The Company has elected to account for the lease and non-lease components together as a single component for all classes of underlying assets. 72 Capitalized Software Development Costs The Company capitalizes qualifying costs incurred during the application development stage related to software developed for internal use. Capitalized software development costs are classified as other non-current assets on the balance sheets. As of December 31, 2025 and 2024, the Company had $ 0.1 million and no capitalized software development costs, respectively. The Company amortizes the capitalized software development costs on a straight-line basis over the estimated useful life of the software, beginning when the asset is substantially ready for use. The amortization of capitalized software development costs is reflected in general and administrative expenses. The Company did not record any amortization expense during the years ended December 31, 2025 and 2024. Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. Deferred Transaction Costs Deferred transaction costs primarily consist of legal fees that are capitalized as incurred and will be offset against the proceeds from future equity financing arrangements. The deferred transaction costs will be reviewed periodically to assess the probability that future securities will be offered. In the event that no future offering will occur, any deferred transaction costs will be expensed. Total costs incurred, but not accounted for as a reduction in equity, were $ 0.2 million and $ 0.2 million as of December 31, 2025 and 2024, respectively. D eferred transaction costs are classified as other assets on the balance sheets. Debt Issuance Costs The Company recognizes debt issuance costs as deferred costs, which are capitalized and amortized over the term of the related debt using the effective interest method. These costs primarily consist of fees, commissions, and legal and other costs directly attributable to securing debt financing. Debt issuance costs are reported as a direct reduction of the carrying amount of the related debt on the balance sheets. Amortization of these costs is recorded as interest expense in the statements of operations over the life of the debt instrument. In the event of early extinguishment of debt, any related unamortized debt issuance costs are written off and recognized as a component of the gain or loss on extinguishment of debt in the statements of operations. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For all periods presented, there was no difference between net loss and comprehensive loss. Commitments and Contingencies The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated. If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount. When no amount within the range is a better estimate than any other amount, the Company accrues the minimum amount in the range. The Company has not recorded any such liabilities as of December 31, 2025 and 2024. Stock-Based Compensation The Company’s stock-based compensation consists of stock options, restricted stock awards and restricted stock units issued to certain employees and non-employees of the Company under the 2017 Amended and Restated Stock Incentive Plan, and shares issued under the 2017 Employee Stock Purchase Plan (the “ESPP”). 73 The Company has elected to account for forfeitures as they occur. Stock Options The Company recognizes stock-based compensation expense based on the estimated grant date fair value using the Black-Scholes option-pricing model and the expense is recognized on a straight-line basis over the requisite service period. Compensation expense for awards with performance-based conditions is recognized when the achievement of the performance condition is deemed probable. The Company utilizes the Monte Carlo simulation model for awards with market-based vesting conditions. If the factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. The inputs for the Black-Scholes valuation model and the Monte Carlo simulation model require management’s significant assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. The expected volatility is estimated based on historical volatility information of peer companies that are publicly available in combination with the Company’s calculated volatility since being publicly traded. The expected term of the award is based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110. The risk-free interest rate is based on the rate for U.S. treasury securities at the date of grant with maturity dates approximately equal to the expected term of the award at the grant date. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date. All assumptions used to calculate the grant date fair value of non-employee options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options issued in connection with such agreements would also be cancelled. Restricted Stock The Company records compensation expense based on the quoted fair value of the shares on the grant date over the requisite service period. ESPP Compensation expense for ESPP rights is recorded in line with each respective offering period. Research and Development Research and development costs are expensed as incurred. Research and development costs were $ 145.0 million and $ 104.2 million during the years ended December 31, 2025 and 2024, respectively. Clinical Trial Costs The Company relies on third-party service providers to conduct certain aspects of clinical studies and to formulate and manufacture its drug product. While there are alternative vendors that can perform these functions, any disruption or delay by the Company’s current third-party service providers in carrying out their contractual duties could delay its clinical trials and/or the commercial launch of gedatolisib, if approved by the U.S. Food and Drug Administration (“FDA”). The Company records prepaid or accrued clinical trial costs conducted by third-party service providers, which includes the conduct of clinical trials. These costs can be a significant component of the Company’s research and development expenses. The Company uses progress reports from third-party service providers, including the respective invoicing, to record actual expenses, along with determining changes to prepaid or accrued clinical trial costs. With the ongoing clinical trials, the Company’s estimated expenses in future periods and actual services performed may vary from these estimates, and these estimates may become more significant. Changes in these estimates that result in material changes to the Company’s prepaid or accrued clinical trial costs could materially affect the Company’s results of operations and financial position. 74 Licenses Upfront payments and other consideration under license agreements are expensed as research and development expense upon receipt of the license, and annual maintenance fees under license agreements are expensed in the period in which they are incurred. Certain license agreements include milestone payments which are recognized when it becomes probable that the achievement of those milestones will be met. The Company records this expense as research and development expense in its statements of operations. Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the statements of operations. Income Taxes The Company accounts for income taxes using the asset and liability method, as required by the accounting standard for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis, as well as net operating loss and tax credit carryforwards. Deferred taxes are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred taxes of a change in tax rates is recognized in results of operations in the period that includes the enactment date. The effects of any future changes in tax laws or rates have not been considered. The Company regularly reviews deferred tax assets to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if the Company does not consider it to be more likely than not that the deferred tax assets will be realized. The Company recognizes the impact of an uncertain tax position in its financial statements if, in management’s judgment, the position is more-likely-than-not sustainable upon audit based on the position’s technical merits. This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position is necessary. Segment Data The Company has one reportable operating segment, which is the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s chief operating decision makers (“CODMs”) are its chief executive officer, chief science officer and chief financial officer, who, together manage the Company’s operations as one operating segment for the purpose of evaluating financial performance and allocating resources. The CODMs assess the performance and allocate resources for the reportable segment based on net loss and total assets, which are the same amounts in all material respects as those reported in the statements of operations and balance sheets. Recently Adopted Accounting Pronouncements In December 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the annual income tax disclosures for the effective tax rate reconciliation, income taxes paid, and continuing operations. ASU 2023-09 also eliminates certain disclosure requirements related to unrecognized tax benefits. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-09 on January 1, 2025 on a retrospective basis. Recent Accounting Pronouncements Not Yet Adopted In November 2024, the FASB issued ASU 2024-03 , Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities to provide disaggregated disclosure of income statement expense. In January 2025, the FASB issued ASU 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date , to clarify the effective date of ASU 2024-03. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of ASU 2024-03 on its financial statements and related disclosures. 75 In July 2025 , the FASB issued ASU 2025-05 , Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”), which provides certain entities with an additional practical expedient for estimating expected credit losses on current accounts receivable and current contract assets arising from revenue transactions under Accounting Standards Codification (“ASC”) 606. ASU 2025-05 is effective for all entities for annual and interim periods in fiscal years beginning after December 15, 2025. Early adoption is permitted for all entities. The Company is currently evaluating the impact of ASU 2025-05 on its financial statements and related disclosures. In September 2025, the FASB issued ASU No. 2025-06, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which modernizes the accounting for internal-use software. ASU 2025-06 removes all references to software development stages and requires capitalization of software costs when management has committed to the software project, and it is probable the software will be completed and perform to its intended use. In evaluating whether it is probable the project will be completed, management is required to consider whether there is significant uncertainty associated with the development activities of the software. ASU 2025-06 is effective for annual and interim periods beginning after December 15, 2027. The guidance may be applied on a prospective basis, a modified basis for in-process projects, or a retrospective basis. The Company is currently evaluating the timing, method of its adoption, and effect of ASU 2025-06 on its financial statements and related disclosures. 3. Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, the common shares underlying the options, convertible note, warrants, restricted stock and preferred stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following table summarizes the potentially-dilutive shares that have been excluded from the calculation of diluted weighted-average shares outstanding because their inclusion would be anti-dilutive: Schedule of Potentially-Dilutive Shares Excluded from Diluted Weighted-Average Shares Outstanding 2025 2024 Year Ended December 31, 2025 2024 Options to purchase common stock 5,842,485 4,306,977 Convertible note as-if-converted-to-common stock 5,296,053 — Warrants to purchase common stock 274,773 5,521,152 Restricted common stock 27,439 1,079 Preferred stock as-if-converted-to-common stock — 3,175,770 Total 11,440,750 13,004,978 The maximum number of shares of common stock issuable upon conversion of the Notes is 5,296,053 . As of December 31, 2025, the number of shares issuable based on the Company’s closing common stock price would be 3,923,002 if the Notes were converted in full. During the years ended December 31, 2025 and 2024, pre-funded warrant shares of 6,147,787 and 5,747,787 , respectively, were included in the computation of basic and diluted net loss per share, as the pre-funded warrants are exercisable for nominal consideration. 4. Investments Debt investments for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through the establishment of an allowance for credit losses. All of the Company’s held-to-maturity investments are U.S. treasury securities that are guaranteed or otherwise supported by the United States government and have no history of credit losses. Accordingly, the Company does not expect to incur any credit losses on held-to-maturity investments and has no allowance for credit losses recorded for these investments. As of December 31, 2025, all of the Company’s held-to-maturity investments had maturities of one year or less. 76 The following tables summarize the Company’s held-to-maturity investments (in thousands): Schedule of Investment Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value As of December 31, 2025 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. treasury securities $ 275,794 $ 225 $ — $ 276,019 Total $ 275,794 $ 225 $ — $ 276,019 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value As of December 31, 2024 Amortized Cost, as Adjusted Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value U.S. treasury securities $ 212,589 $ 82 $ — $ 212,671 Total $ 212,589 $ 82 $ — $ 212,671 The Company’s U.S. treasury securities are classified as Level 2 investments within the fair value hierarchy. These assets have been valued based on quoted prices in active markets for similar assets or other inputs that are observable or can be corroborated by observable market data. There were no changes in valuation techniques or transfers within the fair value hierarchy during the years presented. 5. Property and Equipment Property and equipment, net consisted of the following (in thousands): Summary of Property and Equipment As of December 31, 2025 2024 Furniture and equipment $ 2,354 $ 2,025 Leasehold improvements 304 303 Total property and equipment, gross 2,658 2,328 Less: Accumulated depreciation ( 2,159 ) ( 1,992 ) Total property and equipment, net $ 499 $ 336 Depreciation expense was $ 0.2 million and $ 0.1 million during the years ended December 31, 2025 and 2024, respectively. 6. Other Accrued Expenses Other accrued expenses consisted of the following (in thousands): Schedule of Other Accrued Expenses As of December 31, 2025 2024 Employee compensation and benefits $ 8,338 $ 4,092 License milestone 5,000 — Interest 3,379 — Consulting and professional fees 2,335 511 Other 1,813 874 Total $ 20,865 $ 5,477 As of December 31, 2025, and 2024, accounts payable included $ 0 and $ 820 of accrued interest, respectively. 77 7. Commitments Operating and Finance Leases The Company leases its corporate space in Minneapolis, Minnesota, with an operating lease in place through April 30, 2026 (the “Existing Lease”). The Existing Lease provides for monthly rent, real estate taxes, and operating expenses. Rent expense is recorded on a straight-line basis over the lease term. In November 2025, the Company entered into a lease for clinical laboratory and office space in Minnesota for 19,594 square feet. The lease term will commence on April 1, 2026 and is 62 months with two options to extend the lease term for five years each. The Company also has a one-time option to terminate the lease at the end of the third year, provided certain conditions are met. To exercise this option, the Company must pay a termination fee equal to eight months’ rent plus the landlord’s unamortized transaction costs, which include abated rent, tenant improvement allowances and broker fees. The initial annual lease payment is $ 0.3 million and increases by 3.5% on an annual basis, resulting in total undiscounted future minimum lease payments of $ 1.5 million over the initial 62 -month term. As of December 31, 2025, the lease has not commenced and is therefore excluded from the tables below. When an implicit rate is not provided, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. Future minimum lease payments under the Company’s Existing Lease consisted of the following (in thousands): Schedule of Minimum Lease Payments Year Ending December 31, 2026 $ 74 Thereafter — Total minimum lease payments 74 Less: Amount representing interest ( 20 ) Present value of operating lease liabilities 54 Less: operating lease liabilities, current ( 54 ) Operating lease liabilities, non-current $ — The weighted-average remaining lease term and discount rate under the Company’s Existing Lease were as follows: As of December 31, 2025 2024 Weighted-average remaining lease term 0.3 years 1.3 years Weighted-average discount rate 10.5 % 10.5 % The following table presents components of lease costs (in thousands): Schedule of Lease Costs Year Ended December 31, 2025 2024 Operating lease cost $ 213 $ 213 Variable lease cost 110 111 Total lease cost $ 323 $ 324 Clinical Research Studies The Company enters into contracts in the normal course of business to conduct research and development programs internally and through third-party service providers that include, among others, arrangements with vendors, consultants, contract manufacturing organizations, and contract research organizations. Contracts related to the Company’s ongoing clinical trials are generally cancelable with advance notice and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subject to amendments as a result of any change orders executed. As of December 31, 2025, the Company had $ 5.5 million of non-cancelable purchase commitments with respect to these arrangements. 78 Registration Rights Agreement In connection with a securities purchase agreement with certain investors pursuant to which the Company agreed to sell to the investors in a private placement pre-funded warrants to purchase up to 5,747,787 shares of the Company’s common stock in October 2023 (the “Securities Purchase Agreement”), the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the investors. Under the Registration Rights Agreement, the Company agreed to file a registration statement and to use commercially reasonable efforts to cause such registration statement to become effective and to keep such registration statement effective until such time as there are no longer registrable securities held by the Investors. If the Company fails to meet the specified filing deadlines, effectiveness deadlines, or maintain the effectiveness of the registration statement, the Company is required to make pro rata payments to each holder as liquidated damages in an amount equal to 1.0% of the aggregate amount paid pursuant to the Securities Purchase Agreement by such investor for each 30-day period or pro rata for any portion thereof during which such event continues, provided that the maximum liquidated damages shall not exceed 6.0% of the aggregate amount invested by each such holder in the registrable securities. The Company accounts for these arrangements in accordance with ASC 825-20, Registration Payment Arrangements . As of December 31, 2025, the required registration statement has been timely filed and declared effective by the SEC, and the Company remains in compliance with the maintenance requirements. Management has determined that it is not probable that the Company will be obligated to pay any liquidated damages; accordingly, no liability has been recorded for these arrangements. 8. Stockholders’ Equity Capital Stock As of December 31, 2025, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 48,244,960 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A Preferred Stock, of which none were outstanding. As of December 31, 2025, no dividends have been declared on the Company’s capital stock. July 2025 Equity Offering On July 30, 2025, the Company entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies LLC (“Jefferies”), TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 shares (the “Shares”) of the Company’s common stock, at a price to the public of $ 38.00 per Share and (ii) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded Warrants”), at a price to the public of $ 37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $ 0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”). In addition, pursuant to the Equity Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025. The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were $ 91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. The Company may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants. Each Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $ 0.001 per share, or alternatively, at the election of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined according to the formula set forth in each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance until all of the Pre-Funded Warrants are exercised. A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to the Company. 79 Sale and Issuance of Stock On May 30, 2024, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $ 15.50 per share, generating gross proceeds of $ 60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to the Company of $ 56.3 million after deducting underwriting discounts and other offering expenses payable by the Company. On May 8, 2024, pursuant to an Open Market Sale Agreement with Jefferies, as agent, the Company sold 149,700 shares of common stock in a single transaction at a price of $ 17.65 per share, generating gross proceeds of $ 2.6 million. On April 22, 2024, pursuant to an Open Market Sale Agreement with Jefferies, as agent, the Company sold 285,714 shares of common stock in a single transaction at a price of $ 17.50 per share, generating gross proceeds of $ 5.0 million. Commissions and other offering expenses related to the Open Market Sale Agreement transactions in May and April 2024 were $ 0.3 million. Common Stock Warrants As of December 31, 2025, the Company had the following common stock warrants outstanding: Schedule of Common Stock Warrants Issue Date Expiration Date Warrants Outstanding Exercise Price Offering 1/21/2016 1/14/2026 28,716 $ 7.56 Private placement offering – issued to placement agent 5/2/2016 5/2/2026 18,175 7.56 Private placement offering – issued to placement agent 4/28/2017 4/28/2027 32,458 8.42 Private placement offering – issued to placement agent 5/17/2017 5/17/2027 14,969 8.42 Private placement offering – issued to placement agent 4/8/2021 4/8/2031 26,042 14.40 Debt financing – issued to lender 5/30/2024 5/30/2034 84,227 14.84 Debt financing – issued to lender 5/30/2024 5/30/2034 19,649 14.84 Debt financing – issued to lender 9/9/2025 9/9/2035 25,269 14.84 Debt financing – issued to lender 9/9/2025 9/9/2035 25,268 14.84 Debt financing – issued to lender 10/18/2023 N/A 5,747,787 0.001 Private placement offering – issued to investors 7/31/2025 N/A 400,000 0.001 Equity offering – issued to underwriters Total warrants outstanding 6,422,560 Pre-Funded Warrants On October 18, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain investors (the “Investors”) pursuant to which the Company agreed to sell to the Investors in a private placement pre-funded warrants to purchase up to 5,747,787 shares of the Company’s common stock, par value $ 0.001 per share. Each warrant to purchase one share had a purchase price of $ 8.699 per share, and an exercise price of $ 0.001 per share for the common stock issuable upon exercise of the warrant. 80 Each warrant is immediately exercisable and will not expire. Under the terms of the warrants, the Company may not effect the exercise of any such warrant, and a holder will not be entitled to exercise any portion of any warrant, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates for purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC (the “Maximum Percentage”). A holder may reset the Maximum Percentage to a higher percentage (not to exceed 19.99%), effective 61 days after written notice to the Company, or a lower percentage, effective immediately upon written notice to the Company. Any such increase or decrease will apply only to that holder and not to any other holder of warrants. The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions. The following table summarizes the activity for all common stock warrants outstanding: Schedule of Common Stock Warrants Outstanding Common stock warrants Weighted- average exercise price per share Outstanding as of December 31, 2024 11,268,939 $ 4.04 Issued 450,537 1.67 Exercised ( 5,282,375 ) 8.07 Surrendered upon cashless exercise ( 14,541 ) 10.43 Expired — — Outstanding as of December 31, 2025 6,422,560 $ 0.53 During the year ended December 31, 2024, several of the Company’s investors exercised 1,827,357 common stock warrants, net of shares withheld for the exercise price, at exercise prices ranging between $ 8.05 and $ 9.50 per share, which generated $ 14.7 million in cash. During the year ended December 31, 2024, 3,544 common stock warrants expired. Preferred Stock Series A preferred stock The Series A preferred stock is non-voting, and each share is convertible at the option of the holder, subject to certain limitations, into 10 shares of common stock. Holders of Series A preferred stock are entitled to receive dividends, on an as-if-converted-to-common stock basis, when, as and if, and in the same form as, dividends are actually paid on the common stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or in the event of a Deemed Liquidation Event (as defined in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock), the holders of Series A preferred stock are entitled to be paid from assets of the Company available for distribution to its stockholders, before any payment is made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the original issue price ( $5.75 on an as-converted-to-common stock basis ), plus all accrued and unpaid dividends and (ii) the amount that the holder would have been entitled to receive at such time if the Series A preferred stock were converted into common stock. The Company may not, without the consent of holders of a majority of the outstanding shares of Series A preferred stock, amend its charter in a manner that adversely affects the powers, preferences or rights of the Series A preferred stock or issue or obligate itself to issue shares of any additional class or series of capital stock unless the same ranks junior to the Series A preferred stock with respect to the distribution of assets on the liquidation, dissolution or winding up of the Company and the payment of dividends. During the year ended December 31, 2025, 317,577 shares of Series A preferred stock were converted into 3,175,770 shares of common stock. As of December 31, 2025, no shares of Series A preferred stock were outstanding. 81 9. Stock-Based Compensation 2012 Equity Incentive Plan In August 2012, the Company adopted the 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provided for options, restricted stock awards, performance stock awards and stock bonuses. The exercise price of each option granted under the 2012 Plan is not less than 100% of the fair market value of one share on the date of grant. The maximum permitted term of options granted under the 2012 Plan is ten years. The Company’s board of directors administers the 2012 Plan and determines the provisions of incentive awards, including eligible recipients, number of shares subject to an incentive award, exercise price, vesting schedule, duration of an incentive award and other restrictions an incentive award may be subject to. In September 2017, the 2012 Plan was frozen and no further awards may be made under the 2012 Plan. 2017 Amended and Restated Stock Incentive Plan In September 2017, the Company adopted the 2017 Amended and Restated Stock Incentive Plan (the “2017 Plan”). The 2017 Plan provides for the grant of options, restricted stock awards, stock appreciation rights, restricted stock units, performance awards and stock bonuses. The exercise price of each option granted under the 2017 Plan is not less than 100% of the fair market value of one share on the date of grant. The maximum permitted term of options granted under the 2017 Plan is ten years. The 2017 Plan is generally administered by the compensation committee of the board of directors, which has the authority to interpret the 2017 Plan, grant awards and make all other determinations necessary for the administration of the 2017 Plan. The number of shares reserved for issuance under the 2017 Plan will automatically increase on January 1 of each year from 2026 to 2027 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31. However, the Company’s board of directors may reduce the amount of the increase in any particular year. The number of shares reserved for issuance under the 2017 Plan was automatically increased by 371,432 and 255,060 shares on January 1, 2025 and 2024, respectively. During the years ended December 31, 2025 and 2024, the board of directors and the stockholders approved additional increases of 3,000,000 and 1,500,000 , respectively, to the number of shares reserved for issuance under the 2017 Plan. As of December 31, 2025, the number of shares available for issuance under the 2017 Plan is 2,591,634 . Stock Options Options granted under the 2017 Plan are exercisable at various dates as determined upon grant and will expire no more than 10 years from their date of grant. The exercise price of each option shall be determined by the board of directors based on the estimated fair value of the Company’s common stock on the grant date. The exercise price shall not be less than 100% of the fair market value of the Company’s common stock on the grant date. Most option grants generally vest 25 % on the first anniversary of the original vesting commencement date, with the balance vesting monthly over the remaining three years . The 2017 Plan is generally administered by the compensation committee of the board of directors, which has the authority to interpret the 2017 Plan, grant awards and make all other determinations necessary for the administration of the 2017 Plan. The following table summarizes the activity for all stock options outstanding: Schedule of Stock Options Activity Shares Weighted- average exercise price per share Weighted-average remaining contractual term Aggregate intrinsic value (in years) (in thousands) Options outstanding as of December 31, 2024 4,306,977 $ 11.13 8.0 $ 13,914 Granted 2,186,593 35.17 Exercised ( 393,301 ) 8.89 Forfeited ( 257,784 ) 14.29 Options outstanding as of December 31, 2025 5,842,485 $ 19.62 7.9 $ 468,191 Options exercisable as of December 31, 2025 2,740,854 $ 11.61 6.6 $ 241,560 82 In January 2025, the Company modified previously granted stock option awards to 44 employees by reducing the exercise price of these options to the Company’s closing common stock price on the modification date. During the year ended December 31, 2025, the incremental compensation expense recognized as a result of these modifications was $ 0.2 million. The effect of these modifications on stock-based compensation over the remaining service periods will be $ 0.3 million. During the year ended December 31, 2025, the market conditions associated with options previously granted to an employee were satisfied following the achievement of the specified stock price threshold. As a result, the options vested and the Company recognized $ 8.4 million in stock-based compensation expense related to these awards during the year ended December 31, 2025. During the years ended December 31, 2025 and 2024, the weighted-average grant date fair value of options granted was $ 25.01 and $ 11.22 per share, respectively. The total intrinsic value of options exercised during the years ended December 31, 2025 and 2024, was $ 35.7 million and $ 0.6 million, respectively. Upon the exercise of stock options, the Company will issue new shares of its common stock. As of December 31, 2025, the unrecognized compensation cost related to outstanding employee and non-employee options was $ 52.7 million and is expected to be recognized as expense over a weighted-average period of 1.7 years. The assumptions used in the Black-Scholes option pricing model and Monte Carlo simulation model to determine the fair value of the employee and non-employee stock option grants issued, were as follows: Schedule of Assumptions for Fair Value of Employee And Non-Employee Stock Option Year Ended December 31, 2025 2024 Risk-free interest rate 3.6 % − 4.7 % 3.5 % − 4.7 % Expected volatility 74.4 % − 82.1 % 71.2 % − 76.2 % Expected life (years) 5.0 − 10.0 5.3 − 10.0 Expected dividend yield 0 % 0 % During the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense for stock options of $ 20.0 million and $ 6.6 million, respectively. Restricted Stock The following table summarizes restricted stock award and restricted stock unit activity during the year ended December 31, 2025: Schedule of Restricted Stock Award And Restricted Stock Unit Activity Shares Weighted-average grant date fair value per share Outstanding as of December 31, 2024 1,079 $ 14.83 Granted 34,039 89.43 Vested ( 1,079 ) 14.83 Forfeited ( 6,600 ) 98.49 Outstanding as of December 31, 2025 27,439 $ 87.25 As of December 31, 2025, the unrecognized compensation cost related to outstanding restricted stock was $ 2.3 million and is expected to be recognized over a weighted-average period of 1.9 years. The total fair value of restricted stock vested during the year ended December 31, 2025 was less than $ 0.1 million. During the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense for restricted stock of $ 0.1 million and less than $ 0.1 million, respectively. 2017 Employee Stock Purchase Plan In September 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides participating employees with an opportunity to purchase shares of the Company’s common stock at a discount through payroll deductions. The ESPP is available to all employees unless they are employed for less than 20 hours per week or own 5% or more of the total combined voting power or value of the Company’s common stock. The ESPP is administered using overlapping 24 month offering periods (the “Offering Periods”). Each Offering Period has four six-month purchase periods. A new Offering Period and purchase period begin every six months on May 1 and November 1 of each year. Participating employees may purchase common stock, on a voluntary after tax-basis, at a price equal to 85% of the fair market value of a share of common stock on either the offering date or the purchase date, whichever is lower. If the purchase date has a lower price, the employee will automatically be placed in the Offering Period beginning immediately after the purchase date. 83 The number of shares reserved for issuance under the ESPP automatically increases on January 1 of each year from 2023 to 2027 by the number of shares equal to 0.5% of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31. However, the Company’s board of directors may reduce the amount of the increase in any particular year. The number of shares reserved for issuance under the ESPP was automatically increased by 185,716 and 127,530 shares on January 1, 2025 and 2024, respectively. As of December 31, 2025, the number of shares available for issuance under the ESPP is 469,576 . During the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense related to the ESPP of $ 1.3 million and $ 0.3 million, respectively. Stock-based Compensation The Company recognized the following stock-based compensation expense in its statements of operations (in thousands): Schedule of Stock-based Compensation Expenses 2025 2024 Year Ended December 31, 2025 2024 Research and development $ 8,409 $ 4,405 General and administrative 12,974 2,583 Total $ 21,383 $ 6,988 Stock-based compensation expense $ 21,383 $ 6,988 10. Debt July 2025 Convertible Notes Offering On July 30, 2025, the Company entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters, subject to customary conditions, to issue and sell in a public offering $ 175.0 million aggregate principal amount of the Notes to the Underwriters (the “Note Offering”). In addition, pursuant to the Note Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional $ 26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $ 26.3 million aggregate principal amount of the Notes. The issuance of $ 201.3 million aggregate principal amount of the Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”), dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were $ 194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. The Notes are general, unsecured, senior obligations of the Company. The Notes will accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750 % per year. In addition, special interest will accrue on the Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company. 84 Noteholders may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $ 1,000 principal amount of the Notes, which is equivalent to an initial conversion price of $ 51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time. The Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding Notes unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption. If a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock. Lastly, the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes; provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation in no event can exceed 19.99%. The fair value of the Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices for the Notes observed in market trading. The market for trading of the Notes is not considered to be an active market and therefore the fair value is determined using Level 2 inputs. As of December 31, 2025, the carrying value and fair value of the Notes was $ 195.3 million and $ 436.5 million, respectively. The issuance costs attributed to the Notes amounted to $ 6.4 million and were discounted from the Notes. The issuance cost discount is being amortized to interest expense over the term of the Notes based on the effective interest rate method. As of December 31, 2025, the effective interest rate was 3.3 %. During the year ended December 31, 2025, interest expense related to the Notes was $ 2.7 million, including $ 0.4 million related to discount amortization. Amended and Restated Loan and Security Agreement Third Amendment On September 9, 2025, the Company entered into the Third Amendment (the “Third Amendment”) to the Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”), as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”)) and provide for the immediate disbursement of the $ 30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $ 50.0 million to up to $ 100.0 million, which Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type ABC patients post CDK4/6 inhibitor therapy; (iv) add three new up to $ 40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), for a total of $ 120.0 million, which may only be drawn upon achievement of certain trailing three months’ product revenue thresholds; (v) replace the prior $ 45.0 million Term F Loan (as defined in the A&R Loan Agreement) with a new $ 150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement), which continues to be available only in the Lenders’ sole discretion upon the Company’s request; (vi) require an amendment fee payable by the Company to the Lenders in the amount of $ 0.1 million, which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that the Company may make by notice to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans to November 1, 2029. The Term E Loan and each Term F Loan also are subject to other customary conditions and limits on when the Company can request funding. With the disbursement of the $ 30.0 million Term D Loan, the Company received net proceeds of $ 27.7 million. 85 In accordance with the A&R Loan Agreement, a Final Fee equal to 4.5 % of the $ 30.0 million Term D Loan was recognized and an additional $ 1.4 million was added to debt principal and a corresponding debt discount to be amortized over the life of the loan. In connection with the Third Amendment, the Company issued warrants with an exercise price of $ 14.84 per share to purchase an aggregate of 50,537 shares of the Company’s common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment Warrants”). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant. A portion of the proceeds from the Term D Loan in the amount of $ 2.8 million was allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional paid in capital in the accompanying balance sheets and were discounted from the Term D Loan. The relative fair value of the Third Amendment Warrants was based on the Black-Scholes model with the following assumptions: risk-free interest rate of 4.1 %; expected volatility of 74.4 %; expected life of 10.0 years; and expected dividend yield of 0 %. The underlying stock price used in the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense ratably over the term of the Term D Loan. Second Amendment On July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $ 180 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of less than $ 0.1 million, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to convert up to 20 % of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 . Further, in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, the Company achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $ 30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment. 86 First Amendment On May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which the Company agreed to (i) pay Oxford an amendment fee of less than $0.1 million on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company had failed to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if the Company subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation. May 30, 2024 Amendment and Restatement On May 30, 2024, the Company entered into the A&R Loan Agreement. The A&R Loan Agreement amended and restated, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”). Funding of the first $ 100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $ 16.8 million (the “Term A Loan”) and $ 21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $ 61.7 million of new borrowings (the “Term C Loan”). As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment. Prior to the Third Amendment, the Company also would have become eligible to draw on a fifth tranche of $ 50.0 million (the “Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders also could have, in their sole discretion upon the Company’s request, made additional term loans to the Company of $ 45.0 million (the “Term F Loan”). Funding of these additional tranches was also subject to other customary conditions and limits on when the Company could have requested funding for such tranches. Costs associated with the new borrowings were approximately $ 2.4 million. Pursuant to the A&R Loan Agreement, the Company is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement is secured by all assets of the Company. Proceeds are being used for working capital purposes and to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures. Prior to the Second Amendment, Innovatus also had the right, at its election and until August 9, 2025, to convert up to 20 % of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $ 10.00 . Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $ 14.40 through April 8, 2031. The A&R Loan Agreement contains a Final Fee, which is equal to 4.5 % of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization provisions related to the Term D Loan are no longer operative. The Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If the Company achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement of the Term E Milestone, of the Company’s intent not to draw the full amount of the Term E Loan, a non-utilization fee with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, the Company shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pays to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30, 2024, the Company recognized the Final Fee of $ 4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan. 87 In connection with the funding of each of the Term C Loan and the Term D Loans, the Company agreed to issue to Innovatus and Oxford warrants to purchase that number of shares of the Company’s common stock equal to 2.5 % of the principal amount of the applicable Term Loan divided by the exercise price, which was, with respect to the Term C Loan, equal to the lower of (i) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the A&R Loan Agreement. Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise price of $ 14.84 per share. The relative fair value of the warrants was approximately $ 1.2 million. For the Term D Loans, the exercise price was based on the lower of (i) the exercise price for the warrants issued pursuant to the Term C Loan or (ii) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the Term D Loan funding. Prior to the Third Amendment, the Company also was required to issue warrants to Innovatus and Oxford in connection with the funding of the Term E Loan and the Term F Loan. The warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding date. The number of shares of common stock for which each warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such warrant. The Company evaluated the change of terms under ASC 470-50, Debt – Modification and Extinguishment with respect to the Third Amendment, the Second Amendment, the First Amendment and the A&R Loan Agreement and concluded the change in terms did not result in significant and consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment of the debt. Note payable, non-current consisted of the following (in thousands): Schedule of Long-term Debt 2025 2024 As of December 31, 2025 2024 Note payable $ 130,000 $ 100,000 Add: Final fee 5,850 4,500 Add: PIK interest (added to principal) 1,697 593 Less: unamortized debt issuance costs ( 2,619 ) ( 1,614 ) Less: unamortized debt discount ( 8,401 ) ( 5,752 ) Total long-term debt $ 126,527 $ 97,727 As of December 31, 2025, the fair value of the note payable, which differs from its carrying value, is determined using the Company’s estimated discount rate, volatility and risk-free rate, which are considered Level 3 inputs. As of December 31, 2025, the fair value of the note payable was $ 160.2 million. As of December 31, 2024, the carrying value of the note payable approximates the fair value (Level 3 inputs). The debt issuance costs and discount will be amortized to interest expense over the term of the Notes based on the effective interest rate method. As of December 31, 2025 and 2024, the effective interest rate was 12.7 % and 12.3 %, respectively. During the year ended December 31, 2025, interest expense related to the note payable was $ 14.4 million, including $ 2.7 million related to discount amortization. During the year ended December 31, 2024, interest expense related to the note payable was $ 10.3 million, including $ 1.3 million related to discount amortization. As of December 31, 2025, future principal payments, including the incurred PIK interest and Final Fee, are as follows (in thousands): Schedule of Long Term Debt Future Principal Payments Year Ending December 31, 2028 $ 43,899 2029 93,648 Total $ 137,547 As of December 31, 2025, the Company was in full compliance with all financial covenants of the Amended A&R Loan Agreement. 88 11. License Agreement On April 8, 2021, the Company entered into a license agreement with Pfizer Inc. (“Pfizer”) to research, develop, manufacture and commercialize gedatolisib. During 2021, the Company paid $ 5.0 million in upfront fees and issued 349,406 shares of the Company’s common stock to Pfizer pursuant to an Equity Grant Agreement. The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $ 335.0 million. One of these milestone events requires a $ 5.0 million payment within 60 days following the FDA regulatory filing of a New Drug Application (“NDA”) for gedatolisib. The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and the Company completed its final NDA submission to the FDA in November 2025. The Company recorded the $ 5.0 million NDA filing milestone as research and development expense in June 2025. As of December 31, 2025, this amount was included in other accrued expenses on the Company’s balance sheets. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid patent claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product, or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, a valid claim of a licensed patent right. The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party. 12. Income Taxes No income tax benefit was recorded during the years ended December 31, 2025 and 2024, due to net losses and recognition of a valuation allowance. The following table, which reflects the Company’s retrospective adoption of ASU 2023-09, presents a reconciliation of the U.S. federal statutory rate to the Company’s effective tax rate, including the amount (in thousands): Schedule of Effective Income Tax Rate Reconciliation Amount % Amount % Year Ended December 31, 2025 2024 Amount % Amount % Tax benefit at statutory rate $ ( 37,179 ) 21.0 % $ ( 23,474 ) 21.0 % State income tax benefit, net of federal tax effect ( 14 ) — ( 3 ) — Federal change in valuation allowance on deferred tax assets 38,249 ( 21.6 ) 23,797 ( 21.3 ) Federal research and development credits ( 1,358 ) 0.8 ( 982 ) 0.9 Prior year adjustments ( 343 ) 0.2 ( 3 ) — Non-deductible items 645 ( 0.4 ) 665 ( 0.6 ) Income tax expense (benefit) $ — — % $ — — % In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted, introducing a series of corporate tax changes in the U.S., including 100% bonus depreciation on qualified property and full expensing of domestic research and development expenditures. The impacts of OBBBA are reflected in our results of operations during the year ended December 31, 2025. OBBBA did not have a material impact on the Company’s effective income tax rate and its net deferred tax assets as the Company maintains a full valuation allowance. 89 Deferred tax assets (liabilities) reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences. In accordance with ASC 740, Income Taxes , the Company recorded a valuation allowance to fully offset the net deferred tax assets as of December 31, 2025 and 2024, because it is more likely than not that the Company will not realize future benefits associated with these deferred tax assets. The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets (liabilities) were (in thousands): Schedule of Deferred Tax Assets and Liabilities 2025 2024 As of December 31, 2025 2024 Gross deferred tax assets (liabilities): Accrued expenses $ 253 $ 459 Stock-based compensation 6,056 2,861 Property and equipment 463 420 Right-of-use assets ( 11 ) ( 45 ) Lease liabilities 12 48 Section 174 expenditures 48,070 30,133 Start-up expenditures 21,955 12,998 Net operating losses and tax credits 23,483 13,340 Deferred tax assets before valuation allowance 100,281 60,214 Valuation allowance ( 100,281 ) ( 60,214 ) Net deferred tax assets $ — $ — As of December 31, 2025, the Company had federal and state net operating loss carryforwards of $ 83.3 million and $ 4.8 million, respectively. The federal and state net operating loss carryforwards for 2017 will begin to expire during the year ending December 31, 2037. The federal net operating loss carryforwards starting in 2018 have no expiration. These deferred tax assets were subject to a full valuation allowance as of December 31, 2025 and 2024. As of December 31, 2025, the Company had federal and state research and development tax credit carryforwards resulting in deferred tax assets of $ 4.3 million and $ 2.0 million, respectively. The federal and state credit carryforwards will begin to expire during the years ending December 31, 2038 and December 31, 2033, respectively. These deferred tax assets were subject to a full valuation allowance as of December 31, 2025 and 2024. Under the provisions of Section 382 of the Internal Revenue Code of 1986, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes in ownership due to sales of equity, may limit in the future the amount of net operating loss carryforwards available to offset future taxable income. The Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more-likely-than not that the tax positions will be sustained upon examination by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. As of December 31, 2025 and 2024, the Company had no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheets that would, if recognized, impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months. The Company is no longer subject to U.S. federal income tax examinations for years before 2022, although carryforward attributes that were generated before 2022 may still be adjusted upon examination if used in a future period. State income tax statutes vary by jurisdiction. In most states in which the Company operates, the statute of limitations remains open for four years, and accordingly, the Company is generally no longer subject to state income tax examinations for years before 2021. The Company’s policy is to recognize interest and penalties related to uncertain tax positions as a component of general and administrative expenses. As of December 31, 2025, the Company had no accrued interest or penalties and no amounts were recognized in the statements of operations. During the years ended December 31, 2025 and 2024, the Company made state tax payments which were deemed immaterial. 13. Subsequent Events On January 9, 2026, the Company filed a new registration statement and accompanying prospectus supplement, which increased the aggregate offering amount under the Open Market Sale Agreement to $ 400.0 million. 90 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.