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Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended
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Dec. 31, 2025
Accounting Policies [Abstract] |
Basis of Presentation and Summary of Significant Accounting Policies | 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. 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. 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. 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. Deferred 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”). 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. 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. 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.

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- Definition The entire disclosure for the basis of presentation and significant accounting policies concepts. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Accounting policies describe all significant accounting policies of the reporting entity. + References Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 235 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Publisher FASB -URI https://asc.fasb.org/1943274/2147483426/235-10-50-1 + Details
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