Audit Information |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Audit Information [Abstract] | |
| Auditor Firm ID | 238 |
| Auditor Name | PricewaterhouseCoopers LLP |
| Auditor Location | San Jose, California |
Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2024 |
May 13, 2024 |
Dec. 31, 2023 |
Apr. 27, 2023 |
Jan. 19, 2023 |
Jan. 18, 2023 |
Dec. 06, 2022 |
Jul. 27, 2022 |
Jul. 26, 2022 |
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| Statement of Financial Position [Abstract] | |||||||||
| Preferred stock par value (in dollars per share) | $ 0.01 | $ 0.01 | |||||||
| Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 | |||||||
| Preferred stock, shares issued (in shares) | 0 | 0 | |||||||
| Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||
| Common stock par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||
| Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 | 1,000,000,000 | 350,000,000 | 350,000,000 | 250,000,000 | |||
| Common stock, shares issued (in shares) | 737,626,004 | 701,660,053 | |||||||
| Common stock, shares outstanding (in shares) | 737,626,004 | 701,660,053 |
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
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| Rights Offering | |||
| Adjustments to additional paid in capital, stock issued, issuance costs | $ 619 | $ 111 | |
| Private placement | |||
| Adjustments to additional paid in capital, stock issued, issuance costs | $ 140 | ||
| At Market Offering | |||
| Adjustments to additional paid in capital, stock issued, issuance costs | $ 1,190 | ||
Nature of Business and Operations and Recent Events |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Nature of Business and Operations and Recent Events | Nature of Business and Operations Summit Therapeutics Inc. (“we”, “Summit” or the “Company”) is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. The Company’s pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology. The Company’s current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule. On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc. and its affiliates (collectively, “Akeso”) pursuant to which the Company has in-licensed intellectual property related to ivonescimab, as further described in Note 5. Through the License Agreement, the Company obtained the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan. The License Agreement and transaction closed in January 2023 following customary waiting periods. On June 3, 2024, the Company entered into an amendment to the License Agreement with Akeso to expand its territories covered under the License Agreement to also include the Latin America, Middle East and Africa regions (collectively, and as expanded, the “Licensed Territory”). The Company’s operations are focused on the development of ivonescimab and other future activities, as the Company determines.
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Basis of Presentation and Use of Estimates |
12 Months Ended |
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Dec. 31, 2024 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates Basis of Presentation The consolidated 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 U.S. Securities and Exchange Commission. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain reclassifications have been made to the prior years’ financial statements to conform to current year presentation. Use of Estimates The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to accrued research and development expenses, stock-based compensation, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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Liquidity and Capital Resources |
12 Months Ended |
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Dec. 31, 2024 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Liquidity and Capital Resources | Liquidity and Capital Resources During the year ended December 31, 2024, the Company incurred a net loss of $221,315 and cash flows used in operating activities was $142,106. As of December 31, 2024, the Company had an accumulated deficit of $1,214,573, and cash and cash equivalents of $104,862 and short term investments in U.S. treasury securities of $307,487. The Company expects to continue to generate operating losses for the foreseeable future. The Company has evaluated and concluded that its cash, cash equivalents and short-term investments provide sufficient cash to fund its operating cash needs for at least the next 12 months from the date of issuance of these consolidated financial statements. Until the Company can generate substantial revenue and achieve profitability, the Company will need to raise additional capital to fund its ongoing operations and capital needs. The Company continues to evaluate options to further finance its operating cash needs for its product candidates through a combination of some, or all, of the following: equity and debt offerings, collaborations, strategic alliances, grants and clinical trial support from government entities, philanthropic, non-government and not-for-profit organizations, and marketing, distribution or licensing arrangements. There is no assurance, however, that additional financing will be available when needed or that management of the Company will be able to obtain financing on terms acceptable to the Company. If the Company is unable to obtain funding when required in the future, the Company could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects.
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Summary of Significant Accounting Policies and Recent Accounting Pronouncements |
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| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Summary of Significant Accounting Policies and Recent Accounting Pronouncements The significant accounting policies adopted by the Company in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. GAAP and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The consolidated financial statements reflect the accounts of Summit Therapeutics Inc. and its wholly owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation. Foreign Currency Translation The financial statements of the Company’s subsidiaries with functional currencies other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive (loss) income in stockholders’ equity. Foreign currency transaction gains and losses are included in other expense, net in the results of operations. The Company recorded realized and unrealized foreign currency transaction (loss) gain of ($97), $613 and ($4,109) for the years ended December 31, 2024, 2023 and 2022, respectively, which is included in other expense, net in the statements of operations and comprehensive loss. Other Operating (Expense) Income, Net The Company generated income from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received within other operating (expense) income, net in the consolidated statements of operations and comprehensive loss. Income from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. If the government agency approves the project proposed by the Company, the government agency funds the project upon receipt of the support for the costs incurred up to the contract limit. Income recognized upon incurring qualifying expenses in advance of billing is recorded as unbilled receivable, a component of other current assets, in the consolidated balance sheet. Grant income is not recognized as deductions of research and development costs because the Company acts as the principal in conducting the research and development activities and these contracts are central to its ongoing operations. The funds received through these means are held as deferred income in the consolidated balance sheets and are released to the consolidated statement of operations and comprehensive loss, classified as other operating (expense) income, net, as the underlying expenditure is incurred and to the extent the conditions of the grant are met. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss. The Company benefits from two United Kingdom ("U.K.") research and development (“R&D”) tax credit cash rebate regimes: Small and Medium Enterprise (“SME”) Program and the Research and Development Expenditure Credit (“RDEC”) Program. Each reporting period, management evaluates which tax relief programs the Company is expected to be eligible for and records as other operating (expense) income, net the portion of the expense that it expects to qualify under the programs, that it plans to submit a claim for, and it has reasonable assurance that the amount will ultimately be realized. Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the diluted net loss by the weighted-average number of common shares outstanding for the period, including potentially dilutive common shares. The dilutive effect of share options and warrants are determined under the treasury stock method using the average market price for the period. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options and warrants that are in-the-money. Goodwill Goodwill represents the excess of the consideration transferred over the fair value of net assets acquired. Goodwill is assigned to reporting units at the time of acquisition or when there is a change in the reporting structure and bases that allocation on which reporting units will benefit from the acquired assets and liabilities. Reporting units are defined as operating segments or one level below an operating segment, referred to as a component. Typically acquisitions related to a single reporting unit do not require the allocation of goodwill to multiple reporting units. If the net assets obtained in an acquisition are assigned to multiple reporting units, the goodwill is distributed to the respective reporting units as part of the purchase price allocation process. The Company assesses goodwill for impairment on an annual basis as of December 31 or more frequently when events and circumstances occur indicating that the recorded goodwill may be impaired. The Company regularly monitors current business conditions and other factors including, but not limited to, adverse industry or economic trends and lower projections of profitability that may impact future operating results. The process of evaluating the potential impairment of goodwill requires significant judgment. In performing the Company’s annual goodwill impairment test, the Company is permitted to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company’s reporting unit is less than its carrying amount, including goodwill. In performing the qualitative assessment, the Company considers certain events and circumstances specific to the reporting unit and to the entity as a whole, such as macroeconomic conditions, industry and market considerations, overall financial performance and cost factors when evaluating whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. The Company is also permitted to bypass the qualitative assessment and proceed directly to the quantitative test. If the Company chooses to undertake the qualitative assessment and concludes that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, the Company would then proceed to the quantitative impairment test. In the quantitative assessment, the Company compares the fair value of the reporting unit to its carrying amount, which includes goodwill. If the fair value exceeds the carrying value, no impairment loss exists. If the fair value is less than the carrying amount, a goodwill impairment loss is measured and recorded. Intangible Assets and Long-lived Assets The Company evaluates the recoverability of its intangible and long-lived assets whenever events and changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. If events and circumstances indicate that the carrying amount may not fully be recoverable, the carrying values of the asset or asset group are evaluated in relation to their operating performance and future undiscounted cash flows of the underlying business. If the future undiscounted cash flows are less than their carrying value, impairment exists. The impairment is measured as the difference between the carrying value and the fair value of the underlying asset or asset group. Fair values are based on estimates of market prices and assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Cost is comprised of the purchase price plus any incidental costs of acquisition and commissioning. Depreciation is calculated based on cost, less residual value, in equal annual installments over the estimated useful lives of the assets. The residual value, if significant, is reassessed annually.
Depreciation is recognized as part of the general and administrative and research and development expense lines shown on the face of the consolidated statement of operations and comprehensive loss depending on the nature of the underlying assets. Expenditures for repairs and maintenance are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Leases The Company has operating leases for real estate. The Company does not have any finance leases. A contract is or contains a lease when the lessee has the right to control the use of an identified asset. The Company determines if an arrangement is a lease at inception of the contract, which is the date on which the terms of the contract are agreed to and the agreement creates enforceable rights and obligations. The lease term used to calculate the lease liability include options to extend or terminate the lease when it is reasonably certain that the option will be exercised. At the lease commencement date, the Company measures and recognizes a lease liability and a right-of-use asset in the financial statements. Lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. The right-of use asset is measured by taking the present value of future lease payments, plus any incremental direct costs incurred, less any lease incentives received. As most of the Company’s leases do not provide an implicit rate, the Company uses an estimated incremental borrowing rate based on the lease term and the economic environment of the lease at the lease commencement date, which is then utilized to determine the present value of future lease payments. Lease expense for minimum lease payments are recognized on a straight-line basis over the lease term, with variable lease payments recognized in the periods in which they are incurred. The Company has existing lease agreements with lease and non-lease components, has elected to account for the lease and non-lease components as a single lease component, and has allocated all of the contract consideration to the lease component only. Leases with an initial lease term of 12 months or less are not recorded on the balance sheet. The Company recognizes lease expense for its short-term leases on a straight-line basis over the lease term. Acquired In-Process Research and Development The Company may enter into agreements with collaboration partners for the development and commercialization of its products. These arrangements may include payments contingent on the occurrence of certain events such as development, regulatory or sales-based milestones. The Company considers the unique nature, terms and facts and circumstances of each transaction. The Company considers whether or not the assets acquired have an alternative future use. The fair value associated with acquired in-process research and development which does not have an alternative future use is expensed and is recorded as research and development expense. Any development or commercial milestone payments are recognized when the achievement of the associated milestone becomes probable and will either be expensed or capitalized depending upon whether or not regulatory approval has been obtained. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop product candidates, including personnel expenses, stock-based compensation expense, allocated facility-related and depreciation expenses, third-party license fees and external costs of outside vendors engaged to conduct preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered. Milestone and other payments made to third-parties with respect to in-process research and development, in accordance with the Company’s license, acquisition and other similar agreements are expensed when determined to be probable and estimable. The Company has entered into various research and development contracts with other companies. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs. These amounts are determined based on the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. Actual results could differ from the Company’s estimates. In all cases, the full cost of each study or activity is expensed by the time the final report or where applicable, product, has been received. The Company’s historical estimates have not been materially different from the actual costs. Stock-Based Compensation The Company measures and recognizes compensation expense for all stock option awards based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards. Additionally, the Company uses a Monte Carlo simulation model to calculate the estimated fair value on the date of grant related to awards with market-based service conditions. The fair value is recognized as expense, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis for each separately vesting portion of the award when the only condition to vesting is continued service. If vesting is subject to a market or performance condition, recognition is based on the derived service period of the award. Expense for awards with performance conditions is estimated and adjusted on a quarterly basis based upon the assessment of the probability that the performance condition will be met. Use of the Black-Scholes option-pricing model requires management to apply judgment under subjective assumptions. These assumptions include: •Expected term—The expected term of stock options represents the weighted-average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. •Expected volatility—The expected volatility is calculated based on historical volatility of the Company’s share price. •Risk-free interest rate—The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options. •Expected dividend—The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not intend to pay dividends. The Company uses a Monte Carlo simulation model to estimate the fair value of Performance and Market-based Stock Options at the date of grant which utilizes multiple input variables to estimate the probability that the market condition will be achieved. Key assumptions used in the model include the risk-free interest rate, which reflects the US Treasury Constant Maturity Yield with a term commensurate with the contractual term of the award, and stock price volatility, which is derived based on the historical volatility of the Company’s stock. The Company estimates expected forfeitures at the time of grant instead of accounting for forfeitures as they occur. Stock option awards have been granted at fair value to non-employees in connection with research and consulting services provided to the Company. Equity awards generally vest over terms of 3 or 4 years. The Company classifies stock-based compensation expense in the consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified. Income Taxes The provision for income taxes is determined using the asset and liability approach. Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements. A current asset or liability is recognized for the estimated taxes receivable or payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes are initially recognized at enacted tax rates in force at the time of initial recognition and are subsequently adjusted for any enacted changes in tax rates and tax laws. Subsequent changes to deferred taxes originally recognized in equity are recognized in income. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The Company has recorded a full valuation allowance against the deferred tax assets in excess of its deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The Company records interest and penalties related to income tax matters as part of income tax expense. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, restricted cash and short-term investments. The Company’s cash is comprised of short-term cash deposits at a variety of financial institutions which the Company believes are of high credit ratings in amounts that may exceed federally insured limits. The Company has not experienced any losses on such accounts. Cash balances maintained during the year have been principally held with U.S.-based and U.K.-based banks. The Company does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a number of vendors to conduct its clinical trials and preclinical studies, manufacture drug product and supply clinical trial and preclinical study materials for its development programs. These programs could be adversely affected by a significant interruption in these services or the availability of materials. Fair Value Measurements In accordance with the provisions of fair value accounting, a fair value measurement assumes that the transaction to sell an asset or transfer a liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market for the asset or liability and defines fair value based on the exit price model. The fair value measurement guidance establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The guidance describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 2 assets and liabilities include debt securities with quoted prices that are traded less frequently than exchange-traded instruments or securities or derivative contracts that are valued using a pricing model with inputs that are observable in the market or can be derived principally from or corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the Company categorizes such assets and liabilities based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset. Cash and Cash Equivalents The Company considers only those investments that are highly liquid, readily convertible to cash and that mature within 90 days or less from date of purchase to be cash equivalents. As of December 31, 2024, cash equivalents were comprised of money market funds. As of December 31, 2023, cash equivalents were comprised of money market funds and U.S. treasury securities. Restricted Cash Restricted cash represents amounts which are legally restricted to withdrawal or usage and is presented in the consolidated balance sheet as restricted cash. On December 15, 2022, the Company transferred $300,000 into an escrow fund reserved for the Company’s initial upfront payment to Akeso in connection with the License Agreement, as described further in Note 5. Following the Antitrust Clearance Date, on January 17, 2023, the License Agreement closed and Akeso was issued 10,000,000 shares of Company common stock pursuant to the Common Stock Issuance Agreement and was paid $274,900 in cash as the initial upfront payment. The remaining amounts in escrow were returned to the Company’s operating cash accounts. As of December 31, 2024 the Company has $325 of restricted cash associated with an irrevocable letter of credit required by the landlord to enter into the lease for Company's corporate office. The Company’s total cash, cash equivalents and restricted cash balances were as follows:
Short-term Investments Marketable securities consist of investments with original maturities greater than ninety days from the date of acquisition. The Company classifies investments with maturities of greater than 90 days and less than one year as short-term, based on the liquid nature of the securities and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of investments as available-for-sale. Accordingly, these investments are recorded at fair value, which is based on quoted market prices or other observable inputs. Unrealized gains and losses are recorded as a component of other comprehensive income (loss). Realized gains and losses are determined on a specific identification basis and are included in other (expense) income. Amortization and accretion of discounts and premiums are also recorded in other (expense) income. When the fair value is below the amortized cost of the asset, an estimate of expected credit losses is made. This estimate is limited to the amount by which fair value is less than amortized cost. The credit-related impairment amount is recognized in the consolidated statements of operations and comprehensive loss and the remaining impairment amount and unrealized gains are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Credit losses are recognized through the use of an allowance for credit losses account and subsequent improvements in expected credit losses are recognized as a reversal of the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis the allowance for credit loss is written off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss. Warrants Warrants issued by the Company are recognized and classified as equity when, upon exercise, the Company would issue a fixed amount of its own equity instruments (common stock) in exchange for a fixed amount of cash or another financial asset. Consideration received, net of incremental costs directly attributable to the issue of such new warrants, is shown in stockholders' equity. Such warrants are not remeasured at fair value in subsequent reporting periods. Warrants issued in which external services are received as consideration for equity instruments of the company should be measured at the fair value of the goods or services received. Only if the fair value of the services cannot be measured reliably would the fair value of the equity instruments granted be used. The fair value for the warrants is calculated using the Black-Scholes model and recorded in the consolidated statement of operations and comprehensive loss on a straight-line basis over the period of the consulting services. If the services are terminated prior to the end of the consultancy agreement, the warrants cease vesting and any unvested portion of the warrants will lapse immediately. The warrants in issue are classified within stockholders’ equity as they are indexed to the Company’s own shares of common stock and require settlement in its shares of common stocks with no provision for any cash settlement. Recently Issued or Adopted Accounting Pronouncements In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards update “ASU” No. 2023-09, “Improvements to Income Tax Disclosures”, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the income tax disclosures within the consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption was permitted, and the amendments should be applied retrospectively. The Company adopted and retrospectively applied the amendments in this update during the fourth quarter of 2024 and in preparation of the annual consolidated financial statements. Refer to Note 6 regarding the additional disclosures included within the consolidated financial statements. In November 2024, the FASB issued ASU 2024-03, “Disaggregation of Income Statement Expenses.” The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures. The guidance is effective for public business entities for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted. The guidance is to be applied prospectively, with the option for retrospective application. The Company is currently evaluating the impact of the ASU on the disclosures within the consolidated financial statements. Other recent authoritative guidance issued by the FASB (including technical corrections to the FASB ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not expected to have a material impact on the Company’s consolidated financial statements.
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Akeso License and Collaboration Agreement |
12 Months Ended |
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Dec. 31, 2024 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Akeso License and Collaboration Agreement | Akeso License and Collaboration Agreement On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc. and its affiliates ("Akeso") pursuant to which the Company is in-licensing its breakthrough bispecific antibody, ivonescimab. The License Agreement and transaction closed in January 2023 following customary waiting periods. Ivonescimab, known as AK112 in China and Australia, and also as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody intending to combine the effect of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF into a single molecule. Ivonescimab was engineered to bring two well established oncology targeted mechanisms together. Ivonescimab is currently in clinical development and, pursuant to the terms of the License Agreement, Summit will design and conduct the clinical trial activities to support regulatory filings in the Licensed Territory that Summit will submit. Pursuant to the terms of the License Agreement, Summit will have final decision making authority with respect to clinical development strategy and execution in the Licensed Territory. For co-joined studies in which both Summit and Akeso participate, mutual agreement is required for material decisions; Summit retains the exclusive decision making with respect to participating in, and continuing its participation in, co-joined studies. Pursuant to the terms of the License Agreement, Summit will have final decision-making authority with respect to commercial strategy, pricing and reimbursement and other commercialization matters in the Licensed Territory. In connection with the License Agreement, the Company has also entered into a Supply Agreement with Akeso, pursuant to which Summit agrees to purchase a certain portion of drug substance for clinical and commercial supply. Summit is not assuming any liabilities (including contingent liabilities), acquiring any physical assets or trade names, or hiring or acquiring any employees from Akeso in connection with the License Agreement. Through the License Agreement, the Company obtained the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan. In exchange for the rights obtained, the Company made an upfront payment of $500,000 to Akeso, of which $274,900 was paid in cash and, pursuant to the License Agreement and Issuance Agreement, Akeso elected to receive 10,000,000 shares of our common stock in lieu of $25,100 cash. The remaining $200,000 amount of the upfront payment was paid on March 6, 2023. Effective June 3, 2024, the Company and Akeso entered into an amendment (the “Second Amendment”) to the License Agreement to expand the Company’s territories covered under the License Agreement to include the Latin America, Middle East and Africa regions. Pursuant to the Second Amendment, the Company paid an upfront payment to Akeso of $15,000 in the third quarter of 2024. Akeso will also be eligible to receive up to an additional $55,000 upon the achievement of certain commercial milestones. Except as specifically modified by the Second Amendment, the terms and conditions of the License Agreement remain in full force and effect. The Company has accounted for the License Agreement and Second Amendment to acquire the rights to develop and commercialize ivonescimab as the acquisition of an asset. All of the consideration relates to ivonescimab and technological feasibility of the asset has not yet been established since ivonescimab is in clinical development. As such, the Company has expensed the consideration as acquired in-process research and development upon closing of the transaction in the consolidated statement of operations and comprehensive loss. Acquired in-process research and development expense for the year ended December 31, 2024 was $15,007 which related to the upfront payment and immaterial transaction costs for the Second Amendment. For the year ended December 31, 2023, acquired in-process research and development expense was $520,915 which was comprised of the $474,900 paid in cash, the fair value of the 10,000,000 shares of common stock on the date of closing the transaction of $45,900, and $115 of direct transactions costs incurred for the License Agreement. In addition to the payments already made to Akeso, under the License Agreement and Second Amendment, there are additional potential milestone payments of up to $4,555,000, as Akeso will be eligible to receive regulatory milestones of up to $1,050,000 and commercial milestones of up to $3,505,000. In addition, Akeso will be eligible to receive low double-digit royalties on net sales.
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Segment Reporting |
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| Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Segment Reporting | Segment Reporting The Company’s chief operating decision makers (the “CODM function"), which are the Company's Co-Chief Executive Officers, Mr. Duggan and Dr. Zanganeh, and Chief Operating Officer and Chief Financial Officer, Mr. Soni, utilize consolidated net loss that is reported on the consolidated statement of operations and comprehensive loss to make decisions about allocating resources and assessing performance for the entire Company. The CODM function approves of key operating and strategic decisions, including key decisions in clinical development and clinical operating activities, entering into significant contracts, such as revenue contracts and collaboration agreements and approves the Company's consolidated operating budget. The CODM function views the Company's operations and manages its business on a consolidated basis and as a single reportable operating segment. The CODM function is regularly provided with the following significant segment expenses:
(1) Revenue relates to amounts received from the license and commercialization agreement related to ridinilazole clinical trials. All prior development activities related to ridinilazole have been terminated. (2) Other expenses include costs for the Company’s antibiotic pipeline research activities and ridinilazole or CDI program activities (collectively, “Anti-infectives), general and administrative expenses excluding compensation and stock-based compensation, and impairment of intangible assets. All prior development activities related to Anti-infectives have been terminated. As of December 31, 2024 and 2023, substantially all of our long-lived assets are located in the United States.
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| Other Operating Income, net | Other Operating Income, net The following table sets forth the components of other operating income by category:
BARDA (as defined below) In September 2017, we were awarded a funding contract from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services, to fund, in part, the clinical and regulatory development of ridinilazole for the treatment of infections caused by C. difficile ("CDI"). The contract provides for a cost-sharing arrangement under which BARDA committed to funding $62,400 of estimated costs for the continued clinical and regulatory development of ridinilazole for CDI. As a result of the Company’s decision, on September 28, 2022, to not pursue further internal clinical development of ridinilazole and seek partners or a divestiture related to ridinilazole as a path forward for the clinical development of the asset, the Company recorded expenses for the remaining clinical trial costs associated with the close out activities of ridinilazole and recognized the remainder of the deferred income that had been received from BARDA. As of December 31, 2022, the Company recognized $59,203 of cumulative income under the BARDA contract and no additional income will be recognized. Research and development credits Research and development tax credits consists of tax credits received in the United Kingdom (“U.K.”). As of December 31, 2024 and 2023, the current and long-term research and development tax credit receivable was $1,255 and $1,807, respectively. Refer to Note 4 for information about the two U.K. research and development tax credit cash rebate regimes which the Company benefits from, as well as criteria established by the HMRC. CARB-X (as defined below) In May 2021, the Company received an award from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator program ("CARB-X") to progress SMT-738 through preclinical development and an option to continue into Phase Ia clinical studies. The award committed initial non-dilutive funding of up to $4,100, with the possibility of up to another $3,700 based on the achievement of future milestones. As of December 31, 2022, the Company recognized $2,920 of cumulative income under the CARB-X contract and no additional income will be recognized.
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| Other Income (Expense), net | Other Income (Expense), net The following table sets forth the components of other (expense) income:
(1) Investment income relates to the Company’s money market funds and short-term investments in U.S. treasury securities. Refer to Note 12 for details. (2) The reclassification of cumulative currency translation gain related to the reclassification of cumulative foreign currency translation gains from accumulated other comprehensive loss due to the dissolution of certain dormant entities.
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Income Tax |
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| Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Tax | Income Tax The Company is primarily subject to corporation taxes in the U.S. and the U.K. The calculation of the Company’s tax provision involves the application of both U.S. and U.K. tax law and requires judgment and estimates. The Company has assessed the applicability of the OECD/G20 Inclusive Framework on Base Erosion and Profit Shifting (BEPS) Pillar 2 rules, which establish a global minimum tax rate. Based on our current financial position and revenue thresholds, the Company is not large enough for Pillar 2 to apply. Therefore, the provisions and requirements under Pillar 2 do not impact our financial statements for the reporting period. The provision for income taxes is determined using the asset and liability approach. Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements. A current asset or liability is recognized for the estimated taxes receivable or payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes are initially recognized at enacted tax rates in force at the time of initial recognition and are subsequently adjusted for any enacted changes in tax rates and tax laws. Subsequent changes to deferred taxes originally recognized in equity are recognized in income. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The Company has recorded a full valuation allowance against the deferred tax assets in excess of its deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The Company records interest and penalties related to income tax matters as part of income tax expense. The Company accounts for uncertainty in income taxes by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed as the amount of benefit to recognize in the consolidated financial statements. The amount of benefits that may be used is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate, as well as the related net interest and penalties. At December 31, 2024 and 2023, the Company had $2,122 and $1,064 uncertain tax positions for the respective reporting periods. Due to the Company’s full valuation allowance, the unrecognized tax benefits would not materially impact the Company’s effective tax rate when recognized. The Company does not anticipate the total amounts of unrecognized tax benefits will significantly increase or decrease in the next 12 months. The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision. For the years ended December 31, 2024 and 2023, the Company had no interest or penalties related to unrecognized tax benefits. The components of the Company’s loss before income taxes are as follows:
The Company has not recognized a current or deferred provision for federal, state or non-United States income taxes in the years ended December 31, 2024, 2023 and 2022. Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The major components of deferred tax assets and liabilities are as follows:
For the year ended December 31, 2024 and 2023, the Company recorded a deferred tax asset of $95,925 and $84,925, respectively. The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets, which are comprised primarily of net operating loss carryforwards and research and development costs capitalized for tax purposes. Management has considered the Company’s history of cumulative net losses in the U.S. and the U.K., estimated future taxable income, as well as prudent and feasible tax planning strategies, and has concluded that it is more likely than not that the Company will not realize the benefits of its U.S. federal and state deferred tax assets and U.K. deferred tax assets. Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2024 and 2023, respectively. The Company reevaluates the positive and negative evidence at each reporting period. The changes in the valuation allowance during the years ended December 31, 2024, 2023 and 2022 primarily related to net operating loss carryforwards and capitalized research and development expenses. The change in the valuation allowance was as follows:
As of December 31, 2024 and 2023, the Company had U.S. federal gross operating loss carryforwards of approximately $44,270 and $48,184, respectively, which may be available to offset future income tax liabilities. The 2017 Tax Cuts and Jobs Act (“TCJA”) will generally allow losses incurred after 2017 to be carried over indefinitely, but will generally limit the net operating loss deduction to the lesser of the net operating loss carryover or 80% of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended). In addition, the Company has approximately $7,045 in U.S. State gross loss carryforwards which expire through various dates through 2043 and as of December 31, 2024, the Company had an estimated U.S. federal and state research and development tax credit carryforwards of $6,982 and $586, respectively, which may be available to offset future tax liabilities, and each begin to expire in 2041 and 2037, respectively. As of December 31, 2024 the Company also had approximately $198,653 in U.K. gross loss carryforwards available to use against future taxable profits on a year-by-year basis. To the extent that U.K. taxable profits exceed £5,000 in each year, the loss available to utilize against profits in excess of £5,000 will be restricted to 50%. The U.K. loss carryforwards do not lapse and therefore, the full amount will be relieved over time provided there are sufficient profits against which the losses can be utilized. Utilization of the U.S. net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not completed a study to assess whether a change of ownership has occurred, or whether there have been multiple ownership changes since its formation. Any limitation may result in the loss of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. U.K. tax losses are subject to additional restrictions where there is a change in ownership in the business and certain other conditions are met. An ownership change of a U.K. tax resident company would occur where (directly or indirectly) a single person acquires more than half of the ordinary share capital of a company, or two or more persons each acquire a holding of at least 5% of the ordinary share capital of a company and these holdings together amount to more than half the ordinary share capital of a company. Where a change in ownership has occurred, and within three years prior to that change in ownership and five years afterwards, there is a major change in the nature and conduct of trade of that company or the trade of that business becomes small or negligible, any losses carried forward will be extinguished from the point of the change in ownership. In addition, losses accrued subsequent to April 1, 2017 will be extinguished on a change of ownership when there is a major change in the nature or conduct of a company’s business, or where there is a major change in the scale of that business, or a company ceases to carry on a particular trade or business. The Company has not completed a study to assess whether a change of ownership has occurred since its formation, or whether there has been a major change in the Company’s business that would restrict the U.K. tax losses. Any limitation may result in the loss of a portion of the net operating loss carryforwards before utilization. The 2017 Tax Cuts and Jobs Act (“TCJA”) created a requirement that US corporations include in income earnings of certain controlled foreign corporations (“CFC”) under the global intangible low taxed income (“GILTI”) regime. Pursuant to the FASB Staff Q&A, Topic 740 No.5. Accounting for Global Intangible Low-taxed Income, the Company is allowed to make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as period expense only. The Company has elected to account for GILTI in the year the tax is incurred and include the current tax impact of GILTI in the effective tax rate. Given the Company’s loss position in the U.S. and the valuation allowance recorded against its U.S. net deferred tax assets, these provisions have not had a material impact on the Company’s consolidated financial statements. A reconciliation of the Company’s effective tax rate to the U.S. federal statutory rate is as follows:
A reconciliation of unrecognized tax benefits from continuing operations is as follows:
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Net Loss per Share |
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| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss per Share | Net Loss per Share The following table sets forth the computation of basic and diluted net loss per share:
As the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods, as the inclusion of all potential common share equivalents outstanding would have been anti-dilutive. Because the 2023 Rights Offering (as defined in Note 17) exercise price of $1.05 per share was less than the closing price of $1.82 per share on March 1, 2023, the expiration, the Company has retroactively adjusted earnings per share and the weighted average number of shares outstanding for the bonus element for the years ended December 31, 2023 and 2022. The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive:
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Goodwill and Intangible Assets |
12 Months Ended |
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Dec. 31, 2024 | |
| Goodwill and Intangible Assets Disclosure [Abstract] | |
| Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill In December 2017, the Company expanded its activities in the field of infectious diseases with the acquisition of Discuva Limited, a privately held United Kingdom-based company. Through this acquisition, the Company obtained a bacterial genetics platform and a suite of software-based technologies (the “Discuva Platform”), which facilitates the discovery and development of new mechanism antibiotics. This resulted in the recognition of goodwill of £1.5 million, which is translated into U.S. dollars at each reporting period. As of December 31, 2024 and 2023, goodwill was $1,864 and $1,893, respectively. Changes year over year are the result of changes in foreign currency. The Company assesses goodwill for impairment on an annual basis as of December 31 or more frequently when events and circumstances occur indicating that recorded goodwill may be impaired. As of December 31, 2024, the Company performed its annual impairment assessment of goodwill and determined that it is more likely than not that the fair value of the reporting unit exceeds its carrying amount. The Company has recorded no goodwill impairment charges to date. Intangible Assets In December 2017, the Company expanded its infectious disease research by acquiring Discuva Limited, a privately held company in the United Kingdom. This acquisition provided a bacterial genetics platform and associated software-based technologies (collectively referred to as the “Discuva Platform”). In conjunction with the significant change in the Company’s strategy and shift in focus to the therapeutic area of oncology, the Company determined that it would cease further investment in the Discuva Platform. Management concluded that the carrying amount of the acquired Discuva Platform intangible asset may not be recoverable and performed an assessment to calculate the fair value of the asset using a probability-weighted approach which was compared to the carrying value of the asset. An impairment charge of $8,468 which represented the carrying value of the Discuva Platform was recognized during the year ended December 31, 2022. This impairment charge is presented as in the consolidated statements of operations and comprehensive loss. There was no amortization expense for the years ended December 31, 2024 and 2023. Amortization expense for the year ended December 31, 2022 was $914.
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Fair Value Measurements and Short-Term Investments |
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| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Measurements and Short-Term Investments | Fair Value Measurements and Short-Term Investments Fair Value Measurements The following tables sets forth the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2024 and 2023:
The tables above do not include cash at December 31, 2024 and 2023 of $16,263 and $11,068, respectively. The Company believes that the carrying amounts of prepaid expenses, other current assets, accounts payable, and accrued expenses approximates their fair values due to the short-term nature of those instruments. As of December 31, 2023, the carrying value of the Company’s promissory note approximated its fair value and the current interest rate of the note outstanding when compared to market interest rates (which represents a Level 2 measurement). Refer to Note 16 for further details. Short-Term Investments The following table sets forth the Company’s short-term investments as of December 31, 2024 and 2023, which have a contractual maturity of less than one year:
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Property and Equipment |
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| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property and Equipment | Property and Equipment Property and equipment consisted of the following:
Depreciation expense for the years ended December 31, 2024, 2023 and 2022 was $89, $198 and $349, respectively. There were no material impairment charges related to fixed assets for the years ended December 31, 2024, 2023 and 2022.
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Research and Development Prepaid Expenses and Accrued Liabilities |
12 Months Ended |
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Dec. 31, 2024 | |
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
| Research and Development Prepaid Expenses and Accrued Liabilities | Research and Development Prepaid Expenses and Accrued Liabilities Included within prepaid expenses and other current assets at December 31, 2024 and 2023 is $8,338 and $1,466, respectively, of prepayments relating to research and development expenditures. Included within accrued liabilities at December 31, 2024 and 2023 is $17,441 and $7,289, respectively, relating to research and development expenditures. The Company records accruals for estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs. These amounts are determined based on the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. However, prepaid expenses decrease and accrued liabilities increase as the activities progress, and if actual costs incurred exceed the prepaid expense, an accrual will be recorded for the liability. The key sensitivity is the estimated current stage of completion of each study or activity, which is based on information received from the supplier and the Company’s operational knowledge of the work completed under those contracts.
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Leases |
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| Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | Leases The Company has operating leases for real estate. The Company does not have any finance leases. The Company leases its offices and facilities in Menlo Park, CA, Miami, FL and Oxford, U.K., under non-cancellable operating lease agreements. The lease agreements for the Company’s offices and facilities in Menlo Park, CA expire from December 2025 to May 2026. The lease agreements for the Company’s offices and facilities in Miami, FL and Oxford, U.K. expire in April 2029 and February 2027, respectively. Under the terms of the lease agreements, the Company is responsible for certain repair and maintenance, utilities, licensing and permit fees. During the year ended December 31, 2024, the Company recorded $4,216 of additional right-of-use assets related to a new lease for office space that commenced during the first fiscal quarter for its Miami, Florida headquarter location. Total future lease payments as of December 31, 2024 are approximately $4,185 on an undiscounted basis. This lease commenced on February 1, 2024 and has a term of 5.3 years. As of December 31, 2024, the Company had $325 of restricted cash associated with an irrevocable letter of credit required by the landlord to enter into this lease. In addition, during the year ended December 31, 2023, the Company terminated the Company’s Cambridge, U.K. laboratory and office space lease as a result of the Company re-prioritizing its investments and financial resources towards the development of ivonescimab. This resulted in disposing the carrying value of the right-of use asset of $788, removing the related lease liability of $809, and there were no penalties charged for early termination of this lease. The carrying value of the right-of-use assets as of December 31, 2024 and 2023 is $7,144 and $5,859, respectively. The elements of lease expense were as follows:
(1) Short-term lease costs relate to the Company’s Cambridge, Massachusetts, United States office lease which the Company exited during fiscal year 2022. The weighted average discount rate and the weighted average remaining lease term were 6.9% and 2.8 years, respectively, as of December 31, 2024. The weighted average discount rate and the weighted average remaining lease term were 6.6% and 2.8 years, respectively, as of December 31, 2023. The Company made cash payments related to lease liabilities of $2,568 and $2,208 for the years ending December 31, 2024 and 2023 respectively. Future lease payments under non-cancelable leases as of December 31, 2024 are detailed as follows:
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Promissory Notes Payable to Related Parties |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Related Party Transactions [Abstract] | |
| Promissory Notes Payable to Related Parties | Promissory Note Payable to Related Parties At December 31, 2024 and 2023, the Company's non-current debt was $0 and $100,000, respectively. As of December 31, 2023, the non-current debt balance consisted of principal amounts due on promissory notes payable to related parties as described below. At December 31, 2024 and 2023, the Company had no current debt. March 2022 Promissory Note On March 10, 2022, Mr. Duggan, entered into a Note Purchase Agreement (the “March 2022 Note”), pursuant to which he loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The March 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal. The March 2022 Note, including all accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the March 2022 Note. Debt issuance costs associated with the March 2022 Note were immaterial and expensed as incurred. The March 2022 Note of $25,000, plus accrued interest of $434 was repaid to Mr. Duggan on August 10, 2022 in connection with the completion of the 2022 Rights Offering (as defined in Note 17) which received aggregate gross proceeds of $100,000. The Company incurred interest expense related to the March 2022 Note of $1,296 for the year ended December 31, 2022, which included amortized imputed interest of $861. December 2022 Promissory Notes On December 6, 2022, the Company entered into a Note Purchase Agreement (the "Note Purchase Agreement"), with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $520,000. Pursuant to the Note Purchase Agreement, the Company issued to Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the amount of $400,000 (the "Duggan February Note") and $20,000 (the "Zanganeh Note"), respectively, which matured and became due on February 15, 2023 and an unsecured promissory note to Mr. Duggan in the amount of $100,000 (the “Duggan September Note” and together with the Duggan February Note and the Zanganeh Note, the “December 2022 Notes”), which was originally due on September 15, 2023. The maturity dates of the December 2022 Notes could have been extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024. In addition, if the Company consummated a public offering, then upon the later to occur of (i) business days after the Company receives the net cash proceeds therefrom or (ii) May 15, 2023, the Duggan February Note and the Zanganeh Note were to be prepaid by an amount equal to the lesser of (a) 100% of the amount of the net proceeds of such offering and (b) the outstanding principal amount on such Notes. On January 19, 2023, the Company provided notice to extend the term of the Duggan February Note and Duggan September Note to a maturity date of September 6, 2024. Furthermore, on January 19, 2023, the Company and Mr. Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the Company may only prepay (i) the Duggan February Note following the completion of a public rights offering to be conducted by Summit in the approximate amount of $500,000 or a similar capital raise, in an amount equal to the lesser of (x) the net proceeds of the Rights Offering or such capital raise or (y) the full amount outstanding of the Duggan February Note, and (ii) Duggan September Note following the completion of a capital raising transaction subsequent to the 2023 Rights Offering (as defined in Note 17) in an amount equal to the lesser of (A) the net proceeds of such capital raise or (B) the full amount outstanding of the Duggan September Note. Following the issuance of the two new Promissory Notes (the “Duggan Promissory Notes”), the Duggan February Note and Duggan September Note were marked as “cancelled” on their face and replaced in their entirety by the Duggan Promissory Notes (together with the Zanganeh Note, the "Notes"). The Notes accrued interest at an initial rate of 7.5%. All interest on the Notes was paid on the date of signing for the period through February 15, 2023. Such prepaid interest was paid in a number of shares of the Company’s common stock, par value $0.01 ("Common Stock") equal to the dollar amount of such prepaid interest, divided by $0.7913 (the consolidated closing bid price immediately preceding the time the Company entered into the Note Purchase Agreement, plus $0.01), which was 9,720,291 shares. For all applicable periods following February 15, 2023, interest accrued on the outstanding principal balance of the Notes at the US prime interest rate, as reported in the Wall Street Journal, plus 50 basis points, as adjusted monthly, for three months immediately following February 15, 2023, and thereafter at the US prime rate plus 300 basis points, as adjusted monthly. Accrued interest was paid in cash, quarterly in arrears, on each of March 31, June 30, September 30 and December 31. On February 15, 2023, the $20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance. In connection with the closing of the 2023 Rights Offering, the $400,000 Duggan Promissory Note matured and became due, and the Company satisfied all principal and accrued interest thereunder using a combination of a portion of the cash proceeds from the 2023 Rights Offering and the extinguishment of a portion of the amount due equal to the subscription price of shares subscribed by Mr. Duggan in the 2023 Rights Offering. Debt issuance costs associated with the Notes were $44 and were capitalized as part of the carrying value of the promissory notes payable to related parties. Imputed interest was calculated as the difference between the expected interest payable and the deemed market rate of interest and is recorded as a debt discount at inception of the note payable with a credit to additional paid-in capital for notes payable to related parties. The debt discount is amortized to interest expense using an effective interest rate method. The effective interest rate of the Duggan February Note and Zanganeh Note was 8.9% and the effective interest rate of the Duggan September Note was 11.3%. On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest accrued on the outstanding principal balance at the greater of 12% or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly. Interest was paid upon maturity of the loan. In accordance with the applicable accounting standards, a short-term debt obligation should be excluded from current liabilities if the entity has both the intent and ability to refinance the obligation on a long-term basis. The intent and ability can be demonstrated by the issuance of a long-term obligation to refinance the short-term obligation on a long-term basis after the date of an entity’s balance sheet but before that balance sheet is issued. As a result of the amendment entered into on February 17, 2024 to extend the maturity date to April 1, 2025, the Company classified $100,000 of notes payable to related party outstanding as of December 31, 2023 as long-term notes payable. During the year ended December 31, 2024, the Company incurred interest expense of $8,686 related to promissory notes payable. During the year ended December 31, 2023, the Company incurred interest expense of $16,461 which included amortized imputed interest of $761. During the year ended December 31, 2022, the Company incurred interest expense of $3,105 related to the December 2022 Notes which included amortized imputed interest of $395. As of December 31, 2024 and 2023, there was $0 and $120, respectively, of accrued interest payable included within accrued expenses in the consolidated balance sheet. As of October 1, 2024, the Company repaid the Duggan September Note in full, resulting in principal payments in the aggregate amount of $100,000 and accrued cash interest of $7,305. Related Party TransactionsJuly 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 25, 2022 the Company entered into a first amendment, dated July 19, 2022, to its existing sublease agreement with Maky Zanganeh and Associates, Inc. ("MZA"), an entity owned by Maky Zanganeh, consisting of 4,500 square feet of office space at 2882 Sand Hill Road, Menlo Park, California. The existing sublease term, which was set to expire on September 30, 2022, was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. The agreement was further amended to include additional space, as noted below under the "August 2, 2024 Third Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc." July 29, 2022 Second Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 29, 2022, the Company entered into a second amendment, dated August 1, 2022, to its existing sublease agreement with MZA, described above. The second amendment was effective as of August 1, 2022 and expires on December 31, 2025. The second amendment includes an additional 1,277 square feet (the "Expansion Premises") of office space at 2882 Sand Hill Road, Menlo Park, California. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2024, 2023 and 2022 payments to MZA related to the above leases were $1,019, $1,018, and $598 were made pursuant to the second amendment to the Sublease Agreement. April 1, 2024 Miami Sublease Agreements On April 1, 2024, the Company entered into two sublease agreements of its Miami headquarters location, one with Genius 24C Inc. ("Genius"), an affiliate of the Company's CEO, Robert W. Duggan (the "Genius Sublease Agreement") and one with Duggan Investments Research LLC ("Investments Research"), also an affiliate of the Company's CEO, Robert W. Duggan (the "Investments Research Sublease Agreement"). Pursuant to the Genius Sublease Agreement, Genius will sublease from the Company 848 square feet of office space in the Miami HQ for a sixty-two month term for total rental payments of approximately $446. Pursuant to the Investments Research Sublease Agreement, Investments Research will sublease from the Company 848 square feet of office space in the Miami HQ for a sixty-two month term for total rental payments of approximately $446. During the year ended December 31, 2024, the Company recognized $156 of sublease income recorded net of operating lease expenses. August 2, 2024 Third Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On August 2, 2024, the Company entered into a third amendment to its existing sublease agreement with MZA. The third amendment has an effective date of August 1, 2024, which includes an additional space of 145 square feet of office space at 2882 Sand Hill Road, Menlo Park, California. The Company continues to be obligated to pay its proportionate share of the net payable by MZA to the third-party landlord, which is revised to 93.6% as of the effective date, based on the square footage of office space sublet by the landlord. 2022 Rights Offering Refer to Note 17 for a discussion on the 2022 Rights Offering. Promissory Note Payable to Related Parties Refer to Note 16 for a discussion of the promissory note payable to related parties issued December 6, 2022 and fully repaid on October 1, 2024. Akeso License Agreement Upon the closing of the License Agreement, the Board of Directors (the “Board”) of the Company appointed Dr. Yu (Michelle) Xia to serve as a member of the Board pursuant to the terms of the License Agreement. Dr. Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012. For details on the License Agreement and Second Amendment entered into on June 3, 2024, see Note 5. Furthermore, in connection with the License Agreement, the Company agreed to purchase a certain portion of drug substance and/or drug product for clinical and commercial supply and to enter into a supply agreement with Akeso. During the years ended December 31, 2024 and 2023, respectively, the Company paid $39,198 and $2,500 to Akeso. As of December 31, 2024 and 2023, respectively, the Company included in accrued expenses approximately $3,956 and $3,619 due to Akeso. 2023 Rights Offering Refer to Note 17 for a discussion on the 2023 Rights Offering. Registration of Shares On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of the Company’s common stock at $0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to the Company’s Co-Chief Executive Officers, Mr. Duggan and Dr. Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company. On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3. Private Placements October 2023 On October 16, 2023, the Company announced the appointment of Mr. Manmeet S. Soni as its Chief Operating Officer, effective immediately. Mr. Soni has been a part of the Company’s Board of Directors since 2019. In conjunction with his appointment, Mr. Soni entered into a share purchase agreement with the Company to purchase $5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $1.68, resulting in the purchase of 2,976,190 shares of the Company’s common stock. September 2024 PIPE On September 11, 2024, the Company's Section 16 officers participated in the "September 2024 Purchase Agreements" along with multiple leading biotech institutional investors, for the sale by the Company in the September 2024 Private Placement for an aggregate of 10,352,418 shares of the Company’s common stock, par value $0.01 per share of Common Stock, at purchase price of $22.70 per Share, which was the closing price of the Common Stock on September 11, 2024, for aggregate gross proceeds to the Company of approximately $235,000. The Company’s CEO and Executive Chairman, Mr. Robert W. Duggan, purchased 3,325,991 shares for an aggregate purchase price of $75,500, CEO, President and member of its Board, Dr. Mahkam Zanganeh, purchased 44,052 shares for an aggregate purchase price of $1,000, COO and CFO, Manmeet S. Soni, purchased 44,052 shares for an aggregate purchase price of $1,000, and member of the Board, Jeff Huber, through his controlled entity, Caspian Capital LLC, purchased 44,052 shares for an aggregate purchase price of $1,000, with their collective participation in the September 2024 Private Placement totaling 3,458,147 shares of Common Stock for an aggregate purchase price of $78,500. The Company used some of the proceeds raised from the September 2024 Private Placement to repay $75,500 in principal on the Duggan September Note. See Note 16 for additional details regarding the promissory note payable to a related party. Warrants Exercise In October 2024, the Shaun Zanganeh Irrevocable Trust exercised a warrant to purchase 315,681 shares of Common Stock. In December 2023, Dr. Zanganeh exercised 805,495 shares of warrants. Refer to Note 17 for the warrants exercise activity for the year ended December 31, 2024.
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Stockholders' Equity |
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| Stockholders' Equity | Stockholders' Equity Preferred Stock As of December 31, 2024 and December 31, 2023, the Company had 20,000,000 shares of preferred stock, par value $0.01 authorized and no shares issued and outstanding. Common Stock As of December 31, 2024 and December 31, 2023, the Company had authorized 1,000,000,000 shares of common stock, par value $0.01 (the "Common Stock"). As of December 31, 2024 and December 31, 2023, the Company had 737,626,004 shares and 701,660,053 shares of Common Stock issued and outstanding, respectively. In August 2022, the Company announced the closing of its 2022 rights offering (“2022 Rights Offering”). The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. The 2022 Rights Offering received aggregate gross proceeds of $100,000 from the sale of 103,092,783 shares of common stock. Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights and oversubscribed, at a price per share of $0.97. Offering costs of $111 were incurred. On December 6, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its Common Stock for $1.05 per share (the “2023 Rights Offering”). The 2023 Rights Offering commenced on February 7, 2023 and the associated subscription rights expired on March 1, 2023. Aggregate gross proceeds from the 2023 Rights Offering were $500,000 from the sale of 476,190,471 shares of the Company’s common stock and issuance costs were $619. Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights at a price of $1.05 per share. To satisfy the $395,314 subscription price for the shares subscribed by Mr. Duggan in the 2023 Rights Offering, Mr. Duggan agreed with the Company to extinguish a portion of the amount due and payable to him by the Company at the closing of the 2023 Rights Offering pursuant to the $400,000 Duggan Promissory Note in an amount equal to the subscription price (see also Note 16). On January 19, 2023, the Company filed Amendment No. 2 to the Restated Certificate of Incorporation (the “Amendment No. 2”) with the Secretary of State of the State of Delaware to increase the number of authorized shares of its common stock by 650,000,000 (from 350,000,000 to 1,000,000,000), which became effective on such date. On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of the Company’s common stock at $0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement (as defined in Note 5) with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to Mr. Duggan and Dr. Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company. On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3. Mr. Soni entered into a share purchase agreement with the Company to purchase $5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $1.68, resulting in the purchase of 2,976,190 shares of the Company’s common stock. June 2024 PIPE (Private Investment in Public Equity) On June 3, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with 667, L.P. and Baker Brothers Life Sciences, L.P., affiliates of Baker Bros. Advisors, L.P. (the “Investors”), for the sale by the Company in a private placement (the “June 2024 Private Placement”) of 22,222,222 shares (the “Shares”) of Common Stock, at a purchase price of $9.00 per share, for an aggregate purchase price of approximately $200,000. The closing of the June 2024 Private Placement was June 6, 2024. The Purchase Agreement contained customary representations, warranties and covenants by the Company, customary indemnification obligations of the Company, including for liabilities under the Securities Act of 1933, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of the Purchase Agreement and as of specific dates, were solely for the benefit of the parties to such agreements and were subject to limitations agreed upon by the contracting parties. On June 3, 2024, in connection with the Purchase Agreement, the Company entered into a Registration Rights Agreement with the Investors (the “Registration Rights Agreement”). The Registration Rights Agreement provides, among other things, that the Company will as soon as reasonably practicable, file with the SEC a registration statement registering the resale of the Shares. The Company agreed to use its reasonable best efforts to have such registration statement declared effective as soon as practicable after the filing thereof. The Company filed the registration statement on August 6, 2024, which was automatically effective upon filing. September 2024 PIPE On September 11, 2024, the Company entered into securities purchase agreements (the “September 2024 Purchase Agreements”) with multiple leading biotech institutional investors and individual accredited investors (the “September 2024 Investors”), for the sale by the Company in a private placement (the “September 2024 Private Placement”) of an aggregate of 10,352,418 shares (the “September 2024 Shares”) of the Company’s common stock, par value $0.01 per share of Common Stock, at purchase price of $22.70 per Share, which was the closing price of the Common Stock on September 11, 2024, for aggregate gross proceeds to the Company of approximately $235,000, with offering costs of $140. All of the Company's Section 16 officers participated in the capital raise. A total of $79,000 was raised by the Company's Co-Chief Executive Officer (“CEO”), Executive Chairman and majority stockholder, its Co-CEO and the President and member of the Company's Board of Directors (the "Board"), its Chief Operating Officer (“COO”), Chief Financial Officer (“CFO”), and member of the Board, its Chief Accounting Officer ("CAO"), and a member of the Board of Directors, who invested via a controlled entity. The remaining $156,000 was raised with multiple leading biotech institutional investors. Refer to Note 20 Related Party Transactions for further details regarding related parties' participation. The closing of the September 2024 Private Placement was September 13, 2024. The Purchase Agreements contain customary representations, warranties and covenants by the Company, customary indemnification obligations of the Company, including for liabilities under the Securities Act, as amended (the “Securities Act”), other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Purchase Agreements were made only for purposes of the Purchase Agreements and as of specific dates, were solely for the benefit of the parties to such agreements and were subject to limitations agreed upon by the contracting parties. On September 11, 2024, in connection with the September 2024 Purchase Agreements, the Company entered into Registration Rights Agreements with the Investors (the “September 2024 Registration Rights Agreements”). The September 2024 Registration Rights Agreements provide, among other things, that the Company will as soon as reasonably practicable file with the SEC a registration statement registering the resale of the Shares. The Company filed the registration statement on September 19, 2024, which was automatically effective upon filing. At-the-Market Offering (ATM Offering) On May 13, 2024, the Company entered into an at-the-market sales agreement (the "ATM Agreement") pursuant to which the Company may, subject to the terms and conditions set forth in the agreement offer and sell, from time to time, through or to the agents, acting as agents or principal, shares of the Company's common stock, par value $0.01, having an aggregate offering price of up to $90,000. From the date of the ATM Agreement through December 31, 2024, the Company sold 1,807,093 shares of common stock under the ATM Agreement at a weighted-average price of $24.47 per share, for gross proceeds of $44,223. The remaining availability under the ATM Agreement as of December 31, 2024 is approximately $45,777. The Company has received net proceeds of $43,033, which is net of sales commissions and other offering fees of approximately $1,190. The Company plans to use the net proceeds from this offering for working capital and general corporate purposes. Warrants As part of the private placement on December 24, 2019, the participating investors were granted warrants with the right to subscribe for 5,261,350 shares of common stock at an exercise price of $1.58, exercisable any time in the period commencing on the date falling six months following December 24, 2019 and ending on the tenth anniversary of admission. Each warrant entitles the warrant holder to subscribe in cash for one share. Shares of common stock allotted pursuant to the exercise of the warrant will rank in full for all dividends and other distributions with a record date after the exercise date with the shares of common stock in issue at that date. The Company has the option to require the warrant holder to exercise some or all of the outstanding warrants after the third anniversary date if the ten-day volume weighted average price of the shares of common stock as reported on Nasdaq represents a premium of at least 50 percent to the exercise price. The warrants are classified within stockholders’ equity as they are indexed to the Company’s shares of common stock and require settlement in its shares of common stock with no provision for any cash settlement. Also, as part of the private placement on December 24, 2019, certain consultants were granted warrants with the right to subscribe for 3,358,732 shares of common stock in exchange for certain services. The warrants have an exercise price of $1.44 and vested quarterly over three years. If the consulting agreement terminated prior to three years after the date of the grant, all unvested warrants were to be deemed cancelled. On June 30, 2020, the consulting agreement was terminated and 2,798,945 warrants cancelled immediately. Warrants granted over shares of common stock to consultants in exchange of certain services are similar to stock-based compensation. The following table summarizes the Company’s warrants activity for the year ended December 31, 2024:
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| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-Based Compensation | Stock-Based Compensation 2016 Long Term Incentive Plan Upon the effectiveness of the 2020 Stock Incentive Plan, no additional grants will be made under the 2016 Long Term Incentive Plan, (the “2016 Plan”) and any outstanding awards continue with their original terms. 2020 Stock Award Plan In September 2020, the Company’s Board of Directors approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on September 21, 2020. The 2020 plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards. A total of 8,000,000 shares of common stock were initially reserved for issuance under the 2020 Plan. Additionally, up to 5,000,000 shares of common stock, including RSUs can be added to the 2020 Plan for future issuance from options that expire, lapse or are terminated from the 2016 Plan or any other predecessor plans. The number of shares of common stock that may be issued under the 2020 Plan will automatically increase on each January 1, beginning in 2021 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2030, equal to the lesser of (i) 6,400,000 shares of common stock, (ii) 4% of the common shares outstanding on the final day of the immediately preceding calendar year and (iii) an amount as determined by the Company’s Board of Directors. On July 27, 2022, the Company held a Special Meeting of Stockholders (the “Special Meeting”) whereby the following matters were submitted to a vote of the Company’s stockholders at the Special Meeting and the Board of Directors resolved the following: (i) an amendment to the Company’s Restated Certificate of Incorporation, dated September 18, 2020, to increase the number of authorized shares of common stock by 100,000,000 (from 250,000,000 to 350,000,000); and (ii) an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan (the “Plan”) to increase the number of shares of the Company’s common stock issuable under the Plan by 8,000,000 shares. On October 12, 2023, the Company held a Special Meeting of Stockholders (the “October Special Meeting”) whereby the following matter was submitted to a vote of the Company’s stockholders at the Special Meeting and the Board of Directors resolved the following: an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan to increase the number of shares of the Company’s common stock issuable under the Plan by 70,000,000 shares. As of December 31, 2024, there are 3,204,109 shares available to be issued under the 2020 Plan. The Company currently grants stock options to employees and directors under the 2020 Stock Incentive Plan (the "2020 Plan") and formerly, the Company granted stock options under the 2016 Long Term Incentive Plan (the "2016 Plan"). The 2020 Plan is administered by the Compensation Committee of the Board. The 2020 Plan is intended to attract and retain employees and directors and provide an incentive for these individuals to assist the Company to achieve long-range performance goals and to enable these individuals to participate in the long-term growth of the Company. On May 3, 2024, the Board adopted the 2024 Inducement Pool (the “Inducement Pool”), which mirrors the terms of the 2020 Plan, with a total of 2,000,000 shares of common stock reserved for issuance under the Inducement Pool. The Inducement Pool provides for the grant of non-qualified stock options and was approved by the Compensation Committee of the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Pool is administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the Inducement Pool may only be made to an employee who has not previously been an employee of the Company or member of the Board (or any parent or subsidiary of the Company), if he or she is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. As of December 31, 2024, there were 339,600 shares available for grant under the Inducement Pool. 2020 Employee Stock Purchase Plan The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was adopted by the Board of Directors and approved by the Company’s shareholders on July 17, 2020 and approved by the predecessor company shareholders on August 19, 2020 and is qualified under Section 423 of the Internal Revenue Code. The 2020 ESPP initially authorized the issuance of up to 1,000,000 shares of common stock to participating employees. The number of common shares that may be issued under the 2020 ESPP automatically increases on each fiscal year commencing January 1, 2021 and continuing for each fiscal year until, and including the fiscal year commencing on, January 1, 2030 equal to the lesser of (i) 1,600,000 shares of common stock, (ii) 1% of the common shares outstanding on such date and (iii) an amount as determined by the Company’s Board of Directors. As of December 31, 2024, there were 1,883,141 shares available to be issued under the 2020 ESPP. The 2020 ESPP is comprised of purchase periods of six months in duration and commence immediately preceding the end of the previous offering period, unless otherwise determined by the Board of Directors or Compensation Committee. Under the 2020 ESPP, eligible employees can purchase shares of common stock through payroll deductions of up to 15% of their compensation received during the plan period or such shorter period during which deductions from payroll are made, up to a defined maximum amount. The option price is determined based on the lesser of the closing price of common stock on (i) the first business day of the plan period or (ii) the exercise date, or shall be based solely on the closing price of the common stock on the exercise date; provided that such option price shall be at least 85% of the applicable closing price. In the absence of a determination by the Board of Directors or the Compensation Committee, the option price is 85% of the lesser of the closing price of the common stock on (i) the first business day of the plan period or (ii) the exercise date. The closing price is the (a) the closing price (for the primary trading session) on the Nasdaq Global Select Market or (b) the average of the closing bid and asked prices in the over-the-counter-market, whichever is applicable, as published in the Wall Street Journal or another source selected by the Board or the Committee. During the fiscal year ended December 31, 2024 and 2023, 353,578 and 392,175 shares, respectively, were issued under the 2020 ESPP Plan. Stock Options Time-based Stock Options The Company estimates the fair value of stock options granted to employees and directors using the Black-Scholes valuation model. Stock options granted under the 2016 and 2020 Plans generally vest over or four years and expire after ten years. This valuation methodology utilizes several key assumptions as highlighted below. The assumptions used in the Company’s valuation are summarized as follows, presented on a weighted average basis:
The following table summarizes the Company’s time-based stock option activity for the year ended December 31, 2024:
As of December 31, 2024, there was $49,901 total unrecognized compensation cost related to unvested time-based stock option grants. The unvested amount is expected to be recognized over a weighted average period of approximately 2.2 years. Performance and Market-based Stock Options The Compensation Committee of the Company’s Board of Directors and management approved 2,825,000 option grants to its executives and certain employees of the Company during the year ended December 31, 2024, which will vest based upon certain revenue and market-based performance conditions. The Company uses a Monte Carlo simulation model to estimate the fair value of Performance and Market-based Stock Options at the date of grant which utilizes multiple input variables to estimate the probability that the market condition will be achieved. Key assumptions used in the model include the risk-free interest rate, which reflects the US Treasury Constant Maturity Yield with a term commensurate with the contractual term of the award, and stock price volatility, which is derived based on the historical volatility of the Company’s stock. The following table summarizes the Company’s performance and market-based stock option activity for the year ended December 31, 2024:
The weighted-average grant-date fair value of stock options granted during the years ended December 31, 2024 and 2023 was $3.40 and $1.41, per share, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2024 and 2023 was $863 and $474, respectively. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. During the year ended December 31, 2024, the Company achieved certain market conditions, which resulted in 9,151,844 shares vesting and acceleration of $7,050 of stock-based compensation expense related to the accelerated vesting of these awards. As of December 31, 2024, the number of unvested performance-based stock options that were deemed to be not probable of vesting and the related unrecognized stock-based compensation expense is 39,215,976 and $52,700, respectively. Stock-Based Compensation Stock‑based compensation expense related to stock options is recorded within the consolidated statements of operations and comprehensive loss as follows:
The following table summarizes stock-based compensation expense associated with each of our stock-based compensation arrangements:
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Commitments and Contingencies |
12 Months Ended |
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Dec. 31, 2024 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | Commitments and Contingencies Fixed asset purchase commitments At December 31, 2024 and 2023, the Company had no capital commitments. Lease commitments Refer to Note 15 for a discussion of the Company’s lease commitments. Debt commitments Refer to Note 16 for discussion of promissory notes payable to related parties. Other commitments The Company enters into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. Most contracts provide for termination upon notice, and therefore are cancellable contracts. As of December 31, 2024, total unconditional purchase obligations, excluding leases commitments, are estimated to be approximately $13,900. The Company has certain commitments under its agreements with Akeso. The License Agreement with Akeso also contains certain manufacturing and purchase commitments. As of December 31, 2024, the Company is unable to estimate the amount, timing or likelihood of achieving the milestones, making future product sales or assessing estimated forecasts for manufacturing and supplied materials which these contingent payment obligations relate to. Indemnifications The Company’s certificate of incorporation provides that it will indemnify the directors and officers to the fullest extent permitted by Delaware law. In addition, the Company has entered into indemnification agreements with all of the directors and executive officers. These indemnification agreements may require the Company, among other things, to indemnify each such director or executive officer for some expenses, including attorneys’ fees, judgments, fines, and settlement amounts incurred by him or her in any action or proceeding arising out of his or her service as one of the Company’s directors or executive officers. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2024. Legal Proceedings The Company is not currently subject to any material legal proceedings.
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Related Party Transactions |
12 Months Ended |
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Dec. 31, 2024 | |
| Related Party Transactions [Abstract] | |
| Related Party Transactions | Promissory Note Payable to Related Parties At December 31, 2024 and 2023, the Company's non-current debt was $0 and $100,000, respectively. As of December 31, 2023, the non-current debt balance consisted of principal amounts due on promissory notes payable to related parties as described below. At December 31, 2024 and 2023, the Company had no current debt. March 2022 Promissory Note On March 10, 2022, Mr. Duggan, entered into a Note Purchase Agreement (the “March 2022 Note”), pursuant to which he loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The March 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal. The March 2022 Note, including all accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the March 2022 Note. Debt issuance costs associated with the March 2022 Note were immaterial and expensed as incurred. The March 2022 Note of $25,000, plus accrued interest of $434 was repaid to Mr. Duggan on August 10, 2022 in connection with the completion of the 2022 Rights Offering (as defined in Note 17) which received aggregate gross proceeds of $100,000. The Company incurred interest expense related to the March 2022 Note of $1,296 for the year ended December 31, 2022, which included amortized imputed interest of $861. December 2022 Promissory Notes On December 6, 2022, the Company entered into a Note Purchase Agreement (the "Note Purchase Agreement"), with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $520,000. Pursuant to the Note Purchase Agreement, the Company issued to Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the amount of $400,000 (the "Duggan February Note") and $20,000 (the "Zanganeh Note"), respectively, which matured and became due on February 15, 2023 and an unsecured promissory note to Mr. Duggan in the amount of $100,000 (the “Duggan September Note” and together with the Duggan February Note and the Zanganeh Note, the “December 2022 Notes”), which was originally due on September 15, 2023. The maturity dates of the December 2022 Notes could have been extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024. In addition, if the Company consummated a public offering, then upon the later to occur of (i) business days after the Company receives the net cash proceeds therefrom or (ii) May 15, 2023, the Duggan February Note and the Zanganeh Note were to be prepaid by an amount equal to the lesser of (a) 100% of the amount of the net proceeds of such offering and (b) the outstanding principal amount on such Notes. On January 19, 2023, the Company provided notice to extend the term of the Duggan February Note and Duggan September Note to a maturity date of September 6, 2024. Furthermore, on January 19, 2023, the Company and Mr. Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the Company may only prepay (i) the Duggan February Note following the completion of a public rights offering to be conducted by Summit in the approximate amount of $500,000 or a similar capital raise, in an amount equal to the lesser of (x) the net proceeds of the Rights Offering or such capital raise or (y) the full amount outstanding of the Duggan February Note, and (ii) Duggan September Note following the completion of a capital raising transaction subsequent to the 2023 Rights Offering (as defined in Note 17) in an amount equal to the lesser of (A) the net proceeds of such capital raise or (B) the full amount outstanding of the Duggan September Note. Following the issuance of the two new Promissory Notes (the “Duggan Promissory Notes”), the Duggan February Note and Duggan September Note were marked as “cancelled” on their face and replaced in their entirety by the Duggan Promissory Notes (together with the Zanganeh Note, the "Notes"). The Notes accrued interest at an initial rate of 7.5%. All interest on the Notes was paid on the date of signing for the period through February 15, 2023. Such prepaid interest was paid in a number of shares of the Company’s common stock, par value $0.01 ("Common Stock") equal to the dollar amount of such prepaid interest, divided by $0.7913 (the consolidated closing bid price immediately preceding the time the Company entered into the Note Purchase Agreement, plus $0.01), which was 9,720,291 shares. For all applicable periods following February 15, 2023, interest accrued on the outstanding principal balance of the Notes at the US prime interest rate, as reported in the Wall Street Journal, plus 50 basis points, as adjusted monthly, for three months immediately following February 15, 2023, and thereafter at the US prime rate plus 300 basis points, as adjusted monthly. Accrued interest was paid in cash, quarterly in arrears, on each of March 31, June 30, September 30 and December 31. On February 15, 2023, the $20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance. In connection with the closing of the 2023 Rights Offering, the $400,000 Duggan Promissory Note matured and became due, and the Company satisfied all principal and accrued interest thereunder using a combination of a portion of the cash proceeds from the 2023 Rights Offering and the extinguishment of a portion of the amount due equal to the subscription price of shares subscribed by Mr. Duggan in the 2023 Rights Offering. Debt issuance costs associated with the Notes were $44 and were capitalized as part of the carrying value of the promissory notes payable to related parties. Imputed interest was calculated as the difference between the expected interest payable and the deemed market rate of interest and is recorded as a debt discount at inception of the note payable with a credit to additional paid-in capital for notes payable to related parties. The debt discount is amortized to interest expense using an effective interest rate method. The effective interest rate of the Duggan February Note and Zanganeh Note was 8.9% and the effective interest rate of the Duggan September Note was 11.3%. On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest accrued on the outstanding principal balance at the greater of 12% or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly. Interest was paid upon maturity of the loan. In accordance with the applicable accounting standards, a short-term debt obligation should be excluded from current liabilities if the entity has both the intent and ability to refinance the obligation on a long-term basis. The intent and ability can be demonstrated by the issuance of a long-term obligation to refinance the short-term obligation on a long-term basis after the date of an entity’s balance sheet but before that balance sheet is issued. As a result of the amendment entered into on February 17, 2024 to extend the maturity date to April 1, 2025, the Company classified $100,000 of notes payable to related party outstanding as of December 31, 2023 as long-term notes payable. During the year ended December 31, 2024, the Company incurred interest expense of $8,686 related to promissory notes payable. During the year ended December 31, 2023, the Company incurred interest expense of $16,461 which included amortized imputed interest of $761. During the year ended December 31, 2022, the Company incurred interest expense of $3,105 related to the December 2022 Notes which included amortized imputed interest of $395. As of December 31, 2024 and 2023, there was $0 and $120, respectively, of accrued interest payable included within accrued expenses in the consolidated balance sheet. As of October 1, 2024, the Company repaid the Duggan September Note in full, resulting in principal payments in the aggregate amount of $100,000 and accrued cash interest of $7,305. Related Party TransactionsJuly 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 25, 2022 the Company entered into a first amendment, dated July 19, 2022, to its existing sublease agreement with Maky Zanganeh and Associates, Inc. ("MZA"), an entity owned by Maky Zanganeh, consisting of 4,500 square feet of office space at 2882 Sand Hill Road, Menlo Park, California. The existing sublease term, which was set to expire on September 30, 2022, was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. The agreement was further amended to include additional space, as noted below under the "August 2, 2024 Third Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc." July 29, 2022 Second Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 29, 2022, the Company entered into a second amendment, dated August 1, 2022, to its existing sublease agreement with MZA, described above. The second amendment was effective as of August 1, 2022 and expires on December 31, 2025. The second amendment includes an additional 1,277 square feet (the "Expansion Premises") of office space at 2882 Sand Hill Road, Menlo Park, California. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2024, 2023 and 2022 payments to MZA related to the above leases were $1,019, $1,018, and $598 were made pursuant to the second amendment to the Sublease Agreement. April 1, 2024 Miami Sublease Agreements On April 1, 2024, the Company entered into two sublease agreements of its Miami headquarters location, one with Genius 24C Inc. ("Genius"), an affiliate of the Company's CEO, Robert W. Duggan (the "Genius Sublease Agreement") and one with Duggan Investments Research LLC ("Investments Research"), also an affiliate of the Company's CEO, Robert W. Duggan (the "Investments Research Sublease Agreement"). Pursuant to the Genius Sublease Agreement, Genius will sublease from the Company 848 square feet of office space in the Miami HQ for a sixty-two month term for total rental payments of approximately $446. Pursuant to the Investments Research Sublease Agreement, Investments Research will sublease from the Company 848 square feet of office space in the Miami HQ for a sixty-two month term for total rental payments of approximately $446. During the year ended December 31, 2024, the Company recognized $156 of sublease income recorded net of operating lease expenses. August 2, 2024 Third Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On August 2, 2024, the Company entered into a third amendment to its existing sublease agreement with MZA. The third amendment has an effective date of August 1, 2024, which includes an additional space of 145 square feet of office space at 2882 Sand Hill Road, Menlo Park, California. The Company continues to be obligated to pay its proportionate share of the net payable by MZA to the third-party landlord, which is revised to 93.6% as of the effective date, based on the square footage of office space sublet by the landlord. 2022 Rights Offering Refer to Note 17 for a discussion on the 2022 Rights Offering. Promissory Note Payable to Related Parties Refer to Note 16 for a discussion of the promissory note payable to related parties issued December 6, 2022 and fully repaid on October 1, 2024. Akeso License Agreement Upon the closing of the License Agreement, the Board of Directors (the “Board”) of the Company appointed Dr. Yu (Michelle) Xia to serve as a member of the Board pursuant to the terms of the License Agreement. Dr. Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012. For details on the License Agreement and Second Amendment entered into on June 3, 2024, see Note 5. Furthermore, in connection with the License Agreement, the Company agreed to purchase a certain portion of drug substance and/or drug product for clinical and commercial supply and to enter into a supply agreement with Akeso. During the years ended December 31, 2024 and 2023, respectively, the Company paid $39,198 and $2,500 to Akeso. As of December 31, 2024 and 2023, respectively, the Company included in accrued expenses approximately $3,956 and $3,619 due to Akeso. 2023 Rights Offering Refer to Note 17 for a discussion on the 2023 Rights Offering. Registration of Shares On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of the Company’s common stock at $0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to the Company’s Co-Chief Executive Officers, Mr. Duggan and Dr. Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company. On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3. Private Placements October 2023 On October 16, 2023, the Company announced the appointment of Mr. Manmeet S. Soni as its Chief Operating Officer, effective immediately. Mr. Soni has been a part of the Company’s Board of Directors since 2019. In conjunction with his appointment, Mr. Soni entered into a share purchase agreement with the Company to purchase $5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $1.68, resulting in the purchase of 2,976,190 shares of the Company’s common stock. September 2024 PIPE On September 11, 2024, the Company's Section 16 officers participated in the "September 2024 Purchase Agreements" along with multiple leading biotech institutional investors, for the sale by the Company in the September 2024 Private Placement for an aggregate of 10,352,418 shares of the Company’s common stock, par value $0.01 per share of Common Stock, at purchase price of $22.70 per Share, which was the closing price of the Common Stock on September 11, 2024, for aggregate gross proceeds to the Company of approximately $235,000. The Company’s CEO and Executive Chairman, Mr. Robert W. Duggan, purchased 3,325,991 shares for an aggregate purchase price of $75,500, CEO, President and member of its Board, Dr. Mahkam Zanganeh, purchased 44,052 shares for an aggregate purchase price of $1,000, COO and CFO, Manmeet S. Soni, purchased 44,052 shares for an aggregate purchase price of $1,000, and member of the Board, Jeff Huber, through his controlled entity, Caspian Capital LLC, purchased 44,052 shares for an aggregate purchase price of $1,000, with their collective participation in the September 2024 Private Placement totaling 3,458,147 shares of Common Stock for an aggregate purchase price of $78,500. The Company used some of the proceeds raised from the September 2024 Private Placement to repay $75,500 in principal on the Duggan September Note. See Note 16 for additional details regarding the promissory note payable to a related party. Warrants Exercise In October 2024, the Shaun Zanganeh Irrevocable Trust exercised a warrant to purchase 315,681 shares of Common Stock. In December 2023, Dr. Zanganeh exercised 805,495 shares of warrants. Refer to Note 17 for the warrants exercise activity for the year ended December 31, 2024.
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Pay vs Performance Disclosure - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
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| Pay vs Performance Disclosure | |||
| Net loss | $ (221,315) | $ (614,928) | $ (78,782) |
Insider Trading Arrangements |
3 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Trading Arrangements, by Individual | |
| Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Rule 10b5-1 Arrangement Terminated | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
Insider Trading Policies and Procedures |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Insider Trading Policies and Procedures [Line Items] | |
| Insider Trading Policies and Procedures Adopted | true |
Cybersecurity Risk Management and Strategy Disclosure |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Cybersecurity Risk Management, Strategy, and Governance [Line Items] | |
| Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block] | We have implemented a risk-based approach to identify and assess the cybersecurity threats that could affect our business and information systems. We use recognized commercially reasonable measures, tools and methodologies designed to manage cybersecurity risk that are tested on a regular cadence. We also monitor and evaluate our cybersecurity posture on an ongoing basis through regular vulnerability scans, penetration tests and third-party reviews. We rely on third-party service providers to provide the systems required to effectively run our clinical trials and endeavor to require third-party service providers that have access to personal, confidential or proprietary information to implement and maintain cybersecurity practices. Specific controls that are used in appropriate portions of our environment include endpoint threat detection and response, identity and access management, privileged access management, logging and monitoring involving the use of security information and event management, multi-factor authentication, firewalls and intrusion detection and prevention, and vulnerability and patch management. Our cybersecurity risk management processes are integrated into our enterprise risk management program. To manage our material risks from cybersecurity threats and to protect against, detect, and prepare to respond to cybersecurity incidents, we endeavor to: •Monitor emerging data protection laws and implement changes to our processes to comply; •Conduct annual cybersecurity management and incident training for employees that process sensitive data; •Conduct onboarding and cybersecurity training for all employees on an ongoing basis; •Conduct regular phishing email simulations for all employees; and •Carry cybersecurity risk insurance meant to provide protection against the potential losses arising from a cybersecurity incident. In addition, we engage several third-party consultants in connection with our risk assessment and risk management, and we have established separate processes and procedures to oversee and identify cybersecurity risks associated with third parties. All third parties involved in our cybersecurity risk assessments and risk management are required to provide reports designed to allow us to monitor and assess such third parties’ security controls. Our incident response plan coordinates the activities that we and our third-party cybersecurity provider take to respond and recover from cybersecurity incidents, which include processes to triage, assess severity, investigate, escalate, contain, and remediate an incident, as well as to comply with legal obligations and attempt to mitigate brand and reputational damage. We have business continuity plans that we periodically review and update in line with our evolving applications architecture.
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| Cybersecurity Risk Management Processes Integrated [Flag] | true |
| Cybersecurity Risk Management Processes Integrated [Text Block] | We have implemented a risk-based approach to identify and assess the cybersecurity threats that could affect our business and information systems. We use recognized commercially reasonable measures, tools and methodologies designed to manage cybersecurity risk that are tested on a regular cadence. We also monitor and evaluate our cybersecurity posture on an ongoing basis through regular vulnerability scans, penetration tests and third-party reviews. We rely on third-party service providers to provide the systems required to effectively run our clinical trials and endeavor to require third-party service providers that have access to personal, confidential or proprietary information to implement and maintain cybersecurity practices. Specific controls that are used in appropriate portions of our environment include endpoint threat detection and response, identity and access management, privileged access management, logging and monitoring involving the use of security information and event management, multi-factor authentication, firewalls and intrusion detection and prevention, and vulnerability and patch management. Our cybersecurity risk management processes are integrated into our enterprise risk management program. To manage our material risks from cybersecurity threats and to protect against, detect, and prepare to respond to cybersecurity incidents, we endeavor to: •Monitor emerging data protection laws and implement changes to our processes to comply; •Conduct annual cybersecurity management and incident training for employees that process sensitive data; •Conduct onboarding and cybersecurity training for all employees on an ongoing basis; •Conduct regular phishing email simulations for all employees; and •Carry cybersecurity risk insurance meant to provide protection against the potential losses arising from a cybersecurity incident. In addition, we engage several third-party consultants in connection with our risk assessment and risk management, and we have established separate processes and procedures to oversee and identify cybersecurity risks associated with third parties. All third parties involved in our cybersecurity risk assessments and risk management are required to provide reports designed to allow us to monitor and assess such third parties’ security controls. Our incident response plan coordinates the activities that we and our third-party cybersecurity provider take to respond and recover from cybersecurity incidents, which include processes to triage, assess severity, investigate, escalate, contain, and remediate an incident, as well as to comply with legal obligations and attempt to mitigate brand and reputational damage. We have business continuity plans that we periodically review and update in line with our evolving applications architecture.
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| Cybersecurity Risk Management Third Party Engaged [Flag] | true |
| Cybersecurity Risk Third Party Oversight and Identification Processes [Flag] | true |
| Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] | false |
| Cybersecurity Risk Board of Directors Oversight [Text Block] | Our Board of Directors provides oversight to our cybersecurity efforts to ensure effective governance in assessing and managing risks associated with cybersecurity threats. |
| Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block] | Our cybersecurity leadership team is responsible for assessing and managing cybersecurity risks and is made up of experienced professionals with an extensive background in information security, risk management, and incident response. This team is led by our Head of Information Technology. The Head of Information Technology is a senior technology strategist and thought leader with over two decades of experience in the bio pharma, life sciences, and high-tech sectors. status updates on various projects intended to enhance the overall cybersecurity posture of the Company, and information about the prevention, detection, mitigation and remediation of any cybersecurity incidents, as appropriate.
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| Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block] | Our Head of Information Technology provides periodic updates to senior management and quarterly updates to the Board of Directors regarding our cybersecurity program, including information about cyber risk management governance, status updates on various projects intended to enhance the overall cybersecurity posture of the Company, and information about the prevention, detection, mitigation and remediation of any cybersecurity incidents, as appropriate. |
| Cybersecurity Risk Role of Management [Text Block] | Our cybersecurity leadership team is responsible for assessing and managing cybersecurity risks and is made up of experienced professionals with an extensive background in information security, risk management, and incident response. This team is led by our Head of Information Technology. The Head of Information Technology is a senior technology strategist and thought leader with over two decades of experience in the bio pharma, life sciences, and high-tech sectors. Our Board of Directors provides oversight to our cybersecurity efforts to ensure effective governance in assessing and managing risks associated with cybersecurity threats. Our Head of Information Technology provides periodic updates to senior management and quarterly updates to the Board of Directors regarding our cybersecurity program, including information about cyber risk management governance, status updates on various projects intended to enhance the overall cybersecurity posture of the Company, and information about the prevention, detection, mitigation and remediation of any cybersecurity incidents, as appropriate.
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| Cybersecurity Risk Management Positions or Committees Responsible [Flag] | true |
| Cybersecurity Risk Management Positions or Committees Responsible [Text Block] | Our cybersecurity leadership team is responsible for assessing and managing cybersecurity risks and is made up of experienced professionals with an extensive background in information security, risk management, and incident response. This team is led by our Head of Information Technology. The Head of Information Technology is a senior technology strategist and thought leader with over two decades of experience in the bio pharma, life sciences, and high-tech sectors.
|
| Cybersecurity Risk Management Expertise of Management Responsible [Text Block] | Our cybersecurity leadership team is responsible for assessing and managing cybersecurity risks and is made up of experienced professionals with an extensive background in information security, risk management, and incident response. This team is led by our Head of Information Technology. The Head of Information Technology is a senior technology strategist and thought leader with over two decades of experience in the bio pharma, life sciences, and high-tech sectors.
|
| Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] | Our Head of Information Technology provides periodic updates to senior management and quarterly updates to the Board of Directors regarding our cybersecurity program, including information about cyber risk management governance, status updates on various projects intended to enhance the overall cybersecurity posture of the Company, and information about the prevention, detection, mitigation and remediation of any cybersecurity incidents, as appropriate. |
| Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag] | true |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) |
12 Months Ended | ||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||
| Accounting Policies [Abstract] | |||||||||||||||||||||||||
| Basis of Presentation | The consolidated 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 U.S. Securities and Exchange Commission. | ||||||||||||||||||||||||
| Reclassification | Certain reclassifications have been made to the prior years’ financial statements to conform to current year presentation. | ||||||||||||||||||||||||
| Use of Estimates | The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to accrued research and development expenses, stock-based compensation, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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| Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. GAAP and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The consolidated financial statements reflect the accounts of Summit Therapeutics Inc. and its wholly owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation.
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| Foreign Currency Translation | Foreign Currency Translation The financial statements of the Company’s subsidiaries with functional currencies other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive (loss) income in stockholders’ equity. Foreign currency transaction gains and losses are included in other expense, net in the results of operations. The Company recorded realized and unrealized foreign currency transaction (loss) gain of ($97), $613 and ($4,109) for the years ended December 31, 2024, 2023 and 2022, respectively, which is included in other expense, net in the statements of operations and comprehensive loss.
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| Other Operating (Expense) Income, Net | Other Operating (Expense) Income, Net The Company generated income from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received within other operating (expense) income, net in the consolidated statements of operations and comprehensive loss. Income from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. If the government agency approves the project proposed by the Company, the government agency funds the project upon receipt of the support for the costs incurred up to the contract limit. Income recognized upon incurring qualifying expenses in advance of billing is recorded as unbilled receivable, a component of other current assets, in the consolidated balance sheet. Grant income is not recognized as deductions of research and development costs because the Company acts as the principal in conducting the research and development activities and these contracts are central to its ongoing operations. The funds received through these means are held as deferred income in the consolidated balance sheets and are released to the consolidated statement of operations and comprehensive loss, classified as other operating (expense) income, net, as the underlying expenditure is incurred and to the extent the conditions of the grant are met. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss. The Company benefits from two United Kingdom ("U.K.") research and development (“R&D”) tax credit cash rebate regimes: Small and Medium Enterprise (“SME”) Program and the Research and Development Expenditure Credit (“RDEC”) Program. Each reporting period, management evaluates which tax relief programs the Company is expected to be eligible for and records as other operating (expense) income, net the portion of the expense that it expects to qualify under the programs, that it plans to submit a claim for, and it has reasonable assurance that the amount will ultimately be realized.
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| Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the diluted net loss by the weighted-average number of common shares outstanding for the period, including potentially dilutive common shares. The dilutive effect of share options and warrants are determined under the treasury stock method using the average market price for the period. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options and warrants that are in-the-money.
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| Goodwill | Goodwill Goodwill represents the excess of the consideration transferred over the fair value of net assets acquired. Goodwill is assigned to reporting units at the time of acquisition or when there is a change in the reporting structure and bases that allocation on which reporting units will benefit from the acquired assets and liabilities. Reporting units are defined as operating segments or one level below an operating segment, referred to as a component. Typically acquisitions related to a single reporting unit do not require the allocation of goodwill to multiple reporting units. If the net assets obtained in an acquisition are assigned to multiple reporting units, the goodwill is distributed to the respective reporting units as part of the purchase price allocation process. The Company assesses goodwill for impairment on an annual basis as of December 31 or more frequently when events and circumstances occur indicating that the recorded goodwill may be impaired. The Company regularly monitors current business conditions and other factors including, but not limited to, adverse industry or economic trends and lower projections of profitability that may impact future operating results. The process of evaluating the potential impairment of goodwill requires significant judgment. In performing the Company’s annual goodwill impairment test, the Company is permitted to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company’s reporting unit is less than its carrying amount, including goodwill. In performing the qualitative assessment, the Company considers certain events and circumstances specific to the reporting unit and to the entity as a whole, such as macroeconomic conditions, industry and market considerations, overall financial performance and cost factors when evaluating whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. The Company is also permitted to bypass the qualitative assessment and proceed directly to the quantitative test. If the Company chooses to undertake the qualitative assessment and concludes that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, the Company would then proceed to the quantitative impairment test. In the quantitative assessment, the Company compares the fair value of the reporting unit to its carrying amount, which includes goodwill. If the fair value exceeds the carrying value, no impairment loss exists. If the fair value is less than the carrying amount, a goodwill impairment loss is measured and recorded.
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| Intangible Assets | Intangible Assets and Long-lived Assets The Company evaluates the recoverability of its intangible and long-lived assets whenever events and changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. If events and circumstances indicate that the carrying amount may not fully be recoverable, the carrying values of the asset or asset group are evaluated in relation to their operating performance and future undiscounted cash flows of the underlying business. If the future undiscounted cash flows are less than their carrying value, impairment exists. The impairment is measured as the difference between the carrying value and the fair value of the underlying asset or asset group. Fair values are based on estimates of market prices and assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.
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| Long-lived Assets | Intangible Assets and Long-lived Assets The Company evaluates the recoverability of its intangible and long-lived assets whenever events and changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. If events and circumstances indicate that the carrying amount may not fully be recoverable, the carrying values of the asset or asset group are evaluated in relation to their operating performance and future undiscounted cash flows of the underlying business. If the future undiscounted cash flows are less than their carrying value, impairment exists. The impairment is measured as the difference between the carrying value and the fair value of the underlying asset or asset group. Fair values are based on estimates of market prices and assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.
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| Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Cost is comprised of the purchase price plus any incidental costs of acquisition and commissioning. Depreciation is calculated based on cost, less residual value, in equal annual installments over the estimated useful lives of the assets. The residual value, if significant, is reassessed annually.
Depreciation is recognized as part of the general and administrative and research and development expense lines shown on the face of the consolidated statement of operations and comprehensive loss depending on the nature of the underlying assets. Expenditures for repairs and maintenance are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations.
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| Leases | Leases The Company has operating leases for real estate. The Company does not have any finance leases. A contract is or contains a lease when the lessee has the right to control the use of an identified asset. The Company determines if an arrangement is a lease at inception of the contract, which is the date on which the terms of the contract are agreed to and the agreement creates enforceable rights and obligations. The lease term used to calculate the lease liability include options to extend or terminate the lease when it is reasonably certain that the option will be exercised. At the lease commencement date, the Company measures and recognizes a lease liability and a right-of-use asset in the financial statements. Lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. The right-of use asset is measured by taking the present value of future lease payments, plus any incremental direct costs incurred, less any lease incentives received. As most of the Company’s leases do not provide an implicit rate, the Company uses an estimated incremental borrowing rate based on the lease term and the economic environment of the lease at the lease commencement date, which is then utilized to determine the present value of future lease payments. Lease expense for minimum lease payments are recognized on a straight-line basis over the lease term, with variable lease payments recognized in the periods in which they are incurred. The Company has existing lease agreements with lease and non-lease components, has elected to account for the lease and non-lease components as a single lease component, and has allocated all of the contract consideration to the lease component only. Leases with an initial lease term of 12 months or less are not recorded on the balance sheet. The Company recognizes lease expense for its short-term leases on a straight-line basis over the lease term.
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| Acquired In-Process Research and Development | Acquired In-Process Research and Development The Company may enter into agreements with collaboration partners for the development and commercialization of its products. These arrangements may include payments contingent on the occurrence of certain events such as development, regulatory or sales-based milestones. The Company considers the unique nature, terms and facts and circumstances of each transaction. The Company considers whether or not the assets acquired have an alternative future use. The fair value associated with acquired in-process research and development which does not have an alternative future use is expensed and is recorded as research and development expense. Any development or commercial milestone payments are recognized when the achievement of the associated milestone becomes probable and will either be expensed or capitalized depending upon whether or not regulatory approval has been obtained.
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| Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop product candidates, including personnel expenses, stock-based compensation expense, allocated facility-related and depreciation expenses, third-party license fees and external costs of outside vendors engaged to conduct preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered. Milestone and other payments made to third-parties with respect to in-process research and development, in accordance with the Company’s license, acquisition and other similar agreements are expensed when determined to be probable and estimable. The Company has entered into various research and development contracts with other companies. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs. These amounts are determined based on the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. Actual results could differ from the Company’s estimates. In all cases, the full cost of each study or activity is expensed by the time the final report or where applicable, product, has been received. The Company’s historical estimates have not been materially different from the actual costs.
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| Stock-Based Compensation | Stock-Based Compensation The Company measures and recognizes compensation expense for all stock option awards based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards. Additionally, the Company uses a Monte Carlo simulation model to calculate the estimated fair value on the date of grant related to awards with market-based service conditions. The fair value is recognized as expense, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis for each separately vesting portion of the award when the only condition to vesting is continued service. If vesting is subject to a market or performance condition, recognition is based on the derived service period of the award. Expense for awards with performance conditions is estimated and adjusted on a quarterly basis based upon the assessment of the probability that the performance condition will be met. Use of the Black-Scholes option-pricing model requires management to apply judgment under subjective assumptions. These assumptions include: •Expected term—The expected term of stock options represents the weighted-average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. •Expected volatility—The expected volatility is calculated based on historical volatility of the Company’s share price. •Risk-free interest rate—The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options. •Expected dividend—The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not intend to pay dividends. The Company uses a Monte Carlo simulation model to estimate the fair value of Performance and Market-based Stock Options at the date of grant which utilizes multiple input variables to estimate the probability that the market condition will be achieved. Key assumptions used in the model include the risk-free interest rate, which reflects the US Treasury Constant Maturity Yield with a term commensurate with the contractual term of the award, and stock price volatility, which is derived based on the historical volatility of the Company’s stock. The Company estimates expected forfeitures at the time of grant instead of accounting for forfeitures as they occur. Stock option awards have been granted at fair value to non-employees in connection with research and consulting services provided to the Company. Equity awards generally vest over terms of 3 or 4 years. The Company classifies stock-based compensation expense in the consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified.
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| Income Taxes | Income Taxes The provision for income taxes is determined using the asset and liability approach. Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements. A current asset or liability is recognized for the estimated taxes receivable or payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes are initially recognized at enacted tax rates in force at the time of initial recognition and are subsequently adjusted for any enacted changes in tax rates and tax laws. Subsequent changes to deferred taxes originally recognized in equity are recognized in income. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The Company has recorded a full valuation allowance against the deferred tax assets in excess of its deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The Company records interest and penalties related to income tax matters as part of income tax expense.
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| Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, restricted cash and short-term investments. The Company’s cash is comprised of short-term cash deposits at a variety of financial institutions which the Company believes are of high credit ratings in amounts that may exceed federally insured limits. The Company has not experienced any losses on such accounts. Cash balances maintained during the year have been principally held with U.S.-based and U.K.-based banks. The Company does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a number of vendors to conduct its clinical trials and preclinical studies, manufacture drug product and supply clinical trial and preclinical study materials for its development programs. These programs could be adversely affected by a significant interruption in these services or the availability of materials.
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| Fair Value Measurements | Fair Value Measurements In accordance with the provisions of fair value accounting, a fair value measurement assumes that the transaction to sell an asset or transfer a liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market for the asset or liability and defines fair value based on the exit price model. The fair value measurement guidance establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The guidance describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 2 assets and liabilities include debt securities with quoted prices that are traded less frequently than exchange-traded instruments or securities or derivative contracts that are valued using a pricing model with inputs that are observable in the market or can be derived principally from or corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the Company categorizes such assets and liabilities based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset.
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| Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers only those investments that are highly liquid, readily convertible to cash and that mature within 90 days or less from date of purchase to be cash equivalents. As of December 31, 2024, cash equivalents were comprised of money market funds. As of December 31, 2023, cash equivalents were comprised of money market funds and U.S. treasury securities.
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| Restricted Cash | Restricted Cash Restricted cash represents amounts which are legally restricted to withdrawal or usage and is presented in the consolidated balance sheet as restricted cash.
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| Short-term Investments | Short-term Investments Marketable securities consist of investments with original maturities greater than ninety days from the date of acquisition. The Company classifies investments with maturities of greater than 90 days and less than one year as short-term, based on the liquid nature of the securities and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of investments as available-for-sale. Accordingly, these investments are recorded at fair value, which is based on quoted market prices or other observable inputs. Unrealized gains and losses are recorded as a component of other comprehensive income (loss). Realized gains and losses are determined on a specific identification basis and are included in other (expense) income. Amortization and accretion of discounts and premiums are also recorded in other (expense) income. When the fair value is below the amortized cost of the asset, an estimate of expected credit losses is made. This estimate is limited to the amount by which fair value is less than amortized cost. The credit-related impairment amount is recognized in the consolidated statements of operations and comprehensive loss and the remaining impairment amount and unrealized gains are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Credit losses are recognized through the use of an allowance for credit losses account and subsequent improvements in expected credit losses are recognized as a reversal of the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis the allowance for credit loss is written off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss.
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| Warrants | Warrants Warrants issued by the Company are recognized and classified as equity when, upon exercise, the Company would issue a fixed amount of its own equity instruments (common stock) in exchange for a fixed amount of cash or another financial asset. Consideration received, net of incremental costs directly attributable to the issue of such new warrants, is shown in stockholders' equity. Such warrants are not remeasured at fair value in subsequent reporting periods. Warrants issued in which external services are received as consideration for equity instruments of the company should be measured at the fair value of the goods or services received. Only if the fair value of the services cannot be measured reliably would the fair value of the equity instruments granted be used. The fair value for the warrants is calculated using the Black-Scholes model and recorded in the consolidated statement of operations and comprehensive loss on a straight-line basis over the period of the consulting services. If the services are terminated prior to the end of the consultancy agreement, the warrants cease vesting and any unvested portion of the warrants will lapse immediately. The warrants in issue are classified within stockholders’ equity as they are indexed to the Company’s own shares of common stock and require settlement in its shares of common stocks with no provision for any cash settlement.
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| Recently Issued or Adopted Accounting Pronouncements | Recently Issued or Adopted Accounting Pronouncements In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards update “ASU” No. 2023-09, “Improvements to Income Tax Disclosures”, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the income tax disclosures within the consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption was permitted, and the amendments should be applied retrospectively. The Company adopted and retrospectively applied the amendments in this update during the fourth quarter of 2024 and in preparation of the annual consolidated financial statements. Refer to Note 6 regarding the additional disclosures included within the consolidated financial statements. In November 2024, the FASB issued ASU 2024-03, “Disaggregation of Income Statement Expenses.” The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures. The guidance is effective for public business entities for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted. The guidance is to be applied prospectively, with the option for retrospective application. The Company is currently evaluating the impact of the ASU on the disclosures within the consolidated financial statements. Other recent authoritative guidance issued by the FASB (including technical corrections to the FASB ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not expected to have a material impact on the Company’s consolidated financial statements.
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Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of property and equipment useful lives | Depreciation is calculated based on cost, less residual value, in equal annual installments over the estimated useful lives of the assets. The residual value, if significant, is reassessed annually.
Property and equipment consisted of the following:
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| Schedule of restricted cash balances | The Company’s total cash, cash equivalents and restricted cash balances were as follows:
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| Schedule of cash and cash equivalents | The Company’s total cash, cash equivalents and restricted cash balances were as follows:
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Segment Reporting (Tables) |
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| Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of concluded that the research and development expenses are significant segment expense | The CODM function is regularly provided with the following significant segment expenses:
(1) Revenue relates to amounts received from the license and commercialization agreement related to ridinilazole clinical trials. All prior development activities related to ridinilazole have been terminated. (2) Other expenses include costs for the Company’s antibiotic pipeline research activities and ridinilazole or CDI program activities (collectively, “Anti-infectives), general and administrative expenses excluding compensation and stock-based compensation, and impairment of intangible assets. All prior development activities related to Anti-infectives have been terminated.
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Other Operating Income, net (Tables) |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of other operating income | The following table sets forth the components of other operating income by category:
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Other Income (Expense), net (Tables) |
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| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of other (expense) income | The following table sets forth the components of other (expense) income:
(1) Investment income relates to the Company’s money market funds and short-term investments in U.S. treasury securities. Refer to Note 12 for details. (2) The reclassification of cumulative currency translation gain related to the reclassification of cumulative foreign currency translation gains from accumulated other comprehensive loss due to the dissolution of certain dormant entities.
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Income Tax (Tables) |
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| Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Components of loss before income taxes | The components of the Company’s loss before income taxes are as follows:
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| Major components of deferred tax assets and liabilities | The major components of deferred tax assets and liabilities are as follows:
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| Change in valuation allowance | The change in the valuation allowance was as follows:
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| Reconciliation of the effective income tax rate to the statutory rate | A reconciliation of the Company’s effective tax rate to the U.S. federal statutory rate is as follows:
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| Reconciliation of unrecognized tax benefits | A reconciliation of unrecognized tax benefits from continuing operations is as follows:
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Net Loss per Share (Tables) |
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| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of net loss per share | The following table sets forth the computation of basic and diluted net loss per share:
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| Schedule of potentially dilutive securities excluded from the computation of loss per share | The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive:
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Fair Value Measurements and Short-Term Investments (Tables) |
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of assets and liabilities measured at fair value on a recurring basis | The following tables sets forth the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2024 and 2023:
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| Schedule of short-term investments | The following table sets forth the Company’s short-term investments as of December 31, 2024 and 2023, which have a contractual maturity of less than one year:
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Property and Equipment (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of property and equipment | Depreciation is calculated based on cost, less residual value, in equal annual installments over the estimated useful lives of the assets. The residual value, if significant, is reassessed annually.
Property and equipment consisted of the following:
|
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Leases (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of lease expense | The elements of lease expense were as follows:
(1) Short-term lease costs relate to the Company’s Cambridge, Massachusetts, United States office lease which the Company exited during fiscal year 2022.
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| Schedule of future lease payments | Future lease payments under non-cancelable leases as of December 31, 2024 are detailed as follows:
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Stockholders' Equity (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of warrant activity | The following table summarizes the Company’s warrants activity for the year ended December 31, 2024:
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Stock Based Compensation (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of weighted-average assumptions | The assumptions used in the Company’s valuation are summarized as follows, presented on a weighted average basis:
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| Schedule of stock option activity | The following table summarizes the Company’s time-based stock option activity for the year ended December 31, 2024:
The following table summarizes the Company’s performance and market-based stock option activity for the year ended December 31, 2024:
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| Schedule of stock-based compensation expense | Stock‑based compensation expense related to stock options is recorded within the consolidated statements of operations and comprehensive loss as follows:
The following table summarizes stock-based compensation expense associated with each of our stock-based compensation arrangements:
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Liquidity and Capital Resources (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
| Net loss | $ 221,315 | $ 614,928 | $ 78,782 |
| Net cash used in operating activities | 142,106 | 76,760 | 41,582 |
| Accumulated deficit | 1,214,573 | 993,258 | |
| Cash and cash equivalents | 104,862 | 71,425 | $ 348,607 |
| Short-term investments | $ 307,487 | $ 114,817 | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Narrative (Details) - USD ($) $ in Thousands |
1 Months Ended | 12 Months Ended | ||||
|---|---|---|---|---|---|---|
Jan. 17, 2023 |
Jan. 31, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 15, 2022 |
|
| Significant Accounting Policies [Line Items] | ||||||
| Foreign currency (losses) gains | $ (97) | $ 613 | $ (4,109) | |||
| Restricted cash | $ 325 | $ 0 | $ 300,000 | $ 300,000 | ||
| Collaborative arrangement, transaction with party to collaborative arrangement, upfront payment one | ||||||
| Significant Accounting Policies [Line Items] | ||||||
| Collaborative arrangement, common stock issued in lieu of cash upfront payment (in shares) | 10,000,000 | 10,000,000 | ||||
| Cash payment for collaborative arrangement, upfront payment | $ 274,900 | $ 274,900 | ||||
| Minimum | ||||||
| Significant Accounting Policies [Line Items] | ||||||
| Equity award, vesting period | 3 years | |||||
| Maximum | ||||||
| Significant Accounting Policies [Line Items] | ||||||
| Equity award, vesting period | 4 years | |||||
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Property and Equipment Useful Lives (Details) |
Dec. 31, 2024 |
|---|---|
| Laboratory equipment | Minimum | |
| Property, Plant and Equipment [Line Items] | |
| Property and equipment, estimated useful Lives | 2 years |
| Laboratory equipment | Maximum | |
| Property, Plant and Equipment [Line Items] | |
| Property and equipment, estimated useful Lives | 10 years |
| Furniture and fixtures, office equipment and software | Minimum | |
| Property, Plant and Equipment [Line Items] | |
| Property and equipment, estimated useful Lives | 3 years |
| Furniture and fixtures, office equipment and software | Maximum | |
| Property, Plant and Equipment [Line Items] | |
| Property and equipment, estimated useful Lives | 5 years |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Total Cash, Cash Equivalents and Restricted Cash Balances (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 15, 2022 |
Dec. 31, 2021 |
|---|---|---|---|---|---|
| Accounting Policies [Abstract] | |||||
| Cash and cash equivalents | $ 104,862 | $ 71,425 | $ 348,607 | ||
| Restricted cash | 325 | 0 | 300,000 | $ 300,000 | |
| Total cash, cash equivalents and restricted cash | $ 105,187 | $ 71,425 | $ 648,607 | $ 71,791 |
Segment Reporting - Narrative (Details) |
12 Months Ended |
|---|---|
|
Dec. 31, 2024
segment
| |
| Segment Reporting [Abstract] | |
| Number of reportable segments | 1 |
| Number of operating segments | 1 |
Segment Reporting - Summary of Significant Expenses (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Segment Reporting Information [Line Items] | |||
| Revenue | $ 0 | $ 0 | $ 705 |
| Oncology clinical trial related costs | 150,777 | 59,471 | 51,999 |
| Acquired in-process research and development | 15,007 | 520,915 | 0 |
| Stock-based compensation | 50,981 | 14,108 | 11,948 |
| Total operating expenses | 226,311 | 610,651 | 87,210 |
| Other operating income, net | 313 | 1,001 | 14,416 |
| Operating loss | (225,998) | (609,650) | (72,089) |
| Other (expense) income | 13,369 | 11,183 | (2,292) |
| Interest expense | (8,686) | (16,461) | (4,401) |
| Net loss | (221,315) | (614,928) | (78,782) |
| Reportable Segment | |||
| Segment Reporting Information [Line Items] | |||
| Revenue | 0 | 0 | 705 |
| Oncology clinical trial related costs | 100,937 | 35,224 | 0 |
| Acquired in-process research and development | 15,007 | 520,915 | 0 |
| Compensation related costs, excluding stock-based compensation | 48,295 | 31,371 | 27,817 |
| Stock-based compensation | 50,981 | 14,108 | 11,948 |
| Other segment expenses | 11,091 | 9,033 | 47,445 |
| Total operating expenses | 226,311 | 610,651 | 87,210 |
| Other operating income, net | 313 | 1,001 | 14,416 |
| Operating loss | (225,998) | (609,650) | (72,089) |
| Other (expense) income | 13,369 | 11,183 | (2,292) |
| Interest expense | (8,686) | (16,461) | (4,401) |
| Net loss | $ (221,315) | $ (614,928) | $ (78,782) |
Other Operating Income, net - Summary by Category (Details) - USD ($) $ in Thousands |
12 Months Ended | 20 Months Ended | 64 Months Ended | ||
|---|---|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2022 |
Dec. 31, 2022 |
|
| Revenue from External Customer [Line Items] | |||||
| Research and development tax credits | $ 313 | $ 946 | $ 4,523 | ||
| Other income | 0 | 10 | 0 | ||
| Other operating income, net | 313 | 1,001 | 14,416 | ||
| BARDA | |||||
| Revenue from External Customer [Line Items] | |||||
| Funding/Grant income | 0 | 0 | 8,085 | $ 59,203 | |
| CARB-X | |||||
| Revenue from External Customer [Line Items] | |||||
| Funding/Grant income | $ 0 | $ 45 | $ 1,808 | $ 2,920 | |
Other Operating Income, net - Narrative (Details) - USD ($) $ in Thousands |
1 Months Ended | 12 Months Ended | 20 Months Ended | 64 Months Ended | ||
|---|---|---|---|---|---|---|
May 31, 2021 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2022 |
Dec. 31, 2022 |
|
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
| Current and long-term research and development tax credit receivable | $ 1,255 | $ 1,807 | ||||
| BARDA | ||||||
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
| Total committed funding | 62,400 | |||||
| Funding/Grant income | 0 | 0 | $ 8,085 | $ 59,203 | ||
| CARB-X | ||||||
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
| Funding/Grant income | $ 0 | $ 45 | $ 1,808 | $ 2,920 | ||
| Maximum funding value | $ 4,100 | |||||
| Funding increase based on achievement of future milestones | $ 3,700 | |||||
Other Income (Expense), net - Components (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Other Income and Expenses [Abstract] | |||
| Foreign currency (losses) gains | $ (97) | $ 613 | $ (4,109) |
| Investment income | 13,466 | 10,403 | 1,513 |
| Reclassification of cumulative currency translation gain | 0 | 419 | 0 |
| Other expense, net | 0 | (252) | 304 |
| Other (expense) income | $ 13,369 | $ 11,183 | $ (2,292) |
Income Tax - Narrative (Details) - USD ($) $ in Thousands |
12 Months Ended | |||
|---|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
|
| Operating Loss Carryforwards [Line Items] | ||||
| Unrecognized tax benefits | $ 2,122 | $ 1,064 | $ 0 | $ 0 |
| Liability for interest and penalties | 0 | 0 | ||
| Current provision for state income taxes | 0 | 0 | 0 | |
| Current provision for non-United States income taxes | 0 | 0 | 0 | |
| Current provision for federal income taxes | 0 | 0 | 0 | |
| Deferred provision for federal income taxes | 0 | 0 | 0 | |
| Deferred provision for state income taxes | 0 | 0 | 0 | |
| Deferred provision for non-United States income taxes | 0 | 0 | $ 0 | |
| Deferred tax asset | 95,925 | 84,925 | ||
| U.S. Federal | ||||
| Operating Loss Carryforwards [Line Items] | ||||
| Operating loss carryforwards | 44,270 | $ 48,184 | ||
| Tax credit carryforward | 6,982 | |||
| U.S. State | ||||
| Operating Loss Carryforwards [Line Items] | ||||
| Operating loss carryforwards | 7,045 | |||
| Tax credit carryforward | 586 | |||
| U.K. | ||||
| Operating Loss Carryforwards [Line Items] | ||||
| Operating loss carryforwards | $ 198,653 | |||
Income Tax - Components of Loss Before Income Taxes (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Income Tax Disclosure [Abstract] | |||
| Foreign | $ (199,040) | $ (499,810) | $ (46,868) |
| United States | (22,275) | (115,118) | (31,914) |
| Loss before income tax | $ (221,315) | $ (614,928) | $ (78,782) |
Income Tax - Major Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|---|---|
| Deferred tax assets: | ||||
| Net operating loss carryforward | $ 59,413 | $ 58,975 | ||
| Research and development credit carryforward | 7,869 | 4,522 | ||
| Stock-based compensation | 14,001 | 4,128 | ||
| Section 174 Research and Development Capitalization | 14,167 | 15,982 | ||
| Other | 475 | 1,318 | ||
| Total deferred tax assets | 95,925 | 84,925 | ||
| Deferred tax liabilities: | ||||
| Other | (337) | (174) | ||
| Total deferred tax liabilities | (337) | (174) | ||
| Net deferred tax assets before valuation allowance | 95,588 | 84,751 | ||
| Valuation allowance | (95,588) | (84,751) | $ (64,016) | $ (51,746) |
| Deferred tax, net | $ 0 | $ 0 |
Income Tax - Valuation Allowance (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Deferred Tax Assets, Valuation Allowance [Roll Forward] | |||
| Valuation allowance as of beginning of year | $ (84,751) | $ (64,016) | $ (51,746) |
| Increase in valuation allowance | (10,837) | (20,735) | (12,270) |
| Valuation allowance as of end of year | $ (95,588) | $ (84,751) | $ (64,016) |
Income Tax - Reconciliation of the Effective Income Tax Rate to Statutory Rate (Details) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Income Tax Disclosure [Abstract] | |||
| U.S. federal income tax statutory rate | 21.00% | 21.00% | 21.00% |
| State income tax, net of federal tax benefit | (0.20%) | 0.20% | 0.00% |
| Change in valuation allowance | (4.80%) | (3.40%) | (16.80%) |
| Research and development tax credit | 1.40% | 0.20% | (3.60%) |
| Effect of foreign operations taxed at various rates | (18.50%) | (17.10%) | 2.10% |
| Stock-based compensation | 0.10% | (0.10%) | (2.20%) |
| Other | 1.00% | (0.90%) | (0.50%) |
| Effective tax rate | 0.00% | 0.00% | 0.00% |
Income Tax - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Unrecognized Tax Benefits [Roll Forward] | |||
| Unrecognized tax benefits, beginning of year | $ 1,064 | $ 0 | $ 0 |
| Increases related to prior year tax positions | 122 | 610 | 0 |
| Increases related to current year tax positions | 936 | 454 | 0 |
| Unrecognized tax benefits, end of year | $ 2,122 | $ 1,064 | $ 0 |
Net Loss per Share - Computation of Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Earnings Per Share [Abstract] | |||
| Net loss | $ (221,315) | $ (614,928) | $ (78,782) |
| Basic weighted average number of shares of common stock outstanding (in shares) | 718,541,896 | 619,646,180 | 193,336,063 |
| Diluted weighted average number of shares of common stock outstanding (in shares) | 718,541,896 | 619,646,180 | 193,336,063 |
| Basic net loss per share (in dollars per share) | $ (0.31) | $ (0.99) | $ (0.41) |
| Diluted net loss per share (in dollars per share) | $ (0.31) | $ (0.99) | $ (0.41) |
Net Loss per Share - Narrative (Details) - $ / shares |
Jun. 06, 2024 |
Mar. 01, 2023 |
Aug. 08, 2022 |
|---|---|---|---|
| Subsidiary, Sale of Stock [Line Items] | |||
| Sale of stock price (in dollars per share) | $ 9.00 | ||
| Share price (in dollars per share) | $ 1.82 | ||
| Rights Offering | |||
| Subsidiary, Sale of Stock [Line Items] | |||
| Sale of stock price (in dollars per share) | $ 1.05 | $ 0.97 |
Goodwill and Intangible Assets (Details) $ in Thousands, £ in Millions |
1 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|
|
Dec. 31, 2017
GBP (£)
|
Dec. 31, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
|
| Finite-Lived Intangible Assets [Line Items] | ||||
| Recognition of goodwill | £ | £ 1.5 | |||
| Goodwill | $ 1,864 | $ 1,893 | ||
| Cumulative goodwill impairment charges | 0 | |||
| Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Impairment of intangible assets | |||
| Amortization of intangible assets | 0 | 0 | $ 914 | |
| Net book value of intangible assets | $ 0 | $ 0 | ||
| Software | Discuva platform | ||||
| Finite-Lived Intangible Assets [Line Items] | ||||
| Impairment charge | $ 8,468 | |||
Fair Value Measurements and Short-Term Investments - Narrative (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Fair Value Disclosures [Abstract] | ||
| Cash | $ 16,263 | $ 11,068 |
Fair Value Measurements and Short-Term Investments - Summary of Short-Term Investments (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Debt Securities, Available-for-Sale [Line Items] | ||
| Amortized Cost | $ 307,387 | $ 114,781 |
| Unrealized Gains | 100 | 36 |
| Unrealized (Losses) | 0 | 0 |
| Credit (Loss) | 0 | 0 |
| Fair Value | 307,487 | 114,817 |
| U.S. Government treasury bills | ||
| Debt Securities, Available-for-Sale [Line Items] | ||
| Amortized Cost | 307,387 | 114,781 |
| Unrealized Gains | 100 | 36 |
| Unrealized (Losses) | 0 | 0 |
| Credit (Loss) | 0 | 0 |
| Fair Value | $ 307,487 | $ 114,817 |
Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 1,372 | $ 1,246 |
| Less: accumulated depreciation | (1,118) | (1,042) |
| Property and equipment, net | 254 | 204 |
| Laboratory equipment | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | 21 | 22 |
| Furniture and fixtures, office equipment and software | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | 1,028 | 896 |
| Leasehold improvements | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 323 | $ 328 |
Property and Equipment - Narrative (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Property, Plant and Equipment [Abstract] | |||
| Depreciation expense | $ 89 | $ 198 | $ 349 |
| Impairment of fixed assets | $ 0 | $ 0 | $ 0 |
Research and Development Prepaid Expenses and Accrued Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
| Prepaid expenses and other current assets | $ 8,338 | $ 1,466 |
| Accrued research and development expenditure | $ 17,441 | $ 7,289 |
Leases - Narrative (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
|---|---|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Feb. 01, 2024 |
Dec. 15, 2022 |
|
| Lessee, Lease, Description [Line Items] | |||||
| Additional right-of-use assets recorded | $ 4,216 | $ 4,245 | $ 2,860 | ||
| Total lease payments | 7,984 | ||||
| Restricted cash | 325 | 0 | 300,000 | $ 300,000 | |
| Removal of lease liability | 167 | 359 | $ (152) | ||
| Operating lease right-of-use assets | $ 7,144 | $ 5,859 | |||
| Weighted average discount rate | 6.90% | 6.60% | |||
| Weighted average remaining lease term | 2 years 9 months 18 days | 2 years 9 months 18 days | |||
| Cash payments related to lease liabilities | $ 2,568 | $ 2,208 | |||
| Letter of Credit | |||||
| Lessee, Lease, Description [Line Items] | |||||
| Restricted cash | 325 | ||||
| Cambridge UK, Laboratory and Office Space | |||||
| Lessee, Lease, Description [Line Items] | |||||
| Disposal of right-of-use asset | 788 | ||||
| Removal of lease liability | $ 809 | ||||
| FLORIDA | |||||
| Lessee, Lease, Description [Line Items] | |||||
| Additional right-of-use assets recorded | 4,216 | ||||
| Total lease payments | $ 4,185 | ||||
| Lease term | 5 years 3 months 18 days | ||||
Leases - Lease Cost (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Lease, Cost [Abstract] | |||
| Fixed lease costs | $ 3,461 | $ 2,214 | $ 1,384 |
| Variable lease costs | 48 | 83 | 137 |
| Short-term lease | 0 | 0 | 31 |
| Total lease cost | $ 3,509 | $ 2,297 | $ 1,552 |
Leases - Future Lease Payments (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Leases [Abstract] | ||
| 2025 | $ 3,800 | |
| 2026 | 1,809 | |
| 2027 | 946 | |
| 2028 | 1,063 | |
| 2029 | 366 | |
| Total lease payments | 7,984 | |
| Less: imputed interest | 766 | |
| Total operating lease liabilities | 7,218 | |
| Total operating lease liabilities balance sheet presentation: | ||
| Current lease liabilities | 3,765 | $ 2,809 |
| Non-current lease liabilities | 3,453 | $ 3,290 |
| Total operating lease liabilities | $ 7,218 |
Stockholders' Equity - Warrant Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 12 Months Ended |
|---|---|---|
Dec. 31, 2023 |
Dec. 31, 2024 |
|
| Number of share warrants | ||
| Outstanding, beginning balance (in shares) | 5,015,642 | |
| Exercised (in shares) | (385,654) | |
| Outstanding, ending balance (in shares) | 5,015,642 | 4,629,988 |
| Weighted average exercise price | ||
| Outstanding, beginning balance (in dollars per share) | $ 1.57 | |
| Exercised (in dollars per share) | 1.55 | |
| Outstanding, ending balance (in dollars per share) | $ 1.57 | $ 1.58 |
| Weighted average remaining contractual term | 5 years 11 months 1 day | 4 years 11 months 23 days |
| Aggregate intrinsic value | $ 5,194 | $ 75,300 |
Stock Based Compensation - Weighted-Average Assumptions used for Stock Option Awards (Details) - Stock options |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
| Risk-free interest rate | 4.20% | 4.59% | 3.11% |
| Expected term (in years) | 6 years 2 months 12 days | 4 years 9 months 18 days | 5 years 10 months 24 days |
| Expected volatility | 107.80% | 98.10% | 91.20% |
| Expected annual dividends per share | 0.00% | 0.00% | 0.00% |
Commitments and Contingencies (Details) - USD ($) |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Commitments and Contingencies Disclosure [Abstract] | ||
| Capital commitments | $ 0 | $ 0 |
| Contractual commitments | $ 13,900,000 |