| Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to the applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board ("FASB"). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, after elimination of intercompany accounts and transactions. Functional and Reporting Currency The functional currency of the Company and its subsidiaries has been the United States Dollar (“USD” or “$”) since January 1, 2023. Prior to that the functional currency of the Company and its subsidiaries was the Euro (“EUR” or “€”). Significant elements involved in the determination of the functional currency change included a shift in the Company’s sources of financing from EUR to USD given its access to the U.S. public market and an increase of operating costs incurred in USD due to Phase 3 trials taking place predominantly in the United States, among other factors. Given these significant changes, management concluded that the majority of the factors supported the determination of the USD as the functional currency. The reporting currency of the Company is USD. Consolidation The consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Subsidiaries are all entities over which the Company has a controlling financial interest either through variable interest or through voting interest. Currently, the Company has no involvement with variable interest entities and all subsidiaries are wholly-owned. Intercompany transactions, balances, income, and expenses are eliminated in consolidation. Profits and losses resulting from intercompany transactions that are recognized in assets are also eliminated. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, assumptions related to the Company’s revenue recognition, accrual of research and development expenses, valuation of stock option awards and valuation of derivative instruments. The Company based its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. Fair Value Measurements Certain assets and liabilities of the Company are carried at fair value under U.S. GAAP either upon initial recognition or for subsequent accounting and reporting. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 – Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. • Level 2 – Valuations based on quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly. • Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. If the inputs used to measure the fair value of an asset or a liability fall into different levels of the fair value hierarchy, then the fair value measurement is categorized in its entirety in the same level of the fair value hierarchy as the lowest level input that is significant to the entire measurement. For assets and liabilities that are recognized in the consolidated financial statements at fair value on a recurring basis, the Company determines whether transfers have occurred between levels in the hierarchy by re-assessing categorization (based on the lowest level input that is significant to the fair value measurement as a whole), at the end of each reporting period. Segment Information Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the chief executive officer. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results, and plans for levels or components below the consolidated unit level. Accordingly, the Company has one operating segment and, therefore, one reportable segment, which comprises the discovery, development and commercialization of transformative therapies for cardio-metabolic diseases. Cash and Cash Equivalents Cash comprises checking and savings deposits. The carrying amount of these assets is approximately equal to their fair value due to their short-term nature. The Company maintains certain deposits which exceed the amounts covered by insurance provided by the government of the country in which the deposits are held. The Company has not experienced any losses related to amounts held in excess of such limits. The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Marketable Securities Marketable securities consist of investments in U.S. government and U.S. government agency obligations that are classified as available-for-sale. All marketable securities have a maturity of less than one year from the date of purchase. Further, since these securities are highly liquid and available to fund current operations, they are classified as current assets on the consolidated balance sheets. The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion as a component of interest income, net based on the effective interest method. Realized gains and losses and declines in value, if any, that the Company judges to be the result of impairment or as a result of recognizing an allowance for credit losses on available-for-sale securities are reported as a component of interest income, net. To determine whether an impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis. During the year ended December 31, 2024 the Company determined it did no t have any securities that were other-than-temporarily impaired. Prior to 2024 the Company held no marketable securities. Marketable securities are stated at fair value, excluding accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. During the years ended December 31, 2024, 2023 and 2022 , the Company did no t have any realized gains or losses on marketable securities. Property Plant and Equipment, Net Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method and is recorded in Selling, general, and administrative expense over the estimated useful lives of the assets. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed as incurred. Upon disposal of an asset, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss on the transaction is recognized. The estimated useful lives of property and equipment are as follows:
Estimated Useful Life (in years)
Computer equipment 5
Office furniture and equipment 5 Impairment of Long-Lived Assets The Company reviews the recoverability of its long-lived assets when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the ability to recover the carrying value of the assets from the expected future cash flows (undiscounted and without interest expense) of the related operations. If these cash flows are less than the carrying value of such assets, an impairment loss for the difference between the estimated fair value and carrying value is recorded. To date, the Company has not recorded any material impairment losses on long-lived assets. Leases In accordance with ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02” or “ASC 842”), the Company classifies leases at the lease commencement date. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. Leases with a term greater than one year will be recognized on the consolidated balance sheets as right-of-use assets (“ROU”), lease liabilities, and if applicable, long-term lease liabilities. The Company includes renewal options to extend the lease in the lease term where it is reasonably certain that it will exercise these options. Lease liabilities and the corresponding ROU are recorded based on the present values of lease payments over the terms. The Company determines the discount rate based on the implicit rate in the contract and if not readily determinable, the Company utilizes the appropriate incremental borrowing rates, which are the rates that would be incurred to borrow on a collateralized basis, over similar terms, amounts equal to the lease payments in a similar economic environment. Variable payments that do not depend on a rate or index are not included in the lease liability and are recognized as incurred. Lease contracts do not include residual value guarantees nor do they include restrictions or other covenants. Certain adjustments to ROUs may be required for items such as initial direct costs paid, incentives received, or lease prepayments. If significant events, changes in circumstances, or other events indicate that the lease term or other inputs have changed, the Company would reassess lease classification, remeasure the lease liability using revised inputs as of the reassessment date, and adjust the ROU. Lease agreements with a noncancelable term of less than 12 months and no purchase option that the Company is reasonably certain to exercise are not recorded on the Company’s consolidated balance sheet. Costs related to such lease agreements are operating cash flows and recorded in selling, general and administrative expenses. Derivative Warrants Liability The Company accounts for the public warrants and private placement warrants in accordance with the guidance contained in ASC 480, Distinguishing Liabilities from Equity ASC 815-40, Derivatives and Hedging—Contracts in Entity's Own Equity , under which the public warrants and private placement warrants do not meet the criteria for equity treatment and must be recorded as liabilities carried at fair value. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as (expense)/income in the consolidated statements of operations and comprehensive loss. The public warrants are valued based on the quoted market price as of each relevant reporting date, which is a Level 1 fair value measurement. The private warrants were initially and subsequently determined to have value equal to the public warrants as the terms of the instruments are substantially equivalent. The valuation of the private warrants is considered to be a Level 2 fair value measurement. Derivative Earnout Liability The Company accounts for the Earnout Shares (as defined below) allocated to Participating Shareholders (as defined below) in accordance with the guidance contained in ASC 480, Distinguishing Liabilities from Equity ASC 815-40, Derivatives and Hedging—Contracts in Entity's Own Equity , under which the Earnout Shares allocated to Participating Shareholders do not meet the criteria for equity treatment and must be recorded as liabilities carried at fair value. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as (expense)/income in the consolidated statements of operations and comprehensive loss. The liability is valued utilizing the Black-Scholes model, taking into account the probability of achieving the applicable milestone. The valuation of the Earnout Shares allocated to Participating Shareholders is considered to be a Level 3 fair value measurement. Tranche Rights On December 30, 2020, we entered into the Series A Subscription Agreement to issue Series A Preferred Shares for up to an aggregate amount of € 160 million, occurring in two tranches. The first tranche closed in January 2021 (the “First Closing”). The Series A subscription agreement entitled us to cause the investors to subscribe for the second tranche Series A Preferred Shares upon the occurrence of certain clinical development and business development milestones. As part of the Series A subscription agreement, investors were entitled to participate in the second tranche earlier, if they elect. This tranche right was determined to be a “freestanding financial instrument” as defined in the ASC Master Glossary because the tranche rights were transferable, and they did not need to be transferred with the related Series A shares. Further, upon the exercise of tranche rights, Series A shares held by investors remain outstanding. Management assessed the freestanding financial instrument under ASC 480, Distinguishing Liabilities from Equity , and determined that the tranche rights should be accounted for as a liability at fair value and revalued at each reporting period until settlement, with changes in the fair value recorded in the consolidated statements of operations and comprehensive loss. This determination was made because the tranche rights were exercisable at the investor’s election, and therefore future issuance of Series A shares were a contingent event that was not in the Company’s control. We issued the second tranche of Series A Preferred Shares in February 2022. This exercise of the tranche rights resulted in cash proceeds to the company, derecognition of the tranche right liability, and Series A Preferred Shares recognized at fair value, with the difference recorded to the consolidated statements of operations and comprehensive loss. Profit rights - Dezima acquisition On April 9, 2020, the Company entered into a purchase agreement with Saga Investments Coöperatief U.A., an affiliate of Amgen (“Amgen”) (the “2020 SPA”), to acquire all of the outstanding share capital of Dezima, a company whose principal activity was to develop compounds that treat cardiovascular disease related to dyslipidemia. The principal reason for this acquisition was to secure the intellectual property, licensing and know-how of the patented drug Obicetrapib and the in-process research and development (“IPR&D”). The Company paid consideration of € 1 for the IPR&D asset and could potentially make an additional contingent payment depending on future qualifying exit events, if they occurred. In connection with the 2020 SPA, the Company and Amgen entered into a profit right and waiver agreement with Mitsubishi Tanabe Pharma Corporation (“MTPC”) (the “Profit Right Agreement”) in consideration for the waiver of certain rights held by MTPC prior to the Dezima transaction. The Company evaluates acquisitions of assets and other similar transactions in accordance with ASC 805, Business Combinations, to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. The acquisition of Dezima was accounted for as an asset acquisition because substantially all of the fair value of the gross assets acquired is concentrated in the IPR&D of Obicetrapib. Additionally, the Company determined that as of the acquisition date, the IPR&D did not have an alternative future use by which the economic benefits could be anticipated and estimated. Therefore, it did not meet the definition of an asset and was expensed as incurred. The aggregate contingent consideration to be paid to Amgen and MTPC would become payable upon a traditional underwritten public offering or an exit event, as defined in the 2020 SPA. These rights were recognized as a contingent consideration liability. Contingent consideration in an asset acquisition is measured and recognized when payment becomes probable and a reliable estimate can be made. Subsequent changes in the accrued amount of contingent consideration are measured and recognized at the end of each reporting period and upon settlement as an adjustment to the cost basis of the acquired asset or group of assets. However, as the acquired asset in the Dezima transaction was IPR&D with no alternative future use, any adjustment to the cost is expensed during the period and not capitalized. The execution of the Menarini License (as defined in Note 4), in combination with the FLAC Merger (as defined in Note 3), qualified as an exit event pursuant to the 2020 SPA. As a result, on the Closing Date (as defined in Note 3), pursuant to the Profit Right Agreement, Amgen and MTPC each received their respective contingent payments in the form of Ordinary Shares. Immediately prior to the closing of the Business Combination, the value of the financial liability was adjusted to equal the fair value of the Ordinary Shares to be issued to Amgen and MPTC at the closing of the Business Combination with the change in fair value recognized through earnings in the consolidated statement of operations and comprehensive loss. Finally, the liability was derecognized with the corresponding offset to equity to record the issuance of the Ordinary Shares to Amgen and MTPC. Revenue Recognition The Company recognizes revenue in accordance with ASU 2014-09, Revenue from Contracts with Customers , and subsequent amendments (collectively, “ASC 606”). Under ASC 606, to determine the recognition of revenue, the Company performs the following five steps: 1. identify the contract(s) with the customer; 2. identify the performance obligations in the in the contract; 3. determine the transaction price; 4. allocate the transaction price to the performance obligations in the contract; and 5. recognize revenue when (or as) the Company satisfies a performance obligation. The Company performs an analysis to identify the performance obligations for its license agreement. Where a license agreement comprises several promises, it must be assessed whether these promises are capable of being distinct within the context of the contract. Promised goods or services are considered distinct when: (i) the customer can benefit from the good or service on its own or together with other readily available resources, and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own and whether the required expertise is readily available. In addition, the Company considers whether the customer can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises. The Company estimates the transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. The consideration may include both fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of the potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected value method to estimate variable consideration to include in the transaction price based on which method better predicts the amount of consideration expected to be received. The amount included in the transaction price is constrained to the amount for which it is highly probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. After the transaction price is determined, it is allocated to the identified performance obligations based on the estimated standalone selling price. The Company must develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the standalone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction, probabilities of technical and regulatory success and the estimated costs. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amounts the Company would expect to receive for each performance obligation. Revenue is recognized when the customer obtains control of the goods and/or services as provided in the license agreement. The control can be transferred over time or at a point in time – which results in the recognition of revenue over time or at a point in time. The Company recognizes revenue over time as the customer simultaneously receive the benefits provided by the Company’s performance, satisfied over time. Upfront licensing payments are recognized as revenue at the point in time when the Company transfers control of the license only if the license is determined to be a separate performance obligation from other undelivered performance obligations. Contingent development costs and milestone payments are generally included in the transaction price at the amount stipulated in the respective agreement and recognized to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company will recognize royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied) Research and Development Expense Research and development costs are recognized as an expense when incurred and are typically made up of clinical and preclinical activities, drug development and manufacturing costs, and include costs for clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided by vendors on their actual costs incurred. The determination of the level of services performed by the vendors and the associated expenditure incurred for the services provided is made at each balance sheet date. Quantification of the research and development expenses incurred during the period requires judgment based on key estimates comprising of non-financial data, because the progress of activities is not directly observable and therefore the precise timing of the research and development activities may not be entirely certain. In estimating progress toward completion of specific tasks, the Company therefore uses non-financial data such as number of patient screenings, patient visits, patient enrollment, clinical site activations and vendor information of actual costs incurred. This data is obtained through reports from outside service providers as to the progress or state of completion of trials or the completion of services and reviewed by Company personnel. The costs of intangibles that are purchased from others for a particular research and development project and that have no alternative future uses are expensed as research and development costs at the time the costs are incurred or at the time when no alternative future use is identified. Selling, General and Administrative Expenses Expenses are recognized on the accrual basis when incurred. Personnel Expenses Wages and salaries, social security contributions, payroll taxes, bonuses, and other employee benefits are recognized on the accrual basis in which the employee provides the associated services. The Company’s pension plans are classified as defined contribution plans, and, accordingly, no pension obligations are recognized in the balance sheet. Costs relating to defined contribution plans are included in the statement of operations and comprehensive loss in the period in which they are incurred, and outstanding contributions are included in trade and other payables. Share-Based Compensation The Company accounts for its share-based compensation in accordance with ASC 178 – Compensation – Stock Compensation ("ASC 718") . Share-based compensation is measured based on the grant date fair value of the equity awards using the Black-Scholes option pricing model. Share-based compensation expense is recognized on a straight-line basis over the requisite service period of the awards. Forfeitures and modifications are accounted for as they occur. The Company classifies share-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of Ordinary Shares outstanding during the period. For the purposes of calculating the weighted-average number of Ordinary Shares outstanding, the Ordinary Shares underlying the Pre-Funded Warrants issued in the February 2024 Offering and the December 2024 Offering (as defined in Note 9 below) are included. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements 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 to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized 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. Foreign Currency and Currency Translation Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at exchange rates prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net loss for the respective periods. Prior to January 1, 2023 the functional currency of the Company and its subsidiaries was the Euro. The reporting currency of the Company is USD. The Company translated assets and liabilities in prior periods at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the exchange rate prevailing at the date of the transaction. Unrealized translation gains and losses are recorded as cumulative translation adjustments which are included in the Company’s balance sheet within accumulated other comprehensive income (loss). Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which requires entities to enhance disclosures around segment reporting. The guidance is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 , with early adoption permitted. The Company adopted and applied the amendments of this ASU to its disclosures. The application of this ASU did no t have a material impact on the Company's financial position, results of operations or cash flows. In December 2023, the FASB issued ASU 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures" which requires entities to enhance disclosures around income taxes. The guidance is effective for annual periods beginning after December 15, 2024, |
