Significant Accounting Policies | NOTE 3-SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The Company ’ Use of Estimates The a i i n a i Functional Currency The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company and subsidiary are conducted. Therefore, the functional currency of the Company is the Dollar. Accordingly, transactions in currencies other than the Do l lar are measured and recorded in the functional currency usi n g the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liab i lities that are denominated in currencies other than the Dollar are measured using the official exch a nge rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the consolidated statements of operations as “ I nterest and other ( income ) expenses , net .” Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist primarily of money market funds and bank money market accounts and are stated at cost, which approximates fair value. Marketable Securities The Company classifies its marketable securities as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt Securities”. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income/loss within shareholders’ equity. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. The Company reviews its available-for-sale securities for other-than-temporary declines in fair value below its cost basis each quarter and whenever events or changes in circumstances indicate that the cost basis of an asset may not be recoverable. This evaluation is based on a number Concentration of Credit Risk Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. The primary objectives for the Company ’ The Company ’ Income Taxes The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which we operate. Deferred l e n s a a The n l w a Property and Equipment Property and equipment is recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. We review our property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Annual % Computers and software 33 Laboratory equipment 15-30 Furniture 6-15 Manufacturing equipment 50 Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 6 for further discussion regarding property and equipment. Leases The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles. The Company currently has no finance leases. Commencing January 1, 2019, the Company accounts for leases in accordance with ASC Topic 842, “Leases” . Lease expense is recognized on a straight-line basis for operating leases. Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs. Variable lease payments are presented as operating expense on the consolidated statements of operations in the same line item as expense arising from fixed lease payments. The Company’s lease terms may include options of the Company as the lessee to extend the lease. The lease extensions are included in the measurement of the right of use asset and lease liability if it is reasonably certain that it will exercise that option. Because the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company has lease agreements with lease and non-lease components and has elected the practical expedient to combine lease and non-lease components for all underlying classes of assets. We applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application (“Transition Date”). Consequently, the disclosures required under Topic 842 are not provided for dates and periods before January 1, 2019. Topic 842 provides for a number of optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits not to reassess under Topic 842 its prior conclusions about lease identification, lease classification, and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company. Topic 842 had a material impact on our consolidated balance sheets but did not have an impact on our consolidated statements of operations. The most significant impact was the recognition of $3.7 million in ROU assets and $4.2 million in lease liabilities. ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360-10, “Property, Plant, and Equipment”, to determine whether a ROU asset is impaired, and if so, the amount of the impairment loss to recognize. Accounts Payable and Accrued Expenses Accrued expenses and other current liabilities consist of the following as of December 31, 2019 and 2018, respectively (in thousands): December 31, 2019 December 31, 2018 Accounts payable $ 4,694 $ 4,272 Accrued clinical expenses 399 673 Accrued research and development costs 2,644 780 Accrued general and administrative expenses 2,767 1,029 Accrued other expense 682 1,786 Total accrued expenses and other current liabilities $ 11,186 $ 8,540 Revenues The Company derives virtually all of its revenues from its license and supply agreement with Allergan. Under the agreement, the Company grants Allergan an exclusive license to develop, commercialize, and otherwise exploit products that contain RTGel and agrees to supply Allergan with pre-clinical and clinical quantities of the RTGel product, also referred to as the RTGel The Company determined that Allergan is its customer and the license and supply agreements are in scope of ASC 606, which was adopted as of January 1, 2018. The Company adopted ASC 606 under the modified retrospective method, which did not have a material impact on the Consolidated Statements of Operations. Previously, the Company analyzed revenues under ASC 605, which states that revenue w o i Under ASC 606, in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements with Allergan, the Company performs the following steps: 1) Identification of the contract; 2) Determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; 3) Measurement of the transaction price, including the constraint on variable consideration; 4) Allocation of the transaction price to the performance obligations; 5) Recognition of revenue when or as the Company satisfies each performance obligation. In 1) The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct); and 2) The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). The license agreement contains two performance obligations: (a) the license component and (b) Allergan’s right to require supply services of RTGel vials from the Company. The l p Allocating the C onsideration in the A rrangement Since the license to the Company’s intellectual property was determined to be functional and distinct from the other performance obligations identified in the arrangement, the Company recognized revenues from non-refundable, up-front fees allocated to the license when the license was transferred to Allergan and Allergan was able to use and benefit from the license. During the year ended December 31, 2016, the Company received A b e l c Development and Regulatory Milestone Payments At the inception of an arrangement that includes development milestone payments, the Company evaluates whether the development milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated development milestone value is included in the transaction price. Development milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The milestones are allocated entirely to the license performance obligation, as (1) the terms of milestone and royalty payments relate specifically to the license and (2) allocating milestones and royalties to the license performance obligation is consistent with the overall allocation objective, because management’s estimate of the supply fee approximates the standalone selling price for RTGel vials and management’s estimate of milestones and royalties approximates the standalone selling price of the license. During the year ended December 31, 2017, the Company recognized revenue of $7.5 million related to a development milestone payment resulting from Allergan’s submission of an IND application for the Company’s RTGel in combination with Allergan’s BOTOX for the treatment of overactive bladder to the U.S. FDA. Royalties Based on Allergan’s Revenue The Company is also n Supply of RTGel to Allergan The Company recognizes revenue related to supply of RTGel at a point in time, upon delivery to Allergan. During the years ended December 31, 2019, 2018 and 2017, the Company recognized $18,000, $1.1 million and $0.7 million of revenue related to RTGel vials supplied to Allergan, respectively. Shipping and handling costs associated with supply of RTGel vials are accounted for as a fulfillment cost and are in included in cost of revenues. General and Administrative Expenses General and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, executives, finance, commercial, medical affairs, business development, investor relations and human resources functions). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. General and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known. Research and Development Research s i d a l l License fees and development milestone payments related to in-licensed products and technology are expensed as in-process research and development if it is determined at that point that they have no established alternative future use. On November 8, 2019, the Company entered into a license agreement with Agenus Inc. pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary antibody of Agenus known as AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery. AGEN1884 is an anti-CTLA-4 antagonist that is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients and in combination with Agenus’ anti-PD-1 antibody in solid tumors. Initially, the Company plans to develop AGEN1884 in combination with UGN-201 for the treatment of high-grade non-muscle invasive bladder cancer. Pursuant to the license agreement, the Company paid Agenus an upfront fee of $10.0 million and has agreed to pay Agenus up to $115.0 million upon achieving certain clinical development and regulatory milestones, up to $85.0 million upon achieving certain commercial milestones, and royalties on net sales of licensed products in the 14% to 20% range. The Company will be responsible for all development and commercialization activities. Under the terms of the license agreement, Agenus has agreed to use commercially reasonable efforts to supply AGEN1884 to the Company for use in preclinical studies or clinical trials. No inventory was purchased on the effective date and subsequent purchases of pre-clinical and clinical supplies are at arm’s length and are priced at cost plus mark-up. The Company’s acquired right to Agenus’s intellectual property represents a single identifiable asset sourced from the license agreement. Therefore, all the fair value associated with the license agreement is concentrated in one identifiable asset and is not considered a business in accordance with ASC 805-10-55-5A. Therefore, the Company has accounted for the right to Agenus’s intellectual property acquired under the license agreement as an acquisition of an asset. Share-Based Compensation Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the required service period, which is equal to the vesting period. The fair value of stock options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit equaled the closing price of our ordinary shares on the grant date.The The s n g As of December 31, 2018, the Company adopted ASU 2018-07, Compensation-Stock Compensation, which establishes that the measurement of equity-classified nonemployee awards will be fixed at the grant date. The adoption of ASU 2018-07 did not have an impact on the condensed consolidated statements of operations. Interest and Other (Income) Expense, net Interest and Other (Income) Expense, net, consisted of the following as of December 31, 2019 and 2018 (in thousands): Year Ended December 31, 2019 2018 2017 Changes in fair value of warrants for preferred shares $ — $ — $ 168 Interest income on cash, cash equivalents and marketable securities (4,616 ) (1,872 ) (125 ) Realized loss on sale of short-term investment — 100 — Other expense (income) 284 124 (12 ) Total interest and other (income) expenses $ (4,332 ) $ (1,648 ) $ 31 Net Loss per Common Share Basic net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. In addition, the net loss attributable to common shareholders is adjusted for Series A and A-1 Preferred Stock dividends for the periods in which Series A and A-1 Preferred Stock is outstanding. For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The following table summarizes the calculation of basic and diluted loss per common share for the periods presented (in thousands, except share and per share amounts): Year Ended December 31, 2019 2018 2017 Basic and diluted: Loss attributable to equity holders of the Company $ 105,146 $ 75,657 $ 20,000 Dividend accumulated for preferred shares during the period $ — $ — $ 825 Loss attributable to equity holders of the Company, after deducting dividend accumulated for preferred shares $ 105,146 $ 75,657 $ 20,825 Weighted-average number of ordinary shares 20,528,727 15,754,193 9,716,790 Loss per ordinary share $ 5.12 $ 4.80 $ 2.14 Recently Issued Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or Accounting Standards Update, or Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, Recently Adopted Accounting Pronouncements In February 2016, FASB issued ASU No. 2016-02, “Leases”, or Topic 842. Topic 842 supersedes existing guidance in Leases (“Topic 840”). Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. Topic 842 requires lessees to recognize right-of-use, or ROU, assets and lease liabilities on the balance sheet for leases with lease terms greater than twelve months, including those classified as operating leases. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The lease liability is measured at the present value of the unpaid lease payments and the ROU assets are derived from the calculation of the lease liability. Lease payments will include fixed and in-substance fixed payments, variable payments based on an index or rate, exercise price of purchase options that are reasonably certain to be exercised, termination penalties, and probable amounts the lessee will owe under a residual value guarantee. Topic 842 also requires lessees to disclose key information about leasing arrangements. Lessor accounting will remain largely unchanged. The Company applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application, or Transition Date. Consequently, financial information was not updated, and the disclosures required under the Topic 842 were not provided for dates and periods before January 1, 2019. |