28 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Emphasis of Matter
−Removed: As discussed in Note 2 to the consolidated financial statements, if the Company is unable to obtain approval for UGN-102 and generate sufficient cash inflows from the sale and distribution of UGN-102, the Company may need to raise additional capital in the future or reduce operating expenditures.
−Removed: Management’s evaluation of the events and conditions and management’s plans to mitigate these matters are also described in Note 2.
Critical Audit Matters
2 unchanged sentences
Revenue Recognition - Gross Revenue from Product Sales
−Removed: As described in Notes 1, 3 and 12 to the consolidated financial statements, product sales from the Company’s commercial product, Jelmyto, are recognized as revenue at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician.
−Removed: All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third-party national specialty distributors.
+Added: As described in Notes 1, 3 and 12 to the consolidated financial statements, product sales from the Company’s commercial products, Jelmyto and Zusduri, are recognized as revenue at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician or mixing pharmacy.
+Added: All product sales of Jelmyto and Zusduri are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third-party national specialty distributors.
Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug.
2 unchanged sentences
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
−Removed: These procedures included, among others (i) testing the Company’s reconciliation of gross revenue recognized from product sales to third-party information, (ii) evaluating reconciling items, as applicable, (iii) confirming sales terms with the Company’s customers, (iv) confirming a sample of outstanding customer invoice balances as of December 31, 2024, and (v) evaluating a sample of gross revenue transactions by obtaining and inspecting source documents, including the customer contract, purchase orders, invoices, proof of delivery, cash remittances, and bank statements, as applicable.
+Added: These procedures included, among others (i) testing the Company’s reconciliation of gross revenue recognized from product sales to third-party information, (ii) evaluating reconciling items, as applicable, (iii) confirming sales terms with the Company’s customers, (iv) confirming a sample of outstanding customer invoice balances as of December 31, 2025 and, for confirmations not returned, obtaining cash receipts from customers or purchase orders, invoices and proof of delivery, and (v) evaluating a sample of gross revenue transactions by obtaining and inspecting source documents, including the customer contract, purchase orders, invoices, proof of delivery, cash remittances, and bank statements, as applicable.
/s/ PricewaterhouseCoopers LLP
9 unchanged sentences
Marketable securities
−Removed: 64,698 41,966
Restricted cash
70 unchanged sentences
$ ( 153,494 ) $ ( 126,874 )
−Removed: Other comprehensive income (loss)
−Removed: Unrealized gain on investments
+Added: Other comprehensive loss
+Added: Unrealized income (loss) on investments
Comprehensive Loss
19 unchanged sentences
Share-based compensation
−Removed: Issuance of pre-funded warrants, net of issuance costs
13,108 13,108
−Removed: Conversion of pre-funded warrants into ordinary shares
+Added: Issuance of pre-funded warrants, net of issuance costs
18,641 18,641
10 unchanged sentences
11,959 11,959
−Removed: Issuance of pre-funded warrants, net of issuance costs
+Added: Conversion of pre-funded warrants into ordinary shares
3,206,271 9 ( 6 ) 3
1 unchanged sentence
2,162,053 7 42,919 42,926
−Removed: Other comprehensive income
+Added: Other comprehensive loss
( 37 ) ( 37 )
+Added: ( 153,494 ) ( 153,494 )
Balance as of December 31, 2025
10 unchanged sentences
Accrued financing on prepaid forward obligation
−Removed: 15,077 11,504
Accretion on marketable securities
1 unchanged sentence
Share-based compensation
+Added: 11,959 13,108
Amortization (accretion) of discount on long-term debt
1 unchanged sentence
Amortization of right-of-use assets
+Added: Acquisitions of IPR&D
Changes in operating assets and liabilities:
3 unchanged sentences
Prepaid expenses and other current assets
+Added: ( 5,827 ) 1,436
Other non-current assets
+Added: ( 4,572 ) 1,449
Accounts payable and accrued expenses
15 unchanged sentences
( 289 ) ( 295 )
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
61,558 ( 20,613 )
Cash Flows From Financing Activities
+Added: Principal payments on finance leases
Proceeds from exercise of options into ordinary shares
1 unchanged sentence
Proceeds from pre-funded warrant issuance, net of issuance costs
−Removed: 18,641 48,700
−Removed: Proceeds from ordinary shares issuance, net of issuance costs
+Added: Proceeds from ordinary shares issuances, net of issuance costs
39,801 151,169
1 unchanged sentence
39,918 194,619
−Removed: Increase in Cash and Cash Equivalents
+Added: Increase (Decrease) in Cash and Cash Equivalents
( 60,968 ) 77,240
4 unchanged sentences
Supplemental Disclosures of Non-Cash Activities
−Removed: Right-of-use assets obtained in exchange for new operating lease liabilities
+Added: Right-of-use assets obtained in exchange for new operating and finance lease liabilities
$ 7,427 $ 2,321
+Added: Acquisitions of IPR&D
The accompanying notes are an integral part of these consolidated financial statements.
7 unchanged sentences
UPL and UPI (together the “Company”) is a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers.
−Removed: Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN- 101, advancing UGN- 102 through regulatory approval, and raising capital to support and expand these activities.
+Added: Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN- 101, developing, securing regulatory approval of and commercializing Zusduri (mitomycin) for intravesical solution, formerly known as UGN- 102, and raising capital to support and expand these activities.
On April 15, 2020, the U.S.
−Removed: Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto , a first -in-class treatment indicated for adults with low-grade upper tract urothelial cancer.
+Added: Food and Drug Administration (“FDA”) granted approval for Jelmyto , a first -in-class treatment indicated for adults with low-grade upper tract urothelial cancer (“low-grade UTUC”).
Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using the Company's proprietary sustained release RTGel technology.
It has been designed to prolong exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.
−Removed: In August 2024, the Company completed the submission of the rolling NDA for UGN- 102.
−Removed: In October 2024, the FDA accepted the Company's NDA for UGN- 102 (mitomycin) for intravesical solution and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of June 13, 2025.
+Added: On June 12, 2025 , the FDA approved Zusduri, the first and only FDA-approved medication for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”).
+Added: Zusduri consists of mitomycin and sterile hydrogel, uses the Company’s proprietary sustained release RTGel technology, and is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.
Note 2 – Basis of Presentation
−Removed: The Company has experienced net losses since its inception and has an accumulated deficit of $ 806.2 million and $ 679.3 million as of December 31, 2024 and 2023 , respectively.
−Removed: The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials.
−Removed: The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan.
+Added: The Company has experienced net losses since its inception and had an accumulated deficit of $ 959.7 million and $ 806.2 million as of December 31, 2025 and 2024 , respectively.
+Added: The Company expects to incur losses and have negative net cash flows from operating activities as it executes its strategy, including the ongoing commercial launch of Zusduri , the continued commercialization of Jelmyto , and engaging in further research and development activities.
+Added: The success of the Company depends on its ability to successfully commercialize its technologies to support its operations and strategic plan.
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States.
3 unchanged sentences
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments relating to the carrying amounts and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.
−Removed: The Company’s ability to continue as a going concern is expected to be impacted by the advancement of UGN- 102 through regulatory approval, its ability to raise additional capital to fund its operations, and produce cash inflows from Jelmyto product sales.
−Removed: Based on the Company's cash, cash equivalents and marketable securities as of December 31, 2024, together with management’s cash flow projections, the Company believes that it has sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these consolidated financial statements.
−Removed: If the Company is unable to obtain approval for UGN- 102 and generate sufficient cash inflows from the sale and distribution of UGN- 102, the Company may need to raise additional capital in the future or reduce operating expenditures.
+Added: The Company’s ability to continue as a going concern is expected to be impacted by its ability to produce cash inflows from Jelmyto and Zusduri product sales, the rate of physician and patient adoption of Zusduri and the Company's ability to raise additional capital to fund its operations in the future.
+Added: Based on the Company's cash and cash equivalents and marketable securities as of December 31, 2025, together with management’s cash flow projections, the Company believes that it has sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these financial statements.
+Added: If the Company is unable to generate sufficient cash inflows from Jelmyto and Zusduri product sales, the Company may need to raise additional capital in the future or reduce operating expenditures.
There can be no assurances that the Company will be able to secure such additional financing on terms that are satisfactory to the Company, in an amount sufficient to meet the Company's needs, or at all.
22 unchanged sentences
Cash and cash equivalents and marketable securities totaled $ 120.5 million as of December 31, 2025.
−Removed: The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt and Equity 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.
+Added: The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt and Equity Securities.” Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) within the consolidated statements of shareholders’ deficit.
Realized gains and losses are recorded as a component of interest and other income, net.
17 unchanged sentences
The accounts are monitored by management to mitigate the risk.
−Removed: The Company’s accounts receivables are composed of net sales of Jelmyto arising from the Company's arrangements with two third -party national specialty distributors.
+Added: The Company’s accounts receivables are composed of net sales of Jelmyto and Zusduri arising from the Company's arrangements with two customers, both of which are third -party national specialty distributors.
The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions.
12 unchanged sentences
The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs.
−Removed: For Jelmyto , the Company commenced capitalization of inventory at the receipt of FDA approval.
+Added: For both Jelmyto and Zusduri , the Company commenced capitalization of inventory at the receipt of FDA approval.
Costs related to inventories that are not expected to be manufactured and sold within the next 12 months are classified as long-term assets and presented within "Other non-current assets" on the consolidated balance sheets.
12 unchanged sentences
Prepaid Forward Obligation
−Removed: The Company is party to a transaction with RTW Investments (the “RTW Transaction”) in which the Company received funds to support the launch of Jelmyto and the development of UGN- 102 in return for tiered, future cash payments based on net sales of Jelmyto and, subject to FDA approval, UGN- 102, UGN- 103 and UGN- 104.
+Added: The Company is party to a transaction (the "RTW Transaction") with RTW Investments (“RTW") in which the Company received funds to support the launch of Jelmyto and the development of Zusduri in return for tiered, future cash payments based on net sales of Jelmyto and Zusduri , and, subject to FDA approval, UGN- 103 and UGN- 104.
The net proceeds received under the RTW Transaction were recognized as a long-term liability.
11 unchanged sentences
Right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date.
−Removed: Certain adjustments to the ROU asset may be required for items such as initial direct costs paid or incentives received.
+Added: Certain adjustments to the ROU assets may be required for items such as initial direct costs paid or incentives received.
Operating and finance lease ROU assets are presented as right-of-use assets on the consolidated balance sheets.
3 unchanged sentences
Lease expense for operating leases is recognized on a straight-line basis over the lease term.
−Removed: For finance leases, the expense consists of interest on the lease liability and amortization of the right-of-use asset.
+Added: For finance leases, the expense consists of interest on the lease liability and amortization of the ROU assets.
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.
2 unchanged sentences
The Company’s lease terms may include options to extend the lease.
−Removed: The lease extensions are included in the measurement of the right-of-use asset and lease liability when it is reasonably certain that it will exercise that option.
−Removed: Because most of 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.
+Added: The lease extensions are included in the measurement of the ROU assets and lease liability when it is reasonably certain that it will exercise that option.
+Added: Because the implicit rates of return on the Company’s leases are not readily determinable, the Company uses an incremental borrowing rate, based on the information available at the commencement date, to determine 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.
ROU assets are periodically reviewed for impairment losses under ASC 360 - 10, “Property, Plant, and Equipment,” to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize.
−Removed: Net revenue from product sales is recognized at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician.
−Removed: All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.
−Removed: Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug, which are estimated based on the Company’s historical experience.
+Added: Net revenue from product sales is recognized at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician or mixing pharmacy.
+Added: All product sales of Jelmyto and Zusduri are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.
+Added: Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug, which are estimated based on the contractual or statutory terms governing the arrangements and the Company’s historical experience.
Research and Development Expenses
Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services.
−Removed: The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed.
+Added: The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, are included in research and development costs and expensed as the contracted work is performed.
The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers.
The Company adjusts its accrual as actual costs become known.
−Removed: Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when such development milestone results are achieved.
+Added: Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when such development milestone results are probable of being achieved.
+Added: When a transaction accounted for as an asset acquisition includes in-process research and development (“IPR&D”), the IPR&D asset is only capitalized as an intangible asset if it is determined to have an alternative future use other than in a particular research and development project.
+Added: Otherwise, acquired IPR&D is recognized as research and development expenses in the period the transaction is closed.
Selling, General and Administrative Expenses
5 unchanged sentences
For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable.
+Added: PSUs that include both a performance condition and a service condition are subject to graded vesting, and the related compensation cost is recognized on a straight-line basis over the requisite service period for each separately vesting tranche.
The fair value of options is determined using the Black-Scholes option-pricing model.
The fair value of a restricted stock unit (“RSU”) or a PSU equals the closing price of the Company’s ordinary shares on the grant date.
−Removed: The Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation.”
−Removed: The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach.
+Added: The Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation.” The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach.
Pre-funded Warrants
−Removed: The Company's outstanding pre-funded warrants are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging.” Accordingly, the Company classifies the pre-funded warrants as a component of permanent shareholders’ equity within additional paid-in capital and records them at the applicable issuance date using a relative fair value allocation method.
+Added: The Company issued pre-funded warrants in connection with both a private placement transaction and a public offering transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging.” Accordingly, the Company classifies the pre-funded warrants as a component of permanent shareholders’ equity within additional paid-in capital and records them at the applicable issuance date using a relative fair value allocation method.
The Company valued the pre-funded warrants at the applicable issuance date, concluding that their sales price approximated their fair value, and allocated the net sales proceeds from the applicable equity transaction proportionately to the ordinary shares and pre-funded warrants.
3 unchanged sentences
For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.
+Added: Such potentially dilutive securities consist solely of outstanding restricted share units and stock options issued under the Company’s share-based compensation plans.
+Added: See Note 17 Share-based Compensation for more information.
The Company’s pre-funded warrants require the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic 260, “Earnings per Share.”
11 unchanged sentences
Recently Adopted or Issued Accounting Pronouncements
−Removed: In November 2023, the FASB issued Accounting Standards Update No.
−Removed: 2023 - 07, Segment Reporting (Topic 280 ):
−Removed: Improvements to Reportable Segment Disclosures ("ASU 2023 - 07" ), which provides guidance to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses.
−Removed: Public entities must adopt the new guidance for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
−Removed: The amendments in this ASU must be applied on a retrospective basis to all prior periods presented in the financial statements and early adoption is permitted.
−Removed: The Company has adopted the new guidance, which applies to all public entities, including those with a single reportable segment.
−Removed: The amendments primarily enhance segment expense disclosures.
In December 2023, the FASB issued Accounting Standards Update No.
2023 - 09, Income Taxes (Topic 740 ):
−Removed: Improvements to Income Tax Disclosures (“ASU 2023 - 09” ), which will require the Company to disclose specified additional information in its income tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.
−Removed: ASU 2023 - 09 will also require the Company to disaggregate its income taxes paid disclosure by federal, state and foreign taxes, with further disaggregation required for significant individual jurisdictions.
−Removed: The Company will adopt ASU 2023 - 09 for the 2025 year-end and is currently evaluating the potential impact of the adoption on the Company’s financial disclosures.
−Removed: ASU 2023 - 09 allows for adoption using either a prospective or retrospective transition method.
+Added: Improvements to Income Tax Disclosures (“ASU 2023 - 09” ), which requires enhanced disclosures related to income tax rate reconciliations, including specified additional information and further disaggregation of reconciling items that meet a quantitative threshold.
+Added: ASU 2023 - 09 also requires disaggregation of income taxes paid by federal, state, and foreign jurisdictions, with additional disaggregation for significant individual jurisdictions.
+Added: The Company adopted ASU 2023 - 09 effective for the year ended December 31, 2025 using a retrospective approach.
+Added: Prior-period income tax disclosures have been recast to conform to the current-year presentation.
+Added: The adoption of ASU 2023 - 09 impacted the Company’s income tax disclosures but did not have an impact on the Company’s consolidated financial position, results of operations, or cash flows.
In November 2024, the FASB issued Accounting Standards Update No.
2 unchanged sentences
The Company is currently evaluating the potential impact of the adoption of ASU 2024 - 03 on the Company’s financial disclosures.
+Added: In July 2025, the FASB issued Accounting Standards Update No.
+Added: 2025 - 05, Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025 - 05” ), which clarifies the application of the current expected credit losses (CECL) model under ASC 326 to current accounts receivable and contract assets arising from transactions accounted for under ASC 606, Revenue from Contracts with Customers.
+Added: The guidance, which is effective for fiscal years beginning after December 15, 2025, including interim periods within those fiscal years, and will be adopted prospectively, is intended to provide consistency in estimating expected credit losses for short-term receivables and contract assets.
+Added: The Company does not expect the adoption of ASU 2025 - 05 to have a material impact on its consolidated financial position, results of operations, or cash flows as the Company’s trade receivables primarily arise from product sales recognized at a point in time and are due from two large, established customers, both of which are third -party national specialty distributors, with short payment terms.
The Company has reviewed other Accounting Standards Updates recently issued by the FASB, and determined that none of these pronouncements will have a significant impact on the Company's consolidated financial statements and related disclosures.
18 unchanged sentences
$ 5,965 $ 8,901
−Removed: Other income (loss), net
+Added: Other loss, net
+Added: ( 670 ) ( 229 )
Total interest and other income, net
9 unchanged sentences
$ 16,464 $ 9,446
−Removed: ( 1 ) $ 0.2 million and $ 1.7 million of raw materials are included within other non-current assets on the consolidated balance sheets at December 31, 2024 and December 31, 2023, respectively.
+Added: ( 1 ) No raw materials were included as other non-current assets on the consolidated balance sheets at December 31, 2025.
+Added: $ 0.2 million of raw materials are included within other non-current assets on the consolidated balance sheets at December 31, 2024.
These raw materials are not expected to be manufactured and sold within the next 12 months.
27 unchanged sentences
Marketable securities
−Removed: $ 26,053 $ 26,053 $ —
Corporate bonds
40 unchanged sentences
Marketable securities
−Removed: $ 26,019 $ 34 $ — $ 26,053
Corporate bonds
33 unchanged sentences
Unrealized gains and losses on available-for-sale debt securities are included as a component of comprehensive loss.
−Removed: As of December 31, 2024 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 14.4 million which consisted of 12 securities.
−Removed: The unrealized loss was primarily driven by fluctuations in interest rates.
−Removed: The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment;
−Removed: the Company expects to recover the entire amortized cost basis of the security.
+Added: As of December 31, 2025 , the Company did not hold any investments in an unrealized loss position.
+Added: Accordingly, no allowance for credit losses was recorded during the period.
In accordance with the Company’s general investment strategy, the Company does not intend to sell the investments before maturity.
−Removed: As of December 31, 2024 , the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no allowance for credit losses were recognized in the period.
−Removed: The Company’s investments as of December 31, 2024 mature at various dates through November 2026.
+Added: The Company believes the cost basis of its marketable securities was recoverable in all material respects as of December 31, 2025 .
+Added: The Company’s investments as of December 31, 2025 mature at various dates through September 2026.
The fair values of investments by contractual maturity consist of the following (in thousands):
7 unchanged sentences
N OTE 8 – P ROPERTY AND E QUIPMENT
−Removed: Property and equipment, consists of the following as of December 31, 2024 and 2023 (in thousands):
+Added: Property and equipment, consisted of the following as of December 31, 2025 and 2024 (in thousands):
Laboratory equipment
8 unchanged sentences
In March 2021, the Company entered into a prepaid forward agreement with RTW.
−Removed: Under the terms of the RTW Transaction, the Company received $ 75.0 million ($ 72.4 million net of transaction costs) to support the launch of Jelmyto and the development of UGN- 102.
−Removed: In return for the transferred funds, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Jelmyto and, subject to FDA approval, UGN- 102, UGN- 103 and UGN- 104, in an amount equal to:
+Added: Under the terms of the RTW Transaction, the Company received $ 75.0 million ($ 72.4 million net of transaction costs) to support the launch of Jelmyto and the development of Zusduri .
+Added: In return for the transferred funds, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Jelmyto and, subject to FDA approval, UGN- 104, in an amount equal to:
(i) 9.5 % of annual net sales up to $200 million, (ii) 3.0 % of annual net sales for annual net sales between $200 million and $300 million, and (iii) 1.0 % of annual net sales for annual net sales above $300 million.
−Removed: Pursuant to the agreement, the initial cash payment rate of 9.5% on Jelmyto aggregate worldwide annual net sales of up to $ 200 million was increased to 13.0 % and remained at that rate during the year ended December 31, 2024 because certain revenue thresholds were not met.
−Removed: In addition, subject to FDA approval of UGN- 102 and UGN- 103, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of UGN- 102 and UGN- 103 in an amount equal to:
+Added: If certain revenue thresholds for Jelmyto aggregate worldwide annual net sales are not met, the future cash payments to RTW with respect to Jelmyto annual net sales up to $ 200 million will increase by 3.5 %, and may decrease back to 9.5 % dependent on the Company meeting certain subsequent Jelmyto aggregate worldwide annual net sales thresholds.
+Added: The rate in effect for the twelve months ended December 31, 2025 for annual net sales up to $ 200 million was 13.0 %.
+Added: RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Zusduri and, subject to FDA approval, UGN- 103, in an amount equal to:
(i) 2.5 % of annual net sales up to $200 million, (ii) 1.0 % of annual net sales for annual net sales between $200 million and $300 million, and (iii) 0.5 % of annual net sales for annual net sales above $300 million.
−Removed: If the Company does not receive FDA approval for UGN- 102 by June 30, 2025, the future cash payments to RTW with respect to aggregate worldwide annual net sales of Jelmyto across all Jelmyto annual net sales tiers will increase by 1.5 %.
In accordance with the prepaid forward agreement, the Company will be required to make payments of amounts owed to RTW each calendar quarter, through and until the quarter in which the aggregate cash payments received by RTW are equal to or greater than $300 million.
As of December 31, 2025, the cumulative amounts paid and payable by the Company were $ 47.4 million.
−Removed: As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW a first priority security interest in Jelmyto, UGN- 102, UGN- 103 and UGN- 104, including the regulatory approvals, intellectual property, material agreements, proceeds and accounts receivable related to these products.
+Added: As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW a first priority security interest in Jelmyto , Zusduri , UGN- 103 and UGN- 104, including the regulatory approvals, intellectual property, material agreements, proceeds and accounts receivable related to these products.
In May 2021, following the receipt of necessary regulatory approvals, the Company received the $ 75.0 million prepaid forward payment ($ 72.4 million net of transaction costs) from RTW and recognized an associated prepaid forward obligation liability.
1 unchanged sentence
Management reassesses the effective rate each period based on the current carrying value of the obligation and the revised estimated future payments.
−Removed: Changes in future payments from previous estimates are included in future financing expense.
−Removed: The Company does not expect to make any principal payments in the next 12 months.
+Added: Changes in future payments from previous estimates are included in future financing expenses.
+Added: The Company is not contractually obligated, nor does it anticipate making any repayments of the original $ 75.0 million received to RTW in the next 12 months.
The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2025 and 2024 (in thousands):
6 unchanged sentences
Carrying value of prepaid forward obligation as of December 31, 2025
−Removed: ( 1 ) $ 6.5 million and $ 3.0 million of the Amounts paid and payable are included as current portion of the prepaid forward obligation within other current liabilities on the consolidated balance sheets as of December 31, 2024 and December 31, 2023 , respectively.
+Added: ( 1 ) $ 3.4 million and $ 6.5 million of the Amounts paid and payable are included as the current portion of the prepaid forward obligation within other current liabilities on the consolidated balance sheets as of December 31, 2025 and December 31, 2024 , respectively.
UROGEN PHARMA LTD.
1 unchanged sentence
NOTE 10 – Long-Term Debt
−Removed: On March 7, 2022, the Company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $ 100 million in two tranches.
+Added: On March 7, 2022, the Company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $ 100 million in two tranches (the "2022 Loan Agreement").
The first tranche of $ 75 million was funded in March 2022.
1 unchanged sentence
On June 29, 2023, the loan agreement with Pharmakon was amended to replace the benchmark governing the interest rate with a rate based on the secured overnight financing rate ("SOFR") published by the Federal Reserve Bank of New York.
−Removed: Effective July 2023, the loan accrued interest using a benchmark rate of 3 -month SOFR plus 8.25 % plus an additional adjustment of 0.26161 %.
−Removed: On March 13, 2024, the Company entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan.
+Added: Effective July 2023, the loan accrued interest using a benchmark rate of three -month SOFR plus 8.25 % plus an additional adjustment of 0.26161 %.
+Added: On March 13, 2024, the Company entered into an amended and restated loan agreement, which replaced the 2022 Loan Agreement, with Pharmakon for an additional third and fourth tranche of senior secured loan (the “2024 Loan Agreement”).
The third tranche of $ 25.0 million was funded in September 2024.
−Removed: The fourth tranche of $ 75.0 million will become available at the Company's option no later than August 29, 2025, subject to (i) receiving FDA approval of a new drug application (“NDA”) for UGN- 102 no later than June 30, 2025 and (ii) the satisfaction of customary bring down conditions and deliverables.
−Removed: Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of 3 -month SOFR plus 7.25 % plus an additional adjustment of 0.26161 %.
−Removed: All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one -year extension possible upon FDA approval of an NDA for UGN- 102 by June 30, 2025.
−Removed: All outstanding loans with Pharmakon can be prepaid in whole at the Company's discretion, at any time, subject to prepayment premiums and make-whole amounts.
−Removed: The Company is not required to maintain any financial covenants.
−Removed: The Company incurred financing expenses of $ 4.2 million related to the first and second tranches funded in 2022, and $ 0.5 million related to the third tranche funded in 2024, which are recognized as a direct offset to the long-term debt on the Company's consolidated balance sheets.
+Added: The fourth tranche of $ 75.0 million became available at the Company's option no later than August 29, 2025, based upon having received FDA approval of a new drug application (“NDA”) for Zusduri by June 30, 2025.
+Added: The Company did not draw down the fourth tranche.
+Added: Under the 2024 Loan Agreement, prior to the refinancing described in the immediately following paragraph, all outstanding loans accrued interest using a benchmark rate of three -month SOFR plus 7.25 % plus an additional adjustment of 0.26161 %.
+Added: On February 26, 2026, the Company entered into a second amended and restated loan agreement, which replaced the 2024 Loan Agreement, with Pharmakon providing for a senior secured term loan facility of up to $ 250.0 million, consisting of two tranches (the “2026 Loan Agreement”).
+Added: The first tranche of $ 200.0 million refinanced the Company's term loan facility under the 2024 Loan Agreement which had $ 125.0 million of outstanding principal, with the remaining proceeds available for general corporate purposes and working capital.
+Added: The second tranche of $ 50.0 million may, at the Company's option, be requested no later than June 30, 2027 for a funding to occur no later than August 29, 2027, subject to customary conditions.
+Added: All outstanding loans with Pharmakon pursuant to the 2026 Loan Agreement accrue interest at a fixed rate of 8.25 %.
+Added: The principal amount of the loans outstanding under the 2026 Loan Agreement shall be repayable in four equal quarterly payments commencing in the first quarter of 2030.
+Added: The Company may prepay the full outstanding principal amount of the loans whole at the Company's discretion at any time, together with accrued but unpaid interest thereon and subject to prepayment premiums, make-whole amounts, as applicable, and fees.
+Added: The obligations of UroGen Pharma, Inc., as the borrower under the 2026 Loan Agreement, are guaranteed by UroGen Pharma Ltd., subject to customary limitations on parent guarantees under Israeli law, and are secured by substantially all of the tangible and intangible assets and property, including intellectual property, of UroGen Pharma, Inc.
+Added: and UroGen Pharma Ltd., subject to certain exceptions.
+Added: The Company incurred financing expenses of $ 4.2 million related to the first and second tranches under the 2022 Loan Agreement funded in 2022, and $ 0.5 million related to the third tranche funded in 2024 under the 2024 Loan Agreement, which are recognized as a direct offset to the long-term debt on the Company's consolidated balance sheets.
These debt issuance costs are amortized over the term of the debt using the effective interest method, and are recorded in the consolidated statements of operations as "Interest expense."
1 unchanged sentence
Carrying value of Pharmakon loan as of December 31, 2023
−Removed: Interest expense
−Removed: Carrying value of Pharmakon loan as of December 31, 2023
Third tranche of Pharmakon loan
2 unchanged sentences
Carrying value of Pharmakon loan as of December 31, 2024
+Added: Interest expense
+Added: Carrying value of Pharmakon loan as of December 31, 2025
+Added: The aggregate principal maturities of long-term debt as of December 31, 2025 are as follows, in thousands:
+Added: Principal Payments
N OTE 11 – L eases
Operating Leases
−Removed: The Company had the following office and laboratory facility leases during the period covered by this report:
+Added: The Company had the following office and laboratory facility leases during the periods covered by this report:
In April 2016, UPL signed an addendum to its November 2014 lease agreement for the Company’s offices located in Israel, in order to increase the office space rented and to extend the rent period for an additional three years until August 2022.
−Removed: In July 2022, the Company signed a lease extension agreement for the Company’s offices located in Israel, extending the term of the lease through September 2025.
+Added: In July 2022, the Company signed a lease extension agreement for the Company’s offices located in Israel, extending the term of the lease through September 2025, and, effective as of June 2025, was renewed through September 2028.
The Company's remaining contractual obligation under this lease is approximately $ 1.0 million as of December 31, 2025 .
8 unchanged sentences
In June 2022, the Company signed a lease extension for the Princeton office, extending the term of the lease through January 31, 2026.
+Added: In August 2025, the Company signed an additional lease extension for the Princeton office, extending the term of the lease through April 30, 2031.
+Added: The Company concluded that the lease renewal option in the agreement is not reasonably certain to be exercised.
+Added: The modification did not result in a separate lease under ASC 842.
+Added: As a result, the Company remeasured its lease liability and corresponding right-of-use asset using its incremental borrowing rate at the modification date.
The Company’s remaining contractual obligation under this lease is approximately $ 3.0 million as of December 31, 2025 .
5 unchanged sentences
The Company may also be required to pay additional rent if the vehicle exceeds certain mileage limits or shows abnormal wear and tear during the lease term.
−Removed: The Company’s remaining contractual obligation under this lease is approximately $ 3.0 million as of December 31, 2024 .
+Added: The Company’s remaining contractual obligation relating to the leases entered into under this master agreement is approximately $ 5.9 million as of December 31, 2025 .
In addition, the Company has other operating office equipment and vehicle leases.
1 unchanged sentence
The Company’s leases do not contain any residual value guarantees or material restrictive covenants.
−Removed: The Company’s active leases expire at various dates from 2025 through 2028, with varying renewal and termination options.
+Added: The Company’s leases expire at various dates from 2026 through 2031, with varying renewal and termination options.
The components of lease cost for the year ended December 31, 2025 and 2024 were as follows (in thousands):
6 unchanged sentences
Sublease income
−Removed: ( 42 ) ( 224 )
Variable lease cost
+Added: $ 2,929 $ 984
The amounts recognized as of December 31, 2025 and 2024 were as follows (in thousands):
13 unchanged sentences
Cash paid for amounts included in the measurement of lease liabilities:
+Added: Financing cash flows from finance leases
Operating cash flows from operating leases
−Removed: $ 933 $ 1,169
Right-of-use assets obtained in exchange for new finance lease liabilities
+Added: $ 4,445 $ 2,321
Right-of-use assets obtained in exchange for new operating lease liabilities
2 unchanged sentences
Weighted-average discount rate of finance leases
+Added: 13.97 % 13.82 %
Weighted-average discount rate of operating leases
9 unchanged sentences
Years ending December 31,
+Added: 2030 and there after
Total future minimum lease payments
5 unchanged sentences
$ 93,989 $ 90,398
−Removed: All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.
−Removed: The Company's largest customer comprises over 90 % of product sales throughout the full year 2024, and approximately 80 % of accounts receivables at December 31, 2024.
−Removed: Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug.
+Added: Total Revenue
+Added: $ 109,788 $ 90,398
+Added: All product sales of Jelmyto and Zusduri are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.
+Added: The Company's largest customer comprises approximately 76 % and over 90 % of product sales for the twelve months ended December 31, 2025 and 2024, respectively.
+Added: The Company's largest customer comprises approximately 59 % and 80 % of accounts receivables at December 31, 2025 and 2024, respectively.
+Added: Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers including rebates that may be offered from time to time, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug.
+Added: The Company does not anticipate any Medicare refunds for discarded drug for Zusduri .
The Company estimates these elements of variable consideration based on the contractual or statutory terms governing the arrangements and the Company’s historical experience, and constrains the net revenue recognized for product sales to the value that is not probable to be reversed when the uncertainty associated with the variable consideration is subsequently resolved.
10 unchanged sentences
( 13,822 ) — ( 10,785 ) ( 24,607 )
+Added: Changes to prior period estimates
+Added: ( 223 ) $ 358 — 135
Balance as of December 31, 2024
13 unchanged sentences
("Agenus"), 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 monoclonal antibody of Agenus known as AGEN1884 (zalifrelimab), an anti-CTLA- 4 antagonist, for the treatment of cancers of the urinary tract via intravesical delivery.
−Removed: UGN- 301 is a formulation of zalifrelimab administered using RTGel technology that is in Phase 1 clinical development for high-grade non-muscle invasive bladder cancer.
+Added: UGN- 301 is a formulation of zalifrelimab administered using RTGel technology that was in Phase 1 clinical development for high-grade NMIBC.
+Added: In November 2025, the Company provided notice to terminate the license agreement with Agenus in connection with its decision to discontinue development of UGN- 301.
+Added: Under the terms of the license agreement, following notice of termination, the agreement will terminate upon the later of (a) the expiration of a 180 -day notice period;
+Added: or (b) completion of all wind-down activities and delivery of all Agenus Improvements (as defined in the license agreement) to Agenus.
+Added: The Company does not expect to incur significant additional costs related to this program going forward.
N OTE 14 – E MPLOYEE R IGHTS U PON R ETIREMENT
8 unchanged sentences
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
+Added: N OTE 15 – ACQUISITIONS
+Added: On February 14, 2025 ( the “Closing Date”), the Company entered into an Asset Purchase Agreement (as amended, the “Agreement”) with IconOVir Bio, Inc.
+Added: (“IconOVir”), pursuant to which the Company purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including the product candidate ICVB- 1042 and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by the Company.
+Added: As consideration for the Transferred Assets and subject to the terms and conditions of the Agreement, on the Closing Date the Company (i) issued 374,843 ordinary shares of the Company (the “Company Shares”) to IconOVir, which represented a purchase price of $ 4.0 million divided by the volume-weighted average closing price of the Company Shares on The Nasdaq Stock Market over the 30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir a one -time payment of $ 15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB- 1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts ((i), (ii), (iii), and (iv) collectively, the “Purchase Price”).
+Added: Entities affiliated with Arie Belldegrun, M.D., the Chair of the Board of Directors of the Company, held certain promissory notes of IconOVir at the time, that may entitle such entities to receive, in the aggregate, approximately 28.3 % of the Purchase Price paid to IconOVir pursuant to the Agreement.
+Added: The Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.
+Added: If so, the transaction is accounted for as an asset acquisition.
+Added: The cost of an asset acquisition is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis.
+Added: Goodwill is not recognized in an asset acquisition.
+Added: Any contingent consideration in an asset acquisition is recognized only when amounts are both probable and estimable, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
+Added: Based on the Company's assessment of the value of the assets acquired as well as consideration of the inputs, processes and outputs, the Company concluded that this represented an asset acquisition.
+Added: When a transaction accounted for as an asset acquisition includes IPR&D, the IPR&D asset is only capitalized as an intangible asset if it is determined to have an alternative future use other than in a particular research and development project.
+Added: Otherwise, amounts allocated to the IPR&D are recognized as research and development expenses in the period.
+Added: The Company accounted for the acquisition of the Transferred Assets from IconOVir as an asset acquisition.
+Added: The Company determined the fair value of the consideration transferred was $ 3.1 million, which represented the fair value of the unregistered shares at issuance date.
+Added: Given the early-stage nature of such assets and level of further development necessary to produce an output, the Company recognized the cost of the acquisition as a research and development expense during the twelve months ended December 31, 2025.
N OTE 16 – S HAREHOLDERS ’ E QUITY
5 unchanged sentences
ATM Sales Agreement
−Removed: In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”)
−Removed: pursuant to which the Company may from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $ 100.0 million.
−Removed: During the first quarter of 2024, the Company sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $ 56.1 million.
−Removed: The net proceeds to the Company after deducting sales commissions to TD Cowen were approximately $ 54.7 million.
−Removed: The remaining capacity under the ATM Sales Agreement was approximately $ 27.3 million as of December 31, 2024.
−Removed: The shares will be offered and sold, if any, pursuant to the Company's shelf registration statement on Form S- 3 filed with the SEC on November 15, 2022, which was declared effective on November 29, 2022, or a subsequent shelf registration statement.
+Added: In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”), pursuant to which the Company may from time to time offer and sell its ordinary shares having an aggregate offering price of up to $ 100.0 million, to or through TD Cowen, acting as sales agent or principal, in any manner deemed to be an “at-the-market offering.”
+Added: During the first quarter of 2024, the Company sold 3,400,468 ordinary shares under the ATM Sales Agreement for net proceeds to the Company of approximately $ 54.7 million after deducting sales commissions to TD Cowen of up to 3 %.
+Added: During the third quarter of 2025, the Company sold 416,248 ordinary shares under the ATM Sales Agreement for net proceeds to the Company of approximately $ 8.0 million after deducting sales commissions to TD Cowen of up to 3 %.
+Added: In November 2025, the Company amended the ATM Sales Agreement to remove the aggregate offering price limit of $ 100.0 million and filed a registration statement on Form S- 3 providing for the offer and sale of ordinary shares pursuant to the ATM Sales Agreement having an aggregate offering price of up to $ 75.0 million, which became effective automatically (the “ATM Prospectus”).
+Added: Following the amendment, during the fourth quarter of 2025, the Company sold 1,370,962 ordinary shares pursuant to the ATM Prospectus for net proceeds of approximately $ 31.8 million after deducting sales commissions to TD Cowen of up to 3 %.
+Added: As of December 31, 2025, the remaining capacity under the ATM Prospectus was approximately $ 42.4 million.
Securities Purchase Agreement
1 unchanged sentence
Each pre-funded warrant has an exercise price of $ 0.001 per ordinary share, subject to customary adjustments, became exercisable upon original issuance and will not expire until exercised in full.
−Removed: The pre-funded warrants may not be exercised to the extent that the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation.
+Added: The pre-funded warrants may not be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation.
The aggregate fee paid by the Company to placement agents and financial advisors was $ 3.6 million, plus the reimbursement of certain expenses.
1 unchanged sentence
333 - 274423 ) filed with the SEC on September 8, 2023, which was declared effective on September 15, 2023.
−Removed: On December 20, 2023, the Company issued 1,599,733 ordinary shares through a cashless conversion of 1,599,840 pre-funded warrants for the purchase of ordinary shares of the Company.
−Removed: On January 24, 2025, the Company issued 3,206,271 ordinary shares through a conversion of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company.
+Added: On December 20, 2023, the Company issued 1,599,733 ordinary shares through a cashless exercise of 1,599,840 pre-funded warrants for the purchase of ordinary shares of the Company.
+Added: On January 24, 2025, the Company issued 3,206,271 ordinary shares upon exercise of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company.
+Added: As of December 31, 2025, 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.
Monograph Capital Partners I, L.P.
−Removed: (“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., a director of the Company at the time, purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $ 15.0 million.
−Removed: Cohen was the Chair and Chief Investment Officer of Monograph at the time of purchase.
+Added: (“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $ 15.0 million.
+Added: Cohen was a director of the Company and the Chair and Chief Investment Officer of Monograph at the time of purchase.
Underwritten Public Offering
−Removed: On June 17, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $ 17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $ 17.499 per pre-funded warrant.
+Added: On June 17, 2024, the Company entered into an underwriting agreement with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $ 17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $ 17.499 per pre-funded warrant.
The offering closed on June 20, 2024.
−Removed: The gross proceeds to the Company from the closing of the offering were $ 107.5 million, before deducting underwriting discounts and commissions and offering expenses of $ 7.3 million.
+Added: The gross proceeds to the Company from this closing of the offering were $ 107.5 million, before deducting underwriting discounts and commissions and offering expenses paid by the Company of $ 7.3 million.
Each pre-funded warrant has an exercise price of $ 0.001 per ordinary share, subject to customary adjustments, is exercisable at any time and will not expire until exercised in full.
The pre-funded warrants may not be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation.
+Added: As of December 31, 2025, all 1,142,857 pre-funded warrants remain outstanding.
In addition, the Underwriters were granted an option exercisable for 30 days, to purchase up to 921,428 additional shares at the public offering price, less the underwriting discounts and commissions.
8 unchanged sentences
As a result, and pursuant to the terms of Section 102, the Company is not allowed to claim as an expense for tax purposes the amounts credited to the employees in respect of options granted to them under the Plans, including amounts recorded as salary benefits in the Company’s accounts, with the exception of the work-income benefit component, if any, determined on grant date.
−Removed: For non-employees and for non-Israeli employees, the Plans is subject to Section 3 (i) of the Israeli Income Tax Ordinance.
+Added: For non-employees and for non-Israeli employees, the Plans are subject to Section 3 (i) of the Israeli Income Tax Ordinance.
Employees are typically granted stock options and/or RSUs, upon commencement of employment.
8 unchanged sentences
The Company also grants PSUs to certain employees.
−Removed: The PSU’s currently outstanding vest based on either the earlier of obtaining regulatory approval for the Company’s lead product candidate UGN- 102 or the occurrence of a change in control, or for certain other awards, the achievement of the first commercial sale of UGN- 102 in the United States following UGN- 102's receipt of regulatory approval.
−Removed: In June 2024, the Company amended certain RSU and PSU awards granted to the chief executive officer to defer vesting until the end of 2025.
−Removed: The Company accounted for the modification as a Type I probable-to-probable modification under ASC 718.
−Removed: As the modification did not result in any incremental fair value at the modification date, the Company continues to recognize the original grant-date fair value ratably over the original service period or expected performance period.
+Added: The PSUs granted during 2023 vested upon U.S.
+Added: regulatory approval of Zusduri .
+Added: The PSUs granted in 2024 vested upon the achievement of the first commercial sale of Zusduri in the United States following receipt of U.S.
+Added: regulatory approval.
+Added: The PSUs granted in 2025 vest based on both performance and service conditions, with one - third of each award vesting upon the filing of financial statements reflecting the achievement of a cumulative net product sales target and with one - third vesting on January 31 st of each of the next two calendar years following such achievement, subject to continued service on each vesting date.
+Added: In June 2024, the Company amended certain RSU and PSU awards granted to its chief executive officer to defer vesting until the end of 2025.
+Added: In December 2025, the Company further amended certain RSU and PSU awards granted to its chief executive offer to defer vesting until the end of 2026.
+Added: The Company accounted for the modifications as Type I probable-to-probable modifications under ASC 718.
+Added: As the modifications did not result in any incremental fair value at the modification dates, the Company continues to recognize the original grant-date fair value ratably over the original service period or expected performance period.
The maximum number of ordinary shares that was initially authorized for issuance under the 2017 Plan was 1,400,000 .
−Removed: On January 1, 2018, the share reserve increased by 250,167 shares to 1,650,167 shares.
−Removed: On October 12, 2018, the Company increased the number of ordinary shares authorized for issuance under the 2017 Plan by 1,900,000 shares to 3,550,167 shares.
+Added: On January 1, 2018, the share reserve increased by 250,167 shares to a total share reserve of 1,650,167 shares.
+Added: On October 12, 2018, the Company increased the number of ordinary shares authorized for issuance under the 2017 Plan by 1,900,000 shares to a total share reserve of 3,550,167 shares.
On June 8, 2020, the Company’s shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 400,000 shares to a total share reserve of 3,950,167 shares.
2 unchanged sentences
On September 7, 2023, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 450,000 shares to a total share reserve of 5,200,167 shares.
−Removed: On August 6, 2024, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 800,000 shares to a total of 6,000,167 shares.
+Added: On August 6, 2024, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 800,000 shares to a total share reserve of 6,000,167 shares.
+Added: On August 26, 2025, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 2,750,000 shares to a total share reserve of 8,750,167 shares.
In May 2019, the Company adopted the UroGen Pharma Ltd.
3 unchanged sentences
In December 2021, the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 300,000 shares.
−Removed: In June 2024, the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 600,000 shares to a total of 1,800,000 shares.
+Added: In June 2024, the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 600,000 shares to a total share reserve of 1,800,000 shares.
As of December 31, 2025, 4,348,248 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 3,425,913 ordinary shares remain available for future awards.
11 unchanged sentences
$ 11.52 - 19.50
+Added: $ 13.11 - 15.16
Dividend yield
9 unchanged sentences
The following table summarizes the number of employee and non-employee options outstanding under the Plans for the years ended December 31, 2025 and 2024 , and related information:
−Removed: average exercise price
−Removed: average remaining
−Removed: contractual life
+Added: Number of options
+Added: Weighted average exercise price per share
+Added: Weighted average remaining contractual life
+Added: Aggregate intrinsic value (in thousands)
Outstanding as of December 31, 2024
14 unchanged sentences
Outstanding Restricted Stock Units
+Added: Weighted Average Grant Date Fair Value
Outstanding as of December 31, 2024
+Added: 1,507,828 $ 13.84
+Added: 1,123,946 11.68
Vested and released
+Added: ( 557,380 ) 12.84
+Added: ( 147,000 ) 12.76
Outstanding as of December 31, 2025
+Added: 1,927,394 $ 12.95
The fair value of RSUs granted during 2025 and 2024 was $ 13.1 million and $ 14.5 million, respectively.
The total unrecognized compensation cost of RSUs as of December 31, 2025 is $ 14.0 million with a weighted average recognition period of 1.83 years.
−Removed: The following table illustrates the effect of share-based compensation on the Statements of Operations:
+Added: The following table illustrates the effect of share-based compensation on the Statements of Operations (in thousands):
Year ended December 31,
10 unchanged sentences
The applicable Israeli tax rate relevant to the Company for 2024 and thereafter is 23 %.
−Removed: For financial reporting purposes, the expense for current income taxes consists of the following (in thousands):
+Added: For financial reporting purposes, the (benefit) expense for current income taxes consists of the following (in thousands):
Current taxes:
1 unchanged sentence
Total current taxes
−Removed: $ 2,832 $ 3,920
+Added: Cash taxes paid
+Added: Total cash taxes paid during 2025 and 2024 totaled approximately $ 3.0 million and $ 1.8 million, respectively, which related entirely to foreign jurisdictions (U.S.
+Added: Federal and U.S.
+Added: No individual U.S.
+Added: states comprised more than 5% of total cash taxes paid in 2025.
+Added: In 2024, cash taxes paid to the state of New Hampshire comprised approximately 6.3 % of total cash taxes paid.
Deferred income taxes
34 unchanged sentences
A reconciliation of the Company’s statutory tax rate to effective tax is as follows (in thousands, except statutory rate):
+Added: December 31, 2025
+Added: December 31, 2024
+Added: USD thousands
+Added: Percentage of Pretax Loss
+Added: USD thousands
+Added: Percentage of Pretax Loss
+Added: Loss before income taxes
$ ( 153,416 ) $ ( 124,042 )
3 unchanged sentences
Additional tax (tax saving) in respect of:
−Removed: Non-deductible expenses
−Removed: R&D and orphan drug credits
+Added: Foreign tax effects
+Added: United States
+Added: Differing tax rate of foreign subsidiaries
605 - 0.39 % 219 - 0.18 %
−Removed: Different tax rate of foreign subsidiaries
+Added: Current and deferred US state taxes
175 - 0.11 % ( 887 ) 0.72 %
−Removed: Uncertain tax positions
−Removed: Change in valuation allowance (1)
+Added: Tax credits in foreign jurisdictions
( 789 ) 0.51 % ( 510 ) 0.41 %
−Removed: Income tax expense
+Added: Changes in valuation allowances in foreign jurisdictions
6,792 - 4.43 % 4,893 - 3.94 %
−Removed: ( 1 ) In the course of preparing the 2022 tax returns, adjustments were made for certain nondeductible amounts, reducing net operating loss carryforward and reflected as a change in valuation allowance of approximately $ 8.9 million in 2023.
+Added: Nontaxable or nondeductible items in foreign jurisdictions
+Added: 1,002 - 0.65 % 1,040 - 0.84 %
+Added: Changes in unrecognized tax benefits in foreign jurisdictions
+Added: 112 - 0.07 % 598 - 0.48 %
+Added: Changes in valuation allowances
+Added: 23,102 - 15.06 % 20,095 - 16.20 %
+Added: Nondeductible financing cost on prepaid forward obligation
+Added: 4,256 - 2.77 % 5,385 - 4.34 %
+Added: Other nontaxable or nondeductible items
+Added: 20 - 0.01 % 502 - 0.40 %
+Added: 89 - 0.06 % 27 - 0.02 %
+Added: Income tax expense
UROGEN PHARMA LTD.
1 unchanged sentence
Pretax loss for December 31, 2025 and 2024 includes pretax loss from foreign (United States) jurisdictions of $ 35.0 million and $ 11.0 million, respectively.
+Added: Losses for tax purposes carried forward to future years
+Added: As of December 31, 2025 and 2024 , the Company had approximately $ 626.7 million and $ 533.9 million of carryforward tax losses, prior to tax effecting, respectively, available to reduce future taxable income without limitation of use in relation to its parent tax jurisdiction, Israel.
+Added: These carryforward tax losses in Israel can be carried forward indefinitely.
+Added: As of December 31, 2025, the Company had approximately $ 51.4 million of carryforward tax losses, prior to tax effecting, of United States federal and state carryforward tax losses, which can be carried forward indefinitely.
The Internal Revenue Code of 1986, as amended (the “Code”), contains provisions that may limit our use of federal net operating loss carryforwards if significant changes occur in the constructive stock ownership of UroGen Pharma, Inc.
In the event it has had an “ownership change” within the meaning of Section 382 of the Code, utilization of its net operating loss carryforwards could be restricted under Section 382 of the Code and similar state provisions.
−Removed: Such limitations could result in the expiration of the net operating carryforwards incurred before 2018 before their utilization.
−Removed: Losses for tax purposes carried forward to future years
−Removed: As of December 31, 2024 and 2023 , the Company had approximately $ 533.9 million and $ 452.0 million of carryforward tax losses, prior to tax effecting, respectively, available to reduce future taxable income without limitation of use.
−Removed: The Company's carryforward tax losses relate to losses generated in Israel and can be carried forward indefinitely.
Uncertain tax positions
2 unchanged sentences
$ 1,974 $ 1,974
−Removed: Gross increases — tax positions in current period
Gross increases — tax positions in prior period 550 —
+Added: Gross decreases— tax positions in prior period
Unrecognized tax benefits at the end of the year
3 unchanged sentences
The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense.
−Removed: If recognized, balances of uncertain tax positions as of December 31, 2024 would result in incremental net operating loss carryforwards, which would be expected to require a full valuation allowance based on present circumstances, therefore, the uncertain tax positions will not impact the effective tax rate.
+Added: If recognized, balances of uncertain tax positions as of December 31, 2025 would affect the Company's effective tax rate.
The Company operates on a global basis and is subject to tax laws and regulations in the United States and Israel.
3 unchanged sentences
The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may result from its uncertain tax positions.
−Removed: Approximately $ 1.4 million of the liability for uncertain tax positions relate to tax years for which the statute of limitations will expire within the next 12 months.
−Removed: Based upon the information currently available, the Company does not reasonably expect any other changes in its existing uncertain tax positions in the next 12 months.
+Added: The current balance of the uncertain tax position relates to tax years for which the statute of limitations will expire within the next 12 months.
The Company has received final tax assessments up to and including its 2017 tax year in Israel and 2020 in the US.
N OTE 19 – R ELATED P ARTIES
−Removed: There were no related party transactions for the year ended December 31, 2024.
−Removed: See Note 15 for discussion regarding an affiliated investor in the private placement transaction for the year ended December 31, 2023 .
−Removed: See Note 21 for discussion related to a subsequent event in February 2025 which involved a related party.
+Added: See Note 15 for discussion related to an asset purchase in February 2025, which involved a related party.
+Added: There were no further related party transactions during the twelve months ended December 31, 2025 or 2024.
N OTE 20 – C OMMITMENTS AND C ONTINGENCIES
3 unchanged sentences
The Company does not anticipate recognizing any significant losses relating to these arrangements.
−Removed: On February 25, 2024, the Company received from Teva, a Paragraph IV Certification Notice Letter dated February 20, 2024, providing notification that Teva submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .
−Removed: In the Notice Letter, Teva alleges that two of the patents listed in the FDA Orange Book for Jelmyto , U.S.
−Removed: Patent Numbers 9,040,074 and 9,950,069, each of which expires in January 2031, are invalid, unenforceable, or will not be infringed by Teva’s manufacture, use, or sale of the generic product described in its ANDA submission.
On April 2, 2024, the Company filed a lawsuit in the U.S.
2 unchanged sentences
market entry of Teva’s generic product prior to the expiry of such patents.
−Removed: The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd.
−Removed: without prejudice and the action continues against the other two Teva entities.
+Added: By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd.
+Added: was dismissed from the action.
+Added: On May 19, 2025, the Company filed an Amended Complaint, adding U.S.
+Added: Patent 12,268,745 to the litigation (the “745 Patent”).
+Added: Patent and Trademark Office issued the ‘745 Patent on April 8, 2025, and the Company subsequently added this patent to the Orange Book for JELMYTO.
+Added: By orders dated February 27, 2025, and June 26, 2025, the court approved the parties’ joint stipulations to remove the Markman hearing and any related claim-construction proceedings from the court’s calendar.
+Added: This matter is scheduled for a bench trial in October 2026.
+Added: Following certain stipulations, the case is now styled as UroGen Pharma Ltd.
+Added: Teva Pharmaceuticals, Inc.
+Added: By order dated January 12, 2026, the court approved the parties’ joint stipulation to dismiss counts I, II, III, and IV of the Company’s Amended Complaint alleging infringement by Teva of U.S.
+Added: Patent Numbers 9,040,074 and 9,950,069, with prejudice, and to dismiss counts I and II of Teva’s counterclaims seeking declaratory judgment that U.S.
+Added: Patent Numbers 9,040,074 and 9,950,069 are invalid, as moot.
+Added: No ANDA may be finally approved by the FDA until the expiration of Orphan Drug Exclusivity covering JELMYTO in April 2027.
If the Company is unsuccessful in securing the requested court relief, JELMYTO may be subject to immediate competition from an FDA approved generic product after regulatory exclusivity for JELMYTO expires in April 2027.
6 unchanged sentences
The Company recognized $ 1.1 million within selling, general and administrative expenses during the year ended December 31, 2024 in relation to this arrangement.
+Added: There were no expenses recognized in relation to this arrangement during the year ended December 31, 2025.
On October 7, 2024, the Company entered into a separation and consulting agreement with Don Kim, pursuant to which Mr.
2 unchanged sentences
The Company recognized $ 0.8 million within selling, general and administrative expenses during the year ended December 31, 2024 in relation to this arrangement.
+Added: There were no expenses recognized in relation to this arrangement during the year ended December 31, 2025.
See Note 11 for further discussion regarding lease commitments.
2 unchanged sentences
The Company has a single operating segment and reportable segment focused on these business activities, and its operations are managed on a consolidated basis.
−Removed: The primary revenue source for the segment comes from sales of the Company’s approved product, Jelmyto, primarily conducted in the United States.
+Added: The primary revenue source for the segment comes from sales of the Company’s approved products, Jelmyto and Zusduri , primarily conducted in the United States.
The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer (“CEO”).
21 unchanged sentences
Travel, meetings & conferences
+Added: 16,383 12,962
Rent, office, utilities & technology
4 unchanged sentences
N OTE 22 – Subsequent events
−Removed: On January 24, 2025, the Company issued 3,206,271 ordinary shares through a conversion of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company.
−Removed: See Note 15 for further discussion related to shareholders' equity.
−Removed: On February 14, 2025 ( the “Closing Date”), the Company entered into an Asset Purchase Agreement (the “Agreement”) with IconOVir Bio, Inc.
−Removed: (“IconOVir”), pursuant to which the Company purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including the product candidate ICVB- 1042 and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by the Company.
−Removed: As consideration for the Transferred Assets and subject to the terms and conditions of the Agreement, on the Closing Date the Company (i) issued 374,843 ordinary shares of the Company (the “Company Shares”) to IconOVir, which represents a purchase price of $ 4.0 million divided by the volume-weighted average closing price of the Company Shares on The Nasdaq Stock Market over the 30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir a one -time payment of $ 15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB- 1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts ((i), (ii), (iii), and (iv) collectively, the “Purchase Price”).
−Removed: The Company also granted IconOVir certain piggyback registration rights with respect to the Company Shares issued to IconOVir, subject to customary exceptions and cutback rights.
−Removed: Entities affiliated with Arie Belldegrun, M.D., the Chair of the Board of Directors of the Company, hold certain promissory notes of IconOVir that may entitle such entities to receive, in the aggregate, approximately 28.3 % of the Purchase Price paid to IconOVir pursuant to the Agreement.
−Removed: UROGEN PHARMA LTD.
−Removed: NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: NOTE 22 - SELECTED UNAUDITED QUARTERLY FINANCIAL DATA
−Removed: Certain unaudited selected quarterly financial results for the quarters within 2024 and 2023 are presented as follows:
−Removed: For the Three Months Ended March 31
−Removed: For the Three Months Ended June 30
−Removed: For the Six Months Ended June 30
−Removed: For the Three Months Ended September 30
−Removed: For the Nine Months Ended September 30
−Removed: For the Three Months December 31
−Removed: For the Year Ended December 31
−Removed: $ 18,781 $ 21,848 $ 40,629 $ 25,204 $ 65,833 $ 24,565 $ 90,398
−Removed: $ 17,053 $ 19,619 $ 36,672 $ 22,751 $ 59,423 $ 22,094 $ 81,517
−Removed: $ ( 32,286 ) $ ( 33,403 ) $ ( 65,689 ) $ ( 23,673 ) $ ( 89,362 ) $ ( 37,512 ) $ ( 126,874 )
−Removed: Weighted-average number of ordinary shares (1)
−Removed: 37,059,186 40,501,315 38,785,924 46,779,637 41,476,892 47,030,820 42,876,737
−Removed: Basic and diluted loss per ordinary share (1)
−Removed: $ ( 0.87 ) $ ( 0.82 ) $ ( 1.69 ) $ ( 0.51 ) $ ( 2.15 ) $ ( 0.80 ) $ ( 2.96 )
−Removed: ( 1 ) The loss per share, both basic and diluted, for the first, second, and third quarters of 2024 was revised to record an immaterial correction to the amounts originally reported in the March 31, 2024 Form 10 -Q filed on May 13, 2024, June 30, 2024 Form 10 -Q filed on August 13, 2024, and September 30, 2024 Form 10 -Q filed on November 6, 2024, by incorporating the 3,679,400 shares of pre-funded warrants outstanding as of each respective reporting period, which were not included in the previous calculations and are now reflected in the weighted average shares outstanding.
−Removed: For the Three Months Ended March 31
−Removed: For the Three Months Ended June 30
−Removed: For the Six Months Ended June 30
−Removed: For the Three Months Ended September 30
−Removed: For the Nine Months Ended September 30
−Removed: For the Three Months December 31
−Removed: For the Year Ended December 31
−Removed: $ 17,192 $ 21,139 $ 38,331 $ 20,852 $ 59,183 $ 23,530 $ 82,713
−Removed: $ 14,927 $ 18,696 $ 33,623 $ 18,485 $ 52,108 $ 21,244 $ 73,352
−Removed: $ ( 30,213 ) $ ( 24,136 ) $ ( 54,349 ) $ ( 21,879 ) $ ( 76,228 ) $ ( 26,016 ) $ ( 102,244 )
−Removed: Weighted-average number of ordinary shares
−Removed: 23,279,951 23,462,016 23,371,878 32,298,182 26,358,719 36,153,634 28,834,303
−Removed: Basic and diluted loss per ordinary share
−Removed: $ ( 1.30 ) $ ( 1.03 ) $ ( 2.33 ) $ ( 0.68 ) $ ( 2.89 ) $ ( 0.72 ) $ ( 3.55 )
+Added: On February 26, 2026, the Company entered into the 2026 Loan Agreement.
+Added: The first tranche of $ 200.0 million refinanced the Company's existing loan facility with Pharmakon which had $ 125.0 million of outstanding principal, with the remaining proceeds available for general corporate purposes and working capital.
+Added: The second tranche of $ 50.0 million may be drawn at the Company's option no later than June 30, 2027, subject to customary conditions.
+Added: All outstanding loans with Pharmakon pursuant to the 2026 Loan Agreement accrue interest at a fixed rate of 8.25 %.
+Added: The principal amount of the loans outstanding under the 2026 Loan Agreement shall be repayable in four equal quarterly payments commencing in the first quarter of 2030.
+Added: The Company may prepay the full outstanding principal amount of the loans in whole at the Company's discretion at any time, together with accrued but unpaid interest thereon and subject to prepayment premiums, make-whole amounts, as applicable, and fees.
UROGEN PHARMA LTD.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.