What changed in this filing

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Item 1. Financial Statements

2026-05-06 compared with 2025-11-06 · 272 added, 459 removed, 943 unchanged (44% of the section changed)

3 unchanged sentences

in thousands, except share amounts and par value)

September 30,

Current assets:

2 unchanged sentences

Marketable securities

36,994 64,698

Restricted cash

1 unchanged sentence

55,412 33,082

20,921 16,464

Prepaid expenses and other current assets

19,530 14,672

Total current assets

4 unchanged sentences

Right of use assets

Marketable securities

Other non-current assets

5 unchanged sentences

Employee related accrued expenses

11,114 10,570

Other current liabilities

12 unchanged sentences

Shareholders' Deficit:

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at September 30, 2025 and December 31, 2024;

46,781,211 and 42,231,746 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at March 31, 2026 and December 31, 2025;

48,708,280 and 48,350,272 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital

11 unchanged sentences

in thousands, except share and per share amounts)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

$ 27,482 $ 25,204 $ 71,951 $ 65,833

For the Three Months Ended March 31,

Cost of revenue

3,278 2,453 9,158 6,410

24,204 22,751 62,793 59,423

Operating expenses:

Research and development expenses

14,008 11,355 52,793 42,251

Selling, general and administrative expenses

37,582 28,941 115,748 86,296

Operating loss

( 27,386 ) ( 17,545 ) ( 105,748 ) ( 69,124 )

Financing on prepaid forward obligation

( 4,621 ) ( 5,915 ) ( 13,848 ) ( 17,348 )

Interest expense on long-term debt

( 3,373 ) ( 2,721 ) ( 11,573 ) ( 8,629 )

Interest and other income, net

979 2,599 4,392 5,922

Loss before income taxes

( 34,401 ) ( 23,582 ) ( 126,777 ) ( 89,179 )

Income tax benefit (expense)

1,054 ( 91 ) ( 353 ) ( 183 )

$ ( 33,347 ) $ ( 23,673 ) $ ( 127,130 ) $ ( 89,362 )

Statements of Comprehensive Loss

$ ( 33,347 ) $ ( 23,673 ) $ ( 127,130 ) $ ( 89,362 )

Other comprehensive loss

Unrealized income (loss) on investments

17 267 ( 33 ) 224

Unrealized loss on investments

Comprehensive Loss

$ ( 33,330 ) $ ( 23,406 ) $ ( 127,163 ) $ ( 89,138 )

Net loss per ordinary share - basic and diluted

$ ( 0.69 ) $ ( 0.51 ) $ ( 2.66 ) $ ( 2.15 )

Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share

48,057,386 46,779,637 47,742,305 41,476,892

The accompanying notes are an integral part of these condensed consolidated financial statements.

5 unchanged sentences

Accumulated other comprehensive

income (loss)

Balance as of July 1, 2025

46,199,134 $ 126 $ 806,497 $ ( 900,005 ) $ 6 $ ( 93,376 )

Changes During the Three Months Ended September 30, 2025

Exercise of options into ordinary shares

165,829 1 301 302

Share-based compensation

Issuance of ordinary shares, net of issuance costs

416,248 1 7,968 7,969

Other comprehensive income

( 33,347 ) ( 33,347 )

Balance as of September 30, 2025

46,781,211 $ 128 $ 817,793 $ ( 933,352 ) $ 23 $ ( 115,408 )

Balance as of July 1, 2024

41,169,954 $ 112 $ 775,270 $ ( 745,037 ) ( 31 ) $ 30,314

Changes During the Three Months Ended September 30, 2024

Exercise of options into ordinary shares

99,433 — 115 115

Share-based compensation

Issuance of ordinary shares, net of issuance costs

921,428 3 15,000 15,003

Other comprehensive income

( 23,673 ) ( 23,673 )

Balance as of September 30, 2024

42,190,815 $ 115 $ 793,874 $ ( 768,710 ) $ 236 $ 25,515

The accompanying notes are an integral part of these condensed consolidated financial statements.

UroGen Pharma Ltd.

Condensed Consolidated Statements of Shareholders ’ Deficit

in thousands, except share amounts)

Ordinary Shares

Additional paid-in

Accumulated other comprehensive

income (loss)

Balance as of January 1, 2026

42,231,746 $ 115 $ 797,248 $ ( 806,222 ) $ 56 $ ( 8,803 )

Changes During the Nine Months Ended September 30, 2025

Changes During the Three Months Ended March 31, 2026

Exercise of options into ordinary shares

552,103 2 627 629

Share-based compensation

Conversion of pre-funded warrants into ordinary shares

3,206,271 9 ( 6 ) 3

Issuance of ordinary shares, net of issuance costs

791,091 2 11,095 11,097

Other comprehensive loss

( 33 ) ( 33 )

( 127,130 ) ( 127,130 )

Balance as of September 30, 2025

46,781,211 $ 128 $ 817,793 $ ( 933,352 ) $ 23 $ ( 115,408 )

Balance as of March 31, 2026

Balance as of January 1, 2025

32,490,119 $ 89 $ 614,035 $ ( 679,348 ) 12 $ ( 65,212 )

Changes During the Nine Months Ended September 30, 2024

Changes During the Three Months Ended March 31, 2025

Exercise of options into ordinary shares

378,800 1 249 250

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

18,641 18,641

Conversion of pre-funded warrants into ordinary shares

Issuance of ordinary shares, net of issuance costs

9,321,896 25 151,144 151,169

Other comprehensive income

( 89,362 ) ( 89,362 )

Balance as of September 30, 2024

42,190,815 $ 115 $ 793,874 $ ( 768,710 ) $ 236 $ 25,515

Other comprehensive loss

Balance as of March 31, 2025

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

in thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash Flows From Operating Activities

3 unchanged sentences

Accrued financing on prepaid forward obligation

Accretion on marketable securities

1,059 ( 1,889 )

Amortization (Accretion) on marketable securities

Share-based compensation

Amortization (accretion) of discount on long-term debt

377 ( 1,330 )

Amortization of discount on long-term debt

Amortization of right of use assets

9 unchanged sentences

Accounts payable and accrued expenses

( 1,258 ) 3,147

Employee related accrued expenses

3 unchanged sentences

( 53 ) ( 738 )

Restricted deposit

Net cash used in operating activities

4 unchanged sentences

Maturities of marketable securities

110,974 37,740

Purchases of property and equipment

( 54 ) ( 44 )

Net cash provided by investing activities

Net cash used in investing activities

( 20,688 ) ( 25,963 )

Cash Flows From Financing Activities

Principal payments on finance leases

Proceeds from exercise of options into ordinary shares

Proceeds from issuance of long-term debt

Proceeds from pre-funded warrant issuance, net of issuance costs

Proceeds from issuance of long-term debt, net

Proceeds from ordinary shares issuances, net of issuance costs

7,970 151,169

Net cash provided by financing activities

8,602 194,548

Increase (Decrease) in Cash and Cash Equivalents

Decrease in Cash and Cash Equivalents

( 800 ) ( 67,953 )

4 unchanged sentences

Supplemental Disclosures of Non-Cash Activities

Right of use assets obtained in exchange for new operating lease liabilities

Right-of-use assets obtained in exchange for new operating and finance lease liabilities

Acquisitions of IPR&D

8 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.

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 and securing regulatory approval of Zusduri (mitomycin) for intravesical solution, formerly known as UGN- 102, and raising capital to support and expand these activities.

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, developing and 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.

13 unchanged sentences

Securities and Exchange Commission (“SEC”) on March 2, 2026.

The Company has experienced net losses since its inception and had an accumulated deficit o f $ 933.4 million and $ 806.2 million as of September 30, 2025 and December 31, 2024, respectively.

The Company expects to incur losses and have negative net cash flows from operating activities as it executes its strategy, including the commercial launch of Zusduri , the continued commercialization of Jelmyto , and engaging in further research and development activities.

The Company has experienced net losses since its inception and had an accumulated deficit o f $ 983.3 million and $ 959.7 million as of March 31, 2026 and December 31, 2025, respectively.

The Company expects to incur losses and have negative net cash flows from operating activities as it executes its strategy, including the ongoing commercialization of Zusduri and Jelmyto , and engaging in further research and development activities.

The success of the Company depends on its ability to successfully commercialize its technologies to support its operations and strategic plan.

2 unchanged sentences

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.

Based on the Company's cash and cash equivalents and marketable securities as of September 30, 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.

Based on the Company's cash and cash equivalents and marketable securities as of March 31, 2026 , 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.

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.

10 unchanged sentences

Functional Currency

dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted.

dollar (“Dollar” or "dollar") is the currency of the primary economic environment in which the operations of the Company are conducted.

Therefore, the functional currency of the Company is the Dollar.

6 unchanged sentences

Cash and cash equivalents generally consist of money market funds and bank money market accounts and are stated at cost, which approximates fair value.

Cash and cash equivalents and marketable securities totaled $ 127.4 million as of September 30, 2025 .

Cash and cash equivalents and marketable securities totaled $ 140.3 million as of March 31, 2026 .

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”.

13 unchanged sentences

The primary objectives for the Company’s investment portfolio are the preservation of capital and the maintenance of liquidity.

The Company does not enter into any investment transaction for trading or speculative purposes.

The Company does not enter into any investment transactions for trading or speculative purposes.

The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S.

59 unchanged sentences

ROU assets for operating leases 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.

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 when control is transferred either upon shipment or upon delivery of the product to the treating physician.

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.

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, which are estimated based on the contractual or statutory terms governing the arrangements and the Company’s historical experience.

Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, such as rebates, 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

25 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.

Such potentially dilutive securities consist solely of outstanding restricted share units and stock options issued under the Company’s share-based compensation plans.

See Note 16 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.”

Recently Adopted or Issued Accounting Pronouncements

In December 2023, the FASB issued Accounting Standards Update No.

2023 - 09, Income Taxes (Topic 740 ):

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.

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.

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.

ASU 2023 - 09 allows for adoption using either a prospective or retrospective transition method.

In November 2024, the FASB issued Accounting Standards Update No.

4 unchanged sentences

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 .

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.

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 guidance, which is effective for fiscal years beginning after December 15, 2025, including interim periods within those fiscal years, was adopted by the Company on January 1, 2026 on a prospective basis.

The adoption of ASU 2025 - 05 did not have a material impact on the Company's 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 condensed consolidated financial statements and related disclosures.

1 unchanged sentence

Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following as of September 30, 2025 and December 31, 2024 (in thousands):

September 30,

Accounts payable and accrued expenses consisted of the following as of March 31, 2026 and December 31, 2025 (in thousands):

Accounts payable

$ 10,279 $ 10,931

Accrued sales reserves

4 unchanged sentences

Total accounts payable and accrued expenses

$ 26,173 $ 27,431

Interest and Other Income, Net

Interest and other income, net consisted of the following for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Interest and other income, net consisted of the following for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Interest income

$ 1,176 $ 2,757 $ 5,057 $ 6,089

Other loss, net

( 197 ) ( 158 ) ( 665 ) ( 167 )

Total interest and other income, net

$ 979 $ 2,599 $ 4,392 $ 5,922

Note 5 – Inventories

Inventories consisted of the following as of September 30, 2025 and December 31, 2024 (in thousands):

September 30,

Inventories consisted of the following as of March 31, 2026 and December 31, 2025 (in thousands):

Raw materials (1)

3 unchanged sentences

$ 23,254 $ 16,464

( 1 ) $ 0.2 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at December 31, 2024.

( 1 ) $ 2.3 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at March 31, 2026.

These raw materials are not expected to be manufactured and sold within the next 12 months.

Changes in non-current inventories are reflected on the condensed consolidated statements of cash flows within the caption of other non-current assets.

No raw materials were included as other non-current assets on the condensed consolidated balance sheets at September 30, 2025.

No raw materials were included as other non-current assets on the condensed consolidated balance sheets at December 31, 2025.

Note 6 – Fair Value Measurements

11 unchanged sentences

The Company estimated the fair value of long-term debt (see Note 10 - Long-Term Debt) using the income approach with Level 3 inputs.

The Company estimated future floating rate interest payments using a forward curve of a three -month benchmark rate, and estimated fair value based on publicly available data reported in the financial statements of publicly traded venture lending companies.

The Company estimated fair value based on publicly available data reported in the financial statements of publicly traded venture lending companies.

Based on a reasonable range of yields for debt instruments of similar tenor in a similar industry, the Company determined that the carrying value of the long-term debt on the Company's balance sheet approximates its fair value.

No transfers between levels have occurred during the periods presented.

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of September 30, 2025 are as follows (in thousands):

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of March 31, 2026 are as follows (in thousands):

Fair Value Measurements Using

1 unchanged sentence

Balance as of

September 30,

Identical Assets

1 unchanged sentence

Money market funds

$ 2,569 $ 2,569 $ —

11,304 11,304 —

Commercial paper

12,566 — 12,566

Total cash equivalents

26,439 13,873 12,566

Marketable securities

24,024 24,024 —

Corporate bonds

6,378 — 6,378

Commercial paper

2,881 — 2,881

Certificates of deposit

4,091 — 4,091

Total marketable securities

37,374 24,024 13,350

Total assets at fair value

$ 63,813 $ 37,897 $ 25,916

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of December 31, 2025 are as follows (in thousands):

5 unchanged sentences

Money market funds

$ 41,008 $ 41,008 $ —

Marketable securities

26,053 26,053 —

Corporate bonds

14,980 — 14,980

Commercial paper

26,622 — 26,622

Certificates of deposit

2,065 — 2,065

Total marketable securities

69,720 26,053 43,667

Total assets at fair value

$ 110,728 $ 67,061 $ 43,667

The Company’s investments in U.S.

government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of September 30, 2025 and December 31, 2024 .

government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of March 31, 2026 and December 31, 2025 .

The Company's investments in corporate bonds, commercial paper and certificates of deposits are measured based on quotes from market makers for similar items in active markets.

Note 7 – Investments

The following table summarizes the Company’s investments as of September 30, 2025 (in thousands):

The following table summarizes the Company’s investments as of March 31, 2026 (in thousands):

Cash equivalents

Money market funds

$ 2,569 $ — $ — $ 2,569

11,305 — ( 1 ) 11,304

Commercial paper

12,567 — ( 1 ) 12,566

Total cash equivalents

26,441 — ( 2 ) 26,439

Marketable securities:

24,025 — ( 1 ) 24,024

Corporate bonds

6,356 22 — 6,378

Commercial paper

2,879 2 — 2,881

Certificates of deposit

4,089 2 — 4,091

Total marketable securities

37,349 26 ( 1 ) 37,374

Total assets at fair value

$ 63,790 $ 26 $ ( 3 ) $ 63,813

The Company classifies its investments as available-for-sale, and they consist entirely of debt securities.

As of September 30, 2025 , the amortized cost of investments included an immaterial amount of accrued interest.

As of September 30, 2025 , marketable securities were in a net unrealized gain position.

As of March 31, 2026 , the amortized cost of investments included an immaterial amount of accrued interest.

As of March 31, 2026 , marketable securities were in a net unrealized gain position.

Unrealized gains and losses on available-for-sale debt securities are included as a component of comprehensive loss.

As of September 30, 2025 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 45.1 million which consisted of 16 securities.

The unrealized loss was primarily driven by minor fluctuations in the fair value of U.S.

government securities.

The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment;

the Company expects to recover the entire amortized cost basis of the security.

As of March 31, 2026 , the Company did not hold any investments in an unrealized loss position.

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.

As of September 30, 2025 , the Company believes the cost basis for its marketable securities was recoverable in all material aspects and no allowance for credit losses was recognized in the period.

The Company’s investments as of September 30, 2025 mature at various dates through November 2026.

As of March 31, 2026 , the Company believes the cost basis for its marketable securities was recoverable in all material aspects.

The Company’s investments as of March 31, 2026 mature at various dates through October 2026.

The fair values of investments by contractual maturity consist of the following (in thousands):

September 30,

Maturities within one year

$ 63,433 $ 105,706

Maturities after one year through three years

Total investments

$ 63,813 $ 110,728

Note 8 – Property and Equipment

Property and equipment, consisted of the following as of September 30, 2025 and December 31, 2024 (in thousands):

September 30,

Property and equipment consisted of the following as of March 31, 2026 and December 31, 2025 (in thousands):

Laboratory equipment

5 unchanged sentences

Property and equipment, net

Depreciation and amortization expense was $ 0.1 million and $ 0.2 million for the three and nine months ended September 30, 2025 , respectively, and $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2024 , respectively.

Depreciation and amortization expense was $ 0.1 million for the three months ended March 31, 2026 , and $ 0.1 million for the three months ended March 31, 2025 .

Note 9 – Prepaid Forward Obligation

4 unchanged sentences

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.

The rate in effect for the nine months ended September 30, 2025 for annual net sales up to $ 200 million was 13.0 %.

The rate in effect for the three months ended March 31, 2026 for annual net sales up to $ 200 million was 13.0 %.

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:

1 unchanged sentence

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 September 30, 2025 , the cumulative amounts paid and payable by the Company were $ 44.0 million.

As of March 31, 2026 , the cumulative amounts paid and payable by the Company were $ 51.0 million.

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.

3 unchanged sentences

Changes in future payments from previous estimates are included in future financing expenses.

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, 2024 and for the nine months ended September 30, 2025 , in thousands:

The Company is not contractually obligated, nor does it anticipate making any repayments to RTW of the original $ 75.0 million received in the RTW Transaction 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 for the three months ended March 31, 2026 , in thousands:

Carrying value of prepaid forward obligation as of December 31, 2024

4 unchanged sentences

Amounts paid and payable (1)

Carrying value of prepaid forward obligation as of September 30, 2025

( 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 condensed consolidated balance sheets as of September 30, 2025 , and December 31, 2024, respectively.

Carrying value of prepaid forward obligation as of March 31, 2026

( 1 ) $ 3.6 million and $ 3.4 million of the Amounts paid and payable are included as the current portion of the prepaid forward obligation within other current liabilities on the condensed consolidated balance sheets as of March 31, 2026 , and December 31, 2025, respectively.

Note 10 – Long-Term Debt

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.

On March 7, 2022, the Company entered into a loan agreement with Pharmakon (the "2022 Loan Agreement") for a senior secured term loan of up to $ 100 million in two tranches.

The first tranche of $ 75 million was funded in March 2022.

2 unchanged sentences

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 %.

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.

On March 13, 2024, the Company entered into an amended and restated loan agreement with Pharmakon, which replaced the 2022 Loan Agreement, 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.

1 unchanged sentence

The Company did not draw down the fourth tranche.

Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of three -month SOFR plus 7.25 % plus an additional adjustment of 0.26161 %.

Per the terms of the agreement, the Company received a one -year extension on the repayment period for all outstanding loans following the FDA's approval of the NDA for Zusduri .

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2027.

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.

The Company is not required to maintain any financial covenants.

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 condensed consolidated balance sheets.

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 %.

On February 26, 2026, ( the "Closing Date") 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”).

The first tranche of $ 200.0 million was advanced on the Closing Date and 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.

The second tranche of $ 50.0 million may, at the Company's option, be requested no later than June 30, 2027 for funding to occur no later than August 29, 2027, subject to customary conditions.

The term loans mature on the fifth anniversary of the Closing Date.

All outstanding loans with Pharmakon pursuant to the 2026 Loan Agreement accrue interest at a fixed rate of 8.25 %.

The principal amount of the loans outstanding under the 2026 Loan Agreement shall be repayable in four equal quarterly payments commencing in the second quarter of 2030, which are subject to an exit fee of 1 % of the principal amount being repaid.

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.

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.

and UroGen Pharma Ltd., subject to certain exceptions.

The refinancing of the Company's term loan facility with the 2026 Loan Agreement was accounted for by the Company as a debt modification under ASC 470, as the terms of the new arrangement were not considered substantially different from those of the existing debt.

Accordingly, the Company did not recognize a gain or loss on extinguishment, and existing unamortized debt issuance costs associated with the prior term loan were carried forward and continue to be amortized over the term of the modified debt using the effective interest method.

The Company incurred financing expenses of $ 9.7 million related to the first tranche of the 2026 Loan Agreement funded in February 2026, which are recognized as a direct offset to the long-term debt on the Company's condensed 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 condensed consolidated statements of operations as "Interest expense".

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Carrying value of Pharmakon loan as of December 31, 2024

Third tranche of Pharmakon loan

Capitalized costs and discounts

Interest expense

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Interest expense

Carrying value of Pharmakon loan as of September 30, 2025

Carrying value of Pharmakon loan as of February 26, 2026

Modification of Pharmakon loan:

Additional borrowing of Pharmakon loan (2026 Loan Agreement - first tranche), net

Capitalized costs and discounts

Interest amount paid

Carrying value of Pharmakon loan as of February 27, 2026

Interest expense

Carrying value of Pharmakon loan as of March 31, 2026

The aggregate principal maturities of long-term debt as of March 31, 2026 are as follows, in thousands:

Principal Payments

Note 11 – Leases

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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.

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 $ 0.9 million as of September 30, 2025 .

In April 2018, UPI entered into a new lease agreement for an office in Los Angeles, California.

The lease commencement date was July 10, 2018 and terminated in March 2024.

The landlord provided a tenant allowance for leasehold improvements of $ 0.2 million that was accounted for as a lease incentive.

In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020 which continued until the end of the lease term in March 2024.

The subtenants exercised their early access clause and moved into the premises at the end of November 2019.

The Company accounted for the sublease as an operating lease in accordance with ASC 842.

In March 2019, UPL utilized the agreement extension option and extended the rent period for an additional three years until August 2022.

In July 2022, UPL 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, the lease was renewed through September 2028.

The Company's remaining contractual obligation under this lease is approximately $ 1.0 million as of March 31, 2026 .

In November 2019, UPI entered into a new lease agreement for an office in Princeton, New Jersey, which the Company now uses as its headquarters.

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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 $ 3.2 million as of September 30, 2025 .

The Company’s remaining contractual obligation under this lease is approximately $ 3.0 million as of March 31, 2026 .

Finance Leases

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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.

The Company’s remaining contractual obligation relating to the leases entered into under this master agreement is approximately $ 6.0 million as of September 30, 2025 .

The Company’s remaining contractual obligation relating to the leases entered into under this master agreement is approximately $ 5.5 million as of March 31, 2026 .

In addition, the Company has other operating office equipment and vehicle leases.

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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 three and nine months ended September 30, 2025 and 2024 were as follows (in thousands):

The components of lease cost for the three months ended March 31, 2026 and 2025 were as follows (in thousands):

Three Months Ended

Nine Months Ended

September 30,

Finance lease cost:

Amortization of right-of-use assets

$ 382 $ — $ 901 $ —

Interest on lease liabilities

Operating lease cost

321 225 773 675

Sublease income

Variable lease cost

$ 884 $ 239 $ 2,117 $ 690

The amounts recognized as of September 30, 2025 and December 31, 2024 were as follows (in thousands):

September 30,

Total lease cost

The amounts recognized as of March 31, 2026 and December 31, 2025 were as follows (in thousands):

Finance lease right-of-use assets

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Other current liabilities related to operating leases

As of September 30, 2025 , no impairment losses have been recognized.

Supplemental information related to leases for the nine months ended September 30, 2025 and 2024 is as follows (in thousands, except for lease terms and discount rate amounts):

Nine Months Ended

September 30,

As of March 31, 2026 , no impairment losses have been recognized.

Supplemental information related to leases for the three months ended March 31, 2026 and 2025 is as follows (in thousands, except for lease terms and discount rate amounts):

Three Months Ended

Cash paid for amounts included in the measurement of lease liabilities:

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Weighted-average discount rate of finance leases

13.82 % 13.82 %

Weighted-average discount rate of operating leases

11.82 % 10.23 %

As of September 30, 2025 , maturities of lease liabilities were as follows (in thousands):

As of March 31, 2026 , maturities of lease liabilities were as follows (in thousands):

Finance Leases

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Present value of lease liabilities

As of September 30, 2024, maturities of lease liabilities were as follows (in thousands):

Years ending December 31,

Remainder of 2024

Total future minimum lease payments

Present value of lease liabilities

Note 12 – Revenue From Product Sales

Net product sales consist of the following for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Net product sales consist of the following for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended

Nine Months Ended

September 30,

$ 21,713 $ 20,254

1,779 — 1,779 —

Total Revenue

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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.

The Company's largest customer comprises approximately 75 % and 80 % of product sales for the three and nine months ended September 30, 2025 , respectively, and approximately 87 % and 93 % of product sales for the three and nine months ended September 30, 2024.

The Company's largest customer comprises approximately 70 % and 80 % of accounts receivables at September 30, 2025 and December 31, 2024, respectively.

The Company's largest customer comprised approximately 58 % of product sales for the three months ended March 31, 2026 , and over 85 % of product sales for the three months ended March 31, 2025.

The Company's largest customer comprised approximately 48 % and 59 % of accounts receivable at March 31, 2026 and December 31, 2025, respectively.

The Company does not anticipate any Medicare refunds for discarded drug for Zusduri .

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Reserves for chargebacks and returns are net settled and recognized as contra accounts receivable while the remaining reserves are recognized within other current liabilities on the condensed consolidated balance sheets.

The following table shows the activity with respect to sales reserves for the period ended September 30, 2025 and 2024 (in thousands):

The following table shows the activity with respect to sales reserves for the period ended March 31, 2026 and 2025 (in thousands):

Reserves related to government sponsored programs

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( 5,566 ) — ( 4,966 ) ( 10,532 )

Changes to prior period estimates

— ( 414 ) — ( 414 )

Balance as of September 30, 2025

Balance as of March 31, 2026

$ 1,569 $ 4,906 $ 5,428 $ 11,903

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( 3,889 ) ( 3,809 ) ( 2,926 ) ( 10,624 )

Balance as of September 30, 2024

Balance as of March 31, 2025

$ 684 $ 4,823 $ 1,733 $ 7,240

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("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.

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 ("high-grade NMIBC").

See Note 21 for further discussion related to the Agenus agreement.

UGN- 301 is a formulation of zalifrelimab administered using RTGel technology that was in Phase 1 clinical development for high-grade NMIBC.

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.

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;

or (b) completion of all wind-down activities and delivery of all Agenus Improvements (as defined in the license agreement) to Agenus.

The Company does not expect to incur significant additional costs related to this program going forward.

Note 14 – Acquisitions

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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”).

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.

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.

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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.

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 nine months ended September 30, 2025.

Note 15 – Shareholders ’ Equity

The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2025 and December 31, 2024 .

The Company had 46.8 million and 42.2 million ordinary shares issued and outstanding as of September 30, 2025 and December 31, 2024 , respectively.

The Company had 100.0 million ordinary shares authorized for issuance as of March 31, 2026 and December 31, 2025 .

The Company had 48.7 million and 48.4 million ordinary shares issued and outstanding as of March 31, 2026 and December 31, 2025 , respectively.

Each ordinary share is entitled to one vote.

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ATM Sales Agreement

In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with Cowen and Company, LLC (“Cowen”) 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.

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.

The net proceeds to the Company after deducting sales commissions to Cowen were approximately $ 54.7 million.

During the third quarter of 2025, the Company sold 416,248 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $ 8.2 million.

The net proceeds to the Company after deducting sales commissions to Cowen were approximately $ 8.0 million.

The remaining capacity under the ATM Sales Agreement was approximately $ 19.1 million as of September 30, 2025.

The shares will be offered and sold 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.

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.”

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 %.

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 %.

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”).

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 to the Company of approximately $ 31.8 million after deducting sales commissions to TD Cowen of up to 3 %.

As of March 31, 2026, the remaining capacity under the ATM Prospectus was approximately $ 42.4 million.

Securities Purchase Agreement

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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.

As of September 30, 2025, 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.

As of March 31, 2026, 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.

Monograph Capital Partners I, L.P.

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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.

As of September 30, 2025, all 1,142,857 pre-funded warrants remain outstanding.

As of March 31, 2026, 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.

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Also, eligible employees may receive an annual grant of options, RSUs and/or PSUs.

Non-employee members of the Board typically receive a grant of stock options upon initial appointment to the Board, and/or stock options annually.

Non-employee members of the Board typically receive a grant of stock options or a mix of options and RSUs upon initial appointment to the Board, and stock options or a mix of stock options and RSUs annually.

The term of any option granted under the Plans cannot exceed 10 years.

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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 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.

The PSUs granted in 2026 vest based upon U.S.

regulatory approval of UGN- 103 and represent 336,411 units with a total grant-date fair value of approximately $ 6.6 million.

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.

In December 2025, the Company further amended certain RSU and PSU awards granted to its chief executive officer to defer vesting until the end of 2026.

The Company accounted for the modification as a Type I probable-to-probable modification under ASC 718.

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.

As the modification 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 .

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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 September 30, 2025 , 4,483,063 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 739,197 ordinary shares remain available for future awards.

As of March 31, 2026 , 5,356,440 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 2,052,792 ordinary shares remain available for future awards.

The following table illustrates the effect of share-based compensation on the condensed consolidated statements of operations (in thousands):

Three Months Ended

Nine Months Ended

September 30,

Research and development expenses

$ 726 $ 579 $ 1,776 $ 1,691

Selling, general and administrative expenses

2,301 2,910 7,053 8,114

Total share-based compensation expense

$ 4,627 $ 3,069

The total unrecognized compensation cost of options, RSUs and PSUs at September 30, 2025 is $ 17.6 million with a weighted average recognition period of 1.82 years.

The total unrecognized compensation cost of options, RSUs and PSUs at March 31, 2026 is $ 39.1 million with a weighted average recognition period of 2.23 years.

Note 17 – Income Taxes

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is taxed under Israeli tax laws.

As of September 30, 2025 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

As of March 31, 2026 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

In evaluating the need for a valuation allowance, the Company considers all sources of taxable income available to realize the deferred tax asset, including the future reversal of existing temporary differences, forecasts of future taxable income, and tax planning strategies.

The Company has cumulative global pretax losses for the years ended 2024, 2023 and 2022, and for the nine months ended September 30, 2025 .

The Company has cumulative global pretax losses for the years ended 2025, 2024 and 2023, and for the three months ended March 31, 2026 .

The Company will continue to assess the extent to which its deferred tax assets may be realized in the future and will adjust the valuation allowance as needed.

The Company has a liability for uncertain tax positions of $ 3.8 million as of September 30, 2025 , for tax positions relating to transfer pricing between affiliated entities.

The Company has a liability for uncertain tax positions of $ 3.9 million as of March 31, 2026 , for tax positions relating to transfer pricing between affiliated entities.

The Company recognizes interest accrued and penalties related to uncertain tax positions as a component of income tax expense.

As of September 30, 2025 , the Company’s liability for uncertain tax positions includes $ 1.8 million of accrued interest and penalties.

As of March 31, 2026 , the Company’s liability for uncertain tax positions includes $ 2.1 million of accrued interest and penalties.

The Company operates on a global basis and is subject to tax laws and regulations in the United States and Israel.

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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.

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.

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 and has recorded the gross uncertain tax positions as a long-term liability.

On July 4, 2025, the One Big Beautiful Bill Act ("OBBBA") was signed into law in the U.S.

The OBBBA includes changes to U.S.

federal income tax, including the temporary and permanent extension of expiring provisions of the Tax Cuts and Jobs Act of 2017.

The Company has recognized the effects of the OBBBA in the quarter ended September 30, 2025 , with the provision reinstating the ability for entities to immediately expense domestic research and development expenditures driving a resulting income tax benefit of approximately $ 1.1 million.

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.

Note 18 – Related Parties

See Note 14 for discussion related to an asset purchase in February 2025 which involved a related party.

There were no further related party transactions during the nine months ended September 30, 2025 or 2024.

There were no further related party transactions during the three months ended March 31, 2026 or 2025.

Note 19 – Commitments and Contingencies

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Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities.

The Company’s maximum exposure under these arrangements is unknown as of September 30, 2025 and December 31, 2024 .

The Company’s maximum exposure under these arrangements is unknown as of March 31, 2026 and December 31, 2025 .

The Company does not anticipate recognizing any significant losses relating to these arrangements.

On February 25, 2024, the Company received from Teva Pharmaceuticals, Inc.

(“Teva”), a Paragraph IV Certification Notice Letter dated February 20, 2024, providing notification that Teva submitted an abbreviated new drug application ("ANDA") to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .

In the Notice Letter, Teva alleges that two of the patents listed in the FDA Orange Book for Jelmyto , U.S.

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.

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market entry of Teva’s generic product prior to the expiry of such patents.

The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd.

without prejudice and the action continues against the other two Teva entities.

On May 19, 2025, the Company filed an amended complaint in this action, adding U.S.

Patent Number 12,268,745 to this patent-infringement litigation.

By orders dated February 27, 2025 and June 26, 2025, the court approved the parties’ joint stipulation to remove the Markman hearing and any related claim-construction proceedings from the court’s calendar.

Additionally, by the court’s order dated August 28, 2025, the parties stipulated that upon final approval of Teva’s ANDA, the commercial manufacture, use, sale, or offer for sale within the United States, or importation into the United States, of that product would infringe certain claims of the patents asserted in the action, thus narrowing the scope of the action to the validity of those certain patent claims.

This matter is scheduled for a bench trial in October 2026.

By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd.

was dismissed from the action.

On May 19, 2025, the Company filed an Amended Complaint, adding U.S.

Patent 12,268,745 to the litigation (the “745 Patent”).

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.

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.

Following certain stipulations, the case is now styled as UroGen Pharma Ltd.

Teva Pharmaceuticals, Inc.

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.

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.

Patent Numbers 9,040,074 and 9,950,069 are invalid, as moot.

By order dated April 27, 2026, the court approved the parties' joint stipulation to extend the deadlines for expert discovery and pre-trial activities and to postpone trial until January 2027, subject to the court's availability.

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.

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Information about significant segment expenses regularly provided to the CODM is as follows (in thousands):

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Research and development expenses

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Employee compensation

4,185 3,758 13,310 11,458

Rent, office, utilities & technology

691 646 2,280 2,260

Other expenses

218 179 452 421

Total research and development expenses

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Commercial & medical affairs services

6,681 5,304 25,752 17,975

Professional services

3,989 3,131 10,337 9,505

Travel, meetings & conferences

3,970 2,917 13,244 9,988

Rent, office, utilities & technology

1,331 874 3,659 2,399

Other expenses (1)

1,894 842 5,348 2,638

Total selling, general and administrative expenses

$ 51,486 $ 34,967

( 1 ) Other expenses primarily consist of insurance, sponsorship, grants, other fees and taxes.

( 1 ) Other expenses primarily consist of insurance, publications, sponsorships, grants, other fees and taxes.

Note 21 – Subsequent Events

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.

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;

or (b) completion of all wind-down activities and delivery of all Agenus Improvements (as defined in the license agreement) to Agenus.

The Company does not expect to incur any costs in connection with the termination of the agreement.

The Company has evaluated and determined there were no further subsequent events.

Note 22 – Selected Unaudited Quarterly Financial Data

Certain unaudited selected quarterly financial results for the three and nine months ended September 30, 2025 are presented as follows:

For the Three Months Ended September 30, 2024

For the Nine Months Ended September 30, 2024

$ 25,204 $ 65,833

$ 22,751 $ 59,423

$ ( 23,673 ) $ ( 89,362 )

Weighted-average number of ordinary shares (1)

46,779,637 41,476,892

Basic and diluted loss per ordinary share (1)

$ ( 0.51 ) $ ( 2.15 )

( 1 ) The loss per share, both basic and diluted, for the third quarter of 2024 was revised to record an immaterial correction to the amounts originally reported in the 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 the reporting period, which were not included in the previous calculations and are now reflected in the weighted average shares outstanding.

The Company has evaluated and determined there were no subsequent events.

Management ’ s Discussion and Analysis of Financial Condition and Results of Operations.

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We estimate that the total addressable market opportunity for Zusduri in recurrent low-grade intermediate risk NMIBC is potentially over $5.0 billion.

We believe Zusduri has the potential to become the new standard of care for recurrent low-grade intermediate risk NMIBC as the first and only FDA-approved non-surgical treatment.

We believe Zusduri has the potential to become the new standard of care for adults with recurrent low-grade intermediate risk NMIBC as the first and only FDA-approved non-surgical treatment.

The existing standard of care for low-grade intermediate risk NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (“TURBT”).

Due to high recurrence rates of low-grade intermediate risk NMIBC, repeat TURBTs may be necessary.

Due to high recurrence rates of low-grade intermediate risk NMIBC following TURBT, repeat TURBTs may be necessary.

We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% of recurrent patients having five or more recurrences.

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Patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

RTGel (or hydrogel) is a novel proprietary polymeric biocompatible, reverse thermal gelation hydrogel technology, which, unlike the general characteristics of most forms of matter, is liquid at lower temperatures and converts into gel form when warmed to body temperature.

RTGel is a novel proprietary polymeric biocompatible, reverse thermal gelation hydrogel technology, which, unlike the general characteristics of most forms of matter, is liquid at lower temperatures and converts into gel form when warmed to body temperature.

We believe that these characteristics promote ease of delivery into and retention of drugs in body cavities, including the bladder and the upper urinary tract, forming a transient reservoir of drug that dissolves over time while preventing rapid excretion, providing for increased dwell time.

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maintaining the active drug’s molecular structure and mode of action.

These characteristics of RTGel enable sustained release of mitomycin in the urinary tract for both Jelmyto and Zusduri .

These characteristics of RTGel enable sustained release of mitomycin in the urinary tract for Jelmyto, Zusduri, UGN-103 and UGN-104.

Further, RTGel may be particularly effective in the bladder and upper urinary tract where tumor visibility and access are challenging, and where there exists a significant amount of urine flow and voiding.

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These patents are listed in the FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations).

Low-grade UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys.

Low-grade UTUC is a rare cancer that develops in the lining of the upper urinary tract, which consists of the kidneys and ureters.

In the United States, there are approximately 6,000 to 7,000 new or recurrent low-grade UTUC patients annually.

It is a challenging condition to treat due to the complex anatomy of the urinary tract system.

Prior to Jelmyto , the standard of care included endoscopic resection(s) and radical nephroureterectomy, the latter involving the removal of the renal pelvis, kidney, ureter and bladder cuff.

Prior to Jelmyto , the current standard of care included endoscopic resection(s) and radical nephroureterectomy (“RNU”), the latter which involves the removal of the renal pelvis, kidney, ureter and bladder cuff.

Treatment is further complicated by the fact that low-grade UTUC is most commonly diagnosed in patients over 70 years of age, who may already have compromised kidney function and may suffer further complications as a result of a major surgery.

We are focused on changing the way urothelial cancers are treated, an area in which there have been no significant advancements in recent years.

Jelmyto is the first drug therapy of its kind, providing an alternative to endoscopic resection(s) and/or radical nephroureterectomy.

We are focused on changing the way urothelial cancers are treated, an area in which there has been no significant advancements in recent years.

Jelmyto is the first drug therapy of its kind, providing an alternative to endoscopic resection(s) and/or RNU.

The FDA approval was based on results from our Phase 3 trial showing Jelmyto achieved clinically significant disease eradication in adults with low-grade UTUC.

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Each region is additionally supported by clinical nurse educators to provide education and training around instillation, as well as field reimbursement managers to help ensure access and reimbursement for appropriate patients and key account directors who engage with C-suite individuals to introduce a Jelmyto service line.

In addition, our organization currently includes several medical science liaisons who appropriately engage with physicians interested in learning more about UroGen, Jelmyto and our technology, both in person and virtually.

In addition, our organization includes medical science liaisons who appropriately engage with physicians interested in learning more about UroGen, Jelmyto and our technology, both in person and virtually.

In total, our customer-facing team comprises approximately 160 colleagues.

We are committed to helping patients access Jelmyto .

Our market access teams have laid the foundation for coverage and reimbursement, meeting multiple times with payors.

Medicare patients with supplemental coverage are covered and the vast majority of commercial plans have policies in place, in whole covering over 150 million lives.

Our market access teams have laid the foundation for coverage and reimbursement.

Medicare patients with supplemental coverage are covered and the vast majority of commercial plans have policies in place to cover Jelmyto .

In addition to reimbursement and access, we have also been focused on ensuring seamless integration into physician practices.

We have implemented processes to help make Jelmyto preparation and administration seamless for practitioners and patients, including entering into agreements with various national, regional and local specialty pharmacies under which the pharmacy, following receipt of a patient prescription, prepares and dispenses the Jelmyto admixture.

We have implemented processes to help make Jelmyto preparation and administration seamless for practitioners and patients, including entering into agreements with various national, regional and local mixing pharmacies under which the pharmacy, following receipt of a patient prescription, prepares and dispenses the Jelmyto admixture.

In September 2022, the FDA authorized an extension of the in-use period for the Jelmyto admixture from eight hours to 96 hours (four days) following reconstitution of the product, adding convenience and flexibility in managing patient care.

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CMS has granted Jelmyto a New Technology Ambulatory Payment Classification ("APC"), effective from October 1, 2023.

We have also launched a registry to capture data and evaluate real world outcomes in patients with low-grade UTUC who have been or will be treated with Jelmyto .

We have also launched a registry to capture data and evaluate real world outcomes in patients with UTUC treated with Jelmyto .

The purpose of the registry is to study the use of Jelmyto in clinical practice in the United States and address specific clinical questions.

On June 12, 2025, the FDA approved our NDA for Zusduri (mitomycin) for intravesical solution, formerly known as UGN-102, for the treatment of adults with recurrent low-grade intermediate risk NMIBC.

Zusduri , which consists of mitomycin and sterile hydrogel, using our proprietary sustained release RTGel technology, 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.

Zusduri , which consists of mitomycin and sterile hydrogel, uses our proprietary sustained release RTGel technology and is delivered directly into the bladder in an outpatient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.

We estimate that the annual treatable population of low-grade intermediate risk NMIBC in the United States is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients.

Zusduri is administered locally using the standard practice of intravesical instillation directly into the bladder via a urinary catheter.

The instillation into the bladder is expected to take place in a physician’s office as a non-operative outpatient treatment, in comparison with TURBT or similar surgical procedures, which are operations usually conducted under general anesthesia and may require an overnight stay.

Complete surgical tumor removal often has limited success due to the inability to properly identify, reach and resect all tumors.

The instillation into the bladder can take place in a physician’s office as a non-operative outpatient treatment, in comparison with TURBT or similar surgical procedures, which are operations usually conducted in an operating room under general anesthesia and may require an overnight stay.

Complete surgical tumor removal often has limited success due to the inability to properly visualize, reach and resect all tumors.

We believe that an effective chemoablation agent can potentially provide better eradication of tumors irrespective of the detectability and location of the tumors.

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Repeated TURBT procedures to treat these recurrences can impact patients’ physical health and quality of life.

Around 35% of patients will experience an adverse event within 90 days of undergoing a TURBT, and patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

Approximately 35% of patients will experience an adverse event within 90 days of undergoing a TURBT, and patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

On July 27, 2023, we announced topline data from our Phase 3 trials, ATLAS and ENVISION.

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Results of the Phase 3b study were published online in the Reviews in Urology-LUGPA Journal in June 2025.

The FDA approval of Zusduri on June 12, 2025 was based on the results from the FDA Analysis Population (n=223) from the Phase 3 ENVISION trial demonstrating 78% of patients achieved CR at 3 months, and 79% of those responders maintained CR at 12 months after the three-month visit (using the observed rate).

The FDA approval of Zusduri on June 12, 2025 was based on the results from the FDA Analysis Population (n=223) from the Phase 3 ENVISION trial demonstrating 78% of patients achieved CR at three months, and 79% of those responders maintained CR at 12 months after the three-month visit (using the observed rate).

The most common (≥ 10%) adverse reactions, including laboratory abnormalities, which occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

Serious adverse reactions occurred in 12% of patients who received Zusduri , including, urinary retention (0.8%) and urethral stenosis (0.4%).

As a post-marketing commitment, we have agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit of Zusduri for the treatment of patients with recurrent low-grade intermediate risk NMIBC.

In addition, we committed to providing the FDA updates on DOR for all patients with ongoing CRs.

As a post-marketing commitment, we agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit of Zusduri in adult patients with recurrent low-grade intermediate risk NMIBC.

We committed to providing the FDA with updates on DOR for all patients with ongoing CRs.

The updates will continue until all ongoing patients experience a recurrence of low-grade intermediate risk NMIBC;

loss to follow-up;

or reach 63 months after the first instillation as planned in the protocol, whichever occurs first.

or reach 63 months after the first instillation as planned in the protocol, or until the study ends, whichever occurs first.

We began promotion of Zusduri in the United States in late June 2025.

We initiated a strategic multi-faceted approach to promote broad adoption and patient access to Zusduri , leveraging our customer-facing team of territory business managers, regional business directors, regional operations managers, clinical nurse educators, field reimbursement managers and medical science liaisons.

We initiated a strategic, multi-faceted approach to promote broad adoption and patient access to Zusduri , leveraging our customer-facing team of territory business managers, regional business directors, regional operations managers, clinical nurse educators and field reimbursement managers.

Zusduri is now broadly accessible to patients through commercial, Medicare, and Medicaid insurance programs, with open access for more than 95% of covered lives and approximately 296 million eligible patients.

In October 2025, Zusduri was assigned a unique, permanent Healthcare Common Procedure Coding System (“HCPCS”) J-code (J9282) by CMS.

The J-code is expected to be effective January 1, 2026.

The J-code became effective on January 1, 2026.

UGN-103 (mitomycin) for intravesical solution and UGN-104 (mitomycin) for pyelocalyceal solution

In January 2024, we entered into a licensing and supply agreement with medac Gesellschaft für klinische Spezialpräparate m.b.H.

(“medac”) to develop UGN-103 and UGN-104, which are intended to be next-generation investigational formulations of Zusduri and Jelmyto , respectively, that combine medac’s proprietary 80 mg mitomycin formulation with our RTGel technology, which we believe will provide advantages related to production, cost, supply and product convenience.

In April 2024, we announced that the FDA accepted our Investigational New Drug Application (“IND”) for UGN-103 and we initiated our Phase 3 UTOPIA trial, a single-arm, multicenter study that will evaluate the efficacy and safety of UGN-103 in patients with recurrent low-grade intermediate risk NMIBC.

(“medac”) to develop UGN-103 and UGN-104, which are next-generation investigational formulations of Zusduri and Jelmyto , respectively, that combine medac’s proprietary 80 mg mitomycin formulation with our RTGel technology, which we believe will provide advantages related to production, cost, supply and product convenience.

In April 2024, we announced that the FDA accepted our Investigational New Drug Application (“IND”) for UGN-103 and we initiated our Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in patients with recurrent low-grade intermediate risk NMIBC.

In October 2024, we announced the first patient dosed in the UTOPIA trial, and in July 2025, we announced the completion of patient enrollment with 99 patients enrolled across multiple centers globally.

Patients in the UTOPIA trial received 75 mg of mitomycin via intravesical instillation once a week for six weeks.

Efficacy will be assessed by the CR rate at the three-month visit.

Patients who have a CR at the three-month visit, defined as having no detectable disease in the bladder, will enter the follow-up period of the study.

Efficacy was assessed by the CR rate at the three-month visit.

Patients who had a CR at the three-month visit, defined as having no detectable disease in the bladder, entered the follow-up period of the study.

Patients will remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (i.e., 15 months after the first instillation), whichever occurs first.

A long-term follow up study will also be conducted following patients remaining in CR for up to five years after initiation of treatment with UGN-103.

We reported a three-month CR rate of 77.8% (95% CI, 68.3%, 85.5%), consistent with results from the ENVISION clinical trial.

The FDA has agreed with the regulatory plan to submit an NDA based on the data from our Phase 3 UTOPIA trial to support potential approval of UGN-103.

In November 2025 we reported a three-month CR rate of 77.8% (95% CI, 68.3%, 85.5%), consistent with results from the ENVISION clinical trial.

The FDA agreed with the regulatory plan to submit an NDA based on the data from our Phase 3 UTOPIA trial to support potential approval of UGN-103.

We anticipate submitting an NDA for UGN-103 in the second half of 2026 with potential FDA approval in 2027.

In February 2025, the FDA accepted our IND for UGN-104, and we initiated a Phase 3 trial of UGN-104 in low-grade UTUC in June 2025.

UGN-301 (zalifrelimab) intravesical solution

Our immuno-uro-oncology pipeline previously included UGN-301, an anti-CTLA-4 monoclonal antibody, which we studied as a combination therapy with multiple agents.

UGN-301 was delivered using our proprietary RTGel technology, which has been designed to significantly improve the effectiveness of certain intravesical therapies.

We expect to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026.

Our pipeline also includes UGN-501, our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer, for which we plan to initiate a Phase 1 clinical trial in NMIBC by the end of 2026.

High-grade NMIBC is a highly aggressive form of bladder cancer.

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Radical cystectomy, or bladder removal is strongly advocated in patients with BCG-unresponsive NMIBC (i.e., patients with BCG-refractory and BCG-relapsing tumors in whom further BCG therapy is not recommended) or for patients who cannot tolerate BCG.

The first combination we investigated clinically involved the sequential use of UGN-201 (imiquimod), a toll like receptor 7 ("TLR 7") agonist, and UGN-301 in high-grade NMIBC.

UGN-201 is a liquid formulation of imiquimod for intravesical administration that has been optimized for delivery in the urinary tract.

The second combination we investigated clinically involved the sequential administration of gemcitabine and UGN-301 to the bladder in high-grade NMIBC.

Gemcitabine is a chemotherapy that is used intravesically to treat high grade NMIBC where it is administered as a liquid formulation.

We believed these two combinations could elicit both an innate and adaptive immune response, which may translate into a long-lasting acquired immune response, and potentially represent a valid post-TURBT adjuvant treatment of high-grade NMIBC.

We investigated these combinations to determine if they could make local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

In February 2025, we acquired ICVB-1042 (now known as UGN-501).

UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus being developed as a locally administered cancer treatment.

IND-enabling studies are nearing completion, and we plan to submit an IND in the second quarter of 2026 and initiate a Phase 1 clinical trial in NMIBC by the end of 2026.

Nonclinical data to date support the potential of UGN-501 to be a best-in-class oncolytic virus, with cytotoxic activity observed across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades.

The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and we plan to evaluate delivery using our proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity.

The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system.

UGN-301 (zalifrelimab) intravesical solution

Our immuno-uro-oncology pipeline previously included UGN-301, an anti-CTLA-4 monoclonal antibody, which we studied as a combination therapy with multiple agents.

UGN-301 was delivered using our proprietary RTGel technology, which has been designed to significantly improve the effectiveness of certain intravesical therapies.

In March 2022, we announced FDA clearance of our IND to begin a novel Phase 1 clinical study of UGN-301 in patients with recurrent NMIBC.

The novel study design utilized a Master Protocol that we believed would be a more efficient and streamlined approach to development.

It provided more flexibility to add study arms as the trial progressed to increase efficiency and potentially reduce costs.

We expected the Master Protocol would allow us to more quickly evaluate safety, tolerability and dosing of UGN-301 in combination with additional immunomodulators and chemotherapies, with the goal of developing optimized treatment regimens for patients.

The multi-arm Phase 1 study, which was expected to support the development of UGN-301 in high-grade NMIBC, was initiated in April 2022 and enrollment in the study is complete.

Safety and dosing data from the first arm evaluating UGN-301 as monotherapy was presented in late 2024.

In November 2025, we decided to discontinue development of UGN-301 based on our strategic priorities and provided Agenus notice of termination of the license agreement.

The multi-arm Phase 1 study, which was expected to support the development of UGN-301 in high-grade NMIBC, was initiated in April 2022 and enrollment in the study was completed.

Safety and dosing data from the first arm evaluating UGN-301 as monotherapy were presented in late 2024.

In November 2025, we made the decision to discontinue development of UGN-301 based on our strategic priorities and provided Agenus, Inc.

("Agenus") notice of termination of the license agreement.

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;

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We do not expect to incur significant additional costs related to this program going forward.

In February 2025, we acquired ICVB-1042 (now known as UGN-501), a next-generation investigational oncolytic virus engineered to selectively target and destroy cancer cells while simultaneously activating a robust anti-tumor immune response.

We are currently conducting IND-enabling studies and plan to initiate a Phase 1 clinical study of UGN-501 as a locally administered agent in patients with recurrent NMIBC in 2026.

Research and Development and License Agreements

License Agreement and Acquisition Agreement

Agenus Agreement

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or (b) completion of all wind-down activities and delivery of all Agenus Improvements (as defined in the license agreement) to Agenus.

For additional information regarding our research and development and license agreements, see Note 13 and Note 21 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

We do not expect to incur significant additional costs related to this program going forward.

IconOVir Agreement

On February 14, 2025 (the “Closing Date”), we entered into an asset purchase agreement (the “IconOVir Agreement”) with IconOVir Bio, Inc.

(“IconOVir”), pursuant to which we purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including UGN-501 (formerly 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 us.

As consideration for the Transferred Assets and subject to the terms and conditions of the IconOVir Agreement, we (i) issued 374,843 of our ordinary shares to IconOVir, which represented a purchase price of $4.0 million divided by the volume-weighted average closing price of our ordinary 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 IconOVir Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts.

Pursuant to the IconOVir Agreement, from the Closing Date until the earlier of the 10 th anniversary of the Closing Date and the first commercial sale of any ICVB Product in any jurisdiction, we agreed to use commercially reasonable efforts to develop and commercialize one ICVB Product.

The IconOVir Agreement contains customary representations, warranties and covenants of the parties and also provides for customary indemnification rights of us and IconOVir related to breaches of certain representations, warranties and covenants of the other party and certain assumed liabilities or excluded liabilities and excluded assets, as applicable.

Components of Operating Results

During the three and nine months ended September 30, 2025 we recognized $27.5 million and $72.0 million of revenue, respectively, from sales of our products.

During the three months ended March 31, 2026 and 2025 we recognized $51.0 million and $20.3 million of revenue, respectively, from sales of our products.

Cost of Revenue

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The following table provides a breakout of expenses by major cost type:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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We adjust our accrual as actual costs become known.

Where at risk contingent milestone payments are due to third parties under research and development and collaboration agreements, the milestone payment obligations are expensed when such development milestone results are achieved.

We are currently focused on advancing our product candidates, and our future research and development expenses will depend on their clinical success.

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the length of time required to enroll eligible patients;

costs of raw materials, product candidates, and other supplies used in the development of our product candidates, which can be negatively impacted by tariffs, trade barriers, and regulatory requirements;

the number of doses that patients receive;

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We have historically incurred operating losses resulting in carry forward tax losses totaling approximately $626.7 million as of December 31, 2025.

We anticipate that we will continue to generate tax losses for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years.

We anticipate that we will continue to generate tax losses and that we will be able to carry forward these tax losses indefinitely to future taxable years.

Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.

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Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

The following table sets forth our results of operations for the three months ended September 30, 2025 and 2024.

Three Months Ended September 30,

Comparison of the three months ended March 31, 2026 and 2025

The following table sets forth our results of operations for the three months ended March 31, 2026 and 2025.

Three Months Ended March 31,

(in thousands)

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Income tax expense

Revenue was $27.5 million and $25.2 million for the three months ended September 30, 2025 and 2024, respectively.

The increase in revenue of $2.3 million primarily reflects higher sales volume of Jelmyto and lower revenue reserves, primarily driven by lower estimated Medicare refunds for discarded drugs based off amounts billed to date, partially offset by CREATES Act related sales of $2.6 million recorded in the third quarter of 2024.

The increase also reflects sales of Zusduri , which was launched in the third quarter of 2025.

Revenue was $51.0 million and $20.3 million for the three months ended March 31, 2026 and 2025, respectively.

The increase in revenue of $30.7 million primarily reflects the volume of sales of Zusduri , which was launched late in the second quarter of 2025.

Cost of Revenue

Cost of revenue was $3.3 million and $2.5 million for the three months ended September 30, 2025 and 2024, respectively.

The increase in cost of revenue of $0.8 million is primarily attributable to higher unit costs for Jelmyto , as well as increased shipping and warehousing expenses.

In periods prior to receiving FDA approval for Zusduri , we recognized inventory and related costs associated with the manufacture of Zusduri as research and development expenses.

We expect this to continue to impact cost of revenue through approximately 2027 as we produce Zusduri at costs reflecting the full cost of manufacturing and as we deplete inventories that we expensed prior to receiving FDA approval.

Cost of revenue was $4.1 million and $2.3 million for the three months ended March 31, 2026 and 2025, respectively.

The increase in cost of revenue of $1.8 million is primarily attributable to increased sales volumes, partially offset given that in periods prior to receiving FDA approval for Zusduri , we recognized inventory and related costs associated with the manufacture of Zusduri as research and development expenses.

We expect this to continue to favorably impact cost of revenue through approximately 2027 as we deplete Zusduri inventories that we expensed prior to receiving FDA approval.

Research and Development Expenses

Research and development expenses were $14.0 million and $11.4 million for the three months ended September 30, 2025 and 2024, respectively.

The increase in research and development expenses of $2.6 million is primarily attributable to costs associated with the Phase 3 UTOPIA trial for UGN-103 and the Phase 3 trial for UGN-104, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection with Zusduri .

Research and development expenses were $15.6 million and $19.9 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease in research and development expenses of $4.3 million is primarily attributable to the acquisition of UGN-501 in the first quarter of 2025, as well as the costs related to manufacturing of Zusduri which were recognized as research and development expenses in the first quarter of 2025 prior to receiving FDA approval in June 2025.

Selling and Marketing Expenses

Selling and marketing expenses were $23.7 milli on and $17.8 million for the three months ended September 30, 2025 and 2024 , respectively.

The increase in selling and marketing expenses of $5.9 million is primarily attributable to Zusduri commercial activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and back office support costs.

Selling and marketing expenses were $32.1 milli on and $22.1 million for the three months ended March 31, 2026 and 2025 , respectively.

The increase in selling and marketing expenses of $10.0 million is primarily attributable to Zusduri commercial activities, including expansion of the sales force and higher brand marketing expenses, as well as an increase in overall commercial operation costs.

General and Administrative Expenses

General and administrative expenses were $13.9 million and $11.2 million for the three months ended September 30, 2025 and 2024 , respectively.

The increase in general and administrative expenses of $2.7 million is primarily attributable to higher compensation expenses, expenses related to commercialization support related to Zusduri , general third-party advisory services, and ongoing managed services.

General and administrative expenses were $19.4 million and $12.8 million for the three months ended March 31, 2026 and 2025 , respectively.

The increase in general and administrative expenses of $6.6 million is primarily attributable to higher compensation expenses, increased spending on third-party advisory services, including fees recognized in the first quarter of 2026 associated with the debt refinancing.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $4.6 million and $5.9 million for the three months ended September 30, 2025 and 2024, respectively.

Financing on prepaid forward obligation was $4.5 million and $4.6 million for the three months ended March 31, 2026 and 2025, respectively.

The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues.

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Interest Expense on Long-term Debt

Interest expense was $3.4 million and $2.7 million for the three months ended September 30, 2025 and 2024, respectively.

The increase in interest expense was primarily attributable to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Interest expense was $4.2 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively.

The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by a lower interest rate.

Interest and Other Income, Net

Interest and other income, net was $1.0 million and $2.6 million for the three months ended September 30, 2025 and 2024, respectively.

Interest and other income, net was $0.6 million and $2.1 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease in interest and other income, net was primarily due to lower cash and investment balances.

Comparison of the nine months ended September 30, 2025 and 2024

The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024.

Nine Months Ended September 30,

(in thousands)

Cost of revenue

Operating expenses:

Research and development

Selling and marketing

General and administrative

Total operating expenses

Operating loss

Financing on prepaid forward obligation

Interest expense on long-term debt

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $72.0 million and $65.8 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase in revenue of $6.2 million primarily reflects the increased volume of sales of Jelmyto as well as sales of Zusduri , which was launched in the third quarter of 2025.

Cost of Revenue

Cost of revenue was $9.2 million and $6.4 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase in cost of revenue of $2.8 million is primarily attributable to the increased volume of sales of Jelmyto as well as increased costs related to a higher unit cost of Jelmyto , increased shipping and warehousing expenses and an inventory write-off.

In periods prior to receiving FDA approval for Zusduri , we recognized inventory and related costs associated with the manufacture of Zusduri as research and development expenses.

Research and Development Expenses

Research and development expenses were $52.8 million and $42.3 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase in research and development expenses of $10.5 million is primarily attributable to higher manufacturing costs for Zusduri , which are recognized as research and development expenses prior to our product candidates receiving FDA approval, costs associated with the Phase 3 UTOPIA trial for UGN-103 and the Phase 3 trial for UGN-104, as well as the acquisition of certain assets of IconOVir, partially offset by lower clinical trial costs and regulatory expenses in connection with Zusduri .

Selling and Marketing Expenses

Selling and marketing expenses were $73.7 milli on and $53.8 million for the nine months ended September 30, 2025 and 2024 , respectively.

The increase in selling and marketing expenses of $19.9 million is primarily attributable to Zusduri commercial preparation activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and back office support costs.

General and Administrative Expenses

General and administrative expenses were $42.1 million and $32.5 million for the nine months ended September 30, 2025 and 2024 , respectively.

The increase in general and administrative expenses of $9.6 million is primarily attributable to higher compensation expenses, expenses related to pre-commercialization readiness support related to Zusduri , general third-party advisory services, and ongoing managed services.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $13.8 million and $17.3 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease in financing on prepaid forward obligation of $3.5 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $11.6 million and $8.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase in interest expense was primarily attributed to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Interest and Other Income, Net

Interest and other income, net was $4.4 million and $5.9 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease in interest and other income, net was primarily attributable to lower average balances in interest-bearing accounts over the period and the interest rate environment in 2025 reflected a lower rate trend, resulting in reduced interest income.

Liquidity and Capital Resources

As of September 30, 2025, we had $127.4 million in cash and cash equivalents and marketable securities.

As of March 31, 2026, we had $140.3 million in cash and cash equivalents and marketable securities.

Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation, and is held primarily in U.S.

Through September 30, 2025, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon, and product sales.

Through March 31, 2026, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon, and product sales.

ATM Sales Agreement

In December 2019, we 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 we may from time to time offer and sell our ordinary shares having an aggregate offering price of up to $100.0 million.

In the first quarter of 2024, we sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $56.1 million.

The net proceeds to us after deducting sales commissions to TD Cowen were approximately $54.7 million.

During the third quarter of 2025, we sold 416,248 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $8.2 million.

The net proceeds to us after deducting sales commissions to TD Cowen were approximately $8.0 million.

The remaining capacity under the ATM Sales Agreement was approximately $19.1 million as of September 30, 2025.

The shares will be offered and sold pursuant to our 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.

In December 2019, we 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 we were able to from time to time offer and sell our 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.”

During the first quarter of 2024, we sold 3,400,468 ordinary shares under the ATM Sales Agreement for net proceeds to us of approximately $54.7 million after deducting sales commissions to TD Cowen of up to 3%.

During the third quarter of 2025, we sold 416,248 ordinary shares under the ATM Sales Agreement for net proceeds to us of approximately $8.0 million after deducting sales commissions to TD Cowen of up to 3%.

In November 2025, we 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”).

Following the amendment, during the fourth quarter of 2025, we sold 1,370,962 ordinary shares pursuant to the ATM Prospectus for net proceeds to us of approximately $31.8 million after deducting sales commissions to TD Cowen of up to 3%.

As of March 31, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.

Prepaid Forward Agreement

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Pharmakon Loan Agreement

On March 7, 2022, we entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100.0 million in two tranches.

On March 7, 2022, we entered into a loan agreement with Pharmakon (the “2022 Loan Agreement”) for a senior secured term loan of up to $100.0 million in two tranches.

The first tranche of $75.0 million ($72.6 million of proceeds were received, $70.8 million net of additional transaction costs) was funded in March 2022, and the second tranche of $25.0 million was funded in December 2022.

On June 29, 2023, the 2022 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.

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%.

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan.

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%.

On March 13, 2024, we 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.

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We elected not to draw down the fourth tranche.

Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of three-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

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%.

On February 26, 2026 (the "Closing Date"), we 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").

The first tranche of $200.0 million was advanced on the Closing Date and refinanced our 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.

The second tranche of $50.0 million may, at our option, be requested no later than June 30, 2027 for funding to occur no later than August 29, 2027, subject to customary conditions.

The term loans mature on the fifth anniversary of the Closing Date.

All outstanding loans with Pharmakon pursuant to the 2026 Loan Agreement accrue interest at a fixed rate of 8.25%.

The principal amount of the loans outstanding under the 2026 Loan Agreement will be repayable in four equal quarterly payments commencing in the second quarter of 2030, which are subject to an exit fee of 1% of the principal amount being repaid.

We may prepay the full outstanding principal amounts of the loans in whole at our discretion at any time, together with accrued but unpaid interest thereon and subject to prepayment premiums, make-whole amounts, as applicable, and fees.

and UroGen Pharma Ltd., subject to certain exceptions.

Securities Purchase Agreement

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On July 18, 2024, we completed the closing of the sale of 921,428 additional shares in the offering following the exercise in full of the Underwriters’ option to purchase additional shares, which resulted in additional gross proceeds of $16.1 million before deducting underwriting discounts and commissions and offering expenses of $1.0 million.

We have incurred losses since our inception and negative cash flows from our operations, and as of September 30, 2025, we had an accumulated deficit of $933.4 million.

We have incurred losses since our inception and negative cash flows from our operations, and as of March 31, 2026, we had an accumulated deficit of $983.3 million.

We expect to incur losses and have negative net cash flows from operating activities as we execute on our strategy, including the commercial launch of Zusduri , the continued commercialization of Jelmyto , and engaging in further research and development activities.

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Our ability to continue as a going concern is expected to be impacted by our ability to produce cash inflows from Jelmyto and Zusduri product sales, the rate of physician and patient adoption of Zusduri and our ability to raise additional capital to fund our operations in the future.

Based on our cash and cash equivalents and marketable securities as of September 30, 2025, together with management’s cash flow projections, we believe we have sufficient cash and cash equivalents to fund our operations beyond one year from the issuance of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

Based on our cash and cash equivalents and marketable securities as of March 31, 2026, together with management’s cash flow projections, we believe we have sufficient cash and cash equivalents to fund our operations beyond one year from the issuance of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

If we are unable to generate sufficient cash inflows from Jelmyto and Zusduri product sales, we may need to raise additional capital in the future or reduce operating expenditures.

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revenues we may derive either directly or in the form of royalty payments from future sales of Jelmyto , Zusduri , and, if approved, UGN-103, UGN-104, UGN-501, RTGel reverse thermal hydrogel technology and any other product candidates;

the timing and amount of any milestone, net sales or royalty payments owed by us from the development and/or commercialization of our products or product candidates;

the repayment of outstanding debt.

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Debt financing, if available, may involve agreements that include covenants that further limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

In addition, the terms of the Prepaid Forward Contract (the “Forward Contract”) with RTW and the loan agreement with Pharmakon limit our ability to take certain actions, including incurring additional indebtedness.

In addition, the terms of the Prepaid Forward Contract (the “Forward Contract”) with RTW and the 2026 Loan Agreement limit our ability to take certain actions, including incurring additional indebtedness.

If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

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In March 2019, we utilized the agreement extension option and extended the rent period for an additional three years until August 2022.

In July 2022, we signed a lease extension agreement extending the term of the lease through September 2025 and in June 2025 the Company exercised its renewal option to extend the lease through September 2028.

In July 2022, we signed a lease extension agreement extending the term of the lease through September 2025 and in June 2025 we exercised our renewal option to extend the lease through September 2028.

In November 2019, we entered into a new lease agreement, dated effective October 31, 2019, for an office in Princeton, NJ.

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Under the terms of the master lease agreement, we will lease various vehicles from time to time with an initial lease term of 48 months commencing on the delivery date of the vehicle with an option to continue month-to-month for an unlimited period of time.

The total obligation for future minimum lease payments under our operating and finance leases are $4.1 million and $6.0 million, respectively, as of September 30, 2025.

The total obligation for future minimum lease payments under our operating and finance leases are $3.9 million and $5.5 million, respectively, as of March 31, 2026.

See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

On March 7, 2022, we entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100.0 million in two tranches.

On March 7, 2022, we entered into the 2022 Loan Agreement with Pharmakon for a senior secured term loan of up to $100.0 million in two tranches.

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan.

On March 13, 2024, we entered into the 2024 Loan Agreement, which replaced the 2022 Loan Agreement.

The third tranche of $25.0 million was funded in September 2024.

The fourth tranche of $75.0 million became available upon our receipt of FDA approval of our NDA for Zusduri and could have been drawn at our option no later than August 29, 2025, subject to customary bringdown conditions and deliverables.

We elected not to draw the fourth tranche.

All outstanding loans with Pharmakon accrue interest using a benchmark rate of three-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

Per the terms of the amended and restated loan agreement, we received a one-year extension on the repayment period for all outstanding loans following the FDA's approval of the NDA for Zusduri .

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2027.

All outstanding loans with Pharmakon can be prepaid in whole at our discretion, at any time, subject to prepayment premiums and make-whole amounts.

The obligations of UroGen Pharma, Inc., as the borrower under the loan agreement are guaranteed on a full and unconditional basis by UroGen Pharma Ltd.

and the other guarantor parties thereto and are secured by substantially all of the respective Credit Parties’ tangible and intangible assets and property, including intellectual property, subject to certain exceptions.

We elected not to draw down the fourth tranche.

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%.

On February 26, 2026, we entered into the 2026 Loan Agreement, which replaced the 2024 Loan Agreement.

The first tranche of $200.0 million was advanced on the Closing Date and refinanced our original 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.

The second tranche of $50.0 million may, at our option, be requested no later than June 30, 2027 for funding to occur no later than August 29, 2027, subject to customary conditions.

The term loans mature on the fifth anniversary of the Closing Date.

All outstanding loans with Pharmakon pursuant to the 2026 Loan Agreement will accrue interest at a fixed rate of 8.25%.

We may prepay the loans in whole at our discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.

and UroGen Pharma Ltd., subject to certain exceptions.

On February 14, 2025, we entered into the IconOVir Agreement pursuant to which we purchased and acquired the Transferred Assets.

As consideration for the Transferred Assets and subject to the terms and conditions of the IconOVir Agreement, we (i) issued 374,843 of our ordinary shares to IconOVir, which represented a purchase price of $4.0 million divided by the volume-weighted average closing price of our ordinary 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 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 IconOVir Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts.

The following table sets forth the significant sources and uses of cash for the periods set forth below:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Operating Activities

Net cash used in operating activities was $124.1 million during the nine months ended September 30, 2025, compared to $83.1 million during the nine months ended September 30, 2024.

The $41.0 million increase was attributable primarily to higher net loss driven by increased operating expenses such as commercial preparation costs related to Zusduri and clinical trials expenses related to UGN-103 and UGN-104, as well as timing of certain payments and accruals.

Net cash used in operating activities was $45.3 million during the three months ended March 31, 2026, compared to $42.0 million during the three months ended March 31, 2025.

The $3.3 million increase was attributable primarily to timing of collections of accounts receivables, inventory purchases, and timing of payments and accruals, partially offset by lower net loss in the first quarter of 2026.

Investing Activities

Net cash provided by investing activities was $33.8 million during the nine months ended September 30, 2025, compared to net cash used in investing activities of $81.2 million during the nine months ended September 30, 2024.

The net change of $115 million primarily reflects higher investments in marketable securities in 2024, funded by the proceeds from the issuance of ordinary shares under the ATM Sales Agreement and the underwritten public offering, compared to 2025.

Net cash used in investing activities was $20.7 million during the three months ended March 31, 2026, compared to $26.0 million during the three months ended March 31, 2025.

The net change of $5.3 million primarily reflects lower reinvestments in marketable securities in the first quarter of 2026 as compared to the first quarter of 2025.

Financing Activities

Net cash provided by financing activities was $8.6 million during the nine months ended September 30, 2025, compared to $194.5 million during the nine months ended September 30, 2024.

The decrease of $185.9 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement in the first quarter of 2024, the underwritten public offering in the second quarter of 2024 and the issuance of debt related to the third tranche of the Pharmakon loan in the third quarter of 2024.

Net cash provided by financing activities was $65.2 million during the three months ended March 31, 2026, compared to $34 thousand during the three months ended March 31, 2025.

The increase of $65.2 million is primarily attributable to proceeds from the 2026 Loan Agreement with Pharmakon in the first quarter of 2026.

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.

What changed 10-Q

Item 1. Financial Statements