What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2026-08-05 compared with 2026-05-06 · 240 added, 180 removed, 1035 unchanged (29% of the section changed)

18 unchanged sentences

Restricted deposit

Right of use assets

Finance lease right-of-use assets

Operating lease right-of-use assets

Other non-current assets

5 unchanged sentences

Employee related accrued expenses

12,253 13,516

Current liabilities related to finance leases

Current liabilities related to operating leases

Other current liabilities

6 unchanged sentences

188,734 122,210

Long-term lease liabilities

Finance long-term lease liabilities

Operating long-term lease liabilities

Uncertain tax positions liability

3 unchanged sentences

Shareholders' deficit:

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

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at June 30, 2026 and December 31, 2025;

48,869,530 and 48,350,272 shares issued and outstanding as of June 30, 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 March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Cost of revenue

2 unchanged sentences

Selling, general and administrative expenses

Operating loss

Operating income (loss)

Financing on prepaid forward obligation

2 unchanged sentences

Loss before income taxes

Income tax benefit (expense)

Income tax expense

Statements of comprehensive loss

11 unchanged sentences

Accumulated other comprehensive

income (loss)

Balance as of April 1, 2026

Changes During the Three Months Ended June 30, 2026

Exercise of options into ordinary shares

Share-based compensation

Other comprehensive loss

Balance as of June 30, 2026

Balance as of April 1, 2025

Changes During the Three Months Ended June 30, 2025

Exercise of options into ordinary shares

Share-based compensation

Other comprehensive loss

Balance as of June 30, 2025

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

Changes During the Three Months Ended March 31, 2026

Changes During the Six Months Ended June 30, 2026

Exercise of options into ordinary shares

1 unchanged sentence

Other comprehensive loss

Balance as of March 31, 2026

Balance as of June 30, 2026

Balance as of January 1, 2025

Changes During the Three Months Ended March 31, 2025

Changes During the Six Months Ended June 30, 2025

Exercise of options into ordinary shares

3 unchanged sentences

Other comprehensive loss

Balance as of March 31, 2025

Balance as of June 30, 2025

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

UroGen Pharma Ltd.

Condensed Consolidated Statements of Cash Flow

Condensed Consolidated Statements of Cash Flows

in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash Flows From Operating Activities

$ ( 23,574 ) $ ( 43,843 )

Adjustment to reconcile net loss to net cash from operating activities:

Adjustments to reconcile net loss to net cash from operating activities:

Depreciation and amortization

Accrued financing on prepaid forward obligation

1,059 ( 1,889 )

Amortization (Accretion) on marketable securities

Accretion on marketable securities

Share-based compensation

3 unchanged sentences

Changes in operating assets and liabilities:

( 4,457 ) 1,637

Accounts receivable, net

( 22,330 ) 664

Prepaid expenses and other current assets

( 4,858 ) ( 4,138 )

Other non-current assets

( 2,332 ) 218

Accounts payable and accrued expenses

Employee related accrued expenses

( 3,679 ) ( 3,603 )

Other current liabilities

Lease liabilities

( 53 ) ( 738 )

Restricted deposit

Net cash used in operating activities

( 45,316 ) ( 42,024 )

Cash Flows From Investing Activities

Purchases of marketable securities

( 24,780 ) ( 66,351 )

Maturities of marketable securities

Purchases of property and equipment

( 54 ) ( 44 )

Net cash used in investing activities

( 20,688 ) ( 25,963 )

Net cash (used in) provided by investing activities

Cash Flows From Financing Activities

2 unchanged sentences

Proceeds from issuance of long-term debt, net

Proceeds from ordinary shares issuances, net of issuance costs

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

Net cash provided by financing activities

Decrease in Cash and Cash Equivalents

( 800 ) ( 67,953 )

Cash, Cash Equivalents and Restricted Cash at Beginning of Period

112,095 173,062

Cash, Cash Equivalents and Restricted Cash at End of Period

$ 111,295 $ 105,109

Supplemental Disclosures of Non-Cash Activities

23 unchanged sentences

Interim results are not necessarily indicative of results for the full fiscal year.

The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States.

The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by GAAP.

The unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in the Company’s Annual Report on Form 10 -K for the year ended December 31, 2025, as filed with the U.S.

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 $ 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 Company has experienced net losses since its inception and had an accumulated deficit o f $ 997.6 million and $ 959.7 million as of June 30, 2026 and December 31, 2025, respectively.

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 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.

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

19 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 $ 140.3 million as of March 31, 2026 .

Cash and cash equivalents and marketable securities totaled $ 108.0 million as of June 30, 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”.

99 unchanged sentences

Pre-funded Warrants

The Company issued pre-funded warrants in connection with both a private placement transaction and a public offering transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging.” Accordingly, the Company classifies the pre-funded warrants as a component of permanent shareholders’ equity within additional paid-in capital and records them at the applicable issuance date using a relative fair value allocation method.

The Company issued pre-funded warrants in connection with both a private placement transaction and a public offering transaction that are accounted for as a freestanding equity-linked financial instrument that meets the criteria for equity classification under ASC 480, “Distinguishing Liabilities from Equity,” and ASC 815, “Derivatives and Hedging.” The pre-funded warrants are exercisable upon original issuance and will not expire until exercised in full.

Accordingly, the Company classifies the pre-funded warrants as a component of permanent shareholders’ equity within additional paid-in capital and records them at the applicable issuance date using a relative fair value allocation method.

The Company valued the pre-funded warrants at the applicable issuance date, concluding that their sales price approximated their fair value, and allocated the net sales proceeds from the applicable equity transaction proportionately to the ordinary shares and pre-funded warrants.

18 unchanged sentences

Accounts Payable and Accrued Expenses

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

Accounts payable and accrued expenses consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

Accounts payable

6 unchanged sentences

Interest and Other Income, Net

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 and other income, net consisted of the following for the three and six months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Interest income

Other loss, net

Total interest and other income, net

Interest and other income, net

Note 5 – Inventories

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

Inventories consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

Raw materials (1)

$ 12,095 $ 11,042

Finished goods

Total inventories

$ 23,254 $ 16,464

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

( 1 ) $ 3.6 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at June 30, 2026 .

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

17 unchanged sentences

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 March 31, 2026 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 June 30, 2026 are as follows (in thousands):

Fair Value Measurements Using

4 unchanged sentences

Money market funds

Total cash equivalents

Marketable securities

Corporate bonds

Commercial paper

Certificates of deposit

15 unchanged sentences

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 March 31, 2026 and December 31, 2025 .

government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of June 30, 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 March 31, 2026 (in thousands):

The following table summarizes the Company’s investments as of June 30, 2026 (in thousands):

Cash equivalents

Money market funds

Total cash equivalents

Marketable securities:

Corporate bonds

Commercial paper

Certificates of deposit

2 unchanged sentences

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

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.

As of June 30, 2026 , the amortized cost of investments included an immaterial amount of accrued interest.

As of June 30, 2026 , marketable securities were in a net unrealized loss position.

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

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.

As of June 30, 2026 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 19.8 million which consisted of three 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.

In accordance with the Company’s general investment strategy, the Company does not intend to sell the investments before maturity.

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.

As of June 30, 2026 , 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 June 30, 2026 mature at various dates through October 2026.

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

3 unchanged sentences

Note 8 – Property and Equipment

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

Property and equipment consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

Laboratory equipment

3 unchanged sentences

accumulated depreciation and amortization

( 4,662 ) ( 4,587 )

Property and equipment, net

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 .

Depreciation and amortization expense was $ 0.1 and $ 0.2 million for the three and six months ended June 30, 2026 , respectively and $ 0.1 and $ 0.2 million for the three and six months ended June 30, 2025 , respectively.

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

The rate in effect for the six months ended June 30, 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 March 31, 2026 , the cumulative amounts paid and payable by the Company were $ 51.0 million.

As of June 30, 2026 , the cumulative amounts paid and payable by the Company were $ 55.1 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 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:

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 six months ended June 30, 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 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.

Carrying value of prepaid forward obligation as of June 30, 2026

( 1 ) $ 7.7 million and $ 3.4 million were classified as the current portion of the prepaid forward obligation and are included within other current liabilities on the condensed consolidated balance sheets as of June 30, 2026 and December 31, 2025, respectively.

The remaining $ 3.5 million of the $ 11.2 million of Amounts paid and payable as of June 30, 2026 represents the expected decrease in the carrying amount of the prepaid forward obligation over the next 12 months and is included within other current liabilities on the condensed consolidated balance sheets.

Note 10 – Long-Term Debt

7 unchanged sentences

The fourth tranche of $ 75.0 million became available at the Company's option no later than August 29, 2025, based upon having received FDA approval of a new drug application (“NDA”) for Zusduri by June 30, 2025.

The Company did not draw down the fourth tranche.

The Company 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, ( 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”).

On February 26, 2026 ( the "Closing Date"), the Company entered into a second amended and restated loan agreement with Pharmakon, which replaced the 2024 Loan Agreement, 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.

9 unchanged sentences

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".

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 on long-term debt".

The following table shows the activity with respect to the carrying value of the long-term debt, in thousands:

10 unchanged sentences

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:

Carrying value of Pharmakon loan as of June 30, 2026

The aggregate principal maturities of long-term debt as of June 30, 2026 are as follows, in thousands:

Principal Payments

5 unchanged sentences

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 .

The Company's remaining contractual obligation under this lease is approximately $ 0.9 million as of June 30, 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.

5 unchanged sentences

As a result, the Company remeasured its lease liability and corresponding right-of-use asset using its incremental borrowing rate at the modification date.

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

The Company’s remaining contractual obligation under this lease is approximately $ 2.9 million as of June 30, 2026 .

Finance Leases

4 unchanged sentences

The Company may also be required to pay additional rent if the vehicle exceeds certain mileage limits or shows abnormal wear and tear during the lease term.

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 .

The Company’s remaining contractual obligation relating to the leases entered into under this master agreement is approximately $ 5.3 million as of June 30, 2026 .

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

2 unchanged sentences

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 months ended March 31, 2026 and 2025 were as follows (in thousands):

In the second quarter of 2026, the Company began presenting right-of-use operating lease assets and lease liabilities separately from right-of-use finance lease assets and lease liabilities on the balance sheet and has adjusted the prior period presentation to conform.

The Company previously reported all right-of-use assets within the financial statement line item “Right of use assets”, all long-term lease liabilities in the financial statement line item “Long-term lease liabilities”, and all short-term lease liabilities in the financial statement line item “Other current liabilities”.

The components of lease cost for the three and six months ended June 30, 2026 and 2025 were as follows (in thousands):

Three Months Ended

Six Months Ended

Finance lease cost:

4 unchanged sentences

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

$ 5,009 $ 5,376

Operating lease right-of-use assets

Finance long-term lease liabilities

Operating long-term lease liabilities

Other current liabilities related to finance leases

Other current liabilities related to operating leases

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

As of June 30, 2026 , no impairment losses have been recognized.

Supplemental information related to leases for the six months ended June 30, 2026 and 2025 is as follows (in thousands, except for lease terms and discount rate amounts):

Six Months Ended

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

5 unchanged sentences

Weighted-average discount rate of finance leases

13.82 % 13.82 %

Weighted-average discount rate of operating leases

11.82 % 10.23 %

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

As of June 30, 2026 , maturities of lease liabilities were as follows (in thousands):

Finance Leases

1 unchanged sentence

Remainder of 2026

2030 and there after

2030 and thereafter

Total future minimum lease payments

2 unchanged sentences

Remainder of 2026

2031 and there after

2031 and thereafter

Total future minimum lease payments

1 unchanged sentence

Note 12 – Revenue From Product Sales

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

Net product sales consist of the following for the three and six months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended

Six Months Ended

$ 22,028 $ 24,215 $ 43,741 $ 44,469

50,429 — 79,675 —

Total Revenue

1 unchanged sentence

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 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's largest customer comprised approximately 52 % and over 75 % of product sales for the three months ended June 30, 2026 and June 30, 2025, respectively, and approximately 52 % and over 80 % of product sales for the six months ended June 30, 2026 and June 30, 2025, respectively.

The Company's largest customer comprised approximately 34 % and 59 % of accounts receivable at June 30, 2026 and December 31, 2025, respectively.

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.

2 unchanged sentences

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 March 31, 2026 and 2025 (in thousands):

The following table shows the activity with respect to sales reserves for the period ended June 30, 2026 and 2025 (in thousands):

Reserves related to government sponsored programs

6 unchanged sentences

( 12,354 ) — ( 11,627 ) ( 23,981 )

Balance as of March 31, 2026

Balance as of June 30, 2026

$ 1,867 $ 5,809 $ 7,663 $ 15,339

3 unchanged sentences

( 6,924 ) ( 3,809 ) ( 5,437 ) ( 16,170 )

Balance as of March 31, 2025

Balance as of June 30, 2025

$ 1,737 $ 5,984 $ 2,274 $ 9,995

9 unchanged sentences

Note 14 – Acquisitions

On February 14, 2025 ( the “Closing Date”), the Company entered into an Asset Purchase Agreement (as amended, the “Agreement”) with IconOVir Bio, Inc.

On February 14, 2025 ( the “APA Closing Date”), the Company entered into an Asset Purchase Agreement (as amended, the “Agreement”) with IconOVir Bio, Inc.

(“IconOVir”), pursuant to which the Company purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including the product candidate ICVB- 1042 and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by the Company.

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”).

As consideration for the Transferred Assets and subject to the terms and conditions of the Agreement, on the APA 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 APA 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”).

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.

11 unchanged sentences

Note 15 – Shareholders ’ Equity

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.

The Company had 100.0 million ordinary shares authorized for issuance as of June 30, 2026 and December 31, 2025 .

The Company had 48.9 million and 48.4 million ordinary shares issued and outstanding as of June 30, 2026 and December 31, 2025 , respectively.

Each ordinary share is entitled to one vote.

7 unchanged sentences

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.

As of June 30, 2026 , the remaining capacity under the ATM Prospectus was approximately $ 42.4 million.

Securities Purchase Agreement

7 unchanged sentences

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

As of June 30, 2026 , 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.

Monograph Capital Partners I, L.P.

7 unchanged sentences

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 March 31, 2026, all 1,142,857 pre-funded warrants remain outstanding.

As of June 30, 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.

39 unchanged sentences

On August 26, 2025, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 2,750,000 shares to a total share reserve of 8,750,167 shares.

On June 22, 2026, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 1,000,000 shares to a total share reserve of 9,750,167 shares.

In May 2019, the Company adopted the UroGen Pharma Ltd.

4 unchanged sentences

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 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.

As of June 30, 2026 , 5,328,864 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 2,926,039 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

Six Months Ended

Research and development expenses

1 unchanged sentence

Total share-based compensation expense

$ 4,627 $ 3,069

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.

The total unrecognized compensation cost of options, RSUs and PSUs at June 30, 2026 is $ 39.0 million with a weighted average recognition period of 2.03 years.

Note 17 – Income Taxes

1 unchanged sentence

is taxed under Israeli tax laws.

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

As of June 30, 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 2025, 2024 and 2023, and for the three months ended March 31, 2026 .

The Company has cumulative global pretax losses for the years ended 2025, 2024 and 2023, and for the six months ended June 30, 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 $ 3.9 million as of March 31, 2026 , 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 June 30, 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 March 31, 2026 , the Company’s liability for uncertain tax positions includes $ 2.1 million of accrued interest and penalties.

As of June 30, 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.

5 unchanged sentences

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 three months ended March 31, 2026 or 2025.

There were no further related party transactions during the six months ended June 30, 2026 or 2025.

Note 19 – Commitments and Contingencies

1 unchanged sentence

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 March 31, 2026 and December 31, 2025 .

The Company’s maximum exposure under these arrangements is unknown as of June 30, 2026 and December 31, 2025 .

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

On April 2, 2024, the Company filed a lawsuit in the U.S.

District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S.

Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing U.S.

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

District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.

(together with Teva Pharmaceuticals, Inc., “Teva”), and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S.

Patent Numbers 9,040,074 and 9,950,069 in response to Teva’s submission of an Abbreviated New Drug Application to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto in the United States prior to the expiration of such patents.

The Company sought a permanent injunction preventing U.S.

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

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.

On June 2, 2026, the Company entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation.

Under the Agreement, the Company has agreed to grant Teva a non-exclusive license to sell its generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur.

On June 3, 2026, the court granted the parties' Stipulated Dismissal Order, dismissing and closing the civil action.

As required by law, the parties submitted the Agreement to the U.S.

Federal Trade Commission and U.S.

Department of Justice for review.

See Note 11 for further discussion regarding lease commitments.

8 unchanged sentences

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

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Research and development expenses

3 unchanged sentences

Employee compensation

4,767 4,744 9,511 9,125

Rent, office, utilities & technology

865 734 1,800 1,590

Other expenses

258 118 471 232

Total research and development expenses

4 unchanged sentences

Commercial & medical affairs services

11,667 10,873 21,603 19,071

Professional services

3,687 3,576 11,212 6,348

Travel, meetings & conferences

3,838 5,629 8,900 9,274

Rent, office, utilities & technology

1,510 1,193 3,034 2,328

Other expenses (1)

2,355 2,365 3,686 3,454

Total selling, general and administrative expenses

52 unchanged sentences

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

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.

Prior to Jelmyto , the 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.

5 unchanged sentences

At the 12-month assessment of durability, 23 of 41 total patients remained in CR, eight patients experienced recurrence of disease and ten patients were unable to be evaluated.

Durability of response was estimated to be 81.8% at 12 months by Kaplan-Meier analysis.

The median duration of response (“DOR”) was not reached.

Durability of response ("DOR") was estimated to be 81.8% at 12 months by Kaplan-Meier analysis.

The median duration of response was not reached.

The most commonly reported adverse events (≥ 20%) were ureteric obstruction, flank pain, urinary tract infection, hematuria, abdominal pain, fatigue, renal dysfunction, nausea, dysuria and vomiting.

2 unchanged sentences

In February 2025, we presented additional new data from the long-term follow-up study to UroGen’s Phase 3 Olympus trial.

Among patients from the trial who achieved a CR after primary chemoablation with Jelmyto (n=41, 20 of whom entered the long-term follow-up study), the median DOR was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]).

Among patients from the trial who achieved a CR after primary chemoablation with Jelmyto (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]).

The study results were published in the March 2025 issue of The Journal of Urology .

46 unchanged sentences

Median follow-up time was 23.7 months after the three-month CR.

The median DOR had not yet been reached.

The median duration of response had not yet been reached.

In May 2026, we announced 36-month DOR data from the Phase 3 ENVISION trial.

The 36-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri was 64.5% (95% CI, 54.6%, 72.8%).

Median follow-up time was 35.5 months after the three-month CR, and the median duration of response had not been reached.

Additionally, in July 2025 we announced outcomes from the five-year long-term extension study of the single-arm, Phase 2b OPTIMA II study.

Among the 41 patients who achieved CR at three months post-treatment with Zusduri in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study.

For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of DOR was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months.

For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI:

For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months.

For the 17 patients in the long-term follow-up study, the median duration of response was 42.1 months by Kaplan-Meier estimate (95% CI:

24.2, NE), with a median follow-up of 50.4 months.

18 unchanged sentences

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

In July 2026, we announced that we received a Notice of Allowance from the U.S.

Patent and Trademark Office for a new U.S.

patent covering methods of treating recurrent low-grade intermediate risk NMIBC without TURBT, supported by data from the ENVISION and ATLAS clinical trials.

Once issued, the patent is expected to provide protection into July 2044, further strengthening the intellectual property supporting Zusduri and UGN-103, if approved, and reinforcing the long-term commercial opportunity for both products.

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

7 unchanged sentences

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.

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.

A long-term follow up study will also be conducted following patients remaining in CR for up to five years after achieving CR at three months.

In November 2025, we reported a three-month CR rate of 77.8% (95% CI, 68.3%, 85.5%), and in May 2026 reported six-month DOR by Kaplan-Meier estimate of 94.5% (95% CI:

86.1%, 97.9%), 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.

We remain on track to submit an NDA for UGN-103 in the third quarter 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.

7 unchanged sentences

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.

In July 2026, we announced that the FDA had cleared our IND for UGN-501, enabling the initiation of a Phase 1 clinical trial in patients with NMIBC.

The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and we plan to subsequently 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.

The Phase 1 study is expected to begin in the fourth quarter of 2026 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.

UGN-301 (zalifrelimab) intravesical solution

1 unchanged sentence

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.

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

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.

4 unchanged sentences

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

While the Phase 1 clinical study of UGN-301 confirmed proof of concept for our proprietary RTGel technology as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet our internal benchmarks for advancement to Phase 2.

While the Phase 1 clinical trial of UGN-301 confirmed proof of concept for our proprietary RTGel technology as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet our internal benchmarks for advancement to Phase 2.

The program achieved key proof of concept objectives, including sustained bladder exposure with minimal systemic absorption and an acceptable safety and tolerability profile, demonstrating the ability to mitigate CTLA-4–related toxicities, and encouraging efficacy signals.

9 unchanged sentences

IconOVir Agreement

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

On February 14, 2025 (the “APA 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.

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 APA 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 APA Closing Date until the earlier of the 10 th anniversary of the APA 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 months ended March 31, 2026 and 2025 we recognized $51.0 million and $20.3 million of revenue, respectively, from sales of our products.

During the three and six months ended June 30, 2026, we recognized $72.5 million and $123.4 million of revenue, respectively, from sales of our products.

Cost of Revenue

12 unchanged sentences

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

7 unchanged sentences

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 probable of being achieved.

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

Research and development expenses will continue to be significant.

Our future research and development expenses will depend on the clinical success of our product candidates.

As we continue to focus on advancing our product candidates, we expect research and development expenses to continue to be significant.

Research and development activities are central to our business model.

48 unchanged sentences

Results of Operations

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,

Comparison of the three months ended June 30, 2026 and 2025

The following table sets forth our results of operations for the three months ended June 30, 2026 and 2025.

Three Months Ended June 30,

(in thousands)

5 unchanged sentences

Total operating expenses

Operating income (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 $72.5 million and $24.2 million for the three months ended June 30, 2026 and 2025, respectively.

The increase in revenue of $48.3 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 $6.6 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively.

The increase in cost of revenue of $3.0 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 into early 2027 as we deplete Zusduri inventories that we expensed prior to receiving FDA approval.

Research and Development Expenses

Research and development expenses were $17.3 million and $18.9 million for the three months ended June 30, 2026 and 2025, respectively.

The decrease in research and development expenses of $1.6 million is primarily attributable to costs related to manufacturing of Zusduri which were recognized as research and development expenses prior to receiving FDA approval in June 2025.

Selling and Marketing Expenses

Selling and marketing expenses were $32.9 milli on and $27.9 million for the three months ended June 30, 2026 and 2025 , respectively.

The increase in selling and marketing expenses of $5.0 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 $15.5 million and $15.3 million for the three months ended June 30, 2026 and 2025 , respectively.

The increase in general and administrative expenses of $0.2 million is primarily attributable to slightly higher spending on third-party advisory services.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $4.5 million and $4.6 million for the three months ended June 30, 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.

The decrease in financing on prepaid forward obligation of $0.1 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $4.9 million and $4.1 million for the three months ended June 30, 2026 and 2025, respectively.

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

Interest and Other Income, Net

Interest and other income, net was $0.6 million and $1.3 million for the three months ended June 30, 2026 and 2025, respectively.

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

Comparison of the six months ended June 30, 2026 and 2025

The following table sets forth our results of operations for the six months ended June 30, 2026 and 2025.

Six Months Ended June 30,

(in thousands)

Cost of revenue

Operating expenses:

Research and development

Selling and marketing

General and administrative

Total operating expenses

Operating loss

4 unchanged sentences

Income tax expense

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

Revenue was $123.4 million and $44.5 million for the six months ended June 30, 2026 and 2025, respectively.

The increase in revenue of $78.9 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 $4.1 million and $2.3 million for the three months ended March 31, 2026 and 2025, respectively.

Cost of revenue was $10.7 million and $5.9 million for the six months ended June 30, 2026 and 2025, respectively.

The increase in cost of revenue of $4.8 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.

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

Research and Development Expenses

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

Research and development expenses were $32.9 million and $38.8 million for the six months ended June 30, 2026 and 2025, respectively.

The decrease in research and development expenses of $5.9 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 $32.1 milli on and $22.1 million for the three months ended March 31, 2026 and 2025 , respectively.

Selling and marketing expenses were $65.1 milli on and $50.0 million for the six months ended June 30, 2026 and 2025 , respectively.

The increase in selling and marketing expenses of $15.1 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 $19.4 million and $12.8 million for the three months ended March 31, 2026 and 2025 , respectively.

General and administrative expenses were $34.9 million and $28.2 million for the six months ended June 30, 2026 and 2025 , respectively.

The increase in general and administrative expenses of $6.7 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 $4.5 million and $4.6 million for the three months ended March 31, 2026 and 2025, respectively.

Financing on prepaid forward obligation was $9.1 million and $9.2 million for the six months ended June 30, 2026 and 2025, respectively.

1 unchanged sentence

Interest Expense on Long-term Debt

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 expense was $9.1 million and $8.2 million for the six months ended June 30, 2026 and 2025, respectively.

Interest and Other Income, Net

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

Interest and other income, net was $1.2 million and $3.4 million for the six months ended June 30, 2026 and 2025, respectively.

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

Liquidity and Capital Resources

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

As of June 30, 2026, we had $108.0 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 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.

Through June 30, 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

4 unchanged sentences

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.

As of June 30, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.

Prepaid Forward Agreement

6 unchanged sentences

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").

On March 13, 2024, we 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.

2 unchanged sentences

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").

On February 26, 2026 (the "Closing Date"), we entered into a second amended and restated loan agreement with Pharmakon, which replaced the 2024 Loan Agreement, 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.

19 unchanged sentences

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 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.

We have incurred losses since our inception and negative cash flows from our operations, and as of June 30, 2026, we had an accumulated deficit of $997.6 million.

Our primary uses of capital are, and we expect will continue to be, commercialization activities, research and development expense, including third-party clinical research and development services, laboratory and related supplies, clinical costs, including manufacturing costs, legal and other regulatory expense and general and administrative costs.

1 unchanged sentence

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 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.

Based on our cash and cash equivalents and marketable securities as of June 30, 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.

36 unchanged sentences

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 $3.9 million and $5.5 million, respectively, as of March 31, 2026.

The total obligation for future minimum lease payments under our operating and finance leases are $3.8 million and $5.3 million, respectively, as of June 30, 2026.

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

18 unchanged sentences

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

5 unchanged sentences

Operating Activities

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.

Net cash used in operating activities was $78.3 million during the six months ended June 30, 2026, compared to $81.8 million during the six months ended June 30, 2025.

The $3.5 million decrease was attributable primarily to a lower net loss in 2026 as compared to 2025, as well as timing of payments and accruals, partially offset by the timing of collections of accounts receivable and inventory purchases.

Investing Activities

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.

Net cash used in investing activities was $19.0 million during the six months ended June 30, 2026, compared to cash provided by investing activities of $2.4 million during the six months ended June 30, 2025.

The net change of $21.4 million primarily reflects reinvestments in marketable securities in the six months ended June 30, 2026 as compared to 2025.

Financing Activities

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.

Net cash provided by financing activities was $65.7 million during the six months ended June 30, 2026, compared to $0.3 million during the six months ended June 30, 2025.

The increase of $65.4 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