What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-11-06 compared with 2025-08-07 · 266 added, 190 removed, 1136 unchanged (29% of the section changed)

3 unchanged sentences

in thousands, except share amounts and par value)

September 30,

Current assets:

36 unchanged sentences

Shareholders' Deficit:

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

46,199,134 and 42,231,746 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

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

Additional paid-in capital

11 unchanged sentences

in thousands, except share and per share amounts)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

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

17 unchanged sentences

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

Income tax expense

Income tax benefit (expense)

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

19 unchanged sentences

income (loss)

Balance as of April 1, 2025

Balance as of July 1, 2025

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

Changes During the Three Months Ended June 30, 2025

Changes During the Three Months Ended September 30, 2025

Exercise of options into ordinary shares

1 unchanged sentence

Share-based compensation

Other comprehensive loss

Issuance of ordinary shares, net of issuance costs

416,248 1 7,968 7,969

Balance as of June 30, 2025

Other comprehensive income

( 33,347 ) ( 33,347 )

Balance as of April 1, 2024

Balance as of September 30, 2025

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

Changes During the Three Months Ended June 30, 2024

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

1 unchanged sentence

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

18,641 18,641

Issuance of ordinary shares, net of issuance costs

2 unchanged sentences

( 23,673 ) ( 23,673 )

Balance as of June 30, 2024

Balance as of September 30, 2024

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

9 unchanged sentences

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

Changes During the Six Months Ended June 30, 2025

Changes During the Nine Months Ended September 30, 2025

Exercise of options into ordinary shares

8 unchanged sentences

( 127,130 ) ( 127,130 )

Balance as of June 30, 2025

Balance as of September 30, 2025

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

1 unchanged sentence

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

Changes During the Six Months Ended June 30, 2024

Changes During the Nine Months Ended September 30, 2024

Exercise of options into ordinary shares

5 unchanged sentences

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

Other comprehensive loss

( 43 ) ( 43 )

Other comprehensive income

( 89,362 ) ( 89,362 )

Balance as of June 30, 2024

Balance as of September 30, 2024

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

3 unchanged sentences

in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash Flows From Operating Activities

7 unchanged sentences

Amortization (accretion) of discount on long-term debt

377 ( 1,330 )

Amortization of right of use assets

9 unchanged sentences

Accounts payable and accrued expenses

( 1,258 ) 3,147

Employee related accrued expenses

8 unchanged sentences

Purchases of marketable securities

( 76,861 ) ( 118,794 )

Maturities of marketable securities

3 unchanged sentences

Net cash provided by investing activities

33,841 ( 81,234 )

Cash Flows From Financing Activities

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 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

32 unchanged sentences

Securities and Exchange Commission (“SEC”) on March 10, 2025.

The Company has experienced net losses since its inception and had an accumulated deficit o f $ 900.0 million and $ 806.2 million as of June 30, 2025 and December 31, 2024, respectively.

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.

3 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 June 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 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.

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 $ 161.6 million as of June 30, 2025 .

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

The Company accounts for its investments, which include cash equivalents and marketable securities, as available-for-sale in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 320, “Investments — Debt and Equity Securities”.

Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive income (loss) within shareholders’ equity (deficit).

Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) within the condensed consolidated statements of shareholders’ deficit.

Realized gains and losses are recorded as a component of interest and other income, net.

17 unchanged sentences

The accounts are monitored by management to mitigate the risk.

The Company’s accounts receivables are composed of net sales of Jelmyto arising from the Company's arrangements with two customers, both of which are third -party national specialty distributors.

The Company’s accounts receivables are composed of net sales of Jelmyto and Zusduri arising from the Company's arrangements with two customers, both of which are third -party national specialty distributors.

The Company assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions.

53 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, typically upon delivery of the product to the treating physician.

All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.

Net revenue recognized includes gross revenue and management’s estimate of returns, consideration paid to the customers, chargebacks relating to differences between the wholesale acquisition cost and the contracted price offered to the end consumer, chargebacks relating to 340B drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refunds for discarded drug, which are estimated based on the Company’s historical experience.

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.

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.

Research and Development Expenses

13 unchanged sentences

For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable.

PSUs that include both a performance condition and a service condition are subject to graded vesting, and the related compensation cost is recognized on a straight-line basis over the requisite service period for each separately vesting tranche.

The fair value of options is determined using the Black-Scholes option-pricing model.

21 unchanged sentences

The Company is currently evaluating the potential impact of the adoption of ASU 2024 - 03 on the Company’s financial disclosures.

In July 2025, the FASB issued Accounting Standards Update No.

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 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 June 30, 2025 and December 31, 2024 (in thousands):

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

September 30,

Accounts payable

8 unchanged sentences

Interest and Other Income, Net

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

Three Months Ended June 30,

Six Months Ended June 30,

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 income

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

Other income (loss), net

Other loss, net

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

2 unchanged sentences

Note 5 – Inventories

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

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

September 30,

Raw materials (1)

3 unchanged sentences

$ 8,341 $ 9,446

( 1 ) $ 0.4 million and $ 0.2 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at June 30, 2025 and December 31, 2024, respectively.

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

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.

Note 6 – Fair Value Measurements

14 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 June 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 September 30, 2025 are as follows (in thousands):

Fair Value Measurements Using

1 unchanged sentence

Balance as of

September 30,

Identical Assets

2 unchanged sentences

$ 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

31 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 June 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 September 30, 2025 and December 31, 2024 .

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 June 30, 2025 (in thousands):

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

Cash equivalents

1 unchanged sentence

$ 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:

11 unchanged sentences

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

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

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

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.

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

As of June 30, 2025 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 57.4 million which consisted of 14 securities.

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.

3 unchanged sentences

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

As of June 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 June 30, 2025 mature at various dates through November 2026.

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.

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

September 30,

Maturities within one year

4 unchanged sentences

Note 8 – Property and Equipment

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

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

September 30,

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 six months ended June 30, 2025 , respectively, and $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2024 , respectively.

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.

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 six months ended June 30, 2025 for annual net sales up to $ 200 million was 13.0 %.

The rate in effect for the nine months ended September 30, 2025 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 June 30, 2025 , the cumulative amounts paid and payable by the Company were $ 40.6 million.

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

4 unchanged sentences

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

Carrying value of prepaid forward obligation as of December 31, 2023

4 unchanged sentences

Amounts paid and payable (1)

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

( 1 ) $ 3.1 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 June 30, 2025 , and December 31, 2024, respectively.

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.

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.

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 %.

12 unchanged sentences

Interest expense

Carrying value of Pharmakon loan as of June 30, 2025

Carrying value of Pharmakon loan as of September 30, 2025

Note 11 – Leases

3 unchanged sentences

In July 2022, the Company signed a lease extension agreement for the Company’s offices located in Israel, extending the term of the lease through September 2025, and, effective as of June 2025, was renewed through September 2028.

The Company's remaining contractual obligation under this lease is approximately $ 1.0 million as of June 30, 2025 .

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.

7 unchanged sentences

In June 2022, the Company signed a lease extension for the Princeton office, extending the term of the lease through January 31, 2026.

The Company’s remaining contractual obligation under this lease is approximately $ 0.3 million as of June 30, 2025 .

In August 2025, the Company signed an additional lease extension for the Princeton office, extending the term of the lease through April 30, 2031.

The Company concluded that the lease renewal option in the agreement is not reasonably certain to be exercised.

The modification did not result in a separate lease under ASC 842.

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 .

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 $ 4.8 million as of June 30, 2025 .

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 .

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 and six months ended June 30, 2025 and 2024 were as follows (in thousands):

The components of lease cost for the three and nine months ended September 30, 2025 and 2024 were as follows (in thousands):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Finance lease cost:

7 unchanged sentences

$ 884 $ 239 $ 2,117 $ 690

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

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

September 30,

Finance lease right-of-use assets

5 unchanged sentences

Other current liabilities related to operating leases

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

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

Six Months Ended

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,

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

7 unchanged sentences

11.77 % 10.26 %

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

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

Finance Leases

6 unchanged sentences

Remainder of 2025

2030 and there after

Total future minimum lease payments

Present value of lease liabilities

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

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

Years ending December 31,

3 unchanged sentences

Note 12 – Revenue From Product Sales

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

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

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

$ 25,703 $ 25,204 $ 70,172 $ 65,833

All product sales of Jelmyto are recognized through the Company's arrangements with two customers as defined by ASC 606, both of which are third -party national specialty distributors.

The Company's largest customer comprises over 75 % and 80 % of product sales for the three and six months ended June 30, 2025 , respectively.

During the six months ended June 30, 2024, the Company had a single customer.

The Company's largest customer comprises approximately 84 % and 80 % of accounts receivables at June 30, 2025 and December 31, 2024, respectively.

1,779 — 1,779 —

Total Revenue

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

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

The Company estimates these elements of variable consideration based on the contractual or statutory terms governing the arrangements and the Company’s historical experience, and constrains the net revenue recognized for product sales to the value that is not probable to be reversed when the uncertainty associated with the variable consideration is subsequently resolved.

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 June 30, 2025 and 2024 (in thousands):

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

Reserves related to government sponsored programs

6 unchanged sentences

( 10,787 ) ( 3,809 ) ( 8,042 ) ( 22,638 )

Balance as of June 30, 2025

Changes to prior period estimates

— ( 414 ) — ( 414 )

Balance as of September 30, 2025

$ 2,209 $ 6,511 $ 2,265 $ 10,985

Balance as of December 31, 2023

2 unchanged sentences

( 10,206 ) — ( 7,219 ) ( 17,425 )

Balance as of June 30, 2024

Balance as of September 30, 2024

$ 689 $ 6,564 $ 1,942 $ 9,195

4 unchanged sentences

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.

Note 14 – Acquisitions

14 unchanged sentences

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 six months ended June 30, 2025.

Note 15 – Shareholders ’ Equity

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

The Company had 46.2 million and 42.2 million ordinary shares issued and outstanding as of June 30, 2025 and December 31, 2024 , respectively.

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.

Each ordinary share is entitled to one vote.

5 unchanged sentences

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

The Company did not sell any ordinary shares under the ATM Sales Agreement in the six months ended June 30, 2025.

The remaining capacity under the ATM Sales Agreement was approximately $ 27.3 million as of June 30, 2025.

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.

8 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 June 30, 2025, 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.

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

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

In addition, the Underwriters were granted an option exercisable for 30 days, to purchase up to 921,428 additional shares at the public offering price, less the underwriting discounts and commissions.

19 unchanged sentences

The Company also grants PSUs to certain employees.

The PSU’s granted during 2023 vested upon regulatory approval of Zusduri .

The PSU's granted in 2024 vest upon the achievement of the first commercial sale of Zusduri in the United States following receipt of regulatory approval.

The PSU's granted in 2025 vest upon achievement of a net product sales target for Zusduri and continued service for three years following the grant date.

The PSUs granted during 2023 vested upon U.S.

regulatory approval of Zusduri .

The PSUs granted in 2024 vested upon the achievement of the first commercial sale of Zusduri in the United States following receipt of U.S.

regulatory approval.

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.

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.

9 unchanged sentences

On August 6, 2024, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 800,000 shares to a total share reserve of 6,000,167 shares.

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

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

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 June 30, 2025 , 4,620,861 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 767,228 ordinary shares remain available for future awards.

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.

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

Nine Months Ended

September 30,

Research and development expenses

4 unchanged sentences

$ 3,027 $ 3,489 $ 8,829 $ 9,805

The total unrecognized compensation cost of options, RSUs and PSUs at June 30, 2025 is $ 18.3 million with a weighted average recognition period of 2.06 years.

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.

Note 17 – Income Taxes

1 unchanged sentence

is taxed under Israeli tax laws.

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

As of September 30, 2025 , 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 six months ended June 30, 2025 .

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 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 June 30, 2025 , for tax positions relating to transfer pricing between affiliated entities.

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

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

As of September 30, 2025 , the Company’s liability for uncertain tax positions includes $ 1.8 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.

7 unchanged sentences

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

The Company is currently evaluating the potential impact of the OBBBA to the Company’s financial statements.

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.

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 six months ended June 30, 2025 or 2024.

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

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 June 30, 2025 and December 31, 2024 .

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

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

12 unchanged sentences

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.

4 unchanged sentences

The Company has a single operating segment and reportable segment focused on these business activities, and its operations are managed on a consolidated basis.

The primary revenue source for the segment comes from sales of the Company’s first approved product, Jelmyto , primarily conducted in the United States.

The primary revenue source for the segment comes from sales of the Company’s approved products, Jelmyto and Zusduri , primarily conducted in the United States.

The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer (“CEO”).

3 unchanged sentences

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

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Research and development expenses

27 unchanged sentences

Note 21 – Subsequent Events

The Company has evaluated and determined there were no 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 six months ended June 30, 2024 are presented as follows:

For the Three Months Ended June 30, 2024

For the Six Months Ended June 30, 2024

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

5 unchanged sentences

$ ( 0.51 ) $ ( 2.15 )

( 1 ) The loss per share, both basic and diluted, for the second quarter of 2024 was revised to record an immaterial correction to the amounts originally reported in the June 30, 2024 Form 10 -Q filed on August 13, 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.

( 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.

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

14 unchanged sentences

Our approved products Jelmyto (mitomycin) for pyelocalyceal solution and Zusduri (mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (“low-grade UTUC”) and recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”), respectively.

In addition, our immuno-uro-oncology pipeline includes UGN-301 (zalifrelimab) intravesical solution, an anti-CTLA-4 antibody, which we intend to study as both a monotherapy and combination therapy, and UGN-501 (formerly known as ICVB-1042), a next-generation investigational oncolytic virus.

In addition, our immuno-uro-oncology pipeline includes UGN-501 (formerly known as ICVB-1042), a next-generation investigational oncolytic virus.

On June 12, 2025, the U.S.

7 unchanged sentences

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

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

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.

4 unchanged sentences

increasing the exposure of active drugs in the bladder and upper urinary tract by significantly extending the dwell time of the active drug while conforming to the anatomy of the bladder and the upper urinary tract, which allows for enhanced drug tissue coverage.

For example, the average dwell time of the standard aqueous mitomycin formulation, currently used as adjuvant treatment, in the upper urinary tract is approximately five minutes, compared to approximately six hours when mitomycin is formulated with RTGel ;

For example, the average dwell time of the standard aqueous mitomycin formulation, currently used as adjuvant treatment, in the upper urinary tract is approximately five minutes, compared to approximately four to six hours when mitomycin is formulated with RTGel ;

administering higher doses of an active drug than would otherwise be possible using standard water-based formulations.

49 unchanged sentences

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 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 often conducted under general anesthesia and may require an overnight stay.

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.

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

In addition, by reducing the need for surgery, patients may avoid potential complications associated with surgery and anesthesia.

In addition, by potentially reducing the need for surgery, patients may avoid potential complications associated with surgery and anesthesia.

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

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

We estimate that 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.

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.

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

8 unchanged sentences

Among all 240 patients enrolled in the ENVISION trial, 60.8% (54.3%, 67.0%) were in CR at 12 months.

In the ENVISION trial, DOR Kaplan-Meier estimates at 15 (n=43) and 18 (n=9) months were both 80.9% (95% CI, 73.9%, 86.2%) with a median follow-up time of 13.8 months after the three-month CR.

The ENVISION trial demonstrated a similar safety profile to that observed in the OPTIMA II and ATLAS trials, with treatment-emergent adverse events typically mild-to-moderate in severity.

The ENVISION trial data was published online in The Journal of Urology in October 2024 and was included in the February 2025 print edition.

In March 2025, we announced updated 18-month DOR data from the Phase 3 ENVISION trial.

The ENVISION trial data were published online in The Journal of Urology in October 2024 and were included in the February 2025 print edition.

In March 2025, we announced 18-month DOR data from the Phase 3 ENVISION trial.

The 18-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri remained consistent with the 12-month DOR data:

4 unchanged sentences

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

The median DOR has not been reached.

The median DOR had not yet 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.

13 unchanged sentences

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 annual updates on DOR for all patients with ongoing CRs.

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

In addition, we committed to providing the FDA 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.

We initiated promotion of Zusduri in the United States in late June 2025 with product available by July 1, 2025.

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.

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.

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

1 unchanged sentence

(“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 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 will receive 75 mg of mitomycin via intravesical instillation once a week for six weeks.

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.

1 unchanged sentence

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.

We expect topline CR data by the end of 2025.

If the trial is successful, an NDA submission is projected for 2026, followed by a standard review period and potential FDA approval and, if approved, the commercial launch in 2027.

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.

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 includes UGN-301, an anti-CTLA-4 monoclonal antibody, which we intend to study as a combination therapy with multiple agents.

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

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.

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

2 unchanged sentences

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 are investigating clinically involves the sequential use of UGN-201 (imiquimod), a toll like receptor 7 ("TLR 7") agonist, and UGN-301 in high-grade NMIBC.

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 are investigating clinically involves the sequential administration of gemcitabine and UGN-301 to the bladder in high-grade NMIBC.

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 believe 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 are investigating these combinations to determine if they may make local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

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 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 utilizes a Master Protocol that we believe is a more efficient and streamlined approach to development.

It will provide more flexibility to add study arms as the trial progresses and is expected to increase efficiency and potentially reduce costs.

We expect the Master Protocol will 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 is expected to support the development of UGN-301 in high-grade NMIBC, was initiated in April 2022 and enrollment in the study is complete.

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.

The treatments demonstrated an acceptable safety profile and were generally well tolerated across dose levels.

Responses were observed in both monotherapy and combination therapy arms, and patient follow-up is ongoing to further assess the durability of these responses.

We expect to report updated data in 2025.

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.

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.

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.

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.

These findings further reinforce the versatility and potential of RTGel technology to enable localized delivery of immunotherapy candidates.

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.

3 unchanged sentences

In November 2019, we entered into a license agreement with Agenus, pursuant to which Agenus granted us 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 an intravesical formulation of zalifrelimab administered using RTGel technology that is in Phase 1 clinical development for high-grade NMIBC.

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

In November 2025, we provided notice to terminate the license agreement with Agenus in connection with our 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.

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.

Components of Operating Results

During the three and six months ended June 30, 2025 we recognized $24.2 million and $44.5 million of revenue, respectively, from sales of our product, Jelmyto .

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.

Cost of Revenue

Cost of revenue consists primarily of inventory and related costs associated with the manufacturing, distribution, warehousing and preparation of Jelmyto, including inventory write-downs.

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

Cost of revenue consists primarily of inventory and related costs associated with the manufacturing, distribution, warehousing and preparation of Jelmyto and Zusduri, including inventory write-downs.

In periods prior to receiving FDA approval for Jelmyto and Zusduri , we recognized inventory and related manufacturing costs as research and development expense.

Research and Development Expenses

9 unchanged sentences

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

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

60 unchanged sentences

Results of Operations

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

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

Three Months Ended June 30,

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,

(in thousands)

11 unchanged sentences

Income tax expense

Revenue was $24.2 million and $21.8 million for the three months ended June 30, 2025 and 2024, respectively.

The increase in revenue of $2.4 million primarily reflects the increased volume of sales of Jelmyto and price favorability.

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.

Cost of Revenue

Cost of revenue was $3.6 million and $2.2 million for the three months ended June 30, 2025 and 2024, respectively.

The increase in cost of revenue of $1.4 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 and an inventory write-off.

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.

Research and Development Expenses

Research and development expenses were $18.9 million and $15.4 million for the three months ended June 30, 2025 and 2024, respectively.

The increase in research and development expenses of $3.5 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 and costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection with Zusduri .

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 .

Selling and Marketing Expenses

Selling and marketing expenses were $27.9 milli on and $18.9 million for the three months ended June 30, 2025 and 2024 , respectively.

The increase in selling and marketing expenses of $9.0 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 software costs.

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.

General and Administrative Expenses

General and administrative expenses were $15.3 million and $11.2 million for the three months ended June 30, 2025 and 2024 , respectively.

The increase in general and administrative expenses of $4.1 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.

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.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $4.6 million and $5.8 million for the three months ended June 30, 2025 and 2024, respectively.

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

1 unchanged sentence

Interest Expense on Long-term Debt

Interest expense was $4.1 million and $3.5 million for the three months ended June 30, 2025 and 2024, respectively.

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 and Other Income, Net

Interest and other income, net was $1.3 million and $1.7 million for the three months ended June 30, 2025 and 2024, respectively.

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

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

Six Months Ended June 30,

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)

11 unchanged sentences

Income tax expense

Revenue was $44.5 million and $40.6 million for the six months ended June 30, 2025 and 2024, respectively.

The increase in revenue of $3.9 million primarily reflects the increased volume of sales of Jelmyto .

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 $5.9 million and $4.0 million for the six months ended June 30, 2025 and 2024, respectively.

The increase in cost of revenue of $1.9 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 and an inventory write-off.

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 $38.8 million and $30.9 million for the six months ended June 30, 2025 and 2024, respectively.

The increase in research and development expenses of $7.9 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 acquisition of certain assets of IconOVir, partially offset by lower clinical trial costs and regulatory expenses in connection with Zusduri .

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 $50.0 milli on and $36.0 million for the six months ended June 30, 2025 and 2024 , respectively.

The increase in selling and marketing expenses of $14.0 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 software costs.

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 $28.2 million and $21.4 million for the six months ended June 30, 2025 and 2024 , respectively.

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 $9.2 million and $11.4 million for the six months ended June 30, 2025 and 2024, respectively.

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

1 unchanged sentence

Interest Expense on Long-term Debt

Interest expense was $8.2 million and $5.9 million for the six months ended June 30, 2025 and 2024, respectively.

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 $3.4 million and $3.3 million for the six months ended June 30, 2025 and 2024, respectively.

The increase in interest and other income, net was primarily attributable to higher average balances in interest-bearing accounts over the period.

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 June 30, 2025, we had $161.6 million in cash and cash equivalents and marketable securities.

As of September 30, 2025, we had $127.4 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 June 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 Jelmyto product sales.

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.

ATM Sales Agreement

2 unchanged sentences

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

We did not sell any ordinary shares under the ATM Sales Agreement in the six months ended June 30, 2025.

The remaining capacity under the ATM Sales Agreement was approximately $27.3 million as of June 30, 2025.

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.

9 unchanged sentences

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 may be drawn at our option no later than August 29, 2025, subject to the satisfaction of customary bringdown conditions and deliverables.

We do not intend to draw down the fourth tranche of $75.0 million.

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 the satisfaction of customary bringdown conditions and deliverables.

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%.

12 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 June 30, 2025, we had an accumulated deficit of $900.0 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 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.

2 unchanged sentences

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 June 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 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.

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.

5 unchanged sentences

Our present and future funding and material cash requirements will depend on many factors, including, among other things:

the progress, timing and completion of clinical trials for UGN-103, UGN-104, UGN-201, UGN-301 and UGN-501;

the progress, timing and completion of clinical trials for UGN-103, UGN-104 and UGN-501;

nonclinical studies and clinical trials for any of our product candidates;

the costs related to obtaining regulatory approval for UGN-103, UGN-104, UGN-201, UGN-301, UGN-501 and any other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of our product candidates;

the costs related to obtaining regulatory approval for UGN-103, UGN-104, UGN-501 and any other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of our product candidates;

selling, marketing and patent-related activities undertaken in connection with the commercialization of Jelmyto , Zusduri and any of our product candidates, if approved, and costs involved in the continued development of an effective sales and marketing organization;

1 unchanged sentence

potential new product candidates we identify and attempt to develop;

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-201, UGN-301, UGN-501, RTGel reverse thermal hydrogel technology and any other product candidates;

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 repayment of outstanding debt.

17 unchanged sentences

In June 2022, we signed an amendment to our November 2019 lease agreement to extend the term for an additional three years through January 31, 2026.

In August 2025, we signed an additional extension to our November 2019 lease agreement to extend the lease term through April 30, 2031.

We concluded that the lease renewal option in the agreement is not reasonably certain to be exercised.

In July 2024, we entered into a new master lease agreement for vehicles, primarily for use by employees in sales, field services, and roles that require regular travel.

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 $1.4 million and $4.8 million, respectively, as of June 30, 2025.

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.

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

3 unchanged sentences

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 may be drawn at our option no later than August 29, 2025, subject to customary bringdown conditions and deliverables.

We do not intend to drawn down the fourth tranche.

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%.

5 unchanged sentences

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

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

5 unchanged sentences

Operating Activities

Net cash used in operating activities was $81.8 million during the six months ended June 30, 2025, compared to $55.5 million during the six months ended June 30, 2024.

The $26.3 million increase was attributable primarily to higher net loss driven by increased operating expenses such as commercial preparation costs related to Zusduri , as well as timing of certain payments and accruals.

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.

Investing Activities

Net cash provided by investing activities was $2.4 million during the six months ended June 30, 2025, compared to net cash provided by investing activities of $25.5 million during the six months ended June 30, 2024.

The decrease of $23.1 million is attributable primarily to additional investments in marketable securities in 2025 as compared to 2024.

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.

Financing Activities

Net cash provided by financing activities was $0.3 million during the six months ended June 30, 2025, compared to $154.9 million during the six months ended June 30, 2024.

The decrease of $154.6 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement in the first quarter of 2024 and the underwritten public offering in the second quarter of 2024.

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.

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