What changed in this filing

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Item 1. Financial Statements

2025-08-07 compared with 2025-05-12 · 426 added, 290 removed, 900 unchanged (44% of the section changed)

26 unchanged sentences

Employee related accrued expenses

11,646 10,570

Other current liabilities

12 unchanged sentences

Shareholders' Deficit:

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

46,101,785 and 42,231,746 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

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

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,

$ 24,215 $ 21,848 $ 44,469 $ 40,629

Cost of revenue

3,550 2,229 5,880 3,957

20,665 19,619 38,589 36,672

Operating expenses:

Research and development expenses

18,914 15,402 38,785 30,896

Selling, general and administrative expenses

43,199 30,056 78,166 57,355

Operating loss

( 41,448 ) ( 25,839 ) ( 78,362 ) ( 51,579 )

Financing on prepaid forward obligation

( 4,644 ) ( 5,773 ) ( 9,227 ) ( 11,433 )

Interest expense on long-term debt

( 4,132 ) ( 3,461 ) ( 8,200 ) ( 5,908 )

Interest and other income, net

1,299 1,708 3,413 3,323

Loss before income taxes

( 48,925 ) ( 33,365 ) ( 92,376 ) ( 65,597 )

Income tax expense

( 1,015 ) ( 38 ) ( 1,407 ) ( 92 )

$ ( 49,940 ) $ ( 33,403 ) $ ( 93,783 ) $ ( 65,689 )

Statements of Comprehensive Loss

$ ( 49,940 ) $ ( 33,403 ) $ ( 93,783 ) $ ( 65,689 )

Other comprehensive loss

Unrealized loss on investments

Unrealized income (loss) on investments

( 8 ) 6 ( 50 ) ( 43 )

Comprehensive Loss

$ ( 49,948 ) $ ( 33,397 ) $ ( 93,833 ) $ ( 65,732 )

Net loss per ordinary share - basic and diluted

$ ( 1.05 ) $ ( 0.82 ) $ ( 1.97 ) $ ( 1.69 )

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

47,739,816 40,501,315 47,582,610 38,785,924

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

6 unchanged sentences

income (loss)

Balance as of April 1, 2025

46,101,785 $ 126 $ 803,467 $ ( 850,065 ) $ 14 $ ( 46,458 )

Changes During the Three Months Ended June 30, 2025

Exercise of options into ordinary shares

97,349 — 297 297

Share-based compensation

Other comprehensive loss

( 49,940 ) ( 49,940 )

Balance as of June 30, 2025

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

Balance as of April 1, 2024

36,127,687 $ 99 $ 671,438 $ ( 711,634 ) ( 37 ) $ ( 40,134 )

Changes During the Three Months Ended June 30, 2024

Exercise of options into ordinary shares

42,267 — 135 135

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

18,641 18,641

Issuance of ordinary shares, net of issuance costs

5,000,000 13 81,496 81,509

Other comprehensive income

( 33,403 ) ( 33,403 )

Balance as of June 30, 2024

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

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, 2025

Changes During the Three Months Ended March 31, 2025

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

Changes During the Six Months Ended June 30, 2025

Exercise of options into ordinary shares

386,274 1 326 327

Share-based compensation

Conversion of pre-funded warrants into ordinary shares

3,206,271 9 ( 6 ) 3

Issuance of ordinary shares, net of issuance costs

374,843 1 3,127 3,128

Other comprehensive loss

Balance as of March 31, 2025

( 50 ) ( 50 )

( 93,783 ) ( 93,783 )

Balance as of June 30, 2025

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

Balance as of January 1, 2024

Changes During the Three Months Ended March 31, 2024

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

Changes During the Six Months Ended June 30, 2024

Exercise of options into ordinary shares

279,367 1 134 135

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

18,641 18,641

Issuance of ordinary shares, net of issuance costs

8,400,468 22 136,144 136,166

Other comprehensive loss

Balance as of March 31, 2024

( 43 ) ( 43 )

( 65,689 ) ( 65,689 )

Balance as of June 30, 2024

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

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

2 unchanged sentences

in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash Flows From Operating Activities

$ ( 93,783 ) $ ( 65,689 )

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

2 unchanged sentences

Accretion on marketable securities

( 1,640 ) ( 481 )

Share-based compensation

3 unchanged sentences

Changes in operating assets and liabilities:

2,099 ( 1,769 )

Accounts receivable, net

653 ( 1,972 )

Prepaid expenses and other current assets

( 3,210 ) ( 1,927 )

Other non-current assets

( 212 ) 1,365

Accounts payable and accrued expenses

Employee related accrued expenses

1,076 ( 3,965 )

Other current liabilities

Lease liabilities

( 1,344 ) ( 442 )

Restricted deposit

Net cash used in operating activities

( 81,849 ) ( 55,483 )

Cash Flows From Investing Activities

1 unchanged sentence

Maturities of marketable securities

70,768 25,600

Purchases of property and equipment

Net cash (used in) provided by investing activities

( 185 ) ( 84 )

Net cash provided by investing activities

Cash Flows From Financing Activities

Proceeds from exercise of options into ordinary shares

Proceeds from ordinary shares issuance, net of issuance costs

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

Proceeds from ordinary shares issuances, net of issuance costs

Net cash provided by financing activities

Increase (Decrease) in Cash and Cash Equivalents

( 79,076 ) 124,975

Cash, Cash Equivalents and Restricted Cash at Beginning of Period

173,062 95,822

Cash, Cash Equivalents and Restricted Cash at End of Period

$ 93,986 $ 220,797

Supplemental Disclosures of Non-Cash Activities

10 unchanged sentences

UPL and UPI (together the “Company”) is a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers.

Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN- 101, advancing UGN- 102 through regulatory approval, development of the Company's other product candidates UGN- 103, UGN- 104, UGN- 301 and UGN- 501 (formerly known as ICVB- 1042 ), and raising capital to support and expand these activities.

Since commencing operations, the Company has devoted substantially all of its efforts to securing intellectual property rights, performing research and development activities, including conducting clinical trials and manufacturing activities, hiring personnel, launching the Company’s first commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN- 101, developing and securing regulatory approval of Zusduri (mitomycin) for intravesical solution, formerly known as UGN- 102, and raising capital to support and expand these activities.

On April 15, 2020, the U.S.

Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto , a first -in-class treatment indicated for adults with low-grade upper tract urothelial cancer.

Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using our proprietary sustained release RTGel technology.

It is designed to prolong exposure of upper urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

In August 2024, the Company completed the submission of the rolling new drug application (“NDA”) for UGN- 102.

In October 2024, the FDA accepted the Company's NDA for UGN- 102 (mitomycin) for intravesical solution and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of June 13, 2025.

Food and Drug Administration (“FDA”) granted approval for Jelmyto , a first -in-class treatment indicated for adults with low-grade upper tract urothelial cancer (“low-grade UTUC”).

Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using the Company's proprietary sustained release RTGel technology.

It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

On June 12, 2025, the FDA approved Zusduri, the first and only FDA-approved medication for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”).

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

Note 2 – Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S.

generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with instructions to Form 10 -Q and Article 10 of Regulation S- X.

generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10 -Q and Article 10 of Regulation S- X.

Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements.

4 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 $ 850.1 million and $ 806.2 million as of March 31, 2025 and December 31, 2024 , respectively.

The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy, including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials.

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

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

1 unchanged sentence

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments relating to the carrying amounts and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.

The Company’s ability to continue as a going concern is expected to be impacted by the timely advancement of UGN- 102 through regulatory approval, its ability to raise additional capital to fund its operations and produce cash inflows from Jelmyto product sales.

Based on the Company's cash, cash equivalents and marketable securities as of March 31, 2025 , together with management’s cash flow projections, the Company believes that it has sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these condensed consolidated financial statements.

If the Company is unable to obtain approval for UGN- 102 and generate sufficient cash inflows from the sale and distribution of UGN- 102, or that approval is delayed beyond the June 13, 2025 PDUFA date, the Company may need to raise additional capital in the future or reduce operating expenditures.

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.

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

There can be no assurances that the Company will be able to secure such additional financing on terms that are satisfactory to the Company, in an amount sufficient to meet the Company's needs, or at all.

18 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 $ 200.4 million as of March 31, 2025 .

Cash and cash equivalents and marketable securities totaled $ 161.6 million as of June 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 loss within shareholders’ equity (deficit).

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).

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

11 unchanged sentences

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

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

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

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

16 unchanged sentences

The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs.

For Jelmyto , the Company commenced capitalization of inventory at the receipt of FDA approval.

For both Jelmyto and Zusduri , the Company commenced capitalization of inventory at the receipt of FDA approval.

Costs related to inventories that are not expected to be manufactured and sold within the next 12 months are classified as long-term assets and presented within "Other non-current assets" on the condensed consolidated balance sheets.

12 unchanged sentences

Prepaid Forward Obligation

The Company is party to a transaction (the “RTW Transaction”) with RTW Investments (“RTW”) in which the Company received funds to support the launch of Jelmyto and the development of UGN- 102 in return for tiered, future cash payments based on net sales of Jelmyto and, subject to FDA approval, UGN- 102, UGN- 103 and UGN- 104.

The Company is party to a transaction with RTW Investments (the “RTW Transaction”) in which the Company received funds to support the launch of Jelmyto and the development of Zusduri in return for tiered, future cash payments based on net sales of Jelmyto and Zusduri , and, subject to FDA approval, UGN- 103 and UGN- 104.

The net proceeds received under the RTW Transaction were recognized as a long-term liability.

22 unchanged sentences

The lease extensions are included in the measurement of the ROU asset and lease liability when it is reasonably certain that it will exercise that option.

Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis.

Because the implicit rates of return on the Company’s leases are not readily determinable, the Company uses an incremental borrowing rate, based on the information available at the commencement date, to determine the present value of lease payments on an individual lease basis.

The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

8 unchanged sentences

The Company adjusts its accrual as actual costs become known.

Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when such development milestone results are probable of being achieved.

When a transaction accounted for as an asset acquisition includes in-process research and development (“IPR&D”), the IPR&D asset is only capitalized as an intangible asset if it is determined to have an alternative future use other than in a particular research and development project.

12 unchanged sentences

Pre-funded Warrants

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

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

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

18 unchanged sentences

Accounts Payable and Accrued Expenses

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

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

Accounts payable

8 unchanged sentences

Interest and Other Income, Net

Interest and other income, net consisted of the following for the three months ended March 31, 2025 and 2024 (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, 2025 and 2024 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Interest income

5 unchanged sentences

Note 5 – Inventories

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

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

Raw materials (1)

3 unchanged sentences

$ 7,560 $ 9,446

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

( 1 ) $ 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.

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 March 31, 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 March 31, 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 June 30, 2025 are as follows (in thousands):

Fair Value Measurements Using

5 unchanged sentences

$ 14,435 $ 14,435 $ —

Commercial paper

4,491 — 4,491

Total cash equivalents

15,672 11,181 4,491

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 March 31, 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 June 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 March 31, 2025 (in thousands):

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

Cash equivalents

1 unchanged sentence

$ 14,435 $ — $ — $ 14,435

Commercial paper

4,492 — ( 1 ) 4,491

Total cash equivalents

15,673 — ( 1 ) 15,672

Marketable securities:

11 unchanged sentences

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

As of March 31, 2025 , the amortized cost of investments included an immaterial amount of accrued interest.

As of March 31, 2025 , marketable securities were in a net unrealized gain position.

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.

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

As of March 31, 2025 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 74.2 million which consisted of 20 securities.

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

government, commercial paper and certificates of deposit positions.

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.

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;

1 unchanged sentence

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

As of March 31, 2025 , the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no allowance for credit losses were recognized in the period.

The Company’s investments as of March 31, 2025 mature at various dates through November 2026.

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.

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

2 unchanged sentences

Maturities after one year through three years

$ 4,514 5,022

Total investments

1 unchanged sentence

Note 8 – Property and Equipment

Property and equipment consists of the following as of March 31, 2025 and December 31, 2024 (in thousands):

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

Laboratory equipment

5 unchanged sentences

Property and equipment, net

Depreciation and amortization expense was $ 0.1 million for the three months ended March 31, 2025 and $ 0.1 million for the three months ended March 31, 2024 .

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.

Note 9 – Prepaid Forward Obligation

In March 2021, the Company entered into a prepaid forward agreement with RTW.

Under the terms of the RTW Transaction, the Company received $ 75.0 million ($ 72.4 million net of transaction costs) to support the launch of Jelmyto and the development of UGN- 102.

In March 2021, the Company entered into a prepaid forward agreement with RTW Investments (“RTW”).

Under the terms of the RTW Transaction, the Company received $ 75.0 million ( $ 72.4 million net of transaction costs) to support the launch of Jelmyto and the development of Zusduri .

In return for the transferred funds, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Jelmyto and, subject to FDA approval, UGN- 104, in an amount equal to:

(i) 9.5 % of annual net sales up to $200 million, (ii) 3.0 % of annual net sales for annual net sales between $200 million and $300 million, and (iii) 1.0 % of annual net sales for annual net sales above $300 million.

Pursuant to the agreement, the initial cash payment rate of 9.5% on Jelmyto aggregate worldwide annual net sales of up to $ 200 million was increased to 13.0 % and remained at that rate during the three months ended March 31, 2025 because certain revenue thresholds were not met.

In addition, subject to FDA approval of UGN- 102 and UGN- 103, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of UGN- 102 and UGN- 103 in an amount equal to:

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 %.

RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of Zusduri and, subject to FDA approval, UGN- 103, in an amount equal to:

(i) 2.5 % of annual net sales up to $200 million, (ii) 1.0 % of annual net sales for annual net sales between $200 million and $300 million, and (iii) 0.5 % of annual net sales for annual net sales above $300 million.

If the Company does not receive FDA approval for UGN- 102 by June 30, 2025, the future cash payments to RTW with respect to aggregate worldwide annual net sales of Jelmyto across all Jelmyto annual net sales tiers will increase by 1.5 %.

In accordance with the prepaid forward agreement, the Company will be required to make payments of amounts owed to RTW each calendar quarter, through and until the quarter in which the aggregate cash payments received by RTW are equal to or greater than $300 million.

As of March 31, 2025 , the cumulative amounts paid and payable by the Company were $ 37.5 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, UGN- 102, UGN- 103 and UGN- 104, including the regulatory approvals, intellectual property, material agreements, proceeds and accounts receivable related to these products.

As of June 30, 2025 , the cumulative amounts paid and payable by the Company were $ 40.6 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.

In May 2021 , following the receipt of necessary regulatory approvals, the Company received the $ 75.0 million prepaid forward payment ($ 72.4 million net of transaction costs) from RTW and recognized an associated prepaid forward obligation liability.

1 unchanged sentence

Management reassesses the effective rate each period based on the current carrying value of the obligation and the revised estimated future payments.

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

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 three months ended March 31, 2025 in thousands:

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

The Company is not contractually obligated, nor does it anticipate making any repayments of the original $ 75.0 million received to RTW in the next 12 months.

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2024 and for the six months ended June 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 March 31, 2025

( 1 ) $ 2.6 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 March 31, 2025 and December 31, 2024 , respectively.

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.

Note 10 – Long-Term Debt

3 unchanged sentences

On June 29, 2023, the loan agreement with Pharmakon was amended to replace the benchmark governing the interest rate with a rate based on the secured overnight financing rate ("SOFR") published by the Federal Reserve Bank of New York.

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 %.

Effective July 2023, the loan accrued interest using a benchmark rate of three -month SOFR plus 8.25 % plus an additional adjustment of 0.26161 %.

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

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

The fourth tranche of $ 75.0 million will become available at the Company's option no later than August 29, 2025, subject to (i) receiving FDA approval of an NDA for UGN- 102 no later than June 30, 2025 and (ii) the satisfaction of customary bring down conditions and deliverables.

Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of 3 -month SOFR plus 7.25 % plus an additional adjustment of 0.26161 %.

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one -year extension possible upon FDA approval of an NDA for UGN- 102 by June 30, 2025.

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.

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

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

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

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

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Interest expense

Carrying value of Pharmakon loan as of March 31, 2025

Carrying value of Pharmakon loan as of June 30, 2025

Note 11 – Leases

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In April 2016, UPL signed an addendum to its November 2014 lease agreement for the Company’s offices located in Israel, in order to increase the office space rented and to extend the rent period for an additional three years until August 2022.

In July 2022, the Company signed a lease extension agreement for the Company’s offices located in Israel, extending the term of the lease through September 2025.

The Company's remaining contractual obligation under this lease is approximately $ 0.1 million as of March 31, 2025 .

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 .

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

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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 $ 0.5 million as of March 31, 2025 .

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

Finance Leases

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

The Company’s remaining contractual obligation relating to the leases entered into under this master agreement is approximately $ 4.7 million as of March 31, 2025 .

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 .

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

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The Company’s leases do not contain any residual value guarantees or material restrictive covenants.

The Company’s active leases expire at various dates from 2025 through 2029, with varying renewal and termination options.

The components of lease cost for the three months ended March 31, 2025 and 2024 were as follows (in thousands):

The Company’s leases expire at various dates from 2025 through 2029, 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):

Three Months Ended

Six Months Ended

Finance lease cost:

Amortization of right-of-use assets

$ 302 $ — $ 519 $ —

Interest on lease liabilities

Operating lease cost

226 225 452 450

Sublease income

Variable lease cost

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

$ 669 $ 239 $ 1,232 $ 451

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

Finance lease right-of-use assets

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Other current liabilities related to operating leases

As of March 31, 2025 , no impairment losses have been recognized.

Supplemental information related to leases for the three months ended March 31, 2025 and 2024 is as follows (in thousands, except for lease terms and discount rate amounts):

Three Months Ended

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

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

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11.26 % 10.26 %

As of March 31, 2025 , maturities of lease liabilities were as follows (in thousands):

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

Finance Leases

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Present value of lease liabilities

As of March 31, 2024 , maturities of lease liabilities were as follows (in thousands):

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

Years ending December 31,

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Note 12 – Revenue From Product Sales

Net product sales consist of the following for the three months ended March 31, 2025 and 2024 (in thousands):

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

Three Months Ended

Six Months Ended

$ 24,215 $ 21,848 $ 44,469 $ 40,629

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 85 % of product sales for the three months ended March 31, 2025 .

During the three months ended March 31, 2024, the Company had a single customer.

The Company's largest customer comprises approximately 80 % of accounts receivables at both March 31, 2025 and December 31, 2024.

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.

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.

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

The following table shows the activity with respect to sales reserves for the period ended March 31, 2025 and 2024 (in thousands):

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

Reserves related to government sponsored programs

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( 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

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( 6,560 ) — ( 4,528 ) ( 11,088 )

Balance as of March 31, 2024

Balance as of June 30, 2024

$ 373 $ 5,594 $ 1,429 $ 7,396

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Any contingent consideration in an asset acquisition is recognized only when amounts are both probable and estimable, at which point the consideration is allocated to the assets acquired on a relative fair value basis.

Based on our assessment of the value of the assets acquired as well as consideration of the inputs, processes and outputs, we concluded that this represented an asset acquisition.

Based on the Company's assessment of the value of the assets acquired as well as consideration of the inputs, processes and outputs, the Company concluded that this represented an asset acquisition.

When a transaction accounted for as an asset acquisition includes IPR&D, the IPR&D asset is only capitalized as an intangible asset if it is determined to have an alternative future use other than in a particular research and development project.

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The Company accounted for the acquisition of the Transferred Assets from IconOVir as an asset acquisition.

The Company determined the fair value of the consideration transferred was $ 3.1 million which represented the fair value of the unregistered shares.

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 three months ended March 31, 2025.

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 March 31, 2025 and December 31, 2024 .

The Company had 46.1 million and 42.2 million ordinary shares issued and outstanding as of March 31, 2025 and December 31, 2024 , respectively.

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.

Each ordinary share is entitled to one vote.

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ATM Sales Agreement

In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”) pursuant to which the Company may from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $ 100.0 million.

In December 2019, the Company entered into a sales agreement (the “ATM Sales Agreement”) with Cowen and Company, LLC (“Cowen”) pursuant to which the Company may from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $ 100.0 million.

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

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

The Company did not sell any ordinary shares under the ATM Sales Agreement in the three months ended March 31, 2025.

The remaining capacity under the ATM Sales Agreement was approximately $ 27.3 million as of March 31, 2025 .

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.

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.

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On January 24, 2025, the Company issued 3,206,271 ordinary shares upon exercise of 3,206,271 pre-funded warrants for the purchase of ordinary shares of the Company.

As of March 31, 2025 , 472,665 pre-funded warrants from the Purchase Agreement remain outstanding.

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

Monograph Capital Partners I, L.P.

(“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., a director of the Company at the time, purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $ 15.0 million.

Cohen was the Chair and Chief Investment Officer of Monograph at the time of purchase.

(“Monograph”), a life sciences venture firm that is affiliated with Fred Cohen, M.D., purchased 1,572,327 of the Shares in the Private Placement, for an aggregate purchase price of $ 15.0 million.

Cohen was a director of the Company and the Chair and Chief Investment Officer of Monograph at the time of purchase.

Underwritten Public Offering

On June 17, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $ 17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $ 17.499 per pre-funded warrant.

On June 17, 2024, the Company entered into an underwriting agreement with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $ 17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $ 17.499 per pre-funded warrant.

The offering closed on June 20, 2024.

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The pre-funded warrants may not be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation.

As of March 31, 2025 , all 1,142,857 pre-funded warrants remain outstanding.

As of June 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.

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As a result, and pursuant to the terms of Section 102, the Company is not allowed to claim as an expense for tax purposes the amounts credited to the employees in respect of options granted to them under the Plans, including amounts recorded as salary benefits in the Company’s accounts, with the exception of the work-income benefit component, if any, determined on grant date.

For non-employees and for non-Israeli employees, the Plans is subject to Section 3 (i) of the Israeli Income Tax Ordinance.

For non-employees and for non-Israeli employees, the Plans are subject to Section 3 (i) of the Israeli Income Tax Ordinance.

Employees are typically granted stock options and/or RSUs, upon commencement of employment.

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

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

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

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

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The Company also grants PSUs to certain employees.

The PSU’s granted during 2023 vest based on either the earlier of obtaining regulatory approval for the Company’s lead product candidate UGN- 102 or the occurrence of a change in control.

The PSU's granted in 2024 vest upon the achievement of the first commercial sale of UGN- 102 in the United States following UGN- 102's receipt of regulatory approval.

The PSU's granted in 2025 vest upon achievement of a net product sales target for UGN- 102 and continued service for three years following the grant date.

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.

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.

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In June 2024, the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 600,000 shares to a total share reserve of 1,800,000 shares.

As of March 31, 2025 , 4,601,627 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 883,811 ordinary shares remain available for future awards.

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.

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

$ 448 $ 594 $ 1,050 $ 1,112

Selling, general and administrative expenses

2,285 2,966 4,752 5,204

Total share-based compensation expense

$ 2,733 $ 3,560 $ 5,802 $ 6,316

The total unrecognized compensation cost of options, RSUs and PSUs at March 31, 2025 is $ 20.6 million with a weighted average recognition period of 2.18 years.

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.

Note 17 – Income Taxes

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is taxed under Israeli tax laws.

As of March 31, 2025 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

As of June 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 three months ended March 31, 2025 .

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 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 March 31, 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 June 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 March 31, 2025 , the Company’s liability for uncertain tax positions includes $ 1.8 million of accrued interest and penalties.

As of June 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.

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The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may result from its uncertain tax positions.

Based upon the information currently available, the Company does not reasonably expect changes in its existing uncertain tax positions in the next 12 months and has recorded the gross uncertain tax positions as a long-term liability.

Approximately $ 1.4 million of the liability for uncertain tax positions relate to tax years for which the statute of limitations will expire within the next 12 months.

Based upon the information currently available, the Company does not reasonably expect any other changes in its existing uncertain tax positions in the next 12 months and has recorded the gross uncertain tax positions as a long-term liability.

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

The OBBBA includes changes to U.S.

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

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

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 three months ended March 31, 2025 and no related party transactions during the three months ended March 31, 2024.

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

Note 19 – Commitments and Contingencies

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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 approved product, Jelmyto , primarily conducted in the United States.

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

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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

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$ 13,318 $ 10,612 $ 24,710 $ 21,341

Acquisitions of IP R&D

Acquisitions of IPR&D

Employee compensation

4,744 3,820 9,125 7,700

Rent, office, utilities & technology

734 846 1,590 1,614

Other expenses

118 124 232 241

Total research and development expenses

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Commercial & medical affairs services

10,873 7,223 19,071 12,671

Professional services

3,576 3,639 6,348 6,374

Travel, meetings & conferences

5,629 3,362 9,274 7,070

Rent, office, utilities & technology

1,193 737 2,328 1,525

Other expenses (1)

2,365 1,135 3,454 1,797

Total selling, general and administrative expenses

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Note 22 – Selected Unaudited Quarterly Financial Data

Certain unaudited selected quarterly financial results for the quarter ended March 31, 2024 are presented as follows:

For the Three Months Ended March 31, 2024

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

$ 21,848 $ 40,629

$ 19,619 $ 36,672

$ ( 33,403 ) $ ( 65,689 )

Weighted-average number of ordinary shares (1)

40,501,315 38,785,924

Basic and diluted loss per ordinary share (1)

( 1 ) The loss per share, both basic and diluted, for the first quarter of 2024 was revised to record an immaterial correction to the amounts originally reported in the March 31, 2024 Form 10 -Q filed on May 13, 2024 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.

$ ( 0.82 ) $ ( 1.69 )

( 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.

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

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These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “ Risk Factors ” in this Quarterly Report.

In addition, statements indicating “ we believe ” and similar statements reflect our beliefs and opinions on the relevant subject.

In addition, statements indicating that “ we believe ” and similar statements reflect our beliefs and opinions on the relevant subject.

These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

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We have developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs.

Our technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option.

Our approved product Jelmyto ® (mitomycin) for pyelocalyceal solution, and our investigational candidates, UGN-102 (mitomycin) for intravesical solution, UGN-103 (mitomycin) for intravesical solution and UGN-104 (mitomycin) for pyelocalyceal 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”) in the case of Jelmyto and UGN-104 and low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”) in the case of UGN-102 and UGN-103.

In addition, our immuno-uro-oncology pipeline includes UGN-301 (zalifrelimab) intravesical solution, an anti-CTLA-4 antibody, which we are currently studying as both monotherapy and combination therapy and UGN-501 (formerly known as ICVB-1042), a next-generation investigational oncolytic virus, which we recently acquired in February 2025.

If approved, UGN-102 would become the first U.S.

Food and Drug Administration ("FDA") approved medicine for recurrent low-grade intermediate risk NMIBC.

Our technology is designed to enable longer exposure of urinary tract tissue to medications, making local therapy a potentially more effective treatment option.

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.

On June 12, 2025, the U.S.

Food and Drug Administration ("FDA") approved our new drug application (“NDA") for Zusduri (formerly known as UGN-102) for the treatment of adults with recurrent low-grade intermediate risk NMIBC.

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.

We estimate that the total addressable market opportunity for UGN-102 in recurrent low-grade intermediate risk NMIBC is potentially over $5.0 billion, assuming an expected pricing range of $16,000 to $19,000 per dose.

UGN-102, if approved, may be an alternative to the current standard of care for patients with recurrent low-grade intermediate risk NMIBC, trans-urethral resection of bladder tumor (“TURBT”).

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

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

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

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

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

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

These characteristics of RTGel enable sustained release of mitomycin in the urinary tract for Jelmyto, UGN-102, UGN-103 and UGN-104.

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

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

We believe that characteristics of RTGel may prove useful for the local delivery of active drugs to other bodily cavities in addition to the bladder and upper urinary tract.

On April 15, 2020, the FDA appro ved our new drug application (“NDA") for Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, for the treatment of adult patients with low-grade UTUC.

We believe that these characteristics of RTGel may prove useful for the local delivery of active drugs to other bodily cavities in addition to the bladder and upper urinary tract.

On April 15, 2020, the FDA appro ved our NDA for Jelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, for the treatment of adult patients with low-grade UTUC.

Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using our proprietary sustained release RTGel technology.

It is designed to prolong exposure of upper urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

New product exclusivity for Jelmyto expired on April 15, 2023, however, orphan drug exclusivity extends until April 15, 2027.

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

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

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

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

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

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

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

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

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

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

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

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

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

Findings from the final study results include:

Complete response (“CR”) rate (primary endpoint) of 58% (41/71) in the intent-to-treat population and in the sub-population of patients who were deemed not capable of surgical removal at diagnosis.

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

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.

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No treatment-related deaths occurred.

In February 2025, we presented additional new data from the long-term follow-up study to the OLYMPUS trial.

Among patients from the OLYMPUS 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]).

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

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]).

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

In June 2020, we initiated our commercial launch of Jelmyto in the United States.

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These territory business manager positions are led by regional business director positions, who are in turn supported by regional operations manager positions.

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

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

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

In total, our customer-facing team comprises approximately 100 representatives.

In total, our customer-facing team comprises approximately 100 colleagues.

We are committed to helping patients access Jelmyto .

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In October 2020, a Medicare C-Code was issued for Jelmyto .

The Centers for Medicare & Medicaid Services established a permanent and product-specific J-code for Jelmyto that took effect on January 1, 2021 and replaced the C-Code.

The Centers for Medicare & Medicaid Services has granted Jelmyto a New Technology Ambulatory Payment Classification, effective from October 1, 2023.

The Centers for Medicare & Medicaid Services ("CMS") established a permanent and product-specific J-code for Jelmyto that took effect on January 1, 2021 and replaced the C-Code.

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

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

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

UGN-102 (mitomycin) for intravesical solution

UGN-102 is our sustained-release gel formulation of mitomycin that we are developing for the treatment of recurrent low-grade intermediate risk NMIBC.

UGN-102 is administered locally using the standard practice of intravesical instillation directly into the bladder via a urethral 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 in an operating room and may require an overnight stay.

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

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

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

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 general anesthesia.

In October 2021, we reported final data from the Phase 2b OPTIMA II trial.

The single-arm, open label trial completed enrollment of 63 patients at clinical sites across the United States and Israel in September 2019.

Patients were treated with six weekly instillations of UGN-102 and underwent assessment of CR rate (the primary endpoint) four to six weeks following the last instillation;

65%, or 41 out of 63 patients, treated with UGN-102 achieved a CR three months after the start of therapy.

In this subset of patients, 39 (95%), 30 (73%), and 25 (61%) remained disease-free at six, nine, and 12 months after treatment initiation, respectively.

The probability of durable response nine months after CR (12 months after treatment initiation) was estimated to be 72.5% by Kaplan-Meier analysis.

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

Thirteen patients had documented recurrences.

Fifty-seven of 63 (90%) patients completed all six instillations of UGN-102 according to the study protocol.

The most common adverse events, occurring in greater than 10% of participants, were most often reported as mild to moderate in severity and include dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection.

The final data were published online in The Journal of Urology in October 2021 and was included in the January 2022 print edition.

In December 2022, we presented new data from a follow-up study to the OPTIMA II study designed to obtain long-term data on UGN-102 that showed median DOR of 24.4 months based on available data for 15 out of 25 patients who achieved a CR in OPTIMA II.

Seven patients remained in CR, six patients had recurrence of low-grade disease, one patient had progression to high-grade disease and one patient withdrew consent but remained in CR at the last evaluation prior to discontinuation.

All patients were alive at the last contact, and five patients were known to have had post-study treatment with TURBT or fulguration.

We initiated our Phase 3 ATLAS trial in December 2020 and until November 2021, were enrolling patients in this trial comparing UGN-102 with or without TURBT to standard of care, TURBT, alone.

In parallel, we continued to engage in discussions with the FDA and based on this dialogue, we designed a pivotal trial in order to demonstrate the efficacy and safety of UGN-102.

This Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate risk NMIBC.

The design of the Phase 3 ENVISION trial was similar to our Phase 2 OPTIMA II trial in that the patient population had similar clinical characteristics, received the same investigational treatment regimen and underwent similar efficacy and safety assessments and qualitative follow-up.

Study participants received six once-weekly intravesical instillations of UGN-102.

The primary endpoint was CR rate at three months after the first instillation, and the key secondary endpoint was DOR in patients who achieved CR at the three-month assessment.

In February 2022, we announced the initiation of the Phase 3 ENVISION trial, targeting enrollment of 220 patients across 90 sites.

In December 2022, we completed our target enrollment of the Phase 3 ENVISION trial.

As a result of the FDA's acceptance of a single arm approach, we stopped enrollment of the Phase 3 ATLAS trial without knowledge of the data.

However, at the time enrollment was stopped, patients who had signed an informed consent were able to complete screening, and if eligible were randomized into the trial.

ATLAS continued until the last ongoing patient completed the month 15 visit.

In addition, by 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.

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

In the ATLAS trial, UGN-102 with or without TURBT met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55% compared to TURBT alone.

Results of the ATLAS trial also showed a 64.8% CR rate at three months for patients who only received UGN-102, compared to a 63.6% CR rate at three months for patients who only received a TURBT.

The ENVISION trial met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.6% rate of CR at three-months following the initial instillation.

In both trials, the safety profile of UGN-102 was acceptable, and comparable to that observed in previous clinical trials of UGN-102.

In June 2024, we announced secondary endpoint DOR data from the Phase 3 ENVISION trial investigating UGN-102 for intravesical solution in patients with recurrent low-grade intermediate risk NMIBC.

In the ENVISION trial, the 12-month DOR data by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of UGN-102 was 82.3% (95% CI, 75.9%, 87.1%).

The ENVISION trial met its primary endpoint with patients having a 79.6% (73.9%, 84.5%) CR rate at three months after the first instillation of UGN-102.

In the ATLAS trial, Zusduri with or without TURBT met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55% compared to TURBT alone.

Results of the ATLAS trial also showed a 64.8% CR rate at three months for patients who only received Zusduri , compared to a 63.6% CR rate at three months for patients who only received a TURBT.

The ENVISION trial met its primary endpoint by demonstrating that patients treated with Zusduri had a 79.6% rate of CR at three-months following the initial instillation.

In both trials, the safety profile of Zusduri was acceptable, and comparable to that observed in previous clinical trials of Zusduri .

In June 2024, we announced secondary endpoint DOR data from the Phase 3 ENVISION trial investigating Zusduri for intravesical solution in patients with recurrent low-grade intermediate risk NMIBC.

In the ENVISION trial, the 12-month DOR data by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri was 82.3% (95% CI, 75.9%, 87.1%).

The ENVISION trial met its primary endpoint with patients having a 79.6% (73.9%, 84.5%) CR rate at three months after the first instillation of Zusduri.

Among the patients in the ENVISION trial who achieved a CR at three months, 76.4% (69.8%, 82.3%) maintained a CR at 12 months.

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 3-month CR.

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.

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In March 2025, we announced updated 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 UGN-102 remained consistent with the 12-month DOR data:

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:

80.6% (95% CI, 74.0%, 85.7%) at 18-months (n=101) compared to 82.5% (76.1%, 87.3%) at 12-months (n=146).

Median follow-up time was 18.7 months after the 3-month CR.

We also completed a Phase 3b study with the objective of demonstrating whether UGN-102 can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.

As per the study design, patients in this study received six once-weekly intravesical instillations of UGN-102 with the initial treatment visit occurring at the investigative site and instillation performed by a qualified physician.

Treatment visits two to six took place at the patient's home and instillations were performed by a properly trained and qualified home health professional.

The primary endpoints of the study include safety and tolerability, discontinuations from at home study treatment and feedback from patients, home health professionals and investigators via standardized questionnaires.

The study completed enrollment with a total of eight patients across four centers and all study visits for these enrolled patients have been completed.

Preliminary results were reported through a press release in February 2023, finding that UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a CR, defined as no detectable disease three months after starting treatment.

Patients, nurses and investigators also completed home instillation feasibility questionnaires.

These standardized feasibility questionnaires highlighted that all eight patients preferred at-home to in-office treatment, and five of six patients recommended UGN-102 home instillation instead of TURBT.

Home instillation was reported as feasible for visiting nurses, and three of four investigators considered at-home treatment “not different” than in-office treatment.

In October 2023, we announced our agreement with the FDA on plans for submission of an NDA for UGN-102 (mitomycin) for intravesical solution.

The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of CR at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of recurrent low-grade intermediate risk NMIBC.

The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the CMC sections of the NDA, which we submitted in January 2024.

In August 2024, we completed the submission of the rolling NDA for UGN-102.

In October 2024, the FDA accepted our NDA for UGN-102 (mitomycin) for intravesical solution and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of June 13, 2025.

The FDA has scheduled an Oncologic Drugs Advisory Committee meeting for May 21, 2025 to review the NDA for UGN-102.

If approved, UGN-102 would become the first FDA-approved medicine for the treatment of recurrent low-grade intermediate-risk NMIBC.

Median follow-up time was 18.7 months after the three-month CR.

In August 2025, we announced 24-month DOR data from the Phase 3 ENVISION trial.

The 24-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation of Zusduri was 72.2% (95% CI, 64.1%, 78.8%).

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

The median DOR has 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:

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

Results of the long-term extension study were published online in the J ournal of Clinical Genitourinary Cancer in July 2025 .

We also completed a Phase 3b study with the objective of demonstrating whether Zusduri can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.

Eight patients with low-grade, intermediate-risk NMIBC were enrolled, of whom six (75.0%) completed all six instillations.

Preliminary results were reported through a press release in February 2023, finding that Zusduri was suitable to administer at home by a home health professional under the supervision of a treating physician and resulted in 75% of patients achieving a CR, defined as no detectable disease three months after starting treatment.

Home instillation was reported as feasible for home health professionals, and three of four investigators considered at-home treatment “not different” than in-office treatment.

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

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

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

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

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

In addition, we committed to providing the FDA 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;

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.

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

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

(“medac”) to develop UGN-103 and UGN-104, which are intended to be next-generation investigational formulations of UGN-102 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.

(“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.

We plan to enroll approximately 90 patients in the UTOPIA trial, with patients receiving 75 mg of mitomycin via intravesical instillation once a week for six weeks.

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.

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

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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.

In October 2024, we announced the first patient dosed in the UTOPIA trial and expect to complete enrollment in mid-2025.

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

In February 2025, the FDA accepted our IND for UGN-104.

We plan to initiate a Phase 3 trial of UGN-104 in low-grade UTUC in mid-2025.

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.

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

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

Enrollment of patients in this arm investigating the combination of UGN-301 and gemcitabine is complete.

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

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

We plan to conduct IND-enabling studies in 2025 and plan to initiate a Phase 1 clinical study of UGN-501 as a locally administered agent in patients with high-grade NMIBC in 2026.

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

Research and Development and License Agreements

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

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.

Components of Operating Results

During the three months ended March 31, 2025 and 2024 we recognized $20.3 million and $18.8 million of revenue, respectively, from sales of our product, Jelmyto.

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 .

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.

Research and Development Expenses

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salaries and related costs, including share-based compensation expense, for our personnel in research and development functions;

facility and equipment costs, including depreciation expense, maintenance and allocated direct and indirect overhead costs;

expense incurred under agreements with third parties, including clinical research organizations (“CROs”), subcontractors, suppliers and consultants, nonclinical studies and clinical trials;

expense incurred to acquire, develop and manufacture nonclinical study and clinical trial materials;

expense incurred to purchase active pharmaceutical ingredients (“API”) in support of R&D activities and other related manufacturing costs.

expense incurred to purchase active pharmaceutical ingredients (“APIs”) in support of R&D activities and other related manufacturing costs;

facility and equipment costs, including depreciation expense, maintenance and allocated direct and indirect overhead costs.

We manage and prioritize our research and development expenses based on scientific data, probability of successful technical development and regulatory approval, market potential and unmet medical need, available human and capital resources and other considerations.

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

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We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

Other than Jelmyto , which was approved by the FDA in April 2020, we have not received approval of any of our product candidates.

UGN-102, UGN-103, UGN-104, UGN-301 and UGN-501 are still in clinical development.

As such, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.

Until such time, if ever, as we can generate sufficient product revenue to support our operations and capital requirements, we expect to supplement our cash needs through a combination of equity or debt financings and collaboration arrangements.

We cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements.

License fees and development milestone payments related to in-licensed products and technology are expensed as incurred, or achieved in the case of milestones, if it is determined at that point that they have no established alternative future use.

Selling and Marketing Expenses

To date, selling and marketing expenses consist primarily of commercial personnel costs (including share-based compensation) along with commercialization activities related to Jelmyto and pre-commercialization activities related to UGN-102.

To date, selling and marketing expenses consist primarily of commercial personnel costs (including share-based compensation) along with commercialization activities related to Jelmyto and Zusduri .

General and Administrative Expenses

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Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation is comprised of financing expense related to the RTW Transaction (see Note 9 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report).

Financing on prepaid forward obligation is comprised of financing expenses related to the transaction with RTW Investments ("RTW") (see Note 9 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report).

Interest Expense

Interest expense is comprised of interest related to our long-term debt with Pharmakon (see Note 10 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report).

Interest expense is comprised of interest related to our long-term debt with Pharmakon Advisors, L.P.

("Pharmakon") (see Note 10 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report).

Interest and Other Income, Net

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We have yet to generate taxable income in Israel.

We have historically incurred operating losses resulting in carry forward tax losses in Israel totaling approximately $533.9 million as of December 31, 2024.

We will be able to carry forward these tax losses indefinitely to future taxable years.

We have historically incurred operating losses resulting in carry forward tax losses totaling approximately $533.9 million as of December 31, 2024.

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

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

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In accordance with U.S.

generally accepted accounting principles ("GAAP"), we base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances at the time such estimates are made.

generally accepted accounting principles, we base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances at the time such estimates are made.

Actual results may differ from these estimates under different assumptions or conditions.

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Results of Operations

Comparison of the three months ended March 31, 2025 and 2024

The following table sets forth our results of operations for the three months ended March 31, 2025 and 2024.

Three Months Ended March 31,

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,

(in thousands)

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Income tax expense

Revenue was $20.3 million and $18.8 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $1.5 million was primarily driven by underlying demand sales of Jelmyto, partially offset by higher revenue reserves primarily driven by chargebacks relating to 340B drug pricing programs and other government sponsored programs.

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.

Cost of Revenue

Cost of revenue was $2.3 million and $1.7 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $0.6 million is primarily attributable to the increased volume of sales of Jelmyto .

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.

Research and Development Expenses

Research and development expenses were $19.9 million and $15.5 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $4.4 million is primarily attributable to higher manufacturing costs, 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 UGN-102.

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 .

Selling and Marketing Expenses

Selling and marketing expenses were $22.1 milli on and $17.1 million for the three months ended March 31, 2025 and 2024 , respectively.

The increase in selling and marketing expenses of $5.0 million is primarily attributable to UGN-102 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 $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.

General and Administrative Expenses

General and administrative expenses were $12.8 million and $10.2 million for the three months ended March 31, 2025 and 2024 , respectively.

The increase in general and administrative expenses of $2.6 million is primarily attributable to higher compensation expenses, expenses related to pre-commercialization readiness support related to UGN-102, general third-party advisory services, and ongoing managed services.

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.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $4.6 million and $5.7 million for the three months ended March 31, 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 Investments (“RTW"), which are based on a percentage of revenues.

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

The decrease in financing on prepaid forward obligation of $1.2 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $4.1 million and $2.4 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $1.7 million was primarily attributable to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Interest expense was $4.1 million and $3.5 million for the three months ended June 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 $2.1 million and $1.6 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $0.5 million in interest and other income, net was primarily due to higher cash and investment balances.

Interest and other income, net was $1.3 million and $1.7 million for the three months ended June 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,

(in thousands)

Cost of revenue

Operating expenses:

Research and development

Selling and marketing

General and administrative

Total operating expenses

Operating loss

Financing on prepaid forward obligation

Interest expense on long-term debt

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $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 .

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.

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 .

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.

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.

The increase in general and administrative expenses of $6.8 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.

The decrease in financing on prepaid forward obligation of $2.2 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

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.

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.

Liquidity and Capital Resources

As of March 31, 2025, we had $200.4 million in cash and cash equivalents and marketable securities.

As of June 30, 2025, we had $161.6 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, 2025, we funded our operations primarily through public equity offerings, private placements of equity securities, our funding arrangements with RTW and Pharmakon and Jelmyto product sales.

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.

ATM Sales Agreement

In December 2019, we entered into the ATM Sales Agreement with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”) pursuant to which we may from time to time offer and sell our ordinary shares having an aggregate offering price of up to $100.0 million.

In December 2019, we entered into a sales agreement (the "ATM Sales Agreement") with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) (“TD Cowen”) pursuant to which we may from time to time offer and sell our ordinary shares having an aggregate offering price of up to $100.0 million.

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

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

We did not sell any ordinary shares under the ATM Sales Agreement in the three months ended March 31, 2025.

The remaining capacity under the ATM Sales Agreement was approximately $27.3 million as of March 31, 2025.

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.

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.

Prepaid Forward Agreement

In March 2021, we entered into a prepaid forward agreement with RTW, pursuant to which RTW agreed to provide us with an upfront cash payment of $75.0 million to support the launch of Jelmyto and the development of UGN-102, and we agreed to provide RTW with tiered future payments based on global annual net product sales of Jelmyto and, subject to FDA approval, UGN-102, UGN-103 and UGN-104.

In March 2021, we entered into a prepaid forward agreement with RTW (the “RTW Transaction”), pursuant to which RTW agreed to provide us with an upfront cash payment of $75.0 million to support the launch of Jelmyto and the development of Zusduri , and we agreed to provide RTW with tiered future payments based on global annual net product sales of Jelmyto and Zusduri , and, subject to FDA approval, UGN-103 and UGN-104.

In May 2021, following the receipt of necessary regulatory approvals, we received the $75.0 million prepaid forward payment ($72.4 million net of transaction costs) from RTW.

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On June 29, 2023, the loan agreement with Pharmakon was amended to replace the benchmark governing the interest rate with a rate based on the secured overnight financing rate (“SOFR”) published by the Federal Reserve Bank of New York.

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%.

Effective July 2023, the loan accrued interest using a benchmark rate of three-month SOFR plus 8.25% plus an additional adjustment of 0.26161%.

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

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

The fourth tranche of $75.0 million will become available at our option no later than August 29, 2025, subject to (i) receiving FDA approval of an NDA for UGN-102 no later than June 30, 2025 and (ii) the satisfaction of customary bring down conditions and deliverables.

Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of 3-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

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.

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%.

Securities Purchase Agreement

On July 26, 2023, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and other accredited investors (the “Purchasers”), pursuant to which we agreed to sell and issue to the Purchasers 12,579,156 ordinary shares of the Company (“Shares”) (or in lieu of Shares, pre-funded warrants to purchase ordinary shares of the Company) at a purchase price of $9.54 per Share (or $9.539 for each ordinary share underlying a pre-funded warrant), in a private placement transaction that closed on July 28, 2023 and August 9, 2023 (the “Private Placement”) for aggregate gross proceeds of $120.0 million, before deducting fees to placement agents and financial advisors and before other expenses.

On July 26, 2023, we entered into a Securities Purchase Agreement with certain institutional and other accredited investors (the “Purchasers”), pursuant to which we agreed to sell and issue to the Purchasers 12,579,156 ordinary shares of the Company (“Shares”) (or in lieu of Shares, pre-funded warrants to purchase ordinary shares of the Company) at a purchase price of $9.54 per Share (or $9.539 for each ordinary share underlying a pre-funded warrant), in a private placement transaction that closed on July 28, 2023 and August 9, 2023 for aggregate gross proceeds of $120.0 million, before deducting fees to placement agents and financial advisors and before other expenses.

Each pre-funded warrant has an exercise price of $0.001 per ordinary share, subject to customary adjustments, and became exercisable upon original issuance and will not expire until exercised in full.

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Underwritten Public Offering

On June 17, 2024, we entered into the Underwriting Agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the "Underwriters"), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $17.499 per pre-funded warrant.

On June 17, 2024, we entered into an underwriting agreement with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the "Underwriters"), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $17.499 per pre-funded warrant.

The offering closed on June 20, 2024.

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

We have incurred losses since our inception and negative cash flows from our operations, and as of March 31, 2025, we had an accumulated deficit o f $850.1 million.

We expect to incur losses and have negative net cash flows from operating activities as we execute on our strategy, including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials.

Our primary uses of capital are, and we expect will continue to be, commercialization activities, research and development expenses, 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, partially offset by proceeds from sales of Jelmyto .

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 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.

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.

We routinely evaluate our liquidity needs, including assessment of our current financial condition, sources of liquidity including current cash and cash equivalents and marketable securities and management’s cash flow projections.

Our ability to continue as a going concern is expected to be impacted by the timely advancement of UGN-102 through regulatory approval, our ability to raise additional capital to fund our operations and produce cash inflows from Jelmyto product sales.

Based on our cash, cash equivalents and marketable securities as of March 31, 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 obtain approval for UGN-102 and generate sufficient cash inflows from the sale and distribution of UGN-102, or that approval is delayed beyond the June 13, 2025 PDUFA date, we may need to raise additional capital in the future or reduce operating expenditures.

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.

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.

There can be no assurances that we will be able to secure such additional financing on terms that are satisfactory to us, in an amount sufficient to meet our needs, or at all.

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We cannot estimate the actual amounts necessary to successfully commercialize any approved products, or whether, or when, we may achieve profitability.

Until such time, if ever, as we can generate sufficient product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements.

Funding and Material Cash Requirements

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

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

the costs related to obtaining regulatory approval UGN-102, UGN-103, UGN-104, 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;

selling and marketing activities undertaken in connection with the commercialization of Jelmyto and, if approved, UGN-102 and any of our other product candidates that receives regulatory approval, and costs involved in the continued development of an effective sales and marketing organization;

the costs involved in filing and prosecuting patent applications and obtaining, maintaining and enforcing patents or defending against challenges, invalidity claims, or infringements raised by third parties, and license royalties or other amounts we may be required to pay to obtain rights to third party intellectual property rights;

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;

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;

the costs involved in filing and prosecuting patent applications and obtaining, maintaining and enforcing patents or defending against claims or infringements raised by third parties, and license royalties or other amounts we may be required to pay to obtain rights to third-party intellectual property rights;

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 and, if approved, UGN-102, UGN-103, UGN-104, 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-201, UGN-301, UGN-501, RTGel reverse thermal hydrogel technology and any other product candidates;

the repayment of outstanding debt.

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If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

For more information as to the risks associated with our future funding needs, see Part II, Item 1A.

– Risk Factors.

For more information as to the risks associated with our future funding needs, see Part II, Item 1A – Risk Factors.

We will require additional financing to achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.

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

In July 2022, we signed a lease extension agreement extending the term of the lease through September 2025.

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

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

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

The total obligation for future minimum lease payments under our operating and finance leases are $0.7 million and $4.7 million, respectively, as of March 31, 2025.

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.

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

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

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

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

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

All outstanding loans with Pharmakon accrue interest using a benchmark rate of 3-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one-year extension possible upon FDA approval of an NDA for UGN-102 by June 30, 2025.

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.

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

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

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

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

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

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

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

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)

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Operating Activities

Net cash used in operating activities was $42.0 million during the three months ended March 31, 2025, compared to $31.7 million during the three months ended March 31, 2024.

The $10.3 million increase was attributable primarily to higher net loss driven by increased operating expenses such as commercial preparation costs related to UGN-102, as well as timing of certain payments and accruals.

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.

Investing Activities

Net cash used in investing activities was $26.0 million during the three months ended March 31, 2025, compared to net cash provided by investing activities of $13.5 million during the three months ended March 31, 2024.

The net change of $39.5 million is attributable primarily to additional investments in marketable securities in 2025 as compared to 2024.

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.

Financing Activities

Net cash provided by financing activities was $34,000 during the three months ended March 31, 2025, compared to $54.7 million during the three months ended March 31, 2024.

The decrease of $54.7 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement in the first quarter of 2024.

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.

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