What changed in this filing

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Item 1. Financial Statements

2025-05-12 compared with 2024-11-06 · 407 added, 370 removed, 783 unchanged (50% of the section changed)

3 unchanged sentences

in thousands, except share amounts and par value)

September 30,

Current assets:

7 unchanged sentences

Prepaid expenses and other current assets

14,053 10,281

Total current assets

7 unchanged sentences

$ 247,618 $ 285,711

Liabilities and Shareholders' Equity (Deficit)

Liabilities and Shareholders' Deficit

Current liabilities:

15 unchanged sentences

Commitments and Contingencies (Note 19)

Shareholders' Equity (Deficit):

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at September 30, 2024 and December 31, 2023;

42,190,815 and 32,490,119 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

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

Additional paid-in capital

3 unchanged sentences

Accumulated other comprehensive income

Total Shareholders' Equity (Deficit)

Total Shareholders' Deficit

( 46,458 ) ( 8,803 )

Total Liabilities and Shareholders' Equity (Deficit)

Total Liabilities and Shareholders' Deficit

$ 247,618 $ 285,711

3 unchanged sentences

in thousands, except share and per share amounts)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Cost of revenue

9 unchanged sentences

Statements of Comprehensive Loss

Other comprehensive income (loss)

Unrealized gain (loss) on investments

Other comprehensive loss

Unrealized loss on investments

Comprehensive Loss

3 unchanged sentences

UroGen Pharma Ltd.

Condensed Consolidated Statements of Shareholders ’ Equity (Deficit)

in thousands, except share amounts)

Ordinary Shares

Additional paid-in

Accumulated other comprehensive

income (loss)

Balance as of July 1, 2024

Changes During the Three Months Ended September 30, 2024

Exercise of options into ordinary shares

Share-based compensation

Issuance of ordinary shares, net of issuance costs

Other comprehensive income

Balance as of September 30, 2024

Balance as of July 1, 2023

Changes During the Three Months Ended September 30, 2023

Exercise of options into ordinary shares

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

Issuance of ordinary shares, net of issuance costs

Other comprehensive income

Balance as of September 30, 2023

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

UroGen Pharma Ltd.

Condensed Consolidated Statements of Shareholders ’ Equity (Deficit)

Condensed Consolidated Statements of Shareholders ’ Deficit

in thousands, except share amounts)

4 unchanged sentences

Balance as of January 1, 2025

Changes During the Nine Months Ended September 30, 2024

Changes During the Three Months Ended March 31, 2025

Exercise of options into ordinary shares

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

Conversion of pre-funded warrants into ordinary shares

Issuance of ordinary shares, net of issuance costs

Other comprehensive income

Balance as of September 30, 2024

Other comprehensive loss

Balance as of March 31, 2025

Balance as of January 1, 2024

Changes During the Nine Months Ended September 30, 2023

Changes During the Three Months Ended March 31, 2024

Exercise of options into ordinary shares

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

Issuance of ordinary shares, net of issuance costs

Other comprehensive loss

Balance as of September 30, 2023

Balance as of March 31, 2024

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

2 unchanged sentences

in thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash Flows From Operating Activities

4 unchanged sentences

Share-based compensation

Amortization of discount on long-term debt

Amortization (accretion) of discount on long-term debt

Amortization of right of use assets

Acquisitions of IPR&D

Changes in operating assets and liabilities:

4 unchanged sentences

Employee related accrued expenses

Other current liabilities

Lease liabilities

Restricted deposit

Net cash used in operating activities

6 unchanged sentences

Proceeds from exercise of options into ordinary shares

Proceeds from issuance of long-term debt

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

Proceeds from ordinary shares issuance, net of issuance costs

5 unchanged sentences

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

Acquisitions of IPR&D

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

7 unchanged sentences

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

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

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.

On April 15, 2020, the U.S.

1 unchanged sentence

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

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

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

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.

8 unchanged sentences

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

The Company has experienced net losses since its inception and has an accumulated deficit o f $ 768.7 million and $ 679.3 million as of September 30, 2024 and December 31, 2023, respectively.

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

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

In accordance with the accounting guidance related to the presentation of financial statements, management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for the next 12 months from the date the financial statements are issued.

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 its ability to raise additional capital to fund its operations, produce cash inflows from Jelmyto product sales and advance UGN- 102 through regulatory approval.

Based on the Company's cash, cash equivalents and marketable securities as of September 30, 2024 , together with management’s cash flow projections, the Company believes that it has sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these condensed consolidated financial statements.

The Company may need to raise additional capital in the future.

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.

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.

In the event the Company is not successful in obtaining sufficient funding, this could force the Company to delay, limit, or reduce the Company's product development, commercialization efforts or other operations.

In the event the Company is not successful in obtaining sufficient funding, this could force the Company to delay, limit, reduce or terminate the Company's product development, commercialization efforts or other operations.

Note 3 – Significant Accounting Policies

16 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 $ 254.2 million as of September 30, 2024 .

Cash and cash equivalents and marketable securities totaled $ 200.4 million as of March 31, 2025 .

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

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

Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported in other comprehensive 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 transaction for trading or speculative purposes.

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

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

3 unchanged sentences

The accounts are monitored by management to mitigate the risk.

The Company’s product sales are recognized through the Company's arrangements with third -party national specialty distributors.

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

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

11 unchanged sentences

For Jelmyto , 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.

The Company values its inventory at the lower of cost or net realizable value.

22 unchanged sentences

See Note 10 for further discussion related to long-term debt.

The Company is a lessee in several noncancelable operating leases, primarily for office space, office equipment and vehicles.

The Company currently has no finance leases.

The Company accounts for leases in accordance with ASC Topic 842, “Leases” .

The Company determines if an arrangement is a lease at inception.

Right-of-use (“ROU”) assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date.

Operating lease ROU assets are presented as operating lease right-of-use assets on the condensed consolidated balance sheets.

The current portion of operating lease liabilities is included in other current liabilities and the long-term portion is presented separately as operating lease liabilities on the condensed consolidated balance sheets.

Lease expense is recognized on a straight-line basis for operating leases.

The Company is a lessee in several noncancelable operating and finance leases, primarily for office space, office equipment and vehicles.

The Company accounts for leases in accordance with ASC Topic 842, “Leases.” The Company determines if an arrangement is a lease at inception.

The Company additionally evaluates leases at their inception to determine if they are to be accounted for as an operating lease or a finance lease.

Right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of lease payments over the lease term as of the commencement date.

Certain adjustments to the ROU assets may be required for items such as initial direct costs paid or incentives received.

Operating and finance lease ROU assets are presented as right-of-use assets on the condensed consolidated balance sheets.

The current portion of lease liabilities is included in other current liabilities and the long-term portion is presented separately as long-term lease liabilities on the condensed consolidated balance sheets.

Lease expense for operating leases is recognized on a straight-line basis over the lease term.

For finance leases, the expense consists of interest on the lease liability and amortization of the ROU asset.

Variable lease payments associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed occurs.

Variable lease payments are presented as operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed lease payments.

Variable lease payments are presented as selling, general and administrative expenses in the condensed consolidated statements of operations.

The Company has elected the practical expedient to not separate between lease and non-lease components.

The Company’s lease terms may include options to extend the lease.

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

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.

1 unchanged sentence

ROU assets for operating leases are periodically reviewed for impairment losses under ASC 360 - 10, “Property, Plant, and Equipment”, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize.

Product sales from Jelmyto are recognized as revenue under ASC 606 at the point in time that control of the product has been transferred to the customer, generally at the point the product has been delivered to the treating physician.

All product sales of Jelmyto are recognized through the Company's arrangements with third -party national specialty distributors.

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

Net revenue from product sales is recognized at the transaction price when the specialty distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of the product to the treating physician.

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

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

Research and Development Expenses

Research and development costs are expensed as incurred and consist primarily of the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities, including nonclinical studies, clinical trials, manufacturing costs and professional services.

The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, shall be included in research and development costs and expensed as the contracted work is performed.

The costs of services performed by others in connection with the research and development activities of the Company, including research and development conducted by others on behalf of the Company, are included in research and development costs and expensed as the contracted work is performed.

The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers.

The Company adjusts its accrual as actual costs become known.

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

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.

Otherwise, acquired IPR&D is recognized as research and development expenses in the period the transaction is closed.

Selling, General and Administrative Expenses

18 unchanged sentences

Recently Adopted or Issued Accounting Pronouncements

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

2023 - 07, Segment Reporting (Topic 280 ):

Improvements to Reportable Segment Disclosures ("ASU 2023 - 07" ), which provides guidance to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses.

Public entities must adopt the new guidance for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.

The amendments in this ASU must be applied on a retrospective basis to all prior periods presented in the financial statements and early adoption is permitted.

The Company is currently assessing the disclosures which will be required under the new guidance and does not believe the adoption of ASU 2023 - 07 will have any material impact on its consolidated financial statements.

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

4 unchanged sentences

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

The Company has reviewed other Accounting Standards Updates recently issued by the FASB, and determined that none of these pronouncements will have a significant impact on the Company's consolidated financial statements and related disclosures.

SEC Climate Disclosures

In March 2024, the SEC issued its final climate disclosure rule, which requires certain disclosures relating to emissions and other climate-related topics.

For smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027.

Subsequently, in April 2024, the SEC issued an order staying implementation of the SEC Climate Disclosure Rules pending the resolution of certain challenges.

The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures.

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

2024 - 03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220 - 40 ) ("ASU 2024 - 03" ), which provides guidance to improve the disclosures about a public business entity’s expenses.

Public entities must adopt the new guidance for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.

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

The Company has reviewed other Accounting Standards Updates recently issued by the FASB, and determined that none of these pronouncements will have a significant impact on the Company's condensed consolidated financial statements and related disclosures.

Note 4 – Other Financial Information

Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands):

September 30,

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

Accounts payable

$ 14,567 $ 10,931

Accrued sales reserves

4 unchanged sentences

Total accounts payable and accrued expenses

$ 30,322 $ 27,431

Interest and Other Income, Net

Interest and other income, net consisted of the following for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

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

Three Months Ended March 31,

Interest income

$ 2,204 $ 1,798

Other income (loss), net

( 90 ) ( 183 )

Total interest and other income, net

$ 2,114 $ 1,615

Note 5 – Inventories

Inventories consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands):

September 30,

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

Raw materials (1)

$ 4,064 $ 4,924

Finished goods

Total inventories

$ 7,590 $ 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 .

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

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

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 September 30, 2024 are as follows (in thousands):

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

Fair Value Measurements Using

1 unchanged sentence

Balance as of

September 30,

Identical Assets

1 unchanged sentence

Money market funds

$ 11,181 $ 11,181 $ —

Commercial paper

4,491 — 4,491

Total cash equivalents

15,672 11,181 4,491

Marketable securities

65,837 65,837 —

Corporate bonds

11,910 — 11,910

Commercial paper

13,582 — 13,582

Certificates of deposit

5,043 — 5,043

Total marketable securities

96,372 65,837 30,535

Total assets at fair value

$ 112,044 $ 77,018 $ 35,026

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of December 31, 2024 are as follows (in thousands):

5 unchanged sentences

Money market funds

$ 41,008 $ 41,008 $ —

Marketable securities

26,053 26,053 —

Corporate bonds

14,980 — 14,980

Commercial paper

26,622 — 26,622

Certificates of deposit

2,065 — 2,065

Total marketable securities

69,720 26,053 43,667

Total assets at fair value

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

The Company’s investments in U.S.

government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of September 30, 2024 and December 31, 2023.

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 .

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

Note 7 – Investments

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):

The following table summarizes the Company’s investments as of March 31, 2025 (in thousands):

Cash equivalents

Money market funds

$ 11,181 $ — $ — $ 11,181

Commercial paper

4,492 — ( 1 ) 4,491

Total cash equivalents

15,673 — ( 1 ) 15,672

Marketable securities:

65,836 8 ( 7 ) 65,837

Corporate bonds

11,895 15 — 11,910

Commercial paper

13,580 3 ( 1 ) 13,582

Certificates of deposit

5,046 — ( 3 ) 5,043

Total marketable securities

96,357 26 ( 11 ) 96,372

Total assets at fair value

$ 112,030 $ 26 $ ( 12 ) $ 112,044

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

As of September 30, 2024 , the amortized cost of investments included an immaterial amount of accrued interest.

As of September 30, 2024 , marketable securities were in a net unrealized gain position.

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.

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

As of September 30, 2024 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 4.6 million which consisted of 4 securities.

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 and corporate bond positions.

government, commercial paper and certificates of deposit positions.

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 September 30, 2024 , the Company believes the cost basis for its marketable securities were recoverable in all material aspects and no allowance for credit losses were recognized in the period.

The Company’s investments as of September 30, 2024 mature at various dates through August 2026.

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.

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

September 30,

Maturities within one year

$ 107,530 $ 105,706

Maturities after one year through three years

$ 4,514 5,022

Total investments

$ 112,044 $ 110,728

Note 8 – Property and Equipment

Property and equipment, consists of the following as of September 30, 2024 and December 31, 2023 (in thousands):

September 30,

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

Laboratory equipment

3 unchanged sentences

accumulated depreciation and amortization

( 4,353 ) ( 4,281 )

Property and equipment, net

Depreciation and amortization expense was $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2024 and $ 0.2 million and $ 0.6 million for the three and nine months ended September 30, 2023 .

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 .

Note 9 – Prepaid Forward Obligation

1 unchanged sentence

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 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, if approved, UGN- 104, in an amount equal to:

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 nine months ended September 30, 2024 because certain revenue thresholds were not met.

This rate may decrease in the future back to 9.5 % if the Company subsequently meets certain Jelmyto aggregate worldwide annual net sales thresholds.

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:

2 unchanged sentences

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

As of September 30, 2024, the cumulative amounts paid and payable by the Company were $ 31.6 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.

3 unchanged sentences

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

The Company does not expect to make any principal payments 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, 2023 and for the nine months ended September 30, 2024, in thousands:

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2024 and for the three months ended March 31, 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 September 30, 2024

( 1 ) $ 3.3 million and $ 3.0 million of the Amounts paid and payable are included as current portion of the prepaid forward obligation within other current liabilities on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023, respectively.

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.

Note 10 – Long-Term Debt

6 unchanged sentences

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 a new drug application (“NDA”) for UGN- 102 no later than June 30, 2025 and (ii) the satisfaction of customary bring down conditions and deliverables.

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 %.

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Carrying value of Pharmakon loan as of December 31, 2023

Interest expense

Carrying value of Pharmakon loan as of December 31, 2023

Third tranche of Pharmakon loan

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Interest expense

Carrying value of Pharmakon loan as of September 30, 2024

Carrying value of Pharmakon loan as of December 31, 2024

Interest expense

Carrying value of Pharmakon loan as of March 31, 2025

Note 11 – Leases

Operating Leases

The Company had the following office and laboratory facility leases during the period covered by this report:

The Company had the following office and laboratory facility leases during the periods covered by this report:

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

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

The Company's remaining contractual obligation under this lease is approximately $ 0.3 million as of September 30, 2024 .

The Company's remaining contractual obligation under this lease is approximately $ 0.1 million as of March 31, 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 $ 0.8 million as of September 30, 2024 .

The Company’s remaining contractual obligation under this lease is approximately $ 0.5 million as of March 31, 2025 .

Finance Leases

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

Under the terms of the master lease agreement, the Company 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.

Lease payments are fixed, with payments due monthly in advance, and include charges for depreciation, maintenance, and other related services.

At the end of each lease term, the Company is required to make a terminal rental adjustment based on the difference between the vehicle’s contractual book value and its estimated wholesale value, which may result in additional payments or refunds.

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 .

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

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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 and nine months ended September 30, 2024 and 2023 were as follows (in thousands):

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

Three Months Ended

Nine Months Ended

September 30,

Finance lease cost:

Amortization of right-of-use assets

Interest on lease liabilities

Operating lease cost

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Variable lease cost

The amounts recognized as of September 30, 2024 and December 31, 2023 were as follows (in thousands):

September 30,

Right-of-use assets

Long-term lease liabilities

Other current liabilities

As of September 30, 2024 , no impairment losses have been recognized.

Supplemental information related to leases for the nine months ended September 30, 2024 and 2023 is as follows (in thousands, except for lease terms and discount rate amounts):

Nine Months Ended

September 30,

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

Finance lease right-of-use assets

$ 4,112 $ 2,285

Operating lease right-of-use assets

Finance long-term lease liabilities

Operating long-term lease liabilities

Other current liabilities related to finance leases

Other current liabilities related to operating leases

As of March 31, 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

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

Financing cash flows from finance leases

Operating cash flows from operating leases

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

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

Weighted-average remaining lease term of finance leases (in years)

Weighted-average remaining lease term of operating leases (in years)

Weighted-average discount rate of finance leases

Weighted-average discount rate of operating leases

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

10.23 % 10.27 %

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

Finance Leases

Years ending December 31,

Remainder of 2025

2029 and there after

Total future minimum lease payments

Present value of lease liabilities

As of September 30, 2023, maturities of lease liabilities were as follows (in thousands):

Years ending December 31,

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Present value of lease liabilities

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

Years ending December 31,

Remainder of 2024

Total future minimum lease payments

Present value of lease liabilities

Note 12 – Revenue From Product Sales

Net product sales consist of the following for the three and nine months ended September 30, 2024 and 2023 (in thousands):

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

Three Months Ended

Nine Months Ended

September 30,

Reserves related to items that are contractually able to be net settled are recognized as contra accounts receivable while other 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 period ended of September 30, 2024 (in thousands):

$ 20,254 $ 18,781

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

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

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

Reserves related to government sponsored programs

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Balance as of December 31, 2024

Balance as of September 30, 2024

$ 887 $ 7,729 $ 1,946 $ 10,562

3,686 903 2,713 7,302

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

Balance as of March 31, 2025

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

Balance as of December 31, 2023

$ 1,062 $ 3,451 $ 1,458 $ 5,971

1,927 845 1,793 4,565

( 2,149 ) — ( 1,996 ) ( 4,145 )

Balance as of March 31, 2024

$ 840 $ 4,296 $ 1,255 $ 6,391

Note 13 – License and Collaboration Agreements

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UGN- 301 is a formulation of zalifrelimab administered using RTGel technology that is in Phase 1 clinical development for high-grade non-muscle invasive bladder cancer ("high-grade NMIBC").

Note 14 – Acquisitions

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

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

As consideration for the Transferred Assets and subject to the terms and conditions of the Agreement, on the Closing Date the Company (i) issued 374,843 ordinary shares of the Company (the “Company Shares”) to IconOVir, which represented a purchase price of $ 4.0 million divided by the volume-weighted average closing price of the Company Shares on The Nasdaq Stock Market over the 30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir a one -time payment of $ 15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB- 1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts ((i), (ii), (iii), and (iv) collectively, the “Purchase Price”).

The Company also granted IconOVir certain piggyback registration rights with respect to the Company Shares issued to IconOVir, subject to customary exceptions and cutback rights.

Entities affiliated with Arie Belldegrun, M.D., the Chair of the Board of Directors of the Company, held certain promissory notes of IconOVir at the time, that may entitle such entities to receive, in the aggregate, approximately 28.3 % of the Purchase Price paid to IconOVir pursuant to the Agreement.

The Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.

If so, the transaction is accounted for as an asset acquisition.

The cost of an asset acquisition is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis.

Goodwill is not recognized in an asset acquisition.

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.

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.

Otherwise, amounts allocated to the IPR&D are recognized as research and development expenses in the period.

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.

Note 15 – Shareholders ’ Equity

The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2024 and December 31, 2023 .

The Company had 42.2 million and 32.5 million ordinary shares issued and outstanding as of September 30, 2024 and December 31, 2023 , respectively.

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.

Each ordinary share is entitled to one vote.

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

The remaining capacity under the ATM Sales Agreement was approximately $ 27.3 million as of September 30, 2024.

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.

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 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.

Securities Purchase Agreement

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333 - 274423 ) filed with the SEC on September 8, 2023, which was declared effective on September 15, 2023.

On December 20, 2023, the Company issued 1,599,733 ordinary shares through a cashless conversion of 1,599,840 pre-funded warrants for the purchase of ordinary shares of the Company.

On December 20, 2023, the Company issued 1,599,733 ordinary shares through a cashless exercise of 1,599,840 pre-funded warrants for the purchase of ordinary shares of the Company.

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.

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 is the Chair and Chief Investment Officer of Monograph.

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

Underwritten Public Offering

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The offering closed on June 20, 2024.

The gross proceeds to the Company from this closing of the offering were $ 107.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company of $ 7.3 million.

The gross proceeds to the Company from this closing of the offering were $ 107.5 million, before deducting underwriting discounts and commissions and offering expenses paid by the Company of $ 7.3 million.

Each pre-funded warrant has an exercise price of $ 0.001 per ordinary share, subject to customary adjustments, is exercisable at any time and will not expire until exercised in full.

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

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

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

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

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

Non-employee members of the Board typically receive a grant of stock options upon initial appointment to the Board, and 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 currently outstanding vest based on either the earlier of obtaining regulatory approval for the Company’s lead product candidate UGN- 102 or the occurrence of a change in control, or for certain other awards, the achievement of the first commercial sale of UGN- 102 in the United States following UGN- 102's receipt of regulatory approval.

In June 2024, the Company amended certain RSU and PSU awards granted to the chief executive officer to defer vesting until the end of 2025.

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.

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.

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

As the modification did not result in any incremental fair value at the modification date, the Company continues to recognize the original grant-date fair value ratably over the original service period or expected performance period.

The expected volatility is based on a mix of the Company’s historical volatility, and the historical volatility of comparable companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage.

The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted.

The expected term is the length of time until the expected dates of exercising the options and is estimated for employees using the simplified method due to insufficient specific historical information of employees’ exercise behavior, and for non-employees, and directors using the contractual term.

The maximum number of ordinary shares that was initially authorized for issuance under the 2017 Plan was 1,400,000 .

On January 1, 2018, the share reserve increased by 250,167 shares to 1,650,167 shares.

On October 12, 2018, the Company increased the number of ordinary shares authorized for issuance under the 2017 Plan by 1,900,000 shares to 3,550,167 shares.

On January 1, 2018, the share reserve increased by 250,167 shares to a total share reserve of 1,650,167 shares.

On October 12, 2018, the Company increased the number of ordinary shares authorized for issuance under the 2017 Plan by 1,900,000 shares to a total share reserve of 3,550,167 shares.

On June 8, 2020, the Company’s shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 400,000 shares to a total share reserve of 3,950,167 shares.

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On September 7, 2023, the Company's shareholders approved an increase to the number of ordinary shares authorized for issuance under the 2017 Plan by 450,000 shares to a total share reserve of 5,200,167 shares.

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

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

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

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In December 2021, the Board approved an increase to the number of shares authorized for issuance under the Inducement Plan of 300,000 shares.

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

As of September 30, 2024 , 3,961,302 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,853,992 ordinary shares remain available for future awards.

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.

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

Three Months Ended

Nine Months Ended

September 30,

Research and development expenses

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Total share-based compensation expense

The total unrecognized compensation cost of options and RSUs at September 30, 2024 is $ 15.1 million with a weighted average recognition period of 1.82 years.

$ 3,069 $ 2,756

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.

Note 17 – Income Taxes

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is taxed under Israeli tax laws.

As of September 30, 2024 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

As of March 31, 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 2023, 2022 and 2021, and for the nine months ended September 30, 2024 .

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 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 $3.2 million as of September 30, 2024 , 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 March 31, 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 September 30, 2024 , the Company’s liability for uncertain tax positions includes $1.2 million of accrued interest and penalties.

As of March 31, 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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Note 18 – Related Parties

There were no related party transactions for the nine months ended September 30, 2024.

See Note 14 for discussion regarding an affiliated investor in the private placement transaction for the nine months ended September 30, 2023 .

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.

Note 19 – Commitments and Contingencies

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

The Company’s maximum exposure under these arrangements is unknown as of September 30, 2024 and December 31, 2023.

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

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

The Company received from Teva Pharmaceuticals, Inc.

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

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 .

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.

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

If the Company is unsuccessful in securing the requested court relief, Jelmyto may be subject to immediate competition from an FDA approved generic product after regulatory exclusivity for Jelmyto expires in April 2027.

Separation Agreement

On June 26, 2024, the Company entered into a separation agreement with Jeff Bova, the Company’s former Chief Commercial Officer, which sets forth the terms of Mr.

Bova's termination of employment with the Company, effective as of September 30, 2024.

The arrangement includes cash severance, a pro rata portion of the target annual bonus for calendar year 2024, and partial acceleration of share-based compensation.

The Company recognized $ 1.1 million within selling, general and administrative expenses during the nine months ended September 30, 2024 in relation to this arrangement.

See Note 11 for further discussion regarding lease commitments.

Note 20 – Segment Reporting

The Company is engaged in the development and commercialization of innovative solutions for the treatment of urothelial and specialty cancers.

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

The CODM assesses performance and allocates resources based on net income or loss, which is the primary measure of performance, as reported in the condensed consolidated statements of operations and comprehensive loss.

Additionally, net income or loss is used to monitor performance relative to budgeted targets and to evaluate financial performance in relation to the Company’s strategic goals.

For additional information, refer to the condensed consolidated statements of operations and comprehensive loss for detailed measures of segment revenues, expenses, and profit or loss.

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

For the Three Months Ended March 31,

Research and development expenses

R&D project materials & services

$ 11,390 $ 10,728

Acquisitions of IP R&D

Employee compensation

Rent, office, utilities & technology

Other expenses

Total research and development expenses

$ 19,871 $ 15,494

Selling, general and administrative expenses

Employee compensation

$ 18,128 $ 13,959

Commercial & medical affairs services

Professional services

Travel, meetings & conferences

Rent, office, utilities & technology

Other expenses (1)

Total selling, general and administrative expenses

$ 34,967 $ 27,299

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

Note 21 – Subsequent Events

On October 7, 2024, the Company entered into a separation and consulting agreement with Don Kim, pursuant to which Mr.

Kim resigned from his positions as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer, effective October 8, 2024.

The arrangement includes cash severance and target annual bonus for calendar year 2024 of approximately $ 0.5 million, which will be recognized in the fourth quarter of 2024, as well as a post-separation consulting arrangement.

Kim's outstanding share-based awards will remain eligible for continued vesting during the post-separation consulting period.

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

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

Weighted-average number of ordinary shares (1)

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.

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

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The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended ( “ Securities Act ” ), and Section 21E of the Securities Exchange Act of 1934, as amended ( “ Exchange Act ” ), which are subject to the “ safe harbor ” created by those sections.

These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, trends, seasonality, projected costs, prospects and plans and objectives of management.

These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, trends, projected costs, prospects and plans and objectives of management.

The words “ anticipates, ” “ believes, ” “ estimates, ” “ expects, ” “ intends, ” “ may, ” “ plans, ” “ projects, ” “ will, ” “ would ” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

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

In addition, statements indicating “ 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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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 candidate, UGN-102 (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 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), an anti-CTLA-4 antibody, which we intend to study as a combination therapy with multiple agents.

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 low-grade intermediate risk NMIBC.

We estimate that the annual treatable population of low-grade intermediate risk NMIBC 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 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 low-grade intermediate risk NMIBC, trans-urethral resection of bladder tumor (“TURBT”).

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.

Food and Drug Administration ("FDA") approved medicine for 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 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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

The median duration of response was not reached.

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

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

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No treatment-related deaths occurred.

In December 2022, we presented new data from a follow up study to the OLYMPUS trial designed to obtain long‐term data on Jelmyto .

Based on data available for 16 of the 23 patients who had remained in CR at the end of the OLYMPUS study, the median duration of response ("DOR") in that subset of patients was 28.9 months.

Thirteen patients remained in CR, two patients had recurrence of low grade‐UTUC on the same side as treated in OLYMPUS, and one patient underwent RNU due to ureteral stricture without evidence of UTUC at the time of surgery.

No patient had progressed to high‐grade disease.

In 2024, we released data from a post-hoc analysis of the OLYMPUS trial assessing the long-term effects in treating low grade-UTUC with Jelmyto .

Of the 71 patients who enrolled in OLYMPUS, 41 achieved a CR and their health outcomes were tracked for up to 12 months.

Twenty of the patients remaining in CR enrolled in a 5-year rollover study.

All 41 patients with an initial CR indicated a promising median DOR of 47.8 months, based on a median follow-up of 28.1 months.

In the 5-year rollover trial, 75% (N=15) showed no disease recurrence at the time of the 4-year data cutoff, indicating potential for extended disease-free periods.

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

We have staffed, trained and prepared a customer-facing team that includes territory business managers with deep experience in both urology and oncology.

These territory business manager positions are led by seven regional business director positions, who are in turn supported by seven 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 key account directors who engage with C-suite individuals to introduce a Jelmyto service line.

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.

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 90 colleagues.

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

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 ("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 that have been or will be treated with 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.

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.

In each of the first three fiscal years beginning after the initiation of our commercial launch of Jelmyto in June 2020, we experienced a moderate decline in revenue during the third quarter from the preceding quarter.

We believe this result was primarily attributable to the nature of low-grade disease, which does not require immediate treatment and therefore we believe there could be an impact in the summer months.

However, we did not observe this trend in 2024 and therefore cannot say with confidence whether this seasonality trend will continue in future periods.

Moreover, our future Jelmyto revenue will be impacted by various factors and we expect our Jelmyto revenue to fluctuate quarter-to-quarter for the foreseeable future.

UGN-102 (mitomycin) for intravesical solution

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

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.

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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 DOR was not reached.

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

Thirteen patients had documented recurrences.

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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 low-grade intermediate risk NMIBC.

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

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

The primary endpoint is CR rate at three months after the first instillation, and the key secondary endpoint is durability of response in patients who achieve CR at the three-month assessment.

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.

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

We also initiated 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.

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.

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.

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

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

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

The 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:

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

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 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.

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 home health professionals, and three of four investigators considered at-home treatment “not different” than in-office treatment.

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 response 12 months after 3-month CR from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate risk NMIBC.

The FDA indicated that it may seek the advice of the Oncologic Drugs Advisory Committee as part of the NDA review process.

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

On June 13, 2024, we announced positive secondary endpoint DOR data from the Phase 3 ENVISION trial investigating UGN-102 for intravesical solution in patients with 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.

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%).

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

The 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.

We anticipate, and are preparing for, an FDA advisory committee meeting.

We expect to receive notification from the FDA in early 2025 regarding such meeting.

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

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.

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 a next-generation formulation 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.

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 low-grade intermediate risk NMIBC.

We plan to enroll 87 patients in the UTOPIA trial, with patients receiving 75 mg of UGN-103 via intravesical instillation once a week for six weeks.

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

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

(“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.

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.

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

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

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.

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

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

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.

UGN-301 (zalifrelimab) intravesical solution

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

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

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

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

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

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

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

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.

Research and Development and License Agreements

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Components of Operating Results

During the three and nine months ended September 30, 2024, we recognized $25.2 million and $65.8 million of revenue, respectively, from sales of our product, Jelmyto .

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.

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 ingredient (“API”) 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.

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

We regularly review our research and development activities and, as necessary, reallocate resources among our program, product candidates and external opportunities that we believe will best support the long-term growth of our business.

We do not track total research and development expenses by program, product candidates, or development phase.

We regularly review our research and development activities and, as necessary, reallocate resources among our programs, product candidates and external opportunities that we believe will best support the long-term growth of our business.

We do not track total research and development expenses by program, product candidate, or development phase.

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

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Clinical and other development costs

See Note 20 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for additional disaggregation of significant research and development expenses.

We expense all research and development costs as incurred.

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

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

Research and development expense will continue to be significant.

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

Research and development expenses will continue to be significant.

Research and development activities are central to our business model.

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In addition, we cannot forecast which product candidates may be subject to future collaborations, if and when such arrangements will be entered into, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We expect our research and development expense to increase over the next several years as our clinical programs progress and as we seek to initiate clinical trials of additional product candidates.

We also expect to incur increased research and development expense as we selectively identify and develop additional product candidates.

We expect our research and development expenses to increase over the next several years as our clinical programs progress and as we seek to initiate clinical trials of additional product candidates.

We also expect to incur increased research and development expenses as we selectively identify and develop additional product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following:

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the length of time required to enroll eligible patients;

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

the number of doses that patients receive;

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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 and UGN-301 are still in clinical development.

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 substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements.

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.

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.

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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 totaling approximately $452.0 million as of December 31, 2023.

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

We 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.

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

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Results of Operations

Comparison of the three months ended September 30, 2024 and 2023

The following table sets forth our results of operations for the three months ended September 30, 2024 and 2023.

Three Months Ended September 30,

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,

(in thousands)

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Income tax expense

Revenue was $25.2 million and $20.9 million for the three months ended September 30, 2024 and 2023, respectively.

The increase in revenue of $4.3 million primarily reflects the increased volume of sales of Jelmyto, including CREATES Act sales of $2.6 million in the third quarter of 2024, compared to $1.1 million of CREATES Act sales in the third quarter of 2023.

The increase in volume of sales of Jelmyto was partially offset by higher revenue reserves primarily driven by estimated Medicare refunds for discarded drugs.

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.

Cost of Revenue

Cost of revenue was $2.5 million and $2.4 million for the three months ended September 30, 2024 and 2023, respectively.

The increase of $0.1 million is primarily attributable to the increased volume of sales of Jelmyto, partially offset by certain nonrecurring payments made in connection with our supply arrangement in the prior year.

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 .

Research and Development Expenses

Research and development expenses were $11.4 million and $10.2 million for the three months ended September 30, 2024 and 2023, respectively.

The increase of $1.2 million is primarily attributable to higher costs related to the initiation of the Phase 3 UTOPIA trial for UGN-103, partially offset by lower UGN-102 clinical trial costs and costs related to the research into ingredient scale-up and production efficiency for Jelmyto .

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.

Selling and Marketing Expenses

Selling and marketing expenses were $17.8 milli on and $12.6 million for the three months ended September 30, 2024 and 2023 , respectively.

The increase in selling and marketing expenses of $5.2 million is primarily attributable to UGN-102 brand marketing costs as well as an increase in overall commercial operation costs related to the planned expansion of the sales force and incentive compensation, meetings, conferences, and trainings.

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.

General and Administrative Expenses

General and administrative expenses were $11.2 million and $9.2 million for the three months ended September 30, 2024 and 2023 , respectively.

The increase in general and administrative expenses of $2.0 million is primarily attributable to higher compensation expenses, expenses related pre-commercialization readiness support related to UGN-102, general third-party advisory services, and ongoing managed services.

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.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $5.9 million and $5.5 million for the three months ended September 30, 2024 and 2023, respectively.

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.

The increase in financing on prepaid forward obligation of $0.4 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $2.7 million and $3.8 million for the three months ended September 30, 2024 and 2023, respectively.

The decrease of $1.1 million was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmakon loan as a result of the amended and restated loan agreement in March 2024.

Interest and Other Income, Net

Interest and other income, net was $2.6 million and $0.9 million for the three months ended September 30, 2024 and 2023, respectively.

The increase of $1.7 million in interest and other income, net was primarily due to higher cash and investment balances.

Comparison of the nine months ended September 30, 2024 and 2023

The following table sets forth our results of operations for the nine months ended September 30, 2024 and 2023.

Nine Months Ended September 30,

(in thousands)

Cost of revenue

Operating expenses:

Research and development

Selling and marketing

General and administrative

Total operating expenses

Operating loss

Financing on prepaid forward obligation

Interest expense on long-term debt

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $65.8 million and $59.2 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase in revenue of $6.6 million primarily reflects the increased volume of sales of Jelmyto, including CREATES Act sales of $2.8 million for the nine months ended September 30, 2024, compared to $2.0 million of CREATES Act sales in same period in 2023.

Cost of Revenue

Cost of revenue was $6.4 million and $7.1 million for the nine months ended September 30, 2024 and 2023, respectively.

The decrease of $0.7 million is primarily attributable to certain nonrecurring payments made in connection with our supply arrangement in the prior year, lower shipping and warehousing costs, and a decrease in the Jelmyto unit cost.

Research and Development Expenses

Research and development expenses were $42.3 million and $34.3 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase of $8.0 million is primarily attributable to higher manufacturing costs, which are recognized as research and development expense prior to our product candidates receiving FDA approval, and regulatory related expense in connection with UGN-102 as well as research and development expenses, in connection with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower UGN-102 clinical trial costs and costs related to the research into ingredient scale-up and production efficiency for Jelmyto .

Selling and Marketing Expenses

Selling and marketing expenses were $53.8 milli on and $40.7 million for the nine months ended September 30, 2024 and 2023 , respectively.

The increase in selling and marketing expenses of $13.1 million is primarily attributable to UGN-102 brand marketing costs as well as an increase in overall commercial operation costs including compensation, advisory, meetings, conferences, trainings and software costs.

General and Administrative Expenses

General and administrative expenses were $32.5 million and $28.1 million for the nine months ended September 30, 2024 and 2023 , respectively.

The increase in general and administrative expenses of $4.4 million is primarily attributable to higher compensation expenses, communication expenses related to UGN-102, third-party advisory services, and ongoing managed services .

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $17.3 million and $16.0 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase in financing on prepaid forward obligation of $1.3 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

The decrease in financing on prepaid forward obligation of $1.1 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $8.6 million and $11.1 million for the nine months ended September 30, 2024 and 2023, respectively.

The decrease of $2.5 million was primarily attributed to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmakon loan as a result of the amended and restated loan agreement in March 2024.

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 and Other Income, Net

Interest and other income, net was $5.9 million and $1.9 million for the nine months ended September 30, 2024 and 2023, respectively.

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.

Liquidity and Capital Resources

As of September 30, 2024, we had $254.2 million in cash and cash equivalents and marketable securities.

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

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

Through September 30, 2024, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon.

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.

ATM Sales Agreement

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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 September 30, 2024.

The remaining capacity under the ATM Sales Agreement was approximately $27.3 million as of September 30, 2024.

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.

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.

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

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

On June 29, 2023, the 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%.

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.

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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%.

Securities Purchase Agreement

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Underwritten Public Offering

On June 17, 2024, we entered into the Underwriting Agreement with 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 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.

The offering closed on June 20, 2024.

The gross proceeds from this closing of the offering were $107.5 million, before deducting underwriting discounts and commissions and estimated offering expenses of $7.3 million.

The gross proceeds from this closing of the offering were $107.5 million, before deducting underwriting discounts and commissions and offering expenses of $7.3 million.

Each pre-funded warrant has an exercise price of $0.001 per ordinary share, subject to customary adjustments, is exercisable at any time and will not expire until exercised in full.

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

We have incurred losses since our inception and negative cash flows from our operations, and as of September 30, 2024 we had an accumulated deficit o f $768.7 million.

We anticipate that we will continue to incur losses for the reasonably foreseeable future.

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, 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 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 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 our ability to raise additional capital to fund our operations, produce cash inflows from Jelmyto product sales and advance UGN-102 through regulatory approval.

Based on our cash, cash equivalents and marketable securities as of September 30, 2024, 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.

We may need to raise additional capital in the future.

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.

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.

In the event we are not successful in obtaining sufficient funding, this could force us to delay, limit, or reduce our product development, commercialization efforts or other operations.

In the event we are not successful in obtaining sufficient funding, this could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.

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 substantial 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

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

the progress, timing and completion of clinical trials for UGN-102, UGN-301, UGN-103 and UGN-104;

the progress, timing and completion of clinical trials for UGN-102, UGN-103, UGN-104, 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-301, UGN-103, UGN-104 and any of our 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 these product candidates;

selling, marketing and patent-related activities undertaken in connection with the commercialization of Jelmyto and UGN-102 and any of our other product candidates, 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;

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;

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

the repayment of outstanding debt.

Accordingly, we may need to obtain additional funding in connection with our continuing operations.

If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

There can be no assurance 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.

In the event we are not successful in obtaining sufficient funding, we may be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts.

We may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements.

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

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

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

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

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

The total obligation for future minimum lease payments under our operating leases is $1.1 million as of September 30, 2024.

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

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

The total obligation for future minimum lease payments under our operating and finance leases are $0.7 million and $4.7 million, respectively, as of March 31, 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 a loan agreement with Pharmakon for a senior secured term loan of up to $100.0 million in two tranches.

On March 7, 2022, we entered into the 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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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.

On June 26, 2024, we entered into a separation agreement with Jeff Bova, our former Chief Commercial Officer, which sets forth the terms of Mr.

Bova's termination of employment, effective as of September 30, 2024.

The arrangement includes cash severance, a pro rata portion of the target annual bonus for calendar year 2024, and partial acceleration of share-based compensation.

We recognized $1.1 million during the nine months ended September 30, 2024 in relation to this arrangement.

On October 7, 2024, we entered into a separation and consulting agreement with Don Kim, pursuant to which Mr.

Kim resigned from his positions as our Chief Financial Officer, principal financial officer and principal accounting officer, effective October 8, 2024.

The arrangement includes cash severance and target annual bonus for calendar year 2024 of approximately $0.5 million, which will be recognized in the fourth quarter of 2024, as well as a post-separation consulting arrangement.

Kim's outstanding share-based awards will remain eligible for continued vesting during the post-separation consulting period.

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

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Operating Activities

Net cash used in operating activities was $83.1 million during the nine months ended September 30, 2024, compared to $63.4 million during the nine months ended September 30, 2023.

The $19.7 million increase was attributable primarily to higher net loss driven by increased operating expenses such as regulatory and brand marketing costs related to UGN-102, as well as timing of certain accruals.

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.

Investing Activities

Net cash used in investing activities was $81.2 million during the nine months ended September 30, 2024, compared to net cash provided by investing activities of $10.4 million during the nine months ended September 30, 2023.

The net change of $91.6 million is attributable primarily to additional investment in marketable securities in 2024 as compared to 2023.

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.

Financing Activities

Net cash provided by financing activities was $194.5 million during the nine months ended September 30, 2024, compared to $116.9 million during the nine months ended September 30, 2023.

The increase of $77.6 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement, the underwritten public offering and the issuance of debt related to the third tranche of the Pharmakon loan.

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.

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