0001437749-24-033454 | 10-Q | XBRL Viewer

Commitments and Contingencies Disclosure [Text Block]

Note 18 – Commitments and Contingencies

In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. 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 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. In the Notice Letter, Teva alleges that two of the patents listed in the FDA Orange Book for Jelmyto, U.S. Patent Numbers 9,040,074 and 9,950,069, each of which expires in January 2031, are invalid, unenforceable, or will not be infringed by Teva’s manufacture, use, or sale of the generic product described in its ANDA submission. On April 2, 2024, the Company filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing U.S. market entry of Teva’s generic product prior to the expiry of such patents. The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd. without prejudice and the action continues against the other two Teva entities. 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.

Leases

See Note 11 for further discussion regarding lease commitments.

Note 10 - Long-term Debt (Details Textual) - Secured Debt [Member] - USD ($) $ in Millions		1 Months Ended
	Mar. 13, 2024	Jul. 31, 2023	Sep. 30, 2024	Mar. 07, 2022
Secured Long-Term Debt, Noncurrent				$ 100.0
Secured Long Term Debt, First Tranche				75.0
Secured Long Term Debt, Additional Draw				25.0
Secured Long Term Debt, Third Tranche	$ 25.0
Secured Long Term Debt, Fourth Tranche	$ 75.0
Debt Issuance Costs, Gross			$ 0.5	$ 4.2
Secured Overnight Financing Rate (SOFR) [Member]
Debt Instrument, Basis Spread on Variable Rate	7.25%	8.25%
Additional Adjustment on SOFR Rate [Member]
Debt Instrument, Basis Spread on Variable Rate	0.26161%	0.26161%

Note 11 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023
Remainder of 2024	$ 219	$ 291
2025	820	923
2026	58	813
Total future minimum lease payments	1,097	2,084
Less: Interest	(60)	(200)
Present value of lease liabilities	$ 1,037	1,884
2026		$ 57

Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flows From Operating Activities
Net loss	$ (89,362)	$ (76,228)
Adjustment to reconcile net loss to net cash from operating activities:
Depreciation and amortization	261	612
Accrued financing on prepaid forward obligation	9,013	8,714
(Accretion) on marketable securities	(1,555)	(622)
Share-based compensation	9,805	6,732
Amortization of discount on long-term debt	(1,330)	981
Amortization of right of use assets	619	669
Changes in operating assets and liabilities:
Inventory	(1,921)	(677)
Accounts receivable, net	(7,359)	(143)
Prepaid expenses and other current assets	(3,772)	(4,937)
Other non-current assets	1,668	690
Accounts payable and accrued expenses	3,147	1,700
Employee related accrued expenses	(1,785)	(105)
Lease liabilities	(626)	(766)
Restricted deposit	50	0
Net cash used in operating activities	(83,147)	(63,380)
Cash Flows From Investing Activities
Purchases of marketable securities	(118,794)	(35,009)
Maturities of marketable securities	37,740	45,538
Purchases of property and equipment	(180)	(138)
Net cash (used in) provided by investing activities	(81,234)	10,391
Cash Flows From Financing Activities
Proceeds from exercise of options into ordinary shares	250	833
Proceeds from issuance of long-term debt	24,488	0
Proceeds from pre-funded warrant issuance, net of issuance costs	18,641	48,700
Proceeds from ordinary shares issuance, net of issuance costs	151,169	67,358
Net cash provided by financing activities	194,548	116,891
Increase (Decrease) in Cash and Cash Equivalents	30,167	63,902
Cash, Cash Equivalents and Restricted Cash at Beginning of Period	95,822	56,220
Cash, Cash Equivalents and Restricted Cash at End of Period	125,989	120,122
Supplemental Disclosures of Non-Cash Activities
Right of use assets obtained in exchange for new operating lease liabilities	$ 0	$ 122

Note 15 - Share-based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Text Block]

Note 15 – Share-Based Compensation

In October 2010, the Board approved a share option plan (the "2010 Plan") for grants to Company employees, consultants, directors, and other service providers. Subsequently, in March 2017, the Board adopted the 2017 Equity Incentive Plan (the "2017 Plan" and, together with the 2010 Plan, the "Plans"), which was approved by the shareholders in April 2017. The 2017 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, RSU awards, performance share awards, performance cash awards, and other forms of share awards to the Company's employees, directors and consultants.

The grant of options to Israeli employees under the Plans is subject to the terms stipulated by Section 102 of the Israeli Income Tax Ordinance (“Section 102”). The option grants are subject to the track chosen by the Company, either the “regular income” track or the “capital gains” track, as set out in Section 102. The Company registered the Plans under the capital gains track, which offers more favorable tax rates to the employees. As a result, and pursuant to the terms of Section 102, the Company is not allowed to claim as an expense for tax purposes the amounts credited to the employees in respect of options granted to them under the Plans, including amounts recorded as salary benefits in the Company’s accounts, with the exception of the work-income benefit component, if any, determined on grant date. For non-employees and for non-Israeli employees, the Plans is subject to Section 3(i) of the Israeli Income Tax Ordinance.

Employees are typically granted stock options and/or RSUs, upon commencement of employment. Also, eligible employees may receive an annual grant of options, RSUs and/or PSUs. Non-employee members of the Board typically receive a grant of stock options upon initial appointment to the Board, and/or stock options annually. The term of any option granted under the Plans cannot exceed 10 years. Options shall not have an exercise price less than 100% of the fair market value of the Company’s ordinary shares on the grant date, and generally vest over a period of three years. If the individual possesses more than 10% of the combined voting power of all classes of equity of the Company, the exercise price shall not be less than 110% of the fair market value of an ordinary share on the date of grant.

The Company’s RSU and option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including a termination in connection with a change in control. RSUs generally vest in a 33% increment upon the first anniversary of grant, and in either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date. Options generally vest in a 33% increment upon the first anniversary of the grant date, and in either equal quarterly or annual amounts for the two years following the one-year anniversary of the grant date. 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 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 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. On June 7, 2021, 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 4,350,167 shares. On June 8, 2022, 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 4,750,167 shares. 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.

In May 2019, the Company adopted the UroGen Pharma Ltd. 2019 Inducement Plan (the “Inducement Plan”). Under the Inducement Plan, the Company is authorized to issue up to 900,000 ordinary shares pursuant to inducement awards. The only persons eligible to receive grants under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. 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.

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,*				*September 30,*
	*2024*		*2023*		*2024*		*2023*
Research and development expenses	$	579	$	415	$	1,691	$	1,436
Selling, general and administrative expenses		2,910		1,809		8,114		5,296
Total share-based compensation expense	$	3,489	$	2,224	$	9,805	$	6,732

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.

Note 10 - Long-term Debt - Long Term Debt (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Interest expense	$ 2,721	$ 3,815	$ 8,629	$ 11,129
Interest expense	2,721	$ 3,815	8,629	$ 11,129
Pharmakon Loan [Member]
Carrying value of Pharmakon loan	121,709		121,709		$ 98,551	$ 97,537
Interest expense			8,629		14,715
Amounts paid	(9,959)		(9,959)		(13,701)
Third tranche of Pharmakon loan	25,000		25,000
Capitalized costs and discounts	$ (512)		(512)
Interest expense			$ 8,629		$ 14,715

Note 9 - Prepaid Forward Obligation (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Activity in the Carrying Value of the Prepaid Forward Liability [Table Text Block]

Carrying value of prepaid forward obligation as of December 31, 2022	$	98,923
Financing on prepaid forward obligation		21,552
Amounts paid and payable ⁽¹⁾		(10,753	)
Carrying value of prepaid forward obligation as of December 31, 2023		109,722
Financing on prepaid forward obligation		17,348
Amountspaid and payable ⁽¹⁾		(8,544	)
Carrying value of prepaid forward obligation as of September 30, 2024	$	118,526

Note 18 - Commitments and Contingencies (Details Textual) $ in Millions	9 Months Ended
	Sep. 30, 2024 USD ($)
Selling, General and Administrative Expenses [Member]
Severance Costs	$ 1.1

Note 15 - Share-based Compensation (Details Textual) - USD ($) $ in Millions								1 Months Ended		9 Months Ended
	Aug. 06, 2024	Sep. 07, 2023	Jun. 08, 2022	Jun. 07, 2021	Jun. 08, 2020	Oct. 12, 2018	Jan. 01, 2018	Jun. 30, 2024	Dec. 31, 2021	Sep. 30, 2024	May 31, 2019	Mar. 31, 2017
Common Stock, Capital Shares Reserved for Future Issuance (in shares)										3,961,302
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares)										1,853,992
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount										$ 15.1
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)										1 year 9 months 25 days
Share-Based Payment Arrangement, Option [Member] \| Share-Based Payment Arrangement, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage										33.00%
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year)										2 years
Restricted Stock Units (RSUs) [Member] \| Share-Based Payment Arrangement, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage										33.00%
Share Option Plan [Member] \| Share-Based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year)										3 years
Share-based Compensation Arrangement By Share-based Payment Award, Individual Voting Powers, Percentage										10.00%
Two Thousand Seventeen Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)	6,000,167	5,200,167	4,750,167	4,350,167	3,950,167	3,550,167	1,650,167					1,400,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)	800,000	450,000	400,000	400,000	400,000	1,900,000	250,167
The 2019 Inducement Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)								1,800,000			900,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)								600,000	300,000
Maximum [Member] \| Share Option Plan [Member] \| Share-Based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year)										10 years
Minimum [Member] \| Share Option Plan [Member] \| Share-Based Payment Arrangement, Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent										100.00%
Share-based Compensation Arrangement By Share-based Payment Award, Percentage of Purchase Price for Individuals Having More than Ten Percent of Combined Voting Power										110.00%

Note 12 - Revenue From Product Sales

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Text Block]

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):

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2024*		*2023*		*2024*		*2023*
Jelmyto	$	25,204	$	20,852	$	65,833	$	59,183

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. 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):

	*Reserves related to government sponsored programs*			*Medicare refunds for discarded drug reserve*		*Other reserves*			*Total accrued sales reserves*
Balance as of December 31, 2023	$	1,062		$	3,451	$	1,458		$	5,971
Accruals		9,833			3,113		7,703			20,649
Utilizations		(10,206	)		—		(7,219	)		(17,425	)
Balance as of September 30, 2024	$	689		$	6,564	$	1,942		$	9,195

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

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Note 3 - Significant Accounting Policies - Useful Lives of Property and Equipment (Details)	Sep. 30, 2024
Computers and Software [Member]
Useful life (Year)	3 years
Laboratory Equipment [Member] \| Minimum [Member]
Useful life (Year)	3 years
Laboratory Equipment [Member] \| Maximum [Member]
Useful life (Year)	6 years 6 months
Furniture [Member[ \| Minimum [Member]
Useful life (Year)	5 years
Furniture [Member[ \| Maximum [Member]
Useful life (Year)	16 years 6 months
Manufacturing Equipment [Member] \| Minimum [Member]
Useful life (Year)	2 years
Manufacturing Equipment [Member] \| Maximum [Member]
Useful life (Year)	10 years

Note 15 - Share-based Compensation - Effect of Share-based Compensation on the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based compensation	$ 3,489	$ 2,224	$ 9,805	$ 6,732
Research and Development Expense [Member]
Share-based compensation	579	415	1,691	1,436
Selling, General and Administrative Expenses [Member]
Share-based compensation	$ 2,910	$ 1,809	$ 8,114	$ 5,296

Note 8 - Property and Equipment

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment Disclosure [Text Block]

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,*			*December 31,*
	*2024*			*2023*
Laboratory equipment	$	473		$	464
Computer equipment and software		2,460			2,293
Furniture		612			612
Leasehold improvements		621			617
Manufacturing equipment		655			655
		4,821			4,641
Less: accumulated depreciation and amortization		(4,213	)		(3,952	)
Property and equipment, net	$	608		$	689

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.

Note 9 - Prepaid Forward Obligation - Activity in the Carrying Value of the Prepaid Forward Liability (Details) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

12 Months Ended

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Dec. 31, 2023

Carrying value of prepaid forward obligation

$ 109,722

$ 98,923

Financing on prepaid forward obligation

$ 5,915

$ 5,479

17,348

$ 16,047

21,552

Amounts paid and payable (1)

^[1]

(8,544)

(10,753)

Carrying value of prepaid forward obligation

$ 118,526

$ 109,722

[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.

Note 5 - Inventories (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Inventory, Current [Table Text Block]

	*September 30,*		*December 31,*
	*2024*		*2023*
Raw materials ⁽¹⁾	$	4,662	$	4,464
Finished goods		2,932		2,877
Total inventories	$	7,594	$	7,341

Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Consolidation, Policy [Policy Text Block]

Principles of Consolidation

The Company's condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation.

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results may differ from those estimates. As applicable to the unaudited condensed consolidated financial statements, the critical accounting estimates relate to the fair value of share-based compensation, measurement of revenue, estimate of uncertain tax positions, and measurement of liabilities accounted for under the interest method.

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Functional Currency

The U.S. dollar (“Dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted. Therefore, the functional currency of the Company is the Dollar.

Accordingly, transactions in currencies other than the Dollar are measured and recorded in the functional currency using the exchange rate in effect at the date of the transaction. At the balance sheet date, monetary assets and liabilities that are denominated in currencies other than the Dollar are measured using the official exchange rate at the balance sheet date. The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.”

Cash, Cash Equivalents and Marketable Securities Policy [Policy Text Block]

Cash and Cash Equivalents; Marketable Securities

The Company presents all highly liquid investments with an original maturity of three months or less when purchased as cash equivalents. 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. 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. Realized gains and losses are recorded as a component of interest and other income, net. The cost of securities sold is based on the specific-identification method.

Certain short-term investments are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. The majority of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

For individual debt securities classified as available-for-sale securities where there has been a decline in fair value below amortized cost, the Company determines whether the decline resulted from a credit loss or other factors. The Company records impairment relating to credit losses through an allowance for credit losses, limited by the amount that the fair value is less than the amortized cost basis. Impairment that has not been recorded through an allowance for credit losses is recorded through other comprehensive income, net of applicable taxes.

Restricted cash is related primarily to cash held to secure corporate credit cards; restricted deposits are related to cash held to secure leases.

Concentration Risk, Credit Risk, Policy [Policy Text Block]

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents and marketable securities. 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’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. The Company maintains cash balances in excess of amounts insured by the Federal Deposit Insurance Corporation and concentrated within a limited number of financial institutions. 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 assesses the need for an allowance for doubtful accounts primarily based on creditworthiness, historical payment experience and general economic conditions. The Company has not experienced any credit losses related to arrangements with customers and has not currently recognized any allowance for doubtful accounts.

Income Tax, Policy [Policy Text Block]

Income Taxes

The Company provides for income taxes based on pretax income, if any, and applicable tax rates available in the various jurisdictions in which it operates, including Israel and the United States. Deferred taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future.

The Company follows a two-step approach in recognizing and measuring uncertain tax positions. After concluding that a particular filing position can be recognized (i.e., has a more-likely-than-not chance of being sustained), ASC 740-10-30-7 requires that the amount of benefit recognized be measured using a methodology based on the concept of cumulative probability. Under this methodology, the amount of benefit recorded represents the largest amount of tax benefit that is greater than 50% likely to be realized upon settlement with a taxing authority that has full knowledge of all relevant information. See Note 16 for further discussion related to income taxes.

Inventory, Policy [Policy Text Block]

Inventory

The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For Jelmyto, the Company commenced capitalization of inventory at the receipt of FDA approval.

The Company values its inventory at the lower of cost or net realizable value. The Company measures inventory approximating actual cost under a first-in, first-out basis. The Company assesses recoverability of inventory each reporting period to determine any write down to net realizable value resulting from excess or obsolete inventories.

Property, Plant and Equipment, Policy [Policy Text Block]

Property and Equipment

Property and equipment are recorded at historical cost, net of accumulated depreciation, amortization and, if applicable, impairment charges. The Company reviews its property and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

Property and equipment are depreciated over the following useful lives (in years):

		*Useful Lives*
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2 - 10

Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 for further discussion regarding property and equipment.

Prepaid Forward Obligation Policy [Policy Text Block]

Prepaid Forward Obligation

The Company is party to a transaction (the “RTW Transaction”) with RTW Investments (“RTW”) in which the Company received funds to support the launch of Jelmyto and the development of UGN-102 in return for tiered, future cash payments based on net sales of Jelmyto and, subject to FDA approval, UGN-102, UGN-103 and UGN-104. The net proceeds received under the RTW Transaction were recognized as a long-term liability. The Company recognizes the current cash payable amounts under the arrangement within other current liabilities on the condensed consolidated balance sheets. The subsequent measurement for the liability follows the accounting principles defined in ASC Topic 835-30, “Imputation of Interest”. See Note 9 for further discussion related to the prepaid forward obligation.

Debt, Policy [Policy Text Block]

Long-Term Debt

The Company is party to a loan agreement with funds managed by Pharmakon Advisors, L.P. (“Pharmakon”). The Company recognizes interest expense in current earnings, and accrued interest within other current liabilities on the condensed consolidated balance sheets. The Company recognizes capitalized financing expenses as a direct offset to the long-term debt on the Company's condensed consolidated balance sheets, and amortizes them over the term of the debt using the effective interest method. See Note 10 for further discussion related to long-term debt.

Lessee, Leases [Policy Text Block]

Leases

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. 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.

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.

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

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.

Revenue [Policy Text Block]

Revenue

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.

Research and Development Expense, Policy [Policy Text Block]

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 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.

Selling, General and Administrative Expenses, Policy [Policy Text Block]

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of personnel costs (including share-based compensation related to directors, employees and consultants). Other significant costs include commercial, medical affairs, external professional service costs, facility costs, accounting and audit services, legal services and other consulting fees. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

Share-Based Payment Arrangement [Policy Text Block]

Share-Based Compensation

Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the required service period, which is equal to the vesting period. For performance stock units (“PSUs”), cost is measured at the grant date based on the fair value of the award and is recognized over any relevant service period as expense when the achievement of the performance condition is probable. The fair value of options is determined using the Black-Scholes option-pricing model. The fair value of a restricted stock unit (“RSU”) or a PSU equals the closing price of the Company’s ordinary shares on the grant date. The Company accounts for forfeitures as they occur in accordance with ASC Topic 718, “Compensation—Stock Compensation”.

The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method and to value the awards based on the single-option award approach.

Stockholders' Equity, Policy [Policy Text Block]

Pre-funded Warrants

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

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Ordinary Share

Basic net loss per share is computed by dividing the net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional ordinary shares that would have been outstanding if the potential ordinary shares had been issued and if the additional ordinary shares were dilutive.

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

The Company’s pre-funded warrants require the holder to pay nominal consideration to receive the Company’s ordinary shares and are therefore considered outstanding shares in determining basic and diluted earnings per share in accordance with ASC Topic 260, “Earnings per Share”.

New Accounting Pronouncements, Policy [Policy Text Block]

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. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which will require the Company to disclose specified additional information in its income tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 will also require the Company to disaggregate its income taxes paid disclosure by federal, state and foreign taxes, with further disaggregation required for significant individual jurisdictions. The Company will adopt ASU 2023-09 for the 2025 year-end and is currently evaluating the potential impact of the adoption on the Company’s financial disclosures. ASU 2023-09 allows for adoption using either a prospective or retrospective transition method.

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.

Note 3 - Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Significant Accounting Policies [Text Block]

Note 3 – Significant Accounting Policies

Principles of Consolidation

The Company's condensed consolidated financial statements include the accounts of UPL and its subsidiary, UPI. Intercompany balances and transactions have been eliminated during consolidation.

Use of Estimates

Functional Currency

Cash and Cash Equivalents; Marketable Securities

Restricted cash is related primarily to cash held to secure corporate credit cards; restricted deposits are related to cash held to secure leases.

Concentration of Credit Risk

Income Taxes

Inventory

Property and Equipment

Property and equipment are depreciated over the following useful lives (in years):

		*Useful Lives*
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2 - 10

Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. See Note 8 for further discussion regarding property and equipment.

Prepaid Forward Obligation

Long-Term Debt

Leases

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.

Revenue

Research and Development Expenses

Selling, General and Administrative Expenses

Share-Based Compensation

Pre-funded Warrants

Net Loss per Ordinary Share

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

Recently Adopted or Issued Accounting Pronouncements

SEC Climate Disclosures

Note 5 - Inventories (Details Textual) - USD ($)
$ in Thousands

Sep. 30, 2024

Dec. 31, 2023

Inventory, Raw Materials, Net of Reserves

^[1]

$ 4,662

$ 4,464

Other Noncurrent Assets [Member]

Inventory, Raw Materials, Net of Reserves

$ 1,700

[1]

$1.7 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at December 31, 2023. 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.

Note 12 - Revenue From Product Sales - Net Product Sales (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue	$ 25,204	$ 20,852	$ 65,833	$ 59,183
Jelmyto [Member]
Revenue	$ 25,204	$ 20,852	$ 65,833	$ 59,183

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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Note 10 - Long-term Debt (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Long-Term Debt Instruments [Table Text Block]

Carrying value of Pharmakon loan as of December 31, 2022	$	97,537
Interest expense		14,715
Amounts paid		(13,701	)
Carrying value of Pharmakon loan as of December 31, 2023		98,551
Third tranche of Pharmakon loan		25,000
Capitalized costs and discounts		(512	)
Interest expense		8,629
Amounts paid		(9,959	)
Carrying value of Pharmakon loan as of September 30, 2024	$	121,709

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

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Note 4 - Other Financial Information - Accounts Payable and Accrued Expense (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accounts payable	$ 5,556	$ 6,514
Accrued sales reserves	7,695	4,391
Accrued clinical expenses	1,094	1,246
Accrued research and development expenses	693	1,049
Accrued selling, general and administrative expenses	2,763	2,752
Accrued other expenses	1,884	586
Total accounts payable and accrued expenses	$ 19,685	$ 16,538

Note 3 - Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment, Useful Life [Table Text Block]

		*Useful Lives*
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2 - 10

Note 6 - Fair Value Measurements

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Text Block]

Note 6 – Fair Value Measurements

The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

Level 1:

Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2:

Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

Level 3:

Unobservable inputs that reflect the reporting entity’s own assumptions.

The carrying amounts of the Company’s cash, restricted cash, other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of the short-term nature of these assets and liabilities.

The carrying value of the prepaid forward obligation (See Note 9 - Prepaid Forward Obligation) approximates its fair value. The Company estimated the fair value of the prepaid forward obligation using Level 3 inputs, including internally developed financial forecasts and management's estimate of probability of success related to product candidates, and determined that the effective interest rate in the obligation approximates market rates for loans with similar terms and risk characteristics.

The Company estimated the fair value of long-term debt (see Note 10 - Long-Term Debt) using the income approach with Level 3 inputs. The Company estimated future floating rate interest payments using a forward curve of a three-month benchmark rate, and estimated fair value based on publicly available data reported in the financial statements of publicly traded venture lending companies. Based on a reasonable range of yields for debt instruments of similar tenor in a similar industry, the Company determined that the carrying value of the long-term debt on the Company's balance sheet approximates its fair value.

No transfers between levels have occurred during the periods presented.

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of September 30, 2024 are as follows (in thousands):

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*September 30,*		*Identical Assets*		*Inputs*
	*2024*		*(Level 1)*		*(Level 2)*
Assets:
Cash equivalents
Money market funds	$	20,878	$	20,878	$	—
Commercial paper		3,991		—		3,991
Total cash equivalents		24,869		20,878		3,991
Marketable securities
U.S. government		75,732		75,732		—
Corporate bonds		15,596		—		15,596
Commercial paper		36,995		—		36,995
Certificates of deposit		978		—		978
Total marketable securities		129,301		75,732		53,569
Total assets at fair value	$	154,170	$	96,610	$	57,560

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of December 31, 2023 are as follows (in thousands):

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*December 31,*		*Identical Assets*		*Inputs*
	*2023*		*(Level 1)*		*(Level 2)*
Assets:
Cash equivalents
Money market funds	$	9,704	$	9,704	$	—
Marketable securities
U.S. government		28,634		28,634		—
Corporate bonds		6,738		—		6,738
Commercial paper		7,101		—		7,101
Certificates of deposit		3,995		—		3,995
Total marketable securities		46,468		28,634		17,834
Total assets at fair value	$	56,172	$	38,338	$	17,834

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. 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.

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

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Note 6 - Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*September 30,*		*Identical Assets*		*Inputs*
	*2024*		*(Level 1)*		*(Level 2)*
Assets:
Cash equivalents
Money market funds	$	20,878	$	20,878	$	—
Commercial paper		3,991		—		3,991
Total cash equivalents		24,869		20,878		3,991
Marketable securities
U.S. government		75,732		75,732		—
Corporate bonds		15,596		—		15,596
Commercial paper		36,995		—		36,995
Certificates of deposit		978		—		978
Total marketable securities		129,301		75,732		53,569
Total assets at fair value	$	154,170	$	96,610	$	57,560

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*December 31,*		*Identical Assets*		*Inputs*
	*2023*		*(Level 1)*		*(Level 2)*
Assets:
Cash equivalents
Money market funds	$	9,704	$	9,704	$	—
Marketable securities
U.S. government		28,634		28,634		—
Corporate bonds		6,738		—		6,738
Commercial paper		7,101		—		7,101
Certificates of deposit		3,995		—		3,995
Total marketable securities		46,468		28,634		17,834
Total assets at fair value	$	56,172	$	38,338	$	17,834

Note 7 - Investments - Summary of Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash equivalents	$ 124,916	$ 95,002
Amortized cost basis	129,065
Unrealized gains	239
Unrealized losses	(3)
Fair value	129,301
Total assets at fair value	153,934
Total assets at fair value, unrealized gains	239
Total assets at fair value, unrealized losses	(3)
Total assets at fair value, fair value	154,170
US Treasury Securities [Member]
Amortized cost basis	75,608
Unrealized gains	125
Unrealized losses	(1)
Fair value	75,732
Corporate Debt Securities [Member]
Amortized cost basis	15,539
Unrealized gains	59
Unrealized losses	(2)
Fair value	15,596
Commercial Paper, Not Included with Cash and Cash Equivalents [Member]
Amortized cost basis	36,940
Unrealized gains	55
Unrealized losses	0
Fair value	36,995
Certificates of Deposit [Member]
Amortized cost basis	978
Unrealized gains	0
Unrealized losses	0
Fair value	978
Money Market Funds [Member]
Cash equivalents	20,878
Cash equivalents, unrealized gains	0
Cash equivalents, unrealized loss	0
Cash equivalents, fair value	20,878
Commercial Paper [Member]
Cash equivalents	3,991
Cash equivalents, unrealized gains	0
Cash equivalents, unrealized loss	0
Cash equivalents, fair value	3,991
Cash Equivalents [Member]
Cash equivalents	24,869
Cash equivalents, unrealized gains	0
Cash equivalents, unrealized loss	0
Cash equivalents, fair value	$ 24,869

Note 11 - Leases - Supplemental Information Related to Leases (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating cash flows from operating leases	$ 714	$ 878
Right-of-use assets obtained in exchange for new operating lease liabilities	$ 0	$ 122
Weighted-average remaining lease term of operating leases (Year)	1 year 3 months 3 days	2 years 1 month 9 days
Weighted-average discount rate of operating leases	10.26%	10.16%

Note 16 - Income Taxes

9 Months Ended

Sep. 30, 2024

Income Tax Disclosure [Text Block]

Note 16 – Income Taxes

UroGen Pharma Ltd. 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. 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 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 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.

The Company operates on a global basis and is subject to tax laws and regulations in the United States and Israel. The estimate of the Company’s tax liabilities relating to uncertain tax positions requires management to assess uncertainties and to make judgments about the application of complex tax laws and regulations, expectations regarding the outcome of tax authority examinations, as well as the ultimate measurement of potential liabilities.

The uncertain tax positions are reviewed quarterly and adjusted as events occur that could affect potential liabilities for additional taxes, including lapsing of applicable statutes of limitations, correspondence with tax authorities, proposed assessments by tax authorities, identification of new issues, and issuance of new legislation or regulations. The Company believes that adequate amounts of tax have been provided in income tax expense for any adjustments that may result from its uncertain tax positions. Based upon the information currently available, the Company does not reasonably expect changes in its existing uncertain tax positions in the next 12 months and has recorded the gross uncertain tax positions as a long-term liability.

The entire disclosure for income tax.

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Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - ₪ / shares	Sep. 30, 2024	Dec. 31, 2023
Ordinary shares, par value (in ILS per share)	₪ 0.01	₪ 0.01
Ordinary shares, authorized (in shares)	100,000,000	100,000,000
Ordinary shares, issued (in shares)	42,190,815	32,490,119
Ordinary shares, outstanding (in shares)	42,190,815	32,490,119

Note 8 - Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property and equipment, gross	$ 4,821	$ 4,641
Less: accumulated depreciation and amortization	(4,213)	(3,952)
Property and equipment, net	608	689
Laboratory Equipment [Member]
Property and equipment, gross	473	464
Computers and Software [Member]
Property and equipment, gross	2,460	2,293
Furniture [Member[
Property and equipment, gross	612	612
Leasehold Improvements [Member]
Property and equipment, gross	621	617
Manufacturing Equipment [Member]
Property and equipment, gross	$ 655	$ 655

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue	$ 25,204	$ 20,852	$ 65,833	$ 59,183
Cost of revenue	2,453	2,367	6,410	7,075
Gross profit	22,751	18,485	59,423	52,108
Operating expenses:
Research and development expenses	11,355	10,230	42,251	34,312
Selling, general and administrative expenses	28,941	21,755	86,296	68,723
Operating loss	(17,545)	(13,500)	(69,124)	(50,927)
Financing on prepaid forward obligation	(5,915)	(5,479)	(17,348)	(16,047)
Interest expense on long-term debt	(2,721)	(3,815)	(8,629)	(11,129)
Interest and other income, net	2,599	906	5,922	1,941
Loss before income taxes	(23,582)	(21,888)	(89,179)	(76,162)
Income tax expense	(91)	9	(183)	(66)
Net Loss	(23,673)	(21,879)	(89,362)	(76,228)
Statements of Comprehensive Loss
Net loss	(23,673)	(21,879)	(89,362)	(76,228)
Other comprehensive income (loss)
Unrealized gain (loss) on investments	267	20	224	(27)
Comprehensive Loss	$ (23,406)	$ (21,859)	$ (89,138)	$ (76,255)
Net loss per ordinary share - basic and diluted (in dollars per share)	$ (0.55)	$ (0.68)	$ (2.36)	$ (2.89)
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares)	43,100,237	32,298,182	37,797,492	26,358,719

Note 7 - Investments (Details Textual) $ in Millions	Sep. 30, 2024 USD ($)
Debt Securities, Available-for-Sale, Unrealized Loss Position	$ 4.6
Debt Securities, Available-for-Sale, Unrealized Loss Position, Number of Positions	4

Note 7 - Investments (Tables)

9 Months Ended

Sep. 30, 2024

Marketable Securities [Table Text Block]

	*Amortized*		*Unrealized*		*Unrealized*
	*Cost Basis*		*Gains*		*Losses*			*Fair Value*
Assets:
Cash equivalents
Money market funds	$	20,878	$	—	$	—		$	20,878
Commercial paper		3,991		—		—			3,991
Total cash equivalents		24,869		—		—			24,869
Marketable securities:
U.S. government		75,608		125		(1	)		75,732
Corporate bonds		15,539		59		(2	)		15,596
Commercial paper		36,940		55		—			36,995
Certificates of deposit		978		—		—			978
Total marketable securities		129,065		239		(3	)		129,301
Total assets at fair value	$	153,934	$	239	$	(3	)	$	154,170

Investments Classified by Contractual Maturity Date [Table Text Block]

	*September 30,*		*December 31,*
	*2024*		*2023*
Maturities within one year	$	149,528	$	51,670
Maturities after one year through three years		4,642		4,502
Total investments	$	154,170	$	56,172

Note 14 - Shareholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands						3 Months Ended	9 Months Ended
	Jul. 18, 2024	Jun. 20, 2024	Jun. 17, 2024	Dec. 20, 2023	Jul. 26, 2023	Mar. 31, 2024	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Dec. 31, 2019
Common Stock, Shares Authorized (in shares)							100,000,000	100,000,000	100,000,000
Proceeds from Issuance of Common Stock							$ 151,169	$ 67,358
Proceeds from Issuance of Private Placement					$ 120,000
Common Stock, Shares, Outstanding (in shares)							42,190,815	42,200,000	32,490,119
Conversion of Prefunded Warrants Into Ordinary Shares [Member]
Conversion of Stock, Shares Issued (in shares)				1,599,733
Conversion of Stock, Shares Converted (in shares)				1,599,840
Pre-funded Warrant [Member]
Class of Warrant or Right, Outstanding (in shares)					5,278,776
Class of Warrants or Rights, Issuance Price Per Share (in dollars per share)					$ 9.539
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)					$ 0.001
Prefunded Warrants Associated With Public Offering [Member]
Class of Warrant or Right, Outstanding (in shares)			1,142,857
Class of Warrants or Rights, Issuance Price Per Share (in dollars per share)			$ 17.499
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 0.001
ATM Sales Agreement [Member]
Sale of Stock, Maximum Authorize Amount										$ 100,000
Stock Issued During Period, Shares, New Issues (in shares)						3,400,468
Proceeds from Issuance of Common Stock						$ 56,100
Net Proceeds From Issuance of Common Stock, After Deducting Sales Commissions						$ 54,700
Sale of Stock, Remaining Amount Authorized							$ 27,300
Private Placement [Member]
Stock Issued During Period, Shares, New Issues (in shares)					7,300,380
Shares Issued, Price Per Share (in dollars per share)					$ 9.54
Placement Agents and Financial Advisors Fees					$ 3,600
Private Placement [Member] \| Monograph Capital Partners [Member]
Stock Issued During Period, Shares, New Issues (in shares)					1,572,327
Proceeds from Issuance of Private Placement					$ 15,000
Underwritten Public Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)			5,000,000
Shares Issued, Price Per Share (in dollars per share)			$ 17.5
Proceeds from Issuance or Sale of Equity		$ 107,500
Payments of Stock Issuance Costs		$ 7,300
Over-Allotment Option [Member]
Stock Issued During Period, Shares, New Issues (in shares)	921,428
Proceeds from Issuance or Sale of Equity	$ 16,100
Payments of Stock Issuance Costs	$ 1,000
Equity Sale, Shares Issuable (in shares)		921,428

Note 12 - Revenue From Product Sales (Tables)

9 Months Ended

Sep. 30, 2024

Disaggregation of Revenue [Table Text Block]

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2024*		*2023*		*2024*		*2023*
Jelmyto	$	25,204	$	20,852	$	65,833	$	59,183

Schedule of Sales Reserves [Table Text Block]

	*Reserves related to government sponsored programs*			*Medicare refunds for discarded drug reserve*		*Other reserves*			*Total accrued sales reserves*
Balance as of December 31, 2023	$	1,062		$	3,451	$	1,458		$	5,971
Accruals		9,833			3,113		7,703			20,649
Utilizations		(10,206	)		—		(7,219	)		(17,425	)
Balance as of September 30, 2024	$	689		$	6,564	$	1,942		$	9,195

Note 8 - Property and Equipment (Details Textual) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Depreciation, Depletion and Amortization	$ 100	$ 200	$ 261	$ 612

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2024	Nov. 01, 2024
Document Information [Line Items]
Entity Central Index Key	0001668243
Entity Registrant Name	UroGen Pharma Ltd.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-38079
Entity Incorporation, State or Country Code	IL
Entity Tax Identification Number	98-1460746
Entity Address, Address Line One	400 Alexander Park Drive
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	646
Local Phone Number	768-9780
Title of 12(b) Security	Ordinary Shares, par value NIS 0.01 per share
Trading Symbol	URGN
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		42,199,414

Note 14 - Shareholders' Equity

9 Months Ended

Sep. 30, 2024

Equity [Text Block]

Note 14 – 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. Each ordinary share is entitled to one vote. The holders of ordinary shares are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors (the “Board”). Since the Company's inception, the Board has not declared any dividends.

ATM Sales Agreement

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

During the first quarter of 2024, the Company sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $56.1 million. The net proceeds to the Company after deducting sales commissions to TD Cowen were approximately $54.7 million. The 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.

Securities Purchase Agreement

On July 26, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and other accredited investors (the “Purchasers”), pursuant to which the Company agreed to sell and issue to the Purchasers 7,300,380 ordinary shares of the Company (“Shares”) and 5,278,776 of pre-funded warrants to purchase ordinary shares of the Company at a purchase price of $9.54 per Share or $9.539 for each ordinary share underlying a pre-funded warrant, in a private placement transaction that closed on July 28, 2023 and August 9, 2023 (the “Private Placement”) for aggregate gross proceeds of $120.0 million, before deducting fees to placement agents and financial advisors and before other expenses paid by the Company. Each pre-funded warrant has an exercise price of $0.001 per ordinary share, subject to customary adjustments, became exercisable upon original issuance 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. The aggregate fee paid by the Company to placement agents and financial advisors was $3.6 million, plus the reimbursement of certain expenses.

Resales of the Shares and the ordinary shares issuable upon exercise of the pre-funded warrants were registered pursuant to the Company’s registration statement on Form S-3 (File No. 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.

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. Dr. Cohen is the Chair and Chief Investment Officer of Monograph.

Underwritten Public Offering

On June 17, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $17.499 per pre-funded warrant. 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. 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. 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. On July 18, 2024, the Company 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 to the Company of $16.1 million before deducting underwriting discounts and commissions and offering expenses paid by the Company of $1.0 million.

The entire disclosure for equity.

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Note 10 - Long-term Debt

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Text Block]

Note 10 – Long-Term Debt

On March 7, 2022, the Company entered into a loan agreement with Pharmakon for a senior secured term loan of up to $100 million in two tranches. The first tranche of $75 million was funded in March 2022. The second tranche of $25 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, the Company entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan. The third tranche of $25.0 million was funded in September 2024. The fourth tranche of $75.0 million will become available at the Company's option no later than August 29, 2025, subject to (i) receiving FDA approval of 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. Under the amended and restated loan agreement, all outstanding loans with Pharmakon accrue interest using a benchmark rate of 3-month SOFR plus 7.25% plus an additional adjustment of 0.26161%. All outstanding principal will be required to be repaid in four equal quarterly installments commencing in the second quarter of 2026, with a one-year extension possible upon FDA approval of an NDA for UGN-102 by June 30, 2025. All outstanding loans with Pharmakon can be prepaid in whole at the Company's discretion, at any time, subject to prepayment premiums and make-whole amounts. The Company is not required to maintain any financial covenants.

The Company incurred financing expenses of $4.2 million related to the first and second tranches funded in 2022, and $0.5 million related to the third tranche funded in 2024, which are recognized as a direct offset to the long-term debt on the Company's condensed consolidated balance sheets. These debt issuance costs are amortized over the term of the debt using the effective interest method, and are recorded in the condensed consolidated statements of operations as "Interest expense".

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

Carrying value of Pharmakon loan as of December 31, 2022	$	97,537
Interest expense		14,715
Amounts paid		(13,701	)
Carrying value of Pharmakon loan as of December 31, 2023		98,551
Third tranche of Pharmakon loan		25,000
Capitalized costs and discounts		(512	)
Interest expense		8,629
Amounts paid		(9,959	)
Carrying value of Pharmakon loan as of September 30, 2024	$	121,709

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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Note 17 - Related Parties

9 Months Ended

Sep. 30, 2024

Note 17 – 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.

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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Note 11 - Leases (Details Textual) - USD ($) $ in Thousands	1 Months Ended	6 Months Ended
Note 11 - Leases (Details Textual) - USD ($) $ in Thousands	Oct. 31, 2020	Sep. 30, 2024	Sep. 30, 2023	Nov. 29, 2019
Lessee, Operating Lease, Liability, to be Paid		$ 1,097	$ 2,084
Operating Lease, Impairment Loss		0
Operating Lease, Liability		1,037	$ 1,884
Company Offices in Israel [Member]
Lessee, Operating Lease, Liability, to be Paid		300
Lease Agreement for Office in Los Angeles, California [Member] \| UroGen Pharma Inc. [Member]
Operating Lease, Impairment Loss	$ 200
Lease Agreement for Office in Princeton, New Jersey [Member] \| UroGen Pharma Inc. [Member]
Lessee, Operating Lease, Term of Contract (Month)				38 months
Operating Lease, Liability		$ 800

Note 16 - Income Taxes (Details Textual) $ in Millions	Sep. 30, 2024 USD ($)
Unrecognized Tax Benefits	$ 3.2
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued	$ 1.2

Note 1 - Business and Nature of Operations

9 Months Ended

Sep. 30, 2024

Nature of Operations [Text Block]

Note 1 – Business and Nature of Operations

Nature of Operations

UroGen Pharma Ltd. is an Israeli company incorporated in April 2004 (“UPL”).

UroGen Pharma, Inc., a wholly owned subsidiary of UPL, was incorporated in Delaware in October 2015 and began operating in February 2016 (“UPI”).

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.

On April 15, 2020, the U.S. Food and Drug Administration (“FDA”) granted expedited approval for Jelmyto, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer. Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using our proprietary sustained release RTGel technology. It 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. 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.

Note 7 - Investments - Fair Values of Marketable Securities by Contractual Maturity (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Maturities within one year	$ 149,528	$ 51,670
Maturities after one year through three years	4,642	4,502
Total investments	$ 154,170	$ 56,172

Note 11 - Leases - Components of Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating lease cost	$ 225	$ 225	$ 675	$ 710
Sublease income	0	(56)	(42)	(168)
Variable lease cost	14	13	57	51
Lease, Cost	$ 239	$ 182	$ 690	$ 593

Note 5 - Inventories - Inventories (Details) - USD ($)
$ in Thousands

Sep. 30, 2024

Dec. 31, 2023

Raw materials

^[1]

$ 4,662

$ 4,464

Finished goods

2,932

2,877

Total inventories

$ 7,594

$ 7,341

[1]

Note 11 - Leases (Tables)

9 Months Ended

Sep. 30, 2024

Lease, Cost [Table Text Block]

	*Three Months Ended*					*Nine Months Ended*
	*September 30,*					*September 30,*
	*2024*		*2023*			*2024*			*2023*
Operating lease cost	$	225	$	225		$	675		$	710
Sublease income		—		(56	)		(42	)		(168	)
Variable lease cost		14		13			57			51
	$	239	$	182		$	690		$	593

Assets and Liabilities, Lessee [Table Text Block]

	*September 30,*		*December 31,*
	*2024*		*2023*
Right-of-use assets	$	1,052	$	1,671
Long-term lease liabilities		212		844
Other current liabilities		825		819

Schedule of Supplemental Information Related to Leases [Table Text Block]

	*Nine Months Ended*
	*September 30,*
	*2024*			*2023*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	714		$	878
Right-of-use assets obtained in exchange for new operating lease liabilities	$	—		$	122
Weighted-average remaining lease term of operating leases (in years)		1.26			2.11
Weighted-average discount rate of operating leases		10.26	%		10.16	%

Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]

	*Operating*
	*Leases*
Years ending December 31,
Remainder of 2024	$	219
2025		820
2026		58
Total future minimum lease payments		1,097
Less: Interest		(60	)
Present value of lease liabilities	$	1,037

	*Operating*
	*Leases*
Years ending December 31,
Remainder of 2023	$	291
2024		923
2025		813
2026		57
Total future minimum lease payments		2,084
Less: Interest		(200	)
Present value of lease liabilities	$	1,884

Note 8 - Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Table Text Block]

	*September 30,*			*December 31,*
	*2024*			*2023*
Laboratory equipment	$	473		$	464
Computer equipment and software		2,460			2,293
Furniture		612			612
Leasehold improvements		621			617
Manufacturing equipment		655			655
		4,821			4,641
Less: accumulated depreciation and amortization		(4,213	)		(3,952	)
Property and equipment, net	$	608		$	689

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 124,916	$ 95,002
Marketable securities	124,659	41,966
Restricted cash	1,073	821
Accounts receivable, net	22,802	15,443
Inventories	7,594	5,673
Prepaid expenses and other current assets	14,053	10,281
Total current assets	295,097	169,186
Non-current assets:
Property and equipment, net	608	689
Restricted deposit	175	225
Right of use assets	1,052	1,671
Marketable securities	4,641	4,502
Other non-current assets	370	2,038
Total Assets	301,943	178,311
Current liabilities:
Accounts payable and accrued expenses	19,685	16,538
Employee related accrued expenses	9,029	10,814
Other current liabilities	4,073	3,860
Total current liabilities:	32,787	31,212
Non-current liabilities:
Prepaid forward obligation	118,526	109,722
Long-term debt	121,709	98,551
Long-term lease liabilities	212	844
Uncertain tax positions liability	3,194	3,194
Total Liabilities	276,428	243,523
Commitments and Contingencies (Note 18)
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	115	89
Additional paid-in capital	793,874	614,035
Accumulated deficit	(768,710)	(679,348)
Accumulated other comprehensive income	236	12
Total Shareholders' Equity (Deficit)	25,515	(65,212)
Total Liabilities and Shareholders' Equity (Deficit)	$ 301,943	$ 178,311

Note 4 - Other Financial Information - Interest and Other Income (Expense), Net (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Interest income	$ 2,757	$ 835	$ 6,089	$ 1,915
Other income (loss), net	(158)	71	(167)	26
Total interest and other income, net	$ 2,599	$ 906	$ 5,922	$ 1,941

Note 15 - Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

	*Three Months Ended*				*Nine Months Ended*
	*September 30,*				*September 30,*
	*2024*		*2023*		*2024*		*2023*
Research and development expenses	$	579	$	415	$	1,691	$	1,436
Selling, general and administrative expenses		2,910		1,809		8,114		5,296
Total share-based compensation expense	$	3,489	$	2,224	$	9,805	$	6,732

Note 17 - Related Parties (Details Textual) $ in Thousands	9 Months Ended
Note 17 - Related Parties (Details Textual) $ in Thousands	Sep. 30, 2024 USD ($)
Related Party Transaction, Amounts of Transaction	$ 0

Note 6 - Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair value	$ 129,301
US Treasury Securities [Member]
Fair value	75,732
Corporate Debt Securities [Member]
Fair value	15,596
Commercial Paper, Not Included with Cash and Cash Equivalents [Member]
Fair value	36,995
Certificates of Deposit [Member]
Fair value	978
Money Market Funds [Member]
Cash equivalents, fair value	20,878
Commercial Paper [Member]
Cash equivalents, fair value	3,991
Fair Value, Recurring [Member]
Cash equivalents, fair value	24,869
Fair value	129,301	$ 46,468
Total assets at fair value	154,170	56,172
Fair Value, Recurring [Member] \| US Treasury Securities [Member]
Fair value	75,732	28,634
Fair Value, Recurring [Member] \| Corporate Debt Securities [Member]
Fair value	15,596	6,738
Fair Value, Recurring [Member] \| Commercial Paper, Not Included with Cash and Cash Equivalents [Member]
Fair value	36,995
Fair Value, Recurring [Member] \| Certificates of Deposit [Member]
Fair value	978	3,995
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents, fair value	20,878
Fair value	75,732	28,634
Total assets at fair value	96,610	38,338
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Fair value	75,732	28,634
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member] \| Corporate Debt Securities [Member]
Fair value	0	0
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member] \| Commercial Paper, Not Included with Cash and Cash Equivalents [Member]
Fair value	0	0
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 1 [Member] \| Certificates of Deposit [Member]
Fair value	0	0
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents, fair value	3,991
Fair value	53,569	17,834
Total assets at fair value	57,560	17,834
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member] \| US Treasury Securities [Member]
Fair value	0	0
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member] \| Corporate Debt Securities [Member]
Fair value	15,596	6,738
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member] \| Commercial Paper, Not Included with Cash and Cash Equivalents [Member]
Fair value	36,995	7,101
Fair Value, Recurring [Member] \| Fair Value, Inputs, Level 2 [Member] \| Certificates of Deposit [Member]
Fair value	978	3,995
Fair Value, Recurring [Member] \| Money Market Funds [Member]
Cash equivalents, fair value	20,878	9,704
Fair Value, Recurring [Member] \| Money Market Funds [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents, fair value	20,878	9,704
Fair Value, Recurring [Member] \| Money Market Funds [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents, fair value	0	0
Fair Value, Recurring [Member] \| Commercial Paper [Member]
Cash equivalents, fair value	3,991
Fair value		$ 7,101
Fair Value, Recurring [Member] \| Commercial Paper [Member] \| Fair Value, Inputs, Level 1 [Member]
Cash equivalents, fair value	0
Fair Value, Recurring [Member] \| Commercial Paper [Member] \| Fair Value, Inputs, Level 2 [Member]
Cash equivalents, fair value	$ 3,991

Note 7 - Investments

9 Months Ended

Sep. 30, 2024

Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block]

Note 7 – Investments

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

	*Amortized*		*Unrealized*		*Unrealized*
	*Cost Basis*		*Gains*		*Losses*			*Fair Value*
Assets:
Cash equivalents
Money market funds	$	20,878	$	—	$	—		$	20,878
Commercial paper		3,991		—		—			3,991
Total cash equivalents		24,869		—		—			24,869
Marketable securities:
U.S. government		75,608		125		(1	)		75,732
Corporate bonds		15,539		59		(2	)		15,596
Commercial paper		36,940		55		—			36,995
Certificates of deposit		978		—		—			978
Total marketable securities		129,065		239		(3	)		129,301
Total assets at fair value	$	153,934	$	239	$	(3	)	$	154,170

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. 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. The unrealized loss was primarily driven by minor fluctuations in the fair value of certain U.S. government and corporate bond positions. The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment; the Company expects to recover the entire amortized cost basis of the security. In accordance with the Company’s general investment strategy, the Company does not intend to sell the investments before maturity. As of 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. The fair values of investments by contractual maturity consist of the following (in thousands):

	*September 30,*		*December 31,*
	*2024*		*2023*
Maturities within one year	$	149,528	$	51,670
Maturities after one year through three years		4,642		4,502
Total investments	$	154,170	$	56,172

Note 9 - Prepaid Forward Obligation (Details Textual) - USD ($) $ in Thousands	1 Months Ended		9 Months Ended
	May 31, 2021	Mar. 31, 2021	Sep. 30, 2024	Dec. 31, 2023	Dec. 31, 2022
Prepaid Forward Obligation			$ 118,526	$ 109,722	$ 98,923
Other Current Liabilities [Member]
Prepaid Forward Obligation			$ 3,300	$ 3,000
RTW Investments [Member]
Proceeds from Prepaid Forward Obligation	$ 75,000	$ 75,000
Proceeds from Prepaid Forward Arrangement, Net	$ 72,400	$ 72,400
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales			9.50%
Prepaid Forward Agreement, Minimum Future Cash Flows			$ 200,000
Prepaid Forward Agreement, Minimum Future Cash Flows, Rate (Rate)			13.00%
Prepaid Forward Obligation, Expected Cash Flows in Next Twelve Months			$ 0
RTW Investments [Member] \| Sales of Up to $200 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		9.50%
RTW Investments [Member] \| Sales Between $200 Million and $300 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		3.00%
RTW Investments [Member] \| Sales Over $300 Million [Member] \| Jelmyto [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		1.00%
RTW Investments [Member] \| Sales Up to $200 Million with FDA Approval [Member] \| UGN-102 [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		2.50%
RTW Investments [Member] \| Sales Between $200 Million and $300 Million with FDA Approval [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		1.00%
RTW Investments [Member] \| Sales Over $300 Million with FDA Approval [Member]
Prepaid Forward Agreement, Future Cash Payments, Percentage of Net Sales		0.50%
Prepaid Forward Agreement, Future Cash Flows, Increase in Percentage of Net Sales		1.50%
Prepaid Forward Agreement, Cumulative Amount Paid and Payable			$ 31,600

Note 11 - Leases - Amounts of Assets and Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Right-of-use assets	$ 1,052	$ 1,671
Long-term lease liabilities	212	844
Other current liabilities	$ 825	$ 819

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Insider Trading Arr Line Items
Rule 10b5-1 Arrangement Adopted [Flag]	false
Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Adopted [Flag]	false

Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Retained Earnings (Accumulated Deficit)	$ (768,710)	$ (679,348)

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Note 3 - Significant Accounting Policies (Details Textual) $ in Millions	Sep. 30, 2024 USD ($)
Cash, Cash Equivalents, and Short-Term Investments	$ 254.2

Note 2 - Basis of Presentation

9 Months Ended

Sep. 30, 2024

Basis of Accounting [Text Block]

Note 2 – Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying condensed consolidated financial statements contain all adjustments (consisting of normal recurring accruals and adjustments) necessary for fair statement of its financial position, results of operations and cash flows of the Company at the dates and for the periods indicated. Interim results are not necessarily indicative of results for the full fiscal year. The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States. The unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 14, 2024.

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

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. 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.

Note 12 - Revenue From Product Sales - Sales Reserves Activity (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
Balance	$ 5,971
Accruals	20,649
Utilizations	(17,425)
Balance	9,195
Government Sponsored Programs Reserves [Member]
Balance	1,062
Accruals	9,833
Utilizations	(10,206)
Balance	689
Medicare Refunds for Discarded Drug Reserve [Member]
Balance	3,451
Accruals	3,113
Utilizations	0
Balance	6,564
Other Reserves [Member]
Balance	1,458
Accruals	7,703
Utilizations	(7,219)
Balance	$ 1,942

Note 19 - Subsequent Events (Details Textual) $ in Millions	Oct. 07, 2024 USD ($)
Subsequent Event [Member]
Postemployment Benefits Liability	$ 0.5

Note 19 - Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events [Text Block]

Note 19 – 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. Mr. Kim's outstanding share-based awards will remain eligible for continued vesting during the post-separation consulting period.

Note 13 - License and Collaboration Agreements

9 Months Ended

Sep. 30, 2024

Collaborative Arrangement Disclosure [Text Block]

Note 13 – License and Collaboration Agreements

Agenus Agreement

In November 2019, the Company entered into a license agreement with Agenus Inc. ("Agenus"), pursuant to which Agenus granted to the Company an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary monoclonal antibody of Agenus known as AGEN1884 (zalifrelimab), an anti-CTLA-4 antagonist, for the treatment of cancers of the urinary tract via intravesical delivery. UGN-301 is a formulation of zalifrelimab administered using RTGel technology that is in Phase 1 clinical development for high-grade non-muscle invasive bladder cancer ("high-grade NMIBC").

Note 4 - Other Financial Information (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]

	*September 30,*		*December 31,*
	*2024*		*2023*
Accounts payable	$	5,556	$	6,514
Accrued sales reserves		7,695		4,391
Accrued clinical expenses		1,094		1,246
Accrued research and development expenses		693		1,049
Accrued selling, general and administrative expenses		2,763		2,752
Accrued other expenses		1,884		586
Total accounts payable and accrued expenses	$	19,685	$	16,538

Interest Income and Interest Expense Disclosure [Table Text Block]

	*Three Months Ended September 30,*					*Nine Months Ended September 30,*
	*2024*			*2023*		*2024*			*2023*
Interest income	$	2,757		$	835	$	6,089		$	1,915
Other income (loss), net		(158	)		71		(167	)		26
Total interest and other income, net	$	2,599		$	906	$	5,922		$	1,941

Condensed Consolidated Statements of Shareholders' Deficit (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings, Appropriated [Member]	AOCI Attributable to Parent [Member]	Total
Balance (in shares) at Dec. 31, 2022	23,129,953
Balance at Dec. 31, 2022	$ 63	$ 487,787	$ (577,104)	$ (107)	$ (89,361)
Exercise of options into ordinary shares (in shares)	424,445
Exercise of options into ordinary shares	$ 1	832			833
Share-based compensation		6,732			6,732
Issuance of ordinary shares, net of issuance costs (in shares)	7,300,380
Issuance of ordinary shares, net of issuance costs	$ 20	67,338			67,358
Other comprehensive income (loss)				(27)	(27)
Net loss			(76,228)		(76,228)
Balance (in shares) at Sep. 30, 2023	30,854,778
Balance at Sep. 30, 2023	$ 84	611,389	(653,332)	(134)	(41,993)
Issuance of pre-funded warrants, net of issuance costs		48,700			48,700
Balance (in shares) at Jun. 30, 2023	23,498,617
Balance at Jun. 30, 2023	$ 64	493,109	(631,453)	(154)	(138,434)
Exercise of options into ordinary shares (in shares)	55,781
Exercise of options into ordinary shares	$ 0	18			18
Share-based compensation		2,224			2,224
Issuance of ordinary shares, net of issuance costs (in shares)	7,300,380
Issuance of ordinary shares, net of issuance costs	$ 20	67,338			67,358
Other comprehensive income (loss)				20	20
Net loss			(21,879)		(21,879)
Balance (in shares) at Sep. 30, 2023	30,854,778
Balance at Sep. 30, 2023	$ 84	611,389	(653,332)	(134)	(41,993)
Issuance of pre-funded warrants, net of issuance costs		48,700			48,700
Balance (in shares) at Dec. 31, 2023	32,490,119
Balance at Dec. 31, 2023	$ 89	614,035	(679,348)	12	(65,212)
Exercise of options into ordinary shares (in shares)	378,800
Exercise of options into ordinary shares	$ 1	249			250
Share-based compensation		9,805			9,805
Issuance of ordinary shares, net of issuance costs (in shares)	9,321,896
Issuance of ordinary shares, net of issuance costs	$ 25	151,144			151,169
Other comprehensive income (loss)				224	224
Net loss			(89,362)		(89,362)
Balance (in shares) at Sep. 30, 2024	42,190,815
Balance at Sep. 30, 2024	$ 115	793,874	(768,710)	236	25,515
Issuance of pre-funded warrants, net of issuance costs		18,641			18,641
Balance (in shares) at Jun. 30, 2024	41,169,954
Balance at Jun. 30, 2024	$ 112	775,270	(745,037)	(31)	30,314
Exercise of options into ordinary shares (in shares)	99,433
Exercise of options into ordinary shares	$ 0	115			115
Share-based compensation		3,489			3,489
Issuance of ordinary shares, net of issuance costs (in shares)	921,428
Issuance of ordinary shares, net of issuance costs	$ 3	15,000			15,003
Other comprehensive income (loss)				267	267
Net loss			(23,673)		(23,673)
Balance (in shares) at Sep. 30, 2024	42,190,815
Balance at Sep. 30, 2024	$ 115	$ 793,874	$ (768,710)	$ 236	$ 25,515

Note 4 - Other Financial Information

9 Months Ended

Sep. 30, 2024

Other Financial Information [Text Block]

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,*		*December 31,*
	*2024*		*2023*
Accounts payable	$	5,556	$	6,514
Accrued sales reserves		7,695		4,391
Accrued clinical expenses		1,094		1,246
Accrued research and development expenses		693		1,049
Accrued selling, general and administrative expenses		2,763		2,752
Accrued other expenses		1,884		586
Total accounts payable and accrued expenses	$	19,685	$	16,538

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,*
	*2024*			*2023*		*2024*			*2023*
Interest income	$	2,757		$	835	$	6,089		$	1,915
Other income (loss), net		(158	)		71		(167	)		26
Total interest and other income, net	$	2,599		$	906	$	5,922		$	1,941

Note 11 - Leases

9 Months Ended

Sep. 30, 2024

Lessee, Operating Leases [Text Block]

Note 11 – Leases

Operating Leases

The Company had the following office and laboratory facility leases during the period 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.

•

In April 2018, UPI entered into a new lease agreement for an office in Los Angeles, California. The lease commencement date was July 10, 2018 and terminated in March 2024. The landlord provided a tenant allowance for leasehold improvements of $0.2 million that was accounted for as a lease incentive. In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of January 1, 2020 which continued until the end of the lease term in March 2024. The subtenants exercised their early access clause and moved into the premises at the end of November 2019. The Company accounted for the sublease as an operating lease in accordance with ASC 842.

•

In November 2019, UPI entered into a new lease agreement for an office in Princeton, New Jersey, which the Company now uses as its headquarters. The lease commencement date was November 29, 2019 with an original lease term of 38 months, expiring January 31, 2023. 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.

In addition, the Company has other operating office equipment and vehicle leases. The Company’s operating leases may require minimum rent payments, contingent rent payments adjusted periodically for inflation, or rent payments equal to the greater of a minimum rent or contingent rent. The Company’s leases do not contain any residual value guarantees or material restrictive covenants. The Company’s active leases expire at various dates from 2025 through 2026, 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):

	*Three Months Ended*					*Nine Months Ended*
	*September 30,*					*September 30,*
	*2024*		*2023*			*2024*			*2023*
Operating lease cost	$	225	$	225		$	675		$	710
Sublease income		—		(56	)		(42	)		(168	)
Variable lease cost		14		13			57			51
	$	239	$	182		$	690		$	593

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

	*September 30,*		*December 31,*
	*2024*		*2023*
Right-of-use assets	$	1,052	$	1,671
Long-term lease liabilities		212		844
Other current liabilities		825		819

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,*
	*2024*			*2023*
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	714		$	878
Right-of-use assets obtained in exchange for new operating lease liabilities	$	—		$	122
Weighted-average remaining lease term of operating leases (in years)		1.26			2.11
Weighted-average discount rate of operating leases		10.26	%		10.16	%

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

	*Operating*
	*Leases*
Years ending December 31,
Remainder of 2024	$	219
2025		820
2026		58
Total future minimum lease payments		1,097
Less: Interest		(60	)
Present value of lease liabilities	$	1,037

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

	*Operating*
	*Leases*
Years ending December 31,
Remainder of 2023	$	291
2024		923
2025		813
2026		57
Total future minimum lease payments		2,084
Less: Interest		(200	)
Present value of lease liabilities	$	1,884

Note 5 - Inventories

9 Months Ended

Sep. 30, 2024