What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2024-08-13 compared with 2024-05-13 · 313 added, 168 removed, 827 unchanged (37% of the section changed)

9 unchanged sentences

Restricted cash

Accounts receivable

Accounts receivable, net

17,415 15,443

10 unchanged sentences

$ 281,849 $ 178,311

Liabilities and Shareholders' Deficit

Liabilities and Shareholders' Equity (Deficit)

Current liabilities:

15 unchanged sentences

Commitments and Contingencies (Note 18)

Shareholders' Deficit:

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

36,127,687 and 32,490,119 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

Shareholders' Equity (Deficit):

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

41,169,954 and 32,490,119 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

Additional paid-in capital

2 unchanged sentences

( 745,037 ) ( 679,348 )

Accumulated other comprehensive loss

Total Shareholders' Deficit

Accumulated other comprehensive income (loss)

Total Shareholders' Equity (Deficit)

30,314 ( 65,212 )

Total Liabilities and Shareholders' Deficit

Total Liabilities and Shareholders' Equity (Deficit)

$ 281,849 $ 178,311

3 unchanged sentences

in thousands, except share and per share amounts)

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Cost of revenue

16 unchanged sentences

UroGen Pharma Ltd.

Condensed Consolidated Statements of Shareholders ’ Deficit

Condensed Consolidated Statements of Shareholders ’ Equity (Deficit)

in thousands, except share amounts)

2 unchanged sentences

Accumulated other comprehensive

Balance as of April 1, 2024

Changes During the Three Months Ended June 30, 2024

Exercise of options into ordinary shares

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

Issuance of ordinary share, net of issuance costs

Other comprehensive income

Balance as of June 30, 2024

Balance as of April 1, 2023

Changes During the Three Months Ended June 30, 2023

Exercise of options into ordinary shares

Share-based compensation

Other comprehensive loss

Balance as of June 30, 2023

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

UroGen Pharma Ltd.

Condensed Consolidated Statements of Shareholders ’ Equity (Deficit)

in thousands, except share amounts)

Ordinary Shares

Additional paid-in

Accumulated other comprehensive

income (loss)

Balance as of January 1, 2024

Changes During the Three Months Ended March 31, 2024

Changes During the Six Months Ended June 30, 2024

Exercise of options into ordinary shares

Share-based compensation

Issuance of pre-funded warrants, net of issuance costs

Issuance of ordinary share, net of issuance costs

Other comprehensive loss

Balance as of March 31, 2024

Balance as of June 30, 2024

Balance as of January 1, 2023

Changes During the Three Months Ended March 31, 2023

Changes During the Six Months Ended June 30, 2023

Exercise of options into ordinary shares

Share-based compensation

Other comprehensive income

Balance as of March 31, 2023

Other comprehensive loss

Balance as of June 30, 2023

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

2 unchanged sentences

in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash Flows From Operating Activities

7 unchanged sentences

Changes in operating assets and liabilities:

Accounts receivable

Accounts receivable, net

Prepaid expenses and other current assets

3 unchanged sentences

Lease liabilities

Restricted deposit

Net cash used in operating activities

3 unchanged sentences

Purchases of property and equipment

Net cash (used in) provided by investing activities

Net cash provided by investing activities

Cash Flows From Financing Activities

Proceeds from exercise of options into ordinary shares

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

Proceeds from ordinary share issuance, net of issuance costs

18 unchanged sentences

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

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

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

Note 2 – Basis of Presentation

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

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

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

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

4 unchanged sentences

Securities and Exchange Commission (“SEC”) on March 14, 2024.

The Company has experienced net losses since its inception and has an accumulated deficit o f $ 711.6 million and $ 679.3 million as of March 31, 2024 and December 31, 2023, respectively.

The Company has experienced net losses since its inception and has an accumulated deficit o f $ 745.0 million and $ 679.3 million as of June 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.

3 unchanged sentences

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 develop UGN- 102.

Based on the Company's cash, cash equivalents and marketable securities as of March 31, 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 financial statements.

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

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

18 unchanged sentences

Cash and cash equivalents generally consist of money market funds and bank money market accounts and are stated at cost, which approximates fair value.

Cash and cash equivalents and marketable securities totaled $ 164.5 million as of March 31, 2024 .

Cash and cash equivalents and marketable securities totaled $ 241.3 million as of June 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”.

19 unchanged sentences

The accounts are monitored by management to mitigate the risk.

The Company’s product sales are recognized through the Company's arrangement with a single customer, a third -party national specialty distributor.

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 this customer and has not currently recognized any allowance for doubtful accounts.

The Company has not experienced any credit losses related to arrangements with customers and has not currently recognized any allowance for doubtful accounts.

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.

49 unchanged sentences

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 arrangement with a single customer, a third -party national specialty distributor.

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.

17 unchanged sentences

Pre-funded Warrants

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

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

See Note 14 for further discussion related to the private placement transaction.

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.

Net Loss per Ordinary Share

2 unchanged sentences

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 requires 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”.

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”.

Recently Adopted or Issued Accounting Pronouncements

19 unchanged sentences

Accounts Payable and Accrued Expenses

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

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

Accounts payable

6 unchanged sentences

Interest and Other Income, Net

Interest and other income, net consisted of the following for the three months ended March 31, 2024 and 2023 (in thousands):

Three Months Ended March 31,

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

Three Months Ended June 30,

Six Months Ended June 30,

Interest income

2 unchanged sentences

Note 5 – Inventories

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

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

Raw materials (1)

$ 3,785 $ 4,464

Finished goods

Total inventories

( 1 ) $ 0.7 million and $ 1.7 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at March 31, 2024 and December 31, 2023, respectively.

$ 7,745 $ 7,341

( 1 ) $ 0.3 million and $ 1.7 million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at June 30, 2024 and December 31, 2023, respectively.

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

16 unchanged sentences

No transfers between levels have occurred during the periods presented.

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

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

Fair Value Measurements Using

4 unchanged sentences

Money market funds

$ 30,943 $ 30,943 $ —

Marketable securities

12,999 12,999 —

Corporate bonds

5,063 — 5,063

Commercial paper

1,236 — 1,236

Certificates of deposit

2,010 — 2,010

Total marketable securities

21,308 12,999 8,309

Total assets at fair value

$ 52,251 $ 43,942 $ 8,309

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):

5 unchanged sentences

Money market funds

$ 9,704 $ 9,704 $ —

Marketable securities

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 March 31, 2024 and December 31, 2023.

government bonds and money market funds are measured based on publicly available quoted market prices for identical securities as of June 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.

Note 7 – Investments

The following table summarizes the Company’s investments as of March 31, 2024 (in thousands):

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

Cash equivalents

Money market funds

$ 30,943 $ — $ — $ 30,943

Marketable securities:

13,014 — ( 15 ) 12,999

Corporate bonds

5,081 1 ( 19 ) 5,063

Commercial paper

1,236 — — 1,236

Certificates of deposit

2,008 2 — 2,010

Total marketable securities

21,339 3 ( 34 ) 21,308

Total assets at fair value

$ 52,282 $ 3 $ ( 34 ) $ 52,251

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

As of March 31, 2024 , the amortized cost of investments included an immaterial amount of accrued interest.

As of March 31, 2024 , marketable securities were in a net unrealized loss position.

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

As of June 30, 2024 , marketable securities were in a net unrealized loss position.

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

As of March 31, 2024 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 16.2 million which consisted of 20 securities.

The unrealized loss was primarily driven by minor fluctuations in the fair value of corporate bonds and historically rising interest rates.

As of June 30, 2024 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 15.9 million which consisted of 14 securities.

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

government securities.

The Company does not expect to settle the debentures at a price less than the amortized cost basis of the investment;

1 unchanged sentence

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

As of March 31, 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 March 31, 2024 mature at various dates through January 2026.

As of June 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 June 30, 2024 mature at various dates through January 2026.

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

Maturities within one year

$ 52,048 $ 51,670

Maturities after one year through three years

Total investments

$ 52,251 $ 56,172

Note 8 – Property and Equipment

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

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

Laboratory equipment

3 unchanged sentences

accumulated depreciation and amortization

( 4,145 ) ( 3,952 )

Property and equipment, net

Depreciation and amortization expense was $ 0.1 million for the three months ended March 31, 2024 and $ 0.2 million for the three months ended March 31, 2023 .

Depreciation and amortization expense was $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2024 and $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 2023 .

Note 9 – Prepaid Forward Obligation

4 unchanged sentences

If certain revenue thresholds for Jelmyto aggregate worldwide annual net sales are not met, the future cash payments to RTW with respect to Jelmyto annual net sales up to $200 million will increase by 3.5 %, and may decrease back to 9.5% dependent on the Company meeting certain subsequent Jelmyto aggregate worldwide annual net sales thresholds.

The rate in effect for the three months ended March 31, 2024 for annual net sales up to $ 200 million was 13.0 %.

The rate in effect for the six months ended June 30, 2024 for annual net sales up to $ 200 million was 13.0 %.

In addition, subject to FDA approval of UGN- 102, UGN- 103 and UGN- 104, RTW is entitled to receive tiered, future cash payments based on aggregate worldwide annual net product sales of UGN- 102, UGN- 103 and UGN- 104 in an amount equal to:

2 unchanged sentences

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

As of June 30, 2024, the cumulative amounts paid and payable by the Company were $ 28.4 million.

As security for the payment and fulfilment of these amounts throughout the arrangement, the Company has granted RTW a first priority security interest in Jelmyto and UGN- 102, including the regulatory approvals, intellectual property, material agreements, proceeds and accounts receivable related to these products.

4 unchanged sentences

The Company does not expect to make any principal payments in the next 12 months.

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2023 and for the three months ended March 31, 2024, in thousands:

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2023 and for the six months ended June 30, 2024, in thousands:

Carrying value of prepaid forward obligation as of December 31, 2022

4 unchanged sentences

Amounts paid and payable (1)

Carrying value of prepaid forward obligation as of March 31, 2024

( 1 ) $ 2.4 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 March 31, 2024 and December 31, 2023, respectively.

Carrying value of prepaid forward obligation as of June 30, 2024

( 1 ) $ 2.8 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 June 30, 2024 and December 31, 2023, respectively.

Note 10 – Long-Term Debt

18 unchanged sentences

Interest expense

Carrying value of Pharmakon loan as of March 31, 2024

Carrying value of Pharmakon loan as of June 30, 2024

Note 11 – Leases

Operating Leases

The Company had the following office and laboratory facility leases as of March 31, 2024 :

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 $ 0.4 million as of March 31, 2024.

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

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

7 unchanged sentences

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

The Company’s remaining contractual obligation under this lease is approximately $ 1.1 million as of March 31, 2024 .

The Company’s remaining contractual obligation under this lease is approximately $ 0.9 million as of June 30, 2024 .

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

1 unchanged sentence

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

The Company’s leases expire at various dates from 2023 through 2026, with varying renewal and termination options.

The components of lease cost for the three months ended March 31, 2024 and 2022 were as follows (in thousands):

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 six months ended June 30, 2024 and 2023 were as follows (in thousands):

Three Months Ended

Six Months Ended

Operating lease cost

$ 225 $ 257 $ 450 $ 485

Sublease income

— ( 56 ) ( 42 ) ( 112 )

Variable lease cost

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

$ 239 $ 220 $ 451 $ 411

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

Right-of-use assets

$ 1,250 $ 1,671

Long-term lease liabilities

Other current liabilities

As of March 31, 2024 , no impairment losses have been recognized.

Supplemental information related to leases for the three months ended March 31, 2024 and 2023 is as follows (in thousands, except for lease terms and discount rate amounts):

Three Months Ended

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

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

Six Months Ended

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

3 unchanged sentences

Weighted-average discount rate of operating leases

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

10.26 % 10.16 %

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

Years ending December 31,

2 unchanged sentences

Present value of lease liabilities

As of March 31, 2023, maturities of lease liabilities were as follows (in thousands):

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

Years ending December 31,

3 unchanged sentences

Note 12 – Revenue From Product Sales

Net product sales consist of the following for the three months ended March 31, 2024 and 2023 (in thousands):

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

Three Months Ended

Six Months Ended

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 March 31, 2024 (in thousands):

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

Reserves related to government sponsored programs

Medicare refunds for discarded drug reserve

Other reserves

1 unchanged sentence

Balance as of December 31, 2023

Balance as of March 31, 2024

Balance as of June 30, 2024

Note 13 – License and Collaboration Agreements

4 unchanged sentences

Note 14 – Shareholders ’ Equity

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

The Company had 36.1 million and 32.5 million ordinary shares issued and outstanding as of March 31, 2024 and December 31, 2023 , respectively.

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

The Company had 41.2 million and 32.5 million ordinary shares issued and outstanding as of June 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 its inception, the Board has not declared any dividends.

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 Cowen and Company, LLC (“Cowen”) pursuant to which the Company may from time to time offer and sell the Company's ordinary shares having an aggregate offering price of up to $ 100.0 million.

In the three months ended March 31, 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 Cowen were approximately $ 54.7 million.

The remaining capacity under the ATM Sales Agreement is approximately $ 27.3 million as of March 31, 2024.

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 June 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.

10 unchanged sentences

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 estimated offering expenses payable by the Company of $ 1.0 million.

Note 15 – Share-Based Compensation

18 unchanged sentences

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.

2 unchanged sentences

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 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 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 to 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 to 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 to 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 to 5,200,167 shares.

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 of 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 of 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 of 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 of 450,000 shares to a total share reserve of 5,200,167 shares.

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

2 unchanged sentences

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 a 300,000 increase in the share reserve of the Inducement Plan.

As of March 31, 2024 , 4,171,525 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 385,469 ordinary shares remain available for future awards.

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 share reserve of 1,800,000 shares.

As of June 30, 2024 , 4,149,388 ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 364,517 ordinary shares remain available for future awards.

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

Three Months Ended

Six Months Ended

Research and development expenses

$ 594 $ 496 $ 1,112 $ 1,021

Selling, general and administrative expenses

2,966 1,726 5,204 3,487

Total share-based compensation expense

The total unrecognized compensation cost of options and RSUs at March 31, 2024 is $ 21.0 million with a weighted average recognition period of 2.24 years.

$ 3,560 $ 2,222 $ 6,316 $ 4,508

The total unrecognized compensation cost of options and RSUs at June 30, 2024 is $ 18.4 million with a weighted average recognition period of 2.01 years.

Note 16 – Income Taxes

1 unchanged sentence

is taxed under Israeli tax laws.

As of March 31, 2024 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

As of June 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 three months ended March 31, 2024 .

The Company has cumulative global pretax losses for the years ended 2023, 2022 and 2021, and for the six months ended June 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 March 31, 2024 , for tax positions relating to transfer pricing between affiliated entities.

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

As of June 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.

4 unchanged sentences

Note 17 – Related Parties

There were no related party transactions for the three months ended March 31, 2024.

There were no related party transactions for the six months ended June 30, 2024 or 2023.

Note 18 – Commitments and Contingencies

1 unchanged sentence

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

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

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

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

8 unchanged sentences

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 $ 0.5 million within selling, general and administrative expenses during the six months ended June 30, 2024 in relation to this arrangement.

See Note 11 for further discussion regarding lease commitments.

Note 19 – Subsequent Events

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

On July 18, 2024, the Company completed the sale of an additional 921,428 ordinary shares in its underwritten public offering pursuant to the exercise in full of the Underwriters’ option to purchase additional shares, which resulted in additional gross proceeds to the Company from the offering of $ 16.1 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company of $ 1.0 million.

See Note 14 – Shareholders’ Equity for further discussion.

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

15 unchanged sentences

In addition, our immuno-uro-oncology pipeline includes UGN-301 (zalifrelimab), an anti-CTLA-4 antibody, which we intend to study as both monotherapy and combination therapy.

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

We estimate that the annual treatable patient population of low-grade UTUC in the United States is approximately 6,000 to 7,000 and the annual treatable population of low-grade intermediate risk NMIBC is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients.

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

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

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

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

We estimate that around 35% of patients will experience an adverse event within 90 days of undergoing a TURBT, and patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

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

10 unchanged sentences

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

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

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

On April 15, 2020, the U.S.

1 unchanged sentence

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

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

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

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

1 unchanged sentence

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

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

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

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

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

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

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

4 unchanged sentences

Findings from the final study results include:

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

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

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

5 unchanged sentences

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

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

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

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

2 unchanged sentences

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

20 of these patients remaining in CR enrolled in a 5-year rollover study.

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

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

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

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

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

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

12 unchanged sentences

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

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

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

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

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

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

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

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

3 unchanged sentences

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

UGN-102 is administered locally using the standard practice of intravesical instillation directly into the bladder via a catheter.

The instillation into the bladder is expected to take place in a physician’s office as a non-operative outpatient treatment, in comparison with trans-urethral resection of bladder tumor ("TURBT") or similar surgical procedures, which are operations often conducted under general anesthesia and may require an overnight stay.

UGN-102 is administered locally using the standard practice of intravesical instillation directly into the bladder via a urethral catheter.

Complete surgical tumor removal often has limited success due to the inability to properly identify, reach and resect all tumors.

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

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

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

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

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

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

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

65.1%, or 41 out of 63 patients, treated with UGN-102 achieved a CR three months after the start of therapy.

1 unchanged sentence

The probability of durable response nine months after CR (12 months after treatment initiation) was estimated to be 69.9% by Kaplan-Meier analysis.

Median DOR was not reached.

Thirteen patients had documented recurrences.

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

Median duration of response was not reached.

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

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

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

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

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

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

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

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

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

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

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

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

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

4 unchanged sentences

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

As a result of the FDA's acceptance of a single arm approach, we stopped enrollment of the Phase 3 ATLAS trial.

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

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

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

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

In the ATLAS trial, UGN-102 met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55%.

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

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

The ENVISION trial met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of CR at three-months following the initial treatment.

Additional data evaluating the secondary endpoint of duration of response from ENVISION is anticipated in the second quarter of 2024.

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

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

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

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

1 unchanged sentence

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

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

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

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

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

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

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

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

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

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

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

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

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

The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of response 12 months after 3-month CR from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate risk NMIBC.

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

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

Based on our agreement with the FDA, we expect to complete the submission of the rolling NDA for UGN-102 in the third quarter of 2024.

Based on our agreement with the FDA, we expect to complete the submission of the rolling NDA for UGN-102 in the third quarter of 2024, with a potential FDA acceptance in the fourth quarter of 2024 and potential FDA approval in the first quarter of 2025 (assuming priority review) or the second quarter of 2025 (assuming standard review).

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

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

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

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

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

In the ENVISION trial, DOR Kaplan-Meier estimates at 15 (n=43) and 18 (n=9) months were both 80.9% (95% CI, 73.9%, 86.2%).

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

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

1 unchanged sentence

(“medac”) to develop UGN-103 and UGN-104 which are intended to be a next-generation formulation of UGN-102 and Jelmyto , respectively, that combine medac’s proprietary 80 mg mitomycin formulation with our RTGel technology, which we believe will provide advantages related to production, cost, supply and product convenience.

We are preparing to initiate clinical endpoint studies to support NDAs for UGN-103 and UGN-104 in low-grade intermediate risk NMIBC and low grade-UTUC, respectively.

In April, we announced that the FDA has accepted our Investigational New Drug Application ("IND") for UGN-103.

We anticipate dosing patients in the planned Phase 3 trial of UGN-103 by the end of this year and initiating a Phase 3 trial of UGN-104 shortly thereafter.

We have initiated a Phase 3 clinical study to support the NDA for UGN-103 in low-grade intermediate risk NMIBC, and plan to enroll approximately 87 patients.

The first patients are expected to be dosed in the third quarter of 2024, with full enrollment anticipated by the first half of 2025.

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

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

UGN-301 (zalifrelimab) intravesical solution

10 unchanged sentences

We believe these two combinations could elicit both an innate and adaptive immune response, which may translate into a long-lasting acquired immune response, and potentially represent a valid post-TURBT adjuvant treatment of high-grade NMIBC.

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

We believe that these combinations make local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

4 unchanged sentences

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

We expect safety and tolerability data from this Phase 1 study in mid-2024.

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

Research and Development and License Agreements

4 unchanged sentences

Components of Operating Results

During the three months ended March 31, 2024 and March 31, 2023 we recognized $18.8 million and $17.2 million of revenue, respectively from sales of our product, Jelmyto .

During the three and six months ended June 30, 2024, we recognized $21.8 million and $40.6 million of revenue, respectively from sales of our product, Jelmyto .

Cost of Revenue

12 unchanged sentences

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

59 unchanged sentences

Results of Operations

Comparison of the three months ended March 31, 2024 and 2023

The following table sets forth our results of operations for the three months ended March 31, 2024 and 2023.

Three Months Ended March 31,

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

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

Three Months Ended June 30,

(in thousands)

11 unchanged sentences

Income tax expense

Revenue was $18.8 million and $17.2 million for the three months ended March 31, 2024 and 2023, respectively.

Revenue was $21.8 million and $21.1 million for the three months ended June 30, 2024 and 2023, respectively.

The increase in revenue of $0.7 million primarily reflects the increased volume of sales of Jelmyto .

Cost of Revenue

Cost of revenue was $1.7 million and $2.3 million for the three months ended March 31, 2024 and 2023, respectively.

The overall decrease of $0.6 million is primarily attributable to certain nonrecurring payments made in connection with our supply arrangement in the prior year, decrease in mixing fees, lower manufacturing costs, and decrease in the Jelmyto unit cost.

Cost of revenue was $2.2 million and $2.4 million for the three months ended June 30, 2024 and 2023, respectively.

The decrease of $0.2 million is primarily attributable to certain nonrecurring payments made in connection with our supply arrangement in the prior year.

Research and Development Expenses

Research and development expenses were $15.5 million and $12.5 million for the three months ended March 31, 2024 and 2023, respectively.

The overall increase of $3.0 million is primarily attributable to higher manufacturing costs and regulatory related expenses in connection with UGN-102 as well as research and development expenses in connection with our initiation of a Phase 3 study for UGN-103, partially offset by lower UGN-102 clinical trial costs.

Research and development expenses were $15.4 million and $11.6 million for the three months ended June 30, 2024 and 2023, respectively.

The increase of $3.8 million is primarily attributable to higher costs related to manufacturing of UGN-102 which are recognized within research and development expenses prior to our product candidates receiving FDA approval as well as research and development expenses in connection with our initiation of a Phase 3 study for UGN-103, partially offset by lower UGN-102 clinical trial costs and costs related to the research into ingredient scale-up and production efficiency for Jelmyto .

Selling and Marketing Expenses

Selling and marketing expenses were $17.1 milli on and $14.1 million for the three months ended March 31, 2024 and 2023 , respectively.

Selling and marketing expenses were $18.9 milli on and $13.9 million for the three months ended June 30, 2024 and 2023 , respectively.

The increase in selling and marketing expenses of $5.0 million is primarily attributable to UGN-102 brand marketing costs as well as an increase in overall commercial operation costs including meetings, conferences, and trainings.

General and Administrative Expenses

General and administrative expenses were $11.2 million and $8.6 million for the three months ended June 30, 2024 and 2023 , respectively.

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

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $5.8 million and $5.3 million for the three months ended June 30, 2024 and 2023, respectively.

The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues.

The increase in financing on prepaid forward obligation of $0.5 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $3.5 million and $3.8 million for the three months ended June 30, 2024 and 2023, respectively.

The decrease of $0.3 million was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmakon loan as a result of the amended and restated loan agreement in March 2024.

Interest and Other Income, Net

Interest and other income, net was $1.7 million and $0.4 million for the three months ended June 30, 2024 and 2023, respectively.

The increase of $1.3 million in interest and other income, net was primarily due to higher cash and investment balances.

Comparison of the six months ended June 30, 2024 and 2023

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

Six Months Ended June 30,

(in thousands)

Cost of revenue

Operating expenses:

Research and development

Selling and marketing

General and administrative

Total operating expenses

Operating loss

Financing on prepaid forward obligation

Interest expense on long-term debt

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $40.6 million and $38.3 million for the six months ended June 30, 2024 and 2023, respectively.

The increase in revenue of $2.3 million primarily reflects the increased volume of sales of Jelmyto .

Cost of Revenue

Cost of revenue was $4.0 million and $4.7 million for the six months ended June 30, 2024 and 2023, respectively.

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

Research and Development Expenses

Research and development expenses were $30.9 million and $24.1 million for the six months ended June 30, 2024 and 2023, respectively.

The increase of $6.8 million is primarily attributable to higher manufacturing costs, which are recognized as research and development expense prior to our product candidates receiving FDA approval, and regulatory related expense in connection with UGN-102 as well as research and development expenses, in connection with our initiation of a Phase 3 study for UGN-103, partially offset by lower UGN-102 clinical trial costs and costs related to the research into ingredient scale-up and production efficiency for Jelmyto .

Selling and Marketing Expenses

Selling and marketing expenses were $36.0 milli on and $28.1 million for the six months ended June 30, 2024 and 2023 , respectively.

The increase in selling and marketing expenses of $7.9 million is primarily attributable to UGN-102 brand marketing costs as well as an increase in overall commercial operation costs including meetings, conferences, trainings and software costs.

General and Administrative Expenses

General and administrative expenses were $10.2 million and $10.3 million for the three months ended March 31, 2024 and 2023 , respectively.

General and administrative expenses in the three months ended March 31, 2024 reflect lower expenses related to legal and compliance activities, offset by higher advisory and ongoing managed services related to medical affairs.

General and administrative expenses were $21.4 million and $18.9 million for the six months ended June 30, 2024 and 2023 , respectively.

The increase in general and administrative expenses of $2.5 million is primarily attributable to higher compensation expenses, legal and compliance activities, marketing communication expenses related to UGN-102, third-party advisory services, and ongoing managed services, partially offset by lower professional services .

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $5.7 million and $5.2 million for the three months ended March 31, 2024 and 2023, respectively.

Financing on prepaid forward obligation was $11.4 million and $10.6 million for the six months ended June 30, 2024 and 2023, respectively.

1 unchanged sentence

Interest Expense on Long-term Debt

Interest expense was $2.4 million and $3.6 million for the three months ended March 31, 2024 and 2023, respectively.

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

Interest expense was $5.9 million and $7.3 million for the six months ended June 30, 2024 and 2023, respectively.

The decrease of $1.4 million was primarily attributed to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmakon loan as a result of the amended and restated loan agreement in March 2024.

Interest and Other Income, Net

Interest and other income, net was $1.6 million and $0.6 million for the three months ended March 31, 2024 and 2023, respectively.

The increase in interest and other income, net was primarily due to higher cash and investment balance earning interest and changes in the overall interest rate environment.

Interest and other income, net was $3.3 million and $1.0 million for the six months ended June 30, 2024 and 2023, respectively.

The increase of $2.3 million in interest and other income, net was primarily due to higher cash and investment balances.

Liquidity and Capital Resources

As of March 31, 2024, we had $164.5 million in cash and cash equivalents and marketable securities.

As of June 30, 2024, we had $241.3 million in cash and cash equivalents and marketable securities.

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

Through March 31, 2024, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon.

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

ATM Sales Agreement

In December 2019, we entered into the ATM Sales Agreement with Cowen pursuant to which we may from time to time offer and sell our ordinary shares having an aggregate offering price of up to $100.0 million.

In December 2019, we entered into the ATM Sales Agreement with TD Cowen pursuant to which we may from time to time offer and sell our ordinary shares having an aggregate offering price of up to $100.0 million.

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

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

The remaining capacity under the ATM Sales Agreement is approximately $27.3 million as of March 31, 2024.

The net proceeds to us 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 June 30, 2024.

The shares will be offered and sold pursuant to our shelf registration statement on Form S-3 filed with the SEC on November 15, 2022, which was declared effective on November 29, 2022.

13 unchanged sentences

The aggregate fee paid by us to placement agents and financial advisors was $3.6 million, plus the reimbursement of certain expenses.

We have incurred losses since our inception and negative cash flows from our operations, and as of March 31, 2024 we had an accumulated deficit of $711.6 million.

Underwritten Public Offering

On June 17, 2024, we entered into the Underwriting Agreement with the Underwriters, relating to the issuance and sale in a public offering of 5,000,000 ordinary shares of the Company for $17.50 per share and pre-funded warrants to purchase 1,142,857 ordinary shares of the Company for $17.499 per pre-funded warrant.

The offering closed on June 20, 2024.

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

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.

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

We have incurred losses since our inception and negative cash flows from our operations, and as of June 30, 2024 we had an accumulated deficit of $744.4 million.

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

2 unchanged sentences

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

Based on our cash, cash equivalents and marketable securities as of March 31, 2024, together with management’s cash flow projections, we believe we have sufficient cash and cash equivalents to fund our operations beyond one year from the issuance of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

We will need to raise additional capital in the future.

Based on our cash, cash equivalents and marketable securities as of June 30, 2024, together with management’s cash flow projections, we believe we have sufficient cash and cash equivalents to fund our operations beyond one year from the issuance of our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

We may need to raise additional capital in the future.

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

4 unchanged sentences

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

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

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

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

the costs related to obtaining regulatory approval UGN-102 and UGN-301 and any of our other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of these product candidates;

the costs related to obtaining regulatory approval UGN-102, UGN-301, UGN-103, UGN-104 and any of our other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of these product candidates;

selling, marketing and patent-related activities undertaken in connection with the commercialization of Jelmyto and UGN-102 and any of our other product candidates, and costs involved in the continued development of an effective sales and marketing organization;

1 unchanged sentence

potential new product candidates we identify and attempt to develop;

revenues we may derive either directly or in the form of royalty payments from future sales of Jelmyto , UGN-102, UGN-301, RTGel reverse thermal hydrogel technology and any other product candidates;

revenues we may derive either directly or in the form of royalty payments from future sales of Jelmyto , UGN-102, UGN-301, UGN-103, UGN-104, RTGel reverse thermal hydrogel technology and any other product candidates;

the repayment of outstanding debt.

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

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

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

11 unchanged sentences

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

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

The lease commencement date was July 10, 2018 and terminated in March 2024.

In November 2019, we subleased our offices in Los Angeles, CA.

The lease commencement date was 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.

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

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

The lease commencement date was November 29, 2019 and the lease term is 38 months.

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

The total obligation for future minimum lease payments under our operating leases is $1.5 million as of March 31, 2024.

The total obligation for future minimum lease payments under our operating leases is $1.3 million as of June 30, 2024.

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

9 unchanged sentences

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

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

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

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

We recognized $0.5 million during the six months ended June 30, 2024 in relation to this arrangement.

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

5 unchanged sentences

Operating Activities

Net cash used in operating activities was $31.7 million during the three months ended March 31, 2024, compared to $25.8 million during the three months ended March 31, 2023.

Net cash used in operating activities was $55.5 million during the six months ended June 30, 2024, compared to $46.1 million during the six months ended June 30, 2023.

The $9.4 million increase was attributable primarily to higher net loss driven by increased operating expenses such as regulatory and brand marketing costs related to UGN-102, as well as timing of certain accruals and higher personnel related spend.

Investing Activities

Net cash provided by investing activities was $13.5 million during the three months ended March 31, 2024, compared to net cash provided by investing activities of $6.3 million during the three months ended March 31, 2023.

Net cash provided by investing activities was $25.5 million during the six months ended June 30, 2024, compared to net cash provided by investing activities of $10.0 million during the six months ended June 30, 2023.

The net change of $15.5 million is attributable primarily to less reinvestment of marketable securities in 2024 as compared to 2023.

Financing Activities

Net cash provided by financing activities was $54.7 million during the three months ended March 31, 2024, compared to $0.7 million during the three months ended March 31, 2023.

The increase of $54.0 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement.

Net cash provided by financing activities was $155.0 million during the six months ended June 30, 2024, compared to $0.8 million during the six months ended June 30, 2023.

The increase of $154.2 million is attributable primarily to proceeds from the issuance of ordinary shares under the ATM Sales Agreement and underwritten public offering.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements