What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2023-11-14 compared with 2023-08-10 · 298 added, 163 removed, 1052 unchanged (30% of the section changed)

3 unchanged sentences

in thousands, except share amounts and par value)

September 30,

Current assets:

47 unchanged sentences

Shareholders' Deficit:

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at June 30, 2023 and December 31, 2022;

23,498,617 and 23,129,953 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

Ordinary shares, NIS 0.01 par value, 100,000,000 shares authorized at September 30, 2023 and December 31, 2022;

30,854,778 and 23,129,953 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

Additional paid-in capital

14 unchanged sentences

in thousands, except share and per share amounts)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

$ 20,852  

30 unchanged sentences

( 11,129 )  

Interest and other income (expense), net

Interest and other income, net

Loss before income taxes

8 unchanged sentences

$ ( 76,228 )  

$ ( 54,349 )  

Statements of Comprehensive Loss

2 unchanged sentences

$ ( 76,228 )  

Other comprehensive loss

Other comprehensive income (loss)

Unrealized gain (loss) on investments

22 unchanged sentences

Accumulated other comprehensive

Balance as of April 1, 2023

Changes During the Three Months Ended June 30, 2023

Balance as of July 1, 2023

23,498,617  

$ 493,109  

$ (631,453 )  

$ (154 )  

Changes During the Three Months Ended September 30, 2023

Exercise of options into ordinary shares

55,781  

Share-based compensation

Other comprehensive loss

Balance as of June 30, 2023

Balance as of April 1, 2022

Changes During the Three Months Ended June 30, 2022

Issuance of pre-funded warrant, net of issuance costs

48,700  

Issuance of ordinary share, net of issuance costs

7,300,380  

67,338  

67,358  

Other comprehensive income

(21,879 )  

Balance as of September 30, 2023

30,854,778  

$ 611,389  

$ ( 653,332 )  

$ ( 134 )  

Balance as of July 1, 2022

22,727,891  

$ 481,485  

$ (522,404 )  

( 56 )  

Changes During the Three Months Ended September 30, 2022

Exercise of options into ordinary shares

283,433  

Share-based compensation

Other comprehensive income

Balance as of June 30, 2022

Other comprehensive loss

( 99 )  

( 25,831 )  

Balance as of September 30, 2022

23,011,324  

$ 485,041  

$ ( 548,235 )  

$ ( 155 )  

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

7 unchanged sentences

Balance as of January 1, 2023

Changes During the Six Months Ended June 30, 2023

23,129,953  

$ 487,787  

$ (577,104 )  

$ (107 )  

Changes During the Nine Months Ended September 30, 2023

Exercise of options into ordinary shares

424,445  

Share-based compensation

Issuance of pre-funded warrant, net of issuance costs

48,700  

Issuance of ordinary share, net of issuance costs

7,300,380  

67,338  

67,358  

Other comprehensive loss

Balance as of June 30, 2023

( 27 )  

(76,228 )  

Balance as of September 30, 2023

30,854,778  

$ 611,389  

$ ( 653,332 )  

$ ( 134 )  

Balance as of January 1, 2022

Changes During the Six Months Ended June 30, 2022

22,462,995  

$ 475,698  

$ (467,321 )  

$ ( 25 )  

$ 8,413  

Changes During the Nine Months Ended September 30, 2022

Exercise of options into ordinary shares

548,329  

Share-based compensation

Other comprehensive loss

Balance as of June 30, 2022

( 130 )  

( 80,914 )  

Balance as of September 30, 2022

23,011,324  

$ 485,041  

$ ( 548,235 )  

$ ( 155 )  

UroGen Pharma Ltd.

1 unchanged sentence

in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash Flows From Operating Activities

$ ( 76,228 )  

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

2 unchanged sentences

Accrued financing on prepaid forward obligation

Amortization (accretion) on marketable securities

11,019  

(Accretion) on marketable securities

( 622 )  

Share-based compensation

2 unchanged sentences

Changes in operating assets and liabilities:

( 677 )  

Accounts receivable

( 143 )  

Prepaid expenses and other current assets

( 4,937 )  

Other non-current assets

1 unchanged sentence

Employee related accrued expenses

( 105 )  

Other current liabilities

Lease liabilities

( 766 )  

Net cash used in operating activities

( 63,380 )  

Cash Flows From Investing Activities

Purchases of marketable securities

( 35,009 )  

Maturities of marketable securities

45,538  

41,202  

Purchases of property and equipment

Net cash provided by investing activities

( 138 )  

Net cash (used in) provided by investing activities

10,391  

Cash Flows From Financing Activities

1 unchanged sentence

Proceeds from issuance of long-term debt

70,793  

Proceeds from pre-funded warrant issuance, net of $ 1,654 of issuance costs

48,700  

Proceeds from ordinary share issuance, net of $ 2,288 of issuance costs

67,358  

Issuance cost related to at-the-market issuances

Net cash provided by financing activities

116,891  

71,766  

Increase (Decrease) in Cash and Cash Equivalents

63,902  

Cash, Cash Equivalents and Restricted Cash at Beginning of Period

56,220  

45,587  

Cash, Cash Equivalents and Restricted Cash at End of Period

$ 120,122  

$ 29,498  

Supplemental Disclosures of Non-Cash Activities

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

$ 2,165  

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

34 unchanged sentences

The Company has experienced net losses since its inception and has an accumulated deficit o f $ 653.3  

million and $ 577.1  million as of June 30, 2023 and December 

million and $ 577.1  million as of September 30, 2023 and December 

31, 2022, respectively.

6 unchanged sentences

26, 2023, the Company entered into a private placement transaction with certain institutional and other accredited investors pursuant to which the Company agreed to sell its ordinary shares and pre-funded warrants to purchase ordinary shares to the investors, for aggregate gross proceeds of $ 120.0 million. 

See Note 19 for further discussion regarding the private placement transaction.

Based on the Company's cash, cash equivalents and marketable securities as of June 30, 2023, together with management’s cash flow projections and the net proceeds to the Company from its private placement transaction in July 2023, 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.

See Note 14  for further discussion regarding the private placement transaction.

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

30, 2023, 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.

17 unchanged sentences

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 (expense), net.”

The effects of foreign currency re-measurements are recorded in the condensed consolidated statements of operations as “Interest and other income, net.”

Cash and Cash Equivalents;

2 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 $ 55.3  million as of June 30, 2023 .

Cash and cash equivalents and marketable securities totaled $ 153.9  million as of September 30, 2023 .

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 —

1 unchanged sentence

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

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

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.

85 unchanged sentences

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”) equaled the closing price of the Company’s ordinary shares on the grant date.

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.

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 stockholders’

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.

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”.

Recently Adopted Issued Pronouncements

3 unchanged sentences

Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consisted of the following as of June 30, 2023 and December 31, 2022  (in thousands):

Accounts payable and accrued expenses consisted of the following as of September 30, 2023 and December 31, 2022  (in thousands):

September 30,

Accounts payable

9 unchanged sentences

$ 12,383  

Interest and Other Income (Expense), Net

Interest and other income (expense), net consisted of the following as of June 30, 2023 and 2022 (in thousands):

Six Months Ended June 30,

Interest and Other Income, Net

Interest and other income, net consisted of the following for the nine months ended 

September 30, 2023 and 2022 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Interest income

$ 1,915  

Other income (expense), net

( 45 )  

Total interest and other income (expense), net

Other income, net

Total interest and other income, net

$ 1,941  

1 unchanged sentence

Inventories consisted of the following as of 

June 30, 2023 and December 31, 2022 (in thousands):

September 30, 2023 and December 31, 2022 (in thousands):

September 30,

Raw materials (1)

5 unchanged sentences

$ 6,695  

( 1 )  $ 2.4  million and $ 2.4  million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at June 

( 1 )  $ 1.7  million and $ 2.4  million of raw materials are included within other non-current assets on the condensed consolidated balance sheets at September 

30, 2023  and December 31, 2022, respectively.

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 June 30, 2023 are as follows (in thousands):

Assets measured at fair value on a recurring basis based on Level 1 and Level 2 fair value measurement criteria as of September 30, 2023 are as follows (in thousands):

Fair Value Measurements Using

1 unchanged sentence

Balance as of

September 30,

Identical Assets

1 unchanged sentence

Money market funds

$ 15,591  

US government

Commercial paper

Total cash equivalents

20,543  

17,567  

Marketable securities

28 unchanged sentences

The Company’s investments in U.S.

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

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

30, 2023 and December 31, 2022.

2 unchanged sentences

 Investments

The following table summarizes the Company’s investments as of June 30, 2023 (in thousands):

The following table summarizes the Company’s investments as of September 30, 2023 (in thousands):

Cash equivalents

Money market funds

$ 15,591  

US government

Commercial paper

Total cash equivalents

20,544  

Marketable securities:

6 unchanged sentences

Certificates of deposit

( 13 )  

Total marketable securities

7 unchanged sentences

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

As of June 30, 2023 , the amortized cost of investments included an immaterial amount of accrued interest.

As of June 30, 2023 , 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. 

June 30, 2023 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 33.9 million which consisted of 

As of September 30, 2023 , the amortized cost of investments included an immaterial amount of accrued interest.

As of September 30, 2023 , 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. 

September 30, 2023 , the aggregate fair value of investments held by the Company in an unrealized loss position was $ 32.7 million which consisted of 

40 securities. The unrealized loss was primarily driven by rising interest rates.

2 unchanged sentences

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

June 30, 2023 , 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, 2023 mature at various dates through January 2026.

September 30, 2023 , 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, 2023 mature at various dates through January 2026.

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

September 30,

Maturities within one year

7 unchanged sentences

Property and Equipment

Property and equipment, consists of the following as of June 30, 2023 and December 31, 2022 (in thousands):

Property and equipment, consists of the following as of September 30, 2023 and December 31, 2022 (in thousands):

September 30,

Laboratory equipment

6 unchanged sentences

$ 1,297  

Depreciation and amortization expense was $ 0.2  million and $ 0.4 million for the 

three and six months ended June 30, 2023 and $ 0.2  million and $ 0.4 million for the three and six months ended June 30, 2022 .

Depreciation and amortization expense was $ 0.2  million and $ 0.6  million for the 

three and nine months ended September 30, 2023 and $ 0.2  million and $ 0.7  million for the three and nine months ended September 30, 2022 .

Note 9 –

5 unchanged sentences

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

The rate in effect for the six  months ended June 

The rate in effect for the nine  months ended September 

30, 2023  for annual net sales up to $ 200 million was 13.0 %.

8 unchanged sentences

Changes in future payments from previous estimates are included in future financing expense. The Company does not expect to make any principal payments in the next 12 months.

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2022 and for the six  months ended June 

The following table shows the activity with respect to the carrying value of the prepaid forward liability for the year ended December 31, 2022 and for the nine  months ended September 

30, 2023, in thousands:

9 unchanged sentences

Amounts paid and payable (1)

Carrying value of prepaid forward obligation as of June 30, 2023

Carrying value of prepaid forward obligation as of September 30, 2023

$ 107,276  

( 1 ) $ 2.7  million and $ 2.3  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, 2023  and December 31, 2022, respectively.

26 unchanged sentences

Interest expense

Carrying value of Pharmakon loan as of June 30, 2023

11,129  

Carrying value of Pharmakon loan as of September 30, 2023

$ 98,518  

Note 11  

Operating Leases

The Company had the following office and laboratory facility leases as of June 30, 2023 :

The Company had the following office and laboratory facility leases as of September 30, 2023 :

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.

2 unchanged sentences

September 2025.  

The Company's remaining contractual obligation under this lease is approximately $ 0.6  million as of June 

The Company's remaining contractual obligation under this lease is approximately $ 0.5  million as of September 

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

1 unchanged sentence

The landlord provided a tenant allowance for leasehold improvements of $ 0.2 million that was accounted for as a lease incentive.

The Company’s remaining contractual obligation under this lease is approximately $ 0.2  million as of June 30, 2023 .

The Company’s remaining contractual obligation under this lease is approximately $ 0.1  million as of September 30, 2023 .

In November 2019, UPI entered into a sublease for this office space, with a lease commencement date of 

1 unchanged sentence

The subtenants exercised their early access clause and moved into the premises at the end of November 2019. 

The remaining rental payments to be received over the lease term is approximately $ 0.2  million as of June 30, 2023 .

The remaining rental payments to be received over the lease term is approximately $ 0.1  million as of September 30, 2023 .

The Company accounts for the sublease as an operating lease in accordance with ASC 842.

4 unchanged sentences

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 $ 1.5  million as of June 30, 2023 .

The Company’s remaining contractual obligation under this lease is approximately $ 1.3  million as of September 30, 2023 .

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

2 unchanged sentences

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 and six months ended June 30, 2023  and 2022  were as follows (in thousands):

The components of lease cost for the three and nine months ended September 30, 2023  and 2022  were as follows (in thousands):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Operating lease cost

4 unchanged sentences

Variable lease cost

The amounts recognized as of June 30, 2023 and 

The amounts recognized as of September 30, 2023 and 

December 31, 2022 were as follows (in thousands):

September 30,

Right-of-use assets

3 unchanged sentences

Other current liabilities

As of June 30, 2023 , no impairment losses have been recognized.

Supplemental information related to leases for the six months ended 

June 30, 2023 and 2022 is as follows (in thousands, except for lease terms and discount rate amounts):

Six Months Ended  

As of September 30, 2023 , no impairment losses have been recognized.

Supplemental information related to leases for the nine months ended 

September 30, 2023 and 2022 is as follows (in thousands, except for lease terms and discount rate amounts):

Nine Months Ended  

September 30,

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

4 unchanged sentences

10.16 %  

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

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

Years ending December 31,

5 unchanged sentences

$ 1,884  

As of June 30, 2023 , undiscounted cash flows to be received under the Company’s operating sublease on an annual basis were as follows (in thousands):

As of September 30, 2023 , undiscounted cash flows to be received under the Company’s operating sublease on an annual basis were as follows (in thousands):

Operating Leases

4 unchanged sentences

Revenue From Product Sales

Net product sales consist of the following for the three and six months ended June 30, 2023 and 2022 (in thousands):

Net product sales consist of the following for the three and nine months ended September 30, 2023 and 2022 (in thousands):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

$ 20,852  

4 unchanged sentences

340b  drug pricing programs and other government sponsored programs, Medicaid drug rebate programs, the Company’s copay assistance program, and Medicare refund 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 June 30, 2023  (in thousands):

Reserves related to government sponsored programs

6 unchanged sentences

( 5,979 )  

Balance as of June 30, 2023

Balance as of September 30, 2023

$ 1,396  

$ 3,144  

$ 4,540  

Note 13  

10 unchanged sentences

Shareholders ’

The Company had 100.0 million ordinary shares authorized for issuance as of June 30, 2023 and December 31, 2022 .

The Company had 23.5  million and 23.1  million ordinary shares issued and outstanding as of June 30, 2023 and December 31, 2022 , respectively.

The Company had 100.0 million ordinary shares authorized for issuance as of September 30, 2023 and December 31, 2022 .

The Company had 30.9  million and 23.1  million ordinary shares issued and outstanding as of September 30, 2023 and December 31, 2022 , respectively.

Each ordinary share is entitled to one vote.

1 unchanged sentence

Since its inception, the Board has not declared any dividends.

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.

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.

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, 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.

Note 15  

23 unchanged sentences

exercise behavior, and for non-employees, and directors using the contractual term.

On January 31, 2023, the Board approved a performance stock unit ("PSU") award of 100,000 shares under the 2017 Plan to the Company's Chief Executive Officer, subject to shareholder approval.

Vesting of these PSUs will depend upon obtaining regulatory approval for the Company’s lead product candidate UGN- 102 in the three years following the grant.

The PSU award was approved by the Company’s shareholders at the 2023 Annual Shareholders’

Meeting on September 7, 2023.

The maximum number of ordinary shares that was initially authorized for issuance under the 2017 Plan was 

3 unchanged sentences

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 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. 

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

4 unchanged sentences

In December 2021, the Board approved a 300,000 increase in the share reserve of the Inducement Plan. 

As of June 30, 2023 , 3,493,724  

As of September 30, 2023 , 3,781,335  

ordinary shares are subject to outstanding awards under the Company's share-based compensation plans and 1,498,367  ordinary shares remain available for future awards.

1 unchanged sentence

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Research and development expenses

7 unchanged sentences

$ 8,212  

The total unrecognized compensation cost of options and RSUs at June 30, 2023 is $ 12.6  million with a weighted average recognition period of 2.0  years.

The total unrecognized compensation cost of options and RSUs at September 30, 2023 is $ 15.6  million with a weighted average recognition period of 2.0  years.

Note 16  

1 unchanged sentence

is taxed under Israeli tax laws.

As of June 30, 2023 , the Company continues to maintain a full valuation allowance against deferred tax assets for all jurisdictions.

As of September 30, 2023 , 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 2022, 2021  and 

2020, and for the six months ended June 30, 2023 .

2020, and for the nine months ended September 30, 2023 .

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 $ 3.0  million as of June 30, 2023 , for tax positions relating to transfer pricing between affiliated entities.

The Company has a liability for uncertain tax positions of $ 3.0  million as of September 30, 2023 , for tax positions relating to transfer pricing between affiliated entities.

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

As of June 30, 2023 , the Company’s liability for uncertain tax positions includes $ 1.1  million of accrued interest and penalties.

As of September 30, 2023 , the Company’s liability for uncertain tax positions includes $ 1.1  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.

5 unchanged sentences

Related Parties

There were no related party transactions for the 

six months ended June 30, 2023 or 2022 .

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

There were no related party transactions for the nine months ended September 30, 2022.

Note 18  

2 unchanged sentences

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

The Company’s maximum exposure under these arrangements is unknown as of June 30, 2023 and December 31, 2022 .

The Company’s maximum exposure under these arrangements is unknown as of September 30, 2023 and December 31, 2022 .

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

2 unchanged sentences

Subsequent Events

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 12,579,156 ordinary shares of the Company (“Shares”) (or in lieu of Shares, pre-funded warrants to purchase ordinary shares of the Company) at a purchase price of $ 9.54 per Share (or $ 9.539 for each ordinary share underlying a pre-funded warrant), in a private placement transaction (the “Private Placement”) for aggregate gross proceeds of $ 120.0 million, before deducting fees to placement agents and financial advisors and before other expenses payable by the Company.

The aggregate fee payable by the Company to placement agents and financial advisors is $ 3.6 million, plus the reimbursement of certain expenses.

Monograph Capital Partners I, L.P.

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

The Company has evaluated and determined there were 

no  subsequent events.

Management ’

63 unchanged sentences

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

New product exclusivity for Jelmyto exists through April 15, 2023, and Orphan Drug exclusivity applies through April 15, 2027, as well as a composition of matter patents set to expire in early 2031. The main patents that protect Jelmyto  in the United States are set to expire in January 2031.

New product exclusivity for Jelmyto expired on April 15, 2023, however, Orphan Drug exclusivity extends until April 15, 2027, as well as a composition of matter patents set to expire in early 2031. The main patents that protect Jelmyto  in the United States are set to expire in January 2031.

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

22 unchanged sentences

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

These territory business managers are led by seven regional business directors, who are in turn supported by three regional operations managers. Each region is additionally supported by one to two clinical nurse educators to provide education and training around instillation, as well as a field reimbursement manager to help ensure access and reimbursement for appropriate patients.

These territory business manager positions are led by seven regional business director positions, who are in turn supported by seven regional operations manager positions. Each region is additionally supported by one to two clinical nurse educators to provide education and training around instillation, as well as a field reimbursement manager to help ensure access and reimbursement for appropriate patients.

In addition, our organization currently includes several medical science liaisons who appropriately engage with physicians interested in learning more about UroGen, 

10 unchanged sentences

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 two full fiscal years following 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 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.

6 unchanged sentences

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;

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

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

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

3 unchanged sentences

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 complete response 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.

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. 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 transurethral resection of the bladder tumors or fulguration.

9 unchanged sentences

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

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

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

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

2 unchanged sentences

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%. UGN-102 also showed a 64.8% complete response rate at three months for patients who only received UGN-102, compared to a 63.6% complete response 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 complete response at 3-months following the initial treatment.

In the ATLAS trial, UGN-102 met its primary endpoint of disease-free survival, reducing risk of recurrence, progression, or death by 55%. UGN-102 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 3-months following the initial treatment.

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

In both trials, UGN-102 was generally well-tolerated, with a side effect profile similar to that of previous clinical trials of UGN-102.

In both trials, the safety profile of UGN-102 was acceptable, with a adverse reaction profile similar to that of 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.

3 unchanged sentences

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 complete response, defined as no detectable disease three months after starting treatment.

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

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

3 unchanged sentences

We believe establishing the precedent for a convenient at home solution may facilitate access to care and address quality of life issues that certain patients may face with the current standard of care.

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 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 is planned for January 2024.

UGN-301 (zalifrelimab) intravesical solution

7 unchanged sentences

UGN-201 is a liquid formulation of imiquimod for intravesical administration that has been optimized for delivery in the urinary tract.

We believe that UGN-201 may elicit an innate immune response in the presence of released bladder cancer antigens, which may translate into a long lasting acquired immune response.

We believe the combination of UGN-301 and UGN-201 could elicit an innate as well as adaptive immune response and potentially represent a valid post-TURBT adjuvant treatment of high-grade NMIBC. UGN-301 is delivered using our proprietary 

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

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

We believe that UGN-201 and gemcitabine may elicit an innate immune response in the presence of released bladder cancer antigens, which may translate into a long lasting acquired immune response.

We believe these two combinations could elicit an innate as well as adaptive 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.

1 unchanged sentence

to develop and commercialize zalifrelimab via intravesical delivery for the treatment of urinary tract cancers, initially in high-grade NMIBC.

We believe that the combination of UGN-301 and UGN-201 makes local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

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

In March 2022, we announced FDA clearance of our Investigational New Drug application ("IND") to begin a novel Phase 1 clinical study of UGN-301 in patients with recurrent NMIBC. The novel study design utilizes a Master Protocol that we believe is a more efficient and streamlined approach to development.

13 unchanged sentences

Components of Operating Results

During the three and six months ended June 30, 2023, we recognized $21.1 million and $38.3 million of revenue, respectively from sales of our product, Jelmyto .

During the three and nine months ended September 30, 2023, we recognized $20.9 million and $59.2 million of revenue, respectively from sales of our product, Jelmyto .

Cost of Revenue

52 unchanged sentences

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

Interest and Other Income (Expense), Net

Interest and other income (expense), net, consisted primarily of interest income, net losses on foreign exchange and bank commissions.

Interest and Other Income, Net

Interest and other income, net, consisted primarily of interest income, net losses on foreign exchange and bank commissions.

We have yet to generate taxable income in Israel.

13 unchanged sentences

Results of Operations

Comparison of the three months ended June 30, 2023 and 2022

The following table sets forth our results of operations for the three months ended June 30, 2023 and 2022.

Three Months Ended June 30,

Comparison of the three months ended September 30, 2023 and 2022

The following table sets forth our results of operations for the three months ended September 30, 2023 and 2022.

Three Months Ended September 30,

(in thousands)

8 unchanged sentences

Interest expense on long-term debt

Interest and other income (expense), net

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $21.1 million and $16.6 million for the three months ended June 30, 2023 and 2022, respectively.

Revenue was $20.9 million and $16.1 million for the three months ended September 30, 2023 and 2022, respectively.

The increase in revenue of $4.8 million primarily reflects the increased volume of sales of Jelmyto .

Cost of Revenue

Cost of revenue was $2.4 million and $1.8 million for the three months ended June 30, 2023 and 2022, respectively.

Cost of revenue was $2.4 million and $2.0 million for the three months ended September 30, 2023 and 2022, respectively.

In periods prior to receiving FDA approval for Jelmyto , we recognized inventory and related costs associated with the manufacture of Jelmyto as research and development expenses. The overall increase of $0.4 million is primarily attributable to the full depletion of inventories that we had expensed prior to receiving FDA approval and increased volume of sales of our product Jelmyto . 

Research and Development Expenses

Research and development expenses were $11.6 million and $12.6 million for the three months ended June 30, 2023 and 2022, respectively.

The overall decrease of $1.0 million is primarily attributable to lower research and development expenses due to the conclusion of the ATLAS trial and lower cost related to the Phase 3 ENVISION trial for UGN-102, partially offset by higher research and development expenses related to our Phase 1 study for UGN-301. 

Additionally, research and development expenses decreased due to the ending of our collaboration with MD Anderson, lower cost incurred related to research into ingredient scale-up and production efficiency for Jelmyto and lower clinical compensation expenses.

Research and development expenses were $10.2 million and $13.1 million for the three months ended September 30, 2023 and 2022, respectively.

The overall decrease of $2.9 million is primarily attributable to lower research and development expenses due to the conclusion of the ATLAS trial, lower cost related to the Phase 3 ENVISION trial for UGN-102, and the ending of our collaboration with MD Anderson, partially offset by higher research and development expenses related to our Phase 1 study for UGN-301, cost incurred related to research into ingredient scale-up and production for UGN-102, and clinical compensation expenses. 

Selling and Marketing Expenses

Selling and marketing expenses were $13.9 milli on and $12.8 million for the three months ended June 30, 2023 and 2022 , respectively.

The increase in selling and marketing expenses of $1.1 million is primarily attributable to 

brand marketing related expenses and commercial operation advertisement, data management and trainings, partially offset by lower market research related expenses.

Selling and marketing expenses were $12.6 milli on and $11.9 million for the three months ended September 30, 2023 and 2022 , respectively.

The increase in selling and marketing expenses of $0.7 million is primarily attributable to commercial operation conferences and trainings, market research related expenses, and commercial compensation expenses, partially offset by lower commercial back-office services and support expenses.

General and Administrative Expenses

General and administrative expenses were $8.6 million and $8.0 million for the three months ended June 30, 2023 and 2022 , respectively.

The increase in general and administrative expenses of $0.6 million resulted primarily from professional services and ongoing managed services.

General and administrative expenses were $9.2 million and $7.2 million for the three months ended September 30, 2023 and 2022 , respectively.

The increase in general and administrative expenses of $2.0 million resulted primarily from higher compensation expenses, recruiting fees, certain media and meeting expenses, and ongoing managed services.

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $5.3 million and $5.8 million for the three months ended June 30, 2023 and 2022, respectively.

Financing on prepaid forward obligation was $5.5 million and $4.8 million for the three months ended September 30, 2023 and 2022, 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 decrease in financing on prepaid forward obligation of $0.5 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

The increase in financing on prepaid forward obligation of $0.7 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-term Debt

Interest expense was $3.8 million and $2.2 million for the three months ended June 30, 2023 and 2022, respectively.

Interest expense was $3.8 million and $2.7 million for the three months ended September 30, 2023 and 2022, respectively.

The increase was primarily driven by increase in interest rates related to the Pharmakon loan and the funding of the second tranche of the Pharmakon loan in December 2022.

Interest and Other Income (Expense), Net

Interest and other income (expense), net was $0.4 million and $0.1 million for the three months ended June 30, 2023 and 2022, respectively.

The increase in interest and other income (expense), net was primarily due to interest earned on investments due to changes in the overall interest rate environment.

Comparison of the six months ended June 30, 2023 and 2022

The following table sets forth our results of operations for the six months ended June 30, 2023 and 2022.

Six Months Ended June 30,

Interest and Other Income, Net

Interest and other income, net was $0.9 million and $0.5 million for the three months ended September 30, 2023 and 2022, 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.

Comparison of the nine months ended September 30, 2023 and 2022

The following table sets forth our results of operations for the nine months ended September 30, 2023 and 2022.

Nine Months Ended September 30,

(in thousands)

8 unchanged sentences

Interest expense on long-term debt

Interest and other income (expense), net

Interest and other income, net

Loss before income taxes

Income tax expense

Revenue was $38.3 million and $30.2 million for the six months ended June 30, 2023 and 2022, respectively.

Revenue was $59.2 million and $46.3 million for the nine months ended September 30, 2023 and 2022, respectively.

The increase in revenue of $12.9 million primarily reflects the increased volume of sales of Jelmyto .

Cost of Revenue

Cost of revenue was $4.7 million and $3.4 million for the six months ended June 30, 2023 and 2022, respectively.

Cost of revenue was $7.1 million and $5.4 million for the nine months ended September 30, 2023 and 2022, respectively.

In periods prior to receiving FDA approval for Jelmyto , we recognized inventory and related costs associated with the manufacture of Jelmyto as research and development expenses. The overall increase of $1.7 million is primarily attributable to the full depletion of inventories that we had expensed prior to receiving FDA approval and increased volume of sales of our product Jelmyto . 

Research and Development Expenses

Research and development expenses were $24.1 million and $25.3 million for the six months ended June 30, 2023 and 2022, respectively.

The overall decrease of $1.2 million is primarily attributable to lower research and development expenses due to the conclusion of the ATLAS trial and lower cost related to the Phase 3 ENVISION trial for UGN-102, partially offset by higher research and development expenses related to our Phase 1 study for UGN-301. 

Research and development expenses were $34.3 million and $38.4 million for the nine months ended September 30, 2023 and 2022, respectively.

The overall decrease of $4.1 million is primarily attributable to lower research and development expenses due to the conclusion of the ATLAS trial, lower cost related to the Phase 3 ENVISION trial for UGN-102, and the ending of our collaboration with MD Anderson, partially offset by higher research and development expenses related to our Phase 1 study for UGN-301, cost incurred related to research into ingredient scale-up and production for UGN-102, and clinical compensation expenses.

Selling and Marketing Expenses

Selling and marketing expenses were $28.1 milli on and $26.2 million for the six months ended June 30, 2023 and 2022 , respectively.

Selling and marketing expenses were $40.7 milli on and $38.1 million for the nine months ended September 30, 2023 and 2022 , respectively.

The increase in selling and marketing expenses of $2.6 million is primarily attributable to 

brand marketing related expenses and commercial operation advertisement, data management and trainings, partially offset by lower market research related expenses.

brand marketing related expenses and commercial operation advertisement, conferences and trainings, and commercial compensation expenses, partially offset by lower commercial back-office services and support expenses .

General and Administrative Expenses

General and administrative expenses were $18.9 million and $15.9 million for the six months ended June 30, 2023 and 2022 , respectively.

The increase in general and administrative expenses of $3.0 million resulted primarily from third-party advisory providers, professional services, and ongoing managed services.

General and administrative expenses were $28.1 million and $23.1 million for the nine months ended September 30, 2023 and 2022 , respectively.

The increase in general and administrative expenses of $5.0 million resulted primarily from higher compensation expenses, recruiting fees, certain media and meeting expenses, third-party advisory providers, and ongoing managed services.  

Financing on Prepaid Forward Obligation

Financing on prepaid forward obligation was $10.6 million and $11.7 million for the six months ended June 30, 2023 and 2022, respectively.

Financing on prepaid forward obligation was $16.0 million and $16.5 million for the nine months ended September 30, 2023 and 2022, respectively.

1 unchanged sentence

Interest Expense on Long-term Debt

Interest expense was $7.3 million and $2.5 million for the six months ended June 30, 2023 and 2022, respectively.

The cost in 2023 relates to interest expense on the Pharmakon loan for two full quarters versus the prior year given the loan closed in March 2022. 

Interest expense was $11.1 million and $5.2 million for the nine months ended September 30, 2023 and 2022, respectively.

The cost in 2023 relates to interest expense on the Pharmakon loan for three full quarters versus the prior year given the loan closed in March 2022. 

In addition, the increase was attributable to increase in interest rates related to the Pharmakon loan and the funding of the second tranche of the Pharmakon loan in December 2022.

Interest and Other Income (Expense), Net

Interest and other income (expense), net was $1.0 million and $0.1 million for the six months ended June 30, 2023 and 2022, respectively.

The increase in interest and other income (expense), net was primarily due to interest earned on investments due to changes in the overall interest rate environment.

Interest and Other Income, Net

Interest and other income, net was $1.9 million and $0.6 million for the nine months ended September 30, 2023 and 2022, 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.

Liquidity and Capital Resources

As of June 30, 2023, we had $55.3 million in cash and cash equivalents and marketable securities.

As of September 30, 2023, we had $153.9 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.

dollars. 

Through June 30, 2023, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon.

Through September 30, 2023, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon.

In December 2019, we entered into a sales agreement (the “ATM Sales Agreement”) with Cowen and Company, LLC (“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.

The remaining capacity under the ATM Sales Agreement is approximately $83.4 million as of June 30, 2023.

The remaining capacity under the ATM Sales Agreement is approximately $83.4 million as of September 30, 2023.

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.

5 unchanged sentences

Effective July 2023, the loan will accrue interest using a benchmark rate of 3-month SOFR plus a 0.26161% adjustment.

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

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

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

The aggregate fee payable by us to placement agents and financial advisors is $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 June 30, 2023 we had an accumulated deficit of $631.5 million.

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 September 30, 2023 we had an accumulated deficit of $653.3 million.

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

35 unchanged sentences

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 $2.4 million as of June 30, 2023. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

The total obligation for future minimum lease payments under our operating leases is $2.1 million as of September 30, 2023. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

In March 2022, UroGen Pharma Ltd., UroGen Pharma, Inc., as the borrower ("Borrower"), and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors ("Guarantors" and, collectively with UroGen Pharma Ltd.

11 unchanged sentences

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

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

5 unchanged sentences

Operating Activities

Net cash used in operating activities was $46.1 million during the six months ended June 30, 2023, compared to $48.2 million during the six months ended June 30, 2022.

The $2.1 million decrease was attributable primarily to timing of certain accruals, as well as increase in net sales of our product Jelmyto during 2023, partially offset by increase in interest on long-term debt.  

Net cash used in operating activities was $63.4 million during the nine months ended September 30, 2023, compared to $65.8 million during the nine months ended September 30, 2022.

The $2.4 million decrease was attributable primarily to timing of certain accruals, as well as increase in net sales of our product Jelmyto during 2023 and higher inventory purchases, including non-current inventory, in 2022, partially offset by increase in interest on long-term debt.  

Investing Activities

Net cash provided by investing activities was $10.0 million during the six months ended June 30, 2023, compared to $13.5 million during the six months ended June 30, 2022.

The net change of $3.5 million is attributable primarily to more reinvestment of marketable securities in 2023 as compared to 2022.

Net cash provided by investing activities was $10.4 million during the nine months ended September 30, 2023, compared to net cash used in investing activities of $22.0 million during the nine months ended September 30, 2022.

The net change of $32.4 million is attributable primarily to less investment of marketable securities in 2023 as compared to 2022.

Financing Activities

Net cash provided by financing activities was $0.8 million during the six months ended June 30, 2023, compared to $70.7 million during the six months ended June 30, 2022.

The decrease of $69.9 million is attributable primarily to proceeds from the Pharmakon loan in the prior year.

Net cash provided by financing activities was $116.9 million during the nine months ended September 30, 2023, compared to $71.8 million during the nine months ended September 30, 2022.

The increase of $45.1 million is attributable primarily to proceeds from the Private Placement in the current year as compared to proceeds from the Pharmakon loan in the prior year.

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