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Item 9A. Controls and Procedures

2025-03-10 compared with 2024-03-14 · 33 added, 50 removed, 129 unchanged (39% of the section changed)

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Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of December 31, 2023.

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

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An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any changes in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Other Information

Trading Plans

On December 26, 2023 , our Chief Medical Officer , Mark Schoenberg , entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c) under the Exchange Act, to sell up to 30,000 ordinary shares.

The trading plan expires on April 10, 2025.

Amended and Restated Loan Agreement

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

The third tranche of $25.0 million is mandatory and required to be drawn by September 30, 2024, subject to satisfaction of customary conditions.

The fourth tranche of $75.0 million may be drawn at our option no later than August 29, 2025, subject to (i) having successfully drawn the immediately preceding $25.0M tranche, (ii) receiving FDA approval of an NDA for UGN- 102 no later than June 30, 2025 and (iii) satisfaction of customary conditions.

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

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

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

Notice of 2024 Annual Meeting Date and Related Deadlines

As of the date of this Annual Report, we intend to hold our 2024 Annual meeting of Shareholders (the "2024 Annual Meeting of Shareholders") on or about August 7, 2024.

This date is more than 30 days before the one -year anniversary of our 2023 annual meeting of shareholders, which was held on September 7, 2023.

Under Section 66 (b) of the Israeli Companies Law, 5759 - 1999, as amended from time to time, and the regulations promulgated thereunder (collectively, the “Companies Law”), shareholders who hold, in the aggregate, at least 1% of the voting power in the Company may submit a request to include an item to the agenda within seven days following the Company’s notice of convening a shareholders’ general meeting at which directors are to be elected and certain other proposals are to be considered (or within three days of the Company’s notice in other instances), provided the requested item is appropriate for presentation at a general meeting and for consideration by the shareholders.

In addition to the eligibility requirements under the Companies Law, our articles of association specify additional procedural requirements for shareholder proposals.

Under our articles of association, in the event that the date of the annual general meeting is advanced more than 30 days prior to the anniversary of the preceding year’s annual general meeting, notice by the proposing shareholder, in order to be timely, must be received no earlier than the close of business 120 days prior to such annual general meeting, April 9, 2024, and no later than the close of business 90 days prior to such annual general meeting, May 9, 2024.

In addition, shareholder proposals may be submitted for inclusion in a proxy statement under Rule 14a - 8 under the Exchange Act.

Under Rule 14a - 8 of the Exchange Act, to be eligible for inclusion in our proxy materials for the 2024 Annual Meeting of Shareholders, shareholder proposals must be received by us a reasonable time before we begin to print and send our proxy materials.

We have determined that April 13, 2024, which is the date disclosed in our definitive proxy statement on Schedule 14A for our 2023 annual meeting of shareholders, remains a reasonable time before we expect to begin to print and distribute our proxy materials for our 2024 Annual Meeting, and that any shareholder proposals must be received on or before the close of business on that day.

In addition, Rule 14a - 8 proposals must otherwise comply with the requirements of the rule.

Additional requirements regarding shareholder proposals submitted for inclusion in our proxy materials for an annual general meeting of shareholders can be found in the articles of association, which is available as an exhibit to this Annual Report.

Proposals should be addressed to:

UroGen Pharma Ltd., 400 Alexander Park Drive, 4 th Floor, Princeton, New Jersey 08540.

In addition to satisfying the foregoing requirements under our articles of association, to comply with the universal proxy rules, shareholders who intend to solicit proxies in support of director nominees other than our board of directors’ nominees must provide notice that sets forth any additional information required by Rule 14a - 19 promulgated under the Exchange Act.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

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Directors, Executive Officers and Corporate Governance

The information required by this item will be set forth in an amendment to this Annual Report on Form 10-K to be filed with the SEC by April 29, 2024 (the "Form 10-K Amendment").

The Corporate Code of Ethics and Conduct is available on our website at http://www.urogen.com under the Governance section of our Investors page.

We will promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver.

The information required by this item will be set forth in our definitive proxy statement for our 2025 annual meeting of shareholders, or an amendment to this Annual Report on Form 10-K, to be filed with the SEC by April 30, 2025 (the "Proxy Statement/Form 10-K Amendment").

We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer) and employees, known as the “Corporate Code of Ethics and Conduct.” The Corporate Code of Ethics and Conduct is available on our website at www.urogen.com under the Governance section of our Investors page.

To the extent requirement by applicable SEC rules, we intend to promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver.

Shareholders may request a free copy of the Corporate Code of Ethics and Conduct from c/o UroGen Pharma Ltd., 400 Alexander Park Dr., Princeton, NJ 08540.

Executive Compensation

The information required by this item will be set forth in the Form 10-K Amendment.

The information required by this item will be set forth in the Proxy Statement/Form 10-K Amendment.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The information required by this item will be set forth in the Form 10-K Amendment.

The information required by this item will be set forth in the Proxy Statement/Form 10-K Amendment.

Certain Relationships and Related Transactions, and Director Independence

The information required by this item will be set forth in the Form 10-K Amendment.

The information required by this item will be set forth in the Proxy Statement/Form 10-K Amendment.

Principal Accountant Fees and Services

The information required by this item will be set forth in the Form 10-K Amendment.

The information required by this item will be set forth in the Proxy Statement/Form 10-K Amendment.

Exhibits, Financial Statement Schedules

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Reference is made to Exhibit 3.1 .

Description of the Registrant’s Ordinary Shares (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 2, 2020).

Description of the Registrant’s Ordinary Shares.

Form of July 2023 Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 27, 2023).

Form of June 2024 Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 18, 2024).

Form of Officer Indemnity and Exculpation Agreement (incorporated by reference to Exhibit 99.2 to the Registrant’s Report Form 6-K, filed with the SEC on July 13, 2018).

Amended and Restated 2010 Israeli Share Option Plan (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 20-F, filed with the SEC on March 15, 2018).

2017 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q, filed with the SEC on November 14, 2023).

2017 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on August 8, 2024) .

2017 Israeli Equity Incentive Sub Plan to the 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form F-1, filed with the SEC on April 7, 2017).

Form of Performance Stock Award Grant Notice and Performance Stock Award Agreement under the UroGen Pharma Ltd.

Israeli Sub-Plan to 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2024).

Form of Stock Option Grant Notice and Stock Option Agreement under the UroGen Pharma Ltd.

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Amendment to Form of Restricted Stock Unit Grant Notice under the UroGen Pharma Ltd.

2017 Equity Incentive Plan.

2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024)

Form of Performance-Based Restricted Stock Unit Grant Notice and Performance-Based Restricted Stock Unit Award Agreement under the UroGen Pharma Ltd.

2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 14, 2023).

Amendment to Form of Performance-Based Restricted Stock Unit Grant Notice under the UroGen Pharma Ltd.

2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant ’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2024).

UroGen Pharma Ltd.

2019 Inducement Plan, as amended (incorporated by reference to Exhibit 10.5 to the Registrant's Annual Report on Form 10-K, filed with the SEC on March 21, 2022).

2019 Inducement Plan, as amended (incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2024).

Form of Stock Option Grant Notice and Stock Option Agreement under the UroGen Pharma Ltd.

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Amendment to Form of Restricted Stock Unit Grant Notice under the UroGen Pharma Ltd.

2019 Inducement Plan.

Amended and Restated Compensation Policy for Officer Holders (incorporated by reference to Exhibit 10.8 to the Registrant's Annual Report on Form 10-K, filed with the SEC on March 24, 2023).

2019 Inducement Plan (incorporated by reference to Exhibit 10.12 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

UroGen Pharma Ltd.

2024 Non-Employee Director and Officer Compensation Policy (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on August 8, 2024).

Employment Agreement by and between the Registrant and Elizabeth Barrett, dated as of January 3, 2019 (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on February 28, 2019).

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Performance-Based Restricted Stock Unit Grant Notice by and between the Registrant and Elizabeth Barrett, dated as of November 13, 2023 (incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 14, 2023).

Amended Restricted Stock Unit Grant Notice by and between the Registrant and Elizabeth Barrett, dated as of December 20, 2023.

Amended Restricted Stock Unit Grant Notice by and between the Registrant and Elizabeth Barrett, dated as of December 20, 2023 (incorporated by reference to Exhibit 10.18 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

Employment Agreement by and between the Registrant and Mark Schoenberg, dated as of December 5, 2017 (incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on February 28, 2019).

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Amendment 1 to Employment Agreement between the Registrant and Jason Smith, dated January 26, 2021 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2021).

Employment Agreement between the Company and Dong Kim, dated March 20, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Current Report on Form 8-K, filed with the SEC on March 21, 2022).

Employment Agreement between the Company and Chris Degnan, dated October 7, 2024 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 9, 2024).

Separation Agreement between the Company and Don Kim, dated October 7, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant ’s Current Report on Form 8-K, filed with the SEC on October 9, 2024).

License Agreement, dated November 8, 2019, by and between the Registrant and Agenus Inc.

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and Cenexi-Laboratoires Thissen s.a.

(incorporated by reference to Exhibit 10.31 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

License and Supply Agreement, dated as of January 16, 2024, by and between UroGen Pharma Ltd.

and Medac Gesellschaft für klinische Spezialprä parate m.b.H.

Loan Agreement, dated as of March 7, 2022, by and among UroGen Pharma Ltd.

(the “ Company ” ), UroGen Pharma, Inc., as the borrower, and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors, BPCR Limited Partnership, as a lender, BioPharma Credit Investments V (Master) LP, as a lender, and BioPharma Credit PLC, as collateral agent for the lenders (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Quarterly Report on Form 10-Q, filed with the SEC on May 10, 2022).

Amendment to Loan Agreement, dated June 29, 2023, by and among the Company, UroGen Pharma, Inc., as the borrower, and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors, BPCR Limited Partnership, as a lender, BioPharma Credit Investments V (Master) LP, as a lender, and BioPharma Credit PLC, as collateral agent for the lenders (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 10, 2023).

(incorporated by reference to Exhibit 10.32 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

Amended and Restated Loan Agreement, dated as of March 13, 2024, by and among UroGen Pharma, Inc., as the borrower, and a credit party, UroGen Pharma Ltd.

as Parent, and a Credit Party, the other guarantors signatory hereto or otherwise party hereto from time to time as additional Credit Parties, BioPharma Credit PLC as collateral agent, BPCR Limited Partnership as a lender and BioPharma Credit Investments V (Master) LP as a lender (incorporated by reference to Exhibit 10.35 to the Registrant ’ s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

Pre-Paid Forward Contract by and among the Registrant and RTW Investments ICAV for and on behalf of RTW Fund 2, dated as of March 18, 2021, as amended April 30, 2021 and August 14, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant ’ s Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2024).

UroGen Pharma Ltd.

Insider Trading Policy.

Subsidiary of the Registrant (incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 24, 2023).

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UroGen Pharma Ltd.

Incentive Compensation Recoupment Policy.

Incentive Compensation Recoupment Policy (incorporated by reference to Exhibit 97 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2024).

The following financial information from the Annual Report on Form 10-K of UroGen Pharma Ltd.

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SIGNATURES AND POWER OF ATTORNEY

We, the undersigned directors and officers of UroGen Pharma Ltd., hereby severally constitute and appoint Elizabeth Barrett and Don Kim, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

We, the undersigned directors and officers of UroGen Pharma Ltd., hereby severally constitute and appoint Elizabeth Barrett and Chris Degnan, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

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(Principal Executive Officer)

/s/ Chris Degnan

Chief Financial Officer

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March 10, 2025

Cohen, M.D., D.Phil.

March 14, 2024

Wen, M.D., M.Sc.

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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-K

Item 9A. Controls and Procedures