DEF 14A of Delcath Systems, Inc., Apr 1, 2025

DEF 14A of Delcath Systems, Inc.

Filed Apr 1, 2025 · FY20240001628280-25-015761

Open on EDGAR

  1. PROPOSAL 1: ELECTION OF TWO CLASS I DIRECTORS

    PROPOSAL 1: ELECTION OF TWO CLASS I DIRECTORS Our certificate of incorporation and bylaws, each as currently amended and in effect, state that our Board will consist of a number of directors that will be fixed exclusively by the Board from time to time in accordance with the bylaws of the Company. Our Board has fixed the number of directors comprising the Board at six members. Each director holds office until his or her successor is duly elected and qualified or, if sooner, until the director’s death, resignation, retirement, disqualification or removal. Any vacancy in the Board, including a vacancy that results from an increase in the number of directors, may be filled only by the vote of a majority of the remaining directors then in office. Our certificate of incorporation also provides that our Board is divided into three classes of directors, with the classes as nearly equal in number as possible. Subject to any earlier resignation or removal in accordance with the terms of our certificate of incorporation and bylaws, our current Class I directors, if elected, will serve until the Company’s 2028 annual meeting of stockholders; our current Class II directors will serve until the 2026 annual meeting of stockholders; and our current Class III directors will serve until the 2027 annual meeting of stockholders. Any additional directorships resulting from an increase in the number of directors will be apportioned by our Board among the three classes as equally as possible. Our Board has nominated Gerard Michel and Gilad Aharon for election as Class I directors at the Annual Meeting, to serve until the Company’s 2028 annual meeting of stockholders. The nominees are presently directors, and have indicated a willingness to continue to serve as director, if elected. If a nominee becomes unable or unwilling to serve, proxies may be voted for substitute nominees selected by our Board.

  2. Nominee for Election as Class I Director

    Nominee for Election as Class I Director

  3. Nominee for Election as Class I Director

    | Name | Age | Position with Delcath | Director Since | | Gerard Michel | 61 | Chief Executive Officer (CEO) and Director | 2020 | | Gilad Aharon, Ph.D. | 51 | Director | 2020 |

  4. Nominee for Election as Class I Director

    Biographical information, including principal occupation and business experience during the last five years, for our director nominee is set forth below. Gerard Michel was appointed as a director of the Company and its CEO in October 2020. Mr. Michel has over 30 years of experience in the pharmaceutical and medical technology industries across multiple functional areas. Prior to joining the Company as its CEO on October 1, 2020, he was Chief Financial Officer of Vericel Corporation, a biopharmaceutical company, since June 2014 where he was a key member of the management team that integrated a transformative acquisition and revised the company’s business model from a research focused company to a fully integrated, profitable commercial business. Mr. Michel also served as Chief Financial Officer and Vice President, Corporate Development of Biodel, Inc. from November 2007 to May 2014, and Chief Financial Officer and Vice President of Corporate Development of NPS Pharmaceuticals Inc. from August 2002 to November 2007. Prior to that, Mr. Michel was a Principal at Booz Allen and held a variety of commercial roles at both Lederle Labs and Wyeth Labs. Mr. Michel holds an M.S. in Microbiology from the University of Rochester School of Medicine, an M.B.A. from the Simon School of Business, and a B.S. in both Biology and Geology from the University of Rochester. We believe that the Board is greatly enhanced by Mr. Michel’s decades of experience in the pharmaceutical and medical technology industries, his strong leadership skills and his in-depth understanding of the Company and its goals from his experience as our CEO. Gilad Aharon, Ph.D. was appointed as a director of the Company in May 2020. Dr. Aharon is a co-founder of and has served as a Portfolio Manager at Rosalind Advisors, Inc., since 2006. Dr. Aharon holds a Ph.D. in Biophysics and Molecular Biology from the University of Toronto. Prior to co-founding Rosalind Advisors, Dr. Aharon worked as an equity analyst at Infinium Securities Inc. Dr. Aharon’s financial and investment industry experience, his understanding of our business and our industry and his educational background make him extremely valuable to our Board. Dr. Aharon also provides a valuable stockholder perspective to the Board. Dr. Aharon was elected to our Board pursuant to a Board Appointment Agreement entered into with certain of our stockholders, Rosalind Master Fund L.P. and Rosalind Opportunities Fund I L.P. THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS A VOTE “FOR” THE ELECTION OF THE TWO CLASS I DIRECTOR NOMINEES.

  5. Directors Continuing in Office Until the 2026 (Class II) and 2027 (Class III) Annual Meetings

    Directors Continuing in Office Until the 2026 (Class II) and 2027 (Class III) Annual Meetings The following table sets forth information concerning our continuing directors:

  6. Directors Continuing in Office Until the 2026 (Class II) and 2027 (Class III) Annual Meetings

    | Name | Age | Position with Delcath | Director Since | | Elizabeth Czerepak | 69 | Director | 2020 | | John R. Sylvester | 61 | Non-Executive Chairman | 2019 | | Steven Salamon | 59 | Director | 2020 | | Bridget Martell, M.A. M.D. | 59 | Director | 2024 |

  7. Directors Continuing in Office Until the 2026 (Class II) and 2027 (Class III) Annual Meetings

    Biographical information, including principal occupation and business experience during the last five years, for our directors whose terms continue is set forth below.

  8. Class II Directors (Term Expires at 2026 Annual Meeting)

    Class II Directors (Term Expires at 2026 Annual Meeting) Elizabeth Czerepak was appointed as a director of the Company in February 2020. Ms. Czerepak has more than thirty-five years of financial leadership and strategy development experience across the pharmaceutical and biotechnology fields. Ms. Czerepak has served as the Acting Chief Executive Officer and Chief Financial Officer at Mirror Biologics, Inc., a private, clinical-stage company focused on cell-based oncology therapies, since July 2024. She has served as Chief Financial Officer since April 2024. Before joining Mirror Biologics, Inc., she served as the Chief Financial Officer at Sorrento Therapeutics, Inc., a clinical stage biopharmaceutical company focused on developing oncology, non-opioid pain, and Covid therapies, from May 2022 to November 2023. Ms. Czerepak also served as Chief Financial Officer at Scilex Holdings Company, a commercial pharmaceutical company focused on developing and commercializing non-opioid pain therapies, from May 2022 to September 2023. She continued to serve as consultant to Scilex until September 2024. Prior to that, from September 2020 to May 2022, she served as Chief Financial Officer at BeyondSpring Inc. (NASDAQ:BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies, and from May 2018 to January 2020, she served as Chief Financial Officer and Chief Business Officer of Genevant Sciences, Inc., a technology focused nucleic acid delivery company. Her pharma executive level experience includes M&A, licensing, business development and finance. Ms. Czerepak served as a member of the board of directors of Sorrento Therapeutics, Inc. from October 2021 to May 2022. In February of 2023, Sorrento announced it commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code and in November 2023 entered into a court-approved asset sale. Ms. Czerepak also served as a director of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) from June 2019 to December 2020, and as a director of Scilex Pharmaceuticals, Inc., a private company, from 2019 to 2020. She received a B.A. magna cum laude in Spanish and Mathematics Education from Marshall University and an MBA from Rutgers University. In 2020, Elizabeth earned a Corporate Director Certificate from Harvard Business School. Ms. Czerepak brings to our Board extensive experience in the pharmaceutical and biotech industries, including as a senior finance executive of publicly traded biopharmaceutical companies. John R. Sylvester was appointed as a director of the Company in July 2019. He has served as the Non-Executive Chairman of the Board since February 2023. Mr. Sylvester most recently served as CEO of Curium Pharma’s SPECT and International businesses. Prior to that he served as Chief Commercial Officer of BTG plc, which he joined in 2011 and had roles leading both their Interventional Oncology and Interventional Vascular businesses as well as a period as Chief Development Officer accountable for Strategy, M&A and Market Access. This culminated in an exit to Boston Scientific for $4.2 billion. Prior to BTG, Mr. Sylvester was Managing Director of Biocompatibles plc, building their Interventional Oncology business which led to a successful exit to BTG for £166.0 million. Mr. Sylvester joined Biocompatibles following a period as the Vice President of Marketing for Baxter Healthcare’s $750.0 million European Medication Delivery business based in Brussels then Zurich accountable for six strategic business units incorporating drugs, devices and drug device combinations. Before this, Mr. Sylvester held a number of senior commercial roles in the industrial sector. Immediately prior to Baxter Healthcare, Mr. Sylvester was the General Manager of a Minerals company with $4.0 billion of assets on three continents, $500.0 million of sales and 1,500 employees. Mr. Sylvester graduated with joint honors in Biochemistry and Applied Molecular Biology from the University of Manchester Institute of Science and Technology (U.M.I.S.T.). Mr. Sylvester’s extensive international experience with business strategy and commercialization in the healthcare space as well as his educational background enhances our Board.

  9. Class III Directors (Term Expires at 2027 Annual Meeting)

    Class III Directors (Term Expires at 2027 Annual Meeting) Steven Salamon was appointed as a director of the Company in May 2020. Mr. Salamon is a co-founder of, and has served as Portfolio Manager at, Rosalind Advisors, Inc., a life sciences-focused investment manager (“Rosalind Advisors”), since 2006. Mr. Salamon holds an MBA from the Ivey Business School and a Bachelors of Applied Science degree in Engineering Physics from the University of Toronto. Prior to co-founding Rosalind Advisors, Mr. Salamon worked as an equity analyst at HSBC Securities and RBC Capital Markets (formerly RBC Dominion Securities). Prior to completing his MBA, Mr. Salamon worked as a product engineer for Chrysler Corporation. Mr. Salamon brings to our Board his manufacturing, financial and investment industry experience, his understanding of our business and our industry and his strategic insight. In addition, Mr. Salamon provides a valuable stockholder perspective to the Board. Mr. Salamon was elected to our Board pursuant to a Board Appointment Agreement entered into with certain of our stockholders, Rosalind Master Fund L.P. and Rosalind Opportunities Fund I L.P. Bridget Martell, M.A. M.D. was appointed to Delcath Systems’ Board of Directors in May 2024. She brings a wealth of experience from her roles in senior management and as a director at multiple biotechnology companies. Currently, she serves as an independent director at Aligos Therapeutics and Achieve Life Sciences. Dr. Martell previously held director roles at POINT Biopharma Global and Ayala Pharmaceuticals. Dr. Martell is also a Biotechnology Operating Partner at Two Bear Capital and founded BAM Consultants. Her past executive roles include President and CEO of Artizan Biosciences and Chief Medical Officer for various biotech companies. Dr. Martell holds a B.S. in Microbiology from Cornell University, an M.A. in Molecular Immunology from Boston University, and an M.D. from Chicago Medical School. She completed her internal medicine residency and served as Chief Resident at Yale University, where she continues to engage as an Entrepreneur In Residence at Yale Ventures.

  10. Board of Directors

    Board of Directors We currently have six directors serving on the Board. The Board oversees the business affairs of the Company and monitors the performance of management. In accordance with our corporate governance principles, our Board does not involve itself in the day-to-day operations of the Company. The directors keep themselves informed through discussions with the Chairman of the Board, Mr. Sylvester, Mr. Michel, in his capacity as Director and CEO, and other key executives, and by reading the reports and other materials that management sends them and by participating in Board and committee meetings. Our directors hold office until their successors are elected and qualified, or, if sooner, until the director’s death, resignation, retirement, disqualification or removal.

  11. Compensation and Stock Option Committee

    Compensation and Stock Option Committee The Compensation and Stock Option Committee, or the Compensation Committee, assists the Board in the discharge of the Board’s responsibilities with respect to the compensation of our directors, executive officers, and other key employees and consultants. The Compensation Committee establishes our overall compensation philosophy and is authorized to approve the compensation payable to our executive officers, including our named executive officers, and other key employees, including all perquisites, equity incentive awards, cash bonuses, and severance packages. The Compensation Committee also administers certain of the Company’s employee benefit plans, including its equity incentive plans, and is responsible for assessing the independence of compensation consultants and legal advisors. The Compensation Committee exercises sole power to retain compensation consultants and advisors and to determine the scope of the associated engagements. During the fiscal year 2024, our Compensation Committee engaged FW Cook in an effort to better align our compensation program with best practices. The current members of the Compensation Committee are Mr. Sylvester (Chair) and Dr. Aharon, each of whom is “independent” within the meaning of the Nasdaq listing rules. During 2024, the Compensation Committee met five times. The Compensation Committee has a written charter, that satisfies the applicable listing standards of Nasdaq and can be accessed on our website; go to www.delcath.com, click on “Investors,” then “Governance.”

  12. Recommendations by Stockholders of Director Nominees

    Recommendations by Stockholders of Director Nominees The Nominating Committee will consider any recommendation by a stockholder of a candidate for nomination as a director. If a stockholder wants to recommend a director candidate for consideration by the Nominating Committee, the stockholder should submit the name of the proposed nominee, together with the reasons why the stockholder believes the election of the candidate would be beneficial to the Company and our stockholders and the information about the nominee that would be required in a proxy statement requesting proxies to vote in favor of the candidate. The stockholder’s submission must be accompanied by the written consent of the proposed nominee to being nominated by the Board and the candidate’s agreement to serve if nominated and elected. Any such submission should be directed to the Nominating Committee at our principal office, 566 Queensbury Avenue, Queensbury, NY 12804. If a stockholder intends to nominate a person for election to the Board at an annual meeting, the stockholder must provide us with written notice of his or her intention no later than the deadline for receiving a stockholder proposal for inclusion in our Proxy Statement for such meeting and must otherwise comply with our amended and restated certificate of incorporation. Copies of any recommendation received in accordance with these procedures will be distributed to each member of the Nominating Committee. One or more members of the Nominating Committee may contact the proposed candidate to request additional information.

  13. NON-EMPLOYEE DIRECTOR COMPENSATION

    NON-EMPLOYEE DIRECTOR COMPENSATION The Compensation Committee reviews and recommends to the Board appropriate non-employee director compensation programs for service as directors, committee chairs, and committee members. In lieu of per-meeting fees, non-employee directors of the Company are paid an annual retainer of $50,000 and certain additional annual retainers for chairing or serving as a member of the committees of the Board as follows:

  14. NON-EMPLOYEE DIRECTOR COMPENSATION

    | Name | Annual Retainer ($)(1) | | Board Service | 50,000 | | Chairman of the Board | 25,000 | | Chair of Audit Committee | 20,000 | | Member of Audit Committee | 10,000 | | Chair of Compensation Committee | 15,000 | | Member of Compensation Committee | 7,500 | | Chair of Nominating and Corporate Governance Committee | 10,000 | | Member of Nominating and Corporate Governance Committee | 5,000 |

  15. NON-EMPLOYEE DIRECTOR COMPENSATION

    (1) Following our Compensation Committee and Board’s review of our non-employee director compensation program in 2024 the following changes were made to our annual retainers, effective May 23, 2024: (i) the Board service retainer was increased from $43,000 to $50,000, (ii) the committee member retainers were increased from $8,000 to $10,000 (Audit Committee), $5,000 to $7,500 (Compensation Committee), and $4,000 to $5,000 (Nominating and Corporate Governance Committee), and (iii) the committee chair retainers for our Compensation and Nominating and Corporate Governance Committees were increased from $12,000 to $15,000 and $8,000 to $10,000, respectively. Each non-employee director who is in service on the date of each annual meeting of stockholders is also entitled to receive an annual grant of options to purchase shares of Common Stock under our 2020 Plan, which vests in 12 equal monthly installments, subject to the director’s continued service to the Company through each applicable vesting date. The number of options granted each year are approved by the Board based on the recommendation by our independent compensation consultant, FW Cook. Additionally, we reimburse all non-employee directors for their reasonable out-of-pocket travel expenses incurred in attending meetings of our Board or any committees of the Board. The following table sets forth the compensation awarded to, earned by or paid to each non-employee director who served on our Board in 2024.

  16. NON-EMPLOYEE DIRECTOR COMPENSATION

    | Name | Fees Earned or Paid in Cash ($) | Option Awards ($)(1)(2) | Total ($) | | Gil Aharon, Ph.D. | 53,853 | 138,347 | 192,200 | | Elizabeth Czerepak | 67,326 | 138,347 | 205,673 | | Bridget Martell, M.A., M.D.(3) | 37,900 | 138,347 | 176,247 | | Steven Salamon | 65,783 | 138,347 | 204,130 | | Roger G. Stoll, Ph.D.(4) | 23,960 | — | 23,960 | | John Sylvester | 90,822 | 138,347 | 229,169 |

  17. NON-EMPLOYEE DIRECTOR COMPENSATION

    (1)Amounts shown in this column do not reflect dollar amounts actually received by non-employee directors. Instead, these amounts reflect the aggregate grant date fair value of each stock option granted computed in accordance with the provisions of FASB ASC Topic 718. Assumptions used in the calculation of these amounts are included in Note 13 to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Commission on March 6, 2025. The Black-Scholes assumptions used were an expected term of 5.2 years, expected volatility 101.82%, and a risk-free interest rate of 4.47%. Our non-employee directors will only realize compensation to the extent the trading price of our Common Stock is greater than the exercise price of such stock options. (2)As of December 31, 2024, the following non-employee directors held options to purchase the following number of shares of our Common Stock:

  18. NON-EMPLOYEE DIRECTOR COMPENSATION

    | Name | Options Outstanding | | Gil Aharon, Ph.D. | 80,182 | | Elizabeth Czerepak | 80,182 | | Bridget Martell, M.A., M.D. | 22,500 | | Steven Salamon | 80,182 | | Roger G. Stoll, Ph.D. | 77,824 | | John Sylvester | 90,182 |

  19. NON-EMPLOYEE DIRECTOR COMPENSATION

    (3)Dr. Martell began serving on the Board effective as of the date of our 2024 annual meeting of stockholders. (4)Dr. Stoll retired from the Board effective as of the date of our 2024 annual meeting of stockholders.

  20. SUMMARY COMPENSATION TABLE

    SUMMARY COMPENSATION TABLE The following table sets forth the total compensation awarded to, earned by or paid to our named executive officers during the fiscal years ending December 31, 2024 and December 31, 2023.

  21. SUMMARY COMPENSATION TABLE

    | Name and Position | Year | Salary ($) | Non-Equity Incentive Plan Compensation ($)(1) | Option Awards ($)(2) | All Other Compensation ($) | Total ($) | | Gerard Michel | 2024 | 560,622 | 366,756 | 1,230,036 | — | 2,157,414 | | Chief Executive Officer | 2023 | 538,078 | 189,888 | 1,792,348 | — | 2,520,314 | | Vojislav Vukovic(3) | 2024 | 465,000 | 210,600 | 410,012 | — | 1,085,612 | | Chief Medical Officer | 2023 | — | — | — | — | — | | Martha Rook(4) | 2024 | 336,458 | 151,014 | 445,625 | — | 933,097 | | Chief Operating Officer | 2023 | — | — | — | — | — |

  22. SUMMARY COMPENSATION TABLE

    (1)Amounts reported in this column represent annual cash incentive bonuses, which were awarded based on achievement of corporate performance goals for the year indicated. The 2024 cash incentive bonus determinations are described in more detail above under the heading “Annual Incentive Plan”. (2)Amounts shown in this column do not reflect dollar amounts actually received by our named executive officers. Instead, these amounts reflect the aggregate grant date fair value of each stock option granted computed in accordance with the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718. Assumptions used in the calculation of these amounts are included in Note 13 to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Commission on March 6, 2025. Our named executive officers will only realize compensation to the extent the trading price of our Common Stock is greater than the exercise price of such stock options. (3)Dr. Vukovic joined Delcath on June 19, 2023 but was not a named executive officer in 2023 and thus, only 2024 compensation is shown for him in this table. (4)Dr. Rook joined Delcath on March 18, 2024 and thus, only 2024 compensation information is shown for her in this table.

  23. Potential Payments upon Termination or Change of Control

    Potential Payments upon Termination or Change of Control Mr. Michel. Under the Michel Employment Agreement, Mr. Michel could resign his at-will employment with the Company for “Good Reason” and the Company could terminate Mr. Michel’s at-will employment other than for “Cause”. If Mr. Michel resigned his at-will employment for Good Reason or the Company terminated Mr. Michel’s employment other than for Cause, then Mr. Michel would have been entitled to his accrued and unpaid compensation and, subject to him entering into and not revoking a general release of claims in favor of the Company and fully complying with the terms of a separation agreement, Mr. Michel would also have been entitled to: •A severance payment equal in the aggregate to twelve (12) months of his annual base salary at the time of termination, payable in twelve (12) equal monthly installments (and subject to applicable withholdings and deductions) beginning on the last Company payroll date of the first full month following termination of employment; and •If Mr. Michel timely and properly elected health plan (medical, dental and/or vision) continuation coverage under COBRA, the Company would have reimbursed Mr. Michel in an amount equal to the difference between the monthly COBRA premium paid by Mr. Michel for him and his dependents and the monthly premium amount paid by similarly situated active executives under the Company’s group health plans (“COBRA Benefits”). Such reimbursement would have been paid to Mr. Michel on or by the last day of the month immediately following the month in which Mr. Michel timely remitted the COBRA premium payment. Mr. Michel will be eligible to receive COBRA premium reimbursement until the earliest of: (x) the twelve-month anniversary of the date his employment with the Company terminated; (y) the date Mr. Michel was no longer eligible to receive COBRA continuation coverage; and (z) the date on which Mr. Michel became eligible to receive substantially similar coverage from another employer. •In addition, the Michel Employment Agreement provided that if Mr. Michel’s at-will employment was terminated by Mr. Michel for Good Reason or by the Company without Cause, in each case within three (3) months before or twelve (12) months following a change in control of the Company (the “CIC Period”), Mr. Michel would have been entitled to receive his accrued and unpaid compensation and, subject to Mr. Michel entering into and not revoking a general release of claims in favor of the Company and fully complying with the Restrictive Covenants Agreement the payments and benefits described in the preceding two bullets as well as (i) immediate acceleration of any unvested portion of any other outstanding stock options granted to him that were outstanding at the time of such termination and (ii) a pro-rated annual cash incentive bonus for the fiscal year in which Mr. Michel’s employment terminated, as determined by the Board or the Compensation Committee based on its assessment of the actual performance of the Company and Mr. Michel following the completion of the fiscal year in which the termination of employment occurred; such pro-rated cash incentive bonus to be paid to Mr. Michel in a lump sum no later than 60 days after the filing of the Company’s Annual Report on Form 10-K for the fiscal year in which the termination of employment occurred. The New Michel Employment Agreement applies to any termination of Mr. Michel’s employment occurring on and after July 16, 2024. Under the New Michel Employment Agreement, if Mr. Michel is involuntarily terminated by the Company without “Cause” or Mr. Michel resigns with Good Reason (each as defined in the New Michel Employment Agreement), and Mr. Michel executes a separation agreement in a form supplied by the Company, then (i) the Company will pay Mr. Michel an amount equal to fifteen (15) months of Mr. Michel’s then-current base salary and a pro-rated portion of any earned annual bonus, as determined by the Company at its discretion, subject to required and authorized deductions and withholdings and (ii) if Mr. Michel timely and properly elects health plan continuation coverage under COBRA, the Company will provide COBRA Benefits for a period of fifteen (15) months or until Mr. Michel becomes eligible to receive substantially similar coverage from another employer. In the event Mr. Michel is terminated without Cause or resigns with Good Reason within the CIC Period, (i) the Company will pay Mr. Michel eighteen (18) months of Mr. Michel’s then-current base salary and a pro-rated portion of any earned annual bonus, to be determined at the Company’s discretion and (ii) the Company will provide COBRA Benefits for a period of eighteen (18) months or until Mr. Michel becomes eligible to receive substantially similar coverage from another employer. Additionally, all then-outstanding unvested stock options granted to Mr. Michel during his employment will become fully vested and exercisable upon such termination. Dr. Vukovic. Under the Vukovic Offer Letter, on and after August 9, 2023, if Dr. Vukovic’s employment terminated for any reason other than by the Company for cause or his voluntary departure, Dr. Vukovic would have been entitled to three (3) months of severance at his then applicable compensation, which would have included benefits. The Vukovic Employment Agreement applies to any termination of Dr. Vukovic’s employment occurring on and after July 25, 2024. Under the Vukovic Employment Agreement, if Dr. Vukovic is involuntarily terminated by the Company without “Cause” or Dr. Vukovic resigns with Good Reason (each as defined in the Vukovic Employment Agreement), and Dr. Vukovic executes a separation agreement in a form supplied by the Company, then (i) the Company will pay Dr. Vukovic an amount equal to twelve (12) months of Dr. Vukovic’s then-current base salary and a pro-rated portion of any earned annual bonus, as determined by the Company at its discretion, subject to required and authorized deductions and withholdings and (ii) if Dr. Vukovic timely and properly elects health plan continuation coverage under COBRA, the Company will provide COBRA Benefits for a period of twelve (12) months or until Dr. Vukovic becomes eligible to receive substantially similar coverage from another employer. In the event Dr. Vukovic is terminated without Cause or resigns with Good Reason within the CIC Period, Dr. Vukovic will be entitled to the payments and benefits described in the immediately preceding sentence and all of the then-outstanding unvested stock options granted to Dr. Vukovic during his employment will become fully vested and exercisable upon such termination. Dr. Rook. Under the Rook Employment Agreement, Dr. Rook could resign her at-will employment with the Company for “Good Reason” (as defined within the Rook Employment Agreement) and the Company could terminate Dr. Rook’s at-will employment other than for “Cause” (as defined within the Rook Employment Agreement). If Dr. Rook resigned her at-will employment for Good Reason or the Company terminated Dr. Rook’s employment other than for Cause, then Dr. Rook would have been entitled to her accrued and unpaid compensation and, subject to her entering into and not revoking a general release of claims in favor of the Company and fully complying with the terms of the Restrictive Covenants Agreement, Dr. Rook would also have been entitled to: • A severance payment equal in the aggregate to nine (9) months of her annual base salary at the time of termination, payable in twelve (12) equal monthly installments (and subject to applicable withholdings and deductions) beginning on the last Company payroll date of the first full month following termination of employment; and

  24. Potential Payments upon Termination or Change of Control

    • If Dr. Rook timely and properly elected health plan (medical, dental and/or vision) continuation coverage under COBRA, the COBRA Benefits. Such reimbursement would have been paid to Dr. Rook on or by the last day of the month immediately following the month in which Dr. Rook timely remitted the COBRA premium payment. Dr. Rook would have been eligible to receive COBRA premium reimbursement until the earliest of: (x) the twelve-month anniversary of the date her employment with the Company terminated; (y) the date Dr. Rook was no longer eligible to receive COBRA continuation coverage; and (z) the date on which Dr. Rook became eligible to receive substantially similar coverage from another employer. • In addition, the Rook Employment Agreement provided that if Dr. Rook’s at-will employment was terminated by Dr. Rook for Good Reason or by the Company without Cause, in each case during the CIC Period, Dr. Rook would have been entitled to receive her accrued and unpaid compensation and, subject to Dr. Rook entering into and not revoking a general release of claims in favor of the Company and fully complying with the Restrictive Covenants Agreement, the payments and benefits described in the preceding two bullets as well as (i) immediate acceleration of any unvested portion of any other outstanding stock options granted to her that were outstanding at the time of such termination and (ii) a pro-rated annual cash incentive bonus for the fiscal year in which Dr. Rook’s employment terminated, as determined by the Board or the Compensation Committee based on its assessment of the actual performance of the Company and Dr. Rook following the completion of the fiscal year in which the termination of employment occurred, with such pro-rated cash incentive bonus to be paid to Dr. Rook in a lump sum. The New Rook Employment Agreement applies to any termination of Dr. Rook’s employment occurring on and after July 16, 2024. Under the New Rook Employment Agreement, if Dr. Rook is involuntarily terminated by the Company without “Cause” or Dr. Rook resigns with Good Reason (each as defined in the New Rook Employment Agreement), and Dr. Rook executes a separation agreement in a form supplied by the Company, then (i) the Company will pay Dr. Rook an amount equal to twelve (12) months of Dr. Rook’s then-current base salary and a pro-rated portion of any earned annual bonus, as determined by the Company at its discretion, subject to required and authorized deductions and withholdings and (ii) if Dr. Rook timely and properly elects health plan continuation coverage under COBRA, the Company will provide COBRA Benefits for a period of twelve (12) months or until Dr. Rook becomes eligible to receive substantially similar coverage from another employer. In the event Dr. Rook is terminated without Cause or resigns with Good Reason within the CIC Period, Dr. Rook will be entitled to the payments and benefits described in the immediately preceding sentence and all of the then-outstanding unvested stock options granted to Dr. Rook during her employment will become fully vested and exercisable upon such termination.

  25. OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END —2024

    OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END —2024 The following table sets forth information concerning unexercised stock options for each named executive officer as of December 31, 2024 that had been granted under the 2020 Plan, unless otherwise noted in the footnotes to this table.

  26. OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END —2024

    | | | Option Awards | | | | | Name | Grant Date | Number of Securities Underlying Unexercised Options (#) Exercisable(1) | Number of Securities Underlying Unexercised Options (#) Unexercisable(1) | Option Exercise Price Per Share ($) | Option Expiration Date | | Gerard Michel | 10/1/2020(2) | 396,000 | — | 11.67 | 10/1/30 | | | 10/1/2020(2) | 51,000 | — | 17.51 | 10/1/30 | | | 10/1/2020(2) | 51,000 | — | 23.34 | 10/1/30 | | | 8/5/2021(3) | 125,000 | — | 10.16 | 8/5/31 | | | 2/8/2022 | 112,910 | 3,227 | 7.14 | 2/8/32 | | | 2/8/2023 | 89,700 | 50,700 | 4.67 | 2/8/33 | | | 6/12/2023 | 89,148 | 79,739 | 7.25 | 6/12/33 | | | 2/12/2024 | 92,125 | 209,375 | 4.78 | 2/12/34 | | Vojislav Vukovic | 6/20/2023(4) | 74,628 | 75,372 | 5.93 | 6/20/33 | | | 2/12/2024 | 30,712 | 69,788 | 4.78 | 2/12/34 | | Martha Rook | 3/18/2024(5) | 34,730 | 90,270 | 4.18 | 3/18/34 |

  27. OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END —2024

    (1)Unless otherwise noted, option shares vest over three years in equal monthly installments with the first vesting occurring on the grant date. (2)On October 1, 2020, Mr. Michel was granted a nonqualified and non-plan stock option “inducement award” to purchase 498,000 shares of our Common Stock in reliance on Nasdaq Rule 5635(c)(4) pursuant to the terms of a stock option award agreement. The stock option vests ratably over a 36-month period beginning on October 31, 2020 (i.e., 1/36th will vest at the end of each month during said 36-month period), subject to Mr. Michel’s continued service with the Company on each respective vesting date. The exercise price of the stock option is equal to (i) $11.67, the closing trading price per share of our Common Stock on October 1, 2020 as to the first 396,000 option shares to vest, (ii) 1.5 times the closing trading price per share of our Common Stock on October 1, 2020 as to the next 51,000 option shares to vest and (iii) 2.0 times the closing trading price per share of the Company’s Common Stock on October 1, 2020 as to the remaining 51,000 option shares to vest. (3)Four-thirty-sixths (4/36th) of the option shares immediately vested on the grant date and the remaining option shares vest and become exercisable at the rate of one-thirty-sixth (1/36th) per month for the next thirty-two months. (4)On June 20, 2023, Dr. Vukovic was granted a nonqualified and non-plan stock option “inducement award” to purchase 150,000 shares of our Common Stock in reliance on Nasdaq Rule 5635(c)(4) pursuant to the terms of a stock option award agreement. The stock option vests ratably over three years, with 33% vesting on the first anniversary of the grant date and the remaining 66% vesting in equal monthly installments over the next two years, subject to Dr. Vukovic’s continued service with the Company on each respective vesting date. (5)On March 18, 2024, Dr. Rook was granted a nonqualified stock option as an “inducement award” under our 2023 Inducement Plan to purchase 125,000 shares of our Common Stock in reliance on Nasdaq Rule 5635(c)(4) pursuant to the terms of a stock option award agreement. The stock option vests in equal monthly installments over three years, subject to Dr. Rook’s continued service with the Company on each respective vesting date.

  28. PAY VERSUS PERFORMANCE

    PAY VERSUS PERFORMANCE

  29. Pay Versus Performance Table

    Pay Versus Performance Table As required by Section 953(a) of The Dodd-Frank Wall Street Reform and Consumer Protection Act and Item 402(v) of Regulation S-K, we are providing the following information about the relationship between executive compensation actually paid, as defined below, and certain financial performance of the Company.

  30. Pay Versus Performance Table

    | Pay Versus Performance | | | | | | | | Year | Summary Compensation Table Total for PEO (1) (3) | Compensation Actually Paid to PEO (1) (2) (5) | Average Summary Compensation Table Total for Non-PEO NEOs (1) (2)(4) | Average Compensation Actually Paid to Non-PEO NEOs (1) (2) (6) | Value of Initial Fixed $100 Investment Based On Total Shareholder Return (7) | Net Income (Loss) (8) | | (a) | (b) | (c) | (d) | (e) | (f) | (h) | | 2024 | $2,157,414 | $4,876,184 | $1,009,355 | $2,000,353 | $152.79 | $(26,386,000) | | 2023 | $2,520,314 | $2,154,023 | $1,109,506 | $952,501 | $52.79 | $(47,678,000) | | 2022 | $1,472,198 | $(188,099) | $770,916 | $266,160 | $45.69 | $(36,508,000) |

  31. Pay Versus Performance Table

    (1)We are a smaller reporting company pursuant to Rule 405 of the Securities Act and as such, we are only required to include information for the past three fiscal years in the table. (2)For each of the three years presented in the above table, Gerard Michel was our Principal Executive Officer (“PEO”). Our Non-PEO Named Executive Officers (“Non-PEO NEOs”) were (i) Vojislav Vukovic and Martha Rook in 2024, (ii) John Purpura, M.S. and Kevin Muir in 2023, and (iii) John Purpura, M.S. and Johnny John in 2022. (3)The dollar amounts reported in column (b) are the amounts of total compensation reported for our PEO for each corresponding year in the “Total” column of the Summary Compensation Table above and in the Summary Compensation Table as disclosed in the proxy statements for the applicable years. (4)The dollar amounts reported in column (d) represent the average of the amounts reported for the Non-PEO NEOs as a group for each corresponding year in the “Total” column of the Summary Compensation Table above and in the Summary Compensation Table as disclosed in the proxy statements for the applicable years. (5)For purposes of this table, the compensation actually paid (“Compensation Actually Paid”) to our PEO has been computed in accordance with Item 402(v) of Regulation S-K under the Exchange Act and does not reflect the actual amount of compensation earned by or paid to our PEO during 2024. The dollar amounts reported in column (c) for 2024 represent total compensation as reflected in the above Summary Compensation Table for 2024, adjusted as follows:

  32. Pay Versus Performance Table

    | | PEO | | | 2024 | | Summary Compensation Table Totals for PEO | $2,157,414 | | Additions (Subtractions) for Equity Awards | | | Stock and Option Award Values Reported in the Summary Compensation Table for the Covered Year | (1,230,036) | | Fair Value at Year-End of Outstanding and Unvested Equity Awards Granted in the Covered Year | 2,155,053 | | Year over Year Change in Fair Value of Outstanding and Unvested Equity Awards Granted in Prior Years | 886,243 | | Fair Value as of Vesting Date of Equity Awards Granted and Vested in the Covered Year | 570,777 | | Year over Year Change in Fair Value of Equity Awards Granted in Prior Years that Vested in the Covered Year | 336,733 | | Fair Value at the End of the Prior Year of Equity Awards that Failed to Meet Vesting Conditions in the Year | — | | Value of Dividends or other Earnings Paid on Stock or Option Awards not Otherwise Reflected in Fair Value or Total Compensation | — | | Compensation Actually Paid to PEO | $4,876,184 |

  33. Pay Versus Performance Table

    (6)The following adjustments were made to average total compensation for the Non-PEO NEOs as a group for 2024 to determine the Compensation Actually Paid, using the same methodology described above in Note 5:

  34. Pay Versus Performance Table

    | | Non-PEO NEOs (Average) | | | 2024 | | Summary Compensation Table Totals for Non-PEO NEOs | $1,009,355 | | Additions (Subtractions) for Equity Awards | | | Stock and Option Award Values Reported in the Summary Compensation Table for the Covered Year | (427,819) | | Average Fair Value at Year-End of Outstanding and Unvested Equity Awards Granted in the Covered Year | 829,850 | | Average Year over Year Change in Fair Value of Outstanding and Unvested Equity Awards Granted in Prior Years | 243,666 | | Average Fair Value as of Vesting Date of Equity Awards Granted and Vested in the Covered Year | 216,393 | | Average Year over Year Change in Fair Value of Equity Awards Granted in Prior Years that Vested in the Covered Year | 128,908 | | Average Fair Value at the End of the Prior Year of Equity Awards that Failed to Meet Vesting Conditions in the Year | — | | Average Value of Dividends or other Earnings Paid on Stock or Option Awards not Otherwise Reflected in Fair Value or Total Compensation | — | | Compensation Actually Paid to Non-PEO NEOs | $2,000,353 |

  35. Pay Versus Performance Table

    (7)Cumulative Total Shareholder Return (“TSR”) represents the return on a fixed investment of $100 in our Common Stock for the period beginning on the last trading day of 2021 through the last trading day of the applicable fiscal year. (8)The dollar amounts reported represent the amount of net loss reflected in the Company’s audited financial statements for the year ended December 31, 2024.

  36. Analysis of the Information Presented in the Pay Versus Performance Table

    Analysis of the Information Presented in the Pay Versus Performance Table In accordance with Item 402(v) of Regulation S-K, we are providing the following descriptions of the relationships between information presented in the Pay Versus Performance table above.

  37. Compensation Actually Paid and Cumulative TSR

    Compensation Actually Paid and Cumulative TSR The following graph sets forth the relationship between Compensation Actually Paid to our PEO, the average of Compensation Actually Paid to our Non-PEO NEOs, and the Company’s cumulative TSR over the three most recently completed fiscal years. l

  38. Compensation Actually Paid and Net Income (Loss)

    Compensation Actually Paid and Net Income (Loss) We commercially launched the HEPZATO KIT in January 2024 and prior to that we incurred expenses related to completing the FOCUS clinical trial and preparing for commercialization of the HEPZATO KIT. We have incurred net losses during the periods presented. Consequently, we have not looked to our net loss as a performance measure for our executive compensation program. Moreover, we do not believe there is any meaningful relationship between our net loss and Compensation Actually Paid to our named executive officers during the periods presented. All information provided above under the “Pay Versus Performance” heading will not be deemed to be incorporated by reference into any filing of the Company under the Securities Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing, except to the extent the Company specifically incorporates such information by reference.