DEF 14A of Iovance Biotherapeutics, Inc., Apr 28, 2025

DEF 14A of Iovance Biotherapeutics, Inc.

Filed Apr 28, 2025 · FY20240001558370-25-005702

Open on EDGAR

  1. PROPOSAL NO. 1 — ELECTION OF DIRECTORS

    PROPOSAL NO. 1 — ELECTION OF DIRECTORS The following is information concerning the nominees for election as directors. We believe that each nominee will be able to serve as a director. In the event that a nominee is unable to serve, the proxy holder will vote the proxies for such other nominee as he or she may determine. Each nominee currently serves as a director of the Company. The term of office of each director will expire at next year’s Annual Meeting of Stockholders and each elected director shall hold office until the expiration of the term and until such director’s successor is elected and qualified or until such director’s earlier death, resignation or removal.

  2. Nominees

    Nominees Our Nominating and Corporate Governance Committee has recommended, and our Board of Directors has approved, as nominees the following individuals for election as directors at the Annual Meeting: Iain Dukes, D. Phil. Athena Countouriotis, M.D. Ryan Maynard Wayne P. Rothbaum Frederick G. Vogt, Ph.D., J.D. Michael Weiser, M.D., Ph.D. Wendy Yarno For information concerning the nominees, please see the section titled “Board of Directors and Corporate Governance” below. If you are a stockholder of record and you sign your proxy card or vote by telephone or over the internet but do not give instructions with respect to the voting of directors, your shares will be voted “FOR” the re-election of the above-mentioned nominees.

  3. Majority Vote Requirement

    Majority Vote Requirement As set forth in our Fourth Amended and Restated Bylaws, for all duly called or convened meetings of stockholders, at which a quorum is present, for the election of directors, a majority of the votes cast shall be sufficient to elect a director; provided, that, for contested elections, directors shall be elected by a plurality of the votes cast if, as of the date of the meeting of the stockholders, the number of nominees exceeds the number of directors to be elected. If any director nominated for re-election at an Annual Meeting fails to receive more votes cast “for” his or her re-election than “against” his or her re-election, such director shall promptly tender his or her resignation for our Board of Director’s consideration. The Nominating and Corporate Governance Committee designated by our Board of Directors shall then make a recommendation to our Board of Directors to accept or reject the tendered resignation. Our Board of Directors will then have 90 days from the date the election results from the applicable Annual Meeting are certified to notify the resigning director of its decision. Our Board of Directors may consider all relevant factors in making its decision, including any stated reasons for “against” votes, whether the underlying cause of the “against” votes are curable, the length of service and contributions by the resigning director to us, and whether the resignation would cause us to fail to comply with any applicable rules or requirements, would lead to a “change of control” as determined pursuant to any financing or other material agreement, or would cause us to default under any material agreements. If the resigning director’s tendered resignation is not accepted, such director will continue to serve on our Board of Directors. THE BOARD OF DIRECTORS RECOMMENDS A VOTE “FOR” EACH OF THE DIRECTOR NOMINEES NAMED ABOVE.

  4. BOARD OF DIRECTORS AND CORPORATE GOVERNANCE

    BOARD OF DIRECTORS AND CORPORATE GOVERNANCE Our business affairs are managed under the direction of our Board of Directors, which is currently composed of seven members. The following table sets forth the names, ages as of the Record Date, and certain other information for the seven directors whose terms are expiring at the Annual Meeting and the individuals who are nominees for election as a director at the Annual Meeting.

  5. BOARD OF DIRECTORS AND CORPORATE GOVERNANCE

    | Directors with Terms Expiring at the Annual Meeting/Nominees | Age | Position | Director Since | | Iain Dukes, D. Phil. | 66 | Chairman of the Board of Directors | 2016 | | Athena Countouriotis, M.D. | 53 | Director | 2019 | | Ryan Maynard | 55 | Director | 2015 | | Wayne P. Rothbaum | 57 | Director | 2016 | | Frederick G. Vogt, Ph.D., J.D. | 51 | Interim Chief Executive Officer and President, General Counsel; Director | 2024 | | Michael Weiser, M.D., Ph.D. | 62 | Director | 2018 | | Wendy Yarno | 69 | Director | 2023 |

  6. BOARD OF DIRECTORS AND CORPORATE GOVERNANCE

    Biographical information for each director and director nominee is included below. Iain Dukes, D. Phil. Dr. Dukes joined our Board of Directors in August 2016 and was appointed Chairman of the Board on August 16, 2016. Dr. Dukes currently is a Venture Partner at OrbiMed Advisors LLC and the CEO of Eilean Therapeutics LLC. He previously served as Senior Vice President and Head of Business Development and Licensing for Merck Research Laboratories through May 2016. He joined Merck in August 2013. Prior to joining Merck, Dr. Dukes was Vice President of External Research & Development at Amgen, from August 2010 to August 2013. From 2007 to 2010, Dr. Dukes was the President and Chief Executive Officer, and a member of the board of directors, of Essentialis Therapeutics, a clinical stage biotechnology company focused on the development of breakthrough medicines for the treatment of rare metabolic diseases. From 2000 to 2007, Dr. Dukes was Vice President of Scientific and Technology Licensing at GlaxoSmithKline, and prior to that, from 1990 to 1999, he held various positions at Glaxo Wellcome, including Head of Exploratory Development for Metabolic and Urogenital Diseases and Head of Ion Channel Drug Discovery Group. He also serves on the board of directors at Ikena Oncology and Traws Pharma, and privately held biotechnology companies NeRRe Therapeutics, Rathlin Therapeutics, ENYO Pharma, Feldan Therapeutics and Angiex Therapeutics. Dr. Dukes holds M.J. and Doctor of Philosophy degrees from the University of Oxford, a M.S. degree in Cardiovascular Studies from the University of Leeds and a Bachelor of Science degree in Pharmacology from the University of Bath. Our Board of Directors believes that Dr. Dukes is highly qualified to serve as a member of the Board of Directors because of his extensive experience in the pharmaceutical industry, including his service in senior management roles. Although Dr. Dukes is an executive officer of privately held companies and a board member of two other public companies, Dr. Dukes is able to devote the time necessary to our Board of Directors. We believe his experience makes him a valuable asset to the Board of Directors. Athena Countouriotis, M.D. Dr. Countouriotis joined our Board of Directors in June 2019. Dr. Countouriotis is the co-founder and Chief Executive Officer of Avenzo Therapeutics, a private biotechnology company focused on oncology. Previously she was the President and Chief Executive Officer and a board member of Turning Point Therapeutics from 2018 until it was acquired by Bristol-Myers Squibb in August 2022. Dr. Countouriotis has also served as the Chief Medical Officer for multiple public biotechnology companies, including Adverum Biotechnologies, Halozyme Therapeutics and Ambit Biosciences. Earlier in her career, Dr. Countouriotis led development of products for Pfizer and Bristol-Myers Squibb, including Sutent®, Mylotarg®, Bosulif® and Sprycel®. She also serves on the board of directors at BioMarin and Passage Bio, and privately held biotechnology companies Capstan Therapeutics, Leal Therapeutics and Recludix Therapeutics. Dr. Countouriotis holds an undergraduate degree from the University of California, Los Angeles and an M.D. from the Tufts University School of Medicine. She received training at the University of California, Los Angeles and at the Fred Hutchinson Cancer Research Center in the Pediatric Hematology-Oncology Program. Our Board of Directors believes that Dr. Countouriotis is highly qualified to serve as a member of the Board of Directors because of her medical and business background and education, her experience as an executive of several biotechnology companies, and her experience in drug development. Although Dr. Countouriotis is an executive officer of a privately held company and a board member of two other public companies, Dr. Countouriotis is able to devote the time necessary to our Board of Directors. We believe her experience makes her a valuable asset to the Board of Directors. Ryan Maynard. Mr. Maynard joined our Board of Directors in February 2015. Mr. Maynard served as Chief Financial Officer of Cara Therapeutics, Inc., a publicly traded commercial-stage biopharmaceutical company, through April 2025. Previously he served as the Chief Financial Officer of LetsGetChecked, from October 2019 to early 2022. Mr. Maynard was the Chief Financial Officer of Blade Therapeutics, Inc., a privately held biotechnology company, from February 2018 to June 2019. Until December 2017, he was the Executive Vice President and Chief Financial Officer of Rigel Pharmaceuticals, Inc., a public commercial-stage drug development company. He joined Rigel in September 2001 as Corporate Controller and was appointed as an Assistant Secretary in October 2001. In June 2006 he became Rigel’s Vice President of Finance and Acting Chief Financial Officer and became its Vice President and Chief Financial Officer in January 2007. Prior to joining Rigel, Mr. Maynard was Corporate Controller and Director of Finance and Accounting for Personify, Inc., an e-commerce software company, from November 1999 to April 2001. From July 1998 to October 1999, he served as Controller of General Magic, Inc. and from July 1994 to June 1998 he held various positions at Siliconix, Inc., most recently as Senior Finance Manager. He previously worked at Ernst & Young LLP. Mr. Maynard holds a B.S. in Commerce - Accounting from Santa Clara University. Our Board of Directors believes that Mr. Maynard is highly qualified to serve as a member of the Board of Directors because of his extensive experience as the Chief Financial Officer of publicly traded and commercial stage biopharmaceutical companies, as well as his expertise in auditing and financial and other related matters pertaining to the operation of publicly traded pharmaceutical companies. Wayne P. Rothbaum. Mr. Rothbaum joined our Board of Directors in June 2016. Mr. Rothbaum is president of Quogue Capital, a single-family office private equity fund focused on investing and supporting small to midcap life sciences companies. Mr. Rothbaum began his career at The Carson Group, a strategic consulting firm, where he managed its life sciences practice and boutique investment bank Evolution Capital. Following The Carson Group’s sale to Thomson Reuters in 2001, Mr. Rothbaum founded Quogue Capital, through which he has founded and/or invested in numerous private and public life sciences companies. In 2012, Mr. Rothbaum co-founded and was the Executive Chairman of Acerta Pharma, a private life sciences company he later sold to AstraZeneca. Acerta’s lead drug, Calquence® (acalabrutinib) was approved by the FDA for mantle cell lymphoma in 2017 and chronic lymphocytic leukemia in 2020. In 2016, Mr. Rothbaum also co-founded Kartos Therapeutics following the in-license of an investigational MDM2 inhibitor from Amgen. More recently, in 2019, he co-founded Telios Pharma after licensing a novel targeted therapy from Merck KGaA to treat selected blood cancers and ophthalmology diseases. Additionally, Mr. Rothbaum has taken a leadership role in transforming the Company, restructuring and reorganizing our Board of Directors, senior management and overall clinical operations and strategy. Currently, Mr. Rothbaum is a board member and our largest shareholder. Mr. Rothbaum graduated Phi Beta Kappa from Binghamton University in 1990 with a dual major in political science and psychology and received his MA in international economics from The George Washington University. He is listed as an inventor on many scientific patents and is published in numerous medical journals, including The New England Journal of Medicine, The Lancet and the Journal of Clinical Oncology.

  7. BOARD OF DIRECTORS AND CORPORATE GOVERNANCE

    Our Board of Directors believes that Mr. Rothbaum is highly qualified to serve as a member of the Board of Directors on the basis of his business background and education, his investment experience as the manager of an investment fund focused on the life sciences industry, and his experience serving in a leadership and management capacity with other biotechnology companies. Frederick G. Vogt, Ph.D., J.D. Dr. Vogt became our Interim Chief Executive Officer and President on June 10, 2021, and became our General Counsel on July 1, 2017. He originally joined the Company in September 2016, and has 25 years of experience in the pharmaceutical and biopharmaceutical industries. Over more than eight years with the Company, Dr. Vogt has led our construction of the Iovance Cell Therapy Center (the “iCTC”), acquisition of Proleukin®, and approval and launch of Amtagvi®, among other major accomplishments. Prior to joining Iovance, Dr. Vogt practiced law at the international firm of Morgan, Lewis & Bockius LLP, focusing on intellectual property and business law in the life sciences and representing clients in patent strategy, transactional, and litigation matters. Previously he served in numerous scientific, management, and legal roles of increasing responsibility over a period of 13 years at GlaxoSmithKline, where he focused primarily on oncology and cardiovascular drug development. While at GSK, Dr. Vogt made contributions to the development and approval of Hycamtin®️, Votrient®️, Tafinlar®️, and Mekinist®️. Dr. Vogt holds a B.S. in Chemistry from Ursinus College, a Ph.D. in Chemistry from the Pennsylvania State University, and a J.D. from Temple University. He has authored or co-authored more than 70 research papers and book chapters and is a co-inventor of numerous patent applications in the drug development and life sciences fields. He is admitted to practice in Pennsylvania and before the U.S. Patent and Trademark Office, the U.S. District Court for the Eastern District of Pennsylvania, and the U.S. Court of Appeals for the Federal Circuit. Our Board of Directors believes that Dr. Vogt is highly qualified to serve as a member of the Board of Directors because of his medical, legal, investment, and business background and education and extensive experience in the pharmaceutical industry, including his service and track record of success in senior management roles at the Company. We believe his experience makes him a valuable asset to the Board of Directors. Michael Weiser, M.D., Ph.D. Dr. Weiser joined our Board of Directors in March 2018. He is the founder and has been a principal of Actin Biomed LLC since 2006. Actin Biomed is a healthcare investment firm focused on the discovery and development of novel treatments for unmet medical needs. Prior to joining Actin Biomed, Dr. Weiser was the Director of Research at Paramount BioCapital, Inc., a pharmaceutical development and healthcare investment firm. Dr. Weiser previously served as the chairman of the board of directors of Chelsea Therapeutics International, Ltd., a development stage pharmaceutical company that was acquired by H. Lundbeck A/S in 2014, served on the board of directors of Ziopharm Oncology, Inc., a publicly traded biopharmaceutical company focused on immunotherapies in oncology and served on the board of directors of Emisphere Technologies, Inc., a pharmaceutical and drug delivery company. Dr. Weiser holds a B.A. in Psychology from the University of Vermont, received his M.D. from New York University School of Medicine and completed his Ph.D. in Molecular Neurobiology at Cornell University Medical College. Our Board of Directors believes that Dr. Weiser is highly qualified to serve as a member of the Board of Directors because of his medical and business background and education, his experience serving on boards of directors, and his investment experience as the manager of an investment fund focused on biotechnology companies. Wendy Yarno. Ms. Yarno joined our Board of Directors in June 2023. Ms. Yarno retired in September 2008 from Merck & Co., Inc., following a 26-year career there in commercial and human resource positions of increasing seniority, most recently Executive Vice President and Chief Marketing Officer before she retired. In that role, Ms. Yarno led an organization charged with global commercialization strategy and all aspects of supporting pre-and post-launch commercialization of pharmaceuticals in more than 20 therapeutic areas. Ms. Yarno currently serves on the board of directors of publicly traded life sciences companies Ideaya Bio, Inc., Tarsus Pharmaceuticals, Inc., and Inovio Pharmaceuticals, Inc. She formerly served on the boards of St. Jude Medical, Inc., MyoKardia, Inc., Medivation, Inc., Global Blood Therapeutics, Inc., Aratana Therapeutics, Inc., Alder Biopharmaceuticals, Inc. and Durata Therapeutics, Inc., prior to their acquisitions. Ms. Yarno received a B.S. in Business Administration from Portland State University and an M.B.A. from Temple University. Our Board of Directors believes that Ms. Yarno is highly qualified to serve as a member of the Board of Directors because of her extensive experience in the pharmaceutical industry, including her service in senior management roles and her experience serving on boards of directors. Although Ms. Yarno is a board member of three other public companies, Ms. Yarno is able to devote the time necessary to our Board of Directors. We believe her experience makes her a valuable asset to the Board of Directors.

  8. Committees of the Board of Directors

    | ● | Review the compensation of non-employee directors and recommend to the Board of Directors, for its approval, the components and amounts of compensation for non-employee directors. |

  9. Director Compensation

    Director Compensation Our Board of Directors has adopted a non-employee director cash and equity compensation policy that is designed to provide a total compensation package that enables us to attract and retain, on a long-term basis, high caliber non-employee directors. The cash and equity compensation for non-employee directors under the policy for 2024 is set forth in the table below. Such compensation amounts do not exceed the 75th percentile of our peer group comparator data for the relevant role.

  10. Director Compensation

    | | | Annual | | | | | Cash | Annual | | | | Retainer | Equity | | | | ($)(1) | Compensation(2) | | Board of Directors membership | | $50,000 | $425,000 | | Chairman of the Board of Directors (Extra Retainer) | | $25,000 | $425,000 | | Audit Committee | Chair | $15,000 | | | | Member | $7,500 | | | Compensation Committee | Chair | $15,000 | | | | Member | $7,500 | | | Nominating and Corporate Governance Committee | Chair | $15,000 | | | | Member | $7,500 | |

  11. Director Compensation

    | (1) The annual cash retainers are payable in quarterly installments in arrears. |

  12. Director Compensation

    | (2) Represents Deferred RSUs (“DRSUs”) with the following features: |

  13. Director Compensation

    | ● | Grant date fair market value equal to the lesser of $425,000 or such other amount not to exceed the 75th percentile of annual equity award compensation paid by the then-applicable peer group, as approved by the Compensation Committee of our Board of Directors, to their non-employee directors, and the number of DRSUs is determined by dividing the dollar amount by the closing stock price on the date of grant rounded to not exceed $425,000 grant date fair value. |

  14. Director Compensation

    | ● | The DRSU vests on the earlier of one year from the date of grant or the day prior to the next annual shareholder meeting. |

  15. Director Compensation

    | ● | Receipt of shares underlying the DRSUs (and the related tax event) is automatically deferred until 90 days after a director ceases to serve on the Board of Directors except in the case of a change in control or certain other corporate events. |

  16. Director Compensation

    | ● | Directors appointed between annual meetings will be eligible for a grant of DRSUs with a value of $425,000 at initial election and will be eligible for the next annual grant. However, the Compensation Committee has discretion to alter this approach for directors joining the Board of Directors if there are fewer than three months until the annual meeting. |

  17. Director Compensation

    The 2018 Plan stipulates that the maximum number of equity awards in any single fiscal year that may be awarded to each of the non-employee directors for serving on the Board of Directors shall be an amount equal to the grant date fair value of $425,000, subject to certain items that do not qualify as equity awards for purposes of calculating the amount of equity awards granted to non-employee directors on an annual basis. In addition to the limits prescribed by the 2018 Plan, our non-employee director compensation policy also provides that until the date of our annual meeting held in 2027, cash retainers or the value of annual equity compensation will not exceed the 75th percentile of the cash retainers or value of annual equity award compensation, respectively, paid by the then-applicable peer group, as approved by the Compensation Committee of our Board of Directors, to their non-employee directors. The Compensation Committee will assess the Company’s peer group annually, based upon a review by its compensation consultant and on such factors as the Compensation Committee deems relevant after discussion with such consultant. Notwithstanding the foregoing, newly appointed non-employee directors may receive compensation in connection with their appointment to the Board having up to two times (2x) the value of the total annual cash retainers and equity compensation provided to any incumbent non-employee director, and directors may receive additional fees or retainers for chair and committee service. Further, no more than 60% of each non-employee director’s annual and initial equity award value will be granted in the form of stock options. In 2024, 100% of equity compensation for our non-employee Directors was paid in the form of DRSUs, as described above. At its February 26, 2024 meeting, the Compensation Committee, acting with the authority of the Board of Directors upon the designation of the same, approved changes to items that do not qualify as equity awards for purposes of calculating the amount of equity awards granted to non-employee directors on an annual basis. The Compensation Committee also approved a special equity award of DRSUs to all members of the Board of Directors in recognition of the exceptional time commitment required to achieve the Company’s first-ever Biologics License Application (“BLA”) approval by the FDA for Amtagvi® (lifileucel), which was the first tumor infiltrating lymphocyte (“TIL”) therapy and first solid tumor T-cell therapy ever approved, and in recognition of the significant value delivered by their efforts to obtain BLA approval to stockholders. The special equity award consisted of 50,000 DRSUs per director (with a pro rata adjustment for Ms. Yarno as a new director), plus an additional special equity award of 50,000 DRSUs for the Company’s Scientific Committee, which is comprised of Mr. Rothbaum and Dr. Weiser, and an additional special equity award for the Chairman of the Board of Directors of 50,000 DRSUs. As a result of such special equity award, each of Dr. Dukes, Mr. Rothbaum, and Dr. Weiser were granted an additional 100,000 DRSUs, each of Dr. Countouriotis, Mr. Maynard, and General McPeak were granted an additional 50,000 DRSUs, and Ms. Yarno was granted an additional 25,000 DRSUs. Per both the 2018 Plan and our non-employee director compensation policy, such special equity awards granted in recognition of an extraordinary achievement by the Company do not count towards the limits on equity awards set forth in the 2018 Plan and our non-employee director compensation policy. Additionally, the table below shows the compensation received by each of our non-employee directors during 2024 for serving on the Board of Directors and on its committees.

  18. Director Compensation Table

    Director Compensation Table

  19. Director Compensation Table

    | | Fees Earned | Deferred | | | | or Paid in | Restricted Stock Unit | Total | | Name | Cash ($) | Awards ($)(1) | ($) | | Athena Countouriotis, M.D. | $65,000 | $1,264,492 | $1,329,492 | | Iain Dukes, D. Phil. | $90,000 | $2,528,992 | $2,618,992 | | Ryan Maynard | $65,000 | $1,264,492 | $1,329,492 | | Merrill A. McPeak (4) | $32,556 | $839,500 | $872,056 | | Wayne Rothbaum(2)(3) | $240,000 | $1,679,000 | $1,919,000 | | Frederick G. Vogt, Ph.D., J.D.(5) | $— | $— | $— | | Michael Weiser, M.D., Ph.D.(2) | $320,000 | $2,103,992 | $2,423,992 | | Wendy Yarno | $57,500 | $844,742 | $902,242 |

  20. Director Compensation Table

    | (1) Represents the grant date value of DRSUs awarded computed in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718, “Compensation — Stock Compensation,” disregarding the estimate of forfeitures. The Company’s methodology is set forth in Note 2 and Note 10 to its audited financial statements included in its Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2024. These amounts do not reflect the actual economic value that will be realized by the directors upon the vesting of the DRSUs or the sale of the common stock underlying such DRSUs. As of December 31, 2024, the aggregate number of shares of our common stock subject to outstanding equity awards for each non-employee director serving during 2024 was as follows: |

  21. Director Compensation Table

    | | Deferred Restricted Stock | | | Unit Awards | | Name | (#) | | Athena Countouriotis, M.D. | 202,462 | | Iain Dukes, D. Phil. | 404,927 | | Ryan Maynard | 202,462 | | Merrill A. McPeak | 153,159 | | Wayne Rothbaum | 100,000 | | Frederick G. Vogt, Ph.D., J.D. | — | | Michael Weiser, M.D., Ph.D. | 252,462 | | Wendy Yarno | 162,114 |

  22. Director Compensation Table

    | (2) The Scientific Committee remained active throughout the year ended December 31, 2024. Given the extensive time required for the Scientific Committee activities, each director serving on the Scientific Committee will be paid $20,000 per month while this committee is active and until such time as the Board of Directors decides to disband this committee. |

  23. Director Compensation Table

    | (3) Mr. Rothbaum declined to receive any compensation, whether cash or equity awards, other than for the Scientific Committee and RSUs awarded in connection with the approval of Amtagvi® on February 16, 2024. |

  24. Director Compensation Table

    | (4) General McPeak did not stand for re-election at our 2024 Annual Meeting of Stockholders. As a result, General McPeak did not receive a grant of DRSUs provided to other directors, and his cash compensation was prorated accordingly. |

  25. Director Compensation Table

    | (5) Dr. Vogt did not receive any compensation, whether cash or equity awards, for his service on our Board of Directors because he is an employee of the Company. |

  26. Compensation Committee

    | ● | Developing annual performance objectives in conjunction with the Board of Directors and the Compensation Committee; |

  27. Compensation Committee

    | ● | Monitoring annual performance versus goals and updating the Compensation Committee of progress at least quarterly; and |

  28. Compensation Committee

    | ● | Reviewing the performance of his direct report and making recommendations to the Compensation Committee for annual and long-term incentive awards and base salary adjustments (excluding his own compensation). |

  29. Compensation Committee

    | ● | Assisting in the development of the 2024 and 2025 peer group; |

  30. Compensation Committee

    | ● | Conducting a non-employee director compensation competitive assessment and advising the Compensation Committee regarding the components and levels; and |

  31. Compensation Determination Process

    | ● | a proposed year-end cash bonus, if any, (i) payable under the terms of each named executive officer’s employment agreement or (ii) under our discretionary cash bonus program, in each case based on the achievement of individual and/or corporate objectives and the applicable terms of the employment agreements; |

  32. Compensation Determination Process

    | ● | an award, if any, of stock options or stock awards for the year under review, including applicable vesting conditions. |

  33. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    Peer and Industry Data and Use of Peer Groups and Industry Surveys The Compensation Committee approves a peer group of companies as a reference group to provide a broad perspective on competitive pay levels and practices. In determining our peer companies, the Compensation Committee considers Company-specific factors, including growth, state of development of our clinical programs, growth in our headcount, changes in our market capitalization and for the 2024-2025 peer group, projected 2025 revenue. With reference to these and other key business metrics, the Compensation Committee selects publicly traded U.S. pharmaceutical and biotechnology companies with comparable operations in the U.S. based on the following criteria:

  34. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Number, stage and indication of development programs — Later-stage companies with a mix of Phase 2 to Phase 3 programs with focus on companies with pivotal trials underway; focused on oncology companies but covers a range of fully integrated, R&D intensive therapeutic targets. For both the 2023-2024 and 2024-2025 peer groups, newly commercial biopharmaceutical companies were also considered. For the 2024-2025 peer group, established commercial biopharmaceutical companies were also considered. |

  35. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Total research and development spending — 2023-2024 and 2024-2025: Range of $250 million to $350 million. |

  36. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Number of employees — 2023-2024: Range of 200 to 1,000 employees; 2024-2025: Range of 500 to 1,500 employees. |

  37. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Location — Primary biotech corridors that have strong competition for talent with focus on California companies. |

  38. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Market capitalization — 2023-2024: Range of $500 million to $2 billion; 2024-2025: Range of $2 billion to $7.5 billion. |

  39. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | ● | Revenue — 2023-2024: Less than $100 million; 2024-2025: Current or projected revenue of $200 million to $1 billion. |

  40. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    2023-2024 Peer Group The Compensation Committee approved the peer group for benchmarking 2023 compensation and setting compensation for 2024 based on its discussions with Haigh and considering changes in the Company’s profile. Using these criteria referenced above, the Compensation Committee identified the following 17 peer companies:

  41. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | 2Seventy Bio, Inc.(2) | Deciphera Pharmaceuticals, Inc.(2) | | Agios Pharmaceuticals, Inc. | Denali Therapeutics Inc. | | Allogene Therapeutics, Inc.(2) | Mirati Therapeutics, Inc.(2) | | Arcus Biosciences, Inc. | ImmunoGen, Inc.(1) (2) | | Beam Therapeutics Inc.(1) | Replimune Group, Inc.(1) | | Blueprint Medicines Corp. | Revolution Medicines, Inc.(1) | | BridgeBio Pharma, Inc. | Sage Therapeutics, Inc.(2) | | Crinetics Pharmaceuticals, Inc.(1) | Xencor, Inc. | | Cytokinetics, Inc. | |

  42. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | (1) New for 2023-2024. |

  43. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | (2) Removed for consideration for 2025. |

  44. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    2024-2025 Peer Group On November 22, 2024, the Compensation Committee approved the peer group for determining the competitiveness of 2024 compensation and setting compensation for 2025 based on its discussions with Haigh and considering changes in the Company’s profile. Six companies were removed and replaced from the peer group as a result of merger and acquisition activity or no longer fitting the peer group criteria described above. Using the criteria identified above, the Compensation Committee identified the following 16 peer companies:

  45. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | Agios Pharmaceuticals, Inc. | Cytokinetics, Inc. | | Apellis Pharmaceuticals, Inc. (1) | Denali Therapeutics Inc. | | Arcus Biosciences, Inc. | Immunity Bio, Inc. (1) | | Beam Therapeutics Inc. | Ionis Pharmaceuticals, Inc. (1) | | Blueprint Medicines Corp. | Replimune Group, Inc. | | BridgeBio Pharma, Inc. | Revolution Medicines, Inc. | | Crinetics Pharmaceuticals, Inc. | Ultragenyx Pharmaceutical Inc.(1) | | Crispr Therapeutics AG(1) | Xencor, Inc. |

  46. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    | (1) New for 2024-2025. |

  47. Peer and Industry Data and Use of Peer Groups and Industry Surveys

    In addition to the compensation data of our peer group, our Compensation Committee and Haigh review industry specific, broad-based compensation surveys. In 2024 and 2025, as in previous years, the Aon/Radford Global Life Science survey was used to supplement the peer company market data.

  48. Benchmarking in the Context of Our Other Executive Compensation Principles

    Benchmarking in the Context of Our Other Executive Compensation Principles Our Compensation Committee and our Board of Directors use market data as one means of evaluating and establishing executive pay. In instances where an executive officer is believed to be especially suited to our Company or important to our success, the Compensation Committee may establish or recommend compensation that deviates from industry averages or other specific benchmarks. Upward or downward variations in total cash compensation and long-term incentives may also occur as a result of the individual’s experience level, the nature and level of the individual’s specific job responsibilities, the balance of the individual’s different elements of compensation, market factors and other strategic considerations. Our Compensation Committee believes that, given the competitiveness of our industry and our corporate culture, our base compensation, annual cash bonuses and equity programs are flexible enough to reward the achievement of clearly defined corporate goals and are sufficient to retain our existing executive officers and to hire new executive officers with the appropriate qualifications and experience.

  49. 2024 Named Executive Officer Compensation

    2024 Named Executive Officer Compensation Base Salary On February 26, 2024, after reviewing the competitive position versus our peer companies and performance of the Named Executive Officers in 2023, our Compensation Committee approved (retroactively to January 1, 2024) a 5.5% salary increase for Dr. Vogt, resulting in a 2024 base salary of $730,060 (which was also in consideration of Dr. Vogt’s continued service as the Interim Chief Executive Officer), a 4.5% salary increase for Dr. Graf Finckenstein, resulting in a 2024 base salary of $612,109, a 4.5% salary increase for Mr. Bellemin, resulting in a 2024 base salary of $551,238 and a 4.5% salary increase for Dr. Bilinsky, resulting in a 2024 base salary of $551,238. Dr. Puri, who became a Named Executive Officer in 2024 following his promotion to Chief Regulatory Officer, had a 2024 ending base salary of $643,000. Equity Awards On February 26, 2024, the Compensation Committee also approved the following restricted stock unit grants, which include a special equity award of restricted stock unit grants for recognition of the achievement of the Company’s first-ever BLA approval and the first TIL therapy and solid tumor T-cell therapy ever approved. Although these awards are granted in part based on 2023 performance, the grant date values of these stock awards are being disclosed in our 2024 executive compensation tables in this proxy statement pursuant to applicable SEC rules:

  50. 2024 Named Executive Officer Compensation

    | | | Number of | | Grant Date | | | | Securities | Base Price of | Fair Value of | | | | Underlying | Stock Awards | Stock Awards | | Name | Grant Date | Stock Awards(1) | ($/Share) | ($)(2) | | Frederick G. Vogt, Ph.D., J.D. | | | | | | Annual Equity Award | 3/1/2024 | 500,000(3) | $16.79 | $8,395,000 | | Special BLA Equity Award | 3/1/2024 | 93,750(4) | $16.79 | $1,574,063 | | Friedrich Graf Finckenstein, M.D. | | | | | | Annual Equity Award | 3/1/2024 | 105,470(3) | $16.79 | $1,770,841 | | Special BLA Equity Award | 3/1/2024 | 46,875(4) | $16.79 | $787,031 | | Jean-Marc Bellemin | | | | | | Annual Equity Award | 3/1/2024 | 105,470(3) | $16.79 | $1,770,841 | | Special BLA Equity Award | 3/1/2024 | 46,875(4) | $16.79 | $787,031 | | Igor Bilinsky, Ph.D. | | | | | | Annual Equity Award | 3/1/2024 | 105,470(3) | $16.79 | $1,770,841 | | Special BLA Equity Award | 3/1/2024 | 46,875(4) | $16.79 | $787,031 | | Raj K. Puri, M.D., Ph.D. | | | | | | Annual Equity Award | 3/1/2024 | 66,630(3) | $16.79 | $1,118,718 | | Special BLA Equity Award | 3/1/2024 | 76,250(4) | $16.79 | $1,280,238 |

  51. 2024 Named Executive Officer Compensation

    | (1) Represents shares of our common stock underlying restricted stock units awarded. |

  52. 2024 Named Executive Officer Compensation

    | (2) Represents the fair value of stock awards on the date of grant, as computed in accordance with FASB ASC 718, “Compensation — Stock Compensation,” disregarding the estimate of forfeitures. The Company’s methodology, including its underlying estimates and assumptions used in calculating these values, is set forth in Note 2 and Note 10 to its audited financial statements included in its Form 10-K filed with the SEC for the year ended December 31, 2024. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the equity awards, or the sale of the common stock underlying such equity awards. |

  53. 2024 Named Executive Officer Compensation

    | (3) The Annual Equity Awards vest over three years, with one third vesting on the first anniversary of the grant date and the remaining awards vesting in equal quarterly installments over the two-year period following such first anniversary. |

  54. 2024 Named Executive Officer Compensation

    | (4) The Special BLA Equity Awards vest over one year, with half of the restricted stock unit awards vesting on the 6-month anniversary of the grant date, and the remaining restricted stock unit awards vesting on the first anniversary of the grant date. |

  55. 2024 Named Executive Officer Compensation

    Annual Incentive Awards Our annual bonus program is an important component of our executive and employee compensation program as awards are tied directly to the achievement of our annual performance objectives. Target annual incentives are stated as a percent of base salary and are intended to provide a competitive annual target total cash opportunity consistent with our performance versus our annual objectives. The corporate goals and objectives for fiscal year 2024 were based on meeting certain goals with respect to the Company’s commercial, regulatory, clinical, manufacturing, and operational performance as follows: (i) achieving revenue targets for full year 2024; (ii) completing certain international regulatory activities; (iii) completing late-stage clinical development milestones; (iv) completing early-stage clinical development milestones; (v) managing the Company’s budget within targeted range, (vi) continuing the successful commercialization of Amtagvi®, and (vii) manufacturing lifileucel to meet patient demand. We have not disclosed the specific performance metrics for our annual bonus program because such metrics contain confidential trade secrets and/or confidential commercial or financial information, the disclosure of which would result in competitive harm. At the time the Compensation Committee set the performance metrics for our annual bonus program, the Compensation Committee believed that each performance metric was achievable at the target level, but only with significant effort. At its March 5, 2025 meeting, the Compensation Committee, in consultation with the Board of Directors, reviewed the Company’s performance against its 2024 corporate goals and objectives, and determined that the Company met 50% of its 2024 corporate goals for employees with a title of, or equivalent to, Vice President and above (including Section 16 officers). For employees with a title below the Vice President level, the Compensation Committee, in consultation with the Board of Directors, reviewed the Company’s performance against its 2024 corporate goals and objectives, and determined that the Company met 75% of its 2024 corporate goals. While not all of the stated 2024 corporate goals were achieved, the Compensation Committee has taken into account the notable performance and efforts of employees below the Vice President level despite the significant impact of factors outside of the control of the Company to determine the 75% payout. Additionally, our NEOs were eligible for adjustments based on their individual performance ratings for fiscal year 2024. Adjustments were determined and approved by the Compensation Committee for Dr. Vogt and by Dr. Vogt and the Compensation Committee for the other NEOs. Based on these assessments, the Compensation Committee approved the payment of the following cash bonuses for 2024 performance:

  56. 2024 Named Executive Officer Compensation

    | | | | | 2024 Bonus | Individual | Individual | | 2024 Actual | | | | Annual | Annual | Award - | Performance | Performance | Total 2024 | Bonus Payment | | | 2024 Base | Bonus Target | Bonus Target | Company | Rating | Rating | Annual | as % of | | Name and Principal Position | Salary | % | $ | Performance | Adjustment ($) | Adjustment (%) | Bonus | Target Award | | Frederick G. Vogt, Ph.D., J.D., | | | | | | | | | | Interim Chief Executive Officer and President, General Counsel | $730,060 | 65% | $474,539 | $237,270 | $- | —% | $237,270 | 50% | | Friedrich Graf Finckenstein, M.D., | | | | | | | | | | Chief Medical Officer | $612,109 | 45% | $275,449 | $137,725 | $- | —% | $137,725 | 50% | | Jean-Marc Bellemin, | | | | | | | | | | Chief Financial Officer | $551,238 | 45% | $248,057 | $124,029 | $- | —% | $124,029 | 50% | | Igor Bilinsky, Ph.D., | | | | | | | | | | Chief Operating Officer | $551,238 | 45% | $248,057 | $124,029 | $- | —% | $124,029 | 50% | | Raj K. Puri, M.D., Ph.D. | | | | | | | | | | Chief Regulatory Officer(1) | $643,000 | 45% | $251,962 | $125,846 | $50,338 | 140% | $176,184 | 70% |

  57. 2024 Named Executive Officer Compensation

    | (1) Effective November 22, 2024, Dr. Puri became an NEO, and received an annual individual performance rating adjustment of 140%, for which his annual bonus was prorated for the time he served as an NEO in 2024. Base salary and target bonus were prorated based on time in each position during the fiscal year. |

  58. Other Compensation Elements

    Other Compensation Elements Retirement Plans Our named executive officers are eligible to participate in the employee benefit plans on the same terms and conditions as they are available to our other regular employees. These benefits include medical, dental, vision, disability and life insurance, flexible spending accounts, health savings accounts, employee stock purchase plan, and a 401(k) plan. Under the tax-qualified employee savings and retirement plan, our 401(k) plan, all eligible U.S. employees, including our named executive officers, may elect to defer a percentage of their eligible compensation in our 401(k) plan, subject to the annual IRS limit. In 2024, we matched 100% of the employee contributions up to 4% of annual eligible compensation. The 2024 matching contributions made under the Safe Harbor Matching Contribution are fully vested. No Perquisites and No Tax Gross-Ups We do not provide perquisites or other personal benefits to our named executive officers other than those that we provide to our employees. We do not provide any tax reimbursement payments (including “gross- ups”) on any personal benefits, except in the case of certain relocation benefits and discretionary non-recurring spot-bonuses to non-executive employees. Discretionary and Sign-On Cash Bonuses From time to time, we may pay cash bonuses to employees upon the successful completion of certain projects. We may also pay sign-on bonuses to aid in recruiting or relocating certain key employees. Employment Agreements and Termination Benefits We have entered into written employment agreements with each of our current and former named executive officers. The main purpose of these agreements is to protect our Company from business risks such as competition for each named executive officer’s service, loss of confidential information or trade secrets, solicitation of our other employees, and to define our respective rights to terminate the employment relationship. Each of these employment agreements can be terminated by either party at any time. Each employment agreement was individually negotiated, so there are some variations in the terms among named executive officers. Generally speaking, however, the employment agreements provide for termination and severance benefits that the Compensation Committee believes are consistent with industry practices for similarly situated executives. The Compensation Committee believes that the termination and severance benefits help the Company retain the named executive officers by providing them with a competitive employment arrangement and compensation for termination of their employment by us without “cause,” or by the named executive officers with “good reason.” The specific terms of the termination and change of control arrangements, as well as an estimate of the compensation that would have been payable had such provisions been triggered as of the end of 2024, are described in detail in the section below entitled “Potential Payments Upon Termination or Change-in-Control.” Responsible Grant Practices We typically grant equity awards upon an employee’s hire. In addition, equity awards may also be granted annually soon after the end of our fiscal year. Stock options or restricted stock unit awards granted by the Company generally vest over three years and stock options have a ten-year contractual term. Unless otherwise agreed to by us with respect to a termination without “cause” or for “good reason,” vesting rights generally cease upon termination of employment and employees have three months in which to exercise vested options, except in the case of death, disability or retirement (subject to a one-year limitation). We grant stock options at an exercise price and restricted stock units with a grant price equal to the closing price on The Nasdaq Global Market of our common stock on the date of the grant. Our Board of Directors has delegated to our Chief Executive Officer the ability to grant equity awards to non-executive employees upon joining our Company, and to make grants during each annual non-executive employee review cycle. Our Board of Directors has reviewed and approved both the total number of shares that our Chief Executive Officer can grant under such equity awards, and the range of shares subject to such grants based on each employee’s position and organization level with the Company. Policies and Practices Related to the Grant of Certain Equity Awards It is our policy that our Board of Directors, our Compensation Committee and our Chief Executive Officer do take material non-public information into account when determining the timing of equity awards. However, we do not time the disclosure of material non-public information for the purpose of impacting the value of executive compensation. During 2024, we did not grant stock options (or similar awards) to any NEO during any period beginning four business days before and ending one business day after the filing or furnishing of any Company periodic report on Form 10-Q or Form 10-K, or the filing or furnishing of any Company Form 8-K that disclosed material non-public information (the “Restricted Period”). We have a program, practice or plan whereby our annual grants for existing employees are consistently made at least two business days after the filing of our Annual Report on Form 10-K. For new employees, we either time the grants to be on the same day of each month to ensure that such grants are not made in connection with the release of material non-public information, or otherwise we do not grant stock options (or similar awards) during the Restricted Period.

  59. 2025 Named Executive Officer Compensation

    | (1) Represents shares of our common stock underlying restricted stock units awarded. |

  60. 2025 Named Executive Officer Compensation

    | (2) Represents the fair value of each equity award on the date of grant, as computed in accordance with FASB ASC 718, “Compensation — Stock Compensation,” disregarding the estimate of forfeitures. The Company’s methodology, including its underlying estimates and assumptions used in calculating these values, is set forth in Note 2 and Note 10 to its audited financial statements included in its Form 10-K filed with the SEC for the year ended December 31, 2024. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the equity awards, or the sale of the common stock underlying such equity awards. |

  61. 2025 Named Executive Officer Compensation

    | (3) The equity awards vest over three years, with one third vesting on the first anniversary of the grant date and the remaining awards vesting in equal quarterly installments over the two-year period following such first anniversary. |

  62. Other Executive Compensation Considerations

    Other Executive Compensation Considerations Stock Ownership Guidelines Although equity awards encourage equity ownership, we do not require our directors or executive officers to own a particular number of shares of our common stock. We believe that stock and option holdings among our directors and named executive officers are adequate at this time to appropriately align their interests with those of our stockholders. Deductibility of Executive Compensation Section 162(m) of the Internal Revenue Code generally sets a limit of $1 million on the amount of compensation that we may deduct for federal income tax purposes in any given year with respect to the compensation of certain executives, including each of our named executive officers. Historically, compensation that qualified as “performance-based compensation” under Section 162(m) of the Code could be excluded from this $1 million limit. This exception was repealed with the Tax Cuts and Jobs Act of 2017, effective for taxable years beginning after 2017, subject to an exception for certain grandfathered amounts, to the extent applicable. While the Compensation Committee may consider the deductibility of compensation as a factor in determining executive compensation, the Compensation Committee retains the discretion to award and pay compensation that is not deductible as it believes that it is in the best interests of our stockholders to maintain flexibility in our approach to executive compensation and to structure a program that we consider to be the most effective in attracting, motivating and retaining key executives, without regard to the deductibility of compensation under it. Accounting for Share-Based Compensation We account for share-based compensation in accordance with the requirements of FASB ASC Topic 718, “Compensation — Stock Compensation.” This accounting treatment has not significantly affected our executive compensation decisions. Section 409A of the Code Section 409A of the Code requires that “nonqualified deferred compensation” be deferred and paid under plans or arrangements that satisfy the requirements of the statute with respect to the timing of deferral elections, timing of payments and certain other matters. Failure to satisfy these requirements can expose employees and other service providers to accelerated income tax liabilities, penalty taxes and interest on their vested compensation under such plans. Accordingly, as a general matter, it is our intention to design and administer our compensation and benefits plans and arrangements for all of our employees and other service providers, including our named executive officers, so that they are either exempt from, or satisfy the requirements of, Section 409A of the Code. Section 280G of the Code Section 280G of the Code disallows a tax deduction with respect to excess parachute payments to certain executives of companies that undergo a change in control. In addition, Section 4999 of the Code imposes a 20% penalty on the individual receiving the excess payment. Parachute payments are compensation that is linked to or triggered by a change in control and may include, but are not limited to, bonus payments, severance payments, certain fringe benefits, and payments and acceleration of vesting from long-term incentive plans, including stock options and other equity-based compensation. Excess parachute payments are parachute payments that exceed a threshold determined under Section 280G of the Code based on the executive’s prior compensation. In approving the compensation arrangements for our named executive officers in the future, the Compensation Committee will consider all elements of the cost to the Company of providing such compensation, including the potential impact of Section 280G of the Code. However, the Compensation Committee may, in its judgment, authorize compensation arrangements that could give rise to loss of deductibility under Section 280G of the Code and the imposition of excise taxes under Section 4999 of the Code when it believes that such arrangements are appropriate to attract and retain executive talent. Clawback Policy We are subject to the clawback provisions of Section 304 of the Sarbanes-Oxley Act and Section 954 of the Dodd-Frank Wall Street Reform and Consumer Protection Act and any rules or regulations promulgated thereunder. In addition, our 2018 Equity Incentive Plan contains a “clawback” provision whereby, to the extent required by applicable law and/or the rules and regulations of Nasdaq or any other securities exchange or inter-dealer quotation service on which our common stock is listed or quoted, awards issued under the 2018 Equity Incentive Plan shall be subject (including on a retroactive basis) to clawback, forfeiture or similar requirements, in the event our Company’s historical financial results are subsequently revised or restated. On November 17, 2023, we approved and adopted a policy related to the recovery of erroneously awarded incentive-based compensation received by certain executive officers of the Company on or after October 2, 2023 (the “Clawback Policy”). We enacted the Clawback Policy in order to comply with a recently enacted Nasdaq listing standard regarding the implementation of Exchange Act Rule 10D-1, which requires public companies to implement “clawback” policies providing for the recovery of incentive-based compensation in the event such company is required to prepare an accounting restatement due to the material noncompliance of such company with any financial reporting requirement under federal securities laws, including any required accounting restatement to correct an error in previously issued financial statements that is material to the previously issued financial statements, or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period. Insider Trading Policy We have adopted an insider trading policy (the “Insider Trading Policy”), which governs the purchase, sale, and/or other dispositions of our securities by our directors, officers, and employees, their immediate family members and entities owned or controlled by them as well as consultants that have access to material nonpublic information. The Insider Trading Policy is designed to promote compliance with insider trading laws, rules, and regulations as well as the listing standards of Nasdaq applicable to us. The Insider Trading Policy was filed as Exhibit 19.1 to our Annual Report on Form 10-K filed with the SEC on February 27, 2025. The Insider Trading Policy expressly prohibits each director, Section 16 officer, and any additional specified persons designated as being subject to the Insider Trading Policy from (i) selling any Company securities of the same class as a previous purchase by such party of the Company’s securities for at least six months after the purchase; (ii) short-selling the Company’s securities; (iii) buying or selling puts or calls or other derivative securities on the Company’s securities; (iv) holding the Company’s securities in a margin account or pledging the Company’s securities as collateral for a loan; and (v) entering into hedging or monetization transactions or similar arrangements with respect to the Company’s securities. Our insider trading policy does not expressly apply to our Company because we ensure compliance with insider trading laws differently in the context of our own transactions in securities. Company compliance is considered at the level of our board of directors, with the advice of counsel and subject to implementation by our executive officers, in the context of our decisions to buy, sell, or otherwise transact in our securities. The foregoing policies remained in place through 2024, and, unless otherwise noted above, we expect to continue to follow them for the foreseeable future.

  63. GRANT OF PLAN-BASED AWARDS

    GRANT OF PLAN-BASED AWARDS The following table provides information regarding plan-based awards granted to our named executed officers in the fiscal year ended December 31, 2024:

  64. GRANT OF PLAN-BASED AWARDS

    | | | | All other | | | | | | | Stock | Exercise or Base | Grant Date | | | | | Awards: | Price of Option | Fair Value | | | | | Number of | and Stock | of Option | | | Grant | Target Bonus | Shares of | Awards | and Stock | | Name | Date | ($) | Stock Units (2) | ($/Share) | Awards | | Frederick G. Vogt, Ph.D., J.D. | | $474,539(1) | — | $— | $— | | Interim Chief Executive Officer and President, and General Counsel | 3/1/2024 | $— | 593,750 | $16.79 | $9,969,063(3) | | Friedrich Graf Finckenstein, M.D. | | $275,449(1) | — | $— | $— | | Chief Medical Officer | 3/1/2024 | $— | 152,345 | $16.79 | $2,557,873(3) | | Jean-Marc Bellemin | | $248,057(1) | — | $— | $— | | Chief Financial Officer | 3/1/2024 | $— | 152,345 | $16.79 | $2,557,873(3) | | Igor Bilinsky, Ph.D. | | $248,057(1) | — | $— | $— | | Chief Operating Officer | 3/1/2024 | $— | 152,345 | $16.79 | $2,557,873(3) | | Raj K. Puri, M.D., Ph.D. | | $251,962(1) | — | $— | $— | | Chief Regulatory Officer | 3/1/2024 | $— | 141,880 | $16.79 | $2,382,165(3) |

  65. GRANT OF PLAN-BASED AWARDS

    | (1) Represents annual target amount for 2024 performance-based cash bonuses based on the terms of each named executive officer’s employment agreement and such other determinations made by the Compensation Committee of our Board of Directors as more fully described above under “Executive Compensation — Compensation Discussion and Analysis — 2024 Named Executive Officer Compensation.” The bonuses do not contain a threshold or maximum bonus opportunity for our named executive officers and therefore the corresponding columns have been omitted from the table above |

  66. GRANT OF PLAN-BASED AWARDS

    | (2) The annual restricted stock unit awards vest as to one third of the shares underlying the equity awards on the first anniversary of the grant date, with remaining restricted stock unit awards vesting in equal quarterly installments over the two-year period following such first anniversary of the grant date. The Special BLA Equity Awards vest over one year, with half of the restricted stock unit awards vesting on the 6-month anniversary of the grant date, and the remaining restricted stock unit awards vesting on the first anniversary of the grant date. |

  67. GRANT OF PLAN-BASED AWARDS

    | (3) Represents the aggregate grant date fair value of restricted stock unit awards computed in accordance with FASB ASC Topic 718, “Compensation — Stock Compensation,” disregarding the estimate of forfeitures. The Company’s methodology, including its underlying estimates and assumptions used in calculating these values, is set forth in Note 2 and Note 10 to its audited financial statements included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on February 28, 2025. This amount does not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the stock options, or the sale of the common stock underlying such stock options. |

  68. Narrative Disclosure to Summary Compensation Table and Grants of Plan-Based Awards Table

    Narrative Disclosure to Summary Compensation Table and Grants of Plan-Based Awards Table The Company’s executive compensation policies and practices, pursuant to which the compensation set forth in the Summary Compensation Table and the Grants of Plan-Based Awards Table was paid or awarded, are described above under “Compensation Discussion and Analysis.”

  69. OUTSTANDING EQUITY AWARDS

    OUTSTANDING EQUITY AWARDS The following table sets forth outstanding stock options and restricted stock units held by our named executive officers as of December 31, 2024. Since 2021, options and restricted stock units were granted under the 2018 Plan and the 2021 plan, as amended.

  70. Outstanding Equity Awards at Year Ended December 31, 2024

    Outstanding Equity Awards at Year Ended December 31, 2024

  71. Outstanding Equity Awards at Year Ended December 31, 2024

    | | | Option Awards | | | | Stock Awards | | | | | Number of | Number of | | | Number | Market Value of | | | | Securities | Securities | | | of Shares | Shares or | | | | Underlying | Underlying | | | or Units | Units of | | | Grant Date and | Unexercised | Unexercised | | | of Stock | Stock That | | | Vesting | Options | Options | Option | Option | That Have | Have Not | | | Commencement | (#) | (#) | Exercise | Expiration | Not Vested | Vested | | | Date(1) | Exercisable | Unexercisable | Price ($) | Date(2) | (#) | ($)(3) | | Frederick G. Vogt, Ph.D., J.D., | 3/1/2024 | — | — | $— | — | 546,875 | $4,046,875 | | Interim Chief Executive Officer and President, General Counsel | 3/2/2023 | 291,656 | 208,344 | $7.12 | 3/2/2033 | 52,087 | $385,444 | | | 1/14/2022 | — | — | $— | — | 20,835 | $154,179 | | | 6/14/2021 | 173,900 | — | $23.87 | 6/14/2031 | — | $— | | | 1/4/2021 | 175,000 | — | $46.26 | 1/4/2031 | — | $— | | | 1/3/2020 | 150,000 | — | $25.54 | 1/3/2030 | — | $— | | | 3/4/2019 | 200,000 | — | $11.26 | 3/4/2029 | — | $— | | | 12/29/2017 | 37,400 | — | $8.00 | 12/29/2027 | — | $— | | | 3/16/2017 | 12,600 | — | $7.45 | 3/16/2027 | — | $— | | | 11/14/2016 | 200,000 | — | $7.55 | 11/14/2026 | — | $— | | Friedrich Graf Finckenstein, M.D., | 3/1/2024 | — | — | $— | — | 128,907 | $953,912 | | Chief Medical Officer | 3/2/2023 | 54,685 | 39,065 | $7.12 | 3/2/2033 | 19,533 | $144,544 | | | 1/14/2022 | 61,874 | 5,626 | $15.49 | 1/14/2032 | 2,813 | $20,816 | | | 1/4/2021 | 100,000 | — | $46.26 | 1/4/2031 | — | $— | | | 1/3/2020 | 75,000 | — | $25.54 | 1/3/2030 | — | $— | | | 7/18/2019 | 160,000 | — | $25.78 | 7/18/2029 | — | $— | | Jean-Marc Bellemin, | 3/1/2024 | — | — | $— | — | 128,907 | $953,912 | | Chief Financial Officer | 3/2/2023 | 98,433 | 70,317 | $7.12 | 3/2/2033 | — | $— | | | 1/14/2022 | 123,749 | 11,251 | $15.49 | 1/14/2032 | — | $— | | | 12/14/2020 | 150,000 | — | $50.26 | 12/14/2030 | — | $— | | Igor Bilinsky, Ph.D., | 3/1/2024 | — | — | $— | — | 128,907 | $953,912 | | Chief Operating Officer | 3/2/2023 | 49,219 | 35,161 | $7.12 | 3/2/2033 | 17,581 | $130,099 | | | 1/14/2022 | 61,874 | 5,626 | $15.49 | 1/14/2032 | 2,813 | $20,816 | | | 3/15/2021 | 150,000 | — | $34.91 | 3/15/2031 | — | $— | | Raj K. Puri, M.D., Ph.D. | 3/1/2024 | — | — | $— | — | 103,755 | $767,787 | | Chief Regulatory Officer | 3/2/2023 | 54,691 | 39,069 | $7.12 | 3/2/2033 | — | $— | | | 3/14/2022 | 297,915 | 27,085 | $12.38 | 3/14/2032 | 8,334 | $61,672 |

  72. Outstanding Equity Awards at Year Ended December 31, 2024

    | (1) Except as otherwise noted, the stock option and restricted stock unit awards vest as to one third of the shares underlying the equity awards on the first anniversary of the grant date, with remaining stock option and restricted stock unit awards vesting in equal quarterly installments over the two-year period following such first anniversary of the grant date. The Special BLA Equity Awards vest over one year, with half of the restricted stock unit awards vesting on the 6-month anniversary of the grant date, and the remaining restricted stock unit awards vesting on the first anniversary of the grant date. |

  73. Outstanding Equity Awards at Year Ended December 31, 2024

    | (2) All stock options have a ten-year term, measured from the date of grant, which is the latest date that the stock options may be exercised. Stock options may terminate earlier in certain circumstances, such as in connection with a named executive officer’s termination of employment or in connection with certain corporate transactions, including a change of control. |

  74. Outstanding Equity Awards at Year Ended December 31, 2024

    | (3) Represents the number of outstanding stock awards multiplied by the fair market value of the common stock at the close of trading on The Nasdaq Global Market on December 31, 2024 ($7.40). |

  75. OPTION EXERCISES AND RESTRICTED STOCK UNITS VESTED

    OPTION EXERCISES AND RESTRICTED STOCK UNITS VESTED The following table contains information for our named executive officers concerning the restricted stock units that vested during the year ended December 31, 2024. None of our named executive officers exercised stock options during the year ended December 31, 2024.

  76. OPTION EXERCISES AND RESTRICTED STOCK UNITS VESTED

    | | Stock Awards | | | | Number of | Value | | | Shares Acquired | Realized on | | Name | on Vesting | Vesting ($)(1) | | Frederick G. Vogt, Ph.D., J.D., Interim Chief Executive Officer and President, General Counsel | 203,125 | $2,316,371 | | Friedrich Graf Finckenstein, M.D., Chief Medical Officer | 62,031 | $738,659 | | Jean-Marc Bellemin, Chief Financial Officer | 23,438 | $254,302 | | Igor Bilinsky, Ph.D., Chief Operating Officer | 59,298 | $701,124 | | Raj K. Puri, M.D., Ph.D., Chief Regulatory Officer | 171,460 | $1,662,175 |

  77. OPTION EXERCISES AND RESTRICTED STOCK UNITS VESTED

    | (1) Represents the price of our common stock at the close of trading on The Nasdaq Global Market on the vesting date multiplied by the number of restricted stock units that vested on that date. |

  78. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL Each of our named executive officers have employment agreements with the Company. These employment agreements have no specified term, and the employment relationship may be terminated by the named executive officers or by us at any time. The following table sets forth information regarding payments that would have been made to our named executive officers if they suffered an involuntary termination without cause not in connection with a change in control, or a termination without cause in connection with a change in control, and such termination payments were triggered on December 31, 2024. There can be no assurance that a triggering event would produce the same or similar results as those estimated below if such event occurs on any other date or at any other price, or if any other assumption used to estimate potential payments and benefits is not correct. Due to the number of factors that affect the nature and amount of any potential payments or benefits, any actual payments and benefits may be different. The terms “cause,” “good reason,” “disability,” and “change in control” in this section have the meanings provided in the applicable employment agreement or equity award agreement. Equity acceleration is calculated based on the closing price of the Company common stock trading on The Nasdaq Global Market on December 31, 2024 ($7.40) (the last trading day of the year). The amounts listed below do not include any taxes due in connection with such payments, including any tax under Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”) that may be triggered by such payments. See the Employment Agreements section following the table for potential additional benefits that may be awarded to the named executive officers as well as additional conditions that may apply to such payments.

  79. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | | Change in | | Termination | | | Control | Termination | Due to | | | Acceleration | Without | Death | | | and Termination | Cause or for | or Disability | | | Without Cause ($) | Good Reason ($) | ($) | | Frederick G. Vogt, Ph.D., J.D. | | | | | Cash severance | 839,569(1) | 1,204,599(5) | 474,539(6) | | Equity acceleration | 9,933,961(2) | 9,933,961(2) | 9,933,961(7) | | Friedrich Graf Finckenstein, M.D. | | | | | Cash severance | 306,055(3) | 306,055(3) | — | | Equity acceleration | 2,357,935(4) | — | 2,357,935(7) | | Jean-Marc Bellemin | | | | | Cash severance | 275,619(3) | 275,619(3) | — | | Equity acceleration | 2,184,037(4) | — | 2,184,037(7) | | Igor Bilinsky, Ph.D. | | | | | Cash severance | 275,619(3) | 275,619(3) | — | | Equity acceleration | 2,342,944(4) | — | 2,342,944(7) | | Raj K. Puri, M.D., Ph.D. | | | | | Cash severance | 321,500(3) | 321,500(3) | — | | Equity acceleration | 1,856,161(4) | — | 1,856,161(7) |

  80. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (1) Dr. Vogt would receive six months of his current annual base salary and his pro-rated target bonus for that year assuming the bonus was earned in 2024. |

  81. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (2) Upon termination without cause, Dr. Vogt’s stock options would vest and he would have six months from the date of termination within which to exercise his vested options. |

  82. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (3) The named executive officer would receive six months of his current annual base salary. |

  83. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (4) The named executive officer’s stock options and restricted stock awards would vest and the named executive officer would have three months from the date of termination within which to exercise their vested options. |

  84. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (5) Upon termination without cause while serving in the Interim CEO role and for three months thereafter, Dr. Vogt would receive twelve months of his annual base salary and his pro-rated target bonus for that year assuming the bonus was earned in 2024. |

  85. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (6) Upon termination due to death or disability, the named executive officer would receive their pro-rated target bonus for that year assuming the bonus was earned in 2024. |

  86. POTENTIAL PAYMENTS UPON TERMINATION OR CHANGE-IN-CONTROL

    | (7) As provided by the stock option and restricted stock unit award agreements for the 2018 Plan, upon termination due to death or disability the named executive officer unvested equity is accelerated and the named executive officer would have twelve months from the date of termination within which to exercise their vested options. |

  87. PAY VERSUS PERFORMANCE

    PAY VERSUS PERFORMANCE 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 (“CAP”) and certain financial performance measures of our company for the last five fiscal years ended December 31, 2024, 2023, 2022, 2021, and 2020.

  88. PAY VERSUS PERFORMANCE

    | | | | | | | | Value of Initial Fixed | | | | | | | | | | | | $100 Investment | | | | | | | | | | Average SCT | Average CAP | | NASDAQ | | Company- | | | SCT | CAP | SCT | CAP | Compensation | Compensation | Company | Biotech Index | | selected | | | Compensation | Compensation | Compensation | Compensation | for Other | for Other | Total Share- | Total Share- | Net Loss | Financial Perf. | | Year | for CEO 1 | for CEO 1 | for CEO 2 | for CEO 2 | NEOs | NEOs | holder Return | holder Return | ($M) | Measure | | (a) | (b) | (c) | (d) | (e) | (f) | (g) | (h) | (i) | (j) | (k) | | 2024 | $10,953,192 | $7,048,573 | $N/A | $N/A | $3,258,633 | $2,925,794 | $26.72 | $118.20 | $(372.2) | $— | | 2023 | $4,794,680 | $5,215,475 | $N/A | $N/A | $1,689,055 | $1,796,364 | $29.36 | $118.87 | $(444.0) | $— | | 2022 | $5,259,100 | $(173,208) | $N/A | $N/A | $2,159,230 | $(50,500) | $23.08 | $113.65 | $(395.9) | $— | | 2021 | $3,216,310 | $3,169,786 | $7,011,698 | $(2,484,140) | $3,270,763 | $(324,022) | $68.95 | $126.45 | $(342.3) | $— | | 2020 | N/A | N/A | $9,039,400 | $22,045,076 | $2,593,418 | $5,003,997 | $167.61 | $126.42 | $(259.6) | $— |

  89. PAY VERSUS PERFORMANCE

    Columns (b), (d) and (f). Reflects compensation amounts reported in the “Summary Compensation Table” (“SCT”) for our CEOs and average amount reported for our non-CEO NEOs, for the respective years shown. Our CEOs and non-CEO NEOs for each of these fiscal years are shown below:

  90. PAY VERSUS PERFORMANCE

    | Year | CEO | Non-CEO NEOs | | 2024 | Frederick G. Vogt, Ph.D., J.D. | Friedrich Graf Finckenstein, M.D., Jean-Marc Bellemin, Igor Bilinsky, Ph.D., Raj K. Puri, M.D., Ph.D. | | 2023 | Frederick G. Vogt, Ph.D., J.D. | Friedrich Graf Finckenstein, M.D., Jean-Marc Bellemin, Igor Bilinsky, Ph.D. | | 2022 | Frederick G. Vogt, Ph.D., J.D. | Friedrich Graf Finckenstein, M.D., Jean-Marc Bellemin, Igor Bilinsky, Ph.D. | | 2021 | Frederick G. Vogt, Ph.D., J.D. (effective June 10, 2021), Maria Fardis, Ph.D. (until June 10, 2021) | Friedrich Graf Finckenstein, M.D., Jean-Marc Bellemin, Igor Bilinsky, Ph.D., Michael Swartzburg | | 2020 | Maria Fardis, Ph.D. | Frederick G. Vogt, Ph.D., J.D (as General Counsel), Friedrich Graf Finckenstein, M.D., Jean-Marc Bellemin, Michael Swartzburg |

  91. PAY VERSUS PERFORMANCE

    Columns (c), (e) and (g). CAP to our CEOs and the average CAP to our non-CEO NEOs for the respective years shown reflect the respective amounts set forth in columns (b), (d) and (f) of the table above, adjusted as determined in accordance with SEC rules and calculation methodology. Adjustments for the fiscal year ended December 31, 2024, are set forth in the table below. The dollar amounts reflected in columns (c), (e) and (g) of the table above do not reflect the actual amount of compensation earned by or paid to our CEOs and non-CEO NEOs during the applicable year. For information regarding the decisions made by our Compensation Committee regarding the CEO’s and average non-CEO NEOs’ compensation for each fiscal year, please see the “Compensation Discussion and Analysis” section in this proxy statement as well as the proxy statements reporting pay for the prior fiscal years covered in these tables.

  92. PAY VERSUS PERFORMANCE

    | | 2024 | | | | CAP | Average | | | Compensation | CAP | | | for | Compensation | | Adjustments | CEO 1 | for other NEOs | | Reported Summary Compensation Table Total | $10,953,192 | $3,258,633 | | Deduction for amounts reported under Stock Awards and Option Awards columns in Summary Compensation Table for applicable fiscal year. | $(9,969,063) | $(2,513,946) | | Add back: The year-end fair value of any equity awards granted during the covered fiscal year that are outstanding and unvested as of the end of the fiscal year | $4,046,870 | $907,379 | | The change in fair value of any awards granted in prior years that are outstanding and unvested as of the end of the fiscal year | $(190,290) | $53,399 | | For awards that are granted and vest in the same year, the fair value as of the vesting date | $546,562 | $316,099 | | For awards granted in prior years that vest in the fiscal year, the change in the fair value from the end of the prior fiscal year to the vesting date | $1,661,302 | $904,229 | | "Compensation Actually Paid" | 7,048,573 | 2,925,794 |

  93. PAY VERSUS PERFORMANCE

    Column (h). Illustrates the value, as of the last day of the indicated fiscal year, of an investment of $100 in the Company’s common stock made on December 31, 2019. Column (i). Illustrates the value, as of the last day of the indicated fiscal year, of an investment of $100 made on December 31, 2019, in the NASDAQ Biotechnology Index, which is the same peer group used for the Stock Performance Graph included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on February 28, 2025. Column (j). Reflects “Net Income” in the Company’s Consolidated Statement of Operations included in the Company’s Annual Reports on Form 10-K for each of the years ended December 31, 2024, 2023, 2022, 2021, and 2020. Column (k). At this time, given that we have only recently become a commercial company without significant revenue, we do not use any specific company-selected financial measures for purposes of determining “compensation actually paid.” As is the case with many companies in the biotechnology industry, our annual incentive objectives are generally tied to the Company’s strategic and operational goals rather than financial goals. However, our Compensation Committee has approved robust goals and objectives discussed annually in our Compensation Discussion and Analysis section in this proxy statement and the proxy statements reporting pay for the fiscal years covered in these tables. Accordingly, we do not have a financial metric in our executive compensation program that would constitute the Company Selected Measure, as contemplated under the SEC Pay Versus Performance disclosure rules.

  94. CHIEF EXECUTIVE OFFICER PAY RATIO

    CHIEF EXECUTIVE OFFICER PAY RATIO SEC rules require companies to disclose the ratio of the total annual compensation of the principal executive officer to the median employee’s total annual compensation. As allowed under the rules, for 2024, we used the same median employee’s total annual compensation that was identified in 2023 since there has been no change in our employee population or employee compensation arrangements that we believe would significantly impact our pay ratio disclosure. For 2023, we identified the median employee by examining the 2023 total annual target cash compensation for all individuals, excluding our Interim Chief Executive Officer, who were employed by us on December 27, 2023. For all employees, we examined target total cash compensation, which included base salary and target annual incentive compensation. We annualized the compensation of all permanent employees who were not employed by us for all of 2024. After identifying the median employee based on target total cash compensation as described above, we calculated annual total compensation for that employee using the same methodology we use for our named executive officers as set forth in the 2024 Summary Compensation Table above. The total annual compensation of the median employee for 2024 was $250,175. The total annual compensation including bonuses for our Interim Chief Executive Officer for 2024 was $10,953,192. The ratio of Interim Chief Executive Officer total annual compensation to the median employee total annual compensation for 2024 was approximately 43.8 to 1. Because Item 402(u) of Regulation S-K permits companies to use a variety of methodologies, to apply certain exclusions, and to make reasonable estimates and assumptions that reflect a Company’s employee population and compensation practices, we believe that our CEO Pay Ratio should not be used as a basis for comparison between companies.