DEF 14A of Summit Therapeutics Inc., Apr 25, 2024

DEF 14A of Summit Therapeutics Inc.

Filed Apr 25, 2024 · FY20230001599298-24-000076

Open on EDGAR

  1. PROPOSAL 1: ELECTION OF DIRECTORS

    PROPOSAL 1: ELECTION OF DIRECTORS Our Board of Directors has nominated Robert W. Duggan, Mahkam Zanganeh, Manmeet Soni, Kenneth A. Clark, Robert Booth, Ujwala Mahatme, Alessandra Cesano, Yu Xia and Mostafa Ronaghi for election at the Annual Meeting with terms expiring at the 2025 annual meeting of stockholders. Please refer to “Board of Directors and Committees of the Board” section below for the nominees’ biographies. The nine nominees receiving the highest number of votes will be elected at the Annual Meeting. In the event a nominee is unable or declines to serve as a director, the proxies will be voted at the Annual Meeting for any nominee who may be designated by the Board of Directors to fill the vacancy. As of the date of this Proxy Statement, the Board of Directors is not aware of any nominee who is unable or will decline to serve as a director. Summary information regarding our nominees is set forth below.

  2. PROPOSAL 1: ELECTION OF DIRECTORS

    | Name | Age | Position | Director Since | | Robert W. Duggan | 79 | Chief Executive Officer & Chairman of the Board of Directors of Summit Therapeutics Inc.; Chief Executive Officer of Duggan Investments, Inc. | 2019 | | Mahkam Zanganeh | 53 | Chief Executive Officer, President & Director of Summit Therapeutics Inc.; Founder and Chief Executive Officer of Maky Zanganeh and Associates | 2020 | | Manmeet Soni | 46 | Chief Operating Officer & Chief Financial Officer of Summit Therapeutics, Inc. | 2019 | | Kenneth A. Clark | 65 | Member of Wilson Sonsini Goodrich & Rosati, P.C. | 2021 | | Robert Booth | 70 | Retired Executive and Professor; Board Member | 2022 | | Ujwala Mahatme | 59 | Founder and Managing Partner of Mahatme Bitterman PLLC | 2020 | | Alessandra Cesano | 63 | Chief Medical Officer of ESSA Pharma | 2022 | | Yu Xia | 57 | Chief Executive Officer and Chairwoman of Akeso, Inc. | 2023 | | Mostafa Ronaghi | 55 | Co-Founder and Executive Board Member of Cellanome | 2024 |

  3. PROPOSAL 1: ELECTION OF DIRECTORS

    There is no family relationship among any of the nominees, directors and/or any of our executive officers, however, Mr. Duggan and Dr. Zanganeh have a personal relationship with each other. Our executive officers serve at the discretion of the Board of Directors. Further information about our directors is provided in the “Board of Directors and Committees of the Board” section below. Shares of common stock represented by executed, but unmarked, proxies will be voted in favor of the election of all nine nominees; provided that, if you hold your shares of our common stock through a broker-dealer, bank nominee, custodian or other securities intermediary, the intermediary will not vote those shares for the nominees unless you give the intermediary specific voting instructions on a timely basis directing the intermediary to vote in such manner.

  4. Board Meetings

    Board Meetings Our Board of Directors meet throughout the year on a set schedule, hold special meetings as needed, and act by written consent from time to time. During fiscal year 2023, our Board of Directors held 3 meetings, and each director attended at least 75% of the aggregate of (i) the total number of meetings of our Board of Directors held during the period for which he or she has been a director and (ii) the total number of meetings held by all committees of our Board of Directors on which he or she served during the periods that he or she served. Our Corporate Governance Guidelines set out that all directors are expected to attend our annual meeting of stockholders. All of the current Board members who were members of the Board at our 2023 annual stockholder meeting attended such meeting. The names of our director nominees and directors, their ages and certain other information about them are set forth below:

  5. Board Meetings

    | Name | Age | Position | | Robert W. Duggan | 79 | Chief Executive Officer and Executive Chairman | | Mahkam Zanganeh | 53 | Chief Executive Officer, President, and Director | | Manmeet Soni | 46 | Chief Operating Officer, Chief Financial Officer and Director | | Kenneth A. Clark | 65 | Lead Independent Director | | Robert Booth | 70 | Director | | Alessandra Cesano | 63 | Director | | Ujwala Mahatme | 59 | Director | | Yu Xia | 57 | Director | | Mostafa Ronaghi | 55 | Director |

  6. Board Meetings

    The principal occupations and positions and directorships for at least the past five years of our directors and director nominees, as well as certain information regarding their individual experience, qualifications, attributes and skills that led our Board of Directors to conclude that they should serve on the Board of Directors, are described below. There are no family relationships among any of our directors or executive officers, however, Mr. Duggan and Dr. Zanganeh have a personal relationship with each other. Robert W. Duggan, age 79, has served as a member of our Board of Directors since December 2019, Executive Chairman since February 2020, and Chief Executive Officer since April 2020. Since 2016, Mr. Duggan has been Chief Executive Officer of Duggan Investments, Inc., a family office of Mr. Duggan dedicated to research and administration of his personal investments primarily in the field of biotech focused on patient-friendly breakthrough solutions to complex diseases of aging. From September 2007 through the acquisition by AbbVie Inc. in May 2015, Mr. Duggan was a member of the board of directors of Pharmacyclics, Inc., a patient-friendly, science-based, employee-driven developer of small-molecule medicines for the treatment of cancers. Mr. Duggan was also the Chairman and Chief Executive Officer of Pharmacyclics from September 2008 to May 2015 as well as its largest investor. From 1990 to 2003, Mr. Duggan was chairman of the board of directors of Computer Motion, Inc. From 1997 to 2003, Mr. Duggan also served as Chief Executive Officer of Computer Motion. In June 2003, Computer Motion merged with Intuitive Surgical Inc. Mr. Duggan has been a director and the chairman of the board of directors of Pulse Biosciences, Inc. since November 2017. From 2003 to 2011, Mr. Duggan served on the board of directors of Intuitive Surgical. Mr. Duggan received a U.S. Congressman’s Medal of Merit from Ron Paul in 1985 and in 2000 he was named a Knight of the Legion of Honor by President Jacques Chirac of France. He is a member of the University of California at Santa Barbara Foundation board of trustees. Mr. Duggan was appointed as a director because of his significant combined service as Chief Executive Officer of an innovative biopharmaceutical company and career spanning over 30 years as a venture investor and advisor for a broad range of companies, and extensive expertise in vision, strategic development, planning, finance and management. Mahkam Zanganeh, age 53, has served as a member of our Board of Directors since November 2020 and as Chief Executive Officer and President since July 2022. Dr. Zanganeh has previously served as the Company’s Chief Operations Officer from November 2020 to July 2022. Dr. Zanganeh is Founder, Chief Executive Officer and Director of Maky Zanganeh and Associates, an executive management and consulting firm founded in 2015. Previously, from August 2012 to September 2015, she served as the Chief Operating Officer of Pharmacyclics Inc. She also served as Chief of Staff and Chief Business Officer of Pharmacyclics from December 2011 to July 2012 and Vice President, Business Development from August 2008 to November 2011. Prior to joining Pharmacyclics Inc., Dr. Zanganeh served as President Director General (2007-2008) for the French government bio-cluster project initiative in France, establishing alliances and developing small life science businesses regionally. From September 2003 to August 2008, Dr. Zanganeh served as Vice President of Business Development for Robert W. Duggan & Associates. Dr. Zanganeh also served as worldwide Vice President of Training & Education (2002-2003) and President Director General for Europe, Middle East and Africa (1998-2002) for Computer Motion Inc. Dr. Zanganeh has been a member of the Board of Directors of Pulse Biosciences, Inc. since February 2017. Dr. Zanganeh received a DDS degree from Louis Pasteur University in Strasbourg, France and MBA from Schiller International University in France. Dr. Zanganeh was appointed as a director because of her years of executive and operational experience in the life sciences industry. Manmeet Soni, age 46, has served as a member of our Board of Directors since December 2019, as Chief Operating Officer since October 2023 and as Chief Financial Officer since April 2024. From February 2022 to October 2023, Mr. Soni was the President, Chief Operating Officer and Chief Financial Officer of Reata Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel therapeutics for the treatment of severe or life-threatening diseases, until its acquisition by Biogen in October 2023. Mr. Soni joined Reata in August 2019 as Chief Financial Officer, Executive Vice President and was promoted in June 2020 to Chief Operating Officer and Chief Financial Officer, Executive Vice President of Reata. Prior to joining Reata Pharmaceuticals, Mr. Soni was the Senior Vice President and Chief Financial Officer of Alnylam Pharmaceuticals Inc. from May 2017 to August 2019. From March 2016 to February 2017, Mr. Soni served as Executive Vice President, Chief Financial Officer and Treasurer of ARIAD Pharmaceuticals, Inc., a biopharmaceutical company, when ARIAD was acquired by Takeda Pharmaceutical Company Limited. Previously, he served as Chief Financial Officer of Pharmacyclics, Inc., a biopharmaceutical company, until its acquisition by AbbVie in 2015. Prior to joining Pharmacyclics, Mr. Soni worked at Zeltiq Aesthetics Inc., a publicly held medical technology company which was acquired by Allergan Inc. (acquired by Abbvie). Prior to Zeltiq, Mr. Soni worked at PricewaterhouseCoopers in the life science and venture capital group. Mr. Soni currently serves as a member of the board of directors of Pulse Biosciences, Inc. since November 2017 and previously served as a member of the board of directors of Arena Pharmaceuticals, Inc. (acquired by Pfizer, Inc.). Mr. Soni is a Certified Public Accountant and Chartered Accountant (India). Mr. Soni was appointed as a director because of his extensive experience in the life sciences industry and his financial and accounting expertise. Kenneth A. Clark, age 65, has served on our Board of Directors since October 2021. Mr. Clark is a partner of Wilson Sonsini Goodrich & Rosati, where he advises biotech companies on strategic partnerships, mergers and acquisitions, financing transactions and operational matters. He is also a partner of TCG Labs, a venture capital fund affiliated with The Column Group. Mr. Clark has previously served as a member of the boards of directors for multiple publicly traded companies, including Pulse BioSciences, Inc. and Pharmacyclics, Inc, and is currently a director of Acurex Biosciences. Mr. Clark received his undergraduate degree from Vanderbilt University and a juris doctorate from the University of Texas School of Law. We believe Mr. Clark is qualified to serve on our Board of Directors because of his expertise in business consulting, deal transactions, financing, and corporate law in the biotechnology sector.

  7. Board Meetings

    Robert Booth, age 70, has served on our Board of Directors since September 2022. Dr. Booth has spent more than 30 years in the biopharmaceutical industry, most recently as founder and chief executive officer of Virobay Inc. Additionally, he has served as operating partner and senior advisor at TPG Biotech. Prior to Virobay, Dr. Booth was the chief scientific officer at Celera Genomics, where he was responsible for all discovery and development activities. At Celera, Dr. Booth conceived and initiated the BTK inhibitor program that was ultimately licensed to Pharmacyclics and from which IMBRUVICA® (ibrutinib) was developed and approved. Dr. Booth served on the board of directors of Pharmacyclics until its acquisition by AbbVie. Prior to Celera, Dr. Booth was senior vice president for Roche in Palo Alto, California, where he was a member of the global research management team and the business development committee, which oversaw licensing opportunities. Dr. Booth additionally currently serves on the boards of Acurex Biosciences and Thryv Therapeutics, private companies that are focused on neurodegenerative diseases and cardiovascular diseases, respectively. Dr. Booth received his BSc and PhD in biochemistry from the University of London. The Board has determined that Dr. Booth qualifies as an independent director under applicable Nasdaq listing rules. We believe Dr. Booth is qualified to serve on our Board of Directors because of his expertise in the life sciences industry. Ujwala Mahatme, age 59, has served as a member of our Board of Directors since July 2020. Currently, Ms. Mahatme serves as the Founder and Managing Partner of Mahatme Bitterman PLLC, a role she has held since 2002. Previously, Ms. Mahatme served as Counsel at Gibson, Dunn & Crutcher and Counsel and Associate at Pillsbury Winthrop Shaw Pittman LLP. She received her Bachelor of Commerce from Brihan Maharashtra College of Commerce, University of Poona, her Bachelor of Laws from ILS Law School, University of Poona, Master of Laws from the University of Cambridge and Master of Laws in Corporation Law from New York University. We believe Ms. Mahatme is qualified to serve on our Board of Directors because of her expertise in corporate law and financing in the biotechnology sector. Alessandra Cesano, age 63, has served as a member of our Board of Directors since November 2022. Dr. Cesano has 26 years of experience in research and development in both drug and diagnostic companies ranging from large, global biopharma to private, venture-backed companies, and currently serves as Chief Medical Officer of ESSA Pharma. Prior to ESSA, Dr. Cesano was the Chief Medical Officer at NanoString Inc., where she built and led the Immuno-Oncology program and the diagnostic pipeline. Prior to NanoString, she was Chief Medical Officer for Cleave Biosciences. There, Dr. Cesano led the successful filing of two INDs for a clinical candidate and led two Phase I trials in Multiple Myeloma and solid tumors. Dr. Cesano has global full-phase development and regulatory experience with large and small molecules and had a substantive and lead role in two approved drugs – Kepivance® (palifermin) and Vectibix® (panitumumab). Dr. Cesano serves on the board of directors at Puma Biotechnology. She received her PhD in tumor immunology and her MD from the University of Turin. The Board has determined that Dr. Cesano qualifies as an independent director under applicable Nasdaq listing rules. We believe Dr. Cesano is qualified to serve on our Board of Directors because of her expertise in the biopharmaceutical industry focused on oncology. Yu (Michelle) Xia, age 57, has served as a member of our Board of Directors since January 2023. Dr. Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012. Dr. Xia has over 27 years of experience in the pharmaceutical industry and academic research. Prior to founding Akeso Biosciences, Dr. Xia held senior leadership roles at Crown Bioscience Inc., where she played a decisive role in constructing Crown Bioscience’s platform, building its team, setting and implementing its strategies, and forging its joint venture with Pfizer (the Pfizer-Crown Asian Cancer Research Centre). From 2006 to 2008, Dr. Xia served as a senior scientist and group leader at PDL BioPharma, Inc. (later acquired by AbbVie). In 2006, Dr. Xia served as a senior process development scientist at Bayer Corporation in the U.S. At both PDL BioPharma and Bayer, Dr. Xia oversaw CMC, process development and manufacturing of therapeutic protein and antibody drugs. Dr. Xia began her pharmaceutical career at Axys Pharmaceuticals, Inc. (later acquired by Celera Genomics), where she held both scientific and managerial roles in drug discovery programs from December 2000 to December 2005, overseeing a broad range of activities from target validation through IND-enabling studies. Dr. Xia earned her Ph.D. degree in molecular biology and microbiology from Newcastle University in the U.K. in 1994. Dr. Xia completed her postdoctoral research training at the University of Glasgow in the U.K. from 1993 to 1996, and she also conducted the cancer immune therapy research at the University of Louisville School of Medicine in the U.S. from 1996 to 2000. Over the years, Dr. Xia has held important roles in numerous influential organizations, including as a member of the Special Committee for Monoclonal Antibody of the China Medicinal Biotech Association, a committee member of the Special Committee for Science and Technology Innovation of China Overseas Returnee Entrepreneur Investment Association, an advisory committee member of the Chinese Antibody Society, and a director of Tongxieyi Antibody Talent Club. Dr. Xia has also received numerous awards and recognitions for her contributions to both the pharmaceutical industry and commercial enterprises. Most recently, Dr. Xia was selected into Forbes’ Powerful Women in Technology in 2020 and in 2023 was named by Forbes China as a Top 100 Women in Business in China. We believe Dr. Xia is qualified to serve on our Board of Directors because of her extensive experience in the biopharmaceutical industry, including in oncology. Mostafa Ronaghi, age 55, has served as a member of our Board of Directors since April 2024. Dr. Ronaghi is the Co-Founder and Executive Board Member of Cellanome. Prior to founding Cellanome, he was Chief Technology Officer, Senior Vice President, and member of the Executive Leadership Team at Illumina, Inc. (Nasdaq: ILMN) from 2008 to 2021. While at Illumina, in 2016, Dr. Ronaghi co-founded GRAIL, a next-gen liquid biopsy platform for cancer detection. Prior to Illumina, Dr. Ronaghi was Principal Investigator at the Stanford Genome Technology Center from 1999 to 2008. Throughout his prolific career, Dr. Ronaghi co-founded several other companies, including Pyrosequencing AB in 1997, ParAllele Biosciences in 2001, NextBio in 2004, Avantome in 2008, and Clear Labs in 2014, each of which sought to increase the understanding of particular diseases through next-generation sequencing (NGS), advanced genotyping, or other advanced technology. Dr. Ronaghi holds a Ph.D. in Biotechnology from Royal Institute of Technology in Stockholm, Sweden.

  8. Director Compensation

    Director Compensation Employee directors are not compensated for Board of Directors services in addition to their regular employee compensation. For 2023, the non-employee members of the Board of Directors were compensated as follows: Cash compensation: Each non-employee member of the Board received the following cash compensation (the “Retainer Cash Payments”): •an annual retainer for each member of the Board of $48,000 paid in equal quarterly installments; •the members of our Audit, Compensation and Nominating and Corporate Governance Committees were eligible to receive an additional annual retainer of $6,500 for their service on each committee; and •the Chairs of the Audit, Compensation and Nominating and Corporate Governance Committees were eligible to receive annual retainers of $36,700, $13,000, and $13,000, respectively. We reimbursed our non-employee directors for all reasonable out-of-pocket expenses incurred in the performance of their duties as directors. Equity Compensation: Each non-employee director received a stock option annual grant to purchase 35,000 shares of the Company’s common stock, par value $0.01 (the "Common Stock"), at a strike price equal to the fair market value of the common stock on the grant date, which shall vest in four equal quarterly installments, with the first such installment occurring on March 31 in the year of grant. Each new non-employee director appointed during 2023 received a stock option grant to purchase 200,000 shares of Common Stock, at a strike price equal to the fair market value of the common stock on the grant date, which shall vest in four equal annual installments, with the first such installment occurring on the one-year anniversary of the grant date. Each new non-employee director appointed during 2023 was also granted a prorated annual grant for their service in the fourth quarter of 2023, at a strike price equal to the fair market value of the common stock on the grant date, which vested in full on December 31, 2023. For 2023, each non-employee director may elect to convert all or a portion of his or her Retainer Cash Payments into a number of options (the “Retainer Option,” and such election, a “Retainer Option Election”) into a set number of options. The number of shares subject to a Retainer Option will be equal to (i) the product of (A) the dollar value of the aggregate Retainer Cash Payments that the non-employee director elects to forego over the course of a specified period covered by a Retainer Option Election in favor of receiving a Retainer Option multiplied by (B) 3.0 (the “Retainer Option Multiplier”), divided by (ii) the fair market value of a share on the date of grant of the Retainer Option, provided that the number of shares covered by such Retainer Option shall be rounded to the nearest whole share. The Retainer Options shall be awarded annually and vest in four equal quarterly installments on March 31, June 30, September 30 and December 31 following the Retainer Option Election, subject to the director remaining as a non-employee director on each such vesting date. The election must have been made by December 31 of the preceding year. The following table sets forth information concerning compensation paid or earned for services rendered to us by the non-employee members of our Board of Directors for the fiscal year ended December 31, 2023. Compensation paid to Mr. Duggan, Dr. Zanganeh and Mr. Soni is included in the section entitled, “Executive Compensation” and excluded from the table below:

  9. Director Compensation

    | Name | Fees Earned or Paid in Cash ($) | Option Awards ($)(1) | Total ($) | | Kenneth A. Clark(2) | 25,792 | 308,855 | 334,647 | | Robert Booth(2) | 1,425 | 263,344 | 264,769 | | Ujwala Mahatme | — | 293,685 | 293,685 | | Alessandra Cesano | 27,250 | 199,744 | 226,994 | | Michelle Xia(3) | — | — | — |

  10. Director Compensation

    _______________ (1)Amounts shown represent the aggregate grant date fair value of the option awards computed in accordance with FASB ASC Topic 718. These amounts do not correspond to the actual value that will be realized by our directors. The assumptions used in the valuation of these awards are consistent with the valuation methodologies specified in the notes to our financial statements. (2)Fees earned or paid in cash for Mr. Clark and Dr. Booth were a result of these individuals filling the vacancies left by Mr. Soni as described above. (3)Dr. Xia did not receive any compensation for her role as a member of the Company's Board of Directors in 2023. The aggregate number of shares subject to stock options outstanding and exercisable on December 31, 2023 for each non-employee director is as follows:

  11. Director Compensation

    | Name | Aggregate Number of Stock Options Outstanding as of December 31, 2023 | Aggregate Number of Stock Options Exercisable as of December 31, 2023 | | Robert Booth | 273,950 | 123,950 | | Alessandra Cesano | 255,516 | 105,516 | | Kenneth A. Clark | 369,160 | 269,160 | | Ujwala Mahatme | 386,712 | 336,712 | | Michelle Xia | — | — |

  12. Summary Compensation Table

    Summary Compensation Table The following table provides information regarding the compensation of our principal executive officers and our next two most highly compensated executive officers, who were serving as executive officers as of December 31, 2023:

  13. Summary Compensation Table

    | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($)(1) | All Other Compensation ($)(2) | Total ($) | | Robert W. Duggan, Chief Executive Officer and Executive Chairman(4) | 2023 | — | — | — | — | — | | | 2022 | — | — | — | — | — | | | 2021 | — | — | — | — | — | | Mahkam Zanganeh, Director, Chief Executive Officer, and President | 2023 | 600,000(4) | — | 19,905,115(6) | 57,809 | 20,562,924 | | | 2022 | 450,000 | 452,500 | 307,200(7) | 32,349 | 1,242,049 | | | 2021 | 450,000 | 182,250 | 8,987,768 | 19,196 | 9,639,214 | | Manmeet Soni, Chief Operating Officer and Chief Financial Officer | 2023 | 100,000 | — | 23,381,640(8) | 131,699 | 23,613,339 | | Ankur Dhingra, Former Chief Financial Officer | 2023 | 500,000(5) | 91,250 | — | 30,001 | 621,251 | | | 2022 | 264,231 | 381,918 | 694,464(9) | 22,237 | 1,362,850 |

  14. Summary Compensation Table

    (1) Amounts shown represent the aggregate grant date fair value of the option awards computed in accordance with FASB ASC Topic 718. These amounts do not correspond to the actual value that will be realized by our named executive officers. The assumptions used in the valuation of these awards are consistent with the valuation methodologies specified in the notes to our financial statements. (2) The amounts paid for all other compensation consisted of the following:

  15. Summary Compensation Table

    | Name and Principal Position | Year | Health, Life and Disability Benefits ($) | 401(k) Match/Pension Scheme ($) | Director Fees | Total ($) | | Robert W. Duggan, Chief Executive Officer and Executive Chairman | 2023 | — | — | — | — | | | 2022 | — | — | — | — | | | 2021 | — | — | — | — | | Mahkam Zanganeh, Director, Chief Executive Officer, and President | 2023 | 38,009 | 19,800 | — | 57,809 | | | 2022 | 14,049 | 18,300 | — | 32,349 | | | 2021 | 1,796 | 17,400 | — | 19,196 | | Manmeet Soni, Chief Operating Officer and Chief Financial Officer | 2023 | 6,178 | — | 125,521 | 131,699 | | Ankur Dhingra, Former Chief Financial Officer | 2023 | 30,001 | — | — | 30,001 | | | 2022 | 22,237 | — | — | 22,237 |

  16. Summary Compensation Table

    (3) Mr. Duggan has declined any compensation from the Company. (4) Dr. Zanganeh’s salary was increased to from $450,000 per annum to $600,000 per annum effective January 1, 2023. (5) Mr. Dhingra’s salary was increased from $450,000 per annum to $500,000 per annum effective January 1, 2023. (6) Dr. Zanganeh was awarded 11,988,198 stock options which vest in four equal annual installments, with an aggregate fair value associated at the date of grant date of $16,524,442. Dr. Zanganeh was also awarded 11,988,198 stock options with performance-based criteria and market service conditions with an aggregate fair value at the grant date of $16,903,359, assuming 100% of the performance conditions are achieved. Only 20% of these awards were estimated to be probable at December 31, 2023 and these awards have a fair value associated with the awards at the date of grant of $3,380,673. (7) Dr. Zanganeh was awarded 360,000 stock options with performance-based criteria and market service conditions with an aggregate fair value at the grant date of $1,384,400, assuming 100% of the performance conditions are achieved. Only 20% of the awards were estimated to be probable at December 31, 2023 and these awards have a fair value associated with the awards at grant date of $307,200. (8) Mr. Soni was awarded 14,000,000 stock options which vest in four equal annual installments, with an aggregate fair value associated at the date of grant date of $19,297,495. Mr Soni was also awarded 14,000,000 stock options with performance-based criteria and market service conditions with an aggregate fair value at the grant date of $19,740,000, assuming 100% of the performance conditions are achieved. Only 20% of these awards were estimated to be probable at December 31, 2023 and these awards have a fair value associated with the awards at the date of grant of $3,948,000. Prior to joining the Company as Chief Operating Officer, Mr. Soni was granted options for serving on the Company's Board of Directors with a fair value of $136,145. (9) Mr. Dhingra was awarded 600,000 stock options which vest in four equal annual installments, with an aggregate fair value associated at the date of grant date of $563,064. Mr. Dhingra was also awarded 750,000 of stock options with performance-based criteria and market service conditions with an aggregate fair value at the grant date of $587,600, assuming 100% of the performance conditions are achieved. Only 20% of these awards were estimated to be probable at December 31, 2023 and these awards have a fair value associated with the awards at the date of grant of $131,400.

  17. Outstanding Equity Awards at Fiscal Year-End

    Outstanding Equity Awards at Fiscal Year-End The following table presents certain information concerning equity awards held by our principal executive officer and our next most highly compensated executive officer, who were serving as executive officers as of December 31, 2023:

  18. Outstanding Equity Awards at Fiscal Year-End

    | | | Option Awards | | | | | Name | | Number of securities underlying outstanding options | | Option exercise price ($/sh) | Option expiration date | | | Grant date | Exercisable | Unexercisable | | | | Robert W. Duggan, Chief Executive Officer and Executive Chairman | — | — | — | — | — | | Mahkam Zanganeh, Director, Chief Executive Officer, and President | 11/11/2020 | 150,000 | 50,000 | $3.71 | 11/11/2030 | | | 11/11/2020 | 3,323 | — | $3.71 | 11/11/2030 | | | 11/22/2020(1) | 1,800,000 | 600,000 | $4.40 | 11/22/2030 | | | 12/15/2021(2) | — | 15,000 | $4.75 | 12/15/2031 | | | 6/28/2022(3) | — | 1,300,000 | $1.06 | 6/28/2032 | | | 9/9/2022(3) | — | 500,000 | $1.29 | 9/9/2032 | | | 10/13/2023(3) | — | 11,988,198 | $1.68 | 10/13/2033 | | | 10/13/2023 | — | 11,988,198 | $1.68 | 10/13/2033 | | Manmeet Soni, Director, Chief Operating Officer and Chief Financial Officer(6) | 12/23/2019 | 200,000 | | $1.37 | 12/23/2029 | | | 5/1/2020 | 27,273 | | $3.30 | 5/1/2030 | | | 2/19/2021(4) | 25,000 | | $7.33 | 2/19/2031 | | | 1/3/2022(4) | 25,000 | | $2.82 | 1/3/2032 | | | 1/3/2022(4) | 82,446 | | $2.82 | 1/3/2032 | | | 1/3/2023(4) | 35,000 | | $5.00 | 1/3/2033 | | | 10/13/2023(3) | | 14,000,000 | $1.68 | 10/13/2033 | | | 10/13/2023 | | 14,000,000 | $1.68 | 10/13/2033 | | Ankur Dhingra, Former Chief Financial Officer | 5/31/2022(5) | 150,000 | 450,000 | $1.33 | 5/31/2032 | | | 6/28/2022(3) | — | 400,000 | $1.06 | 6/28/2032 | | | 9/9/2022(3) | — | 350,000 | $1.29 | 9/9/2032 |

  19. Outstanding Equity Awards at Fiscal Year-End

    _______________ (1) Option award was originally a performance-based award. In September 2021, this award was modified to a time-based award, which vest in four equal annual installments beginning on November 22, 2021. (2) Options vest in three years on December 15, 2024. (3) Option award is a performance-based award with market service conditions. As of December 31, 2023, none of the conditions had been met. (4) Options vest in four equal quarterly installments. (5) Options vest in four equal annual installments beginning May 31, 2023. (6) On October 13, 2023, the Company appointed Manmeet Soni as Chief Operating Officer. Awards granted prior to October 13, 2023 were for Mr. Soni’s service on the Company’s Board of Directors.

  20. Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End

    Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End

  21. 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 and certain financial performance of our Company. The disclosure included in this section is prescribed by SEC rules and does not necessarily align with how the Company or the compensation committee view the link between the Company’s performance and its NEOs pay.

  22. Pay Versus Performance Table

    Pay Versus Performance Table

  23. Pay Versus Performance Table

    | Year | Summary Compensation Table Total for PEO-RD (1) (3) | Summary Compensation Table Total for PEO-MZ (1) (3) | Compensation Actually Paid to PEO-RD (1) (4) | Compensation Actually Paid to PEO-MZ (1) (4) | | Average Summary Compensation Table Total for Non-PEO NEO (2) (3) | Average Compensation Actually Paid to Non-PEO NEO (2) (4) | Value of initial fixed $100 investment based on total shareholder return (TSR) (5) | Net Loss | | 2023 | $— | $20,562,924 | $— | $30,062,629 | $— | $12,049,222 | $18,441,114 | $55.53 | $(614,928,000) | | 2022 | $— | $1,242,049 | $— | $3,786,649 | | $1,362,850 | $3,502,186 | $90.43 | $(78,782,000) | | 2021 | $— | $9,639,214 | $— | $5,123,646 | | $1,325,423 | $(11,289) | $57.23 | $(88,602,000) |

  24. Pay Versus Performance Table

    | (1) For 2023 and 2022, the principal executive officers (PEOs) were Robert W. Duggan (Chief Executive Officer) and Mahkam Zanganeh (Chief Executive Officer). For 2021, Mr. Duggan was the sole PEO, and the non-PEO NEOs were Mahkam Zanganeh and Jeffrey Maranian, Former Principal Accounting Officer and David Powell, Former Chief Scientific Officer. | | (2) For 2022, the sole non-PEO NEO was Ankur Dhingra, our former Chief Financial Officer who served in such role from May 2022 to April 2024. For 2023, the NEOs were Manmeet Soni (Chief Operating Officer) and Ankur Dhingra (Chief Financial Officer). Mr. Soni has served as Chief Operating Officer since October 2023 and as Chief Financial Officer since April 2024. | | (3) Amounts in this column represent the “Total” column set forth in the Summary Compensation Table (“SCT”). See the footnotes to the SCT for further detail regarding the amounts in these columns. | | (4) The dollar amounts reported in these columns represent the amounts of “Compensation Actually Paid” (otherwise known as “CAP”). The Amounts are computed in accordance with Item 402(v) of Regulation S-K by deducting and adding the following amounts from the “Total” column of the SCT (pursuant to SEC rules, fair value at each measurement date is computed in a manner consistent with the fair value methodology used to account for share-based payments in our financial statements under GAAP). | | (5) Total Shareholder Return illustrates the value, as of the last day of the indicated fiscal year, of an investment of $100 in our common stock on December 31, 2021. |

  25. Pay Versus Performance Table

    | 2023 | PEO-RD(1) | PEO-MZ(1) | Non-PEO NEO(2) | | SCT Total Compensation(3) | $— | $20,562,924 | $12,049,222 | | Deduct amounts reported under the “Option Awards” column of the SCT | — | (19,905,115) | (11,622,747) | | Add fair value of awards granted in the fiscal year and unvested as of the fiscal year end | — | 32,164,255 | 18,659,499 | | Add change in fair value of awards granted in prior years and unvested as of the fiscal year end | — | (1,488,273) | (462,633) | | Add change in fair value of awards granted in prior years that vested during the fiscal year as of the vesting date | — | (1,271,162) | (182,227) | | Total Compensation Actually Paid(4) | $— | $30,062,629 | $18,441,114 |

  26. Pay Versus Performance Table

    | 2022 | PEO-RD(1) | PEO-MZ(1) | Non-PEO NEO(2) | | SCT Total Compensation(3) | $— | $1,242,049 | $1,362,850 | | Deduct amounts reported under the “Option Awards” column of the SCT | — | (307,200) | (694,464) | | Add fair value of awards granted in the fiscal year and unvested as of the fiscal year end | — | 1,369,200 | 2,833,800 | | Add change in fair value of awards granted in prior years and unvested as of the fiscal year end | — | 2,099,100 | — | | Add change in fair value of awards granted in prior years that vested during the fiscal year as of the vesting date | — | (616,500) | — | | Total Compensation Actually Paid(4) | $— | $3,786,649 | $3,502,186 |

  27. Pay Versus Performance Table

    | 2021 | PEO-RD(1) | PEO-MZ(1) | Non-PEO NEO(2) | | SCT Total Compensation(3) | $— | $9,639,214 | $1,325,423 | | Deduct amounts reported under the "Option Awards" column of the SCT | — | (8,987,768) | (974,749) | | Add fair value of awards granted in the fiscal year and unvested as of the fiscal year end | — | 2,740,950 | — | | Add change in the fair value of awards granted in prior years and unvested as of the fiscal year end | — | (244,000) | (277,123) | | Add Fair value of awards granted and vested in the fiscal year as of the vesting date | — | 1,952,250 | — | | Add change in fair value of awards granted in prior years that vested during the fiscal year as of the vesting date | — | 23,000 | (84,840) | | Total Compensation Actually Paid(4) | $— | $5,123,646 | $(11,289) |

  28. Pay Versus Performance Narrative Disclosure

    Pay Versus Performance Narrative Disclosure 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 on CAP and each of total shareholder return (“TSR”) and net loss. We do not link our PEOs and NEO compensation to the Company’s financial and stock price performance. As a development stage company, we link a significant portion of their compensation to the achievement of key product development milestones. For purposes of this disclosure, there were no financial performance measures used to link Company performance to Compensation Actually Paid to our PEOs and non-PEO NEO in 2023. Each of Dr. Zanganeh and Mr. Soni are entitled to receive gross up payments from the Company in the event it is determined that any payment received pursuant to such person’s employment agreement would be subject to excise tax by reason of being considered “contingent on a change in ownership or control” of the Company within the meaning of 280G of the Internal Revenue Code.