Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) under the supervision and the participation of the company’s management, which is responsible for the management of the internal controls, and which includes our Chief Executive Officers (our Principal Executive Officers) and our Chief Financial Officer (our Principal Financial Officer). The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives. Based upon our evaluation of our disclosure controls and procedures as o f December 31, 2023, our Chief Executive Officer and Executive Chairman and Chief Executive Officer, President and Director (our Principal Executive Officers), and our Chief Financial Officer (our Principal Financial Officer) concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable level of assurance.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is a process designed, under the supervision of the Chief Executive Officers (our Principal Executive Officers), and our Chief Financial Officer (our Principal Financial Officer), to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external reporting purposes in accordance with Generally Accepted Accounting Principles.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Moreover, projections of any evaluation of the effectiveness of internal control to future periods are subject to a risk that controls may become inadequate because of changes in conditions and that the degree of compliance with the policies or procedures may deteriorate.
Our management has assessed the effectiveness of internal control over financial reporting as of December 31, 2023 , based on the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) 2013. Based on this assessment, our management has concluded that our internal control over financial reporting as of December 31, 2023 , was effective.
This report does not include an attestation report of our registered public accounting firm as we are a non-accelerated filer and a smaller reporting company.
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Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a‑15(f) and 15d‑15(f) under the Exchange Act) during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest shall accrue on the outstanding principal balance at the greater of 12% or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly. Interest shall be paid upon maturity of the loan.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III s
Item 10. Directors, Executive Officers and Corporate Governance
CORPORATE GOVERNANCE
Overview
Our Board of Directors oversees our Chief Executive Officers, and other senior management in the competent and ethical operation of our business and affairs and assures that the long-term interests of the stockholders are being served. Our Board of Directors has adopted Corporate Governance Guidelines that address items such as the qualifications and responsibilities of our directors and director candidates and corporate governance policies and standards applicable to us in general. We believe that good governance leads to high board effectiveness, promotes the long-term interests of our stockholders, strengthens the accountability of our Board of Directors and management and improves our standing in our industry.
Board Leadership Structure
Our Board of Directors believes that the roles of Chairman and Chief Executive Officer may be filled by the same or different individuals. This allows our Board of Directors to have the flexibility to determine whether the two roles should be combined or separated based upon the needs of the Company and our Board of Directors’ assessment of our leadership from time to time. Our Board of Directors also believes that combining the role of Chairman and Chief Executive Officer facilitates the strategic development of the Company and the flow of information between the Board and management. In our Board’s view, Mr. Duggan is best situated to serve as Chairman because of his familiarity with the Company’s business and industry and his insight into the strategies and policies to be discussed by the Board of Directors. At this time, our Board of Directors believes it is in the best interests of our Company and our stockholders for Robert W. Duggan to serve as our Chief Executive Officer and Chairman of the Board of Directors. The Chairman of the Board of Directors presides over all Board meetings and approves the agenda for meetings of the Board of Directors. He also works with the Board of Directors to drive decisions about particular strategies and policies.
The Appointment of the Lead Independent Director
Our Board of Directors has determined that it is advisable, in light of having the same person, Robert W. Duggan, serve as both Chief Executive Officer and Chairman of the Board of Directors, to appoint a lead independent director (“LID”). The Board of Directors has approved the appointment of Kenneth Clark as LID. The LID shall be responsible for the following duties: (i) to chair any meeting of the independent directors in executive sessions; (ii) to meet with any director who is not adequately performing his or her duties as a member of the Board of Directors; (iii) to facilitate communications between other members of the Board of Directors and the Chairman of the Board and Chief Executive Officer; (iv) to monitor, with the
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assistance of the Company’s legal advisors, communications from stockholders and other interested parties; (v) to work with the Chairman of the Board in the preparation of the agenda for each Board of Directors meeting; and (vi) to otherwise consult with the Chairman of the Board and Chief Executive Officer on corporate governance matters and the Board of Directors’ performance.
The Board of Director’s Role in Risk Oversight
Our management has day-to-day responsibility for identifying risks facing us, including implementing suitable mitigating processes and controls, assessing risks in relation to Company strategies and objectives, and appropriately managing risks in a manner that serves the best interests of the Company, our stockholders, and other stakeholders. Our Board of Directors is responsible for ensuring that an appropriate culture of risk management exists within the Company and for setting the right “tone at the top,” overseeing our aggregate risk profile, and assisting management in addressing specific risks.
Generally, various committees of our Board of Directors oversee risks associated with their respective areas of responsibility and expertise. For example, our Audit Committee oversees, reviews and discusses with management and the independent auditor risks associated with our internal controls and procedures for financial reporting and the steps management has taken to monitor and mitigate those exposures; our Audit Committee also oversees the manage ment of other risks, including those associated with credit risk. Our Compensation Committee oversees the management of risks associated with our compensation policies, plans and practices. Our Nominating and Corporate Governance Committee oversees the management of risks associated with director independence and the composition and organization of the Board of Directors. Our Board of Directors provides direct oversight over cybersecurity risks. Management and other employees report to the Board of Directors and/or relevant committee from time to time on risk-related issues.
Diversity of the Board
Although the Nominating and Corporate Governance Committee does not maintain a specific policy with respect to board diversity, the Board of Directors believes that the Board of Directors should be a diverse body. Diversity in experiences, perspectives, and backgrounds is just one of many factors considered by the Nominating and Corporate Governance Committee in considering director nominees. In August 2021, the SEC adopted Nasdaq’s proposal that requires listed companies to provide statistical information about their boards of directors, in the form of a matrix chart. The below Diversity Matrix reports self-identified diversity statistics for the Board in the format required by Nasdaq’s rules.
Board Diversity Matrix (as of February 13, 2024)
Total Number of Directors
8
Female Male Non-Binary Did Not Disclose
Gender
Gender Identity
Directors 4 4 — —
Demographic Background
African American or Black — — — —
Alaskan Native or Native American — — — —
Asian 2 1 — —
Hispanic or Latinx — — — —
Native Hawaiian or Pacific Islander — — — —
White 2 3 — —
Two or More Races or Ethnicities — — — —
LGBTQ+ — — — —
Did Not Disclose Demographic Background — — — —
Director Independence
Under applicable Nasdaq rules, a director will only qualify as an “independent director” if, in the opinion of the listed company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent
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judgment in carrying out the responsibilities of a director. In order to be considered independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee, accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries or otherwise be an affiliated person of the listed company or any of its subsidiaries. In order to be considered independent for purposes of Rule 10C-1, the board must consider, for each member of a compensation committee of a listed company, all factors specifically relevant to determining whether a director has a relationship to such company which is material to that director’s ability to be independent from management in connection with the duties of a compensation committee member, including, but not limited to: (1) the source of compensation of the director, including any consulting advisory or other compensatory fee paid by such company to the director; and (2) whether the director is affiliated with the company or any of its subsidiaries or affiliates.
Based upon information requested from and provided by each director concerning his or her background, employment and affiliations, including family relationships, our Board of Directors has determined that each of Mr. Clark, Ms. Mahatme, Mr. Booth and Ms. Cesano, representing four of our eight directors, is “independent” as that term is defined under the rules of The Nasdaq Stock Market and none of these directors has or has had a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
Our Board of Directors also determined that Mr. Clark, Ms. Mahatme, Mr. Booth, and Ms. Cesano, who comprise our Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee, satisfy the independence standards for those committees established by applicable SEC rules, including Rule 10A-3 of the Exchange Act, and the rules of The Nasdaq Stock Market. In making this determination, our Board of Directors considered the relationships that each non-employee director has or has had with our Company and all other facts and circumstances that our Board of Directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director.
Under The Nasdaq Stock Market listing requirements, a company of which more than 50% of the voting power is held by an individual, group, or another company is a “controlled company.” Because Mr. Duggan owns more than a majority of the voting power of our outstanding shares of common stock, we are a “controlled company” under the corporate governance rules for Nasdaq-listed companies. A “controlled company” may elect not to comply with certain Nasdaq corporate governance requirements, including the requirements that:
• a majority of the board of directors consist of independent directors;
• the compensation committee be composed entirely of directors meeting Nasdaq independence standards applicable to compensation committee members with a written charter addressing the committee’s purpose and responsibilities;
• the compensation committee be responsible for the hiring and overseeing of persons acting as compensation consultants and be required to consider certain independence factors when engaging such persons; and
• director nominees either be selected, or recommended for board of directors’ selection, either by “independent directors” as defined under the rules of Nasdaq constituting a majority of the board of director’s “independent directors” in a vote in which only “independent directors” participate, or by a nominations committee comprised solely of “independent directors.”
We have elected to take advantage of these exemptions. As a result, our stockholders may not have the same protections afforded to stockholders of companies that are subject to all of the Nasdaq corporate governance rules.
Director Nominations
Candidates for nomination to our Board of Directors are selected by the Nominating and Corporate Governance Committee in accordance with the committee’s charter, and our Certificate of Incorporation and Bylaws. The Nominating and Corporate Governance Committee evaluates all candidates in the same manner and using the same criteria, regardless of the source of the recommendation.
The Nominating and Corporate Governance Committee may retain recruiting professionals to assist in identifying and evaluating candidates for director nominees. Our Board of Directors has adopted Corporate Governance Guidelines and the Nominating and Corporate Governance Committee has adopted Policies and Procedures for Director Candidates which sets out, among other things, that the Nominating and Corporate Governance Committee considers factors such as character, integrity, judgment, diversity of experience (including age, gender, international background, race and professional experience), independence, area of expertise, length of service, potential conflicts of interest, other commitments and the like. The
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Nominating and Corporate Governance Committee considers the following minimum qualifications to be satisfied by any nominee to the Board of Directors: a reputation for integrity, honesty and adherence to high ethical standards; a demonstrated business acumen, experience and ability to exercise sound judgments in matters that relate to the current and long-term objectives of the Company; a commitment to understanding the Company and its industry; a commitment to regularly attend and participate in meetings of the Board and its committees; an interest and ability to understand the sometimes conflicting interests of the various constituencies of the Company, including stockholders, employees, customers, governmental units, credito rs and the general public, and to act in the interests of all stockholders. Based on the Nominating and Corporate Governance Committee’s recommendation, the Board of Directors selects director nominees and recommends them for election by our stockholders, and also fills any vacancies that may arise between annual meetings of stockholders.
The Nominating and Corporate Governance Committee will consider director candidates who are proposed by our stockholders in accordance with our Bylaws, our Nominating and Corporate Governance Committee’s Policies and Procedures for Director Candidates and other procedures established from time to time by the Nominating and Corporate Governance Committee. If you would like the Nominating and Corporate Governance Committee to consider a prospective director candidate, please follow the procedures in our Bylaws and submit the candidate’s name and qualifications to: Corporate Secretary, Summit Therapeutics Inc., 601 Brickell Key Drive, Suite 1000, Miami, FL 33131.
Code of Business Conduct and Ethics
We have also adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officers, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of the code is filed herewith as Exhibit 14.1 and posted on the “Investor Center/Corporate Governance” section of our website, which is located at https://www.smmttx.com/. If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K to be filed with the SEC.
Policy on Short Sales, Derivative Transactions and Hedging Transactions
The Company’s Insider Trading Policy prohibits any director or employee from engaging in any of the following types of transactions with respect to the Company’s securities: (i) short sales, including short sales “against the box”, (ii) purchases or sales of puts, calls, or other derivative securities or (iii) purchases of financial instruments (including prepaid variable forward contracts, equity swaps, collars and exchange funds) or other similar transactions that directly hedge or offset, or are designed to directly hedge or offset, any decrease in the market value of Company securities.
Communication with the Board of Directors
Any stockholder communication with our Board of Directors or individual directors should be directed to Summit Therapeutics Inc., c/o Corporate Secretary, 601 Brickell Key Drive, Suite 1000, Miami, FL 33131. The Corporate Secretary will forward these communications, as appropriate, directly to the director(s). The independent directors of the Board of Directors review and approve the stockholder communication process periodically in an effort to enable an effective method by which stockholders can communicate with the Board of Directors.
BOARD OF DIRECTORS AND COMMITTEES OF THE BOARD
Board and Committee Meetings
Our Board of Directors and its committees 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.
The names of our director nominees and directors, their ages and certain other information about them are set forth below:
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Name Age Position
Robert W. Duggan 79
Chief Executive Officer and Executive Chairman
Mahkam Zanganeh 53
Chief Executive Officer, President, and Director
Manmeet S. Soni 46
Chief Operating 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
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 (Maky) 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 S. Soni , age 46, has served as a member of our Board of Directors since December 2019 and as Chief Operating Officer since October 2023. 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
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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.
Robert Booth , age 70, has served on our Board of Directors since September 2022 and also serves as a member of the Audit Committee and the Nominating and Corporate Governance Committee. 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 and the Nominating and Corporate Governance Committee 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
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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) Xi a, 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 served important roles in numerous influential organizations, including 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.
Board Committees
Our Board of Directors has the following standing committees: Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee, each of which has the composition and the responsibilities described below. The Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee all operate under charters approved by our Board of Directors, which charters are available on the Investor Center of our website at https://www.smmttx.com under “Corporate Governance.” Our Board of Directors from time to time establishes additional committees to address specific needs.
The following table sets forth (i) the three standing committees of the Board of Directors, (ii) the members of each committee as of December 31, 2023, and (iii) the number of meetings held by each committee in fiscal year 2023:
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Name of Director Audit Compensation Nominating and Corporate Governance
Robert W. Duggan
Mahkam Zanganeh
Manmeet S. Soni (1)
Kenneth A. Clark (1)
X (Chair) X (Chair) (2)
X (Chair)
Robert Booth
X
X
Alessandra Cesano
X
Ujwala Mahatme
X
X
X
Number of Meetings Held During 2023
5 2 1
_______________
(1) On October 13, 2023, the Company appointed Manmeet Soni as Chief Operating Officer. In connection with his employment as Chief Operating Officer, Mr. Soni resigned from his seat on the Board’s Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee, as well as from his position as lead independent director. To fill the vacancies left by Mr. Soni, Robert Booth was appointed to the Audit Committee and Kenneth A. Clark was appointed as the lead independent director on the Board.
(2) On February 16, 2024, Mr. Clark was appointed to serve as Compensation Committee Chair.
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.
Audit Committee
Our Audit Committee oversees our corporate accounting and financial reporting process and assists the Board of Directors in monitoring our financial systems and our legal and regulatory compliance. Our Audit Committee is responsible for, among other things:
• appointing, approving the compensation of, and assessing the independence of our registered public accounting firm;
• overseeing the work of our registered public accounting firm, including through the receipt and consideration of reports from such firm;
• reviewing and discussing with management and the registered public accounting firm our annual and quarterly financial statements and related disclosures;
• monitoring our internal control over financial reporting, disclosure controls and procedures and code of business conduct and ethics;
• establishing policies regarding the receipt and retention of accounting related complaints and concerns;
• meeting independently with our internal auditing staff, if any, our registered public accounting firm and management;
• reviewing and approving or ratifying any related person transactions; and
• preparing the Audit Committee report required by SEC rules.
The members of our Audit Committee are Mr. Clark, Mr. Booth and Ms. Mahatme. Mr. Clark serves as our Audit Committee Chair. Our Board of Directors has determined that each member of our Audit Committee is independent within the meaning of the independent director guidelines of The Nasdaq Stock Market. We believe that the composition of our Audit Committee meets the requirements for independence under, and the functioning of our Audit Committee complies with, all applicable requirements of The Nasdaq Stock Market and SEC rules and regulations. In addition, our Board of Directors has determined that Mr. Clark meets the financial literacy requirements under the rules of The Nasdaq Stock Market and the SEC and that he qualifies as Audit Committee financial expert as defined under SEC rules and regulations.
Compensation Committee
Our Compensation Committee oversees our corporate compensation policies, plans and programs. Our Compensation Committee is responsible for, among other things:
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• reviewing and approving, or making recommendations to our Board of Directors with respect to, the compensation of our chief executive officers and our other executive officers;
• overseeing an evaluation of our senior executives;
• overseeing and administering our cash and equity incentive plans;
• reviewing and making recommendations to our Board of Directors with respect to director compensation;
• reviewing and discussing annually with management our “Compensation Discussion and Analysis” disclosure if and to the extent then required by SEC rules; and
• preparing the Compensation Committee report required by SEC rules.
The members of our Compensation Committee are Mr. Clark and Ms. Mahatme. Mr Clark serves as our Compensation Committee Chair. Our Board of Directors has determined that each member of our Compensation Committee is independent within the meaning of the independent director guidelines of The Nasdaq Stock Market. We believe that the composition of our Compensation Committee meets the requirements for independence under, and the functioning of our Compensation Committee complies with, all applicable requirements of The Nasdaq Stock Market and SEC rules and regulations.
Nominating and Corporate Governance Committee
Our Nominating and Corporate Governance Committee oversees and assists our Board of Directors in reviewing and recommending corporate governance policies and nominees for election to our Board of Directors. Our Nominating and Corporate Governance Committee is responsible for, among other things:
• identifying individuals qualified to become members of our Board of Directors;
• recommending to our Board of Directors the persons to be nominated for election as directors and to each of our Board of Directors’ committees;
• reviewing and making recommendations to our Board of Directors with respect to our Board of Directors leadership structure;
• reviewing and making recommendations to our Board of Directors with respect to management succession planning;
• developing and recommending to our Board of Directors corporate governance principles; and
• overseeing an annual evaluation of our Board of Directors.
As of December 31, 2023 the members of our Nominating and Corporate Governance Committee are Mr. Clark, Dr. Booth, Ms. Mahatme and Dr. Cesano. Mr. Clark serves as our Nominating and Corporate Governance Committee Chair. Our Board of Directors has determined that each member of our Nominating and Corporate Governance Committee is independent within the meaning of the independent director guidelines of The Nasdaq Stock Market.
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, 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 the Company’s common stock, par value $0.01, at a strike price equal to the fair market value of the common stock on the grant
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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:
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)
— — —
_______________
(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 Mr. 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:
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
— —
DELINQUENT SECTION 16(a) REPORTS
Section 16(a) of the Exchange Act requires that our executive officers and directors and other persons who beneficially own more than 10% of a registered class of our equity securities file with the SEC reports of ownership and reports of changes in ownership of shares and other equity securities. Such executive officers and directors and other persons who beneficially
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own more than 10% of a registered class of our equity securities are required by the SEC to furnish us with copies of all Section 16(a) reports filed by such reporting persons.
Based solely on our review of such forms furnished to us or written representations provided to us by the reporting person, we are aware of no late Section 16(a) reports required to be filed by our executive officers, directors and other persons who beneficially own more than 10% of a registered class of our equity securities in the year ended December 31, 2023, other than: (i) a late Form 4 to report the acquisition by Akeso of 10,000,000 shares of common stock on January 17, 2023 in connection with the entry into the License Agreement; and (ii) a late Form 4 to report the acquisition by Akeso of 21,523,530 shares of common stock on March 7, 2023 in the Company’s 2023 Rights Offering. Dr. Xia is a stockholder and exercises the right to vote approximately 28.9% of Akeso's ordinary shares, and serves as chairwoman, president and chief executive officer of Akeso. Dr. Xia disclaims beneficial ownership of the shares of Issuer's Common Stock beneficially owned by Akeso, except to the extent of her pecuniary interest therein. Dr. Xia filed a Form 5 on February 14, 2024 to report each of the transactions described in clauses (i) and (ii) of this paragraph.
Item 11. Executive Compensation
EXECUTIVE COMPENSATION
Compensation Committee Report
The information contained in the following report of the Compensation Committee shall not be deemed to be “soliciting material” or to otherwise be considered “filed” with the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act except to the extent that the Company specifically incorporates it by reference into such filing.
The Compensation Committee has reviewed and discussed the following “Executive Compensation” section of this Annual Report with management. Based on this review and discussion, the Compensation Committee recommended to our Board of Directors that such information be included in this Annual Report.
Members of the Compensation Committee:
Kenneth A. Clark (Chair)
Ujwala Mahatme
Executive Compensation
The following is a discussion and analysis of compensation arrangements of our named executive officers (NEOs). This discussion contains forward looking statements that are based on our current plans, considerations, expectations and determinations regarding future compensation programs. Actual compensation programs that we adopt may differ materially from currently planned programs as summarized in this discussion. As a smaller reporting company, we are not required to include a Compensation Discussion and Analysis section and have elected to comply with the scaled disclosure requirements applicable to smaller reporting companies.
We seek to ensure that the total compensation paid to our executive officers is reasonable and competitive. Compensation of our executives is structured around the achievement of individual performance and near-term corporate targets as well as long-term business objectives.
Our NEOs for fiscal year 2023 were as follows, who are comprised of (1) our principal executive officers in fiscal year 2023 and (2) our next most highly compensated executive officers who were serving as executive officers as of December 31, 2023:
• Robert W. Duggan, our Chief Executive Officer and Executive Chairman;
• Mahkam Zanganeh, our Chief Executive Officer, President and Director;
• Manmeet Soni, our Chief Operating Officer and Director
• Ankur Dhingra, our Chief Financial Officer;
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:
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Name and Principal Position Year Salary ($)
Bonus ($)
Option Awards ($) (2)
All Other Compensation ($) (3)
Total
($)
Robert W. Duggan,
Chief Executive Officer and Executive Chairman (4)
2023
— — — — —
2022
— — — — —
2021
— — — — —
Mahkam Zanganeh, Director, Chief Executive Officer, and President
2023
600,000 (5)
(1) 19,905,115 (7)
57,809 20,562,924
2022
450,000 452,500 307,200 (8)
32,349 1,242,049
2021
450,000 182,250 8,987,768 19,196 9,639,214
Manmeet Soni, Chief Operating Officer
2023
100,000
(1) 23,381,640 (9)
131,699
23,613,339
Ankur Dhingra, Chief Financial Officer
2023 500,000 (6)
(1) — 30,001 530,001
2022
264,231 381,918 694,464 (10)
22,237 1,362,850
_______________
(1) Final bonus amounts for 2023 have not yet been approved by the Compensation Committee and will be paid in April 2024.
(2) Amounts shown represent the aggregate grant date fair value of the option awards computed in accordance with FASB ASC Topic 718. These amounts do not correspond to the actual value that will be realized by our named executive officers. The assumptions used in the valuation of these awards are consistent with the valuation methodologies specified in the notes to our financial statements.
(3) The amounts paid for all other compensation consisted of the following:
Name and Principal Position Year Health, Life and Disability Benefits ($)
401(k) Match/Pension Scheme ($) Director Fees
Total
($)
Robert W. Duggan,
Chief Executive Officer and Executive Chairman (3)
2023
— — — —
2022
— — — —
2021
— — — —
Mahkam Zanganeh, Director, co- 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
2023
6,178 — 125,521 131,699
Ankur Dhingra, Chief Financial Officer
2023 30,001 — — 30,001
2022 22,237 — — 22,237
(4) Mr. Duggan has declined any compensation from the Company.
(5) Dr. Zanganeh’s salary was increased to from $450,000 per annum to $600,000 per annum effective January 1, 2023.
(6) Mr. Dhingra’s salary was increased from $450,000 per annum to $500,000 per annum effective January 1, 2023.
(7) Dr. Zanganeh was awarded 11,988,198 of 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 of 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.
(8) Dr. Zanganeh was awarded 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
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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.
(9) 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.
(10) Mr. Dhingra was awarded 600,000 of options which vest in four equal annual installments, with an aggregate fair value associated at the date of grant date of $563,064. Mr Soni 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 $131,400.
Outstanding Equity Awards at Fiscal Year-End
The following table presents certain information concerning equity awards held by our principal executive officer and our next most highly compensated executive officer, who were serving as executive officers as of December 31, 2023:
Option Awards
Name Number of securities underlying outstanding options Option exercise price ($/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 (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, 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
_______________
(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.
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(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.
Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End
Employment Agreement with Mahkam Zanganeh
We entered into an employment agreement with Dr. Zanganeh, our current Chief Executive Officer and President, on November 22, 2020. The employment relationship between the Company and Dr. Zanganeh is “at-will”, and the employment agreement has no specific term. Dr. Zanganeh’s annual base salary as of December 31, 2022 was $450,000. Pursuant to her employment agreement, upon her appointment she received a grant of options to purchase 2,400,000 shares of our common stock, vesting in four equal annual installments, subject to the satisfaction of certain performance conditions. During fiscal year ended December 31, 2021, the Compensation Committee of the Board of Directors determined to eliminate the requirements for satisfying performance-based stock option awards and deemed all performance-based vesting requirements satisfied. Following this determination, the option awards are subject only to previous existing time-based vesting conditions. Dr. Zanganeh was eligible for an annual target bonus equal to 45% of her salary in 2021 and 2022 and 60% of her annual base salary for 2023, subject to achievement of performance objectives. Dr. Zanganeh was paid a discretionary cash bonus of $182,250 relating to 2021 and this bonus was paid in March of 2022. Dr. Zanganeh was paid a discretionary cash bonus of $202,500 and an extraordinary bonus of $250,000 relating to 2022 and this bonus was paid in January 2023. Dr. Zanganeh’s salary was increased to from $450,000 per annum to $600,000 per annum effective January 1, 2023.
Dr. Zanganeh is eligible to participate in employee benefit plans maintained from time to time by us of general applicability to other senior executives. During her term of service as an executive officer, Dr. Zanganeh will not receive compensation that would otherwise be owed to her in her capacity as a member of our Board of Directors.
Employment Agreement with Manmeet Soni
We entered into an employment agreement with Mr. Soni, our Chief Operating Officer on October 13, 2023. The employment relationship between the Company and Mr. Soni is “at-will”, and the employment agreement has no specific term. Mr. Soni’s annual base salary as of December 31, 2023 was $600,000. Pursuant to his employment agreement upon his appointment he received a grant of options to purchase 14,000,000 shares of our common stock, vesting in four equal annual installments. In addition, Mr. Soni received a performance-based grant of options to purchase 14,000,000 shares of our common stock, vesting annually over four years, subject to the satisfaction of certain performance and market service conditions. Mr. Soni will be eligible for a yearly discretionary cash bonus in an amount solely determined by the Company of up to 60% of annual base salary.
Employment Agreement with Ankur Dhingra
We entered into an employment letter with Mr. Dhingra, our Chief Financial Officer, on April 15, 2022. The employment relationship between the Company and Mr. Dhingra is “at-will”, and the employment agreement has no specific term. Mr. Dhingra’s annual base salary as of December 31, 2023 was $500,000. Pursuant to his employment agreement, upon his appointment he received a grant of options to purchase 600,000 shares of our common stock, vesting in four equal annual installments on the date approved by the Compensation Committee, and then on the next three anniversaries of such date. Mr. Dhingra was eligible in 2022 for an annual target bonus equal to 50% of his annual base salary, payable in accordance with the Company’s normal payroll practices. Mr. Dhingra was paid a discretionary cash bonus of $131,918 and an extraordinary bonus of $250,000 relating to 2022 and this bonus was paid in January 2023. Mr. Dhingra’s salary was increased from $450,000 per annum to $500,000 per annum effective January 1, 2023.
Mr. Dhingra is eligible to participate in employee benefit plans maintained from time to time by us of general applicability to other senior executives.
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
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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.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth certain information as of February 9, 2024 with respect to the beneficial ownership of our common stock by (i) each person we believe beneficially holds more than 5% of the outstanding shares of our common stock based solely on our review of SEC filings or information provided to us by such person; (ii) each director and nominee; (iii) each named executive officer listed in the table entitled, “Summary Compensation Table” under the section entitled, “Executive Compensation”; and (iv) all directors and executive officers as a group. As of February 9, 2023, 701,697,179 shares of our common stock were issued and outstanding. Unless otherwise indicated, all persons named as beneficial owners of our common stock have sole voting power and sole investment power with respect to the shares indicated as beneficially owned. Unless otherwise noted below, the address of each stockholder listed on the table is c/o Summit Therapeutics Inc., 601 Brickell Key Drive, Suite 1000, Miami, FL 33131.
Name and Address of Beneficial Owner
Number of Shares Owned (1)
Right to Acquire Shares (2)
Total Beneficial Ownership
Percent of Class (3)
5% Stockholders:
Robert W. Duggan (4)
548,369,106 4,003,691 552,372,797 78.3%
Mahkam Zanganeh (5)
35,268,388 2,269,004 37,537,392 5.3%
Yu Xia (6)
31,523,530 8,750 31,532,280 4.5%
Named executive officers and directors:
Robert W. Duggan (4)
548,369,106 4,003,691 552,372,797 78.3%
Mahkam Zanganeh (5)
35,268,388 2,269,004 37,537,392 5.3%
Yu Xia (6)
31,523,530 8,750 31,532,280 4.5%
Manmeet S. Soni (7)
2,976,190 394,719 3,370,909 *
Ankur Dhingra (8)
294,485 150,000 444,485 *
Kenneth A. Clark — 295,533 295,533 *
Robert Booth — 144,613 144,613 *
Ujwala Mahatme — 358,606 358,606 *
Alessandra Cesano — 119,607 119,607 *
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All named executive officers and directors as a group (9 people)
618,431,699 7,744,523 626,176,222 88.3 %
_______________
(*) Represents beneficial ownership of less than 1% of the outstanding shares of our common stock.
(1) Excludes shares that may be acquired through the exercise of outstanding stock options or other equity awards.
(2) Represents shares issuable within 60 days after February 9, 2024 upon exercise of exercisable options and warrants; however, unless otherwise indicated, these shares do not include any equity awards awarded after February 9, 2024.
(3) For purposes of calculating the Percent of Class, shares that the person or entity had a right to acquire within 60 days after February 9, 2024 are deemed to be outstanding when calculating the Percent of Class of such person or entity.
(4) This information is based upon a Schedule 13D/A filed by Mr. Duggan with the Securities and Exchange Commission on February 16, 2023, updated by a Form 4 filed by Mr. Duggan on January 4, 2024, and information known to the Company. The 552,372,797 shares of common stock beneficially owned by Mr. Duggan includes (i) 548,369,106 shares of common stock, 9,346,434 shares of common stock, representing the number of shares of common stock issued to Mr. Duggan as payment of interest in connection with the Note Purchase Agreement, (ii) warrants to purchase 3,985,055 shares of common stock, which are exercisable until December 24, 2029 and (iii) options to purchase 18,636 shares of Common Stock, comprised of 18,636 options (exercisable beginning on March 31, 2024 and exercisable until January 2, 2034).
(5) This information is based upon a Schedule 13D/A filed by Dr. Zanganeh with the Securities and Exchange Commission on March 13, 2023, updated by a Form 4 filed by and information known to the Company. The 37,537,392 shares of Common Stock beneficially owned consist of (i) 35,268,388 shares of Common Stock owned in the aggregate by the Mahkam Zanganeh Revocable Trust and the Shaun Zanganeh Irrevocable Trust, (ii) warrants to purchase 315,681 shares of Common Stock (exercisable until December 24, 2029), and (iii) options to purchase 1,953,323 shares of Common Stock, comprising of 153,323 options (exercisable beginning on December 31, 2020 and exercisable until November 11, 2030) and 1,800,000 options (exercisable beginning on November 22, 2021 and exercisable until November 22, 2030). Of the warrants to purchase 315,681 shares of Common Stock, 315,681 are held by the Shaun Zanganeh Irrevocable Trust. The options to purchase 1,953,323 shares of Common Stock are held individually by Dr. Zanganeh.
(6) The shares beneficially owned by Dr. Xia include (i) 31,520,000 shares of Common Stock owned by Akeso, a company in which Dr. Xia is a stockholder and exercises the right to vote approximately 28.9% of Akeso’s ordinary shares, and in which Dr. Xia serves as chairwoman, president and chief executive officer, and (ii) options to purchase 8,750 shares of Common Stock held individually by Dr. Xia. Dr. Xia disclaims beneficial ownership of all shares of Common Stock held by Akeso, except to the extent of her pecuniary interest therein.
(7) This information is based upon a Form 4 filed by Mr. Soni with the securities and Exchange Commission on October 16, 2023 and information known to the Company. The 3,370,909 shares of common stock beneficially owned by Mr. Soni includes 2,976,190 shares acquired in the private placement on October 13, 2023.
(8) This information is based upon a Form 4 filed by Mr. Dhingra with the Securities and Exchange Commission on December 13, 2023 and information known to the Company. The 444,485 shares of common stock beneficially owned by includes (i) 39,527 shares of common stock directly owned and (ii) 254,958 shares of common stock indirectly held by the Dhingra Family Revocable Trust.
EXECUTIVE OFFICERS
Biographical data for our current executive officers, including their ages as of December 31, 2023 is set forth below, except Mr. Duggan’s, Dr. Zanganeh and Mr. Soni’s biography, each of which are included under the heading, “Board of Directors and Committees of the Board” above.
Ankur Dhingra , age 48, has served as Chief Financial Officer since May 2022. Mr. Dhingra served as Chief Financial Officer at CareDx, a company focused on transplant patient journey, from March 25, 2021 through May 25, 2022. In his role at CareDx, Mr. Dhingra was responsible for finance, information technology and market access functions. Prior to CareDx, Mr. Dhingra spent 18 years at Agilent Technologies (“Agilent”) in various finance and business management roles. From January 2019 through March 2021, he was Vice President of Investor Relations and prior to that, Mr. Dhingra served as Group CFO for Agilent’s Life Sciences and Applied Markets business. Mr. Dhingra has demonstrated a track record of success scaling businesses by executing and influencing growth-oriented business strategies, expanding margins and deploying M&A policies. He has extensive experience managing global teams of finance and accounting professionals. Mr. Dhingra is a qualified Chartered Accountant (India).
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Equity Compensation Plan Information
The following table presents information about our equity compensation plans as of December 31, 2023:
Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted average exercise price of outstanding options, warrants and rights ($) Number of securities remaining available for future issuance under equity compensation plans excluding securities reflected in column (a)
Equity compensation plans approved by security holders (1)
105,809,178 $ 1.95 3,261,496
Equity compensation plans not approved by security holders (2)
69,973 $ 1.44 —
_______________
(1) Includes the following plans: the 2020 Stock Incentive Plan (the “Stock Incentive Plan”), the 2016 Long Term Incentive Plan (the “LTIP”) and the 2005 EMI Scheme Rules (the “EMI Plan” and together with the LTIP, the “Legacy Plans”). Our Stock Incentive Plan provides that the number of shares available for issuance thereunder will be increased on the first day of each fiscal year beginning with the 2021 fiscal year in an amount equal to the least of (i) 6,400,000 shares, (ii) 4% of the outstanding shares of our common stock as of such date, or (iii) such number of shares as determined by our Board of Directors. On January 1, 2024, the number of shares available for issuance under the Stock Incentive Plan increased by 6,400,000 shares pursuant to these provisions. This increase is not reflected in the table above. On September 18, 2020, the Company became the successor issuer to Summit Therapeutics plc (“Old Summit”), at which point the Company assumed Old Summit’s obligations under our Legacy Plans and replaced all equity awards granted under the Legacy Plans with equivalent equity awards for our common stock. Excludes shares issued under the 2020 Employee Stock Purchase Plan.
(2) Includes outstanding warrants granted to Elaine Stracker for consultancy services provided to the Company pursuant to the Company’s consultancy agreement that was terminated by mutual agreement in June 2020.
Item 13. Certain Relationships and Related Party Transactions
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Our Board of Directors has adopted written policies and procedures for the review of any transaction, arrangement or relationship in which the Company is a participant, the amount involved exceeds $120,000, and one of our executive officers, directors, director nominees or 5% stockholders (or their immediate family members), each of whom we refer to as a “related person,” has a direct or indirect material interest. If a related person proposes to enter into such a transaction, arrangement or relationship, which we refer to as a “related person transaction,” the related person must report the proposed related person transaction to our Chief Executive Officers or principal financial officer. The policy calls for the proposed related person transaction to be reviewed and, if deemed appropriate, approved by our Audit Committee. Whenever practicable, the reporting, review and approval will occur prior to entry into the transaction. If advance review and approval is not practicable, the Audit Committee will review, and, in its discretion, may ratify the related person transaction. The policy also permits the Chair of the Audit Committee to review and, if deemed appropriate, approve proposed related person transactions that arise between Audit Committee meetings, subject to ratification by the Audit Committee at its next meeting. Any related person transactions that are ongoing in nature will be reviewed annually.
A related person transaction reviewed under the policy will be considered approved or ratified if it is authorized by the Audit Committee after full disclosure of the related person’s interest in the transaction. As appropriate for the circumstances, the Audit Committee will review and consider:
• the related person’s interest in the related person transaction;
• the approximate dollar value of the amount involved in the related person transaction;
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• the approximate dollar value of the amount of the related person’s interest in the transaction without regard to the amount of any profit or loss;
• whether the transaction was undertaken in the ordinary course of our business;
• whether the terms of the transaction are no less favorable to us than terms that could have been reached with an unrelated third party;
• the purpose of, and the potential benefits to us of, the transaction; and
• any other information regarding the related person transaction or the related person in the context of the proposed transaction that would be material to investors in light of the circumstances of the particular transaction.
The Audit Committee may approve or ratify the transaction only if the Audit Committee determines that, under all of the circumstances, the transaction is in the best interests of the Company and its stockholders. The Audit Committee may impose any conditions on the related person transaction that it deems appropriate.
In addition to the transactions that are excluded by the instructions to the SEC’s related person transaction disclosure rule, our Board of Directors has determined that the following transactions do not create a material direct or indirect interest on behalf of related persons and, therefore, are presumed not to be related person transactions for purposes of this policy:
• interests arising solely from the related person’s position as an executive officer of another entity (whether or not the person is also a director of such entity), that is a participant in the transaction, where (a) the related person and all other related persons own in the aggregate less than a 10% equity interest in such entity, (b) the related person and his or her immediate family members are not involved in the negotiation of the terms of the transaction and do not receive any special benefits as a result of the transaction, and (c) the amount involved in the transaction equals less than the greater of $200,000 or 5% of the annual gross revenues of the entity receiving payment under the transaction; and
• a transaction that is specifically contemplated by provisions of our charter or Bylaws.
The policy provides that transactions involving compensation of executive officers shall be reviewed and approved by our Compensation Committee in the manner specified in its charter.
Related Party Transactions
In addition to the compensation arrangements, including employment, termination of employment and change in control arrangements discussed above in the sections titled “Director Compensation” and “Executive Compensation,” we describe below transactions and series of similar transactions, since the beginning of our last fiscal year, to which we were a party or will be a party, in which:
• the amounts involved exceeded or will exceed $120,000; and
• any of our directors, nominees for director, executive officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household with, any of these individuals or entities, had or will have a direct or indirect material interest.
Transactions with Robert W. Duggan
On December 6, 2022, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $520 million. Pursuant to the Note Purchase Agreement, the Company issued to Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the amount of $400 million (the “Duggan February Note”) and $20 million (the “Zanganeh Note”), respectively, which matured and became due on February 15, 2023 and an unsecured promissory note to Mr. Duggan in the amount of $100 million (the “Duggan September Note” and together with the Duggan February Note and the Zanganeh Note, the “December 2022 Notes”), which was originally due on September 15, 2023. The maturity dates of the December 2022 Notes could have been extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024. In addition, if the Company consummates a public offering, then upon the later to occur of (i) five business days after the Company receives the net cash proceeds therefrom or (ii) May 15, 2023, the Duggan February Note and the Zanganeh Note shall be prepaid by an amount equal to the lesser of (a) 100% of the amount of the net proceeds of such offering and (b) the outstanding principal amount on such notes.
On January 19, 2023, the Company provided notice to extend the term of the Duggan February Note and Duggan September Note to a maturity date of September 6, 2024. Furthermore, on January 19, 2023, the Company and Mr. Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the
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Company may only prepay (i) the Duggan February Note following the completion of a public rights offering to be conducted by Summit in the approximate amount of $500 million (the “2023 Rights Offering”), or a similar capital raise, in an amount equal to the lesser of (x) the net proceeds of the Rights Offering or such capital raise or (y) the full amount outstanding of the Duggan February Note, and (ii) the Duggan September Note following the completion of a capital raising transaction subsequent to the 2023 Rights Offering in an amount equal to the lesser of (A) the net proceeds of such capital raise or (B) the full amount outstanding of the Duggan September Note. Following the issuance of the two new Promissory Notes (the “Duggan Promissory Notes”), the Duggan February Note and Duggan September Note were marked as “cancelled” on their faces and replaced in their entirety by the Duggan Promissory Notes (together with the Zanganeh Note, the “Notes”). The Notes accrue interest at an initial rate of 7.5%. All interest on the Notes were paid on the date of signing for the period through February 15, 2023. Such prepaid interest was paid in a number of shares of the Company’s common stock, par value $0.01 equal to the dollar amount of such prepaid interest, divided by $0.7913 (the consolidated closing bid price immediately preceding the time the Company entered into the Note Purchase Agreement, plus $0.01), which was 9,346,434 shares to Mr. Duggan and 373,857 shares to Dr. Zanganeh. For all applicable periods following February 15, 2023, interest shall accrue on the outstanding principal balance of the Notes at the US prime interest rate, as reported in the Wall Street Journal, plus 50 basis points, as adjusted monthly, for three months immediately following February 15, 2023, and thereafter at the US prime rate plus 300 basis points, as adjusted monthly. In connection with the closing of the 2023 Rights Offering, the $400 million Duggan February Note matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from the 2023 Rights Offering. During the year ended December 31, 2023, the Company made payments for interest of $10.7 million .
On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest shall accrue on the outstanding principal balance at the greater of 12% or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly. Interest shall be paid upon maturity of the loan.
On March 10, 2022, the Company entered into a note purchase agreement with Mr. Duggan, pursuant to which Mr. Duggan loaned the Company $25.0 million in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25.0 million (the “2022 Note”). The 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal, which was 3.25% as of the effective date. The 2022 Note became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25.0 million or (ii) 18 months from the date of issuance of the 2022 Note, and was repaid on August 10, 2022.
On August 16, 2022, 94,849,203 shares were purchased by Mr. Duggan in connection with the July 2022 rights offering (“2022 Rights Offering”).
Transactions with Dr. Mahkam Zanganeh
In December 2023, Dr. Zanganeh exercised warrants to purchase 805,495 shares. Refer to Note 20 in our consolidated financial statements contained in this Annual Report on Form 10-K for the warrants exercise activity for the year ended December 31, 2023.
As described above, on December 6, 2022, the Company entered into the Note Purchase Agreement with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to Mr. Duggan and Dr. Zanganeh the Notes in the aggregate amount of $520 million. Pursuant to the Note Purchase Agreement, the Company issued Dr. Zanganeh the Zanganeh Note in the amount of $20 million, which matured and became due on February 15, 2023. All interest on the Notes shall be paid on the date of signing for the period through February 15, 2023. Such prepaid interest was paid in a number of shares of the Company’s common stock equal to the dollar amount of such prepaid interest, which was 373,857 shares to Dr. Zanganeh. On February 15, 2023, the $20 million Zanganeh Note matured and the Company repaid the outstanding principal balance.
On August 16, 2022, (i) 184,430 shares were purchased by Dr. Zanganeh (ii) 4,593,777 shares were purchased by the Mahkam Zanganeh Revocable Trust, of which Dr. Zanganeh is a trustee, and (iii) 1,030,925 shares were purchased by the Shaun Zanganeh Irrevocable Trust, of which Dr. Zanganeh is a trustee in connection with the 2022 Rights Offering.
On May 12, 2021, 389,977 shares were purchased by the Mahkam Zanganeh Revocable Trust in connection with the 2021 Rights Offering.
On March 26, 2021, the Company entered into the Sublease with Dr. Zanganeh and Associates, Inc. (“MZA”) consisting of 4,500 square feet of space at 2882 Sand Hill Road, Menlo Park, CA (the “Sublease”). The Sublease runs until
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September 2022. The rent payable under the terms of the Sublease is equivalent to the proportionate share of the rent payable by MZA to the third party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2021, payments of $556 thousand were made pursuant to the sublease. During the year ended December 31, 2022, payments of $537 thousand were made pursuant to the sublease.
On July 25, 2022, the Company entered into the First Amendment, dated July 19, 2022 to the Sublease with MZA. The existing Sublease term, which was set to expire on September 30, 2022, was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the Sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2023, payments of $0.8 million , were made pursuant to the first amendment to the Sublease Agreement.
On July 29, 2022, the Company entered into the Second Amendment, dated August 1, 2022, to the Sublease with MZA. The Second Amendment was effective as of August 1, 2022 and expires on December 31, 2025. The Second Amendment includes an additional 1,277 square feet (the “ Expansion Premises”) of office space at 2882 Sand Hill Road, Menlo Park, California. The rent payable under the terms of the Sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2023 payments of $218 thousand, were made pursuant to the Secondment Amendment to the Sublease.
Transactions with Dr. Yu (Michelle) Xia
On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc. and its affiliates (“Akeso”) and certain ancillary transaction documents as set forth in the License Agreement. The License Agreement closed on January 17, 2023 following customary waiting periods, and both Akeso and Summit entered into the Common Stock Issuance Agreement (“Issuance Agreement”). Pursuant to the License Agreement and Issuance Agreement, Akeso elected to receive 10 million shares of Company common stock in lieu of cash and was paid $274.9 million in cash as the initial upfront payment. The $200 million remaining amount of the $500 million upfront payment was paid on March 5, 2023. The Company and Akeso also entered into Amendment No. 1 to the License Agreement, dated January 16, 2023 (the “License Agreement Amendment”), to modify the Akeso party receiving payments under the License Agreement from Akeso Biopharma Co., Ltd. to Akeso, Inc. Upon the closing of the License Agreement, the Board of Directors of the Company appointed Dr. Yu (Michelle) Xia, current Chief Executive Officer and Chairwoman of Akeso, to serve as a member of the Board of Directors pursuant to the terms of the License Agreement.
The Company paid approximately $2.5 million to Akeso during year ended December 31, 2023. As of December 31, 2023, the Company included in accrued expenses approximately $3.6 million due to Akeso.
Transactions with Mr. Manmeet Soni
On October 16, 2023, the Company announced the appointment of Mr. Manmeet Soni as its Chief Operating Officer, effective immediately. Mr. Soni has been a part of the Company’s Board of Directors since 2019. He will remain a member of the Board of Directors. In conjunction with his appointment, Mr. Soni entered into a share purchase agreement with the Company to purchase $5.0 million of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $1.68, resulting in the purchase of 2,976,190 shares of the Company’s common stock.
Indemnification Agreements
Our certificate of incorporation provides that we will indemnify our directors and officers to the fullest extent permitted by Delaware law. In addition, we have entered into indemnification agreements with all of our directors and named executive officers. These indemnification agreements may require us, among other things, to indemnify each such director or executive officer for some expenses, including attorneys’ fees, judgments, fines, and settlement amounts incurred by him or her in any action or proceeding arising out of his or her service as one of our directors or executive officers.
Employment Arrangements
We have entered into employment agreements with certain of our executive officers. For more information regarding the agreements with our named executive officers, see “Executive Compensation.”
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Item 14. Principal Accounting Fees and Services
Auditor Services and Fees
Policy on Audit Committee’s Pre-Approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
The Audit Committee reviews and pre-approves all audit and permissible non-audit services provided by the independent registered public accounting firm. These services may include audit services, audit-related services and tax services, as well as specifically designated non-audit services which, in the opinion of the Audit Committee, will not impair the independence of the independent registered public accounting firm. Pre-approval generally is provided for up to one year, and any pre-approval is detailed as to the particular service or category of services and generally is subject to a specific budget. The independent registered public accounting firm and the Company’s management are required to periodically report to the Audit Committee regarding the extent of services provided by the independent registered public accounting firm in accordance with this pre-approval, including the fees for the services performed to date. In addition, the Audit Committee also may pre-approve particular services on a case-by-case basis, as necessary or appropriate.
Auditor Fees
The following table sets forth the approximate aggregate fees billed to the Company by PricewaterhouseCoopers LLP for the years ending December 31, 2023 and 2022, respectively (in thousands):
Fee Category
Year Ended December 31, 2023
Year Ended December 31, 2022
Audit Fees
$ 1,175 $ 1,234
Audit-Related Fees
— —
Tax Fees
— —
All Other Fees
4 4
Total
$ 1,179 $ 1,238
Audit Fees: Audit fees for both years consisted of professional services rendered for: (i) the audit of our annual consolidated financial statements, (ii) statutory audits, (iii) the review of our consolidated financial statements included in our quarterly reports on Form 10-Q and (iv) audit services associated with other reports filed with the Securities and Exchange Commission.
Audit-Related Fees: Consists of fees for professional services that are reasonably related to the performance of the audit or review of the Corporation’s financial statements and which are not reported under “Audit Fees” above. There were no audit-related fees for the year ended December 31, 2023 and 2022, respectively.
Tax Fees: Consists of fees for professional services for tax compliance, tax advice and tax planning. There were no tax fees for the year ended December 31, 2023 and 2022, respectively.
All Other Fees: All other fees for the year ended December 31, 2023 and 2022, respectively, related to a subscription to a global research and disclosure software platform.
The Audit Committee has concluded that the provision of the non-audit services listed above was compatible with maintaining the independence of PricewaterhouseCoopers LLP.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
(1)
Financial Statements
As part of this Report, the consolidated financial statements are listed in the accompanying index to financial statements on page 106.
(2) Financial Statement Schedules
All financial statement schedules have been omitted because they are not applicable, not required, or the information required is shown in the consolidated financial statements or the notes thereto.
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(3) Exhibits
The exhibits filed as part of this Report are listed below.
Exhibit No. Description
2.1 Scheme of Arrangement, dated September 18, 2020 (incorporated by reference to Exhibit 99.1 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on July 27, 2020)
3.1 Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020 )
3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
3.3 Amendment to Restated Certificate of Incorporation of Summit Therapeutics Inc., as filed with the Delaware Secretary of State on July 27, 2022 (incorporated by reference to Exhibit 3.1 of Form 8-K filed by the Company on July 29, 2022, File No. 001-36866)
3.4 Amendment No. 2 to Restated Certificate of Incorporation, dated January 19, 2023 (incorporated by reference to Exhibit 5.1 of Form 8-K filed by the Company on January 20, 2023, File No. 001-36866)
4.1 Registration Rights Agreement, dated January 9, 2019, by and among Summit Therapeutics plc and Robert W. Duggan (incorporated by reference to Exhibit 2.1 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on January 10, 2019)
4.2 Form of Specimen Stock Certificate (incorporated by reference to Exhibit 4.2 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 29, 2020)
4.3 Form of Consultant Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
4.4 Form of Investor Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
4.5 Description of Securities Registered Under Section 12 of the Exchange Act (incorporated by reference to the description of securities contained in the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
4.6 Registration Rights Agreement, dated November 6, 2020, by and among Summit Therapeutics Inc., Polar Capital Funds plc - Biotechnology Fund and the Mahkam Zanganeh Revocable Trust (incorporated by reference to Exhibit 10.3 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on November 6, 2020)
4.7 Form of Subscription Rights Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on April 21, 2021)
10.1† Translation Award Funding Agreement, entered into as of October 19, 2012, by and between the Wellcome Trust Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 27, 2015)
10.2 Service Agreement, effective as of January 14, 2015, by and between Cambridge Innovation Center and Summit Therapeutics Inc. (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
10.3# 2005 Enterprise Management Incentive Scheme (incorporated by reference to Exhibit 4.3 to the Company’s Transition Report on 20-F (File No. 333-36866), as amended, filed with the Securities and Exchange Commission on April 30, 2020)
10.4# 2016 Long Term Incentive Plan (incorporated by reference to Exhibit 4.22 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
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Exhibit No. Description
10.5† License and Collaboration Agreement, dated October 3, 2016, by and between Summit (Oxford) Ltd. and Sarepta Therapeutics, Inc. (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
10.6 Lease, dated February 17, 2017, by and among MEPC Milton Park No. 1 Limited, MEPC Milton Park No. 2 Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.25 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
10.7† Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.26 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.8† Amendment of Solicitation/Modification of Contract (0001), dated June 19, 2018, to Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.13 to the Company’s Transition Report on 20-F (File No. 333-36866) filed with the Securities and Exchange Commission on March 29, 2019)
10.9+ Amendment of Solicitation/Modification of Contract (0002), dated August 14, 2018, to Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.14 to the Company’s Transition Report on 20-F(File No. 333-36866) filed with the Securities and Exchange Commission on March 29, 2019)
10.10+ Amendment of Solicitation/Modification of Contract (0003), dated February 14, 2019, to Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.15 to the Company’s Transition Report on 20-F (File No. 333-36866), filed with the Securities and Exchange Commission on March 29, 2019)
10.11† License and Commercialization Agreement, dated December 18, 2017, by and between Summit (Oxford) Ltd. and Eurofarma Laboratórios S.A. (incorporated by reference to Exhibit 4.27 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.12† (1)
Share Purchase Agreement, dated December 23, 2017, by and among Summit Therapeutics plc and the shareholders of Discuva Limited (incorporated by reference to Exhibit 4.28 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.13† Transfer Incentive Agreement, dated December 23, 2017, by and among Discuva Limited and certain of its managers (incorporated by reference to Exhibit 4.29 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.14 Lease, dated December 22, 2017, by and between Merrifield Centre Ltd and Discuva Limited (incorporated by reference to Exhibit 4.31 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.15† Equity and Revenue Sharing Agreement, dated October 16, 2017, by and between Summit (Oxford) Limited and the Wellcome Trust Limited (incorporated by reference to Exhibit 4.32 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.16 Form of Non-Executive Director Restricted Stock Unit (RSU) Agreement (incorporated by reference to Exhibit 4.33 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on April 13, 2018)
10.17 Securities Purchase Agreement, dated December 14, 2018, by and among Summit Therapeutics plc and Robert W. Duggan (incorporated by reference to Exhibit 10.1 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 17, 2018)
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Exhibit No. Description
10.18+ Amendment of Solicitation/Modification of Contract (0004), dated June 17, 2019, to Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.24 to the Company’s Transition Report on 20-f (File No. 333-36866) filed with the Securities and Exchange Commission on April 30, 2020)
10.19 Securities Purchase Agreement, dated December 6, 2019, by and among Summit Therapeutics plc and Robert W. Duggan (incorporated by reference to Exhibit 4.1 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 6, 2019)
10.20 Placing Agreement, December 6, 2019, by and between Summit Therapeutics plc and Nplus1 Singer Advisory LLP (incorporated by reference to Exhibit 4.2 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 6, 2019)
10.21 Consulting Agreement, dated December 6, 2019, by and between Summit Therapeutics plc and Maky Zanganeh & Associates, Inc. (incorporated by reference to Exhibit 4.4 to the Company ’ s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 6, 2019)
10.22 Relationship Agreement, dated December 14, 2018, by and among Summit Therapeutics plc, Robert W. Duggan and Cairn Financial Advisers LLP (incorporated by reference to Exhibit 10.2 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 17, 2018)
10.23 Deed of Termination, dated December 6, 2019, by and among Summit Therapeutics plc, Robert Duggan and Cairn Financial Advisers LLP (incorporated by reference to Exhibit 4.3 to the Company’s Report on Form 6-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 6, 2019)
10.24+ Amendment of Solicitation/Modification of Contract (0005), dated January 21, 2020, to Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) (incorporated by reference to Exhibit 4.36 to the Company’s Transition Report on 20-F (File No. 333-36866) filed with the Securities and Exchange Commission on April 30, 2020)
10.25 (1)
Securities Purchase Agreement, dated October 2, 2020, by and between Summit Therapeutics Inc. and Robert W. Duggan (incorporated by reference to Exhibit 10.1 to the Company ’ s Current Report on Form 8-K (File No. 001-36866) filed with the Securities and Exchange Commission on October 5, 2020)
10.26 (1)
Securities Purchase Agreement, dated November 6, 2020, by and between Summit Therapeutics Inc. and Polar Capital Fund plc - Biotechnology Fund (incorporated by reference to Exhibit 10.1 to the Company ’ s Current Report on Form 8-K (File No. 001-36866) filed with the Securities and Exchange Commission on November 6, 2020)
10.27 (1)
Securities Purchase Agreement, dated November 6, 2020, by and between Summit Therapeutics Inc. and Mahkam Zanganeh Revocable Trust (incorporated by reference to Exhibit 10.2 to the Company ’ s Current Report on Form 8-K (File No. 001-36866) filed with the Securities and Exchange Commission on November 6, 2020)
10.28# Form of Indemnification Agreement between Summit Therapeutics Inc. and each of its Executive Officers and Directors (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
10.29# Offer of Employment, dated May 21, 2020, by and between Summit Therapeutics Inc. and Michael Donaldson (incorporated by reference to Exhibit 10.25 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 29, 2020)
10.30# Contract of Employment, dated May 29, 2020, by and between Summit Therapeutics Inc. and Ventzislav Stefanov (incorporated by reference to Exhibit 10.26 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 29, 2020)
10.31# 2020 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
10.32# Form of Option Award under 2020 Stock Incentive Plan (incorporated by reference to Exhibit 10.28 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 29, 2020)
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Exhibit No. Description
10.33# Form of Restricted Stock Unit Agreement under 2020 Stock Incentive Plan (incorporated by reference to Exhibit 10.29 to the Company ’ s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 29, 2020)
10.34# 2020 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
10.35# Contract of Employment, dated November 22, 2020, by and between Summit Therapeutics Inc. and Mahkam Zanganeh (incorporated by reference to Exhibit 10.35 to the Company ’ s Annual Report on Form 10-K (File No. 001-36866), filed with the Securities and Exchange Commission on March 31, 2021)
10.36 Sublease Agreement, dated March 26, 2021, by and between Maky Zanganeh & Associates Inc. and Summit Therapeutics Sub Inc. (incorporated by reference to Exhibit 10.36 to the Company ’ s Annual Report on Form 10-K (File No. 001-36866), filed with the Securities and Exchange Commission on March 31, 2021)
10.37 Exit Agreement, dated May 28, 2021, by and between Summit Therapeutics Inc. and Michael Donaldson (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on May 28, 2021)
10.38 (1)
Note Purchase Agreement, dated March 10, 2022, by and between Summit Therapeutics Inc. and Robert W. Duggan (incorporated by reference to Exhibit 10.1 to the Company ’ s Current Report on Form 8-K (File. No. 001-36866), filed with the Securities and Exchange Commission on March 11, 2022)
10.39 Promissory Note, dated March 10, 2022, in the name of Robert W. Duggan (incorporated by reference to Exhibit 10.2 to the Company ’ s Current Report on Form 8-K (File. No. 001-36866), filed with the Securities and Exchange Commission on March 11, 2022)
10.40 Note Purchase Agreement, dated December 6, 2022, by and among Summit Therapeutics Inc., Robert W. Duggan, and Dr. Mahkam Zanganeh (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on December 6, 2022)
10.41† Collaboration and License Agreement ,dated December 5, 2022, by and between Akeso, Inc. and its affiliates and Summit Therapeutics Sub Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Form S-3 (File No. 333-268932) filed with the Securities and Exchange Commission on December 21, 2022)
10.42 Amendment No. 1 to Collaboration and License Agreement Amendment, dated January 16, 2023, by and among Summit Therapeutics Inc. and Akeso, Inc. (incorporated by reference to Exhibit 10.1 of Form 8-K filed by the Company on January 20, 2023, File No. 001-36866)
10.43 Common Stock Issuance Agreement, dated January 17, 2023, by and among Summit Therapeutics Inc. and Akeso, Inc. (incorporated by reference to Exhibit 10.2 of Form 8-K filed by the Company on January 20, 2023, File No. 001-36866)
10.44 Promissory Notes, dated January 19, 2023, by and among Summit Therapeutics Inc. and Robert W. Duggan (incorporated by reference to Exhibit 10.3 of Form 8-K filed by the Company on January 20, 2023, File No. 001-36866)
10.45#
Amended and Restated 2020 Stock Incentive Plan, dated July 27, 2022
10.46†
First Amendment to Sublease Agreement, dated July 25, 2022, by and among Summit Therapeutics Inc. and Maky Zanganeh and Associates, Inc.
10.47†
Second Amendment to Sublease Agreement, dated July 29, 2022, by and among Summit Therapeutics Inc. and Maky Zanganeh and Associates, Inc.
10.48#
Contract of Employment, dated April 15, 2022, by and between Summit Therapeutics Inc. and Ankur Dhingra
10.49 Employment Agreement, dated October 13, 2023, by and between Summit Therapeutics Inc. and Manmeet Soni
10.50 Securities P urchase Agreement, dated October 13, 2023, by and between Summit Therapeutics Inc. and Manmeet Soni
10.51*
Amended and Restated Promissory Note, dated February 17, 2024, by and between Summit Therapeutics Inc. and Robert W. Duggan .
14.1 Code of Business Conduct and Ethics of Summit Therapeutics Inc. Restated Certificate of Incorporation (incorporated by reference to Exhibit 14.1 to the Company’s Current Report on Form 8-K (File No. 001-36866), filed with the Securities and Exchange Commission on September 18, 2020 )
21.1* List of Significant Subsidiaries
23.1* Consent of PricewaterhouseCoopers LLP , an independent registered public accounting firm
101
Exhibit No. Description
31.1* Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
31.2* Certification of Co-Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
31.3* Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
32.1* Certification pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002
97.1*
S um mit Ther apeutics , Inc. Incentive-bas ed Compensation Clawback Policy
101.INS* Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH* Inline XBRL Taxonomy Extension Schema Document
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document
104* Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Filed herewith.
† Portions of this exhibit have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv) because the Registrant has determined that the information is not material and is the type that the Registrant treats as private or confidential.
+ Certain portions of this exhibit have been omitted because they are not material and would likely cause competitive harm to the registrant if disclosed.
(1) The schedules and exhibits have been omitted. A copy of any omitted schedule or exhibit will be furnished to the Securities and Exchange Commission upon request.
# Indicates management contract or compensatory plan or arrangement.
Item 16. Report Summary
None.
102
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SUMMIT THERAPEUTICS INC.
By: /s/ Robert W. Duggan
Name:
Title: Robert W. Duggan
Chief Executive Officer and Executive Chairman; Principal Executive Officer
By: /s/ Mahkam Zanganeh
Name:
Title: Dr. Mahkam Zanganeh
Chief Executive Officer, President and member of the Board; Principal Executive Officer
By: /s/ Ankur Dhingra
Name:
Title: Ankur Dhingra
Chief Financial Officer; Principal Financial Officer
Date: February 20, 2024
103
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name Title Date
/s/ Robert W. Duggan Chief Executive Officer and Executive Chairman ( Principal Executive Officer )
February 18, 2024
Robert W. Duggan
/s/ Mahkam Zanganeh Chief Executive Officer, President and Director
( Principal Executive Officer )
February 18, 2024
Dr. Mahkam Zanganeh
/s/ Manmeet Soni Chief Operating Officer and Director
February 18, 2024
Manmeet Soni
/s/ Ankur Dhingra Chief Financial Officer
(Principal Financial Officer)
February 18, 2024
Ankur Dhingra
/s/ Robert F. Booth Director February 16, 2024
Dr. Robert F. Booth
/s/ Alessandra Cesano Director February 16, 2024
Dr. Alessandra Cesano
/s/ Kenneth Clark Director February 16, 2024
Kenneth Clark
/s/ Ujwala Mahatme Director
February 18, 2024
Ujwala Mahatme
/s/ Yu Xia Director February 18, 2024
Dr. Yu Xia
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Summit Therapeutics Inc. Page
Index to the Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
106
Consolidated Balance Sheets
108
Consolidated Statements of Operations and Comprehensive Loss
109
Consolidated Statements of Stockholders ’ Equity
110
Consolidated Statements of Cash Flows
111
Notes to the Consolidated Financial Statements
112
105
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Summit Therapeutics Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Summit Therapeutics Inc. and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt About the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the consolidated financial statements, the Company has incurred losses and cash outflows from operations and has a note payable with a principal amount of $100 million maturing on April 1, 2025 that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accrued and Prepaid Research and Development Costs
As described in Notes 4 and 16 to the consolidated financial statements, included within prepaid expenses as of December 31, 2023 is $1.5 million of prepayments relating to research and development expenditures. Included within accrued liabilities as of December 31, 2023 is $7.3 million relating to research and development expenditures. The Company records accruals for
106
estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs. These amounts are determined by management based on the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. However, prepaid expenses decrease, and accrued liabilities increase as the activities progress, and if actual costs incurred exceed the prepaid expense, an accrual will be recorded for the liability. The key sensitivity is the estimated current stage of completion of each study or activity, which is based on information received from the supplier and management’s operational knowledge of the work completed under those contracts.
The principal considerations for our determination that performing procedures relating to accrued and prepaid research and development costs is a critical audit matter are the significant judgment by management when determining the estimated research and development costs, which in turn led to significant auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence related to estimated current stage of completion of each study or activity.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others, (i) evaluating management’s process on a sample basis for determining the current stage of completion of each study or activity; (ii) reading a sample of research and development contracts; (iii) evaluating the reasonableness of progress towards completion for a sample of research and development activities and the associated incurred cost based on invoices, external confirmations or other information received from the supplier; and (iv) testing the completeness and accuracy of the underlying data including total costs included within contracts and actual billed amounts for a sample of contracts.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 20, 2024
We have served as the Company’s auditor since 2021.
107
Summit Therapeutics Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31, 2023 December 31, 2022
Assets
Current assets:
Cash and cash equivalents $ 71,425 $ 348,607
Restricted cash — 300,000
Accounts receivable — 349
Short-term investments
114,817 —
Prepaid expenses 2,441 1,504
Other current assets 181 486
Research and development tax credit receivable 848 5,766
Total current assets 189,712 656,712
Non-current assets:
Property and equipment, net 204 906
Right-of-use assets 5,859 4,175
Goodwill 1,893 1,798
Research and development tax credit receivable 959 —
Other assets 4,322 577
Total assets $ 202,949 $ 664,168
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 2,667 $ 355
Accrued liabilities 8,783 10,664
Accrued compensation 5,429 5,641
Lease liabilities 2,809 1,690
Other current liabilities 717 662
Promissory note payable to related parties — 19,770
Total current liabilities 20,405 38,782
Non-current liabilities
Lease liabilities, net of current portion 3,290 2,763
Other non-current liabilities 1,562 1,429
Promissory notes payable to related parties 100,000 494,540
Total liabilities 125,257 537,514
Commitments and contingencies (Note 22)
Stockholders’ equity:
Preferred stock, $ 0.01 par value, 20,000,000 shares authorized; none issued and outstanding at December 31, 2023 and 2022, respectively
— —
Common stock, $ 0.01 par value: 1,000,000,000 shares authorized;
701,660,053 and 211,091,425 shares issued and outstanding at
December 31, 2023 and 2022, respectively
7,017 2,110
Additional paid-in capital 1,066,381 504,767
Accumulated other comprehensive loss ( 2,448 ) ( 1,893 )
Accumulated deficit ( 993,258 ) ( 378,330 )
Total stockholders’ equity
77,692 126,654
Total liabilities and stockholders’ equity
$ 202,949 $ 664,168
The accompanying notes are an integral part of the consolidated financial statements
108
Summit Therapeutics Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Year Ended December 31, 2023 Year Ended December 31, 2022
Revenue $ — $ 705
Operating expenses:
Research and development 59,471 51,999
General and administrative 30,265 26,743
In-process research and development 520,915 —
Impairment of intangible assets — 8,468
Total operating expenses 610,651 87,210
Other operating income 1,001 14,416
Operating loss ( 609,650 ) ( 72,089 )
Other expense, net ( 5,278 ) ( 6,693 )
Loss before income tax ( 614,928 ) ( 78,782 )
Net loss $ ( 614,928 ) $ ( 78,782 )
Net loss per share:
Basic and diluted $ ( 0.99 ) $ ( 0.41 )
Weighted average common shares outstanding:
Basic and diluted 619,646,180 193,336,063
Other comprehensive (loss) income:
Foreign currency translation adjustments ( 172 ) 304
Reclassification of cumulative currency translation gain to other expense, net
( 419 ) —
Unrealized gain on short-term investments
36 —
Comprehensive loss $ ( 615,483 ) $ ( 78,478 )
The accompanying notes are an integral part of the consolidated financial statements.
109
Summit Therapeutics Inc.
Consolidated Statements of Stockholders’ Equity
(in thousands, except share data)
Common Stock Additional Paid-In Capital Accumulated Other Comprehensive Loss Total Accumulated Deficit Total Stockholders’ Equity
Shares Amount
Balance at December 31, 2021
98,039,540 $ 980 $ 384,049 $ ( 2,197 ) $ ( 299,548 ) $ 83,284
2022 Rights Offering of common stock, net of offering costs of $ 111
103,092,783 1,031 98,858 — 99,889
Issuance of common stock in lieu of interest to related parties 9,720,291 97 7,497 — — 7,594
Issuance of common stock under stock purchase plans and exercise of stock options 238,811 2 397 — — 399
Stock-based compensation — — 11,948 — — 11,948
Imputed interest expense on promissory note payable to a related party — — 2,018 — — 2,018
Foreign currency translation adjustment — — — 304 — 304
Net loss — — — — ( 78,782 ) ( 78,782 )
Balance at December 31, 2022
211,091,425 $ 2,110 $ 504,767 $ ( 1,893 ) $ ( 378,330 ) $ 126,654
2023 Rights Offering of common stock, net of offering costs of $ 619
476,190,471 4,762 494,619 — — 499,381
Issuance of common stock under employee stock purchase plans and exercise of stock options
596,472 7 922 — — 929
Issuance of common stock in lieu of cash for Akeso upfront payment 10,000,000 100 45,800 — — 45,900
Private placement of common stock 2,976,190 30 4,970 — — 5,000
Exercise of warrants 805,495 8 1,195 — — 1,203
Stock-based compensation — — 14,108 — — 14,108
Unrealized gain on short-term investments
— — — 36 — 36
Reclassification of cumulative translation gain (Note 10)
— — — ( 419 ) — ( 419 )
Foreign currency translation adjustment — — — ( 172 ) — ( 172 )
Net loss — — — — ( 614,928 ) ( 614,928 )
Balance at December 31, 2023
701,660,053 $ 7,017 $ 1,066,381 $ ( 2,448 ) $ ( 993,258 ) $ 77,692
The accompanying notes are an integral part of the consolidated financial statements.
110
Summit Therapeutics Inc.
Consolidated Statements of Cash Flows
(in thousands)
December 31, 2023 December 31, 2022
Cash flows used in operating activities:
Net loss $ ( 614,928 ) $ ( 78,782 )
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on remeasurement of liabilities — ( 1,265 )
Non-cash interest expense
6,253 4,303
Amortization of discount on short-term investments
( 1,924 ) —
Unrealized foreign currency (gain) loss
( 812 ) 2,616
Reclassification of currency translation gain
( 419 ) —
Impairment of fixed assets
474 —
Amortization of operating right-of-use assets 1,852 1,251
Depreciation 198 349
Amortization of intangible assets — 914
Impairment of intangible assets — 8,468
Stock-based compensation 14,108 11,948
Loss on disposal of assets
( 109 ) —
In-process research and development expense 520,915 —
Changes in operating assets and liabilities:
Accounts receivable 359 975
Prepaid expenses ( 914 ) 5,107
Other current and long-term assets ( 3,421 ) 215
Research and development tax credit receivable 4,168 8,437
Deferred revenue and other income — ( 7,278 )
Accounts payable 2,263 ( 4,132 )
Accrued liabilities ( 2,377 ) 4,782
Accrued compensation ( 235 ) 1,609
Operating lease liabilities ( 2,211 ) ( 1,099 )
Net cash used in operating activities ( 76,760 ) ( 41,582 )
Cash flows used in investing activities:
Purchase of property and equipment
( 128 ) ( 624 )
Proceeds from sale of property. plant and equipment 226 —
Purchase of short-term investments ( 321,022 ) —
Maturities and sales of short-term investments 208,165 —
Payments to Akeso for upfront milestone payments and associated direct transaction costs
( 475,015 ) —
Net cash used in investing activities ( 587,774 ) ( 624 )
Cash flows provided by financing activities:
Proceeds from the issuance of common stock for rights offering
104,686 100,000
Transaction costs from the issuance of common stock for rights offering
( 619 ) ( 111 )
Proceeds from the issuance of common stock via private placement
5,000 —
Net receipts related to the exercise of warrants
1,203 —
Proceeds received related to employee stock purchase plan and exercise of stock options
929 399
Proceeds from related party promissory notes — 545,000
Re-payment of related party promissory notes ( 24,686 ) ( 25,000 )
Payments of related party promissory notes issuance costs — ( 44 )
Net cash provided by financing activities 86,513 620,244
Effect of exchange rates on cash and cash equivalents
839 ( 1,222 )
(Decrease) Increase in cash, cash equivalents and restricted cash
( 577,182 ) 576,816
Cash, cash equivalents and restricted cash at beginning of period
648,607 71,791
Cash, cash equivalents and restricted cash at end of period $ 71,425 $ 648,607
Supplemental Disclosure of Cash Flow Information
Cash paid for interest on related party promissory note $ 10,650 $ 434
Cash paid for income taxes
$ 52 $ —
Debt issuance costs in accrued expenses $ — $ 31
Consideration for the issuance of common stock for rights offering used to satisfy a portion of a related party promissory note (Note 18)
$ 395,314 $ —
Deferred transaction costs included in other non-current assets $ — $ 425
Leased assets obtained in exchange for operating lease liabilities $ 4,245 $ 2,860
Issuance of common stock pursuant to the Akeso License Agreement (Note 6)
$ 45,900 $ —
The accompanying notes are an integral part of the consolidated financial statements.
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Notes to Consolidated Financial Statements
1. Nature of Business and Operations and Recent Events
Nature of Business and Operations
Summit Therapeutics Inc. ( “ we”, “ Summit” or the “ Company”) is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. The Company ’ s pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology.
The Company’s current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule. On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc. and its affiliates (“Akeso”) pursuant to which the Company has in-licensed ivonescimab. Through the License Agreement (as defined in Note 6) , the Company obtained the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan (the “Licensed Territory”). The License Agreement and transaction closed in January 2023 following customary waiting periods. The Company’s operations will be focused on the development of ivonescimab and other future activities, as the Company determines.
The Company has begun its development for ivonescimab in non-small cell lung cancer ( “ NSCLC”), specifically launching Phase III clinical trials in the following indications:
a) ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor ( “ EGFR”)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor ( “ TKI”) (“HARMONi”); and
b) ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
As of the date of these financial statements, both studies are enrolling patients.
The entry into the License Agreement with Akeso represents a significant change in the Company’s strategy and its future operations will be focused on the development of ivonescimab and other future activities as the Company determines. The Company’s portfolio includes ridinilazole, a product candidate for treating patients suffering from Clostridioides difficile infection, also known as C. difficile infection, or CDI. All prior development and marketing activities related to ridinilazole have been terminated. The Company’s anti-infectives portfolio includes SMT-738, the first of a novel class of precision antibiotics for combating multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae (“CRE”) infections. The Company will continue to pursue partnerships for further development of SMT-738.
Recent Events
In addition to the events detailed in the Company Overview section above, the following other recent developments have occurred.
As noted above, on December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso pursuant to which the Company is in-licensing breakthrough bispecific antibody, ivonescimab (Note 6).
On December 6, 2022, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Mr. Robert Duggan and Dr. Maky Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $ 520,000 (Note 18) .
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
On January 19, 2023, the Company filed Amendment No. 2 to the Restated Certificate of Incorporation (the “Amendment No. 2”) with the Secretary of State of the State of Delaware to increase the number of authorized shares of its common stock by 650,000,000 (from 350,000,000 to 1,000,000,000 ), which became effective on such date.
On February 7, 2023, the Company commenced its previously announced rights offering (“2023 Rights Offering”). On March 1, 2023, the Company closed the 2023 Rights Offering, which was fully subscribed. The Company received aggregate gross proceeds from the 2023 Rights Offering of $ 500,000 from the sale of 476,190,471 shares of its common stock at a price per share of $ 1.05 . Issuance costs associated with the 2023 Rights Offering were approximately $ 619 . In connection with the closing of the 2023 Rights Offering, $ 400,000 of the unsecured promissory notes, issued by the Company to Mr. Duggan, matured and became due and the Company repaid the principal amount and all outstanding accrued interest thereunder using a portion of the proceeds from this 2023 Rights Offering (Note 18 ).
On February 15, 2023, $ 20,000 of the unsecured promissory notes, issued by us to Dr. Zanganeh, matured and the Company repaid the outstanding principal balance.
On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of its common stock at $ 0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of common stock issued in December 2022 to its Chief Executive Officers, Mr. Robert Duggan and Dr. Mahkam Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company (Note 18 ). On April 27, 2023, the SEC issued a Notice of Effectiveness for the registration statement on Form S-3 filed with the SEC.
On October 12, 2023, the Company held a Special Meeting of Stockholders (the “October Special Meeting”) whereby an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan (the “Plan”) to increase the number of shares of the Company ’ s common stock issuable under the Plan by 70,000,000 shares was approved by a vote of the Company’s stockholders at the Special Meeting and subsequently ratified by the Board of Directors.
On October 16, 2023, the Company announced the appointment of Mr. Manmeet Soni as its Chief Operating Officer, effective immediately. Mr. Soni has been a part of the Company ’ s Board of Directors since 2019. He will remain a member of the Board of Directors. In conjunction with his appointment, Mr. Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $ 1.68 , resulting in the purchase of 2,976,190 shares of the Company ’ s common stock.
On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest shall accrue on the outstanding principal balance at the greater of 12 % or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly (Note 18 ). Interest shall be paid upon maturity of the loan.
2. Basis of Presentation, Use of Estimates, and Risks and Uncertainties
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued research and development expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
3. Liquidity and Capital Resources
During the year ended December 31, 2023, the Company incurred a net loss of $ 614,928 and cash flows used in operating activities was $ 76,760 . As of December 31, 2023, the Company had an accumulated deficit of $ 993,258 , and cash and cash equivalents and short term investments in U.S. treasury securities of $ 186,242 . The Company expects to continue to generate operating losses for the foreseeable future.
The Company has evaluated whether its cash, cash equivalents, short-term investments and U.K. research and development tax credits provide sufficient cash to fund its operating cash needs for the next twelve months from the date of issuance of these annual financials. The Company is investing in the clinical development of ivonescimab, including its ongoing clinical trials. In addition, the Company has a $ 100,000 promissory note payable to a related party (refer to Note 18 for further details) that matures on April 1, 2025. Based upon the Company's cash and cash equivalents and short-term investments as of December 31, 2023, the Company expects to be able to operate into the first quarter of 2025. In order to further fund the Company's operating cash needs and repay this promissory note, the Company intends to raise additional capital. As of the date of the issuance of these financial statements the additional capital has not been secured. As a result, these conditions raise substantial doubt about the Company's ability to continue as a going concern.
Until the Company can generate substantial revenue and achieve profitability, the Company will need to raise additional capital to fund its ongoing operations and capital needs. The Company continues to evaluate options to further finance its operating cash needs for its product candidates through a combination of some, or all, of the following: equity and debt offerings, collaborations, strategic alliances, grants and clinical trial support from government entities, philanthropic, non-government and not-for-profit organizations, and marketing, distribution or licensing arrangements. There is no assurance, however, that additional financing will be available when needed or that management of the Company will be able to obtain financing on terms acceptable to the Company. If the Company is unable to obtain funding when required in the future, the Company could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects.
The accompanying consolidated financial statements are prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of the business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classifications of liabilities that might result from the outcome of this uncertainty.
4. Summary of Significant Accounting Policies
The significant accounting policies adopted by the Company in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.
Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The consolidated financial statements reflect the accounts of Summit Therapeutics Inc. and its wholly owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation.
Foreign Currency Translation
The financial statements of the Company’s subsidiaries with functional currencies other than the United States ( “ U.S. ” ) dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
accumulated other comprehensive (loss) income in shareholders’ equity. Foreign currency transaction gains and losses are included in other expen se, net in the results of operations. The Company recorded realized and unrealized foreign currency transaction gains (losses) of $ 613 and ($ 4,109 ) for the years ended December 31, 2023 and 2022, respectively, which is included in other expense, net in the statements of operations and comprehensive loss.
Other Operating Income
The Company generates income from government contracts that reimburse the Company for certain allowable costs for funded projects. For contracts with government agencies where the funding arrangement is considered central to the Company’s ongoing operations, the Company classifies the recognized funding received as other operating income.
Income from government grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. If the government agency approves the project proposed by the Company, the government agency funds the project upon receipt of the support for the costs incurred up to the contract limit. Income recognized upon incurring qualifying expenses in advance of billing is recorded as unbilled receivable, a component of other current assets, in the consolidated balance sheet.
Grant income is not recognized as deductions of research and development costs because the Company acts as the principal in conducting the research and development activities and these contracts are central to its ongoing operations. The funds received through these means are held as deferred income in the consolidated balance sheets and are released to the consolidated statement of operations and comprehensive loss, classified as other operating income, as the underlying expenditure is incurred and to the extent the conditions of the grant are met. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations and comprehensive loss.
The Company benefits from two U.K. research and development (“R&D”) tax credit cash rebate regimes: Small and Medium Enterprise (“SME”) Program and the Research and Development Expenditure Credit (“RDEC”) Program. Each reporting period, management evaluates which tax relief programs the Company is expected to be eligible for and records as other operating income the portion of the expense that it expects to qualify under the programs, that it plans to submit a claim for, and it has reasonable assurance that the amount will ultimately be realized. Based on criteria established by HM Revenue and Customs (“HMRC”), management of the Company expects a proportion of expenditures being undertaken in relation to its pipeline research, clinical trials management and manufacturing development activities to be eligible for the research and development tax relief programs for the year ended December 31, 2023. Qualifying expenditures largely comprise of employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs incurred as part of research projects for which the Company does not receive commercial or other funding income. Credits related to the SME and RDEC Programs are recorded as other operating income in the consolidated statements of operations and other comprehensive (loss)/income. Under the SME scheme, the Company receives cash rebate payments of up to 33.3% up to March 31, 2023 and 18.6% from April 1, 2023 of eligible research and development expenditures, and under the RDEC scheme the Company receives cash rebate payments of up to 10.53% up to March 31, 2023 and 15% from April 1, 2023 of eligible research and development expenditure, and these payments are not dependent on the Company’s pre-tax net income levels. The Company has qualified under the more favorable SME regime and expects such elements of expenditures will also continue to be eligible for the SME regime for future periods.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the diluted net loss by the weighted-average number of common shares outstanding for the period, including potentially dilutive common shares. The dilutive effect of share options and warrants are determined under the treasury stock method using the average market price for the period. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options and warrants that are in-the-money.
115
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Business Combinations
Business combinations are accounted for under the acquisition method. Acquired assets and assumed liabilities are measured at their fair values at the acquisition date. The excess of the consideration transferred over the net fair value of assets acquired and liabilities assumed is recorded as goodwill. The accounting for an acquisition involves a considerable amount of judgement and estimation. Cost, income, market or a combination of approaches may be used to establish the fair value of consideration exchanged, assets acquired, and liabilities assumed, depending on the nature of those items. The valuation approach is determined in accordance with generally accepted valuation methods. Key areas of estimation and judgment may include the selection of valuation approaches, cost of capital, market characteristics, cost structure, impacts of synergies, and estimates of terminal value, among other factors.
While the Company uses estimates and assumptions as part of the purchase price allocation process to estimate the value of assets acquired and liabilities assumed, estimates are inherently uncertain and subject to refinement. During the measurement period, which maybe up to one year from the acquisition date, the Company may record adjustments to the assets acquired and liabilities assumed, with a corresponding offset to goodwill, to the extent that adjustments are identified to the preliminary purchase price allocation. Upon conclusion of the measurement period, or final determination of the value of the assets acquired and liabilities assumed, whichever comes first, any subsequent adjustments are recorded to results of operations. Results of operations related to business combinations are included prospectively beginning with the date of acquisition and transaction costs related to business combinations are recorded within general and administrative expenses.
Goodwill
Goodwill represents the excess of the consideration transferred over the fair value of net assets acquired. Goodwill is assigned to reporting units at the time of acquisition or when there is a change in the reporting structure and bases that allocation on which reporting units will benefit from the acquired assets and liabilities. Reporting units are defined as operating segments or one level below an operating segment, referred to as a component. Typically acquisitions related to a single reporting unit do not require the allocation of goodwill to multiple reporting units. If the products obtained in an acquisition are assigned to multiple reporting units, the goodwill is distributed to the respective reporting units as part of the purchase price allocation process.
The Company assesses goodwill for impairment on an annual basis or more frequently when events and circumstances occur indicating that the recorded goodwill may be impaired. The Company regularly monitors current business conditions and other factors including, but not limited to, adverse industry or economic trends and lower projections of profitability that may impact future operating results. The process of evaluating the potential impairment of goodwill requires significant judgment. In performing the Company’s annual goodwill impairment test, the Company is permitted to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company’s reporting unit is less than its carrying amount, including goodwill. In performing the qualitative assessment, the Company considers certain events and circumstances specific to the reporting unit and to the entity as a whole, such as macroeconomic conditions, industry and market considerations, overall financial performance and cost factors when evaluating whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. The Company is also permitted to bypass the qualitative assessment and proceed directly to the quantitative test. If the Company chooses to undertake the qualitative assessment and concludes that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, the Company would then proceed to the quantitative impairment test. In the quantitative assessment, the Company compares the fair value of the reporting unit to its carrying amount, which includes goodwill. If the fair value exceeds the carrying value, no impairment loss exists. If the fair value is less than the carrying amount, a goodwill impairment loss is measured and recorded.
The Company assesses goodwill for impairment on an annual basis as of December 31 or more frequently when events and circumstances occur indicating that recorded goodwill may be impaired.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Cost is comprised of the purchase price plus any incidental costs of acquisition and commissioning.
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Depreciation is calculated based on cost, less residual value, in equal annual installments over the estimated useful lives of the assets. The residual value, if significant, is reassessed annually.
Laboratory equipment 2 - 10 years
Furniture and fixtures, office equipment and software
3 - 5 years
Leasehold improvements Over the shorter of the asset ’ s useful life or the remaining lease term
Depreciation is recognized as part of the general and administrative and research and development expense lines shown on the face of the consolidated statement of operations and comprehensive loss depending on the nature of the underlying assets.
Expenditures for repairs and maintenance are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations.
Leases
The Company has operating leases for real estate. The Company does not have any finance leases. Under ASC 842, a contract is or contains a lease when the lessee has the right to control the use of an identified asset. The Company determines if an arrangement is a lease at inception of the contract, which is the date on which the terms of the contract are agreed to and the agreement creates enforceable rights and obligations. The lease term used to calculate the lease liability include options to extend or terminate the lease when it is reasonably certain that the option will be exercised.
At the lease commencement date, the Company measures and recognizes a lease liability and a right-of-use asset in the financial statements. Lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. The right-of use asset is measured by taking the present value of future lease payments, plus any incremental direct costs incurred, less any lease incentives received. As most of the Company ’ s leases do not provide an implicit rate, the Company uses an estimated incremental borrowing rate based on the lease term and the economic environment of the lease at the lease commencement date, which is then utilized to determine the present value of future lease payments. Lease expense for minimum lease payments are recognized on a straight-line basis over the lease term, with variable lease payments recognized in the periods in which they are incurred.
The Company has existing lease agreements with lease and non-lease components, has elected to account for the lease and non-lease components as a single lease component, and has allocated all of the contract consideration to the lease component only.
Leases with an initial lease term of 12 months or less are not recorded on the balance sheet. The Company recognizes lease expense for its short-term leases on a straight-line basis over the lease term.
Acquired In-Process Research and Development
The Company may enter into agreements with collaboration partners for the development and commercialization of its products. These arrangements may include payments contingent on the occurrence of certain events such as development, regulatory or sales-based milestones. The Company considers the unique nature, terms and facts and circumstances of each transaction. The Company considers whether or not the assets acquired have a future alternative use.
The fair value associated with acquired in-process research and development which does not have an alternative future use is expensed and is recorded as research and development expense. Any development or commercial milestone payments are recognized when the achievement of the associated milestone becomes probable and will either be expensed or capitalized depending upon whether or not regulatory approval has been obtained.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop product candidates, including personnel expenses, stock-based compensation expense, allocated facility-related and depreciation expenses, third-party license fees and external costs of outside vendors engaged to conduct
117
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered. Milestone and other payments made to third-parties with respect to in-process research and development, in accordance with the Company’s license, acquisition and other similar agreements are expensed when determined to be probable and estimable.
The Company has entered into various research and development contracts with other companies. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs or prepaid expenses where the payments made exceeds the estimated costs. When evaluating the adequacy of these balances, the Company analyzes progress of the studies, including the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. Actual results could differ from the Company’s estimates. In all cases, the full cost of each study or activity is expensed by the time the final report or where applicable, product, has been received. The Company’s historical estimates have not been materially different from the actual costs.
Stock-Based Compensation
The Company measures and recognizes compensation expense for all stock option and restricted stock unit awards based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards. Additionally, the Company uses a Monte Carlo simulation model to calculate the estimated fair value on the date of grant related to awards with market-based service conditions. The fair value is recognized as expense, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis for each separately vesting portion of the award when the only condition to vesting is continued service. If vesting is subject to a market or performance condition, recognition is based on the derived service period of the award. Expense for awards with performance conditions is estimated and adjusted on a quarterly basis based upon the assessment of the probability that the performance condition will be met. Use of the Black-Scholes option-pricing model requires management to apply judgment under highly subjective assumptions. These assumptions include:
• Expected term—The expected term of stock options represents the weighted-average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the Securities and Exchange Commission. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.
• Expected volatility—The expected volatility is calculated based on historical volatility of the Company ’ s share price.
• Risk-free interest rate—The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options.
• Expected dividend—The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not intend to pay dividends.
The Company estimates expected forfeitures at the time of grant instead of accounting for forfeitures as they occur. Stock option and restricted stock unit awards have been granted at fair value to non-employees in connection with research and consulting services provided to the Company. Equity awards generally vest over terms of 3 or 4 years.
The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified.
Income Taxes
The provision for income taxes is determined using the asset and liability approach. Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements. A current asset or liability is recognized for the estimated taxes receivable or payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes are initially recognized at enacted tax rates in force at the time of initial recognition and are subsequently adjusted for any enacted changes in tax rates
118
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
and tax laws. Subsequent changes to deferred taxes originally recognized in equity are recognized in income. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The Company has recorded a full valuation allowance against the deferred tax assets in excess of its deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The Company records interest and penalties related to income tax matters as part of income tax expense.
The Company accounts for uncertainty in income taxes by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed as the amount of benefit to recognize in the consolidated financial statements. The amount of benefits that may be used is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate, as well as the related net interest and penalties. At December 31, 2023 and 2022, the Company had unrecognized tax positions of $ 1,064 and $ 0 , respectively. Due to the Company ’ s full valuation allowance, the unrecognized tax benefits would not materially impact the Company ’ s effective tax rate when recognized. The Company does not anticipate the total amount of unrecognized tax benefits to significantly increase or decrease in the next 12 months. The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision. For the years ended December 31, 2023and 2022, the Company had no interest or penalties related to unrecognized tax benefits.
Concentration of Credit Risk and of Significant Supplier
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of short-term cash deposits and accounts and other receivables. The Company’s cash is comprised of short-term cash deposits at a variety of financial institutions with strong credit ratings in amounts that may exceed federally insured limits and has not experienced any losses on such accounts. Cash balances maintained during the year have been principally held with reputable U.K.-based and U.S.-based banks. The Company does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The credit risk with respect to customers and funding bodies is limited as the Company has only a small number of these arrangements.
The Company relies, and expects to continue to rely, on a number of vendors to conduct its clinical trials and preclinical studies, manufacture drug product and supply clinical trial and preclinical study materials for its development programs. These programs could be adversely affected by a significant interruption in these services or the availability of materials.
Fair Value Measurements
In accordance with the provisions of fair value accounting, a fair value measurement assumes that the transaction to sell an asset or transfer a liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market for the asset or liability and defines fair value based on the exit price model.
The fair value measurement guidance establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The guidance describes three levels of inputs that may be used to measure fair value:
Level 1
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Quoted prices in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 2 assets and liabilities include debt securities with quoted prices that are traded less frequently than exchange-traded instruments or securities or derivative contracts that are valued using a pricing model with inputs that are observable in the market or can be derived principally from or corroborated by observable market data.
Level 3
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the Company categorizes such assets and liabilities based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset.
Cash and Cash Equivalents
The Company considers only those investments that are highly liquid, readily convertible to cash and that mature within 90 days or less from date of purchase to be cash equivalents. As of December 31, 2023 and 2022 , cash equivalents were comprised of a money market funds and U.S. treasury securities with maturities less than 90 days from the date of purchase.
Restricted Cash
Restricted cash of $ 300,000 as of December 31, 2022, represents amounts which are legally restricted to withdrawal or usage and is presented in the Consolidated Balance Sheet as restricted cash. On December 15, 2022, the Company transferred $ 300,000 into an escrow fund reserved for the Company ’ s initial upfront payment to Akeso in connection with the License Agreement, as described further in Note 6 . Following the Antitrust Clearance Date, on January 17, 2023, the License Agreement closed and Akeso was issued 10,000,000 shares of Company common stock pursuant to the Common Stock Issuance Agreement and was paid $ 274,900 in cash as initial upfront payment. The remaining amounts in escrow were returned to the Company ’ s operating cash accounts.
Assumed Contingent Liabilities
As part of the acquisition of Discuva Limited in December 2017, the Company assumed certain contingent liabilities as certain employees, former employees and former directors of Discuva Limited are eligible for payments from Discuva Limited based on specified development and clinical milestones related to proprietary product candidates developed under the Discuva Platform. The timing of these potential payments is uncertain. The fair value of the assumed contingent liability was estimated using the expected value of the payments. The assumed contingent liabilities are subsequently measured at amortized cost using discounted cash flow models which calculate the risk adjusted net present values of estimated potential future cash flows of the payments. The assumed contingent liabilities are remeasured when there is a specific significant event that provides evidence of a significant change in the probability of successful development and clinical milestones being achieved. The models will be updated for changes in the probability of successful development and clinical milestones being achieved and other associated assumptions with the discount factor remaining unchanged within the model. A discount factor of 13 % has been used to discount the contingent liabilities back to net present value. This discount factor has been calculated using appropriate measures and rates which could have been obtained in the period that the contingent liabilities were assumed. Accretion of the discount
120
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
factor and gains or losses upon remeasurement are recognized as part of operating expenses in the consolidated statements of operations and comprehensive loss.
Warrants
Warrants issued by the Company are recognized and classified as equity when, upon exercise, the Company would issue a fixed amount of its own equity instruments (common stock) in exchange for a fixed amount of cash or another financial asset.
Consideration received, net of incremental costs directly attributable to the issue of such new warrants, is shown in equity. Such warrants are not remeasured at fair value in subsequent reporting periods.
Warrants issued in which external services are received as consideration for equity instruments of the company should be measured at the fair value of the goods or services received. Only if the fair value of the services cannot be measured reliably would the fair value of the equity instruments granted be used. The fair value for the warrants is calculated using the Black-Scholes formula and recorded in the consolidated statement of operations and comprehensive loss on a straight-line basis over the period of the consulting services. If the services are terminated prior to the end of the consultancy agreement, the warrants cease vesting and any unvested portion of the warrants will lapse immediately.
The warrants in issue are classified within stockholders’ equity as they are indexed to the Company ’ s own shares of common stock and require settlement in its shares of common stocks with no provision for any cash settlement.
5. Recently Issued or Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards update “ASU” No. 2023-09, “Improvements to Income Tax Disclosures”, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the income tax disclosures within the consolidated financial statements.
In November 2023, the FASB issued ASU No. 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption is permitted, and the amendments should be applied retrospectively. The Company is currently evaluating the impact of the ASU on the consolidated financial statement disclosures.
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments”, which has subsequently been amended by ASU 2019-04 and ASU 2019-10 (collectively “ASU 2016-03”). ASU 2016-13 amends the guidance on the impairment of financial instruments. This update adds an impairment model (known as the current expected credit losses model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes, as an allowance, its estimate of expected credit losses. The Company adopted this standard on January 1, 2023, and it did not have a material impact on the consolidated financial statements or related disclosures.
Other recent authoritative guidance issued by the FASB (including technical corrections to the FASB ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not expected to have a material impact on the Company ’ s consolidated financial statements.
6. Akeso License and Collaboration Agreement
On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso pursuant to which the Company is in-licensing its breakthrough bispecific antibody, ivonescimab. The License Agreement and transaction closed in January 2023 following customary waiting periods.
121
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Ivonescimab, known as AK112 in China and Australia, and also as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody intending to combine the benefits of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. Ivonescimab was engineered to bring two well established oncology targeted mechanisms together. Ivonescimab is currently in clinical development and, pursuant to the terms of the License Agreement, Summit will design and conduct the clinical trial activities to support regulatory filings in the Licensed Territory that Summit will submit. Pursuant to the terms of the License Agreement, Summit will have final decision making authority with respect to commercial strategy, pricing and reimbursement and other commercialization matters in the Licensed Territory. In connection with the License Agreement, the Company has also entered into a Supply Agreement with Akeso, pursuant to which Summit agrees to purchase a certain portion of drug substance for clinical and commercial supply. Summit is not assuming any liabilities (including contingent liabilities), acquiring any physical assets or trade names, or hiring or acquiring any employees from Akeso in connection with the License Agreement. Through the License Agreement, the Company obtained the rights to develop and commercialize SMT112 in the United States, Canada, Europe, and Japan (the “Licensed Territory”).
In exchange for the rights obtained, an upfront payment of $ 500,000 was made to Akeso, of which $ 274,900 was paid in cash and, pursuant to the License Agreement and Issuance Agreement, Akeso elected to receive 10,000,000 shares of our common stock in lieu of $ 25,100 cash. The remaining $ 200,000 amount of the upfront payment was paid on March 6, 2023.
The Company has accounted for the License Agreement to acquire the rights to develop and commercialize SMT112 as the acquisition of an asset. All of the consideration relates to SMT112 and technological feasibility of the asset has not yet been established since SMT112 is in clinical development. As such, the Company has expensed the consideration as in-process research and development upon closing of the transaction in the consolidated statement of comprehensive loss. In-process research and development expense for the year ended December 31, 2023 was $ 520,915 , which is comprised of the $ 474,900 paid in cash, the fair value of the 10,000,000 shares of common stock on the date of closing the transaction of $ 45,900 , and $ 115 of direct transactions costs incurred.
In addition to the payments already made to Akeso, under the License Agreement, there are additional potential milestone payments of up to $ 4,500,000 , as Akeso will be eligible to receive regulatory milestones of up to $ 1,050,000 and commercial milestones of up to $ 3,450,000 . In addition, Akeso will be eligible to receive low double-digit royalties on net sales.
7. Segment Reporting
The Company ’ s chief operating decision makers (the “CODM function”), which are the Company ’ s Chief Executive Officers, Mr. Duggan and Dr. Zanganeh, utilize consolidated financial information to make decisions about allocating resources and assessing performance for the entire Company. The CODM function approves of key operating and strategic decisions, including key decisions in clinical development and clinical operating activities, entering into significant contracts, such as revenue contracts and collaboration agreements and approves the Company’s consolidated operating budget. The CODM function views the Company’s operations and manages its business as a single reportable operating segment. The Company’s single operating segment covers the Company’s research and development activities, primarily comprising of oncology product research activities (including ivonescimab), antibiotic pipeline research activities, and CDI program activities. As the Company operates in one operating segment, all required financial segment information can be found in the consolidated financial statements.
The Company operates in two geographic regions: the U.K. and the U.S. The following table summarizes the Company’s long-lived assets, which include the Company’s property and equipment, net and right-of-use assets by geography:
Year Ended December 31, 2023 Year Ended December 31, 2022
United Kingdom (1)
$ 808 $ 2,517
United States (2)
5,254 2,564
$ 6,062 $ 5,081
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
(1) The decrease of long-lived assets in the United Kingdom is primarily attributed to the Company exiting its lease for its Sawston, United Kingdom location.
(2) The increase of long-lived assets in the United States is primarily attributed to additional right-of-use assets recorded related to the Company’s amendment to its sublease agreement during the period for its Menlo Park, California, U.S. location.
For details of revenue from external customers by geography refer to Note 8.
8. Revenue
The Company recognized no revenue and $ 705 during the year ended December 31, 2023 and 2022, respectively.
Revenue recognized during the year ended December 31, 2022 consists of amounts received from the Company ’ s license and commercialization agreement with Eurofarma Laboratórios S.A. Revenue recognized during the year ended December 31, 2022 was from Latin America. The analysis of revenue by geography has been identified on the basis of the geographical location of each collaboration partner.
The following table summarizes the deferred revenue relating to Eurofarma Laboratórios S.A. and deferred other income relating to BARDA (as defined in Note 9):
2023
2022
Beginning deferred revenue and other income, January 1
$ — $ 7,939
Additions — 1,397
Amount of deferred revenue and other income recognized in the statement of operations — ( 8,790 )
Foreign currency adjustment — ( 546 )
Ending deferred revenue and other income, December 31
$ — $ —
Refer to Note 9 below for further details regarding other income recognized under the BARDA contract.
9. Other Operating Income, net
The following table sets forth the components of other operating income by category:
Year Ended December 31, 2023 Year Ended December 31, 2022
Funding income from BARDA (as defined below) $ — $ 8,085
Research and development tax credits 946 4,523
Grant income from CARB-X (as defined below) 45 1,808
Other income
10 —
$ 1,001 $ 14,416
BARDA (as defined below)
In September 2017, the Company was awarded a funding contract from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services, in support of the Company’s Ri-CoDIFy clinical trials and clinical development of ridinilazole. The awarded contract was originally worth up to $ 62,000 . In June 2019 and again in January 2020, BARDA increased the value of the contract such that it is now worth up to $ 72,500 and brought the total amount of committed funding to $ 62,400 .
The remaining federal government funding is dependent on BARDA in its sole discretion exercising the final independent option work segment, upon the achievement by the Company of certain agreed-upon milestones for ridinilazole. This option work segment was never exercised by BARDA. The contract ran through April 2022 and was extended through December 2022
123
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
as a no cost contract, solely to close out open activities. As of December 31, 2022, based on translation of historical foreign currency amounts in the period of recognition, the Company has recognized $ 59,203 of cumulative income since contract inception. As a result of the Company ’ s decision, on September 28, 2022, to not pursue further internal clinical development of ridinilazole and seek partners or a divestiture related to ridinilazole as a path forward for the clinical development of the asset, the Company recorded expenses for the remaining clinical trial costs associated with the close out activities of ridinilazole and recognized the remainder of the deferred income that had been received from BARDA prior to the expenses being recognized during the third quarter of 2022.
Research and development credits
Income from tax credits, consist of R&D tax credits received in the U.K. The Company benefits from two U.K. research and development tax credit cash rebate regimes: Small and Medium Enterprise Program (“SME, Program”) and the Research and Development Expenditure Credit Program (“RDEC Program”). Qualifying expenditures largely comprise of employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs incurred as part of research projects for which the Company does not receive income. Tax credits related to the SME Program and RDEC Program are recorded as other operating income in the consolidated statements of operations and other comprehensive loss. Under both schemes, the Company receives cash payments that are not dependent on the Company’s pre-tax net income levels.
Based on criteria established by His Majesty’s Revenue and Customs (“HMRC”), a portion of expenditures being carried out in relation to the Company ’ s pipeline research and development, clinical trials management and third-party manufacturing development activities are eligible for the SME regime and the Company expects such elements of research and development expenditure incurred in its UK entities will also continue to be eligible for the SME regime for future periods.
As of December 31, 2023 and 2022, the current and long-term research and development tax credit receivable was $ 1,807 and $ 5,766 , respectively.
CARB-X (as defined below)
In May 2021, the Company announced the selection of a new preclinical candidate, SMT-738, from the DDS-04 series for development in the fight against multi-drug resistant infections, specifically Carbapenem-resistant Enterobacteriaceae (“CRE”) infections. Simultaneously, the Company announced it had received an award from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator program (“CARB-X”) to progress this candidate through preclinical development and Phase Ia clinical trials. The award commits initial funding of up to $ 4,100 , with the possibility of up to another $ 3,700 based on the achievement of future milestones. As of December 31, 2023, based on translation of historical foreign currency amounts in the period that the amounts were recognized, the Company has recognized $ 2,920 of cumulative income since contract inception. During the quarter ended September 30, 2022, CARB-X announced changes to its funding arrangements and terms and conditions. As a result, the current arrangement concluded as of June 30, 2022, however the Company has the ability to recognize reimbursements for any milestone payments related to work incurred subsequent to this date in accordance with this agreement.
10. Other (Expense) Income, net
The following table sets forth the components of other (expense) income:
124
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Year Ended December 31, 2023 Year Ended December 31, 2022
Foreign currency gains (losses) $ 613 $ ( 4,109 )
Interest expense on promissory notes payable to related parties ( 16,461 ) ( 4,401 )
Interest income 10,403 1,513
Reclassification of cumulative currency translation gain (1)
419 —
Other (expense) income, net
( 252 ) 304
$ ( 5,278 ) $ ( 6,693 )
_____________________
(1) Effective January 17, 2023, the Company dissolved the following dormant entities; Summit (Cambridge) Limited, Summit (Wales) Limited, Summit Corporation Employee Benefit Trust Company Limited, Summit Corporation Limited, Summit Discovery 1 Limited and Summit Infectious Diseases Limited. As a result, the Company reclassified $ 419 of cumulative foreign currency translation adjustments from accumulated other comprehensive loss relating to these entities.
For the year ended December 31, 2023, other expense, net primarily consisted of loan interest expense incurred related to the promissory notes described in Note 18. These amounts are partially offset in the year ended December 31, 2023 by interest income related to the Company’s money market funds and the Company’s short-term investments in U.S. treasury securities and favorable changes in foreign currency.
For the year ended December 31, 2022, other expense, net primarily consisted of unfavorable changes in foreign currency, loan interest expense incurred related to the promissory notes described in Note 18, partially offset by investment income related to the Company’s money market funds and investments in highly liquid U.S. treasury securities, which are classified as cash equivalents as of December 31, 2022.
11. Income Tax
The Company is primarily subject to corporation taxes in the U.S. and the U.K.. The calculation of the Company’s tax provision involves the application of both U.S. and U.K. tax law and requires judgment and estimates.
The provision for income taxes is determined using the asset and liability approach. Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements. A current asset or liability is recognized for the estimated taxes receivable or payable for the current year. Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes are initially recognized at enacted tax rates in force at the time of initial recognition and are subsequently adjusted for any enacted changes in tax rates and tax laws. Subsequent changes to deferred taxes originally recognized in equity are recognized in income. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The Company has recorded a full valuation allowance against the deferred tax assets in excess of its deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The Company records interest and penalties related to income tax matters as part of income tax expense.
The Company accounts for uncertainty in income taxes by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed as the amount of benefit to recognize in the consolidated financial statements. The amount of benefits that may be used is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for
125
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate, as well as the related net interest and penalties.
The components of the Company’s loss before income taxes are as follows:
Year Ended December 31, 2023 Year Ended December 31, 2022
Foreign
$ ( 499,810 ) $ ( 46,868 )
United States ( 115,118 ) ( 31,914 )
Loss before income taxes $ ( 614,928 ) $ ( 78,782 )
The Company has not recognized a current or deferred provision for federal, state or non-United States income taxes in either of the years ending December 31, 2023 or 2022, respectively.
Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes.
The major components of deferred tax assets and liabilities are as follows:
Year Ended December 31, 2023
Year Ended December 31, 2022
Deferred tax assets:
Net operating loss carryforward $ 58,975 $ 52,948
Research and development credit carryforward 4,522 1,723
Stock-based compensation 4,128 3,879
Section 174 Research and Development Capitalization 15,982 3,553
Lease liability
1,143 737
Other 1,260 2,053
Total deferred tax assets 86,010 64,893
Deferred tax liabilities:
Right-of-use assets
( 1,085 ) ( 651 )
Other ( 174 ) ( 226 )
Total deferred tax liabilities ( 1,259 ) ( 877 )
Net deferred tax assets before valuation allowance 84,751 64,016
Valuation allowance ( 84,751 ) ( 64,016 )
Deferred tax, net $ — $ —
The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets, which are comprised primarily of net operating loss carryforwards and research and development costs capitalized for tax purposes. Management has considered the Company’s history of cumulative net losses in the United States (“U.S.”) and the United Kingdom (“U.K.”), estimated future taxable income, as well as prudent and feasible tax planning strategies, and has concluded that it is more likely than not that the Company will not realize the benefits of its U.S. federal and state deferred tax assets and U.K. deferred tax assets. Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2023 and 2022, respectively. The Company reevaluates the positive and negative evidence at each reporting period.
126
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The change in the valuation allowance was as follows:
Year Ended December 31, 2023
Year Ended December 31, 2022
Valuation allowance as of beginning of year
$ ( 64,016 ) $ ( 51,746 )
Net increase recorded to the income tax provision
( 20,735 ) ( 12,270 )
Valuation allowance as of end of year
$ ( 84,751 ) $ ( 64,016 )
As of December 31, 2023 and 2022, the Company had U.S. Federal gross operating loss carryforwards of approximately $ 48,184 and $ 11,620 , respectively, which may be available to offset future income tax liabilities. The 2017 Tax Cuts and Jobs Act (“TCJA”) will generally allow losses incurred after 2017 to be carried over indefinitely, but will generally limit the net operating loss deduction to the lesser of the net operating loss carryover or 80% of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended). In addition, the Company has approximately $ 3,705 in U.S. State gross loss carryforwards which expire through various dates through 2043 and as of December 31, 2023, the Company had an estimated U.S. federal and state research and development tax credit carryforwards of $ 2,900 and $ 900 , respectively, which may be available to offset future tax liabilities, and each begin to expire in 2041 and 2037, respectively. The Company also had approximately $ 194,454 in U.K. gross loss carryforwards available to use against future taxable profits on a year-by-year basis. To the extent that U.K. taxable profits exceed £5,000 in each year, the loss available to utilize against profits in excess of £5,000 will be restricted to 50%. The U.K. loss carryforwards do not lapse and therefore, the full amount will be relieved over time provided there are sufficient profits against which the losses can be utilized.
Utilization of the U.S. net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not completed a study to assess whether a change of ownership has occurred, or whether there have been multiple ownership changes since its formation. Any limitation may result in the loss of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization.
U.K. tax losses are subject to additional restrictions where there is a change in ownership in the business and certain other conditions are met. An ownership change of a UK tax resident company would occur where (directly or indirectly) a single person acquires more than half of the ordinary share capital of a company, or two or more persons each acquire a holding of at least 5% of the ordinary share capital of a company and these holdings together amount to more than half the ordinary share capital of a company. Where a change in ownership has occurred, and within three years prior to that change in ownership and five years afterwards, there is a major change in the nature and conduct of trade of that company or the trade of that business becomes small or negligible, any losses carried forward will be extinguished from the point of the change in ownership. In addition, losses accrued subsequent to April 1, 2017 will be extinguished on a change of ownership when there is a major change in the nature or conduct of a company’s business, or where there is a major change in the scale of that business, or a company ceases to carry on a particular trade or business. The Company has not completed a study to assess whether a change of ownership has occurred since its formation, or whether there has been a major change in the Company ’ s business that would restrict the U.K. tax losses. Any limitation may result in the loss of a portion of the net operating loss carryforwards before utilization.
The 2017 Tax Cuts and Jobs Act (“TCJA”) created a requirement that US corporations include in income earnings of certain controlled foreign corporations (“CFC”) under the global intangible low taxed income (“GILTI”) regime. The Company is allowed to make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as period expense only. The Company has elected to account for GILTI in the year the tax is incurred and include the current tax impact of GILTI in the effective tax rate. Given the Company’s loss position in the U.S. and the valuation allowance recorded against
127
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
its U.S. net deferred tax assets, these provisions have not had a material impact on the Company’s consolidated financial statements.
IRC Section 174 generally permitted taxpayers that incurred research expenses to deduct them in the current year. For tax years beginning before January 1, 2022, taxpayers were able to make an election with respect to research and experimental (“R&E”) expenditures incurred in connection with a trade or business to either currently deduct or defer and amortize such expenditures. The TCJA amended this provision to require that R&E expenditures be capitalized and amortized, but delayed the effective date of this amendment, which applies to tax years beginning January 1, 2022 or later. As such, the changes to IRC Section 174 pursuant to the TCJA are currently applicable to the Company for the 2022 tax year. R&E expenditures attributable to U.S. based research must be amortized over a period of five years and R&E expenditures attributable to research conducted outside of the U.S. must be amortized over a period of 15 years. As such, the Company is capitalizing $ 73,129 R&E expenditures with a net adjustment of $ 65,816 to account for the capitalization and amortization of R&D expenses incurred in the U.S.
A reconciliation of the Company’s effective tax rate to the U.S. federal statutory rate is as follows:
Year Ended December 31, 2023 Year Ended December 31, 2022
U.S. federal income tax statutory rate 21.0 % 21.0 %
Change in valuation allowance ( 3.4 ) ( 16.8 )
Refundable research and development tax credit 0.3 ( 3.6 )
Effect of foreign operations taxed at various rates ( 17.0 ) 2.1
Stock-based compensation ( 0.1 ) ( 2.2 )
Other ( 0.8 ) ( 0.5 )
— % — %
In the U.K., the Company is entitled to a research and development tax relief for small and medium-sized enterprises which allows the Company an enhanced deduction rate of 230% (up to March 31, 2023) and 186% (from April 1, 2023) on qualifying research and development expenditure (the tax relief). If the Company incurs tax losses, it is entitled to surrender the lesser of unrelieved tax loss sustained and the tax relief. As the realization of the tax relief does not depend on generation of future taxable income or the Company’s ongoing tax status or tax position, the Company does not consider the tax relief as an element of income tax accounting under ASC 740.
For the year ended December 31, 2023 and 2022, the Company recognized research and development tax relief of $ 946 and $ 4,523 respectively, which is included in other operating income in the consolidated statements of operations and other comprehensive loss.
It is the intention of the Company to reinvest the earnings of its non-U.S. subsidiaries in those operations and not to repatriate the earnings to the U.S. Accordingly, the Company does not provide for deferred taxes on differences between financial reporting and tax basis in its investments in foreign subsidiaries as they are considered permanent in duration or are not expected to reverse in the foreseeable future. As of December 31, 2023, there are no unremitted earnings of the Company’s foreign subsidiaries.
The Company records unrecognized tax benefits in accordance with ASC 740-10, Income Taxes. ASC 740-10 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in the Company’s income tax return and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. As of December 31, 2023 and 2022, the Company had total unrecognized tax benefits of $ 1,064 and $ 0 , respectively.
128
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Due to the Company’s full valuation allowance, the unrecognized tax benefits would not materially impact the Company’s effective tax rate when recognized. The Company does not anticipate the total amounts of unrecognized tax benefits will significantly increase or decrease in the next 12 months. The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision. For the years ended December 31, 2023 and 2022, the Company had no interest or penalties related to unrecognized tax benefits.
A reconciliation of unrecognized tax benefits from continuing operations is as follows:
Year Ended December 31, 2023 Year Ended December 31, 2022
Unrecognized tax benefits, beginning of year
$ — $ —
Increases related to prior year tax positions
610 —
Decreases related to prior year tax positions
— —
Increases related to current year tax positions
454 —
Unrecognized tax benefits, end of year
$ 1,064 $ —
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal, state, and foreign jurisdictions, where applicable. the U.S. In the U.S., tax years from 2020 remain subject to examination by the U.S. Internal Revenue Service and state tax authorities. The Company is not currently under examination by the Internal Revenue Service or any other jurisdiction for years 2020 through present. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may be adjusted upon examination by the Internal Revenue Service or state tax authorities to the extent utilized in a future period. In the U.K., tax returns for the year ended December 31, 2022 remains subject to examination by HMRC.
12. Net Loss per Share
The following table sets forth the computation of basic and diluted net loss per share:
Year Ended December 31, 2023 Year Ended December 31, 2022
Net loss $ ( 614,928 ) $ ( 78,782 )
Basic weighted average number of shares of common stock outstanding 619,646,180 193,336,063
Diluted weighted average number of shares of common stock outstanding 619,646,180 193,336,063
Basic net loss per share $ ( 0.99 ) $ ( 0.41 )
Diluted net loss per share $ ( 0.99 ) $ ( 0.41 )
129
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the diluted net loss by the weighted-average number of common shares outstanding for the period, including potentially dilutive common shares. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods, as the inclusion of all potential common share equivalents outstanding would have been anti-dilutive.
Because the 2023 Rights Offering (as defined in Note 20) exercise price of $ 1.05 per share was less than the closing price of $ 1.82 per share on March 1, 2023, the expiration of the , the Company has retroactively adjusted earnings per share and weighted average number of shares outstanding for the bonus element for all periods presented.
The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive:
2023 2022
Options to purchase common stock 54,209,289 19,476,359
Warrants 5,015,642 5,821,137
Shares expected to be purchased under employee stock purchase plan 155,163 229,475
59,380,094 25,526,971
Stock options that are outstanding and contain performance-based or market-based vesting criteria for which the performance or market conditions have not been met are excluded from the presentation of common stock equivalents outstanding in the chart above. Refer to Note 21 for further information on market-based awards.
13. Goodwill and Intangible Assets
In December 2017, the Company expanded its activities in the field of infectious diseases with the acquisition of Discuva Limited, a privately held United Kingdom-based company. Through this acquisition, the Company obtained a bacterial genetics platform and a suite of software-based technologies (the “Discuva Platform”), which facilitates the discovery and development of new mechanism antibiotics. This resulted in the recognition of goodwill of £ 1.5 million, which is translated into U.S. dollars at each reporting period.
The Company assesses goodwill for impairment on an annual basis as of December 31 or more frequently when events and circumstances occur indicating that recorded goodwill may be impaired.
As of December 31, 2023, the Company performed its annual impairment assessment of goodwill and determined that it is more likely than not that the fair value of the reporting unit exceeds its carrying amount. There have been no cumulative goodwill impairment charges recognized to date.
As of December 31, 2023 and 2022, goodwill was $ 1,893 and $ 1,798 , respectively. Changes year over year are the result of changes in foreign currency.
Intangible Assets
Components of the Company’s acquired intangible assets are comprised of the following:
130
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
December 31, 2023 December 31, 2022
Gross Accumulated amortization and impairment charges Net Gross Accumulated amortization and impairment charges Net
Utrophin program acquired (1)
$ — $ — $ — $ 4,015 $ ( 4,015 ) $ —
Discuva platform acquired (2)
13,583 ( 13,583 ) — 12,900 ( 12,900 ) —
Option over non-financial asset 859 ( 859 ) — 816 ( 816 ) —
Other intangibles 140 ( 140 ) — 133 ( 133 ) —
$ 14,582 $ ( 14,582 ) $ — $ 17,864 $ ( 17,864 ) $ —
(1) During the year ended December 31, 2023, the Company dissolved the wholly-owned subsidiary, Muox Limited, a dormant entity. The Utrophin program intangible assets, which arose from the Muox Limited acquisition were fully impaired and have been removed from the Company’s accounting records.
(2) In conjunction with the significant change in the Company’s strategy and shift in focus to the therapeutic area of oncology, the Company determined that it would cease further investment in the Discuva Platform. Management concluded that the carrying amount of the acquired Discuva Platform intangible asset may not be recoverable and performed an assessment to calculate the fair value of the asset using a probability-weighted approach which was compared to the carrying value of the asset. An impairment charge of $ 8,468 which represented the carrying value of the Discuva Platform was recognized during the year ended December 31, 2022. This impairment charge is presented as impairment of intangible assets in the consolidated statements of operations and comprehensive loss.
Changes year over year in the gross and accumulation amortization amounts of intangible assets are the result of changes in foreign currency. Amortization expense was $ 0 and $ 914 for the years ended December 31, 2023 and 2022, respectively.
14. Fair Value Measurements and Short-Term Investments
Fair Value Measurements
The following tables sets forth the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2023 and 2022:
Fair Value Measurements as of December 31, 2023
Level 1 Level 2 Level 3 Total
Cash equivalents:
Money market funds $ 21,016 $ — $ — $ 21,016
U.S. Government treasury bills — 39,341 — 39,341
Short-term investments:
U.S. Government treasury bills — 114,817 — 114,817
Total assets
$ 21,016 $ 154,158 $ — $ 175,174
Fair Value Measurements as of December 31, 2022
Level 1 Level 2 Level 3 Total
Cash equivalents:
Money market funds $ 60,783 $ — $ — $ 60,783
U.S. Government treasury bills — 225,730 — 225,730
Total assets
$ 60,783 $ 225,730 $ — $ 286,513
131
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The table above does not include cash at December 31, 2023 and 2022 of $ 11,068 and $ 62,094 , respectively.
The Company believes that the carrying amounts of prepaid expenses, other current assets, accounts payable, and accrued expenses approximates their fair values due to the short-term nature of those instruments. The carrying value of the Company’s promissory note approximates its fair value due to the recent issuance of the notes in December 2022 and the current interest rate of the note outstanding when compared to market interest rates (which represents a Level 2 measurement). Refer to Note 18 for further details.
Short-Term Investments
The following table sets forth the Company’s short-term investments as of December 31, 2023, which have a contractual maturity of less than one year:
December 31, 2023
Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Loss Fair Value
Assets
U.S. Government treasury bills $ 114,781 $ 36 $ — $ — $ 114,817
Total $ 114,781 $ 36 $ — $ — $ 114,817
The Company did not have any short-term investments as of December 31, 2022.
15. Property and Equipment
Property and equipment consisted of the following:
December 31, 2023
December 31, 2022
Laboratory equipment $ 22 $ 505
Furniture and fixtures, office equipment and software 896 889
Leasehold improvements 328 809
Property and equipment, gross 1,246 2,203
Less: accumulated depreciation 1,042 1,297
Property and equipment, net $ 204 $ 906
Depreciation expense for the years ended December 31, 2023 and 2022 was $ 198 and $ 349 , respectively. The Company recognized a fixed asset impairment charge of $ 474 for the year ended December 31, 2023. There were no impairment charges related to fixed assets for the year ended December 31, 2022.
16. Research and Development Prepaid Expenses and Accrued Liabilities
Included within prepaid expenses at December 31, 2023 and 2022 is $ 1,466 and $ 442 , respectively, of prepayments relating to research and development expenditures. Included within accrued liabilities at December 31, 2023 and 2022 is $ 7,289 and $ 8,911 , respectively, relating to research and development expenditures.
These amounts are determined based on the estimated costs to complete each study or activity, the estimation of the current stage of completion and the invoices received, as well as predetermined milestones which are not reflective of the current stage of development for prepaid expenses. However, prepaid expenses decrease and accrued liabilities increase as the activities progress, and if actual costs incurred exceed the prepaid expense, an accrual will be recorded for the liability. The key sensitivity is the estimated current stage of completion of each study or activity, which is based on information received from the supplier and the Company’s operational knowledge of the work completed under those contracts.
132
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
17. Leases
The Company has operating leases for real estate. The Company does not have any finance leases.
During the year ended December 31, 2023, the Company recorded $ 4,245 of additional right-of-use assets related to a new lease for additional office space which commenced in May 2023 at its Menlo Park, California location. The Company will make total lease payments of $ 4,701 over the 36 month term of the new lease, which expires in May 2026. In addition, during the year ended December 31, 2023, the Company terminated the Company’s Cambridge, U.K. laboratory and office space lease as a result of the Company re-prioritizing its investments and financial resources towards the development of ivonescimab. This resulted in disposing the carrying value of the right-of use asset of $ 788 , removing the related lease liability of $ 809 , and there were no penalties charged for early termination of this lease. The Company recorded $ 2,860 of right-of-use assets during the year ended December 31, 2022 related to its Menlo Park, California location.
The carrying value of the right-of-use assets as of December 31, 2023 and 2022 is $ 5,859 and $ 4,175 , respectively.
The elements of lease expense were as follows:
Lease Cost: Year Ended December 31, 2023 Year Ended December 31, 2022
Fixed lease costs $ 2,214 $ 1,384
Variable lease costs 83 137
Short-term lease (1)
— 31
Total lease cost $ 2,297 $ 1,552
(1) Short-term lease costs relate to the Company’s Cambridge, Massachusetts, United States office lease which the Company exited during fiscal year 2022.
The weighted average discount rate and the weighted average remaining lease term were 6.6 % and 2.4 years, respectively, as of December 31, 2023. The weighted average discount rate and the weighted average remaining lease term were 5.7 % and 3.4 years, respectively, as of December 31, 2022. The Company made cash payments related to lease liabilities of $ 2,208 and $ 1,092 for the years ending December 31, 2023 and 2022 respectively.
Future lease payments under non-cancelable leases as of December 31, 2023 are detailed as follows:
Year Ending December 31,
2024 $ 2,810
2025 2,886
2026 893
2027 —
Total lease payments 6,589
Less: imputed interest 490
Total operating lease liabilities $ 6,099
Total operating lease liabilities balance sheet presentation:
Current lease liabilities $ 2,809
Non-current lease liabilities 3,290
$ 6,099
The Company signed a lease agreement on January 8, 2024 for executive office space for its new headquarters in Miami, Florida. The office space is approximately 9,000 square feet. The term of the lease is 64 months. Total payments for this office
133
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
space is approximately $ 5,100 over the term of the lease. The table above excludes payments related to the lease signed in January 2024.
18. Promissory Notes Payable to Related Parties
Non-current and current debt consisted of the following:
Current notes Non-current notes
December 31, 2023 December 31, 2022 December 31, 2023 December 31, 2022
Principal amounts $ — $ 20,000 $ 100,000 $ 500,000
Debt discount — ( 230 ) — ( 5,460 )
Total promissory notes payable to related parties $ — $ 19,770 $ 100,000 $ 494,540
March 2022 Promissory Note
On March 10, 2022, Mr. Duggan, entered into a Note Purchase Agreement (the “March 2022 Note”), pursuant to which he loaned the Company $ 25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $ 25,000 . The March 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal . The March 2022 Note, including all accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $ 25,000 or (ii) 18 months from the date of issuance of the March 2022 Note. Debt issuance costs associated with the March 2022 Note were immaterial and expensed as incurred. The March 2022 Note of $ 25,000 , plus accrued interest of $ 434 has been repaid to Mr. Duggan on August 10, 2022 in connection with the completion of the rights offering with aggregate gross proceeds of $ 100,000 .
The Company incurred interest expense related to the March 2022 Note of $ 1,296 for the year ended December 31, 2022, which included amortized imputed interest of $ 861 .
December 2022 Promissory Notes
On December 6, 2022, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $ 520,000 . Pursuant to the Note Purchase Agreement, the Company issued to Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the amount of $ 400,000 (the “Duggan February Note”) and $ 20,000 (the “Zanganeh Note”), respectively, which matured and become due on February 15, 2023 and an unsecured promissory note to Mr. Duggan in the amount of $ 100,000 (the “Duggan September Note” and together with the Duggan February Note and the Zanganeh Note, the “December 2022 Notes”), which was originally due on September 15, 2023. The maturity dates of the December 2022 Notes could have been extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024. In addition, if the Company consummates a public offering, then upon the later to occur of (i) five business days after the Company receives the net cash proceeds therefrom or (ii) May 15, 2023, the Duggan February Note and the Zanganeh Note shall be prepaid by an amount equal to the lesser of (a) 100 % of the amount of the net proceeds of such offering and (b) the outstanding principal amount on such Notes.
134
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
On January 19, 2023, the Company provided notice to extend the term of the Duggan February Note and Duggan September Note to a maturity date of September 6, 2024. Furthermore, on January 19, 2023, the Company and Mr. Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the Company may only prepay (i) the Duggan February Note following the completion of a public rights offering to be conducted by Summit in the approximate amount of $ 500,000 (the “Rights Offering”), or a similar capital raise, in an amount equal to the lesser of (x) the net proceeds of the Rights Offering or such capital raise or (y) the full amount outstanding of the Duggan February Note, and (ii) the Duggan September Note following the completion of a capital raising transaction subsequent to the Rights Offering in an amount equal to the lesser of (A) the net proceeds of such capital raise or (B) the full amount outstanding of the Duggan September Note. Following the issuance of the two new Promissory Notes (the “Duggan Promissory Notes”), the Duggan February Note and Duggan September Note were marked as “cancelled” on their face and replaced in their entirety by the Duggan Promissory Notes (together with the Zanganeh Note, the “Notes”).
On February 15, 2023, the $ 20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance. In connection with the closing of the rights offering, the $ 400,000 Duggan Promissory Note matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from this rights offering.
The Notes accrued interest at an initial rate of 7.5 %. All interest on the Notes was paid on the date of signing for the period through February 15, 2023. Such prepaid interest was paid in a number of shares of the Company’s common stock, par value $ 0.01 (“Common Stock”) equal to the dollar amount of such prepaid interest, divided by $ 0.7913 (the consolidated closing bid price immediately preceding the time the Company entered into the Note Purchase Agreement, plus $ 0.01 ), which was 9,720,291 shares. For all applicable periods following February 15, 2023, interest shall accrue on the outstanding principal balance of the Notes at the US prime interest rate, as reported in the Wall Street Journal, plus 50 basis points, as adjusted monthly, for three months immediately following February 15, 2023, and thereafter at the US prime rate plus 300 basis points, as adjusted monthly.
Debt issuance costs associated with the Notes were $ 44 and were capitalized as part of the carrying value of the promissory notes payable to related parties. During the year ended December 31, 2023, the Company incurred interest expense of $ 16,461 for the year ended December 31, 2023, which included amortized imputed interest of $ 761 . The Company incurred interest expense of $ 3,105 for the year ended December 31, 2022 related to the December 2022 Notes, which included amortized imputed interest of $ 395 .
As of December 31, 2023 and 2022 there was $ 120 of accrued interest payable included within accrued expenses in the consolidated balance sheet.
Imputed interest is calculated as the difference between the expected interest payable and the deemed market rate of interest and is recorded as a debt discount at inception of the note payable with a credit to additional paid-in capital for notes payable to related parties. The debt discount is amortized to interest expense using an effective interest rate method. The effective interest rate of the Duggan February Note and Zanganeh Note was 8.9 % and the effective interest rate of the Duggan September Note was 11.3 %.
On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest shall accrue on the outstanding principal balance at the greater of 12 % or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly.Interest shall be paid upon maturity of the loan.
In accordance with the applicable accounting standards, a short-term debt obligation should be excluded from current liabilities if the entity has both the intent and ability to refinance the obligation on a long-term basis. The intent and ability can be demonstrated by the issuance of a long-term obligation to refinance the short-term obligation on a long-term basis after the date of an entity’s balance sheet but before that balance sheet is issued. As a result of the amendment entered into on February 17, 2024, to extend the maturity date to April 1, 2025, the Company classified $ 100,000 of notes payable to related party outstanding as of December 31, 2023 as long-term notes payable
135
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The estimated future principal payments are $ 0 and $ 100,000 for 2024 and 2025, respectively, as the note matures on April 1, 2025.
19. Other Non-Current Liabilities
Included within other non-current liabilities at December 31, 2023 and 2022 is $ 1,356 and $ 1,209 , respectively, relating to assumed contingent liabilities. As part of the acquisition of Discuva Limited in December 2017, the Company assumed certain contingent liabilities as certain employees, former employees and former directors of Discuva Limited are eligible for payments from Discuva Limited based on specified development and clinical milestones related to proprietary product candidates developed under the Discuva Platform. The timing of these potential payments is uncertain.
In conjunction with the significant change in the Company’s strategy and shift in focus to the therapeutic area of oncology, the Company determined that it will cease further investment in the Discuva platform and evaluate further options for the use of the Discuva Platform. As a result, management has revised the estimated presented value of these payments and remeasured the contingent liabilities. This resulted in recording a gain on remeasurement of liabilities of $ 1,265 during the year ended December 31, 2022, which is included net as part of the research and development expenses in the consolidated statement of operations and comprehensive loss.
There were no remeasurement losses or gains recognized during the year ended December 31, 2023.
20. Stockholders' Equity
Common Stock
In August 2022, the Company announced the closing of its 2022 rights offering (“2022 Rights Offering”). The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. The 2022 Rights Offering received aggregate gross proceeds of $ 100,000 from the sale of 103,092,783 shares of common stock. Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights and oversubscribed, at a price per share of $ 0.97 . Offering costs of $ 111 were incurred.
On December 6, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its Common Stock for $ 1.05 per share (the “2023 Rights Offering”). The 2023 Rights Offering commenced on February 7, 2023 and the associated subscription rights expired on March 1, 2023. Aggregate gross proceeds from the 2023 Rights Offering were $ 500,000 from the sale of 476,190,471 shares of the Company’s common stock and issuance costs were $ 619 . Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights at a price of $ 1.05 per share. To satisfy the $ 395,314 subscription price for the shares subscribed by Mr. Duggan in the 2023 Rights Offering, Mr. Duggan agreed with the Company to extinguish a portion of the amount due and payable to him by the Company at the closing of the 2023 Rights Offering pursuant to the $ 400,000 Duggan Promissory Note in an amount equal to the subscription price (see also Note 18 ).
On January 19, 2023, the Company filed Amendment No. 2 to the Restated Certificate of Incorporation (the “Amendment No. 2”) with the Secretary of State of the State of Delaware to increase the number of authorized shares of its common stock by 650,000,000 (from 350,000,000 to 1,000,000,000 ), which became effective on such date.
136
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of the Company’s common stock at $ 0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement (as defined in Note 6 ) with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to Mr. Duggan and Dr. Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company. On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3.
As described in Note 1, Mr. Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $ 1.68 , resulting in the purchase of 2,976,190 shares of the Company’s common stock.
Warrants
As part of the private placement on December 24, 2019, the participating investors were granted warrants with the right to subscribe for 5,261,350 shares of common stock at an exercise price of $ 1.58 , exercisable any time in the period commencing on the date falling six months following December 24, 2019 and ending on the tenth anniversary of admission. Each warrant entitles the warrant holder to subscribe in cash for one share. Shares of common stock allotted pursuant to the exercise of the warrant will rank in full for all dividends and other distributions with a record date after the exercise date with the shares of common stock in issue at that date. The Company has the option to require the warrant holder to exercise some or all of the outstanding warrants after the third anniversary date if the ten-day volume weighted average price of the shares of common stock as reported on Nasdaq represents a premium of at least 50 percent to the exercise price. The warrants are classified within stockholders’ equity as they are indexed to the Company’s shares of common stock and require settlement in its shares of common stock with no provision for any cash settlement.
Also, as part of the private placement on December 24, 2019, certain consultants were granted warrants with the right to subscribe for 3,358,732 shares of common stock in exchange for certain services. The warrants have an exercise price of $ 1.44 and vest quarterly over three years . If the consulting agreement terminated prior to three years after the date of the grant, all unvested warrants will be deemed cancelled. On June 30, 2020, the consulting agreement was terminated and 2,798,945 warrants cancelled immediately. The remaining 559,787 of outstanding warrants are held by Dr. Zanganeh and Dr. Elaine Stracker.
Warrants granted over shares of common stock to consultants in exchange of certain services are similar to stock-based compensation (see Note 21).
The following table summarizes the Company’s warrants activity for the year ended December 31, 2023
Number of share warrants
Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value
Outstanding as of December 31, 2022 5,821,137 $ 1.56 6.99 years
$ 15,640
Exercised ( 805,495 ) $ 1.49
Outstanding as of December 31, 2023 5,015,642 $ 1.57 5.92 years
$ 5,194
21. Stock-Based Compensation
2016 Long Term Incentive Plan
Upon the effectiveness of the 2020 Stock Incentive Plan, no additional grants will be made under the 2016 Long Term Incentive Plan, (the “2016 Plan”) and any outstanding awards continue with their original terms.
137
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
2020 Stock Award Plan
In September 2020, the Company’s Board of Directors approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on September 21, 2020. The 2020 plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards.
A total of 8,000,000 shares of common stock were initially reserved for issuance under the 2020 Plan. Additionally, up to 5,000,000 shares of common stock, including RSUs can be added to the 2020 Plan for future issuance from options that expire, lapse or are terminated from the 2016 Plan or any other predecessor plans. The number of shares of common stock that may be issued under the 2020 Plan will automatically increase on each January 1, beginning in 2021 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2030, equal to the lesser of (i) 6,400,000 shares of common stock, (ii) 4 % of the common shares outstanding on the final day of the immediately preceding calendar year and (iii) an amount as determined by the Company’s Board of Directors.
On July 27, 2022, the Company held a Special Meeting of Stockholders (the “Special Meeting”) whereby the following matters were submitted to a vote of the Company’s stockholders at the Special Meeting and the Board of Directors resolved the following: (i) an amendment to the Company’s Restated Certificate of Incorporation, dated September 18, 2020, to increase the number of authorized shares of common stock by 100,000,000 (from 250,000,000 to 350,000,000 ); and (ii) an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan (the “Plan”) to increase the number of shares of the Company’s common stock issuable under the Plan by 8,000,000 shares.
On October 12, 2023, the Company held a Special Meeting of Stockholders (the “October Special Meeting”) whereby the following matter was submitted to a vote of the Company’s stockholders at the Special Meeting and the Board of Directors resolved the following: an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan to increase the number of shares of the Company ’ s common stock issuable under the Plan by 70,000,000 shares.
As of December 31, 2023, there are 3,261,496 shares available to be issued under the 2020 Plan.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was adopted by the Board of Directors and approved by the Company’s shareholders on July 17, 2020 and approved by the predecessor company shareholders on August 19, 2020 and is qualified under Section 423 of the Internal Revenue Code. The 2020 ESPP initially authorized the issuance of up to 1,000,000 shares of common stock to participating employees. The number of common shares that may be issued under the 2020 ESPP automatically increases on each fiscal year commencing January 1, 2021 and continuing for each fiscal year until, and including the fiscal year commencing on, January 1, 2030 equal to the lesser of (i) 1,600,000 shares of common stock, (ii) 1 % of the common shares outstanding on such date and (iii) an amount as determined by the Company’s Board of Directors. As of December 31, 2022, there were 2,628,893 shares available to be issued under the 2020 ESPP.
The first offering period of the 2020 ESPP plan consisted of seven months , commencing on August 2, 2021 and completed on February 28, 2022. The second offering period commenced on March 1, 2022 and was completed on August 31, 2022. Offering periods thereafter will be six months in duration and will commence immediately proceeding the end of the previous offering period, unless otherwise determined by the Board of Directors or Compensation Committee. Under the 2020 ESPP, eligible employees can purchase shares of common stock through payroll deductions of up to 15 % of their compensation received during the plan period or such shorter period during which deductions from payroll are made, up to a defined maximum amount. The option price is determined based on the lesser of the closing price of common stock on (i) the first business day of the plan period or (ii) the exercise date, or shall be based solely on the closing price of the common stock on the exercise date; provided that such option price shall be at least 85 % of the applicable closing price. In the absence of a determination by the Board of Directors or the Compensation Committee, the option price is 85 % of the lesser of the closing price of the common stock on (i) the first business day of the plan period or (ii) the exercise date.
138
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The closing price is the (a) the closing price (for the primary trading session) on the Nasdaq Global Select Market or (b) the average of the closing bid and asked prices in the over-the-counter-market, whichever is applicable, as published in the Wall Street Journal or another source selected by the Board or the Committee.
During the fiscal year ended December 31, 2023 and 2022, 392,175 and 176,857 shares, respectively, were issued under the 2020 ESPP Plan.
Stock Options
Time-based Stock Options
The Company estimates the fair value of stock options granted to employees and directors using the Black-Scholes valuation model. Stock options granted under the 2016 and 2020 Plans generally vest over three or four years and expire after ten years . This valuation methodology utilizes several key assumptions as highlighted below.
The assumptions used in the Company’s valuation are summarized as follows, presented on a weighted average basis:
Year Ended December 31, 2023 Year Ended December 31, 2022
Risk-free interest rate 4.59 % 3.11 %
Expected term (in years) 4.8 5.9
Expected volatility 98.1 % 91.2 %
Expected annual dividends per share — % — %
The following table summarizes the Company’s time-based stock option activity for the year ended December 31, 2023:
Number of share options Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value
Outstanding as of December 31, 2022 12,712,359 $ 4.83 8.4 years $ 8,702
Granted 44,135,170 $ 1.72
Forfeited ( 2,433,943 ) $ 5.56
Exercised ( 204,297 ) $ 2.20
Outstanding as of December 31, 2023 54,209,289 $ 2.28 9.3 years $ 42,574
Outstanding as of December 31, 2023 - vested and expected to vest 49,407,492 $ 2.31 9.3 years $ 38,406
Exercisable at December 31, 2023 5,716,319 $ 4.89 7.2 years $ 892
139
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Performance and Market-based Stock Options
The Compensation Committee of the Company’s Board of Directors and management approved 40,835,220 option grants to its executives and certain employees of the Company during the year ended December 31, 2023, which will vest based upon certain revenue and market-based performance conditions. The fair value of performance and market-based stock options that include a market condition is determined using a Monte Carlo valuation model, which utilizes multiple input variables to estimate the probability that the market condition will be achieved.
The following table summarizes the Company’s performance and market-based stock option activity for the year ended December 31, 2023:
Number of share options Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value
Outstanding as of December 31, 2022 6,764,000 $ 1.15 9.6 years $ 20,955
Granted 40,835,220 $ 1.69
Forfeited ( 945,000 ) $ 1.20
Exercised — $ —
Outstanding as of December 31, 2023 46,654,220 $ 1.62 9.6 years $ 46,237
Outstanding as of December 31, 2023 - vested and expected to vest 8,397,760 $ 1.62 9.6 years $ 8,323
Exercisable at December 31, 2023 — $ — — $ —
The weighted-average grant-date fair value of stock options granted during the years ended December 31, 2023 and 2022 was $ 1.41 and $ 0.87 , per share, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2023 and 2022 was $ 474 and $ 142 , respectively. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.
As of December 31, 2023, total unrecognized compensation cost related to unvested stock option grants was approximately $ 61,162 . This amount is expected to be recognized over a weighted average period of approximately 2.2 years.
Warrants
The fair value of warrants is estimated on the date of grant using the Black-Scholes valuation methodology. Expected volatilities are based on historical share price performance, weighted to exclude periods of unusually high volatility. The Company assumed the warrants to be exercised immediately on vesting. The risk-free rate is equal to the prevailing U.K. Gilts rate at grant date that most closely matches the expected term of the grant, as the warrants were issued when the Company was domiciled in the U.K.. Expected dividend yield is zero , and consistent with the Board of Directors’ view that the Company’s business model is to generate value through capital growth rather than the payment of dividends.
Each warrant entitles the warrant holder to subscribe in cash for one share. Shares of common stock allotted pursuant to the exercise of the warrant will rank in full for all dividends and other distributions with a record date after the exercise date with the shares of common stock in issue at that date.
Refer to Note 20 for the Company’s warrants activity for the year ended December 31, 2023.
140
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
At December 31, 2023, there was no unrecognized compensation expense related to warrants.
Stock-Based Compensation
Stock‑based compensation expense related to stock options is recorded within the consolidated statements of operations and comprehensive loss as follows:
Year Ended December 31, 2023 Year Ended December 31, 2022
Research and development
$ 4,408 $ 4,303
General and administrative
9,700 $ 7,645
Total stock-based compensation
$ 14,108 $ 11,948
The following table summarizes share-based compensation expense associated with each of our share-based compensation arrangements:
Year Ended December 31, 2023 Year Ended December 31, 2022
Time-based stock options
$ 12,606 $ 11,630
Performance and market-based stock options
1,318 84
Employee stock purchase plan
184 234
Total stock-based compensation
$ 14,108 $ 11,948
22. Commitments and Contingencies
Fixed asset purchase commitments
At December 31, 2023 and 2022, the Company had no capital commitments.
Lease commitments
Refer to Note 17 for a discussion of the Company’s lease commitments.
Debt commitments
Refer to Note 18 for discussion of promissory notes payable to related parties.
Other commitments
The Company enters into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. Most contracts provide for termination upon notice, and therefore are cancellable contracts. As of December 31, 2023, total contractual commitments, excluding leases commitments and debt commitments, are estimated to be approximately $ 37,700 and the majority of these commitments are due within one year .
Subsequent to December 31, 2023, through February 9, 2024 the Company entered into additional contractual commitments of approximately $ 23,000 with various third parties related to its clinical trials.
The Company has certain commitments under its agreements with the Akeso, Wellcome Trust, the University College London and certain employees, former employees and former directors of Discuva, pursuant to which it will be required to pay royalties or make milestone payments. The License Agreement with Akeso also contains certain manufacturing and purchase commitments. As of December 31, 2023, the Company is unable to estimate the amount, timing or likelihood of achieving the
141
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
milestones, making future product sales or assessing estimated forecasts for manufacturing and supplied materials which these contingent payment obligations relate to.
Indemnifications
The Company’s certificate of incorporation provides that it will indemnify the directors and officers to the fullest extent permitted by Delaware law. In addition, the Company has entered into indemnification agreements with all of the directors and executive officers. These indemnification agreements may require the Company, among other things, to indemnify each such director or executive officer for some expenses, including attorneys’ fees, judgments, fines, and settlement amounts incurred by him or her in any action or proceeding arising out of his or her service as one of the Company’s directors or executive officers. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2023.
Legal Proceedings
The Company is not currently subject to any material legal proceedings.
23. Related Party Transactions
July 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc.
On July 25, 2022 the Company entered into a first amendment, dated July 19, 2022, to its existing sublease agreement with MZA, described above. The existing sublease term, which was set to expire on September 30, 2022, was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2023, payments of $ 762 , were made pursuant to the first amendment to the Sublease Agreement.
July 29, 2022 Second Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc.
On July 29, 2022, the Company entered into a second amendment, dated August 1, 2022, to its existing sublease agreement with MZA, described above. The second amendment was effective as of August 1, 2022 and expires on December 31, 2025. The second amendment includes an additional 1,277 square feet (the “Expansion Premises”) of office space at 2882 Sand Hill Road, Menlo Park, California. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the year ended December 31, 2023 payments of $ 218 , were made pursuant to the secondment amendment to the sublease.
March 10, 2022 Note Purchase Agreement
On March 10, 2022, the Company entered into a Note Purchase Agreement (the “March 2022 Note”), with Mr. Duggan, pursuant to which Mr. Duggan loaned the Company $ 25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $ 25,000 . The March 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal , which was 3.25 % as of the effective date and 4.75 % as of June 30, 2022. The March 2022 Note, including accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $ 25,000 or (ii) 18 months from the date of issuance of the March 2022 Note, and was repaid on August 10, 2022.
2022 Rights Offering
The 2022 Rights Offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Aggregate gross proceeds received from the rights offering were $ 100,000 from the sale of 103,092,783 shares of common stock. Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights and oversubscribed, at a price of $ 0.97 per share. Issuance costs were $ 111 . In connection with the closing of the 2022 Rights Offering, the March 2022 Note
142
Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from the 2022 Rights Offering on August 10, 2022.
December 6, 2022 Note Purchase Agreement
On December 6, 2022, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Mr. Duggan and Dr. Zanganeh, pursuant to which the Company agreed to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the aggregate amount of $ 520,000 . Pursuant to the Note Purchase Agreement, the Company issued to Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the amount of $ 400,000 (the “Duggan February Note”) and $ 20,000 (the “Zanganeh Note”), respectively, which would mature and become due on February 15, 2023 and an unsecured promissory note to Mr. Duggan in the amount of $ 100,000 (the “Duggan September Note” and together with the Duggan February Note and the Zanganeh Note, the “December 2022 Notes”), which matured and became due on September 15, 2023. The maturity dates of the December 2022 Notes could have been extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024. In addition, if the Company consummates a public offering, then upon the later to occur of (i) five business days after the Company receives the net cash proceeds therefrom or (ii) May 15, 2023, the Duggan February Note and the Zanganeh Note shall be prepaid by an amount equal to the lesser of (a) 100 % of the amount of the net proceeds of such offering and (b) the outstanding principal amount on such notes.
On January 19, 2023, the Company provided notice to extend the term of the Duggan February Note and Duggan September Note to a maturity date of September 6, 2024. Furthermore, on January 19, 2023, the Company and Mr. Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the Company may only prepay (i) the Duggan February Note following the completion of a public rights offering to be conducted by Summit in the approximate amount of $ 500,000 (the “Rights Offering”), or a similar capital raise, in an amount equal to the lesser of (x) the net proceeds of the Rights Offering or such capital raise or (y) the full amount outstanding of the Duggan February Note, and (ii) Duggan September Note following the completion of a capital raising transaction subsequent to the Rights Offering in an amount equal to the lesser of (i) the net proceeds of such capital raise or (ii) the full amount outstanding of the Duggan September Note. Following the issuance of the two new Promissory Notes (the “Duggan Promissory Notes”), the Duggan February Note and Duggan September Note were marked as “cancelled” on their face and replaced in their entirety by the Duggan Promissory Notes.
On February 15, 2023, the $ 20,000 Zanganeh Note, matured and the Company repaid the outstanding principal balance. In connection with the closing of the 2023 Rights Offering, the $ 400,000 Duggan Promissory Note, matured and became due, and the Company satisfied all principal and accrued interest thereunder using a combination of a portion of the cash proceeds from the 2023 Rights Offering and the extinguishment of a portion of the amount due equal to the subscription price for shares subscribed by Mr. Duggan in the 2023 Rights Offering (as defined above).
The Notes accrue interest at an initial rate of 7.5 %. All interest on the Notes shall be paid on the date of signing for the period through February 15, 2023. Such prepaid interest shall be paid in a number of shares of the Company’s common stock, par value $ 0.01 (“Common Stock”) equal to the dollar amount of such prepaid interest, divided by $ 0.7913 (the consolidated closing bid price immediately preceding the time the Company entered into the Note Purchase Agreement, plus $ 0.01 ), which was 9,720,291 shares. For all applicable periods following February 15, 2023, interest shall accrue on the outstanding principal balance of the Notes at the United States prime interest rate, as reported in the Wall Street Journal, plus 50 basis points, as adjusted monthly, for three months immediately following February 15, 2023, and thereafter at the United States prime rate plus 300 basis points, as adjusted monthly. During the year ended December 31, 2023, the Company made payments for interest of $ 10,650 .
On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025. For all applicable periods commencing February 17, 2024, interest shall accrue on the outstanding principal balance at the greater of 12 % or the US prime interest rate, as reported in the Wall Street Journal plus 350 basis points, as adjusted monthly, compounded quarterly. Interest shall be paid upon maturity of the loan.
Akeso License Agreement
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Summit Therapeutics Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Upon the closing of the License Agreement, the Board of Directors (the “Board”) of the Company appointed Dr. Yu (Michelle) Xia to serve as a member of the Board pursuant to the terms of the License Agreement. Dr. Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012. For details on the License Agreement, see Note 6. Furthermore, in connection with the License Agreement, the Company also entered into a Supply Agreement with Akeso, pursuant to which Summit agreed to purchase a certain portion of drug substance for clinical and commercial supply (the “Supply Agreement”). All transactions pursuant to the Supply Agreement, which occurred during 2023, were in the ordinary course of business. The Company paid approximately $ 2,500 to Akeso during year ended December 31, 2023. As of December 31, 2023, the Company included in accrued expenses approximately $ 3,619 due to Akeso.
2023 Rights Offering
On December 6, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its Common Stock for $ 1.05 per share. The 2023 Rights Offering commenced on February 7, 2023 and the associated subscription rights expired on March 1, 2023. Aggregate gross proceeds from the 2023 Rights Offering were $ 500,000 from the sale of 476,190,471 shares of the Company’s common stock and issuance costs were $ 619 . Mr. Duggan and Dr. Zanganeh fully subscribed to their respective basic subscription rights at a price of $ 1.05 per share. To satisfy the $ 395,314 subscription price for the shares subscribed by Mr. Duggan in the 2023 Rights Offering, Mr. Duggan agreed with the Company to extinguish a portion of the amount due and payable to him by the Company at the closing of the 2023 Rights Offering pursuant to the $ 400,000 Duggan Promissory Note in an amount equal to the subscription price.
Registration of Shares
On March 17, 2023, the Company filed a registration statement on Form S-3 to register for resale the following shares of the Company’s common stock at $ 0.01 par value: (i) 10,000,000 shares of Common Stock issued on January 17, 2023 in connection with the License Agreement with Akeso pursuant to which the Company issued Akeso such shares; and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to the Company’s Chief Executive Officers, Mr. Duggan and Dr. Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr. Duggan, Dr. Zanganeh and the Company. On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3.
Private Placement
On October 16, 2023, the Company announced the appointment of Mr. Manmeet Soni as its Chief Operating Officer, effective immediately. Mr. Soni has been a part of the Company’s Board of Directors since 2019. He will remain a member of the Board of Directors. In conjunction with his appointment, Mr. Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement. The transaction was effective October 13, 2023 with a closing price of $ 1.68 , resulting in the purchase of 2,976,190 shares of the Company’s common stock.
Warrants Exercise
In December 2023, Dr. Zanganeh exercised 805,495 shares of warrants. Refer to Note 20 for the warrants exercise activity for the year ended December 31, 2023.
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