1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: 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 Officer (our Principal Executive Officer and Principal Financial Officer).
+Added: 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.
2 unchanged sentences
Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.
−Removed: Based upon our evaluation of our disclosure controls and procedures as o f December 31, 2022, our Chief Executive Officer and Co-Chief Executive Officer (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.
−Removed: Management's Report on Internal Control Over Financial Reporting and Attestation Report of Registered Public Accounting Firm
+Added: 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.
+Added: Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
−Removed: Our internal control over financial reporting is a process designed, under the supervision of the Chief Executive Officer and Co-Chief Executive Officer (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.
+Added: 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.
6 unchanged sentences
Other Information
−Removed: The Compensation Committee of the Company’s Board of Directors reviewed and approved employee 2022 bonuses.
−Removed: A discretionary cash bonus of $202,500 and an extraordinary bonus of $250,000 was paid to Dr.
−Removed: Zanganeh, the Company’s co-Chief Executive Officer, President and member of the Board , on January 10, 2023.
−Removed: A discretionary cash bonus of $131,918 and an extraordinary bonus of $250,000 was paid to Ankur Dhingra, the Company’s Chief Financial Officer on January 10, 2023.
+Added: On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025.
+Added: 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.
+Added: Interest shall be paid upon maturity of the loan.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
1 unchanged sentence
Directors, Executive Officers and Corporate Governance
−Removed: The information required by this Item is incorporated herein by reference to the information that will be included in our proxy statement related to the 2023 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
+Added: CORPORATE GOVERNANCE
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Board Leadership Structure
+Added: Our Board of Directors believes that the roles of Chairman and Chief Executive Officer may be filled by the same or different individuals.
+Added: 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.
+Added: 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.
+Added: In our Board’s view, Mr.
+Added: 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.
+Added: At this time, our Board of Directors believes it is in the best interests of our Company and our stockholders for Robert W.
+Added: Duggan to serve as our Chief Executive Officer and Chairman of the Board of Directors.
+Added: The Chairman of the Board of Directors presides over all Board meetings and approves the agenda for meetings of the Board of Directors.
+Added: He also works with the Board of Directors to drive decisions about particular strategies and policies.
+Added: The Appointment of the Lead Independent Director
+Added: Our Board of Directors has determined that it is advisable, in light of having the same person, Robert W.
+Added: Duggan, serve as both Chief Executive Officer and Chairman of the Board of Directors, to appoint a lead independent director (“LID”).
+Added: The Board of Directors has approved the appointment of Kenneth Clark as LID.
+Added: The LID shall be responsible for the following duties:
+Added: (i) to chair any meeting of the independent directors in executive sessions;
+Added: (ii) to meet with any director who is not adequately performing his or her duties as a member of the Board of Directors;
+Added: (iii) to facilitate communications between other members of the Board of Directors and the Chairman of the Board and Chief Executive Officer;
+Added: (iv) to monitor, with the
+Added: assistance of the Company’s legal advisors, communications from stockholders and other interested parties;
+Added: (v) to work with the Chairman of the Board in the preparation of the agenda for each Board of Directors meeting;
+Added: 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.
+Added: The Board of Director’s Role in Risk Oversight
+Added: 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.
+Added: 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.
+Added: Generally, various committees of our Board of Directors oversee risks associated with their respective areas of responsibility and expertise.
+Added: 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;
+Added: our Audit Committee also oversees the manage ment of other risks, including those associated with credit risk.
+Added: Our Compensation Committee oversees the management of risks associated with our compensation policies, plans and practices.
+Added: 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.
+Added: Our Board of Directors provides direct oversight over cybersecurity risks.
+Added: Management and other employees report to the Board of Directors and/or relevant committee from time to time on risk-related issues.
+Added: Diversity of the Board
+Added: 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.
+Added: Diversity in experiences, perspectives, and backgrounds is just one of many factors considered by the Nominating and Corporate Governance Committee in considering director nominees.
+Added: 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.
+Added: The below Diversity Matrix reports self-identified diversity statistics for the Board in the format required by Nasdaq’s rules.
+Added: Board Diversity Matrix (as of February 13, 2024)
+Added: Total Number of Directors
+Added: Female Male Non-Binary Did Not Disclose
+Added: Gender Identity
+Added: Directors 4 4 — —
+Added: Demographic Background
+Added: African American or Black — — — —
+Added: Alaskan Native or Native American — — — —
+Added: Asian 2 1 — —
+Added: Hispanic or Latinx — — — —
+Added: Native Hawaiian or Pacific Islander — — — —
+Added: White 2 3 — —
+Added: Two or More Races or Ethnicities — — — —
+Added: LGBTQ+ — — — —
+Added: Did Not Disclose Demographic Background — — — —
+Added: Director Independence
+Added: 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
+Added: judgment in carrying out the responsibilities of a director.
+Added: 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.
+Added: 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:
+Added: (1) the source of compensation of the director, including any consulting advisory or other compensatory fee paid by such company to the director;
+Added: and (2) whether the director is affiliated with the company or any of its subsidiaries or affiliates.
+Added: 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.
+Added: Booth and Ms.
+Added: 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.
+Added: Our Board of Directors also determined that Mr.
+Added: Booth, and Ms.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: A “controlled company” may elect not to comply with certain Nasdaq corporate governance requirements, including the requirements that:
+Added: • a majority of the board of directors consist of independent directors;
+Added: • 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;
+Added: • 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;
+Added: • 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.”
+Added: We have elected to take advantage of these exemptions.
+Added: 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.
+Added: Director Nominations
+Added: 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.
+Added: 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.
+Added: The Nominating and Corporate Governance Committee may retain recruiting professionals to assist in identifying and evaluating candidates for director nominees.
+Added: 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.
+Added: Nominating and Corporate Governance Committee considers the following minimum qualifications to be satisfied by any nominee to the Board of Directors:
+Added: a reputation for integrity, honesty and adherence to high ethical standards;
+Added: 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;
+Added: a commitment to understanding the Company and its industry;
+Added: a commitment to regularly attend and participate in meetings of the Board and its committees;
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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:
+Added: Corporate Secretary, Summit Therapeutics Inc., 601 Brickell Key Drive, Suite 1000, Miami, FL 33131.
+Added: Code of Business Conduct and Ethics
+Added: 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.
+Added: 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/.
+Added: 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.
+Added: Policy on Short Sales, Derivative Transactions and Hedging Transactions
+Added: 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:
+Added: (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.
+Added: Communication with the Board of Directors
+Added: 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.
+Added: The Corporate Secretary will forward these communications, as appropriate, directly to the director(s).
+Added: 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.
+Added: BOARD OF DIRECTORS AND COMMITTEES OF THE BOARD
+Added: Board and Committee Meetings
+Added: 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.
+Added: 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.
+Added: The names of our director nominees and directors, their ages and certain other information about them are set forth below:
+Added: Name Age Position
+Added: Chief Executive Officer and Executive Chairman
+Added: Mahkam Zanganeh 53
+Added: Chief Executive Officer, President, and Director
+Added: Chief Operating Officer and Director
+Added: Lead Independent Director
+Added: Robert Booth 70
+Added: Alessandra Cesano 63
+Added: Ujwala Mahatme 59 Director
+Added: 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.
+Added: There are no family relationships among any of our directors or executive officers, however, Mr.
+Added: Duggan and Dr.
+Added: Zanganeh have a personal relationship with each other.
+Added: 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.
+Added: Since 2016, Mr.
+Added: Duggan has been Chief Executive Officer of Duggan Investments, Inc., a family office of Mr.
+Added: 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.
+Added: From September 2007 through the acquisition by AbbVie Inc.
+Added: in May 2015, Mr.
+Added: 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.
+Added: Duggan was also the Chairman and Chief Executive Officer of Pharmacyclics from September 2008 to May 2015 as well as its largest investor.
+Added: From 1990 to 2003, Mr.
+Added: Duggan was chairman of the board of directors of Computer Motion, Inc.
+Added: From 1997 to 2003, Mr.
+Added: Duggan also served as Chief Executive Officer of Computer Motion.
+Added: In June 2003, Computer Motion merged with Intuitive Surgical Inc.
+Added: Duggan has been a director and the chairman of the board of directors of Pulse Biosciences, Inc.
+Added: since November 2017.
+Added: From 2003 to 2011, Mr.
+Added: Duggan served on the board of directors of Intuitive Surgical.
+Added: Duggan received a U.S.
+Added: 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.
+Added: He is a member of the University of California at Santa Barbara Foundation board of trustees.
+Added: 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.
+Added: 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.
+Added: Zanganeh has previously served as the Company’s Chief Operations Officer from November 2020 to July 2022.
+Added: Zanganeh is Founder, Chief Executive Officer and Director of Maky Zanganeh and Associates, an executive management and consulting firm founded in 2015.
+Added: Previously, from August 2012 to September 2015, she served as the Chief Operating Officer of Pharmacyclics Inc.
+Added: 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.
+Added: Prior to joining Pharmacyclics Inc., Dr.
+Added: 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.
+Added: From September 2003 to August 2008, Dr.
+Added: Zanganeh served as Vice President of Business Development for Robert W.
+Added: Duggan & Associates.
+Added: 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.
+Added: Zanganeh has been a member of the Board of Directors of Pulse Biosciences, Inc.
+Added: since February 2017.
+Added: Zanganeh received a DDS degree from Louis Pasteur University in Strasbourg, France and MBA from Schiller International University in France.
+Added: Zanganeh was appointed as a director because of her years of executive and operational experience in the life sciences industry.
+Added: Soni , age 46, has served as a member of our Board of Directors since December 2019 and as Chief Operating Officer since October 2023.
+Added: From February 2022 to October 2023, Mr.
+Added: 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
+Added: October 2023.
+Added: 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.
+Added: Prior to joining Reata Pharmaceuticals, Mr.
+Added: Soni was the Senior Vice President and Chief Financial Officer of Alnylam Pharmaceuticals Inc.
+Added: from May 2017 to August 2019.
+Added: From March 2016 to February 2017, Mr.
+Added: 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.
+Added: Previously, he served as Chief Financial Officer of Pharmacyclics, Inc., a biopharmaceutical company, until its acquisition by AbbVie in 2015.
+Added: Prior to joining Pharmacyclics, Mr.
+Added: Soni worked at Zeltiq Aesthetics Inc., a publicly held medical technology company which was acquired by Allergan Inc.
+Added: (acquired by Abbvie).
+Added: Prior to Zeltiq, Mr.
+Added: Soni worked at PricewaterhouseCoopers in the life science and venture capital group.
+Added: Soni currently serves as a member of the board of directors of Pulse Biosciences, Inc.
+Added: since November 2017 and previously served as a member of the board of directors of Arena Pharmaceuticals, Inc.
+Added: (acquired by Pfizer, Inc.).
+Added: Soni is a Certified Public Accountant and Chartered Accountant (India).
+Added: Soni was appointed as a director because of his extensive experience in the life sciences industry and his financial and accounting expertise.
+Added: Clark , age 65, has served on our Board of Directors since October 2021.
+Added: 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.
+Added: He is also a partner of TCG Labs, a venture capital fund affiliated with The Column Group.
+Added: Clark has previously served as a member of the boards of directors for multiple publicly traded companies, including Pulse BioSciences, Inc.
+Added: and Pharmacyclics, Inc, and is currently a director of Acurex Biosciences.
+Added: Clark received his undergraduate degree from Vanderbilt University and a juris doctorate from the University of Texas School of Law.
+Added: We believe Mr.
+Added: 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.
+Added: 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.
+Added: Booth has spent more than 30 years in the biopharmaceutical industry, most recently as founder and chief executive officer of Virobay Inc.
+Added: Additionally, he has served as operating partner and senior advisor at TPG Biotech.
+Added: Prior to Virobay, Dr.
+Added: Booth was the chief scientific officer at Celera Genomics, where he was responsible for all discovery and development activities.
+Added: At Celera, Dr.
+Added: Booth conceived and initiated the BTK inhibitor program that was ultimately licensed to Pharmacyclics and from which IMBRUVICA® (ibrutinib) was developed and approved.
+Added: Booth served on the board of directors of Pharmacyclics until its acquisition by AbbVie.
+Added: Prior to Celera, Dr.
+Added: 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.
+Added: 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.
+Added: Booth received his BSc and PhD in biochemistry from the University of London.
+Added: The Board has determined that Dr.
+Added: Booth qualifies as an independent director under applicable Nasdaq listing rules.
+Added: We believe Dr.
+Added: Booth is qualified to serve on our Board of Directors because of his expertise in the life sciences industry.
+Added: Ujwala Mahatme , age 59, has served as a member of our Board of Directors since July 2020.
+Added: Currently, Ms.
+Added: Mahatme serves as the Founder and Managing Partner of Mahatme Bitterman PLLC, a role she has held since 2002.
+Added: Previously, Ms.
+Added: Mahatme served as Counsel at Gibson, Dunn & Crutcher and Counsel and Associate at Pillsbury Winthrop Shaw Pittman LLP.
+Added: 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.
+Added: We believe Ms.
+Added: Mahatme is qualified to serve on our Board of Directors because of her expertise in corporate law and financing in the biotechnology sector.
+Added: Alessandra Cesano , age 63, has served as a member of our Board of Directors and the Nominating and Corporate Governance Committee since November 2022.
+Added: 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
+Added: Chief Medical Officer of ESSA Pharma.
+Added: Prior to ESSA, Dr.
+Added: Cesano was the Chief Medical Officer at NanoString Inc., where she built and led the Immuno-Oncology program and the diagnostic pipeline.
+Added: Prior to NanoString, she was Chief Medical Officer for Cleave Biosciences.
+Added: Cesano led the successful filing of two INDs for a clinical candidate and led two Phase I trials in Multiple Myeloma and solid tumors.
+Added: 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).
+Added: Cesano serves on the board of directors at Puma Biotechnology.
+Added: She received her PhD in tumor immunology and her MD from the University of Turin.
+Added: The Board has determined that Dr.
+Added: Cesano qualifies as an independent director under applicable Nasdaq listing rules.
+Added: We believe Dr.
+Added: Cesano is qualified to serve on our Board of Directors because of her expertise in the biopharmaceutical industry focused on oncology.
+Added: Yu (Michelle) Xi a, age 57, has served as a member of our Board of Directors since January 2023.
+Added: Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012.
+Added: Xia has over 27 years of experience in the pharmaceutical industry and academic research.
+Added: Prior to founding Akeso Biosciences, Dr.
+Added: 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).
+Added: From 2006 to 2008, Dr.
+Added: Xia served as a senior scientist and group leader at PDL BioPharma, Inc.
+Added: (later acquired by AbbVie).
+Added: Xia served as a senior process development scientist at Bayer Corporation in the U.S.
+Added: At both PDL BioPharma and Bayer, Dr.
+Added: Xia oversaw CMC, process development and manufacturing of therapeutic protein and antibody drugs.
+Added: Xia began her pharmaceutical career at Axys Pharmaceuticals, Inc.
+Added: (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.
+Added: Xia earned her Ph.D.
+Added: degree in molecular biology and microbiology from Newcastle University in the U.K.
+Added: Xia completed her postdoctoral research training at the University of Glasgow in the U.K.
+Added: 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.
+Added: from 1996 to 2000.
+Added: Over the years, Dr.
+Added: 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.
+Added: Xia has also received numerous awards and recognitions for her contributions to both the pharmaceutical industry and commercial enterprises.
+Added: Most recently, Dr.
+Added: 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.
+Added: We believe Dr.
+Added: Xia is qualified to serve on our Board of Directors because of her extensive experience in the biopharmaceutical industry, including in oncology.
+Added: Board Committees
+Added: Our Board of Directors has the following standing committees:
+Added: Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee, each of which has the composition and the responsibilities described below.
+Added: 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.
+Added: 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:
+Added: Name of Director Audit Compensation Nominating and Corporate Governance
+Added: Mahkam Zanganeh
+Added: X (Chair) X (Chair) (2)
+Added: Alessandra Cesano
+Added: Ujwala Mahatme
+Added: Number of Meetings Held During 2023
+Added: _______________
+Added: (1) On October 13, 2023, the Company appointed Manmeet Soni as Chief Operating Officer.
+Added: In connection with his employment as Chief Operating Officer, Mr.
+Added: 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.
+Added: To fill the vacancies left by Mr.
+Added: Soni, Robert Booth was appointed to the Audit Committee and Kenneth A.
+Added: Clark was appointed as the lead independent director on the Board.
+Added: (2) On February 16, 2024, Mr.
+Added: Clark was appointed to serve as Compensation Committee Chair.
+Added: Our Corporate Governance Guidelines set out that all directors are expected to attend our annual meeting of stockholders.
+Added: All of the current Board members who were members of the Board at our 2023 annual stockholder meeting attended such meeting.
+Added: Audit Committee
+Added: 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.
+Added: Our Audit Committee is responsible for, among other things:
+Added: • appointing, approving the compensation of, and assessing the independence of our registered public accounting firm;
+Added: • overseeing the work of our registered public accounting firm, including through the receipt and consideration of reports from such firm;
+Added: • reviewing and discussing with management and the registered public accounting firm our annual and quarterly financial statements and related disclosures;
+Added: • monitoring our internal control over financial reporting, disclosure controls and procedures and code of business conduct and ethics;
+Added: • establishing policies regarding the receipt and retention of accounting related complaints and concerns;
+Added: • meeting independently with our internal auditing staff, if any, our registered public accounting firm and management;
+Added: • reviewing and approving or ratifying any related person transactions;
+Added: • preparing the Audit Committee report required by SEC rules.
+Added: The members of our Audit Committee are Mr.
+Added: Booth and Ms.
+Added: Clark serves as our Audit Committee Chair.
+Added: 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.
+Added: 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.
+Added: In addition, our Board of Directors has determined that Mr.
+Added: 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.
+Added: Compensation Committee
+Added: Our Compensation Committee oversees our corporate compensation policies, plans and programs.
+Added: Our Compensation Committee is responsible for, among other things:
+Added: • 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;
+Added: • overseeing an evaluation of our senior executives;
+Added: • overseeing and administering our cash and equity incentive plans;
+Added: • reviewing and making recommendations to our Board of Directors with respect to director compensation;
+Added: • reviewing and discussing annually with management our “Compensation Discussion and Analysis” disclosure if and to the extent then required by SEC rules;
+Added: • preparing the Compensation Committee report required by SEC rules.
+Added: The members of our Compensation Committee are Mr.
+Added: Clark and Ms.
+Added: Mr Clark serves as our Compensation Committee Chair.
+Added: 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.
+Added: 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.
+Added: Nominating and Corporate Governance Committee
+Added: 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.
+Added: Our Nominating and Corporate Governance Committee is responsible for, among other things:
+Added: • identifying individuals qualified to become members of our Board of Directors;
+Added: • recommending to our Board of Directors the persons to be nominated for election as directors and to each of our Board of Directors’ committees;
+Added: • reviewing and making recommendations to our Board of Directors with respect to our Board of Directors leadership structure;
+Added: • reviewing and making recommendations to our Board of Directors with respect to management succession planning;
+Added: • developing and recommending to our Board of Directors corporate governance principles;
+Added: • overseeing an annual evaluation of our Board of Directors.
+Added: As of December 31, 2023 the members of our Nominating and Corporate Governance Committee are Mr.
+Added: Mahatme and Dr.
+Added: Clark serves as our Nominating and Corporate Governance Committee Chair.
+Added: 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.
+Added: Director Compensation
+Added: Employee directors are not compensated for Board of Directors services in addition to their regular employee compensation.
+Added: For 2023, the non-employee members of the Board of Directors were compensated as follows:
+Added: Cash compensation :
+Added: Each non-employee member of the Board received the following cash compensation (the “Retainer Cash Payments”):
+Added: • an annual retainer for each member of the Board of $48,000 paid in equal quarterly installments;
+Added: • 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;
+Added: • 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.
+Added: We reimbursed our non-employee directors for all reasonable out-of-pocket expenses incurred in the performance of their duties as directors.
+Added: Equity Compensation :
+Added: 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.
+Added: 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
+Added: date, which shall vest in four equal annual installments, with the first such installment occurring on the one-year anniversary of the grant date.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The election must have been made by December 31 of the preceding year.
+Added: 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.
+Added: Compensation paid to Mr.
+Added: Zanganeh and Mr.
+Added: Soni is included in the section entitled, “Executive Compensation” and excluded from the table below:
+Added: Name Fees Earned or Paid in Cash ($)
+Added: Option Awards ($) (1)
+Added: 25,792 308,855 334,647
+Added: Robert Booth (2)
+Added: 1,425 263,344 264,769
+Added: Ujwala Mahatme — 293,685 293,685
+Added: Alessandra Cesano 27,250 199,744 226,994
+Added: Michelle Xia (3)
+Added: _______________
+Added: (1) Amounts shown represent the aggregate grant date fair value of the option awards computed in accordance with FASB ASC Topic 718.
+Added: These amounts do not correspond to the actual value that will be realized by our directors.
+Added: The assumptions used in the valuation of these awards are consistent with the valuation methodologies specified in the notes to our financial statements.
+Added: (2) Fees earned or paid in cash for Mr.
+Added: Clark and Mr.
+Added: Booth were a result of these individuals filling the vacancies left by Mr.
+Added: Soni as described above.
+Added: Xia did not receive any compensation for her role as a member of the Company's Board of Directors in 2023.
+Added: The aggregate number of shares subject to stock options outstanding and exercisable on December 31, 2023 for each non-employee director is as follows:
+Added: Name Aggregate Number of Stock Options Outstanding as of December 31, 2023
+Added: Aggregate Number of Stock Options Exercisable as of December 31, 2023
+Added: Robert Booth 273,950 123,950
+Added: Alessandra Cesano 255,516 105,516
+Added: Clark 369,160 269,160
+Added: Ujwala Mahatme 386,712 336,712
+Added: DELINQUENT SECTION 16(a) REPORTS
+Added: 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.
+Added: Such executive officers and directors and other persons who beneficially
+Added: 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.
+Added: 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:
+Added: (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;
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Xia filed a Form 5 on February 14, 2024 to report each of the transactions described in clauses (i) and (ii) of this paragraph.
Executive Compensation
−Removed: The information required by this Item is incorporated herein by reference to the information that will be included in our proxy statement related to the 2023 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
+Added: EXECUTIVE COMPENSATION
+Added: Compensation Committee Report
+Added: 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.
+Added: The Compensation Committee has reviewed and discussed the following “Executive Compensation” section of this Annual Report with management.
+Added: Based on this review and discussion, the Compensation Committee recommended to our Board of Directors that such information be included in this Annual Report.
+Added: Members of the Compensation Committee:
+Added: Clark (Chair)
+Added: Ujwala Mahatme
+Added: Executive Compensation
+Added: The following is a discussion and analysis of compensation arrangements of our named executive officers (NEOs).
+Added: This discussion contains forward looking statements that are based on our current plans, considerations, expectations and determinations regarding future compensation programs.
+Added: Actual compensation programs that we adopt may differ materially from currently planned programs as summarized in this discussion.
+Added: 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.
+Added: We seek to ensure that the total compensation paid to our executive officers is reasonable and competitive.
+Added: Compensation of our executives is structured around the achievement of individual performance and near-term corporate targets as well as long-term business objectives.
+Added: 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:
+Added: Duggan, our Chief Executive Officer and Executive Chairman;
+Added: • Mahkam Zanganeh, our Chief Executive Officer, President and Director;
+Added: • Manmeet Soni, our Chief Operating Officer and Director
+Added: • Ankur Dhingra, our Chief Financial Officer;
+Added: Summary Compensation Table
+Added: 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:
+Added: Name and Principal Position Year Salary ($)
+Added: Option Awards ($) (2)
+Added: All Other Compensation ($) (3)
+Added: Chief Executive Officer and Executive Chairman (4)
+Added: Mahkam Zanganeh, Director, Chief Executive Officer, and President
+Added: (1) 19,905,115 (7)
+Added: 57,809 20,562,924
+Added: 450,000 452,500 307,200 (8)
+Added: 32,349 1,242,049
+Added: 450,000 182,250 8,987,768 19,196 9,639,214
+Added: Manmeet Soni, Chief Operating Officer
+Added: (1) 23,381,640 (9)
+Added: Ankur Dhingra, Chief Financial Officer
+Added: 2023 500,000 (6)
+Added: (1) — 30,001 530,001
+Added: 264,231 381,918 694,464 (10)
+Added: 22,237 1,362,850
+Added: _______________
+Added: (1) Final bonus amounts for 2023 have not yet been approved by the Compensation Committee and will be paid in April 2024.
+Added: (2) Amounts shown represent the aggregate grant date fair value of the option awards computed in accordance with FASB ASC Topic 718.
+Added: These amounts do not correspond to the actual value that will be realized by our named executive officers.
+Added: The assumptions used in the valuation of these awards are consistent with the valuation methodologies specified in the notes to our financial statements.
+Added: (3) The amounts paid for all other compensation consisted of the following:
+Added: Name and Principal Position Year Health, Life and Disability Benefits ($)
+Added: 401(k) Match/Pension Scheme ($) Director Fees
+Added: Chief Executive Officer and Executive Chairman (3)
+Added: Mahkam Zanganeh, Director, co- Chief Executive Officer, and President
+Added: 38,009 19,800 — 57,809
+Added: 14,049 18,300 — 32,349
+Added: 1,796 17,400 — 19,196
+Added: 6,178 — 125,521 131,699
+Added: Ankur Dhingra, Chief Financial Officer
+Added: 2023 30,001 — — 30,001
+Added: 2022 22,237 — — 22,237
+Added: Duggan has declined any compensation from the Company.
+Added: Zanganeh’s salary was increased to from $450,000 per annum to $600,000 per annum effective January 1, 2023.
+Added: Dhingra’s salary was increased from $450,000 per annum to $500,000 per annum effective January 1, 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Prior to joining the Company as Chief Operating Officer, Mr.
+Added: Soni was granted options for serving on the Company's Board of Directors with a fair value of $136,145.
+Added: 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.
+Added: 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.
+Added: 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 $131,400.
+Added: Outstanding Equity Awards at Fiscal Year-End
+Added: The following table presents certain information concerning equity awards held by our principal executive officer and our next most highly compensated executive officer, who were serving as executive officers as of December 31, 2023:
+Added: Option Awards
+Added: Name Number of securities underlying outstanding options Option exercise price ($/sh) Option expiration date
+Added: Grant date Exercisable Unexercisable
+Added: Duggan, Chief Executive Officer and Executive Chairman — — — — —
+Added: Mahkam Zanganeh, Director, Chief Executive Officer, and President
+Added: 150,000 50,000 $ 3.71 11/11/2030
+Added: 11/11/2020 3,323 — $ 3.71 11/11/2030
+Added: 11/22/2020 (1)
+Added: 1,800,000 600,000 $ 4.40 11/22/2030
+Added: 12/15/2021 (2)
+Added: — 15,000 $ 4.75 12/15/2031
+Added: 6/28/2022 (3)
+Added: — 1,300,000 $ 1.06 6/28/2032
+Added: — 500,000 $ 1.29 9/9/2032
+Added: 10/13/2023 (3)
+Added: — 11,988,198 $ 1.68 10/13/2033
+Added: — 11,988,198 $ 1.68 10/13/2033
+Added: Manmeet Soni, Director, Chief Operating Officer (6)
+Added: 12/23/2019 200,000 $ 1.37 12/23/2029
+Added: 5/1/2020 27,273 $ 3.30 5/1/2030
+Added: 2/19/2021 (4)
+Added: 25,000 $ 7.33 2/19/2031
+Added: 25,000 $ 2.82 1/3/2032
+Added: 82,446 $ 2.82 1/3/2032
+Added: 35,000 $ 5.00 1/3/2033
+Added: 10/13/2023 (3)
+Added: 14,000,000 $ 1.68 10/13/2033
+Added: 14,000,000 $ 1.68 10/13/2033
+Added: Ankur Dhingra, Chief Financial Officer 5/31/2022 (5)
+Added: 150,000 450,000 $ 1.33 5/31/2032
+Added: 6/28/2022 (3)
+Added: — 400,000 $ 1.06 6/28/2032
+Added: — 350,000 $ 1.29 9/9/2032
+Added: _______________
+Added: (1) Option award was originally a performance-based award.
+Added: In September 2021, this award was modified to a time-based award, which vest in four equal annual installments beginning on November 22, 2021.
+Added: (2) Options vest in three years on December 15, 2024.
+Added: (3) Option award is a performance-based award with market service conditions.
+Added: As of December 31, 2023, none of the conditions had been met.
+Added: (4) Options vest in four equal quarterly installments.
+Added: (5) Options vest in four equal annual installments beginning May 31, 2023.
+Added: (6) On October 13, 2023, the Company appointed Manmeet Soni as Chief Operating Officer.
+Added: Awards granted prior to October 13, 2023 were for Mr.
+Added: Soni’s service on the Company’s Board of Directors.
+Added: Narrative to Summary Compensation Table and Outstanding Equity Awards at Fiscal Year End
+Added: Employment Agreement with Mahkam Zanganeh
+Added: We entered into an employment agreement with Dr.
+Added: Zanganeh, our current Chief Executive Officer and President, on November 22, 2020.
+Added: The employment relationship between the Company and Dr.
+Added: Zanganeh is “at-will”, and the employment agreement has no specific term.
+Added: Zanganeh’s annual base salary as of December 31, 2022 was $450,000.
+Added: 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.
+Added: 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.
+Added: Following this determination, the option awards are subject only to previous existing time-based vesting conditions.
+Added: 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.
+Added: Zanganeh was paid a discretionary cash bonus of $182,250 relating to 2021 and this bonus was paid in March of 2022.
+Added: 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.
+Added: Zanganeh’s salary was increased to from $450,000 per annum to $600,000 per annum effective January 1, 2023.
+Added: Zanganeh is eligible to participate in employee benefit plans maintained from time to time by us of general applicability to other senior executives.
+Added: During her term of service as an executive officer, Dr.
+Added: Zanganeh will not receive compensation that would otherwise be owed to her in her capacity as a member of our Board of Directors.
+Added: Employment Agreement with Manmeet Soni
+Added: We entered into an employment agreement with Mr.
+Added: Soni, our Chief Operating Officer on October 13, 2023.
+Added: The employment relationship between the Company and Mr.
+Added: Soni is “at-will”, and the employment agreement has no specific term.
+Added: Soni’s annual base salary as of December 31, 2023 was $600,000.
+Added: 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.
+Added: In addition, Mr.
+Added: 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.
+Added: 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.
+Added: Employment Agreement with Ankur Dhingra
+Added: We entered into an employment letter with Mr.
+Added: Dhingra, our Chief Financial Officer, on April 15, 2022.
+Added: The employment relationship between the Company and Mr.
+Added: Dhingra is “at-will”, and the employment agreement has no specific term.
+Added: Dhingra’s annual base salary as of December 31, 2023 was $500,000.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Dhingra’s salary was increased from $450,000 per annum to $500,000 per annum effective January 1, 2023.
+Added: Dhingra is eligible to participate in employee benefit plans maintained from time to time by us of general applicability to other senior executives.
+Added: PAY VERSUS PERFORMANCE
+Added: 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
+Added: compensation and certain financial performance of our Company.
+Added: 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.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The information required by this Item is incorporated herein by reference to the information that will be included in our proxy statement related to the 2023 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
−Removed: Certain Relationships and Related Transactions, and Director Independence.
−Removed: The information required by this Item is incorporated herein by reference to the information that will be included in our proxy statement related to the 2023 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
+Added: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
+Added: 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;
+Added: (ii) each director and nominee;
+Added: (iii) each named executive officer listed in the table entitled, “Summary Compensation Table” under the section entitled, “Executive Compensation”;
+Added: and (iv) all directors and executive officers as a group.
+Added: As of February 9, 2023, 701,697,179 shares of our common stock were issued and outstanding.
+Added: 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.
+Added: 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.
+Added: Name and Address of Beneficial Owner
+Added: Number of Shares Owned (1)
+Added: Right to Acquire Shares (2)
+Added: Total Beneficial Ownership
+Added: Percent of Class (3)
+Added: 5% Stockholders:
+Added: 548,369,106 4,003,691 552,372,797 78.3%
+Added: Mahkam Zanganeh (5)
+Added: 35,268,388 2,269,004 37,537,392 5.3%
+Added: 31,523,530 8,750 31,532,280 4.5%
+Added: Named executive officers and directors:
+Added: 548,369,106 4,003,691 552,372,797 78.3%
+Added: Mahkam Zanganeh (5)
+Added: 35,268,388 2,269,004 37,537,392 5.3%
+Added: 31,523,530 8,750 31,532,280 4.5%
+Added: 2,976,190 394,719 3,370,909 *
+Added: Ankur Dhingra (8)
+Added: 294,485 150,000 444,485 *
+Added: Clark — 295,533 295,533 *
+Added: Robert Booth — 144,613 144,613 *
+Added: Ujwala Mahatme — 358,606 358,606 *
+Added: Alessandra Cesano — 119,607 119,607 *
+Added: All named executive officers and directors as a group (9 people)
+Added: 618,431,699 7,744,523 626,176,222 88.3 %
+Added: _______________
+Added: (*) Represents beneficial ownership of less than 1% of the outstanding shares of our common stock.
+Added: (1) Excludes shares that may be acquired through the exercise of outstanding stock options or other equity awards.
+Added: (2) Represents shares issuable within 60 days after February 9, 2024 upon exercise of exercisable options and warrants;
+Added: however, unless otherwise indicated, these shares do not include any equity awards awarded after February 9, 2024.
+Added: (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.
+Added: (4) This information is based upon a Schedule 13D/A filed by Mr.
+Added: Duggan with the Securities and Exchange Commission on February 16, 2023, updated by a Form 4 filed by Mr.
+Added: Duggan on January 4, 2024, and information known to the Company.
+Added: The 552,372,797 shares of common stock beneficially owned by Mr.
+Added: 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.
+Added: 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).
+Added: (5) This information is based upon a Schedule 13D/A filed by Dr.
+Added: Zanganeh with the Securities and Exchange Commission on March 13, 2023, updated by a Form 4 filed by and information known to the Company.
+Added: 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).
+Added: Of the warrants to purchase 315,681 shares of Common Stock, 315,681 are held by the Shaun Zanganeh Irrevocable Trust.
+Added: The options to purchase 1,953,323 shares of Common Stock are held individually by Dr.
+Added: (6) The shares beneficially owned by Dr.
+Added: Xia include (i) 31,520,000 shares of Common Stock owned by Akeso, a company in which Dr.
+Added: Xia is a stockholder and exercises the right to vote approximately 28.9% of Akeso’s ordinary shares, and in which Dr.
+Added: Xia serves as chairwoman, president and chief executive officer, and (ii) options to purchase 8,750 shares of Common Stock held individually by Dr.
+Added: Xia disclaims beneficial ownership of all shares of Common Stock held by Akeso, except to the extent of her pecuniary interest therein.
+Added: (7) This information is based upon a Form 4 filed by Mr.
+Added: Soni with the securities and Exchange Commission on October 16, 2023 and information known to the Company.
+Added: The 3,370,909 shares of common stock beneficially owned by Mr.
+Added: Soni includes 2,976,190 shares acquired in the private placement on October 13, 2023.
+Added: (8) This information is based upon a Form 4 filed by Mr.
+Added: Dhingra with the Securities and Exchange Commission on December 13, 2023 and information known to the Company.
+Added: 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.
+Added: EXECUTIVE OFFICERS
+Added: Biographical data for our current executive officers, including their ages as of December 31, 2023 is set forth below, except Mr.
+Added: Duggan’s, Dr.
+Added: Zanganeh and Mr.
+Added: Soni’s biography, each of which are included under the heading, “Board of Directors and Committees of the Board” above.
+Added: Ankur Dhingra , age 48, has served as Chief Financial Officer since May 2022.
+Added: Dhingra served as Chief Financial Officer at CareDx, a company focused on transplant patient journey, from March 25, 2021 through May 25, 2022.
+Added: In his role at CareDx, Mr.
+Added: Dhingra was responsible for finance, information technology and market access functions.
+Added: Prior to CareDx, Mr.
+Added: Dhingra spent 18 years at Agilent Technologies (“Agilent”) in various finance and business management roles.
+Added: From January 2019 through March 2021, he was Vice President of Investor Relations and prior to that, Mr.
+Added: Dhingra served as Group CFO for Agilent’s Life Sciences and Applied Markets business.
+Added: 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.
+Added: He has extensive experience managing global teams of finance and accounting professionals.
+Added: Dhingra is a qualified Chartered Accountant (India).
+Added: Equity Compensation Plan Information
+Added: The following table presents information about our equity compensation plans as of December 31, 2023:
+Added: 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)
+Added: Equity compensation plans approved by security holders (1)
+Added: 105,809,178 $ 1.95 3,261,496
+Added: Equity compensation plans not approved by security holders (2)
+Added: 69,973 $ 1.44 —
+Added: _______________
+Added: (1) Includes the following plans:
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: This increase is not reflected in the table above.
+Added: 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.
+Added: Excludes shares issued under the 2020 Employee Stock Purchase Plan.
+Added: (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.
+Added: Certain Relationships and Related Party Transactions
+Added: CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
+Added: 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.
+Added: 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.
+Added: The policy calls for the proposed related person transaction to be reviewed and, if deemed appropriate, approved by our Audit Committee.
+Added: Whenever practicable, the reporting, review and approval will occur prior to entry into the transaction.
+Added: If advance review and approval is not practicable, the Audit Committee will review, and, in its discretion, may ratify the related person transaction.
+Added: 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.
+Added: Any related person transactions that are ongoing in nature will be reviewed annually.
+Added: 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.
+Added: As appropriate for the circumstances, the Audit Committee will review and consider:
+Added: • the related person’s interest in the related person transaction;
+Added: • the approximate dollar value of the amount involved in the related person transaction;
+Added: • 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;
+Added: • whether the transaction was undertaken in the ordinary course of our business;
+Added: • whether the terms of the transaction are no less favorable to us than terms that could have been reached with an unrelated third party;
+Added: • the purpose of, and the potential benefits to us of, the transaction;
+Added: • 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.
+Added: 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.
+Added: The Audit Committee may impose any conditions on the related person transaction that it deems appropriate.
+Added: 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:
+Added: • 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;
+Added: • a transaction that is specifically contemplated by provisions of our charter or Bylaws.
+Added: 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.
+Added: Related Party Transactions
+Added: 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:
+Added: • the amounts involved exceeded or will exceed $120,000;
+Added: • 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.
+Added: Transactions with Robert W.
+Added: On December 6, 2022, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Mr.
+Added: Duggan and Dr.
+Added: Zanganeh, pursuant to which the Company agreed to sell to each of Mr.
+Added: Duggan and Dr.
+Added: Zanganeh unsecured promissory notes in the aggregate amount of $520 million.
+Added: Pursuant to the Note Purchase Agreement, the Company issued to Mr.
+Added: Duggan and Dr.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Furthermore, on January 19, 2023, the Company and Mr.
+Added: Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent that the
+Added: 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.
+Added: 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”).
+Added: The Notes accrue interest at an initial rate of 7.5%.
+Added: All interest on the Notes were paid on the date of signing for the period through February 15, 2023.
+Added: 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.
+Added: Duggan and 373,857 shares to Dr.
+Added: 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.
+Added: 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.
+Added: During the year ended December 31, 2023, the Company made payments for interest of $10.7 million .
+Added: On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025.
+Added: 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.
+Added: Interest shall be paid upon maturity of the loan.
+Added: On March 10, 2022, the Company entered into a note purchase agreement with Mr.
+Added: Duggan, pursuant to which Mr.
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: On August 16, 2022, 94,849,203 shares were purchased by Mr.
+Added: Duggan in connection with the July 2022 rights offering (“2022 Rights Offering”).
+Added: Transactions with Dr.
+Added: Mahkam Zanganeh
+Added: In December 2023, Dr.
+Added: Zanganeh exercised warrants to purchase 805,495 shares.
+Added: 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.
+Added: As described above, on December 6, 2022, the Company entered into the Note Purchase Agreement with Mr.
+Added: Duggan and Dr.
+Added: Zanganeh, pursuant to which the Company agreed to sell to Mr.
+Added: Duggan and Dr.
+Added: Zanganeh the Notes in the aggregate amount of $520 million.
+Added: Pursuant to the Note Purchase Agreement, the Company issued Dr.
+Added: Zanganeh the Zanganeh Note in the amount of $20 million, which matured and became due on February 15, 2023.
+Added: All interest on the Notes shall be paid on the date of signing for the period through February 15, 2023.
+Added: 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.
+Added: On February 15, 2023, the $20 million Zanganeh Note matured and the Company repaid the outstanding principal balance.
+Added: On August 16, 2022, (i) 184,430 shares were purchased by Dr.
+Added: Zanganeh (ii) 4,593,777 shares were purchased by the Mahkam Zanganeh Revocable Trust, of which Dr.
+Added: Zanganeh is a trustee, and (iii) 1,030,925 shares were purchased by the Shaun Zanganeh Irrevocable Trust, of which Dr.
+Added: Zanganeh is a trustee in connection with the 2022 Rights Offering.
+Added: On May 12, 2021, 389,977 shares were purchased by the Mahkam Zanganeh Revocable Trust in connection with the 2021 Rights Offering.
+Added: On March 26, 2021, the Company entered into the Sublease with Dr.
+Added: Zanganeh and Associates, Inc.
+Added: (“MZA”) consisting of 4,500 square feet of space at 2882 Sand Hill Road, Menlo Park, CA (the “Sublease”).
+Added: The Sublease runs until
+Added: September 2022.
+Added: 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.
+Added: During the year ended December 31, 2021, payments of $556 thousand were made pursuant to the sublease.
+Added: During the year ended December 31, 2022, payments of $537 thousand were made pursuant to the sublease.
+Added: On July 25, 2022, the Company entered into the First Amendment, dated July 19, 2022 to the Sublease with MZA.
+Added: 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.
+Added: 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.
+Added: During the year ended December 31, 2023, payments of $0.8 million , were made pursuant to the first amendment to the Sublease Agreement.
+Added: On July 29, 2022, the Company entered into the Second Amendment, dated August 1, 2022, to the Sublease with MZA.
+Added: The Second Amendment was effective as of August 1, 2022 and expires on December 31, 2025.
+Added: The Second Amendment includes an additional 1,277 square feet (the “ Expansion Premises”) of office space at 2882 Sand Hill Road, Menlo Park, California.
+Added: 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.
+Added: During the year ended December 31, 2023 payments of $218 thousand, were made pursuant to the Secondment Amendment to the Sublease.
+Added: Transactions with Dr.
+Added: Yu (Michelle) Xia
+Added: On December 5, 2022, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Akeso, Inc.
+Added: and its affiliates (“Akeso”) and certain ancillary transaction documents as set forth in the License Agreement.
+Added: 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”).
+Added: 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.
+Added: The $200 million remaining amount of the $500 million upfront payment was paid on March 5, 2023.
+Added: The Company and Akeso also entered into Amendment No.
+Added: 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.
+Added: to Akeso, Inc.
+Added: Upon the closing of the License Agreement, the Board of Directors of the Company appointed Dr.
+Added: 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.
+Added: The Company paid approximately $2.5 million to Akeso during year ended December 31, 2023.
+Added: As of December 31, 2023, the Company included in accrued expenses approximately $3.6 million due to Akeso.
+Added: Transactions with Mr.
+Added: On October 16, 2023, the Company announced the appointment of Mr.
+Added: Manmeet Soni as its Chief Operating Officer, effective immediately.
+Added: Soni has been a part of the Company’s Board of Directors since 2019.
+Added: He will remain a member of the Board of Directors.
+Added: In conjunction with his appointment, Mr.
+Added: Soni entered into a share purchase agreement with the Company to purchase $5.0 million of its common stock via a private placement.
+Added: 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.
+Added: Indemnification Agreements
+Added: Our certificate of incorporation provides that we will indemnify our directors and officers to the fullest extent permitted by Delaware law.
+Added: In addition, we have entered into indemnification agreements with all of our directors and named executive officers.
+Added: 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.
+Added: Employment Arrangements
+Added: We have entered into employment agreements with certain of our executive officers.
+Added: For more information regarding the agreements with our named executive officers, see “Executive Compensation.”
Principal Accounting Fees and Services
−Removed: The information required by this Item is incorporated herein by reference to the information that will be included in our proxy statement related to the 2023 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.
+Added: Auditor Services and Fees
+Added: Policy on Audit Committee’s Pre-Approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
+Added: The Audit Committee reviews and pre-approves all audit and permissible non-audit services provided by the independent registered public accounting firm.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: In addition, the Audit Committee also may pre-approve particular services on a case-by-case basis, as necessary or appropriate.
+Added: 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):
+Added: Year Ended December 31, 2023
+Added: Year Ended December 31, 2022
+Added: $ 1,175 $ 1,234
+Added: Audit-Related Fees
+Added: All Other Fees
+Added: $ 1,179 $ 1,238
+Added: Audit fees for both years consisted of professional services rendered for:
+Added: (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.
+Added: Audit-Related Fees:
+Added: 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.
+Added: There were no audit-related fees for the year ended December 31, 2023 and 2022, respectively.
+Added: Consists of fees for professional services for tax compliance, tax advice and tax planning.
+Added: There were no tax fees for the year ended December 31, 2023 and 2022, respectively.
+Added: All Other Fees:
+Added: 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.
+Added: The Audit Committee has concluded that the provision of the non-audit services listed above was compatible with maintaining the independence of PricewaterhouseCoopers LLP.
Exhibits, Financial Statement Schedules
10 unchanged sentences
001-36866), filed with the Securities and Exchange Commission on September 18, 2020)
−Removed: 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.
−Removed: 1 of Form 8-K filed by the Company on July 2 9 , 2022, File No.
+Added: 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.
3.4 Amendment No.
−Removed: 2 to Restated Certificate of Incorp oration , dated Januar y 19, 2023 ( incorporated by reference to Exhibit 5.1 of Form 8- K filed by the Company on January 20, 2023, File No.
+Added: 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.
4.1 Registration Rights Agreement, dated January 9, 2019, by and among Summit Therapeutics plc and Robert W.
147 unchanged sentences
and Ankur Dhingra
−Removed: 16.1 Letter from PwC to the Securities and Exchange Commission, dated May 26, 2021 (incorporated by reference to Exhibit 16.1 to the Company’s Current Report on Form 8-K (File No.
−Removed: 001-36866), filed with the Securities and Exchange Commission on May 26, 2021)
+Added: 10.49 Employment Agreement, dated October 13, 2023, by and between Summit Therapeutics Inc.
+Added: and Manmeet Soni
+Added: 10.50 Securities P urchase Agreement, dated October 13, 2023, by and between Summit Therapeutics Inc.
+Added: and Manmeet Soni
+Added: Amended and Restated Promissory Note, dated February 17, 2024, by and between Summit Therapeutics Inc.
+Added: and Robert W.
+Added: 14.1 Code of Business Conduct and Ethics of Summit Therapeutics Inc.
+Added: Restated Certificate of Incorporation (incorporated by reference to Exhibit 14.1 to the Company’s Current Report on Form 8-K (File No.
+Added: 001-36866), filed with the Securities and Exchange Commission on September 18, 2020 )
21.1* List of Significant Subsidiaries
−Removed: 23.1* Consent of PricewaterhouseCoopers LLP, a Delaware limited liability partnership
+Added: 23.1* Consent of PricewaterhouseCoopers LLP , an independent registered public accounting firm
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
−Removed: 31.2* Certification of C o- 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
+Added: 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
1 unchanged sentence
§1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002
+Added: S um mit Ther apeutics , Inc.
+Added: 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
19 unchanged sentences
Mahkam Zanganeh
−Removed: Co-Chief Executive Officer, President and member of the Board;
+Added: Chief Executive Officer, President and member of the Board;
Principal Executive Officer
3 unchanged sentences
Principal Financial Officer
−Removed: March 9, 2023
+Added: February 20, 2024
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.
2 unchanged sentences
Duggan Chief Executive Officer and Executive Chairman ( Principal Executive Officer )
−Removed: March 9, 2023
−Removed: /s/ Mahkam Zanganeh Co-Chief Executive Officer, President and member of the Board
+Added: February 18, 2024
+Added: /s/ Mahkam Zanganeh Chief Executive Officer, President and Director
( Principal Executive Officer )
−Removed: March 9, 2023
+Added: February 18, 2024
Mahkam Zanganeh
+Added: /s/ Manmeet Soni Chief Operating Officer and Director
+Added: February 18, 2024
/s/ Ankur Dhingra Chief Financial Officer
(Principal Financial Officer)
−Removed: March 9, 2023
+Added: February 18, 2024
Ankur Dhingra
/s/ Robert F.
−Removed: Booth Director March 9, 2023
−Removed: /s/ Alessandra Cesano Director March 9, 2023
+Added: Booth Director February 16, 2024
+Added: /s/ Alessandra Cesano Director February 16, 2024
Alessandra Cesano
−Removed: /s/ Kenneth Clark Director March 9, 2023
+Added: /s/ Kenneth Clark Director February 16, 2024
Kenneth Clark
−Removed: /s/ Ujwala Mahatme Director March 9, 2023
+Added: /s/ Ujwala Mahatme Director
+Added: February 18, 2024
Ujwala Mahatme
−Removed: /s/ Manmeet Soni Director March 9, 2023
−Removed: /s/ Yu Xia Director March 9, 2023
+Added: /s/ Yu Xia Director February 18, 2024
Summit Therapeutics Inc.
11 unchanged sentences
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”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years then ended in conformity with accounting principles generally accepted in the United States of America.
+Added: 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.
+Added: Substantial Doubt About the Company’s Ability to Continue as a Going Concern
+Added: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: 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.
+Added: Management’s plans in regard to these matters are also described in Note 3.
+Added: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
4 unchanged sentences
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
+Added: 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.
5 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Emphasis of Matter
−Removed: As discussed in Note 17 to the consolidated financial statements, the Company has a note payable with a principal amount of $100 million maturing in September 2024.
−Removed: Management’s evaluation of the events and conditions related to future funding are described in Note 3.
Critical Audit Matters
4 unchanged sentences
Included within accrued liabilities as of December 31, 2023 is $7.3 million relating to research and development expenditures.
−Removed: The Company records accruals for estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs.
−Removed: These amounts are determined by management based on the estimated costs to complete each study or activity, the estimation
−Removed: 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.
+Added: The Company records accruals for
+Added: estimated ongoing research and development costs or prepaid expenses where the payments made exceed the estimated costs.
+Added: 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.
8 unchanged sentences
Boston, Massachusetts
−Removed: March 9, 2023
+Added: February 20, 2024
We have served as the Company’s auditor since 2021.
7 unchanged sentences
Accounts receivable — 349
+Added: Short-term investments
Prepaid expenses 2,441 1,504
6 unchanged sentences
Goodwill 1,893 1,798
−Removed: Intangible assets, net — 10,399
+Added: Research and development tax credit receivable 959 —
Other assets 4,322 577
6 unchanged sentences
Lease liabilities 2,809 1,690
−Removed: Deferred revenue and other income — 7,939
Other current liabilities 717 662
18 unchanged sentences
Total stockholders’ equity
+Added: 77,692 126,654
Total liabilities and stockholders’ equity
+Added: $ 202,949 $ 664,168
The accompanying notes are an integral part of the consolidated financial statements
7 unchanged sentences
General and administrative 30,265 26,743
+Added: In-process research and development 520,915 —
Impairment of intangible assets — 8,468
9 unchanged sentences
Basic and diluted 619,646,180 193,336,063
−Removed: Other comprehensive income (loss):
+Added: Other comprehensive (loss) income:
Foreign currency translation adjustments ( 172 ) 304
+Added: Reclassification of cumulative currency translation gain to other expense, net
+Added: Unrealized gain on short-term investments
Comprehensive loss $ ( 615,483 ) $ ( 78,478 )
9 unchanged sentences
103,092,783 1,031 98,858 — 99,889
−Removed: Issuance on common stock from exercise of share options 1,151,500 11 3,077 — — 3,088
+Added: Issuance of common stock in lieu of interest to related parties 9,720,291 97 7,497 — — 7,594
+Added: 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
6 unchanged sentences
476,190,471 4,762 494,619 — — 499,381
−Removed: Issuance of common stock in lieu of interest to related parties 9,720,291 97 7,497 — — 7,594
−Removed: Issuance of common stock under stock purchase plans and exercise of stock options 238,811 2 397 — — 399
+Added: Issuance of common stock under employee stock purchase plans and exercise of stock options
+Added: 596,472 7 922 — — 929
+Added: Issuance of common stock in lieu of cash for Akeso upfront payment 10,000,000 100 45,800 — — 45,900
+Added: Private placement of common stock 2,976,190 30 4,970 — — 5,000
+Added: Exercise of warrants 805,495 8 1,195 — — 1,203
Stock-based compensation — — 14,108 — — 14,108
−Removed: Imputed interest expense on promissory notes payable to related parties — — 2,018 — — 2,018
+Added: Unrealized gain on short-term investments
+Added: — — — 36 — 36
+Added: Reclassification of cumulative translation gain (Note 10)
+Added: — — — ( 419 ) — ( 419 )
Foreign currency translation adjustment — — — ( 172 ) — ( 172 )
12 unchanged sentences
Non-cash interest expense
−Removed: Unrealized foreign exchange loss 2,614 326
+Added: Amortization of discount on short-term investments
+Added: Unrealized foreign currency (gain) loss
+Added: ( 812 ) 2,616
+Added: Reclassification of currency translation gain
+Added: Impairment of fixed assets
Amortization of operating right-of-use assets 1,852 1,251
3 unchanged sentences
Stock-based compensation 14,108 11,948
−Removed: Other adjustments 2 301
+Added: Loss on disposal of assets
+Added: In-process research and development expense 520,915 —
Changes in operating assets and liabilities:
11 unchanged sentences
Purchase of property and equipment
+Added: ( 128 ) ( 624 )
+Added: Proceeds from sale of property.
+Added: plant and equipment 226 —
+Added: Purchase of short-term investments ( 321,022 ) —
+Added: Maturities and sales of short-term investments 208,165 —
+Added: Payments to Akeso for upfront milestone payments and associated direct transaction costs
+Added: ( 475,015 ) —
Net cash used in investing activities ( 587,774 ) ( 624 )
Cash flows provided by financing activities:
−Removed: Proceeds from the issuance of common stock 100,000 75,000
−Removed: Transaction costs from the issuance of common stock ( 111 ) ( 118 )
+Added: Proceeds from the issuance of common stock for rights offering
+Added: 104,686 100,000
+Added: Transaction costs from the issuance of common stock for rights offering
+Added: ( 619 ) ( 111 )
+Added: Proceeds from the issuance of common stock via private placement
+Added: Net receipts related to the exercise of warrants
+Added: Proceeds received related to employee stock purchase plan and exercise of stock options
Proceeds from related party promissory notes — 545,000
1 unchanged sentence
Payments of related party promissory notes issuance costs — ( 44 )
−Removed: Proceeds from exercise of share options 399 3,088
Net cash provided by financing activities 86,513 620,244
−Removed: Effect of exchange rates on cash and restricted cash ( 1,222 ) 351
−Removed: Increase in cash, cash equivalents and restricted cash 576,816 5,374
−Removed: Cash at beginning of period 71,791 66,417
+Added: Effect of exchange rates on cash and cash equivalents
+Added: 839 ( 1,222 )
+Added: (Decrease) Increase in cash, cash equivalents and restricted cash
+Added: ( 577,182 ) 576,816
+Added: Cash, cash equivalents and restricted cash at beginning of period
+Added: 648,607 71,791
Cash, cash equivalents and restricted cash at end of period $ 71,425 $ 648,607
1 unchanged sentence
Cash paid for interest on related party promissory note $ 10,650 $ 434
+Added: Cash paid for income taxes
Debt issuance costs in accrued expenses $ — $ 31
−Removed: Transaction costs included in accrued expenses $ — $ 41
+Added: Consideration for the issuance of common stock for rights offering used to satisfy a portion of a related party promissory note (Note 18)
+Added: $ 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
+Added: Issuance of common stock pursuant to the Akeso License Agreement (Note 6)
The accompanying notes are an integral part of the consolidated financial statements.
5 unchanged sentences
Nature of Business and Operations
−Removed: 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.
−Removed: The Company's pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines.
−Removed: Recent Events
−Removed: On September 28, 2022, the Company determined that it would seek partners or a divestiture of ridinilazole, the Company's lead product candidate for treating patients suffering from Clostridioides difficile infection, also known as C.
−Removed: difficile infection, or CDI, as the path forward for the clinical development of the asset.
−Removed: As a result of this determination, the Company discontinued its only active study for ridinilazole, a pediatric clinical trial evaluating ridinilazole for treating adolescent patients with CDI.
−Removed: The Company is currently involved in activities related to closeout of ridinilazole clinical trials.
+Added: Summit Therapeutics Inc.
+Added: ( “ 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.
+Added: 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.
+Added: 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.
−Removed: and its affiliates (“Akeso”) pursuant to which we are partnering with Akeso to in-license its breakthrough bispecific antibody, ivonescimab.
−Removed: 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 power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule.
−Removed: Ivonescimab was engineered to bring two well established oncology targeted mechanisms together.
−Removed: Through the License Agreement, the Company obtained the rights to develop and commercialize SMT112 in the United States, Canada, Europe, and Japan.
−Removed: In exchange for these rights, an upfront payment of $ 500,000 is payable to Akeso, $ 300,000 of which was payable within the later of 15 days after execution of the License Agreement or upon the earliest date on which the parties have actual knowledge that all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and any comparable extension periods with respect to the transactions contemplated by the License Agreement have expired or been terminated (the “Antitrust Clearance Date”) and $ 200,000 of which is payable within the later of (i) 90 days after execution of the License Agreement or (ii) the Antitrust Clearance Date.
−Removed: In connection with the first payment, up to 16 million shares of Company common stock may be issued in lieu of cash at Akeso’s election (the “Share Transfer”), with the value of such shares based on the ten ( 10 ) day volume-weighted average price for the five -trading day period prior to and the five -trading day period after the execution of the License Agreement.
−Removed: The total of the upfront payment and potential milestone payments is $ 5,000,000 , as Akeso will be eligible to receive regulatory milestones of up to $ 1,050,000 and commercial milestones of up to $ 3,450,000 .
−Removed: In addition, Akeso will be eligible to receive low double-digit royalties on net sales.
−Removed: The License Agreement closed on January 17, 2023, and both Akeso and Summit entered into the Common Stock Issuance Agreement (“Issuance Agreement”).
−Removed: 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 $ 274,900 dollars in cash as the initial upfront payment.
−Removed: The remaining $ 200,000 amount of the upfront payment was paid on March 6, 2023.
+Added: and its affiliates (“Akeso”) pursuant to which the Company has in-licensed ivonescimab.
+Added: 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”).
+Added: The License Agreement and transaction closed in January 2023 following customary waiting periods.
+Added: The Company’s operations will be focused on the development of ivonescimab and other future activities, as the Company determines.
+Added: 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:
+Added: 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”);
+Added: b) ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
+Added: As of the date of these financial statements, both studies are enrolling patients.
+Added: 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.
+Added: The Company’s portfolio includes ridinilazole, a product candidate for treating patients suffering from Clostridioides difficile infection, also known as C.
+Added: difficile infection, or CDI.
+Added: All prior development and marketing activities related to ridinilazole have been terminated.
+Added: 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.
+Added: The Company will continue to pursue partnerships for further development of SMT-738.
+Added: Recent Events
+Added: In addition to the events detailed in the Company Overview section above, the following other recent developments have occurred.
+Added: 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.
−Removed: Duggan and Dr.
−Removed: Zanganeh, pursuant to which the Company agreed to sell to each of Mr.
+Added: Robert Duggan and Dr.
+Added: Maky Zanganeh, pursuant to which the Company agreed to sell to each of Mr.
Duggan and Dr.
−Removed: Zanganeh unsecured promissory notes in the aggregate amount of $ 520,000 .
−Removed: For further details see Note 17.
−Removed: On January 6, 2023, the Company held a Special Meeting of Stockholders (the “Shareholder Special Meeting”), whereby the following matters were submitted to a vote of the Company’s stockholders:
−Removed: (i) an amendment to the Company’s Restated Certificate of Incorporation, dated September 18, 2020, as amended on July 27, 2022 (the “Restated Certificate”), to increase the number of authorized shares of common stock by 650,000,000 (from 350,000,000 to 1,000,000,000 );
−Removed: and (ii) an amendment to the Restated Certificate to effect, as needed, a reverse stock split of all of the outstanding shares of the Company’s common stock at a ratio in the range of 1-for-5 to 1-for-10.
+Added: Zanganeh unsecured promissory notes in the aggregate amount of $ 520,000 (Note 18) .
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: Each of the matters submitted to a vote of the Company’s stockholders at the Special Meeting was approved by the requisite vote of the Company’s stockholders in accordance with the recommendation of the Company’s Board of Directors.
−Removed: The final decision of whether to proceed with the amendments may be determined by the Company's Board of Directors, in its discretion, at any time prior to January 6, 2024.
On January 19, 2023, the Company filed Amendment No.
3 unchanged sentences
On March 1, 2023, the Company closed the 2023 Rights Offering, which was fully subscribed.
−Removed: The Company received aggregate gross proceeds from the Rights Offering of $ 500,000 from the sale of 476,190,471 shares of our common stock at a price per share of $ 1.05 .
+Added: 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 .
−Removed: In connection with the closing of the Rights Offering, $ 400,000 of the unsecured promissory notes, issued by us to Mr.
−Removed: 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 Rights Offering.
+Added: In connection with the closing of the 2023 Rights Offering, $ 400,000 of the unsecured promissory notes, issued by the Company to Mr.
+Added: 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.
−Removed: Basis of Presentation and Use of Estimates
+Added: 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:
+Added: (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;
+Added: and (ii) the 9,346,434 and 373,857 shares of common stock issued in December 2022 to its Chief Executive Officers, Mr.
+Added: Robert Duggan and Dr.
+Added: Mahkam Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr.
+Added: Zanganeh and the Company (Note 18 ).
+Added: On April 27, 2023, the SEC issued a Notice of Effectiveness for the registration statement on Form S-3 filed with the SEC.
+Added: On October 12, 2023, the Company held a Special Meeting of Stockholders (the “October Special Meeting”) whereby an amendment to the Summit Therapeutics Inc.
+Added: 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.
+Added: On October 16, 2023, the Company announced the appointment of Mr.
+Added: Manmeet Soni as its Chief Operating Officer, effective immediately.
+Added: Soni has been a part of the Company ’ s Board of Directors since 2019.
+Added: He will remain a member of the Board of Directors.
+Added: In conjunction with his appointment, Mr.
+Added: Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement.
+Added: 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.
+Added: On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025.
+Added: 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 ).
+Added: Interest shall be paid upon maturity of the loan.
+Added: 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.
5 unchanged sentences
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.
−Removed: 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 assets and liabilities that are not readily apparent from other sources.
+Added: 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
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different assumptions or conditions.
−Removed: The progression of the COVID-19 pandemic continues to evolve and its enduring impact on the Company's business remains uncertain.
−Removed: Management believes the estimates and assumptions underlying its financial statements are reasonable and supportable based on the information available as of December 31, 2022, however, the extent to which the COVID-19 pandemic impacts the Company's financial results beyond December 31, 2022 will depend on future developments that are highly uncertain and cannot be predicted at this time.
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 .
−Removed: As of December 31, 2022, the Company had an accumulated deficit of $ 378,330 , cash and cash equivalents of $ 348,607 , restricted cash of $ 300,000 , research and development tax credit receivable of $ 5,766 and accounts receivable of $ 349 .
+Added: 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.
+Added: treasury securities of $ 186,242 .
The Company expects to continue to generate operating losses for the foreseeable future.
−Removed: Based on the Company's existing cash, cash equivalents and U.K.
−Removed: research and development tax credits, after considering the payments made to Akeso in January and March 2023 totaling $ 474,900 , the net proceeds of $ 499,500 from the Rights Offering that closed on March 1, 2023, and repayments of the promissory notes payable to related parties in February and March 2023
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: totaling $ 420,000 , the Company has the ability to fund its operating costs and working capital needs for its planned clinical trials for ivonescimab for a period of at least twelve months from the date of issuance of these consolidated financial statements.
+Added: The Company has evaluated whether its cash, cash equivalents, short-term investments and U.K.
+Added: 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.
+Added: The Company is investing in the clinical development of ivonescimab, including its ongoing clinical trials.
+Added: 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.
+Added: 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.
+Added: In order to further fund the Company's operating cash needs and repay this promissory note, the Company intends to raise additional capital.
+Added: As of the date of the issuance of these financial statements the additional capital has not been secured.
+Added: 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.
1 unchanged sentence
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.
−Removed: While the Company believes that funds would be available in this manner before 2024, 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.
+Added: 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.
12 unchanged sentences
Foreign Currency Translation
−Removed: The financial statements of the Company’s subsidiaries with functional currencies other than the United States ("U.S.") dollar are translated into U.S.
+Added: The financial statements of the Company’s subsidiaries with functional currencies other than the United States ( “ U.S.
+Added: ” ) 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.
−Removed: Translation gains and losses are included in accumulated other comprehensive (loss) income in shareholders’ equity.
−Removed: Foreign currency transaction gains and losses are included in other expense, net in the results of operations.
−Removed: The Company recorded realized and unrealized foreign currency transaction losses of $ 4,109 and $ 2,135 for the years ended December 31, 2022 and 2021, respectively, which is included in other expense, net in the statements of operations and comprehensive loss.
−Removed: Revenue Recognition
−Removed: The Company accounts for revenue using ASC 606.
−Removed: This standard applies to all contracts with customers, except for contracts that are within the scope of other standards.
−Removed: The Company enters into out-licensing agreements within the scope of ASC 606 under which it licenses certain rights to its product candidates to third parties.
−Removed: Such agreements may include the transfer of intellectual property rights in the form of licenses, transfer of technological know-how, delivery of drug substances, research and development services, and participation on certain committees with the counterparty.
−Removed: Payments made by the customers may include one or more of the following:
−Removed: non-refundable, up-front license fees;
−Removed: development, regulatory, and commercial milestone payments;
−Removed: payments for manufacturing supply services the Company provides through its contract manufacturers;
−Removed: and royalties on net sales of licensed products if they are successfully approved and commercialized.
−Removed: Each of these payments may result in license, collaboration, or other revenue, except revenue from royalties on net sales of licensed products, which would be classified as royalty revenue.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its out-licensing agreements, the following steps are performed:
−Removed: (i) identification of the promised goods or services in the contract;
−Removed: (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;
−Removed: (iii) measurement of the transaction price, including the constraint on variable consideration;
−Removed: (iv) allocation of the transaction price to the performance obligations;
−Removed: and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
−Removed: At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
−Removed: Revenue is then recognized in respect of the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
−Removed: As part of the accounting for these arrangements, the Company must use significant judgment to determine:
−Removed: (a) the performance obligations based on the determination under step (ii) above;
−Removed: (b) the transaction price under step (iii) above;
−Removed: and (c) the standalone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above.
−Removed: The Company also uses judgment to determine whether milestone payments or other variable consideration, except for royalties and sales-based milestones, should be included in the transaction price, as described below.
−Removed: The transaction price is allocated to each performance obligation based on the relative standalone selling price of each performance obligation in the contract, and the Company recognizes revenue based on those amounts when, or as, the performance obligations under the contract are satisfied.
−Removed: Exclusive Licenses
−Removed: If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from nonrefundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.
−Removed: In assessing whether a promise or performance obligation is distinct from the other promises, the Company considers factors such as the research, development, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace.
−Removed: In addition, the Company considers whether the collaboration partner can benefit from a promise for its intended purpose without the receipt of the remaining promises, whether the value of the promise is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises, and whether it is separately identifiable from the remaining promises.
−Removed: For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.
−Removed: The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition.
−Removed: The measure of progress, and the resulting periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the research, development and licensing arrangement.
−Removed: Such a change could have a material impact on the amount of revenue the Company records in future periods.
−Removed: Under the Company’s existing license and collaboration agreements, the Company has concluded that the transfer of control to the customer occurs over the time period that the research and development services are to be provided by the Company, and this output method is, in management’s judgment, the best measure of progress towards satisfying the performance obligation.
−Removed: Milestone Payments
−Removed: At the inception of each arrangement that includes potential research, development or regulatory milestone payments, the Company evaluates whether the milestones are considered likely to be met and estimates the amount to be considered for inclusion in the transaction price using the most-likely-amount method.
−Removed: If it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur, the associated milestone payment value is included in the transaction price.
−Removed: For milestone payments due upon events that are not within the control of the Company or the licensee, such as regulatory approvals, the Company is not able to assert that it is likely that the regulatory approval will be granted and that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur until those approvals are received.
−Removed: In making this assessment, the Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the particular milestone.
−Removed: There is considerable judgment involved in determining whether it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur.
−Removed: At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint
+Added: Translation gains and losses are included in
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: and, if necessary, adjusts its estimate of the overall transaction price of the arrangement.
−Removed: Any such adjustments are recorded on a cumulative catch-up basis, which would affect the amounts of revenue and earnings in the period of adjustment.
−Removed: For arrangements that include sales-based royalties, including milestone payments due upon first commercial sales or based on a level of sales, that are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) the occurrence of the related sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.
−Removed: To date, the Company has not recognized any royalty revenue from any of its licensing arrangements.
+Added: accumulated other comprehensive (loss) income in shareholders’ equity.
+Added: Foreign currency transaction gains and losses are included in other expen se, net in the results of operations.
+Added: 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
14 unchanged sentences
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.
−Removed: Under both schemes, the Company receives cash rebate payments of up to 33.3 % of eligible research and development expenditures and these payments are not dependent on the Company’s pre-tax net income levels.
−Removed: The Company has qualified under the more favorable SME regime for the year ended December 31, 2021 and expects to qualify under the SME regime for the year ending December 31, 2022.
+Added: 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.
+Added: 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
33 unchanged sentences
If the fair value is less than the carrying amount, a goodwill impairment loss is measured and recorded.
−Removed: The Company performed its annual impairment assessment of goodwill in the fourth quarter of 2022 by performing a qualitative analysis for its single identified reporting unit for goodwill and determined that it is more likely than not that the fair value of the reporting unit exceeded its carrying amount.
+Added: 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.
+Added: Property and Equipment
+Added: Property and equipment are stated at cost less accumulated depreciation.
+Added: Cost is comprised of the purchase price plus any incidental costs of acquisition and commissioning.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: Intangible Assets
−Removed: Intangible assets are estimated by management based on the fair value of assets acquired.
−Removed: These include acquired technology, licenses, an option over non-financial assets and a research and development discovery platform ("Discuva Platform").
−Removed: Intangible assets are amortized from one to 18 years on a straight-line basis which represents the estimated periods of benefit and the expected pattern of consumption.
−Removed: Our intangible assets are recorded at fair value at the time of their acquisition, assigned an estimated useful life, and amortized primarily on a straight-line basis over their estimated useful lives or over the period of the relevant agreement for an option over non-financial assets.
−Removed: Intangible assets are stated in our consolidated balance sheets net of accumulated amortization and impairments, if applicable.
−Removed: The Company evaluates the recoverability of its intangible and long-lived assets whenever events and changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable.
−Removed: If events and circumstances indicate that the carrying amount may not fully be recoverable, the carrying values of the asset or asset group are evaluated in relation to their operating performance and future undiscounted cash flows of the underlying business.
−Removed: If the future undiscounted cash flows are less than their carrying value, impairment exists.
−Removed: The impairment is measured as the difference between the carrying value and the fair value of the underlying asset or asset group.
−Removed: Fair values are based on estimates of market prices and assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.
−Removed: Amortization of intangible assets is included as part of the research and development expense line shown on the face of the consolidated statement of operations and comprehensive loss.
−Removed: As of December 31, 2022 and 2021, intangible assets were $ 0 and $ 10,399 , respectively.
−Removed: The carrying value of $ 10,399 as of December 31, 2021 related to the Discuva Platform has been impaired in full during the year end December 31, 2022.
−Removed: Property and Equipment
−Removed: Property and equipment are stated at cost less accumulated depreciation.
−Removed: Cost comprises the purchase price plus any incidental costs of acquisition and commissioning.
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.
−Removed: Leasehold improvements Over the shorter of the asset's useful life or the remaining lease term
Laboratory equipment 2 - 10 years
−Removed: Office and IT equipment 3 - 5 years
+Added: Furniture and fixtures, office equipment and software
+Added: 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.
6 unchanged sentences
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.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
At the lease commencement date, the Company measures and recognizes a lease liability and a right-of-use asset in the financial statements.
6 unchanged sentences
The Company recognizes lease expense for its short-term leases on a straight-line basis over the lease term.
+Added: Acquired In-Process Research and Development
+Added: The Company may enter into agreements with collaboration partners for the development and commercialization of its products.
+Added: These arrangements may include payments contingent on the occurrence of certain events such as development, regulatory or sales-based milestones.
+Added: The Company considers the unique nature, terms and facts and circumstances of each transaction.
+Added: The Company considers whether or not the assets acquired have a future alternative use.
+Added: 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.
+Added: 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.
−Removed: 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 preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials.
+Added: 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
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: 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.
20 unchanged sentences
The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
• Expected volatility—The expected volatility is calculated based on historical volatility of the Company ’ s share price.
7 unchanged sentences
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.
−Removed: The Company is primarily subject to corporation taxes in the U.S.
−Removed: and the U.K..
−Removed: The calculation of the Company’s tax provision involves the application of both U.S.
−Removed: tax law and requires judgment and estimates.
The provision for income taxes is determined using the asset and liability approach.
2 unchanged sentences
Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid.
−Removed: 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.
+Added: 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
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: and tax laws.
Subsequent changes to deferred taxes originally recognized in equity are recognized in income.
7 unchanged sentences
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.
−Removed: At December 31, 2022 and 2021, the Company had no uncertain tax positions.
+Added: At December 31, 2023 and 2022, the Company had unrecognized tax positions of $ 1,064 and $ 0 , respectively.
+Added: Due to the Company ’ s full valuation allowance, the unrecognized tax benefits would not materially impact the Company ’ s effective tax rate when recognized.
+Added: The Company does not anticipate the total amount of unrecognized tax benefits to significantly increase or decrease in the next 12 months.
+Added: The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision.
+Added: 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
6 unchanged sentences
The credit risk with respect to customers and funding bodies is limited as the Company has only a small number of these arrangements.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
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.
4 unchanged sentences
The guidance describes three levels of inputs that may be used to measure fair value:
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
Quoted prices in active markets for identical assets or liabilities as of the reporting date.
10 unchanged sentences
Cash and Cash Equivalents
−Removed: We consider 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, and the related investment income is recognized in net loss.
−Removed: As of December 31, 2022 , cash equivalents were comprised of a money market funds and U.S.
+Added: 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.
+Added: 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.
−Removed: We did not have cash equivalents as of December 31, 2021.
Restricted Cash
−Removed: Restricted cash represents amounts which are legally restricted to withdrawal or usage and is presented in the Consolidated Balance Sheet as restricted cash.
+Added: 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 .
−Removed: Following the Antitrust Clearance Date, on January 17, 2023, the License Agreement closed and Akeso was issued 10 million shares of Company common stock pursuant to the Common Stock Issuance Agreement and was paid $ 274,900 in cash as initial upfront payment.
+Added: 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.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
Assumed Contingent Liabilities
7 unchanged sentences
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.
−Removed: Accretion of the discount factor and gains or losses upon remeasurement are recognized as part of operating expenses in the consolidated statements of operations and comprehensive loss.
+Added: Accretion of the discount
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: factor and gains or losses upon remeasurement are recognized as part of operating expenses in the consolidated statements of operations and comprehensive loss.
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.
7 unchanged sentences
Recently Issued or Adopted Accounting Pronouncements
−Removed: In November 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No.
−Removed: 2021-10, " Government Assistance (Topic 832)".
−Removed: This ASU increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity's accounting for the assistance, and (3) the effect of the assistance on an entity's financial statements as diversity currently exists in the recognition, measurement, presentation and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in U.S.
−Removed: This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2021.
−Removed: Early application of this ASU is permitted.
−Removed: The Company applied the amendments of this ASU to its disclosures during the fourth quarter of 2021 and the application of this ASU did not have a material impact on its financial position, results of operations or cash flows.
−Removed: In October 2021, the FASB issued ASU No.
−Removed: 2021-08, "Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers".
−Removed: This ASU improves the accounting for acquired revenue contracts with customers in a business combination by addressing diversity in practice and inconsistency relating to:
−Removed: 1) recognition of an acquired contract liability and 2) payment terms and their effect on subsequent revenue recognized by the acquirer.
−Removed: The amendments in this ASU require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination, whereas current U.S.
−Removed: GAAP requires that the acquirer measure such assets and liabilities at
+Added: In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards update “ASU” No.
+Added: 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.
+Added: 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of the ASU on the income tax disclosures within the consolidated financial statements.
+Added: In November 2023, the FASB issued ASU No.
+Added: 2023-07, “Segment Reporting (Topic 280):
+Added: 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.
+Added: 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024.
+Added: Early adoption is permitted, and the amendments should be applied retrospectively.
+Added: The Company is currently evaluating the impact of the ASU on the consolidated financial statement disclosures.
+Added: In June 2016, the FASB issued ASU 2016-13, “Financial Instruments - Credit Losses (Topic 326):
+Added: Measurement of Credit Losses on Financial Instruments”, which has subsequently been amended by ASU 2019-04 and ASU 2019-10 (collectively “ASU 2016-03”).
+Added: ASU 2016-13 amends the guidance on the impairment of financial instruments.
+Added: This update adds an impairment model (known as the current expected credit losses model) that is based on expected losses rather than incurred losses.
+Added: Under the new guidance, an entity recognizes, as an allowance, its estimate of expected credit losses.
+Added: 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.
+Added: 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.
+Added: Akeso License and Collaboration Agreement
+Added: 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.
+Added: The License Agreement and transaction closed in January 2023 following customary waiting periods.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: fair value on the acquisition date.
−Removed: This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2022.
−Removed: The Company will apply this ASU on a prospective basis for business combinations once this ASU is effective and at that time, will be able to determine the potential impact on its financial position, results of operations or cash flows.
−Removed: In May 2021, the FASB issued AS No.
−Removed: 2021-04, "Earnings Per Share (Topic 260), Debt - Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging Contracts in Entity's Own Equity (Subtopic 815-40) - Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options".
−Removed: This ASU provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange.
−Removed: This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2021.
−Removed: The Company will apply this ASU on a prospective basis for any modifications or exchanges once this ASU is effective and at that time, will be able to determine the potential impact on its financial position, results of operations or cash flows.
−Removed: In December 2019, the FASB issued ASU No.
−Removed: 2019-12, "Income Taxes (Topic 740)".
−Removed: This ASU simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740.
−Removed: The amendments also improve consistent application and simplify U.S.
−Removed: GAAP for other areas of Topic 740 by clarifying and amending existing guidance.
−Removed: This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2020.
−Removed: The Company adopted this ASU during the first quarter of 2021 and the adoption of this ASU did not have a material impact on its financial position, results of operations or cash flows.
+Added: 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.
+Added: Ivonescimab was engineered to bring two well established oncology targeted mechanisms together.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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”).
+Added: 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.
+Added: The remaining $ 200,000 amount of the upfront payment was paid on March 6, 2023.
+Added: The Company has accounted for the License Agreement to acquire the rights to develop and commercialize SMT112 as the acquisition of an asset.
+Added: All of the consideration relates to SMT112 and technological feasibility of the asset has not yet been established since SMT112 is in clinical development.
+Added: 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.
+Added: 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.
+Added: 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 .
+Added: In addition, Akeso will be eligible to receive low double-digit royalties on net sales.
Segment Reporting
−Removed: The Company's chief operating decision makers (the "CODM function"), which are the Company's Co-CEOs, Mr.
+Added: The Company ’ s chief operating decision makers (the “CODM function”), which are the Company ’ s Chief Executive Officers, Mr.
Duggan and Dr.
8 unchanged sentences
United Kingdom (1)
+Added: $ 808 $ 2,517
United States (2)
$ 6,062 $ 5,081
−Removed: (1) 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 first and second amendments to its sublease agreement during the period for its Menlo Park, California, U.S.
−Removed: For details of revenue from external customers by geography refer to Note 7.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: The following table summarizes revenue by category:
−Removed: Year Ended December 31, 2022 Year Ended December 31, 2021
−Removed: Licensing agreements $ 705 $ 1,809
−Removed: Revenue recognized consists of amounts received from the Company's license and commercialization agreement with Eurofarma Laboratórios S.A.
−Removed: The following table summarizes revenue by geography:
−Removed: Year Ended December 31, 2022 Year Ended December 31, 2021
−Removed: Latin America $ 705 $ 1,809
+Added: (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.
+Added: (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.
+Added: For details of revenue from external customers by geography refer to Note 8.
+Added: The Company recognized no revenue and $ 705 during the year ended December 31, 2023 and 2022, respectively.
+Added: 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.
+Added: 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.
2 unchanged sentences
Beginning deferred revenue and other income, January 1
−Removed: $ 7,939 $ 8,939
Additions — 1,397
2 unchanged sentences
Ending deferred revenue and other income, December 31
−Removed: (1) Beginning deferred revenue and other income as of January 1, 2022 and 2021 included $ 7,939 of current and $ 0 of long-term deferred revenue and other income, and $ 8,370 of current and $ 569 of long-term deferred revenue and other income, respectively.
−Removed: (2) Ending deferred revenue and other income as of December 31, 2022 and 2021 included $ 0 of current and $ 0 of long-term deferred revenue and other income, and $ 7,939 of current and $ 0 of long-term deferred revenue and other income, respectively.
−Removed: As of January 1, 2022, deferred revenue and other income is compromised of $ 756 and $ 7,183 relating to Eurofarma and BARDA, respectively.
−Removed: As of December 31, 2022, deferred revenue was $ 0 .
Refer to Note 9 below for further details regarding other income recognized under the BARDA contract.
−Removed: Eurofarma Laboratórios S.A.
−Removed: On December 21, 2017, Summit announced it had entered into an exclusive license and commercialization agreement with Eurofarma Laboratórios S.A.
−Removed: ("Eurofarma"), pursuant to which the Company granted Eurofarma the exclusive right to commercialize ridinilazole in specified countries in South America, Central America and the Caribbean.
−Removed: The Company has retained commercialization rights in the rest of the world.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: Under the terms of the license and commercialization agreement with Eurofarma, the Company received an upfront payment of $ 2,500 in December 2017.
−Removed: In February 2020, the Company reached the first enrollment milestone and earned $ 1,000 .
−Removed: In September 2021, the Company reached the second enrollment milestone and earned $ 1,250 .
−Removed: The terms of the contract have been assessed under ASC 606 and currently only the upfront payment and the first two enrollment milestone payments are included in the transaction price.
−Removed: These payments were initially reported as deferred revenue in the balance sheet and were recognized as revenue ratably over the performance period.
−Removed: Revenue recognized during the years ended December 31, 2022 and 2021 related to the upfront payment and the first two enrollment milestones earned in accordance with the Company's revenue recognition policy.
−Removed: The revenue was recognized ratably over the determined performance period to reflect the transfer of control to the customer occurring over the time period that the research and development services were provided by the Company.
−Removed: This output method is, in management’s judgment, the best measure of progress towards satisfying the performance obligation.
−Removed: As of December 31, 2022 and 2021, the current contract liability relating to the Eurofarma contract was $ 0 and $ 756 , respectively, and was recorded in current deferred revenue in the consolidated balance sheet.
−Removed: As of December 31, 2022, the Company has recognized $ 4,678 of cumulative income since inception.
−Removed: Other Operating Income
+Added: 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
−Removed: Other operating income by category:
Funding income from BARDA (as defined below) $ — $ 8,085
3 unchanged sentences
BARDA (as defined below)
−Removed: 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 of ridinilazole.
+Added: 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 .
2 unchanged sentences
This option work segment was never exercised by BARDA.
−Removed: The contract ran through April 2022 and was extended through December 2022 as a no cost contract, solely to close out open activities.
+Added: The contract ran through April 2022 and was extended through December 2022
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: 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.
4 unchanged sentences
research and development tax credit cash rebate regimes:
−Removed: Small and Medium Enterprise Program ("SME, Program") and the Research and
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: Development Expenditure Credit Program ("RDEC Program").
+Added: 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.
2 unchanged sentences
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.
−Removed: As of December 31, 2022 and 2021, the current research and development tax credit receivable was $ 5,766 and $ 15,695 , respectively.
+Added: 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)
5 unchanged sentences
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.
−Removed: Other Expense, net
+Added: Other (Expense) Income, net
The following table sets forth the components of other (expense) income:
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
Year Ended December 31, 2023 Year Ended December 31, 2022
−Removed: Foreign currency loss $ ( 4,109 ) $ ( 2,135 )
+Added: Foreign currency gains (losses) $ 613 $ ( 4,109 )
Interest expense on promissory notes payable to related parties ( 16,461 ) ( 4,401 )
−Removed: Investment income 1,513 —
−Removed: Other income (expense), net 304 ( 39 )
−Removed: Other Expense, net $ ( 6,693 ) $ ( 2,416 )
−Removed: 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 $ 520,000 and $ 25,000 promissory notes, as described in Note 17, partially offset by investment income related to our money market funds and investments in highly liquid U.S.
+Added: Interest income 10,403 1,513
+Added: Reclassification of cumulative currency translation gain (1)
+Added: Other (expense) income, net
+Added: $ ( 5,278 ) $ ( 6,693 )
+Added: _____________________
+Added: (1) Effective January 17, 2023, the Company dissolved the following dormant entities;
+Added: 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.
+Added: As a result, the Company reclassified $ 419 of cumulative foreign currency translation adjustments from accumulated other comprehensive loss relating to these entities.
+Added: 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.
+Added: 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.
+Added: treasury securities and favorable changes in foreign currency.
+Added: 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.
−Removed: For the year ended December 31, 2021, other expense, net primarily consisted of unfavorable changes in foreign currency and loan interest expense incurred related to the $ 55,000 promissory note, as described in Note 22.
+Added: The Company is primarily subject to corporation taxes in the U.S.
+Added: and the U.K..
+Added: The calculation of the Company’s tax provision involves the application of both U.S.
+Added: tax law and requires judgment and estimates.
+Added: The provision for income taxes is determined using the asset and liability approach.
+Added: Tax laws may require items to be included in tax filings at different times than the items are reflected in the financial statements.
+Added: A current asset or liability is recognized for the estimated taxes receivable or payable for the current year.
+Added: Deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid.
+Added: 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.
+Added: Subsequent changes to deferred taxes originally recognized in equity are recognized in income.
+Added: Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized.
+Added: 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.
+Added: The Company records interest and penalties related to income tax matters as part of income tax expense.
+Added: The Company accounts for uncertainty in income taxes by applying a two-step process to determine the amount of tax benefit to be recognized.
+Added: First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities.
+Added: 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.
+Added: 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.
+Added: The provision for
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
+Added: 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
−Removed: United Kingdom $ ( 46,868 ) $ ( 72,244 )
+Added: $ ( 499,810 ) $ ( 46,868 )
United States ( 115,118 ) ( 31,914 )
Loss before income taxes $ ( 614,928 ) $ ( 78,782 )
−Removed: 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, 2022 or December 31, 2021.
+Added: 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:
−Removed: Year Ended December 31, 2022 Year Ended December 31, 2021
+Added: Year Ended December 31, 2023
+Added: Year Ended December 31, 2022
Deferred tax assets:
3 unchanged sentences
Section 174 Research and Development Capitalization 15,982 3,553
+Added: Lease liability
Other 1,260 2,053
1 unchanged sentence
Deferred tax liabilities:
−Removed: Intangible asset — ( 2,600 )
+Added: Right-of-use assets
+Added: ( 1,085 ) ( 651 )
Other ( 174 ) ( 226 )
3 unchanged sentences
Deferred tax, net $ — $ —
−Removed: For the year ended December 31, 2022 and 2021, the Company recorded a deferred tax asset of $ 64,242 and $ 54,400 respectively.
−Removed: 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 excess tax benefits related to stock-based compensation.
+Added: 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.
2 unchanged sentences
Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2023 and 2022, respectively.
−Removed: The Company reevaluates the positive and negative evidence at each
+Added: The Company reevaluates the positive and negative evidence at each reporting period.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: reporting period.
−Removed: The Company’s valuation allowance increased during 2021 by $ 12,270 primarily due to the generation of net operating loss and stock-based compensation.
+Added: The change in the valuation allowance was as follows:
+Added: Year Ended December 31, 2023
+Added: Year Ended December 31, 2022
+Added: Valuation allowance as of beginning of year
+Added: $ ( 64,016 ) $ ( 51,746 )
+Added: Net increase recorded to the income tax provision
+Added: ( 20,735 ) ( 12,270 )
+Added: Valuation allowance as of end of year
+Added: $ ( 84,751 ) $ ( 64,016 )
As of December 31, 2023 and 2022, the Company had U.S.
3 unchanged sentences
State gross loss carryforwards which expire through various dates through 2043 and as of December 31, 2023, the Company had an estimated U.S.
−Removed: federal research and development tax credit carryforwards of $ 1,723 which may be available to offset future tax liabilities, and each begin to expire in 2041.
+Added: 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.
−Removed: gross loss carryforwards available to use against future taxable profits on a year-by-year basis (a potential deferred tax asset of $ 49,773 ).
+Added: gross loss carryforwards available to use against future taxable profits on a year-by-year basis.
To the extent that U.K.
14 unchanged sentences
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.
−Removed: Pursuant to the FASB Staff Q&A, Topic 740 No.5.
−Removed: Accounting for Global Intangible Low-taxed Income, 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.
+Added: 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.
−Removed: and the valuation allowance recorded against its U.S.
+Added: and the valuation allowance recorded against
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
net deferred tax assets, these provisions have not had a material impact on the Company’s consolidated financial statements.
2 unchanged sentences
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.
−Removed: As such, the changes to IRC Section 174
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: pursuant to the TCJA are currently applicable to the Company for the 2022 tax year.
+Added: 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.
2 unchanged sentences
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.
−Removed: On March 27, 2020, the United States enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).
−Removed: The Cares Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, and technical corrections to tax depreciation methods for qualified improvement property.
−Removed: The CARES Act also established a Paycheck Protection Program whereby certain small businesses are eligible for a loan to fund payroll expenses, rent, and related costs.
−Removed: The Company considered the provisions under the CARES Act and elected not to take advantage of the provisions of the CARES Act as the effect of such provisions was not expected to have a material impact on the Company’s results of operations, cash flows, and consolidated financial statements.
−Removed: During 2021, the U.K.
−Removed: Government announced that from April 1, 2023, the corporation tax rate would increase to 25%.
−Removed: This new law was enacted on June 10, 2021.
−Removed: The overall effect of the change was an increase in net deferred tax assets by $ 9,311 and an increase in valuation allowance by an equal amount for the year ended December 31, 2021.
−Removed: No changes to this rate have been made during 2022.
A reconciliation of the Company’s effective tax rate to the U.S.
3 unchanged sentences
Change in valuation allowance ( 3.4 ) ( 16.8 )
−Removed: Non-deductible expenses — ( 0.4 )
Refundable research and development tax credit 0.3 ( 3.6 )
2 unchanged sentences
Other ( 0.8 ) ( 0.5 )
−Removed: 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% on qualifying research and development expenditure (the tax relief).
+Added: 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.
4 unchanged sentences
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.
+Added: As of December 31, 2023, there are no unremitted earnings of the Company’s foreign subsidiaries.
+Added: The Company records unrecognized tax benefits in accordance with ASC 740-10, Income Taxes.
+Added: 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.
+Added: As of December 31, 2023 and 2022, the Company had total unrecognized tax benefits of $ 1,064 and $ 0 , respectively.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: The Company does not have any uncertain tax positions as of December 31, 2022.
−Removed: In the U.K., tax returns for the year ended December 31, 2021 remains subject to examination by HMRC.
−Removed: In the U.S., the Company files income tax returns in various states.
+Added: Due to the Company’s full valuation allowance, the unrecognized tax benefits would not materially impact the Company’s effective tax rate when recognized.
+Added: The Company does not anticipate the total amounts of unrecognized tax benefits will significantly increase or decrease in the next 12 months.
+Added: The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision.
+Added: For the years ended December 31, 2023 and 2022, the Company had no interest or penalties related to unrecognized tax benefits.
+Added: A reconciliation of unrecognized tax benefits from continuing operations is as follows:
+Added: Year Ended December 31, 2023 Year Ended December 31, 2022
+Added: Unrecognized tax benefits, beginning of year
+Added: Increases related to prior year tax positions
+Added: Decreases related to prior year tax positions
+Added: Increases related to current year tax positions
+Added: Unrecognized tax benefits, end of year
+Added: The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates.
+Added: In the normal course of business, the Company is subject to examination by federal, state, and foreign jurisdictions, where applicable.
In the U.S., tax years from 2020 remain subject to examination by the U.S.
2 unchanged sentences
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.
−Removed: The Company’s policy is to recognize interest and penalties related to uncertain tax positions as part of its income tax provision.
−Removed: As of December 31, 2022, and 2021, the Company has recorded no liability for unrecognized tax benefits, interest, or penalties related to federal, state or foreign income tax matters.
−Removed: Loss per Share
+Added: In the U.K., tax returns for the year ended December 31, 2022 remains subject to examination by HMRC.
+Added: Net Loss per Share
The following table sets forth the computation of basic and diluted net loss per share:
5 unchanged sentences
Diluted net loss per share $ ( 0.99 ) $ ( 0.41 )
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (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.
1 unchanged sentence
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.
−Removed: Because the Rights Offering 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 Rights Offering (further detailed in Note 23), the Company has retroactively adjusted earnings per share and weighted average number of shares outstanding for the bonus element for all periods presented.
+Added: 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:
3 unchanged sentences
59,380,094 25,526,971
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
+Added: 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.
+Added: Refer to Note 21 for further information on market-based awards.
Goodwill and Intangible Assets
−Removed: The Company’s annual evaluation for impairment of goodwill consists of one reporting unit.
−Removed: In accordance with the Company’s policy, the Company completed its annual evaluation for impairment in the fourth quarter of 2022 using the qualitative assessment.
−Removed: No impairment charge was recognized for the year ended December 31, 2022 and there have been no cumulative goodwill impairment charges recognized to date.
+Added: 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.
+Added: 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.
+Added: This resulted in the recognition of goodwill of £ 1.5 million, which is translated into U.S.
+Added: dollars at each reporting period.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: Changes year over year are the result of foreign currency movements.
+Added: 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:
−Removed: December 31, 2022
−Removed: Gross Accumulated amortization and impairment charges Net
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: December 31, 2023 December 31, 2022
+Added: Gross Accumulated amortization and impairment charges Net Gross Accumulated amortization and impairment charges Net
Utrophin program acquired (1)
−Removed: Discuva platform acquired 12,900 ( 12,900 ) —
−Removed: Option over non-financial asset 816 ( 816 ) —
−Removed: Other intangibles 133 ( 133 ) —
$ — $ — $ — $ 4,015 $ ( 4,015 ) $ —
−Removed: December 31, 2021
−Removed: Gross Accumulated amortization and impairment charges Net
−Removed: Utrophin program acquired $ 4,487 $ ( 4,487 ) $ —
Discuva platform acquired (2)
+Added: 13,583 ( 13,583 ) — 12,900 ( 12,900 ) —
Option over non-financial asset 859 ( 859 ) — 816 ( 816 ) —
1 unchanged sentence
$ 14,582 $ ( 14,582 ) $ — $ 17,864 $ ( 17,864 ) $ —
−Removed: In December 2017, we expanded our activities in the field of infectious diseases with the acquisition of Discuva Limited, a privately held United Kingdom-based company.
−Removed: Through this acquisition, we obtained a bacterial genetics platform and a suite of software-based technologies (collectively termed our “Discuva Platform”), which facilitates the discovery and development of new mechanism antibiotics.
−Removed: 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.
−Removed: Management have concluded that this indicated the carrying amount of the acquired Discuva Platform intangible asset may not be recoverable and hence performed an assessment using a probability-weighted approach to determine the undiscounted cash flows of the asset, which indicated that an impairment exists.
−Removed: Based on the assessment to compare the fair value of the asset to its carrying amount, an impairment charge of $ 8.5 million was recognized during the year ended December 31, 2022, representing the aggregate carrying value of the intangible asset.
+Added: (1) During the year ended December 31, 2023, the Company dissolved the wholly-owned subsidiary, Muox Limited, a dormant entity.
+Added: 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.
+Added: (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.
+Added: 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.
+Added: 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.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: Changes year over year in the gross amount of intangible assets are the result of foreign currency movements only.
+Added: 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.
−Removed: Changes year over year in the accumulated amount of amortization and impairment also include the effect of foreign currency movements.
−Removed: Cash Equivalents and Fair Value Measurements
−Removed: The following tables set forth the fair value of the Company's financial assets measured at fair value on a recurring basis and indicates the level within the fair value hierarchy utilized to determine such values:
−Removed: Fair Value Measurements as of December 31, 2022 using:
+Added: Fair Value Measurements and Short-Term Investments
+Added: Fair Value Measurements
+Added: 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:
+Added: Fair Value Measurements as of December 31, 2023
Level 1 Level 2 Level 3 Total
2 unchanged sentences
Government treasury bills — 39,341 — 39,341
−Removed: Total financial assets $ 60,783 $ 225,730 $ — $ 286,513
−Removed: The table above does not include cash at December 31, 2022 of $ 62,094 .
−Removed: There were no cash equivalents held by the Company as of December 31, 2021.
−Removed: Cash at December 31, 2021 was $ 71,791 .
−Removed: The Company's financial instruments include cash and cash equivalents and restricted cash.
−Removed: Cash consists of non-interest-bearing deposits denominated in the U.S.
−Removed: dollar, British pound and Euro, while cash equivalents consists of interest-bearing money market fund deposits denominated in the U.S.
−Removed: dollar and U.S.
−Removed: treasury bills, and restricted cash consists of interest-bearing deposits denominated in the U.S.
+Added: Short-term investments:
+Added: Government treasury bills — 114,817 — 114,817
+Added: $ 21,016 $ 154,158 $ — $ 175,174
+Added: Fair Value Measurements as of December 31, 2022
+Added: Level 1 Level 2 Level 3 Total
+Added: Cash equivalents:
+Added: Money market funds $ 60,783 $ — $ — $ 60,783
+Added: Government treasury bills — 225,730 — 225,730
+Added: $ 60,783 $ 225,730 $ — $ 286,513
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: 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.
−Removed: The carrying value of the Company’s promissory notes approximates its fair value due to the recent issuance of the notes in December 2022 when compared to market interest rates (which represents a Level 2 measurement).
+Added: 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).
+Added: Refer to Note 18 for further details.
+Added: Short-Term Investments
+Added: 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:
+Added: December 31, 2023
+Added: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Loss Fair Value
+Added: Government treasury bills $ 114,781 $ 36 $ — $ — $ 114,817
+Added: Total $ 114,781 $ 36 $ — $ — $ 114,817
+Added: The Company did not have any short-term investments as of December 31, 2022.
Property and Equipment
Property and equipment consisted of the following:
−Removed: December 31, 2022 December 31, 2021
+Added: December 31, 2023
+Added: December 31, 2022
Laboratory equipment $ 22 $ 505
5 unchanged sentences
Depreciation expense for the years ended December 31, 2023 and 2022 was $ 198 and $ 349 , respectively.
+Added: The Company recognized a fixed asset impairment charge of $ 474 for the year ended December 31, 2023.
+Added: There were no impairment charges related to fixed assets for the year ended December 31, 2022.
Research and Development Prepaid Expenses and Accrued Liabilities
1 unchanged sentence
Included within accrued liabilities at December 31, 2023 and 2022 is $ 7,289 and $ 8,911 , respectively, relating to research and development expenditures.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
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.
1 unchanged sentence
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.
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
The Company has operating leases for real estate.
The Company does not have any finance leases.
−Removed: During the year ended December 31, 2022, the Company recorded $ 2,860 of additional right-of-use assets of which $ 2,755 related to the first and second amendments to its sublease agreement during the period for its Menlo Park, California, United States location and $ 105 which related to a remeasurement of the right of use asset and lease liability following a contractual rent review resulting in an increase in rent payments during the period for its Oxfordshire, United Kingdom location.
+Added: 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.
+Added: The Company will make total lease payments of $ 4,701 over the 36 month term of the new lease, which expires in May 2026.
+Added: In addition, during the year ended December 31, 2023, the Company terminated the Company’s Cambridge, U.K.
+Added: laboratory and office space lease as a result of the Company re-prioritizing its investments and financial resources towards the development of ivonescimab.
+Added: 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.
+Added: 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.
17 unchanged sentences
Non-current lease liabilities 3,290
+Added: The Company signed a lease agreement on January 8, 2024 for executive office space for its new headquarters in Miami, Florida.
+Added: The office space is approximately 9,000 square feet.
+Added: The term of the lease is 64 months.
+Added: Total payments for this office
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
+Added: space is approximately $ 5,100 over the term of the lease.
+Added: The table above excludes payments related to the lease signed in January 2024.
Promissory Notes Payable to Related Parties
13 unchanged sentences
Duggan on August 10, 2022 in connection with the completion of the rights offering with aggregate gross proceeds of $ 100,000 .
−Removed: The Company incurred interest expense of $ 1,296 for the year ended December 31, 2022, which included amortized imputed interest of $ 861 for the year ended December 31, 2022.
+Added: 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
6 unchanged sentences
Duggan and Dr.
−Removed: 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.
−Removed: 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 will mature and become due on September 15, 2023.
−Removed: The maturity dates of the December 2022 Notes could be extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024.
−Removed: In addition, if the Company shall consummate 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.
−Removed: 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.
−Removed: Furthermore, on January 19, 2023, the Company and Mr.
−Removed: 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.
−Removed: 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").
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: The Notes accrue interest at an initial rate of 7.5 %.
−Removed: All interest on the Notes shall be paid on the date of signing for the period through February 15, 2023.
−Removed: 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.
−Removed: For all applicable periods following the 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.
−Removed: Debt issuance costs associated with the Notes were $ 44 and we capitalized as part of the carrying value of the promissory notes payable to related parties.
−Removed: The Company incurred interest expense of $ 3,105 for the year ended December 31, 2022, which included amortized imputed interest of $ 395 .
+Added: 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.
+Added: Furthermore, on January 19, 2023, the Company and Mr.
+Added: 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.
+Added: 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”).
+Added: On February 15, 2023, the $ 20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance.
+Added: 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.
+Added: The Notes accrued interest at an initial rate of 7.5 %.
+Added: All interest on the Notes was paid on the date of signing for the period through February 15, 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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 .
+Added: 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 .
+Added: 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.
1 unchanged sentence
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 %.
−Removed: The Company incurred interest expense of $ 244 for the year ended December 31, 2021, which included amortized imputed interest $ 159 for the year ended December 31, 2021, respectively, related to the March 24, 2021 Note Purchase Agreement with Mr.
−Removed: Duggan, for $ 55,000 which was subsequently rescinded and replaced by a second note on April 20, 2021, of the same amount, and paid in full in May 2021, as described further in Note 22.
−Removed: As of December 31, 2022, and reflecting the Company's election to extend the term of the Duggan February Note and the Duggan September Note, the estimated future principal payments due were as follows:
−Removed: Year Ending December 31,
−Removed: 2023 $ 20,000
−Removed: On February 15, 2023, the $ 20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance.
−Removed: 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.
+Added: On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: The estimated future principal payments are $ 0 and $ 100,000 for 2024 and 2025, respectively, as the note matures on April 1, 2025.
Other Non-Current Liabilities
6 unchanged sentences
There were no remeasurement losses or gains recognized during the year ended December 31, 2023.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
Stockholders' Equity
5 unchanged sentences
Offering costs of $ 111 were incurred.
−Removed: On May 12, 2021, the Company closed its rights offering ("2021 Rights Offering"), which was fully subscribed and received aggregate gross proceeds of $ 75,000 from the sale of 14,312,976 shares of common stock to existing investors at a price per share of $ 5.24 .
−Removed: Offering costs of $ 159 were incurred.
+Added: 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”).
+Added: The 2023 Rights Offering commenced on February 7, 2023 and the associated subscription rights expired on March 1, 2023.
+Added: 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 .
+Added: Duggan and Dr.
+Added: Zanganeh fully subscribed to their respective basic subscription rights at a price of $ 1.05 per share.
+Added: To satisfy the $ 395,314 subscription price for the shares subscribed by Mr.
+Added: Duggan in the 2023 Rights Offering, Mr.
+Added: 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 ).
+Added: On January 19, 2023, the Company filed Amendment No.
+Added: 2 to the Restated Certificate of Incorporation (the “Amendment No.
+Added: 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.
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: 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:
+Added: (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;
+Added: and (ii) the 9,346,434 and 373,857 shares of Common Stock issued in December 2022 to Mr.
+Added: Duggan and Dr.
+Added: Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr.
+Added: Zanganeh and the Company.
+Added: On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3.
+Added: As described in Note 1, Mr.
+Added: Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement.
+Added: 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.
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.
11 unchanged sentences
Warrants granted over shares of common stock to consultants in exchange of certain services are similar to stock-based compensation (see Note 21).
−Removed: The Company had 5,821,137 total warrants outstanding as of December 31, 2022 and 2021, respectively, and an intrinsic value of $ 15,640 as of December 31, 2022 and $ 6,559 as of December 31, 2021.
−Removed: The Company has never declared or paid cash dividends on its shares of common stock or on Summit Therapeutics plc's ordinary shares.
−Removed: The Company currently intends to retain all of its future earnings to fund the development and expansion of its business.
+Added: The following table summarizes the Company’s warrants activity for the year ended December 31, 2023
+Added: Number of share warrants
+Added: Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value
+Added: Outstanding as of December 31, 2022 5,821,137 $ 1.56 6.99 years
+Added: Exercised ( 805,495 ) $ 1.49
+Added: Outstanding as of December 31, 2023 5,015,642 $ 1.57 5.92 years
Stock-Based Compensation
14 unchanged sentences
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.
+Added: 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:
+Added: an amendment to the Summit Therapeutics Inc.
+Added: 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.
11 unchanged sentences
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.
−Removed: 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.
−Removed: During the fiscal year ended December 31, 2022, 176,857 shares were issued under the 2020 ESPP.
−Removed: As the first offering period of the 2020 ESPP plan completed during the fiscal year ended December 31, 2022, no shares were issued under the 2020 ESPP during the fiscal year ended December 31, 2021.
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: Stock Option Valuation
+Added: 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.
+Added: During the fiscal year ended December 31, 2023 and 2022, 392,175 and 176,857 shares, respectively, were issued under the 2020 ESPP Plan.
+Added: Stock Options
+Added: Time-based Stock Options
The Company estimates the fair value of stock options granted to employees and directors using the Black-Scholes valuation model.
7 unchanged sentences
Expected annual dividends per share — % — %
−Removed: The following table summarizes the Company's stock option activity for the year ended December 31, 2022:
+Added: 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
6 unchanged sentences
Exercisable at December 31, 2023 5,716,319 $ 4.89 7.2 years $ 892
−Removed: During the year ended December 31, 2022, the Compensation Committee of the Company's Board of Directors and management approved 6,984,000 option grants to its executives and certain employees of the Company which will vest based upon certain market-based and revenue performance conditions.
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: Performance and Market-based Stock Options
+Added: 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.
+Added: 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.
+Added: The following table summarizes the Company’s performance and market-based stock option activity for the year ended December 31, 2023:
+Added: Number of share options Weighted average exercise price Weighted average remaining contractual term Aggregate intrinsic value
+Added: Outstanding as of December 31, 2022 6,764,000 $ 1.15 9.6 years $ 20,955
+Added: Granted 40,835,220 $ 1.69
+Added: Forfeited ( 945,000 ) $ 1.20
+Added: Exercised — $ —
+Added: Outstanding as of December 31, 2023 46,654,220 $ 1.62 9.6 years $ 46,237
+Added: Outstanding as of December 31, 2023 - vested and expected to vest 8,397,760 $ 1.62 9.6 years $ 8,323
+Added: 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.
−Removed: The aggregate intrinsic value of stock options exercised during the years ended December 31, 2022 and December 31, 2021 was $ 142 and $ 3,744 , respectively.
+Added: 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.
1 unchanged sentence
This amount is expected to be recognized over a weighted average period of approximately 2.2 years.
−Removed: This excludes unvested market-based and performance stock options outstanding that were deemed not probable of vesting as of December 31, 2022, constituting 6,764,000 shares with unrecognized stock-based compensation expense of $ 4,655 , for which the timing of recognition will be determined once the conditions for achievement become probable.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: In September 2021, the Compensation Committee of the Board of Directors approved a modification to the Company's outstanding performance-based stock option awards for active employees which removed the performance-based vesting criteria from these awards.
−Removed: Following this modification, the option awards are subject only to previously existing time-based vesting conditions.
−Removed: The Company accounted for this change as a modification in accordance with the requirements of Accounting Standards Codification Topic 718.
−Removed: As a result, 9,250,000 options, related to twenty-five employees, that were previously authorized that had not achieved a grant date became granted on September 24, 2021 relating to the modification.
−Removed: The Company is recognizing the newly assessed measurement date fair value of the awards as compensation expense over the remaining vesting period.
The fair value of warrants is estimated on the date of grant using the Black-Scholes valuation methodology.
6 unchanged sentences
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.
−Removed: As of December 31, 2022, 5,821,137 warrants were granted, of which 559,787 warrants were granted to consultants and 5,261,350 warrants were granted to investors.
−Removed: All warrants are considered vested at December 31, 2022, have a weighted-average exercise price of $ 1.56 , an aggregate intrinsic value of $ 15,640 , and a weighted average remaining contractual life of 3.5 years.
+Added: Refer to Note 20 for the Company’s warrants activity for the year ended December 31, 2023.
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
At December 31, 2023, there was no unrecognized compensation expense related to warrants.
5 unchanged sentences
General and administrative
+Added: 9,700 $ 7,645
Total stock-based compensation
$ 14,108 $ 11,948
+Added: The following table summarizes share-based compensation expense associated with each of our share-based compensation arrangements:
+Added: Year Ended December 31, 2023 Year Ended December 31, 2022
+Added: Time-based stock options
+Added: $ 12,606 $ 11,630
+Added: Performance and market-based stock options
+Added: Employee stock purchase plan
+Added: Total stock-based compensation
+Added: $ 14,108 $ 11,948
Commitments and Contingencies
5 unchanged sentences
Refer to Note 18 for discussion of promissory notes payable to related parties.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
Other commitments
2 unchanged sentences
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 .
+Added: 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.
−Removed: As of December 31, 2022, the Company is unable to estimate the amount, timing or likelihood of achieving the milestones, making future product sales or assessing estimated forecasts for manufacturing and supplied materials which these contingent payment obligations relate to.
+Added: As of December 31, 2023, the Company is unable to estimate the amount, timing or likelihood of achieving the
+Added: Summit Therapeutics Inc.
+Added: Notes to Consolidated Financial Statements
+Added: (in thousands, except share and per share data)
+Added: milestones, making future product sales or assessing estimated forecasts for manufacturing and supplied materials which these contingent payment obligations relate to.
Indemnifications
7 unchanged sentences
Related Party Transactions
−Removed: March 24, 2021 Note Purchase Agreement
−Removed: On March 24, 2021, Mr.
−Removed: Duggan, the Company's Executive Chairman and Chief Executive Officer and primary stockholder, entered into a Note Purchase Agreement (the “Initial Purchase Agreement”) pursuant to which he loaned the Company $ 55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Initial Note”) in the amount of $ 55,000 .
−Removed: The Initial Note was to accrue interest at a rate per annum equal to 150 % of the applicable 10 Year United States Treasury rate, as adjusted monthly.
−Removed: The rate was initially estimated to be approximately 2.4 %.
−Removed: The terms of the Initial Note were that it would mature and become due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $ 55,000 , or (ii) 13 months from the date of issuance of the Initial Note.
−Removed: On April 20, 2021, the Company determined, with Mr.
−Removed: Duggan’s agreement, to rescind both the Initial Purchase Agreement and the Initial Note issued thereunder, and repaid the principal amount of the Initial Note in full, without interest or penalty.
−Removed: April 20, 2021 Note Purchase Agreement
−Removed: On April 20, 2021, subsequent to the repayment of the Initial Note, Mr.
−Removed: Duggan entered into a second Note Purchase Agreement (the “Second Purchase Agreement”) pursuant to which he loaned the Company $ 55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Second Note”) in the amount of $ 55,000 .
−Removed: The Second Note accrued interest at a rate per annum equal to 150 % of the applicable 10 Year United States Treasury rate, as adjusted monthly (initially estimated to be approximately 2.4 %).
−Removed: The Company was permitted to prepay any portion of the Second Note at its option without penalty.
−Removed: Summit Therapeutics Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: (in thousands, except share and per share data)
−Removed: May 12, 2021 Rights Offering ("2021 Rights Offering")
−Removed: On May 12, 2021, the Company closed its 2021 Rights Offering, which was fully subscribed.
−Removed: Aggregate gross proceeds from the 2021 Rights Offering were $ 75,000 from the sale of 14,312,976 shares of the Company's common stock, of which 11,365,921 shares were purchased by Mr.
−Removed: Duggan and 389,977 shares were purchased by Dr.
−Removed: Zanganeh, at price of $ 5.24 per share.
−Removed: In connection with the closing of the 2021 Rights Offering, the Second Note, issued by the Company to Mr.
−Removed: Duggan, matured and became due and was repaid using a portion of the proceeds from the 2021 Rights Offering.
−Removed: March 26, 2021 Sublease Agreement with Maky Zanganeh and Associates, Inc.
−Removed: On March 26, 2021, the Company entered into a sublease with Maky Zanganeh and Associates, Inc.
−Removed: ("MZA") consisting of 4,500 square feet of office space at 2882 Sand Hill Road, Menlo Park, California (the “Sublease”).
−Removed: Zanganeh, the Company's Co-Chief Executive Officer and President, is the sole owner of MZA.
−Removed: The sublease ran until September 2022.
−Removed: The rent payable under the terms of the sublease was 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.
−Removed: During the years ended December 31, 2022 and 2021, payments of $ 544 and $ 556 , were made pursuant to the sublease.
July 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc.
2 unchanged sentences
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.
+Added: 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.
10 unchanged sentences
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.
−Removed: 2022 Rights Offering ("2022 Rights Offering")
−Removed: In August 2022, the Company announced the closing and final results of its previously announced rights offering.
+Added: 2022 Rights Offering
The 2022 Rights Offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022.
3 unchanged sentences
Issuance costs were $ 111 .
−Removed: In connection with the closing of the 2022 Rights Offering, the March 2022 Note 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.
+Added: In connection with the closing of the 2022 Rights Offering, the March 2022 Note
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
+Added: 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
7 unchanged sentences
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.
−Removed: 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 will mature and become due on September 15, 2023.
−Removed: The maturity dates of the December 2022 Notes could be extended one or more times at the Company’s election, but in no event to a date later than September 6, 2024.
−Removed: In addition, if the Company shall consummate 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.
+Added: 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.
+Added: 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.
+Added: 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.
1 unchanged sentence
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.
−Removed: 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").
+Added: 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.
+Added: On February 15, 2023, the $ 20,000 Zanganeh Note, matured and the Company repaid the outstanding principal balance.
+Added: 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.
+Added: Duggan in the 2023 Rights Offering (as defined above).
The Notes accrue interest at an initial rate of 7.5 %.
1 unchanged sentence
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.
−Removed: For all applicable periods following the 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.
−Removed: Subsequent Events
−Removed: Akeso Collaboration and License Agreement
−Removed: On December 5, 2022, the Company entered into the License Agreement with Akeso, which is detailed further in Note 1.
−Removed: The License Agreement closed on January 17, 2023, and both Akeso and Summit entered into the Common Stock Issuance Agreement (“Issuance Agreement”).
−Removed: 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 $ 274,900 in cash as the initial upfront payment.
−Removed: The remaining $ 200,000 of the upfront payment was paid on March 6, 2023.
−Removed: As regulatory approval for ivonescimab has not yet been granted, the Company will record in-process research and development expenses in the first quarter of 2023 for the cash payments of $ 474,900 and for the fair market value of the 10 million shares issued to Akeso.
+Added: 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.
+Added: During the year ended December 31, 2023, the Company made payments for interest of $ 10,650 .
+Added: On February 17, 2024 the Duggan February Note was amended to extend the maturity date from September 6, 2024 to April 1, 2025.
+Added: 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.
+Added: Interest shall be paid upon maturity of the loan.
+Added: Akeso License Agreement
Summit Therapeutics Inc.
1 unchanged sentence
(in thousands, except share and per share data)
−Removed: Maturity date extension and rectification of promissory notes issued pursuant to the Note Purchase Agreement
−Removed: As disclosed in Notes 17 and 22, 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.
−Removed: Furthermore, on January 19, 2023, the Company and Mr.
−Removed: Duggan rectified the Duggan February Note and Duggan September Note in order to correctly reflect the parties’ intent, see Notes 17 and 22 for further details.
−Removed: 2023 Rights Offering ("Rights Offering")
−Removed: 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.
+Added: Upon the closing of the License Agreement, the Board of Directors (the “Board”) of the Company appointed Dr.
+Added: Yu (Michelle) Xia to serve as a member of the Board pursuant to the terms of the License Agreement.
+Added: Xia is the founder of Akeso, Inc., and has been the chairwoman, president and CEO of the Company since its inception in 2012.
+Added: For details on the License Agreement, see Note 6.
+Added: 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”).
+Added: All transactions pursuant to the Supply Agreement, which occurred during 2023, were in the ordinary course of business.
+Added: The Company paid approximately $ 2,500 to Akeso during year ended December 31, 2023.
+Added: As of December 31, 2023, the Company included in accrued expenses approximately $ 3,619 due to Akeso.
+Added: 2023 Rights Offering
+Added: 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.
−Removed: Aggregate gross proceeds from the Rights Offering were $ 500,000 from the sale of 476,190,471 shares of the Company's common stock at a price of $ 1.05 per share.
−Removed: Issuance costs were approximately $ 500 .
−Removed: Repayment of promissory notes
−Removed: On February 15, 2023, the $ 20,000 Zanganeh Note matured and the Company repaid the outstanding principal balance.
−Removed: In connection with the closing of the Rights Offering, the $ 400,000 Duggan Promissory Note, which is defined in Note 17, matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from the Rights Offering.
+Added: 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 .
+Added: Duggan and Dr.
+Added: Zanganeh fully subscribed to their respective basic subscription rights at a price of $ 1.05 per share.
+Added: To satisfy the $ 395,314 subscription price for the shares subscribed by Mr.
+Added: Duggan in the 2023 Rights Offering, Mr.
+Added: 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.
+Added: Registration of Shares
+Added: 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:
+Added: (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;
+Added: 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.
+Added: Duggan and Dr.
+Added: Zanganeh, respectively, as payment of prepaid interest in connection with the Note Purchase Agreement dated December 6, 2022 between Mr.
+Added: Zanganeh and the Company.
+Added: On April 27, 2023, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-3.
+Added: Private Placement
+Added: On October 16, 2023, the Company announced the appointment of Mr.
+Added: Manmeet Soni as its Chief Operating Officer, effective immediately.
+Added: Soni has been a part of the Company’s Board of Directors since 2019.
+Added: He will remain a member of the Board of Directors.
+Added: In conjunction with his appointment, Mr.
+Added: Soni entered into a share purchase agreement with the Company to purchase $ 5,000 of its common stock via a private placement.
+Added: 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.
+Added: Warrants Exercise
+Added: In December 2023, Dr.
+Added: Zanganeh exercised 805,495 shares of warrants.
+Added: Refer to Note 20 for the warrants exercise activity for the year ended December 31, 2023.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.