Summit Therapeutics Inc

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2024

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number:001-36866

(Exact Name of Registrant as Specified in its Charter)

(305)203-2034

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No☒

The aggregate market value of the voting common stock held by non-affiliates based on the closing stock price on June 30, 2024, was $827.3 million. For purposes of this computation only, all executive officers and directors have been deemed affiliates.

The number of outstanding shares of the registrant’s common stock, par value $0.01 per share, as of February 18, 2025 was 737,679,704.

Documents Incorporated by Reference

Portions of the registrant’s definitive proxy statement relating to the registrant’s 2025 annual meeting of stockholders to be filed hereafter are incorporated by reference into Part III of this Annual Report on Form 10-K. The registrant’s definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.

TABLE OF CONTENTS

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), regarding the future financial performance, business prospects and growth of Summit Therapeutics Inc., that involve substantial risks and uncertainties. All statements contained in this Annual Report on Form 10-K, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this Annual Report on Form 10-K include, among other things, statements about:

•the ability to develop a successful product candidate under the License Agreement (as defined in Part I, Item I Business, Overview);

•our ability to raise sufficient additional funds to make payments under the License Agreement, and fund ongoing operations and capital needs;

•the timing of and the ability to effectively execute clinical development of ivonescimab;

•the timing, costs, conduct and outcomes of clinical trials for any product candidates, including ivonescimab;

•our plans with respect to possible future collaborations and partnering arrangements;

•the potential benefits of possible future acquisitions or investments in other businesses, products or technologies;

•our plans to pursue research and development of other future product candidates;

•our estimates regarding the potential market opportunity and patient population for commercializing our product candidates, if approved for commercial use;

•our sales, marketing and distribution capabilities and strategy;

•our ability to establish and maintain arrangements with third parties, such as contract research organizations, contract manufacturing organizations, suppliers and distributors;

•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims;

•our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

•the impact of government laws and regulations in the United States and in foreign countries;

•the timing and likelihood of regulatory filings and approvals for our product candidates;

•whether regulatory authorities determine that additional trials or data are necessary in order to accept a new drug application for review and approval;

•our competitive position;

•our planned use of our existing cash, cash equivalents and marketable securities;

•our ability to attract and retain key scientific or management personnel;

•the impact of public health epidemics, such as the novel coronavirus pandemic (“COVID-19”), natural disasters or geopolitical instability, the response to such events and the potential effects of such events on our business, financial results, supply chain and market; and

•general economic conditions, including economic slowdowns or other adverse economic conditions, such as periods of increased or prolonged inflation.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Annual Report on Form 10-K, particularly in the “Risk Factors” in Part 1, Item 1A of this Annual Report on Form 10-K, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to this Annual Report on Form 10-K completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements.

i

Below is a summary of the principal factors that make an investment in Summit speculative or risky. The following summary does not contain all of the information that may be important to you, and you should read the below summary in conjunction with the more detailed discussion of risks set forth under the heading “Risk Factors” in Part I, Item IA of this Annual Report on Form 10-K.

Risks Related to Our Financial Position and Need for Additional Capital

•We are a development-stage company and have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for at least the next several years and may never generate profits from operations or maintain profitability.

•We have not yet demonstrated an ability to successfully complete development of any product candidates.

•We will need substantial additional capital to fund our operations. Raising additional capital may cause dilution to our investors or restrict our operations.

•We depend heavily on the success of ivonescimab. If we are unable to successfully develop and commercialize ivonescimab, or experience significant delays in doing so, we may extend the period in which we will incur significant financial losses as an organization.

•Worldwide economic, social and geopolitical instability could adversely affect our business and ability to raise capital in the future.

Risks Related to the Development and Commercialization of our Product Candidates

•We can provide no assurance that our clinical product candidates, including our lead product candidate, ivonescimab, will obtain regulatory approval or that the results of clinical studies will be favorable.

•Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials conducted by us or Akeso, as well as any interim results thereof, may not be predictive of future trial results and may negatively impact the size and scope of our ongoing or future Phase III clinical trials.

•Regulatory requirements and timelines may affect the scope and timeline of our trials and the potential market for our product candidates.

•If we experience unforeseen events, including unfavorable results, in connection with our clinical trials, potential marketing approval or commercialization of our product candidates could be delayed or prevented.

•Serious adverse events may limit our development of a product candidate.

•Even if a product candidate receives marketing approval, it may fail to achieve commercial success.

•We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.

•Others may discover, develop or commercialize products before us or more successfully than we do.

Risks Related to our Dependencies on Third Parties

•We depend on our relationship with, and the intellectual property licensed from, Akeso.

•We may be reliant on Akeso for knowledge transfer relating to any improvements in manufacturing of ivonescimab.

•We depend on collaborations with third parties for the development and commercialization of some of our product candidates.

•We rely on the use of third parties, including Akeso, to manufacture our product candidate.

•We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily.

Legal, Tax, Regulatory and Compliance Risks

•Any approved product candidate may become subject to unfavorable pricing regulations, third-party reimbursement practices or other healthcare reform initiatives.

•Our business is subject to the risks associated with doing business in China.

•Product liability lawsuits against us could materially harm our business.

•If we fail to comply with applicable laws and regulations, we could face material adverse consequences.

•Changes to tax laws or the interpretation thereof could increase our future tax liabilities and adversely affect our business.

ii

•Our future tax liabilities may be greater than expected if our net operating loss carryforwards and other tax attributes are limited, we do not generate expected deductions, or tax authorities challenge our tax positions.

•If we are unsuccessful or delayed in obtaining required regulatory approvals, we may not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.

•Our ability to obtain and maintain conditional marketing authorizations in the E.U. and other countries in our Licensed Territory may be more limited in number as well as scope of the relevant authorizations and subject to several conditions and obligations that could prevent us from continuing to market our products.

•The terms of any received marketing approvals, including post-marketing requirements, and regulations may limit how we manufacture, market and price our products.

Risks Related to Our Intellectual Property, Cybersecurity and Data Privacy

•Insufficient patent protection could materially negatively impact our competitive position.

•Any litigation relating to our intellectual property may have a material adverse effect on our business.

•We may be subject to claims by third parties asserting misappropriation of their intellectual property.

•If we are unable to protect the confidentiality of our trade secrets, our business could be harmed.

•Any interruption, malfunction, or lapse related to information technology, including any cybersecurity incidents, could harm our business.

•Failure to comply with data privacy and security obligations could harm our business.

Risks Related to Operations

•We depend on our ability to retain our Co-Chief Executive Officers, Chief Operating Officer and other key executives and personnel.

•We or the third parties we rely on may be adversely affected by social unrest, terrorism or natural disasters.

•Widespread health concerns or pandemics or epidemics could harm our business.

•Any non-compliance with regulations or other misconduct by employees could harm our business.

Risks Related to Owning Our Common Stock

•Our principal stockholder and Co-Chief Executive Officer maintains the ability to control or significantly influence all matters submitted to stockholders for approval.

•We are a “controlled company” under the listing requirements of the Nasdaq Stock Market, which could adversely affect our stockholders.

•The price of our shares of common stock have been, and may continue to be, volatile.

•Substantial future sales of our shares of common stock in the public market, or the perception that these sales could occur, could cause the price of the shares to decline significantly, even if our business is doing well.

•Any failure to maintain an effective system of internal control over financial reporting could decrease confidence in our financial and other public reporting, which would harm our business.

•Our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers and employees is limited by our Certificate of Incorporation.

•Because we do not anticipate paying any cash dividends on our shares of common stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.

•We are exposed to risks related to currency exchange rates.

iii