Aktis Oncology (AKTS) risk factors, FY2025 10-K

Aktis Oncology's FY2025 10-K, filed Mar 30, 2026, lists 129 risk factors. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
1290 groups
Section length
53k wordsItem 1A

Aktis Oncology's biggest risks in the FY2025 10-K

  • Aktis Oncology focuses on developing targeted radiopharmaceuticals, relying heavily on licensing agreements and partnerships like Eli Lilly.
  • The company faces ongoing financial losses and relies on recent IPO proceeds to fund operations into 2029.

The risks most specific to Aktis Oncology

  • ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval

    We must establish commercial infrastructure and face significant net loss fluctuations depending on clinical trial timing and expenditures.

  • License and collaboration agreements

    We may incur unpredictable contingent regulatory milestones, commercial milestones, and royalty payments under our license and collaboration agreements.

  • To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future, if ever. Substantially all of our revenue to date has been derived from the work performed under the Collaboration Agreement

    We have generated no product sales revenue to date and rely heavily on work performed under our collaboration agreement with Eli Lilly.

  • the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory clearances to market [ 225 Ac]Ac-AKY-1189 for any Nectin-4 expressing tumors or any future product candidates

    We lack committed capital sources to fund commercializing [225 Ac]Ac-AKY-1189 for Nectin-4 expressing tumors or other future candidates.

All 129 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Our management team, led by our Chief Operating Officer, has primary responsibility for developing and managing our overall cybersecurity risk management program. The Chief Operating Officer oversees our internal information technology functions and supervises third-party cybersecurity vendors and consultants
  2. 02Ite m 3. Legal Proceedings
  3. 03Holders of our Common Stock
  4. 04Recent Sales of Unregistered Equity Securities
  5. 05Use of Proceeds from our Initial Public Offering
  6. 06Ite m 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
  7. 07ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval
  8. 08License and collaboration agreements
  9. 09Blaze Bioscience license agreement
  10. 10Institute for Protein Innovation, Inc. license agreement
  11. 11University of Minnesota license agreement
  12. 12Eli Lilly and Company research and collaboration agreement
  13. 13To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future, if ever. Substantially all of our revenue to date has been derived from the work performed under the Collaboration Agreement
  14. 14Research and development expenses
  15. 15the cost of obtaining and maintaining patent and trade secret protection for our product candidates
  16. 16General and administrative expenses
  17. 17Comparison of the years ended December 31, 2025 and 2024
  18. 18Net cash provided by investing activities was $66.0 million for the year ended December 31, 2025, primarily consisting of maturities of marketable securities of $269.4 million, partially offset by purchases of marketable securities and property and equipment of $193.8 million and $9.6 million, respectively
  19. 19Net cash used in financing activities was $1.2 million during the year ended December 31, 2025, primarily consisting of payments of deferred offering costs of $1.5 million, partially offset by proceeds received from the exercise of common stock options of $0.3 million
  20. 20Future funding requirements
  21. 21the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory clearances to market [ 225 Ac]Ac-AKY-1189 for any Nectin-4 expressing tumors or any future product candidates
  22. 22Royalty transfer agreement
  23. 23Purchase and other obligations
  24. 24Critical accounting estimates
  25. 25Accrued research and development expenses
  26. 26Determination of fair value of common stock valuations
  27. 27the analysis of initial public offerings and the market performance of similar companies in the biopharmaceutical industry
  28. 28Recently issued accounting pronouncements
  29. 29Emerging Growth Company and Smaller Reporting Company status
  30. 30Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk
  31. 31Opinion on the Financial Statements
  32. 32Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit
  33. 33Commitments and contingencies (Note 13)
  34. 34$500 as of December 31, 2025
  35. 351. Nature of the business and basis of presentation
  36. 36Basis of presentation and consolidation
  37. 37Cash and cash equivalents
  38. 38Restricted cash equivalents
  39. 39Concentration of credit risk
  40. 40Impairment of long-lived assets
  41. 41Level 1—Quoted prices in active markets for identical assets or liabilities
  42. 42Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques
  43. 43Research and development costs
  44. 44Accrued research and development costs
  45. 45Asset acquisitions and acquired in-process research and development expense
  46. 46Stock-based compensation expense
  47. 47The fair value of each restricted stock award is estimated on the date of grant based on the fair value of the Company’s common stock on that same date
  48. 48Redeemable convertible preferred stock
  49. 49Net loss per common share
  50. 50Emerging growth company status
  51. 51Collaborative arrangements
  52. 52Revenue from contracts with customers
  53. 53not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes
  54. 54Recently adopted accounting pronouncements
  55. 55Recent accounting pronouncements not yet adopted
  56. 563. Fair value measurements
  57. 57Valuation of marketable securities
  58. 58interest receivable relating to the Company’s available-for-sale securities is presented within prepaid expenses and other current assets in the accompanying consolidated balance sheets, and amounted to $1.1 million as of December 31, 2025 and 2024
  59. 595. Property and equipment, net
  60. 606. Accrued expenses and other current liabilities
  61. 61In August 2020, the Company issued 5,000,000 shares of Series Seed redeemable convertible preferred stock (the "Series Seed Preferred Stock") for total net proceeds of $5.0 million pursuant to the Series Seed Preferred Stock Purchase Agreement (the “Series Seed Agreement”) between the Company and certain investors
  62. 62In May 2024, the Preferred Stock Warrants were exercised for nominal consideration and the Company issued 250,000 shares of Partner Preferred Stock
  63. 63The weighted-average grant date fair value per share of stock options granted during the years ended December 31, 2025 and 2024 was $8.14 and $5.95, respectively. The total intrinsic value of stock options exercised during the years ended December 31, 2025 and 2024 was $1.2 million and $0.4 million, respectively
  64. 64Effective income tax rate
  65. 65of the Company's product candidates currently incorporate, or rely on, the licensed patents and know-how from the TRIUMF License
  66. 66Eli Lilly collaboration agreement
  67. 6714. Related party transactions
  68. 6815.Employee Benefit Plans
  69. 69Weighted-average discount rate
  70. 70Certain segment information for prior period has been recast to conform to the current year presentation. The recast did not impact the Company's previously reported consolidated results of operations
  71. 711 IT, facilities, office and other includes depreciation, amortization, stock-based compensation expense, and allocations
  72. 72Evaluation of Disclosure Controls and Procedures
  73. 73Management’s Annual Report on Internal Control Over Financial Reporting
  74. 74Changes in Internal Control over Financial Reporting
  75. 75Rule 10b5-1 Trading Arrangements
  76. 76Executive Officers and Directors
  77. 77Class III consists of Ken Herrmann, Michael A. Sherman and Matthew Roden, and their terms will expire at our annual meeting of stockholders to be held in 2029
  78. 78Board Leadership Structure
  79. 79Role of the Board in Risk Oversight
  80. 80All audit services and all non-audit services, other than de minimis non-audit services, to be provided to us by our independent registered public accounting firm must be approved in advance by our audit committee
  81. 81Nominating and Corporate Governance Committee
  82. 82Code of Business Conduct and Ethics
  83. 83Item 11. Exec utive Compensation
  84. 84Summary Compensation Table
  85. 85The amounts shown in this column represent annual bonuses earned with respect to fiscal year 2025 under our annual bonus program
  86. 86Employment Arrangements With Our Named Executive Officers
  87. 87Potential Payments Upon Termination of Employment or Change in Control
  88. 88Employment Arrangements in Place as of the Closing of the IPO for Named Executive Officers
  89. 89Employee and Retirement Benefits
  90. 90Outstanding Equity Awards at Fiscal Year-End 2025
  91. 91We will reimburse our non-employee directors for reasonable out-of-pocket travel and other expenses incurred in connection with attending meetings of our board of directors and any committee of our board of directors on which they serve
  92. 92Director IPO Option Grants
  93. 932026 Equity Incentive Plan
  94. 94We have also designated a plan administrator to administer the day-to-day operations of the 2026 Plan
  95. 95common stock and cash) or in any other form of payment, as determined by our board of directors and specified in the stock appreciation right agreement
  96. 96In 2020, our board of directors adopted and our stockholders initially approved the 2020 Plan. No further awards will be made under the 2020 Plan following the completion of our IPO in January 2026; however, awards outstanding under the 2020 Plan will continue to be governed by their existing terms
  97. 97by us at no more than the price at which the shares were previously issued will again become available for issuance under the 2026 Plan
  98. 98other stock-based awards
  99. 99other lawful consideration as our board of directors may determine
  100. 100Other Stock-Based Awards . The administrator could grant other awards based on our common stock having such terms and conditions that it may determine, including stock appreciation rights, phantom stock awards or stock units
  101. 101provide for the termination of the award immediately prior to the change of control
  102. 102In order to incentivize our employees, our board of directors and stockholders have adopted the 2026 Employee Stock Purchase Plan, or the ESPP, which became effective on January 8, 2026. The material terms of the ESPP are summarized below
  103. 103The common stock purchasable under the ESPP will be shares of authorized but unissued or reacquired common stock, including shares repurchased by us on the open market
  104. 104All determinations, interpretations and constructions made by our board of directors in good faith will not be subject to review by any person and will be final, binding and conclusive on all persons
  105. 105The purchase price of shares acquired pursuant to purchase rights will not be less than the lesser of (i) 85% of the fair market value of a share of our common stock on the first day of an offering; or (ii) 85% of the fair market value of a share of our common stock on the date of purchase
  106. 106outstanding offerings and purchase rights; and (iv) the class(es) and number of shares that are subject to purchase limits under each ongoing offering. Our board of directors will make these adjustments, and its determination will be final, binding and conclusive
  107. 107Other Compensation and Benefits
  108. 108Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
  109. 109Compensation Recovery Policy
  110. 110Limitations On Liability and Indemnification
  111. 111Such limitation of liability does not apply to liabilities arising under federal securities laws and does not affect the availability of equitable remedies such as injunctive relief or rescission
  112. 112We believe that these Restated Charter and Restated Bylaw provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers. We also maintain customary directors’ and officers’ liability insurance
  113. 113Compensation Committee Interlocks
  114. 114Security Ownership of Certain Beneficial Owners and Management
  115. 115all of our current executive officers and directors as a group
  116. 116Based on a Schedule 13D filed with the SEC on January 15, 2026. Consists of 6,344,114 shares of common stock held directly by Eli Lilly and Company
  117. 117Consists of (i) 144,568 shares of common stock and (ii) 284,806 shares of common stock underlying outstanding stock options exercisable within 60 days of March 10, 2026
  118. 118Consists of 84,302 shares of common stock underlying outstanding stock options exercisable within 60 days of March 10, 2026
  119. 119Consists of 23,410 shares of common stock underlying outstanding stock options exercisable within 60 days of March 10, 2026
  120. 120Ite m 13. Certain Relationships and Related Transactions, and Director Independence
  121. 121Series B Redeemable Convertible Preferred Stock Financing
  122. 122Royalty Transfer Agreement with MPM Oncology Charitable Foundation and UBS Optimus Foundation
  123. 123Consulting and Management Services with MPM BioImpact LLC
  124. 124Investors’ Rights, Voting and Right of First Refusal Agreements
  125. 125Indemnification agreements
  126. 126Related person transaction policy
  127. 127Audit Committee Pre-Approval of Audit and Non-Audit Services
  128. 128Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K, filed on January 12, 2026)
  129. 129# Indicates management contract or compensatory plan

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.