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
- 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
- 02Ite m 3. Legal Proceedings
- 03Holders of our Common Stock
- 04Recent Sales of Unregistered Equity Securities
- 05Use of Proceeds from our Initial Public Offering
- 06Ite m 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
- 07ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval
- 08License and collaboration agreements
- 09Blaze Bioscience license agreement
- 10Institute for Protein Innovation, Inc. license agreement
- 11University of Minnesota license agreement
- 12Eli Lilly and Company research and collaboration agreement
- 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
- 14Research and development expenses
- 15the cost of obtaining and maintaining patent and trade secret protection for our product candidates
- 16General and administrative expenses
- 17Comparison of the years ended December 31, 2025 and 2024
- 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
- 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
- 20Future funding requirements
- 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
- 22Royalty transfer agreement
- 23Purchase and other obligations
- 24Critical accounting estimates
- 25Accrued research and development expenses
- 26Determination of fair value of common stock valuations
- 27the analysis of initial public offerings and the market performance of similar companies in the biopharmaceutical industry
- 28Recently issued accounting pronouncements
- 29Emerging Growth Company and Smaller Reporting Company status
- 30Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk
- 31Opinion on the Financial Statements
- 32Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit
- 33Commitments and contingencies (Note 13)
- 34$500 as of December 31, 2025
- 351. Nature of the business and basis of presentation
- 36Basis of presentation and consolidation
- 37Cash and cash equivalents
- 38Restricted cash equivalents
- 39Concentration of credit risk
- 40Impairment of long-lived assets
- 41Level 1—Quoted prices in active markets for identical assets or liabilities
- 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
- 43Research and development costs
- 44Accrued research and development costs
- 45Asset acquisitions and acquired in-process research and development expense
- 46Stock-based compensation expense
- 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
- 48Redeemable convertible preferred stock
- 49Net loss per common share
- 50Emerging growth company status
- 51Collaborative arrangements
- 52Revenue from contracts with customers
- 53not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes
- 54Recently adopted accounting pronouncements
- 55Recent accounting pronouncements not yet adopted
- 563. Fair value measurements
- 57Valuation of marketable securities
- 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
- 595. Property and equipment, net
- 606. Accrued expenses and other current liabilities
- 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
- 62In May 2024, the Preferred Stock Warrants were exercised for nominal consideration and the Company issued 250,000 shares of Partner Preferred Stock
- 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
- 64Effective income tax rate
- 65of the Company's product candidates currently incorporate, or rely on, the licensed patents and know-how from the TRIUMF License
- 66Eli Lilly collaboration agreement
- 6714. Related party transactions
- 6815.Employee Benefit Plans
- 69Weighted-average discount rate
- 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
- 711 IT, facilities, office and other includes depreciation, amortization, stock-based compensation expense, and allocations
- 72Evaluation of Disclosure Controls and Procedures
- 73Management’s Annual Report on Internal Control Over Financial Reporting
- 74Changes in Internal Control over Financial Reporting
- 75Rule 10b5-1 Trading Arrangements
- 76Executive Officers and Directors
- 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
- 78Board Leadership Structure
- 79Role of the Board in Risk Oversight
- 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
- 81Nominating and Corporate Governance Committee
- 82Code of Business Conduct and Ethics
- 83Item 11. Exec utive Compensation
- 84Summary Compensation Table
- 85The amounts shown in this column represent annual bonuses earned with respect to fiscal year 2025 under our annual bonus program
- 86Employment Arrangements With Our Named Executive Officers
- 87Potential Payments Upon Termination of Employment or Change in Control
- 88Employment Arrangements in Place as of the Closing of the IPO for Named Executive Officers
- 89Employee and Retirement Benefits
- 90Outstanding Equity Awards at Fiscal Year-End 2025
- 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
- 92Director IPO Option Grants
- 932026 Equity Incentive Plan
- 94We have also designated a plan administrator to administer the day-to-day operations of the 2026 Plan
- 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
- 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
- 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
- 98other stock-based awards
- 99other lawful consideration as our board of directors may determine
- 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
- 101provide for the termination of the award immediately prior to the change of control
- 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
- 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
- 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
- 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
- 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
- 107Other Compensation and Benefits
- 108Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
- 109Compensation Recovery Policy
- 110Limitations On Liability and Indemnification
- 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
- 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
- 113Compensation Committee Interlocks
- 114Security Ownership of Certain Beneficial Owners and Management
- 115all of our current executive officers and directors as a group
- 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
- 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
- 118Consists of 84,302 shares of common stock underlying outstanding stock options exercisable within 60 days of March 10, 2026
- 119Consists of 23,410 shares of common stock underlying outstanding stock options exercisable within 60 days of March 10, 2026
- 120Ite m 13. Certain Relationships and Related Transactions, and Director Independence
- 121Series B Redeemable Convertible Preferred Stock Financing
- 122Royalty Transfer Agreement with MPM Oncology Charitable Foundation and UBS Optimus Foundation
- 123Consulting and Management Services with MPM BioImpact LLC
- 124Investors’ Rights, Voting and Right of First Refusal Agreements
- 125Indemnification agreements
- 126Related person transaction policy
- 127Audit Committee Pre-Approval of Audit and Non-Audit Services
- 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# Indicates management contract or compensatory plan
About this page
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.