Aktis Oncology, Inc. (AKTS)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q (the "Quarterly Report") and our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the "SEC") on March 30, 2026 (the "Annual Report"). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report and the “Risk Factors” section of our Annual Report, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

Overview

We are a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. The field of targeted radiopharmaceuticals is currently led by two marketed products that illustrated that transformative survival outcomes and quality-of-life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate-specific membrane antigen or somatostatin-2 receptor, are each currently approved in only one tumor type, but in those indications, have seen considerable commercial uptake and have become fundamental pillars of cancer treatment. Despite these advances, we believe that the field of radiopharmaceuticals is still in its infancy, with many emerging companies still primarily focused on these same two targets. In contrast, we see a significant opportunity to broaden the cancer patient populations benefiting from targeted radiopharmaceuticals by developing next-generation technologies that expand the scope of tumor targets for which it is possible to safely deliver a powerful payload of an alpha-emitting radioisotope. To ensure patient demand is reliably met, we are also establishing efficient end-to-end supply, with a combination of critical internal capabilities paired with experienced external vendors. Through these efforts, we seek to maximize clinical utility across multiple indications in multiple tumor types, and to expand the commercial uptake of radiopharmaceuticals beyond the traditional nuclear medicine setting and into the more expansive clinical oncology setting.

Since our inception in August 2020, we have devoted substantially all of our resources to developing our miniprotein radioconjugate platform, identifying and developing our product candidates and programs, establishing and protecting our intellectual property, conducting research and development activities, building our supply chain and manufacturing capabilities, organizing and staffing our company, raising capital and providing general and administrative support for these operations. We do not have any products approved for commercial sale and have not generated any revenues from product sales. We have funded our operations primarily with proceeds from the issuance and sale of our redeemable convertible preferred stock and upfront payments from a Research and Collaboration Agreement, the Collaboration Agreement, with Eli Lilly and Company, or Eli Lilly, and have received aggregate net proceeds of $345.5 million from the sale of our redeemable convertible preferred stock, $60.0 million in upfront payments upon entering into the Collaboration Agreement, and $1.0 million upon achieving the first development milestone under the Collaboration Agreement. In January 2026, we completed our IPO of 20,297,500 shares of common stock, which included 2,647,500 shares of common stock sold pursuant to the underwriters' full exercise of their option to purchase additional shares. We received net proceeds from the IPO of $334.4 million after deducting underwriter discounts, commissions and other offering expenses.

We have incurred significant operating losses in every year since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. As of June 30, 2026, we had an accumulated deficit of $199.0 million and our net losses were $42.5 million and $33.1 million for the six months ended June 30, 2026 and 2025, respectively. We expect our expenses and operating losses will increase substantially as we:

•
advance [225Ac]Ac-AKY-1189 for Nectin-4 expressing tumors and [225Ac]Ac-AKY-2519 for B7-H3 expressing tumors through clinical trials;

•
continue investigational new drug, or IND, -enabling preclinical studies for our other programs;

•
continue to advance our miniprotein radioconjugate platform;

•
acquire or in-license other product candidates, targeting molecules and technologies;

•
conduct preclinical studies and clinical trials for our other product candidates;

•
seek to identify additional product candidates;

•
continue to utilize third-parties to manufacture our lead product candidate;

•
scale up our supply of 225Ac and other radioisotopes;

•
continue to expand manufacturing capabilities through additional in-house facilities and expertise, as well as additional third party contractors to enable global commercial scale;

14

Table of Contents

•
seek regulatory approval of product candidates that successfully complete clinical development;

•
expand our operational, legal, compliance, financial, and management information systems and increase personnel, including personnel to support our preclinical and clinical development, manufacturing, and future commercialization efforts as well as to support our operations as a public company;

•
obtain, expand, maintain, defend and enforce our intellectual property portfolio;

•
contract with manufacturing sources for preclinical and clinical development of any future product candidates we may develop and commercial supply with respect to any such product candidates that receive regulatory approval;

•
undertake pre-commercial activities to enhance commercialization prospects for any current or future product candidates that may obtain regulatory approval; and

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

In addition, we have several clinical development, regulatory, and commercial milestones, as well as royalty payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our ongoing and planned clinical trials and our expenditures on other research and development activities.

We do not have any products approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our current and any future product candidates, which we expect will take a number of years or may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings or other capital sources, including collaborations, licenses or other strategic arrangements. See “—Liquidity and capital resources.” We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Due to the numerous risks and uncertainties associated with the development of radiopharmaceutical candidates, we are unable to accurately predict the timing or amount of increased expenses or the timing of when, or if, we will be able to achieve or maintain profitability. Even if we generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $517.3 million. Based upon our current operating plans, we believe our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the sections titled “—Liquidity and capital resources” and “Risk Factors” included elsewhere in this Quarterly Report.

License and collaboration agreements

We may incur contingent regulatory and development milestones, commercial milestones and royalty payments that we are required to make under our license and collaboration agreements, in which the amounts to be paid by us are not fixed or determinable at this time. For a more detailed description of these agreements, see Notes 11 and 12 to our audited consolidated financial statements in the Annual Report. There have been no material changes to the terms and conditions, or accounting conclusions, previously disclosed in the Annual Report.

Components of results of operations

Revenue

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.

If our development efforts for our current or future product candidates are successful and result in regulatory approval or if we enter into additional license or collaboration agreements with third parties, we may generate revenue in the future from product sales, payments from such license or collaboration agreements, or any combination thereof. We cannot predict if, when or to what extent we will generate revenue as we may never succeed in obtaining regulatory approval for any of our product candidates. If we fail to complete preclinical and clinical development of our current or future product candidates or fail to obtain regulatory approval for any that successfully

15

Table of Contents

complete clinical trials, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.

Operating expenses

Research and development expenses

We recognize research and development expenses in the periods in which they are incurred. Research and development expenses consist primarily of employee-related costs and other internal and external costs associated with our discovery and development efforts and the preclinical development of our current and future product candidates. In particular, our research and development expenses include:

•
employee-related costs, including salaries, bonuses, benefits and stock-based compensation for employees engaged in research and development functions;

•
the costs to

[Excerpt truncated for page length; source filing is linked above.]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” As a result of many factors, including those factors set forth in the "Risk Factors" section of this Annual Report and "Cautionary Note Regarding Forward-Looking Statements", our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Overview

We are a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. The field of targeted radiopharmaceuticals is currently led by two marketed products that illustrated transformative survival outcomes and quality of life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate specific membrane antigen or somatostatin-2 receptor, are each currently approved in only one tumor type, but in those indications, have seen considerable commercial uptake and have become fundamental pillars of cancer treatment. Despite these advances, we believe that the field of radiopharmaceuticals is still in its infancy, with many emerging companies still primarily focused on these same two targets. In contrast, we see a significant opportunity to broaden the cancer patient populations benefiting from targeted radiopharmaceuticals by developing next-generation technologies that expand the scope of tumor targets for which it is possible to safely deliver a powerful payload of an alpha-emitting radioisotope. To ensure patient demand is reliably met, we are also establishing efficient end-to-end supply, with a combination of critical internal capabilities paired with experienced external vendors. Through these efforts, we seek to maximize clinical utility across multiple indications in multiple tumor types, and to expand the commercial uptake of radiopharmaceuticals beyond the traditional nuclear medicine setting and into the more expansive clinical oncology setting.

Since our inception in August 2020, we have devoted substantially all of our resources to developing our miniprotein radioconjugate platform, identifying and developing our product candidates and programs, establishing and protecting our intellectual property, conducting research and development activities, building our supply chain and manufacturing capabilities, organizing and staffing our company, raising capital and providing general and administrative support for these operations. We do not have any products approved for commercial sale and have not generated any revenues from product sales. We have funded our operations primarily with proceeds from the issuance and sale of our redeemable convertible preferred stock and upfront payments from a Research and Collaboration Agreement, the Collaboration Agreement, with Eli Lilly and Company, or Eli Lilly, and have received aggregate net proceeds of $345.5 million from the sale of our redeemable convertible preferred stock, $60.0 million in upfront payments upon entering into the Collaboration Agreement, and $1.0 million upon achieving the first development milestone under the Collaboration Agreement. In January 2026, we completed our initial public offering, or the IPO, and raised aggregate net proceeds of $335.3 million from the sale of 20,297,500 shares of common stock, which included 2,647,500 shares of common stock sold pursuant to the underwriters' full exercise of their option to purchase additional shares.

We have incurred significant operating losses in every year since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. As of December 31, 2025, we had an accumulated deficit of $156.6 million and our net losses were $63.7 million and $44.0 million for the years ended December 31, 2025 and 2024, respectively. We expect our expenses and operating losses will increase substantially as we:

•
advance our lead product candidate, [225Ac]Ac-AKY-1189 for Nectin-4 expressing tumors, through clinical trials;

•
seek regulatory approval to commence clinical trials for [225Ac]Ac-AKY-2519 for B7-H3 expressing tumors;

•
continue IND-enabling preclinical studies for our other programs;

•
continue to advance our miniprotein radioconjugate platform;

•
acquire or in-license other product candidates, targeting molecules and technologies;

•
conduct preclinical studies and clinical trials for our other product candidates;

•
seek to identify additional product candidates;

•
continue to utilize third-parties to manufacture our lead product candidate;

•
scale up our supply of 225Ac and other radioisotopes;

•
continue to expand manufacturing capabilities through additional in-house facilities and expertise, as well as additional third party contractors to enable global commercial scale;

107

•
seek regulatory approval of product candidates that successfully complete clinical development;

•
expand our operational, legal, compliance, financial, and management information systems and increase personnel, including personnel to support our preclinical and clinical development, manufacturing, and future commercialization efforts as well as to support our operations as a public company;

•
obtain, expand, maintain, defend and enforce our intellectual property portfolio;

•
contract with manufacturing sources for preclinical and clinical development of any future product candidates we may develop and commercial supply with respect to any such product candidates that receive regulatory approval;

•
undertake pre-commercial activities to enhance commercialization prospects for any current or future product candidates that may obtain regulatory approval; and

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

In addition, we have several clinical development, regulatory, and commercial milestones, as well as royalty payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our ongoing and planned clinical trials and our expenditures on other research and development activities.

We do not have any products approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our current and any future product candidates, which we expect will take a number of years or may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings or other capital sources, including collaborations, licenses or other strategic arrangements. See “—Liquidity and capital resources.” We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Due to the numerous risks and uncertainties associated with the development of radiopharmaceutical candidates, we are unable to accurately predict the timing or amount of increased expenses or the timing of when, or if, we will be able to achieve or maintain profitability. Even if we generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $226.8 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities, together with the net proceeds of approximately $335.3 million from our IPO completed in January 2026, will be sufficient to fund our operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the sections titled “—Liquidity and capital resources” and “Risk Factors” included elsewhere in this Annual Report.

License and collaboration agreements

We may incur contingent regulatory and development milestones, commercial milestones and royalty payments that we are required to make under our license and collaboration agreements, in which the amounts to be paid by us are not fixed or determinable at this time. For a more detailed description of these agreements, see the section titled “Business—License and collaboration agreements” and Notes 11 and 12 to our consolidated financial statements included elsewhere in this Annual Report.

108

Blaze Bioscience license agreement

On July 22, 2021, we entered into a Discovery, License and Option Agreement, or the Blaze Agreement, as amended on March 3, 2022, May 20, 2022 and December 19, 2022, with Blaze Bioscience Inc., or Blaze, pursuant to which we granted to each other certain exclusive and non-exclusive licenses and an option to license Blaze’s platform technology to use in conducting certain research and development activities. We made a one-time non-refundable upfront payment of $1.8 million to Blaze, as partial consideration for the rights and licenses granted to us under the Blaze Agreement. We paid an additional one-time payment of $0.2 million in connection with the December 19, 2022 amendment. The Blaze Agreement required us to make specified non-refundable, non-creditable milestone payments of up to $0.7 million per collaboration target as well as royalty payments on a product-by-product basis until the later of (a) the date of expiration of the last-to-expire valid claim covering such collaboration target, or (b) ten years following the date of the first commercial sale of such collaboration target. None of the milestones had been achieved prior to termination.

Upon execution of the Blaze Agreement, we also issued to Blaze, warrants, or the Preferred Stock Warrants, to purchase 2,000,000 shares of partner preferred stock, or the Partner Preferred Stock, as a partial consideration for the rights granted by Blaze to us. The Preferred Stock Warrants represent an additional upfront payment and the initial fair value of the Preferred Stock Warrants was $0.6 million. See Note 11 to our consolidated financial statements included elsewhere in this Annual Re

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]