Aktis Oncology, Inc.
A clinical-stage biotech developing targeted alpha radiopharmaceuticals for solid tumors, Aktis Oncology builds its medicines from tiny engineered proteins called miniproteins that slip deep into tumors and clear quickly from the body. Its lead candidate targets Nectin-4, found on bladder and other cancers, while a second program targets B7-H3 for prostate and lung cancers. The company has a discovery collaboration with Eli Lilly and is building its own manufacturing facility.
10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗
The original filing sections are available below.
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 A…
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 acquire in-process research and development with no alternative future use acquired in an asset acquisition; •external expenses, including expenses incurred under arrangements with third parties, such as contract research organizations, or CROs, contract development and manufacturing organizations, or CDMOs, consultants and our scientific advisors; •the cost of manufacturing our product candidates, including costs for laboratory supplies, research materials and reagents; •license and collaboration fees, including any milestone-based payments; •facility costs, depreciation and other expenses, which include direct and allocated expenses; and •the cost of obtaining and maintaining patent and trade secret protection for our product candidates. We track direct external research and development expenses by stage of program, clinical or preclinical. We expect to report external research and development expenses for each clinical drug candidate following development candidate designation. Our internal research and development expenses are deployed across multiple programs and, as such, are not separately tracked. Significant judgments and estimates are made in determining the accrued, or prepaid expense balances at the end of any reporting period. Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. We expect to fund our research and development expenses from our current cash, cash equivalents, investments in marketable securities, and a combination of public and private equity offerings, debt financings, or other sources of capital, which may include additional collaborations with other companies, marketing, distribution, or licensing arrangements with third parties, or other similar arrangements. General and administrative expenses General and administrative expenses consist primarily of employee-related costs, including salaries, bonuses, benefits, and stock-based compensation expenses for personnel in executive, finance, accounting, human resources, and other administrative functions. General and administrative expenses also include professional and consulting expenses, including legal fees relating to patent, intellectual property, and corporate matters, professional fees for accounting, audit, and consulting services, and facility and depreciation expenses, including expenses for rent, director and officer insurance expenses, and other operating costs not included in research and development. We recognize general and administrative expenses in the periods in which they are incurred. We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our expansion of the business. We also anticipate that we will incur significantly increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company. Other income, net Other income, net consists of interest earned, the accretion or amortization of discount or premiums on our cash equivalents and investments in marketable securities on investments classified as available-for-sale, and realized and unrealized foreign currency transaction losses. 16 Table of Contents Income taxes Since our inception, we have not recorded any income tax benefits or expense for the net losses we have incurred in each period or for our earned research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of December 31, 2025, we had net operating loss carryforwards, or NOLs, for federal and state income tax purposes of $45.8 million and $40.8 million, respectively. The federal NOLs are not subject to expiration and the state NOLs begin to expire in 2041. These loss carryforwards are available to reduce future federal taxable income, if any. As of the three and six months ended June 30, 2026 and 2025, we have recorded a full valuation allowance against our net deferred tax assets. Results of operations Comparison of the three months ended June 30, 2026 and 2025 The following table summarizes our results of operations (in thousands): Three Months Ended June 30, 2026 2025 Change Revenue: Collaboration revenue $ 3,384 $ 1,601 $ 1,783 Total revenue 3,384 1,601 1,783 Operating expenses: Research and development 25,280 18,628 6,652 General and administrative 7,003 3,936 3,067 Total operating expenses 32,283 22,564 9,719 Loss from operations (28,899 ) (20,963 ) (7,936 ) Total other income, net 4,755 2,888 1,867 Net loss $ (24,144 ) $ (18,075 ) $ (6,069 ) Revenue Collaboration revenue was $3.4 million and $1.6 million for the three months ended June 30, 2026 and 2025, respectively, driven by revenue recognized from our Collaboration Agreement with Eli Lilly, which is recognized over time using the cost incurred input method. Research and development expenses The following table summarizes our research and development expenses (in thousands): Three Months Ended June 30, 2026 2025 Change Direct external research and development expenses: Discovery and development $ 2,610 $ 4,523 $ (1,913 ) [225Ac]Ac-AKY-1189 6,516 2,934 3,582 [225Ac]Ac-AKY-2519 4,271 1,755 2,516 Unallocated research and development expenses: Employee-related (including stock-based compensation) 7,565 5,593 1,972 Facility, lab and depreciation 3,732 3,196 536 Other research and development related expenses 586 627 (41 ) Total research and development expenses $ 25,280 $ 18,628 $ 6,652 Research and development expenses were $25.3 million for the three months ended June 30, 2026, compared to $18.6 million for the comparable prior year period. The increase of $6.7 million was primarily due to: •$3.6 million increase related to the operations of our ongoing Phase 1b clinical trial for [225Ac]Ac-AKY-1189; •$2.5 million increase associated with advancing [225Ac]Ac-AKY-2519 through IND-enabling studies and into clinical trials; 17 Table of Contents •$2.0 million increase primarily driven by an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount to support the advancement of our clinical development programs and manufacturing; and •$0.5 million increase in facility, lab and depreciation costs primarily related to an increase in laboratory equipment as a result of our expansion of laboratory space and an increase in software subscriptions, partially offset by; •$1.9 million decrease in discovery and development activities with [225Ac]Ac-AKY-2519 advancing into clinical trials. General and administrative expenses The following table summarizes our general and administrative expenses (in thousands): Three Months Ended June 30, 2026 2025 Change Employee-related (including stock-based compensation) $ 3,339 $ 2,003 $ 1,336 Professional and consulting 3,065 1,678 1,387 Facility, depreciation, and other 599 255 344 Total general and administrative expenses $ 7,003 $ 3,936 $ 3,067 General and administrative expenses were $7.0 million for the three months ended June 30, 2026, compared to $3.9 million for the comparable prior year period. The increase of $3.1 million was primarily due to an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount, as well as higher professional and consulting costs and director and officer insurance costs associated with operating as a public company. Other income, net Other income, net was $4.8 million for the three months ended June 30, 2026, compared to $2.9 million for the comparable prior year period. The increase of $1.9 million was primarily driven by an increase in interest income earned due to higher average balances in cash equivalents and marketable securities during the three months ended June 30, 2026 compared to the comparable prior year period. Comparison of the six months ended June 30, 2026 and 2025 The following table summarizes our results of operations (in thousands): Six Months Ended June 30, 2026 2025 Change Revenue: Collaboration revenue $ 6,611 $ 3,048 $ 3,563 Total revenue 6,611 3,048 3,563 Operating expenses: Research and development 45,316 34,491 10,825 General and administrative 12,900 7,663 5,237 Total operating expenses 58,216 42,154 16,062 Loss from operations (51,605 ) (39,106 ) (12,499 ) Total other income, net 9,136 6,046 3,090 Net loss $ (42,469 ) $ (33,060 ) $ (9,409 ) Revenue Collaboration revenue was $6.6 million and $3.0 million for the six months ended June 30, 2026 and 2025, respectively, driven by revenue recognized from our Collaboration Agreement with Eli Lilly, which is recognized over time using the cost incurred input method. 18 Table of Contents Research and development expenses The following table summarizes our research and development expenses (in thousands): Six Months Ended June 30, 2026 2025 Change Direct external research and development expenses: Discovery and development $ 5,169 $ 8,241 $ (3,072 ) [225Ac]Ac-AKY-1189 10,261 5,841 4,420 [225Ac]Ac-AKY-2519 7,256 2,510 4,746 Unallocated research and development expenses: Employee-related (including stock-based compensation) 14,955 10,889 4,066 Facility, lab and depreciation 6,754 5,983 771 Other research and development related expenses 921 1,027 (106 ) Total research and development expenses $ 45,316 $ 34,491 $ 10,825 Research and development expenses were $45.3 million for the six months ended June 30, 2026, compared to $34.5 million for the comparable prior year period. The increase of $10.8 million was primarily due to: •$4.7 million increase associated with advancing [225Ac]Ac-AKY-2519 through IND-enabling studies and into clinical trials; •$4.4 million increase related to the operations of our ongoing Phase 1b clinical trial for [225Ac]Ac-AKY-1189; •$4.1 million increase primarily driven by an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount to support the advancement of our clinical development programs and manufacturing; and •$0.8 million increase in facility, lab and depreciation costs primarily related to an increase in laboratory equipment as a result of our expansion of laboratory space and an increase in software subscriptions, partially offset by; •$3.1 million decrease in discovery and development activities with [225Ac]Ac-AKY-2519 advancing into clinical trials. General and administrative expenses The following table summarizes our general and administrative expenses (in thousands): Six Months Ended June 30, 2026 2025 Change Employee-related (including stock-based compensation) $ 6,763 $ 3,998 $ 2,765 Professional and consulting 4,982 3,029 1,953 Facility, depreciation, and other 1,155 636 519 Total general and administrative expenses $ 12,900 $ 7,663 $ 5,237 General and administrative expenses were $12.9 million for the six months ended June 30, 2026, compared to $7.7 million for the comparable prior year period. The increase of $5.2 million was primarily due to an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount, as well as higher professional and consulting costs and director and officer insurance costs associated with operating as a public company. Other income, net Other income, net was $9.1 million for the six months ended June 30, 2026, compared to $6.0 million for the comparable prior year period. The increase of $3.1 million was primarily driven by an increase in interest income earned due to higher average balances in cash equivalents and marketable securities during the six months ended June 30, 2026 compared to the comparable prior year period. 19 Table of Contents Liquidity and capital resources Sources of liquidity Since our inception, we have incurred significant operating losses. We have not generated any revenue from product sales and we do not expect to generate revenue from sales of products in the near term, if at all. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. As such, we expect our research and development and general and administrative expenses to continue to increase significantly, including the costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings or strategic agreements. In January 2026, we raised aggregate net proceeds of $334.4 million from the sale of shares of common stock in our initial public offering, after deducting underwriter discounts, commissions and other offering costs. As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $517.3 million. Cash flows The following table sets forth a summary of the net cash flow activity (in thousands): Six Months Ended June 30, 2026 2025 Net cash used in operating activities $ (44,829 ) $ (33,662 ) Net cash (used in) provided by investing activities (248,167 ) 107,186 Net cash provided by (used in) financing activities 337,703 (468 ) Net increase in cash, cash equivalents, and restricted cash $ 44,707 $ 73,056 Operating activities Net cash used in operating activities was $44.8 million for the six months ended June 30, 2026, primarily consisting of our net loss of $42.5 million and net changes in operating assets and liabilities of $8.6 million, offset by non-cash charges of $6.2 million related to accretion of investment discounts, stock-based compensation and depreciation. Net cash used in operating activities was $33.7 million for the six months ended June 30, 2025, primarily consisting of our net loss of $33.1 million, changes in operating assets and liabilities of $1.2 million, offset by non-cash charges of $0.6 million related to accretion of investment discounts, stock-based compensation and depreciation. Investing activities Net cash used in investing activities was $248.2 million for the six months ended June 30, 2026, primarily consisting of purchases of marketable securities and property and equipment of $300.4 million and $3.1 million, respectively, partially offset by the maturities of marketable securities of $55.4 million. Net cash provided by investing activities was $107.2 million for the six months ended June 30, 2025, primarily consisting of maturities of marketable securities of $121.4 million, partially offset by purchases of marketable securities and property and equipment of $10.8 million and $3.4 million, respectively. Financing activities Net cash provided by financing activities was $337.7 million for the six months ended June 30, 2026, primarily consisting of net proceeds from the IPO of $339.8 million, partially offset by payment of offering costs of $2.3 million. Net cash used in financing activities was $0.5 million for the six months ended June 30, 2025, primarily consisting of payments of offering costs of $0.5 million. Future funding requirements 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 that 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 expend our capital resources sooner than we expect. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. In addition, we expect to incur additional 20 Table of Contents costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. We may also require additional capital to pursue additional research and collaboration agreements. Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical product candidates, we are unable to estimate the amount of our future working capital requirements. Our future capital requirements will depend on many factors, including: •the scope, progress, results and costs related to the clinical development of [225Ac]Ac-AKY-1189 for Nectin-4 expressing tumors and [225Ac]Ac-AKY-2519 for B7-H3 expressing tumors; •the scope, progress, results and costs of discovery, preclinical development and planned clinical trials for our future product candidates; •the costs, timing and outcome of regulatory review of our product candidates; •the cost of advancing and furthering our miniprotein radioconjugate platform; •the costs of establishing, operating and maintaining our manufacturing facility, or securing other manufacturing arrangements for clinical-supply and commercial production; •the cost and availability of sufficient supply of 225Ac and other radioisotopes; •the achievement of milestones or occurrence of other developments that trigger payments by us or our collaborators under any current or future collaboration agreements; •our ability to establish and maintain additional collaborations on favorable terms, if at all; •the emergence of competing therapies for oncology indications and other adverse market developments; •the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, protecting, defending and enforcing our intellectual property rights and defending intellectual property-related claims; •the extent to which we acquire or in-license other product candidates and technologies; and •the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory clearances to market any of our current or future product candidates. We have no committed sources of capital. Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, potentially including collaborations, licenses or other strategic arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. In addition, debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through a strategic agreement, we may have to grant rights to develop and market our current and future product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional capital or obtain adequate funding when needed or on acceptable terms, we may be required to delay, scale back, or discontinue our research, product development, or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Contractual obligations and commitments Royalty transfer agreement In August 2020, we entered into a royalty transfer agreement, or the Royalty Transfer Agreement, with MPM Oncology Charitable Foundation, Inc., or MPM Charitable Foundation, an affiliate of a stockholder holding more than 5% of our total outstanding stock, and the UBS Optimus Foundation, or UBS, and together with MPM Charitable Foundation, the Charitable Foundations. Pursuant to the Royalty Transfer Agreement, we will pay 0.5% of our annual global net sales to each of the Charitable Foundations, for a total of 1.0% of net sales, subject to customary reductions, for products that incorporate or utilize intellectual property that was discovered or developed by us prior to our initial public offering. Our payment obligations for each product will continue on a country-by-country basis upon the later of the twelfth anniversary of the first commercial sale of our product in such country or the expiration of the last to expire of certain patents owned or controlled by us covering such products in such country. 21 Table of Contents Our payment obligations to MPM Charitable Foundation will terminate immediately upon the authorization of the MPM Charitable Foundation’s board of directors (or similar body) or upon the winding up or dissolution of MPM Charitable Foundation. Our payment obligations to UBS will terminate immediately upon the winding up of Oncology Impact Fund 2, L.P., a Cayman Islands exempted limited partnership, which is associated with MPM Charitable Foundation. Leases As of June 30, 2026, we had future minimum operating lease payment obligations under non-cancellable leases of $15.5 million related to leases we have recognized on our consolidated balance sheet, which are due over the following 6.33 years. License agreements Our agreements with certain third parties to license intellectual property include potential milestone fees, sublicense fees and royalty fees. The milestone fees are dependent upon the development of products using the intellectual property licensed under the arrangements and contingent upon the achievement of development or regulatory approval milestones, as well as commercial milestones. These potential obligations are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding these agreements, please see Notes 11 and 12 to our audited consolidated financial statements in the Annual Report. Purchase and other obligations We enter into contracts in the normal course of business with CROs and other third-party vendors for preclinical and commercial supply manufacturing, support for pre-commercial activities, research and development activities, and other services and products for our operations. These contracts are generally cancelable upon written notice. For additional information on our contractual obligations and commitments please see Note 13 to our audited consolidated financial statements included in the Annual Report. Critical accounting policies and estimates Our management’s discussion and analysis of financial condition and results of operations is based on our condensed financial statements, which are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience, known trends and other factors that we believe 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. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates. In making estimates and judgments, management employs critical accounting policies. There have been no material changes to our critical accounting policies from those described in detail in Note 2 to our audited consolidated financial statements included in our Annual Report. Recently issued accounting pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our audited consolidated financial statements and unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report. Emerging Growth Company and Smaller Reporting Company status We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, as amended, or JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our consolidated financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the time that we are no longer an “emerging growth company.” We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means, among other things, the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second fiscal quarter and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. 22 Table of Contents We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. Based on the aggregate market value of our common stock and Class A common stock held by non-affiliates as of June 30, 2026, we expect to lose our smaller reporting company status effective January 1, 2027. As such, we will be required to comply with certain requirements that are currently inapplicable to us as a smaller reporting company but are not exempt under our emerging growth company status, including the quantitative market risk disclosures required by Item 305 of Regulation S-K. 23 Table of Contents
Read original filing text →As a "smaller reporting company," as defined by Rule 12b-2 of the Exchange Act, and pursuant to Item 305 of Regulation S-K we are not required to provide quantitative and qualitative disclosures about market risk.
As a "smaller reporting company," as defined by Rule 12b-2 of the Exchange Act, and pursuant to Item 305 of Regulation S-K we are not required to provide quantitative and qualitative disclosures about market risk.
Read original filing text →From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by u…
From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by us is required to determine both probability and the estimated amount. We are not currently subject to any material legal or arbitration proceedings.
Read original filing text →There have been no material changes to the risk factors set forth in Part I, Item 1A of our Annual Report filed with the SEC on March 30, 2026.
There have been no material changes to the risk factors set forth in Part I, Item 1A of our Annual Report filed with the SEC on March 30, 2026.
Read original filing text →