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Evommune, Inc.: Form 10-Q for the period ended Jun 30, 2026

Filed with the SEC on Aug 6, 2026 and accepted by EDGAR at Aug 6, 2026, 16:09 ET.

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Management's discussion and analysis

As filed, 29,721 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and related notes appearing in this Quarterly Report on Form 10-Q and our audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025. This discussion and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans, and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements of our plans, objectives, expectations, intentions, forecasts and projections. Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors including, but not limited to, those set forth under the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Our historical results are not necessarily indicative of the results that may be expected for any period in the future, and you should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.

Overview

Evommune is a clinical-stage biotechnology company developing innovative therapies that target key drivers of chronic inflammatory diseases, with initial clinical development programs focusing on chronic spontaneous urticaria (“CSU”), atopic dermatitis (“AD”), migraine and ulcerative colitis (“UC”). Chronic inflammation is a significant healthcare problem in the world, substantially impacting patients’ quality of life and leading to life-threatening conditions.

Our mission is to improve patients’ daily lives and prevent the long-term effects of uncontrolled inflammation that are a consequence of the limitations of existing therapies. To achieve this, we are advancing a portfolio of differentiated product candidates that target key drivers of chronic inflammation.

Among our portfolio of programs, we currently have two product candidates, EVO756 and EVO301, in Phase 2 development. We are developing EVO756 for the treatment of AD and migraine, and EVO301 for the treatment of AD and UC. We see broad expansion potential for both programs across additional chronic inflammatory diseases. We also intend to advance additional preclinical programs into clinical development.

In June 2026, we announced top-line results from our randomized, double-blind, placebo-controlled, dose-ranging Phase 2b trial evaluating EVO756 in adults with moderate-to-severe CSU. The trial did not meet its primary endpoint of mean change in Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose, and based on these results, we have decided to cease development of EVO756 for CSU. We are continuing to evaluate EVO756 in additional indications in which neuroinflammation and mast cell degranulation are key drivers of disease. Our Phase 2b dose-ranging trial of EVO756 in moderate-to-severe AD was initiated in August 2025, and we expect to report initial results in September 2026.

We have also initiated a Phase 2b trial of EVO756 in migraine prophylaxis in July 2026 and we expect to report initial results in 2027. The trial is a global randomized, double-blind, placebo-controlled Phase 2b dose-ranging clinical trial in migraine prophylaxis, evaluating EVO756 in adults with refractory migraine experiencing ≥6 migraine days per month. Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment. The trial is exploring daily doses of up to 100 mg. The primary endpoint of the Phase 2b trial is the mean change from baseline in monthly migraine days (MMD). Key secondary endpoints include the proportion of patients achieving ≥50% and ≥75% reductions in MMD, change from baseline in monthly headache days and monthly acute migraine medication use.

For EVO301, we have completed work on a high concentration of subcutaneous formulation, and manufacturing has been initiated. Our planned Phase 2b, placebo-controlled, dose-ranging clinical trial is expected to include at least three dosing regimens of EVO301 tested over a 16-week treatment period, with a planned commencement in mid-2027 following completion of standard scale-up and toxicology activities. We continue to evaluate EVO301 in additional indications, including UC, certain cardiovascular-related inflammatory conditions and food allergy, with planning underway for additional potential Phase 2 clinical trials.

We were incorporated under the laws of the State of Delaware in April 2020 under the name “Evommune, Inc.” We have two wholly owned subsidiaries: Evommune Research, LLC and Evommune Biologics, LLC.

We have incurred significant operating losses in each year since our inception. As of June 30, 2026, we had an accumulated deficit of $275.0 million. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

We expect to continue to incur significant and increasing net operating losses for the next several years as we:

  • continue the research and development of our clinical- and preclinical-stage product candidates and discovery-stage programs, including the continued development of our most advanced product candidates, EVO756 and EVO301;
  • increase the amount of research and development activities to identify and develop product candidates;
  • make milestone, royalty or other payments under in-license or collaboration agreements;
  • maintain, expand and protect our intellectual property portfolio;
  • expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts;
  • establish sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly with third parties;
  • address any competing therapies and market developments;
  • incur additional costs associated with operating as a public company;
  • invest in or in-license other technologies; and
  • experience any delays or encounter any issues with any of the above, including but not limited to failed studies or trials, complex results, manufacturing challenges, safety issues or other regulatory challenges.

As a result, we will require substantial additional funding to further develop our product candidates and support our continuing operations. To date, we have not had any products approved for sale and, therefore, have not generated any approved product-related revenue. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash requirements through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on commercially acceptable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.

Strategic Collaborations and License Agreements

Dermira, Inc.

In December 2020, we entered into a License, Development and Commercialization Agreement with Dermira (the “Dermira License Agreement”), pursuant to which we obtained an exclusive, worldwide license to develop and commercialize certain compounds, including EVO756.

The Dermira License Agreement remains in effect on a product-by-product and a country-by-country basis until the expiration of the royalty term, unless earlier terminated by either party due to the other party’s uncured material breach or bankruptcy. Additionally, we may terminate the Dermira License Agreement for convenience upon a set number of days’ prior notice.

Under the terms of the Dermira License Agreement, we are obligated to pay up to $45.0 million in development milestones for the development of EVO756 (or up to $135.0 million for the development of all licensed products), and up to $240.0 million in sales milestones for the development of EVO756 (or up to $720.0 million for the development of all licensed products) as well as tiered royalty payments in mid-single digit to low-tens percentages on worldwide sales of the licensed products.

As of June 30, 2026, we have paid a total of $11.0 million in upfront payments and development milestones under the Dermira License Agreement. No development milestones were achieved under the Dermira License Agreement during the six months ended June 30, 2026 and 2025. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due.

Under the Dermira License Agreement, we may sublicense EVO756 to third parties. Dermira has consented to our sublicense of EVO756 to Maruho in Japan and certain Asian countries as described below.

Maruho Co., Ltd.

Maruho Japan Agreement

In September 2023, we entered into a strategic collaboration with Maruho and granted Maruho an exclusive license to develop and commercialize EVO756 in Japan (the “Maruho Japan Agreement”). Under the Maruho Japan Agreement, we are eligible to receive up to $60.0 million in upfront and customary milestone payments and royalty payments on future sales of EVO756 in Japan. As of June 30, 2026, we have received a total of $18.0 million in upfront payments and development milestones under the Maruho Japan Agreement. No other development or sales milestones have been achieved as of June 30, 2026.

Maruho Greater Asia Agreement

In March 2024, we entered into a second strategic collaboration with Maruho (the “Maruho Greater Asia Agreement”) and granted Maruho the exclusive license to develop and commercialize EVO756 in Greater China and certain other Asian countries. Under the Maruho Greater Asia Agreement, we are eligible to receive up to $61.5 million in upfront and customary milestone payments. As of June 30, 2026, we have received a total of $7.0 million in upfront payments under the Maruho Greater Asia Agreement. No other development or sales milestones have been achieved as of June 30, 2026.

AprilBio Co., Ltd.

In June 2024, we entered into a license agreement with AprilBio (the “AprilBio License Agreement”) under which AprilBio granted us an exclusive worldwide license to develop and commercialize EVO301. Under the AprilBio License Agreement, we paid an upfront payment of $15.0 million and may be required to pay milestone payments up to $460.0 million upon achievement of future milestones and royalties on future sales of EVO301. For the six months ended June 30, 2026 and 2025, we recorded $0.5 million and $1.5 million, respectively, as research and development expense upon achievement of development milestones under the AprilBio License Agreement. No other development or sales milestones have been achieved as of June 30, 2026.

Results of Operations

Three and Six Months ended June 30, 2026 and 2025

The following sets forth our results of operations:

Three Months Ended June 30, 2026 2025 Six Months Ended June 30, 2026 2025
Revenue $- $- $- $3,000
Operating expenses:
Research and development 26,412 19,638 43,731 34,000
General and administrative 8,483 3,356 15,118 7,026
Total operating expenses 34,895 22,994 58,849 41,026
Loss from operations (34,895) (22,994) (58,849) (38,026)
Other income, net 2,649 9,429 4,929 9,904
Net loss $(32,246) $(13,565) $(53,920) $(28,122)

Revenue

For the six months ended June 30, 2026, we did not recognize any revenue. For the six months ended June 30, 2025, we recognized $3.0 million in revenue through our license agreements. The decrease was due to non-recurring license revenue recognized under the Maruho Japan Agreement in 2025 of $3.0 million upon the satisfaction of the performance obligation.

Operating Expenses

Research and Development

The following table summarizes our research and development expenses for each of the periods indicated:

Three Months Ended June 30, 2026 2025 Six Months Ended June 30, 2026 2025
EVO756 $13,036 $10,189 $19,902 $14,859
EVO301 870 1,375 1,495 4,402
Discovery research 9,021 5,455 15,691 9,512
Personnel costs 3,485 2,619 6,643 5,227
Total research and development expenses $26,412 $19,638 $43,731 $34,000

Research and development expenses increased $9.7 million for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily due to increase in clinical trial expenses for EVO756 and preclinical research expenses for undisclosed discovery programs, which is classified as discovery research expense in the table above. This was partially offset by a decrease in clinical trial expenses for EVO301. Research and development expenses increased $6.8 million for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily due to increase in clinical trial expenses for EVO756 and preclinical research expenses for undisclosed discovery programs.

General and Administrative

The following table summarizes our general and administrative expenses for each of the periods indicated:

Three Months Ended June 30, 2026 2025 Six Months Ended June 30, 2026 2025
Personnel costs $2,251 $1,620 $4,292 $3,366
Stock-based compensation 720 341 2,936 674
Professional fees 1,225 525 2,032 1,177
Other general and administrative expenses 4,287 870 5,858 1,809
Total general and administrative expenses $8,483 $3,356 $15,118 $7,026

General and administrative expenses increased $5.1 million and $8.1 million for the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, respectively. The increase was primarily due to other general and administrative expenses incurred to support public company operations, including increased insurance coverage.

Other Income, Net

Other income, net decreased $6.8 million and $5.0 million for the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, respectively. The decrease was primarily due to a gain recognized in the prior year period upon the settlement of the convertible preferred stock forward of $8.9 million, offset by an increase in interest income received from cash, cash equivalents, and investments.

Liquidity and Capital Resources

Sources of Liquidity

Our operations to date have been financed primarily by aggregate net proceeds from the issuance of convertible preferred stock and common stock. As of June 30, 2026, we maintained $288.0 million in cash, cash equivalents and investments. In February 2026, we received net proceeds of $117.2 million from the issuance of 4,494,279 shares of common stock in a private placement at a price of $27.88 per share. We expect that our cash, cash equivalents, and investments as of June 30, 2026 will enable us to fund our operating expenses and capital expenditures requirements through 2028, based on our current business plan.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

Six Months Ended June 30, 2026 2025
Net cash used in operating activities $(47,819) $(50,107)
Net cash (used in) provided by investing activities (54,065) 31,500
Net cash provided by financing activities 117,643 64,189
Net increase in cash, cash equivalents and restricted cash $15,759 $45,582

21

Operating Activities

Cash used in operating activities of $47.8 million during the six months ended June 30, 2026 was attributable to our net loss of $53.9 million, and a net decrease of $1.3 million in our working capital, partially offset by non-cash items, including stock-based compensation, accretion of discount on investments and depreciation and amortization expense totaling $7.4 million.

Cash used in operating activities of $50.1 million during the six months ended June 30, 2025 was attributable to our net loss of $28.1 million, and a net decrease of $14.2 million in our working capital, and a non-cash gain of $8.9 million recognized upon settlement of preferred stock forward, partially offset by non-cash items, including stock-based compensation, accretion of discount on short-term investments and depreciation and amortization expense totaling $1.2 million.

Investing Activities

Cash used in investing activities of $54.1 million during the six months ended June 30, 2026 comprised purchases of investments of $126.4 million and property and equipment of $0.3 million, partially offset by maturities of investments of $72.6 million.

Cash provided by investing activities in the six months ended June 30, 2025 comprised maturities of investments of $31.5 million.

Financing Activities

Cash provided by financing activities for the six months ended June 30, 2026 was $117.6 million, which comprised net proceeds from the sale and issuance of common stock in our 2026 Private Placement of $117.1 million and proceeds from exercise of stock options of $0.7 million, partially offset by principal payments on finance leases of $0.2 million.

Cash used in financing activities for the six months ended June 30, 2025 was $64.2 million, which comprised net proceeds from the sale and issuance of our Series C Preferred Stock, in June 2025 of $65.2 million, partially offset by payments of deferred offering costs of $0.7 million and principal payments on finance leases and financing obligations of $0.3 million.

Future Funding Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses; costs related to third-party clinical research, manufacturing and development services; costs relating to the build-out of our headquarters and other offices, our laboratories and our manufacturing facility; license payments or milestone obligations that may arise; laboratory expenses and costs for related supplies; clinical costs; manufacturing costs; legal and other regulatory expenses and general overhead costs. We expect that our research and development expenses, general and administrative expenses and capital expenditures will continue to increase. Any product candidates we may develop may never achieve commercialization and we anticipate that we will continue to incur losses for the foreseeable future.

We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds, which may be through equity offerings, debt financings or other capital sources, including potential collaborations, out-licenses or dispositions and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through offerings of equity or equity-linked securities, the ownership interest of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that may adversely affect our stockholders’ rights. Debt and equity financings, 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. Any failure to raise capital as and 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 capital, we will need to delay, reduce or terminate planned activities to reduce costs.

Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

  • the progress, timing and completion of preclinical studies and clinical trials for our current or any future product candidates, as well as the associated costs, including any unforeseen costs we may incur as a result of preclinical study or clinical trial delays due to disease outbreaks, epidemics and pandemics or other causes;
  • the timing and amount of milestone and royalty payments we are required to make or are eligible to receive under our license agreements and any future license or collaboration agreements;
  • the number and characteristics of potential new product candidates we identify and decide to develop;
  • the need for additional or expanded preclinical studies and clinical trials beyond those that we plan to conduct with respect to our current and future product candidates;
  • the cost involved in growing the organization to the size needed to allow for the research, development and potential commercialization of our current or any future product candidates;
  • the costs involved in filing patent applications, maintaining and enforcing patents or defending against infringement or other claims raised by third parties;
  • the maintenance of our existing license and collaboration agreements and the entry into new license and collaboration agreements;
  • the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of our product candidates;
  • the effect of competing technological and market developments;
  • the cost and timing of completion of commercial-scale outsourced manufacturing activities;
  • the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own;
  • the cost associated with manufacturing and supply of our product candidates;
  • the cost associated with operating as a public company;
  • the amount of revenues, if any, we may derive either directly or in the form of royalty payments from future sales of our product candidates, if approved; and
  • market acceptance of any approved product candidates.

A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities.

Contractual Obligations and Commitments

As of June 30, 2026, we did not have any commitments related to operating leases with non-cancelable terms of less than 12 months. In July 2025, we executed a sixty-three month lease agreement to lease approximately 32,016 square feet of office space in Palo Alto, California. The lease commenced in March 2026 and includes annual lease payments during each of the first three years of approximately $1.5 million, with increases of approximately 3% each year thereafter for the remainder of the lease. We enter into contracts in the normal course of business with third-party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. We may also enter into additional research, manufacturing, supplier and other agreements in the future, which may require up-front payments and even long-term commitments of cash.

Critical Accounting Estimates

There have been no material changes to our critical accounting estimates from those described in our Annual Report on Form 10-K for the year ended December 31, 2025.

Recently Adopted Accounting Pronouncements

Refer to Note 2, “Summary of Significant Accounting Policies,” of the notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for a summary of recently issued and adopted accounting pronouncements.

Emerging Growth Company and Smaller Reporting Company Status

As an “emerging growth company” under the JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited consolidated financial statements in a registration statement for an IPO, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation and less extensive disclosure about our executive compensation arrangements.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

We may remain classified as an emerging growth company until the end of the fiscal year following the fifth anniversary of our IPO or such earlier time that we are no longer an emerging growth company. If the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of June 30 of any year, or if we have annual gross revenues of $1.235 billion or more in any fiscal year, we would cease to be an emerging growth company as of December 31 of the applicable year. We also would cease to be an emerging growth company if we issue more than $1.0 billion of non-convertible debt over a three-year period.

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 and will be able to take advantage of these scaled disclosures until the fiscal year following the determination that (i) our voting and non-voting common stock held by non-affiliates is at least $250.0 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is at least $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is at least $700.0 million measured on the last business day of our second fiscal quarter.

Market risk

As filed, 153 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Controls and procedures

As filed, 1,613 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes to our internal control over financial reporting that occurred during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Risk factors

As filed, 3,728 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

In addition to the information set forth in this report, you should carefully consider the risks discussed under the heading "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 5, 2026, and subsequent filings with the SEC, which could have a material adverse effect on our business or financial statements, results of operations, and cash flows. Additional risks not currently known, or risks that are currently believed to be not material, may also impair business operations. There have been no material changes to our risk factors since the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, except as set forth below.

Our use and provision of AI-powered solutions could lead to operational or reputational damage, competitive harm, legal and regulatory risk and additional costs.

Our employees and personnel use artificial intelligence (“AI”) technologies in the course of performing their work, and the disclosure and use of personal, confidential, or other proprietary data in AI technologies is subject to various laws and other obligations, including those related to third-party intellectual property, data privacy and information security, publicity, contractual or other rights. Governments have passed and are likely to pass additional laws regulating AI. Several jurisdictions around the globe, including Europe and certain U.S. states, have proposed, enacted, or are considering laws governing the development and use of AI technologies, such as the EU’s AI Act, the Colorado Artificial Intelligence Act, California Bot Disclosure Law, the Utah Artificial Intelligence Policy Act, and the CCPA regulations on automated decision-making technology. For example, the EU AI Act sets out a risk-based framework, subjecting certain AI technologies to numerous compliance obligations, including transparency, conformity and risk assessment, monitoring and human oversight requirements. Under the EU AI Act, non-compliant companies may be subject to administrative fines of up to €35 million or 7% of a company’s total worldwide annual turnover for the preceding financial year, whichever is higher. Certain of our activities subject us to the EU AI Act and depending on how the EU AI Act is implemented and interpreted, we may have to adapt our business practices, contractual arrangements, and services to comply with such obligations. We expect other jurisdictions will adopt similar laws.

Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits. If we are unable to use AI, it could make our business less efficient and result in competitive disadvantages. Our use of AI technologies and tools may inadvertently reduce our effectiveness and efficiency or cause unintentional or unexpected outputs that are incorrect, do not match our business goals, standards and values, do not comply with our policies or procedures, harm our brand and reputation, or negatively impact the performance of our business.

Additionally, sensitive information of ours could be leaked, disclosed, or revealed as a result of or in connection with the use of AI technologies by our employees, clinical research organizations or vendors, including if sensitive information is used to train any third parties’ AI technology. Additionally, where an AI technology model ingests personal or sensitive data and makes connections using such data, those technologies may reveal other personal or sensitive information generated by the model. Inadvertent disclosure of such information could result in adverse impact to our business, reputation and operations.

Figures reported in this filing

Standardized line items from the XBRL in this filing, for the period ended 2026-06-30. Comparative periods it repeats are left out.

Figures reported in this filing
Line itemPeriodValueXBRL concept
Revenue3 months2026-04-01 to 2026-06-30$0us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax
Revenue6 months2026-01-01 to 2026-06-30$0us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax
Research and development3 months2026-04-01 to 2026-06-30$26.4mus-gaap:ResearchAndDevelopmentExpense
Research and development6 months2026-01-01 to 2026-06-30$43.7mus-gaap:ResearchAndDevelopmentExpense
Operating income3 months2026-04-01 to 2026-06-30−$34.9mus-gaap:OperatingIncomeLoss
Operating income6 months2026-01-01 to 2026-06-30−$58.8mus-gaap:OperatingIncomeLoss
Income tax6 months2026-01-01 to 2026-06-30$0us-gaap:IncomeTaxExpenseBenefit
Net income3 months2026-04-01 to 2026-06-30−$32.2mus-gaap:NetIncomeLoss
Net income6 months2026-01-01 to 2026-06-30−$53.9mus-gaap:NetIncomeLoss
Diluted EPS3 months2026-04-01 to 2026-06-30−$0.89us-gaap:EarningsPerShareDiluted
Diluted EPS6 months2026-01-01 to 2026-06-30−$1.54us-gaap:EarningsPerShareDiluted
Basic EPS3 months2026-04-01 to 2026-06-30−$0.89us-gaap:EarningsPerShareBasic
Basic EPS6 months2026-01-01 to 2026-06-30−$1.54us-gaap:EarningsPerShareBasic
Diluted shares (weighted)3 months2026-04-01 to 2026-06-3036,135,644 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Diluted shares (weighted)6 months2026-01-01 to 2026-06-3034,908,631 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Operating cash flow6 months2026-01-01 to 2026-06-30−$47.8mus-gaap:NetCashProvidedByUsedInOperatingActivities
Capital expenditure6 months2026-01-01 to 2026-06-30$266.0kus-gaap:PaymentsToAcquirePropertyPlantAndEquipment
Cash and equivalentsAt period end2026-06-30$60.0mus-gaap:CashAndCashEquivalentsAtCarryingValue
Current assetsAt period end2026-06-30$204.2mus-gaap:AssetsCurrent
Total assetsAt period end2026-06-30$301.9mus-gaap:Assets
Current liabilitiesAt period end2026-06-30$17.5mus-gaap:LiabilitiesCurrent
Total liabilitiesAt period end2026-06-30$24.4mus-gaap:Liabilities
Shareholders' equityAt period end2026-06-30$277.6mus-gaap:StockholdersEquity

Source: SEC EDGAR, the filing index for accession 0001193125-26-337984. Last ingested by Listed: Nov 5, 2026, 11:36 ET. Listed shows no prices and gives no investment advice.