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What changed in Xilio Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Xilio Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+1002 added−373 removedSource: 10-K (2026-03-23) vs 10-K (2025-03-11)

Top changes in Xilio Therapeutics, Inc.'s 2025 10-K

1002 paragraphs added · 373 removed · 285 edited across 2 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

284 edited+323 added−88 removed608 unchanged
Biggest changeOur future capital requirements, both short-term and long-term, will depend on many factors, including: ● our ability to implement and maintain further cost reduction strategies, as well as the timing of such cost reductions; ● the scope, progress, results and costs of research and development for our current and future product candidates, including our ongoing and planned clinical trials for our clinical-stage product candidates; ● the scope, prioritization and number of our research and development programs; ● the progress of the development efforts of parties with whom we have entered or may in the future enter into collaboration agreements; ● the timing and amount of payments we may receive or are obligated to pay under our collaboration agreements and license agreements; ● the scope, costs, timing and outcome of regulatory review of our product candidates; ● the costs of expanding manufacturing capacity through third-party manufacturers and securing manufacturing materials for use in preclinical studies, clinical trials and, for any product candidates for which we receive regulatory approval, if any, use as commercial supply; ● the costs and timing of future commercialization activities for any of our product candidates for which we receive regulatory approval; ● the amount and timing of revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims; ● the extent to which we may acquire or in-license other products, product candidates, technologies or intellectual property, as well as the terms of any such arrangements; 45 Table of Contents ● our ability to maintain our current collaborations and partnership, including our clinical collaboration with F.
Biggest changeOur future capital requirements, both short-term and long-term, will depend on many factors, including, but not limited to: • the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials for our clinical-stage product candidates, vilastobart and efarindodekin alfa, and ongoing preclinical development for our current and future product candidates; • our ability to maintain our collaboration and license agreements with AbbVie and Gilead; • the timing and amount of milestones, option-related fees and other contingent payments under our collaboration, license and option agreement with AbbVie for masked immunotherapies and our license agreement with Gilead for efarindodekin alfa, as well as the scope, costs and timing of our development obligations under these agreements; • the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all of the outstanding Series C common stock warrants issued in connection with our June 2025 follow-on offering are exercised at their current exercise price of $10.50 per warrant; • our ability to secure additional capital in the future; • the scope, prioritization and number of our research and development programs; • the costs of securing manufacturing materials for use in preclinical studies, clinical trials and, for any product candidates for which we receive regulatory approval, if any, commercial supply; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims; • the extent to which we may acquire or in-license other products, product candidates, technologies or intellectual property, as well as the terms of any such arrangements; • the scope, costs, timing and outcome of regulatory review of our product candidates; 36 Table of Contents • the costs and timing of future commercialization activities for any of our product candidates for which we receive regulatory approval; • the amount and timing of revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval; • general economic conditions, including inflation and the imposition of new or revised global trade tariffs; and • the costs of maintaining our operations and continuing to operate as a public company.
In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.
In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.
The FDA, or comparable foreign regulatory authority, may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.
The FDA, or comparable foreign regulatory authority, may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.
We expect that current or future litigation involving provisions of the IRA will have unpredictable and uncertain results on the implementation and impact of the IRA on biotechnology industry generally, as well as our business and current or future products.
We expect that current or future litigation involving provisions of the IRA will have unpredictable and uncertain results on the implementation and impact of the IRA on the biotechnology industry generally, as well as our business and current or future products.
Collaborations, licenses or similar arrangements involving our research programs or any product candidates currently pose, and will continue to pose, numerous risks to us, including the following: ● collaborators or licensors have significant discretion in determining the efforts and resources that they will apply to these arrangements; ● collaborators or licensors may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in such third party’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ● collaborators or licensors may delay programs, preclinical studies or clinical trials, provide insufficient funding for programs, preclinical studies or clinical trials, stop a preclinical study or clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators or licensors could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ● collaborators or licenses may be acquired by a third party having competitive products or different priorities; ● collaborators or licensors with marketing and distribution rights to one or more product candidates may not commit sufficient resources to the marketing and distribution of such product candidate(s); ● collaborators or licensors may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; ● disputes may arise between the collaborators or licensors and us that result in the delay or termination of the research, development, or commercialization of our product candidates or any of our product candidates or that 64 Table of Contents result in costly litigation or arbitration that diverts management attention and resources or that jeopardize or invalidate our intellectual property or proprietary information; ● we may lose certain valuable rights under certain circumstances, including if we undergo a change of control; ● collaborations or licenses may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and ● collaborations or license agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.
Collaborations, licenses or similar arrangements involving our research programs or any product candidates currently pose, and will continue to pose, numerous risks to us, including the following: • collaborators or licensors have significant discretion in determining the efforts and resources that they will apply to these arrangements; • collaborators or licensors may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in such third party’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; • collaborators or licensors may delay programs, preclinical studies or clinical trials, provide insufficient funding for programs, preclinical studies or clinical trials, stop a preclinical study or clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaborators or licensors could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; • collaborators or licenses may be acquired by a third party having competitive products or different priorities; • collaborators or licensors with marketing and distribution rights to one or more product candidates may not commit sufficient resources to the marketing and distribution of such product candidate(s); • collaborators or licensors may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; • disputes may arise between the collaborators or licensors and us that result in the delay or termination of the research, development, or commercialization of our product candidates or any of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources or that jeopardize or invalidate our intellectual property or proprietary information; • we may lose certain valuable rights under certain circumstances, including if we undergo a change of control; • collaborations or licenses may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and • collaborations or license agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.
The enrollment of patients depends on many factors, including: ● clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; ● the severity of the disease under investigation; ● the patient eligibility and the inclusion and exclusion criteria defined in the protocol; ● AEs in our clinical trials and in third-party clinical trials of agents similar to our product candidates; ● the size and health of the patient population required for analysis of the trial’s primary endpoints; ● the proximity of patients to trial sites; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; 54 Table of Contents ● our ability to obtain and maintain patient consents; ● our ability to monitor patients adequately during and after treatment; ● the risk that patients enrolled in clinical trials will drop out of the trials before completion; and ● factors we may not be able to control that may limit the availability of patients, principal investigators or staff or clinical sites, such as public health crises, including epidemics and pandemics.
The enrollment of patients depends on many factors, including: • clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; • the severity of the disease under investigation; • the patient eligibility and the inclusion and exclusion criteria defined in the protocol; • AEs in our clinical trials and in third-party clinical trials of agents similar to our product candidates; • the size and health of the patient population required for analysis of the trial’s primary endpoints; • the proximity of patients to trial sites; • the design of the trial; • our ability to recruit clinical trial investigators with the appropriate competencies and experience; • our ability to obtain and maintain patient consents; • our ability to monitor patients adequately during and after treatment; 44 Table of Contents • the risk that patients enrolled in clinical trials will drop out of the trials before completion; and • factors we may not be able to control that may limit the availability of patients, principal investigators or staff or clinical sites, such as public health crises, including epidemics and pandemics.
We may experience numerous unforeseen events leading up to, during or as a result of clinical trials that could delay or prevent the initiation or completion of a clinical trial or our ability to receive marketing approval or commercialize our product candidates, including: ● we may be unable to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to obtain regulatory authorizations to commence a clinical trial; ● we may experience issues in reaching a consensus with regulatory authorities on trial design; ● regulators or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● clinical trial sites may deviate from a trial protocol or drop out of a trial or fail to conduct the trial in accordance with regulatory requirements; ● the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, or subjects may fail to enroll or remain in clinical trials at the rate we expect; ● subjects that enroll in our studies may misrepresent their eligibility or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the subject from the trial, increase the needed enrollment size for the clinical trial or extend its duration; ● subjects may choose an alternative treatment for the indication for which we are developing our product candidates, or participate in competing clinical trials; ● subjects may experience severe or unexpected treatment-related adverse effects; ● clinical trials of our product candidates may produce unfavorable, inconclusive, or clinically insignificant results; ● we may decide to, or regulators, or IRBs, or ethics committees may require us to, make changes to a clinical trial protocol or conduct additional preclinical studies or clinical trials, or we may decide to abandon product development programs; ● we may need to add new or additional clinical trial sites; 52 Table of Contents ● our third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; ● we may experience manufacturing delays, and any changes to manufacturing processes or third-party contractors that may be necessary or desired could result in other delays; ● we or our third-party contractors may experience delays due to complications resulting from the impact of public health crises, including epidemics and pandemics; ● the cost of preclinical testing and studies and clinical trials of any product candidates may be greater than we anticipate or greater than our available financial resources; ● the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate or we may not be able to obtain sufficient quantities of combination therapies for use in current or future clinical trials; ● reports may arise from preclinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates; and ● regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate.
We may experience numerous unforeseen events leading up to, during or as a result of clinical trials that could delay or prevent the initiation or completion of a clinical trial or our ability to receive marketing approval or commercialize our product candidates, including: • we may be unable to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to obtain regulatory authorizations to commence a clinical trial; • we may experience issues in reaching a consensus with regulatory authorities on trial design; 42 Table of Contents • regulators or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • clinical trial sites may deviate from a trial protocol or drop out of a trial or fail to conduct the trial in accordance with regulatory requirements; • the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, or subjects may fail to enroll or remain in clinical trials at the rate we expect; • subjects that enroll in our studies may misrepresent their eligibility or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the subject from the trial, increase the needed enrollment size for the clinical trial or extend its duration; • subjects may choose an alternative treatment for the indication for which we are developing our product candidates, or participate in competing clinical trials; • subjects may experience severe or unexpected treatment-related adverse effects; • clinical trials of our product candidates may produce unfavorable, inconclusive, or clinically insignificant results; • we may decide to, or regulators, or IRBs, or ethics committees may require us to, make changes to a clinical trial protocol or conduct additional preclinical studies or clinical trials, or we may decide to abandon product development programs; • we may need to add new or additional clinical trial sites; • our third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • we may experience manufacturing delays, and any changes to manufacturing processes or third-party contractors that may be necessary or desired could result in other delays; • we or our third-party contractors may experience delays due to complications resulting from the impact of public health crises, including epidemics and pandemics, or geopolitical tensions; • the cost of preclinical testing and studies and clinical trials of any product candidates may be greater than we anticipate or greater than our available financial resources; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate or we may not be able to obtain sufficient quantities of combination therapies for use in current or future clinical trials; • reports may arise from preclinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates; and • regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate.
While this guidance is currently only in draft form and will ultimately not be legally binding even when finalized, sponsors typically observe the FDA’s guidance closely to ensure that their investigational products qualify for accelerated approval. In the EU, a “conditional” marketing authorization may be granted in cases where all the required safety and efficacy data are not yet available.
While the guidance is currently only in draft form and will ultimately not be legally binding even when finalized, sponsors typically observe the FDA’s guidance closely to ensure that their investigational products qualify for accelerated approval. In the EU, a “conditional” marketing authorization may be granted in cases where all the required safety and efficacy data are not yet available.
Among other things, the IRA contains many provisions aimed at reducing this financial burden on individuals by reducing the co-insurance and co-payment costs, expanding eligibility for lower income subsidy plans, and price caps on annual out-of-pocket expenses, each of which could have potential pricing and reporting implications.
Among other things, the IRA contains many provisions aimed at reducing this financial burden on individuals by reducing the co-insurance and co-payment costs, expanding eligibility for lower income subsidy plans, and placing price caps on annual out-of-pocket expenses, each of which could have potential pricing and reporting implications.
For example: ● others may be able to make or use polypeptides or nucleic acids that are similar to our product candidates or components of our product candidates but that are not covered by the claims of our patents; ● the active biological ingredients in our current product candidates will eventually become commercially available in biosimilar drug products, and no patent protection may be available with regard to formulation or method of use; ● we or our licensors, as the case may be, may fail to meet our obligations to the U.S. government in regard to any patents and patent applications funded by U.S. government grants, leading to the loss of patent rights; 77 Table of Contents ● we or our licensors, as the case may be, might not have been the first to file patent applications for these inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies; ● it is possible that our pending patent applications will not result in issued patents; ● it is possible that there are prior public disclosures that could invalidate our or our licensors’ patents, as the case may be, or parts of our or their patents; ● it is possible that others may circumvent our owned or in-licensed patents; ● it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our products or technology similar to ours; ● the laws of foreign countries may not protect our or our licensors’, as the case may be, proprietary rights to the same extent as the laws of the United States; ● the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates or technology; ● our owned or in-licensed issued patents may not provide us with any competitive advantages, may be narrowed in scope, or be held invalid or unenforceable as a result of legal challenges by third parties; ● the inventors of our owned or in-licensed patents or patent applications may become involved with competitors, develop products or processes which design around our patents, or become hostile to us or the patents or patent applications on which they are named as inventors; ● it is possible that our owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable; ● we have engaged in scientific collaborations in the past and will continue to do so in the future, and such collaborators may develop adjacent or competing products to ours that are outside the scope of our patents; ● we may not develop additional proprietary technologies for which we can obtain patent protection; ● it is possible that product candidates or technology we develop may be covered by third parties’ patents or other exclusive rights; or ● the patents of others may have an adverse effect on our business.
For example: • others may be able to make or use polypeptides or nucleic acids that are similar to our product candidates or components of our product candidates but that are not covered by the claims of our patents; • the active biological ingredients in our current product candidates will eventually become commercially available in biosimilar drug products, and no patent protection may be available with regard to formulation or method of use; • we or our licensors, as the case may be, may fail to meet our obligations to the U.S. government in regard to any patents and patent applications funded by U.S. government grants, leading to the loss of patent rights; • we or our licensors, as the case may be, might not have been the first to file patent applications for these inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies; • it is possible that our pending patent applications will not result in issued patents; • it is possible that there are prior public disclosures that could invalidate our or our licensors’ patents, as the case may be, or parts of our or their patents; • it is possible that others may circumvent our owned or in-licensed patents; • it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our products or technology similar to ours; • the laws of foreign countries may not protect our or our licensors’, as the case may be, proprietary rights to the same extent as the laws of the U.S.; 64 Table of Contents • the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates or technology; • our owned or in-licensed issued patents may not provide us with any competitive advantages, may be narrowed in scope, or be held invalid or unenforceable as a result of legal challenges by third parties; • the inventors of our owned or in-licensed patents or patent applications may become involved with competitors, develop products or processes which design around our patents, or become hostile to us or the patents or patent applications on which they are named as inventors; • it is possible that our owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable; • we have engaged in scientific collaborations in the past and will continue to do so in the future, and such collaborators may develop adjacent or competing products to ours that are outside the scope of our patents; • we may not develop additional proprietary technologies for which we can obtain patent protection; • it is possible that product candidates or technology we develop may be covered by third parties’ patents or other exclusive rights; or • the patents of others may have an adverse effect on our business.
For example, on June 6, 2023, Merck & Co., or Merck, filed a lawsuit against the HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution. Subsequently, a number of other parties, including the U.S.
On June 6, 2023, Merck & Co., or Merck, filed a lawsuit against the HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution. Subsequently, a number of other parties, including the U.S.
In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.
In addition, responding to any such action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.
There have been several U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.
There have been U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.
The factors that may limit any potential competitive advantage provided by our intellectual property rights include: ● pending patent applications that we own or license may not lead to issued patents; ● patents, should they issue, that we own or license, may not provide us with any competitive advantages, or may be challenged and held invalid or unenforceable; ● others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of any of our owned or in-licensed patents, should any such patents issue; ● third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection; ● we (or our licensors) might not have been the first to make the inventions covered by a pending patent application that we own or license; ● we (or our licensors) might not have been the first to file patent applications covering a particular invention; ● others may independently develop similar or alternative technologies without infringing our intellectual property rights; 84 Table of Contents ● we may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all; ● third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property; ● we may not be able to maintain the confidentiality of our trade secrets or other proprietary information; ● we may not develop or in-license additional proprietary technologies that are patentable; and ● the patents of others may have an adverse effect on our business.
The factors that may limit any potential competitive advantage provided by our intellectual property rights include: • pending patent applications that we own or license may not lead to issued patents; • patents, should they issue, that we own or license, may not provide us with any competitive advantages, or may be challenged and held invalid or unenforceable; • others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of any of our owned or in-licensed patents, should any such patents issue; • third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection; • we (or our licensors) might not have been the first to make the inventions covered by a pending patent application that we own or license; • we (or our licensors) might not have been the first to file patent applications covering a particular invention; • others may independently develop similar or alternative technologies without infringing our intellectual property rights; • we may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all; • third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property; • we may not be able to maintain the confidentiality of our trade secrets or other proprietary information; • we may not develop or in-license additional proprietary technologies that are patentable; and • the patents of others may have an adverse effect on our business.
The incurrence of any additional indebtedness would result in additional payment obligations and is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, would be repaid before holders of our equity securities received any distribution of our corporate assets.
In addition, the incurrence of any indebtedness would result in additional payment obligations and is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, would be repaid before holders of our equity securities received any distribution of our corporate assets.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such product candidates after such approval, a number of potentially significant negative consequences could result, including: ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; ● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; ● regulatory authorities may require a REMS plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; 55 Table of Contents ● we may be required to change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates; ● we may be subject to regulatory investigations and government enforcement actions; ● regulatory authorities may withdraw or limit their approval of such product candidates; ● we may decide to remove such product candidates from the marketplace; ● we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and ● we may suffer reputational harm.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such product candidates after such approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; • we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; • regulatory authorities may require a REMS plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; • we may be required to change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates; • we may be subject to regulatory investigations and government enforcement actions; • regulatory authorities may withdraw or limit their approval of such product candidates; • we may decide to remove such product candidates from the marketplace; • we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and • we may suffer reputational harm.
In addition, for any activities conducted in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the U.S. or Chinese governments, political unrest or unstable economic or geopolitical conditions, including sanctions in China or against certain Chinese companies; changes in U.S. export laws or the imposition by the United States of trade barriers; sanctions; limitations on uses of U.S. government executive agency contract, grant or loan funds; or other restrictions on doing business with certain Chinese companies, including WuXi Biologics, which could have a material adverse effect on our business.
In addition, for any activities conducted in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the U.S. or Chinese governments, political unrest or unstable economic or geopolitical conditions, including sanctions in China or against certain Chinese companies; changes in U.S. export laws or the imposition by the U.S . of trade barriers; sanctions; limitations on uses of U.S. government executive agency contract, grant or loan funds; or other restrictions on doing business with certain Chinese companies, including WuXi Biologics, which could have a material adverse effect on our business.
These laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
These laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our drug product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected. Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition. Changes in tax law may adversely affect our business or financial condition.
Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected. Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
The final guidance calls for such communications to be truthful, non-misleading, and scientifically sound and to include all information necessary for healthcare providers to interpret the strengths and weaknesses and validity and utility of the information about the unapproved use of the approved product.
The final guidance calls for such communications to be non-promotional, truthful, non-misleading, and scientifically sound and to include all information necessary for healthcare providers to interpret the strengths and weaknesses and validity and utility of the information about the unapproved use of the approved product.
The degree of market acceptance of any product, if approved for commercial sale, will depend on a number of factors, including: ● the product’s efficacy, safety and potential advantages compared to alternative treatments; ● the prevalence and severity of any side effects; ● the product’s convenience and ease of administration compared to alternative treatments; ● the clinical indications for which the product is approved; ● the willingness of the target patient population to try a novel treatment and of physicians to prescribe such treatments; ● the recommendations with respect to the product in guidelines published by scientific organizations; ● the ability to obtain sufficient third-party insurance coverage and adequate reimbursement, including, if applicable, with respect to the use of the product as a combination therapy; ● the strength of marketing, sales and distribution support; ● the effectiveness of our sales and marketing efforts; ● the approval of other new products for the same indications; and 70 Table of Contents ● our ability to offer the product for sale at competitive prices.
The degree of market acceptance of any product, if approved for commercial sale, will depend on a number of factors, including: • the product’s efficacy, safety and potential advantages compared to alternative treatments; • the prevalence and severity of any side effects; • the product’s convenience and ease of administration compared to alternative treatments; • the clinical indications for which the product is approved; • the willingness of the target patient population to try a novel treatment and of physicians to prescribe such treatments; • the recommendations with respect to the product in guidelines published by scientific organizations; • the ability to obtain sufficient third-party insurance coverage and adequate reimbursement, including, if applicable, with respect to the use of the product as a combination therapy; • the strength of marketing, sales and distribution support; • the effectiveness of our sales and marketing efforts; • the approval of other new products for the same indications; and • our ability to offer the product for sale at competitive prices.
Food and Drug Administration, or FDA, clearance for any investigational new drug application, or IND, for any current or future product candidates; ● successfully initiate and complete clinical trials for our clinical-stage product candidates and any other current or future product candidates, including all safety and efficacy studies necessary to obtain U.S. and foreign regulatory approval for our product candidates; ● establish and maintain clinical and commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical supply and commercial manufacturing; ● launch commercial sales of our products, if and when approved, whether alone or in collaboration with others; ● obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payors; ● effectively compete with other therapies; ● obtain and maintain healthcare coverage and adequate reimbursement for our products, if and when approved; ● maintain a continued acceptable safety profile of our products following approval; and ● enforce and defend intellectual property rights and claims.
Food and Drug Administration, or FDA, clearance for any investigational new drug application, or IND, for any current or future product candidates; • successfully initiate and complete clinical trials for our clinical-stage product candidates and any other current or future product candidates, including all safety and efficacy studies necessary to obtain U.S. and foreign regulatory approval for our product candidates; • establish and maintain clinical and commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical supply and commercial manufacturing; • launch commercial sales of our products, if and when approved, whether alone or in collaboration with others; • obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payors; • effectively compete with other therapies; 39 Table of Contents • obtain and maintain healthcare coverage and adequate reimbursement for our products, if and when approved; • maintain a continued acceptable safety profile of our products following approval; and • enforce and defend intellectual property rights and claims.
For these reasons, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes. 49 Table of Contents Risks Related to the Discovery and Development of Our Product Candidates Our business is highly dependent on the success of our current product candidates, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and commercially launch a product.
For these reasons, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes. 40 Table of Contents Risks Related to the Discovery and Development of Our Product Candidates Our business is highly dependent on the success of our current product candidates, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and commercially launch a product.
These exemptions include: ● being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of financial Condition and Results of Operations” disclosure; ● not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; ● not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; 110 Table of Contents ● reduced disclosure obligations regarding executive compensation; and ● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
These exemptions include: • being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of financial Condition and Results of Operations” disclosure; • not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; • not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; • reduced disclosure obligations regarding executive compensation; and • exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
Individual EU member states continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
Failure to comply with regulatory requirements, may yield various results, including: ● restrictions on such products, manufacturers or manufacturing processes; ● restrictions on the labeling or marketing of a product; ● restrictions on distribution or use of a product; ● requirements to conduct post-marketing studies or clinical trials; ● warning letters or untitled letters; ● withdrawal of the products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products; ● damage to relationships with collaborators; 89 Table of Contents ● unfavorable press coverage and damage to our reputation; ● fines, restitution or disgorgement of profits or revenues; ● suspension or withdrawal of marketing approvals; ● refusal to permit the import or export of our products; ● product seizure; ● injunctions or the imposition of civil or criminal penalties; and ● litigation involving patients using our products.
Failure to comply with regulatory requirements, may yield various results, including: • restrictions on such products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on distribution or use of a product; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that we submit; • recall of products; • damage to relationships with collaborators; • unfavorable press coverage and damage to our reputation; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of our products; • product seizure; • injunctions or the imposition of civil or criminal penalties; and • litigation involving patients using our products.
Furthermore, if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement 61 Table of Contents suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue or market share with respect to any product that has received marketing approval.
Furthermore, if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of production at a 50 Table of Contents substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue or market share with respect to any product that has received marketing approval.
We also plan to seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating, including conducting marketing and sales activities, in international jurisdictions if we obtain the necessary approvals, including: ● regulatory requirements in foreign countries that differ from those in the United States; ● unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; ● economic weakness, including inflation, or political instability in particular foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● foreign taxes, including withholding of payroll taxes; ● foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; ● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; ● difficulties staffing and managing foreign operations; ● workforce uncertainty in countries where labor unrest is more common than in the United States; 105 Table of Contents ● potential liability under the FCPA or other comparable foreign regulations; ● challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and ● business interruptions resulting from geopolitical actions, including war, armed conflicts and terrorism or natural disasters, including pandemics or other outbreaks of infectious disease, earthquakes, typhoons, floods and fires.
We also plan to seek regulatory approval of our product candidates outside of the U.S. and, accordingly, we expect that we will be subject to additional risks related to operating, including conducting marketing and sales activities, in international jurisdictions if we obtain the necessary approvals, including: • regulatory requirements in foreign countries that differ from those in the U.S.; • unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; • complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; • difficulties staffing and managing foreign operations; • workforce uncertainty in countries where labor unrest is more common than in the U.S.; • potential liability under the FCPA or other comparable foreign regulations; • challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geopolitical actions, including war, armed conflicts and terrorism or natural disasters, including pandemics or other outbreaks of infectious disease, earthquakes, typhoons, floods and fires.
As has been the case with traditional immuno-oncology, or I-O, treatments for cancer, it is possible that there may be severe side effects associated with the use of our current or future product candidates. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these or other side effects.
As has been the case with traditional I-O treatments for cancer, it is possible that there may be severe side effects associated with the use of our current or future product candidates. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these or other side effects.
If our or our partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.
If our or our partners’ or service providers’ privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data and/or fines of up to 20 million Euros or up to 83 Table of Contents 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill.
If we are unable to raise sufficient additional capital, our business, financial condition, stock price and results of operations could be adversely affected, and we will need to implement cost reduction strategies, which could include delaying, reducing or altogether terminating both internal and external costs related to our operations and research and development programs.
If we are unable to raise sufficient additional capital, our business, financial condition, stock price and results of operations could be adversely affected, and we may need to implement cost reduction strategies, which could include delaying, reducing or altogether terminating both internal and external costs related to our operations and research and development programs.
A key element of our strategy is to use our novel platform technology to engineer and develop tumor-activated molecules with the potential to trigger anti-tumor immunity with minimal systemic toxicity in order to advance a pipeline of product candidates. We may not be able to continue to identify and develop novel I-O therapies.
A key element of our strategy is to use our novel platform technology to engineer and develop masked I-O molecules with the potential to trigger anti-tumor immunity with minimal systemic toxicity in order to advance a pipeline of product candidates. We may not be able to continue to identify and develop novel I-O therapies.
If any such inspection identifies a failure to comply with applicable regulations, or if a violation of our product specifications or applicable regulations occurs independent of such an inspection, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales, the temporary or permanent closure of a facility, or other remedial measures that may delay or disrupt the manufacture or release of our product candidates or other potential products.
If any such inspection identifies a failure to comply with applicable regulations, or if a violation of our product specifications or applicable regulations occurs independent of such an inspection, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales, the temporary or permanent closure of a facility, or other remedial measures that may delay or disrupt 49 Table of Contents the manufacture or release of our product candidates or other potential products.
Item 1A. Risk Factors The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Item 1A. Ri sk Factors The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Additionally, in raising funds through our collaborations and licensing arrangements with third parties, we have had to, and may in the future need to, relinquish valuable rights, partially or fully, to our technologies, future revenue streams, research programs or product candidates and grant licenses on terms unfavorable to us.
Further, in raising funds through our collaborations and licensing arrangements with third parties, we have had to, and may in the future need to, relinquish valuable rights, partially or fully, to our technologies, future revenue streams, research programs or product candidates and grant licenses on terms unfavorable to us.
While we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development efforts, including for example, our employees, external academic scientific collaborators, CROs, CDMOs, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose our confidential or proprietary information before a patent application is filed, thereby endangering our ability to seek patent protection.
While we enter into 59 Table of Contents non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development efforts, including for example, our employees, external academic scientific collaborators, CROs, CDMOs, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose our confidential or proprietary information before a patent application is filed, thereby endangering our ability to seek patent protection.
We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the United States, including tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; and workforce uncertainty in countries where labor unrest is more common than in the United States.
We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the U.S., including tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; and workforce uncertainty in countries where labor unrest is more common than in the U.S.
The IRA permits the Secretary of the Department of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
In February 2025, Xilio Development entered into a collaboration, license and option agreement with AbbVie, pursuant to which AbbVie was granted (i) an exclusive option for (a) an initial program to discover, develop and commercialize masked T cell engager molecules for an agreed upon initial target and backup target and (b) subject to the terms of the agreement, up to two additional programs to discover, develop, and commercialize masked T cell engager molecules for an initial target and backup target determined at the time of program initiation and (ii) an exclusive license to develop and commercialize a 63 Table of Contents masked antibody-based immunotherapy.
In February 2025, Xilio Development entered into a collaboration, license and option agreement with AbbVie, pursuant to which AbbVie was granted (i) an exclusive option for (a) an initial program to discover, develop and commercialize masked T cell engager molecules for an agreed upon initial target and backup target and (b) subject to the terms of the agreement, up to two additional programs to discover, develop, and commercialize masked T cell engager molecules for an initial target and backup target determined at the time of program initiation and (ii) an exclusive license to develop and commercialize a masked antibody-based immunotherapy.
In addition, the cost of directors’ and officers’ liability insurance, or D&O insurance, is subject to change, which could result in D&O insurance becoming significantly more expensive for us to maintain or require us to accept coverage terms or policy limits that are less favorable.
Furthermore, the cost of directors’ and officers’ liability insurance, or D&O insurance, is subject to change, which could result in D&O insurance becoming significantly more expensive for us to maintain or require us to accept coverage terms or policy limits that are less favorable.
If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the 80 Table of Contents holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.
If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.
The Regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas.
The HTA intends to boost cooperation among EU member states in assessing health technologies, including new medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas.
It will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
It permits EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
A competitor may be able to circumvent this type of patent by skinny labelling. Furthermore, this type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method.
A competitor may be able to circumvent this type of patent by skinny labeling. Furthermore, this type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method.
Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 202, the U.S.
Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S.
Despite any precautions that we or any third parties on whom we depend take for catastrophic events, including terrorist attacks, wars or other armed conflicts, geopolitical tensions or trade wars, pandemics or natural disasters, these events could result in significant disruptions to our research and development, manufacturing, preclinical studies, clinical trials, and, ultimately, if approved, the commercialization of our products.
Despite any precautions that we or 88 Table of Contents any third parties on whom we depend take for catastrophic events, including terrorist attacks, wars or other armed conflicts, geopolitical tensions or trade wars, pandemics or natural disasters, these events could result in significant disruptions to our research and development, manufacturing, preclinical studies, clinical trials, and, ultimately, if approved, the commercialization of our products.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or the DGCL, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the 113 Table of Contents person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or the DGCL, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
If we are unable to successfully obtain rights to required third-party 81 Table of Contents intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.
If we are unable to 67 Table of Contents successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated 79 Table of Contents subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
If a court were to find that either exclusive forum provision contained in our restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could materially adversely affect our business, financial condition and operating results.
If a court were to find that either exclusive forum provision contained in our restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could materially adversely affect our business, financial condition and operating results. Ite m 1B.
As a result of their share ownership, these stockholders, if they act together, would have the ability to influence our management and policies and would be able to significantly affect the outcome of matters requiring stockholder approval, such as elections of directors, amendments of our organizational documents or approvals of any merger, sale of assets or 109 Table of Contents other major corporate transaction.
As a result of their share ownership, these stockholders, if they act together, would have the ability to influence our management and policies and would be able to significantly affect the outcome of matters requiring stockholder approval, such as elections of directors, amendments of our organizational documents or approvals of any merger, sale of assets or other major corporate transaction.
In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as 111 Table of Contents appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
A natural disaster, epidemic or pandemic, such as the COVID-19 pandemic, trade war, political unrest, economic conditions, changes in legislation, including the passage of the People’s Republic of China Biosecurity law, which became effective on April 15, 2021, and subsequent legislation that China or the United States may adopt in the future, or other events in China could disrupt our ability to continue to rely upon CROs, CDMOs, collaborators, manufacturers or other third parties with whom we conduct business now or in the future.
A natural disaster, epidemic or pandemic, such as the COVID‑19 pandemic, trade war, political unrest, economic conditions, changes in legislation, including the passage of the People’s Republic of China Biosecurity law, which became effective on April 15, 2021, and subsequent legislation that China or the U.S. may adopt in the future, or other events in China could disrupt our ability to continue to rely upon CROs, CDMOs, collaborators, manufacturers or other third parties with whom we conduct business now or in the future.
If we fail to produce positive results in our planned and ongoing 51 Table of Contents preclinical studies or clinical trials, or if we experience material changes in clinical data or results from those we have previously reported, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business, financial condition and results of operations would be materially and adversely affected.
If we fail to produce positive results in our planned and ongoing preclinical studies or clinical trials, or if we experience material changes in clinical data or results from those we have previously reported, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business, financial condition and results of operations would be materially and adversely affected.
Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects. If any of our product candidates were to cause adverse 58 Table of Contents side effects during clinical trials or after approval thereof, we may be exposed to substantial liabilities.
Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects. If any of our product candidates were to cause adverse side effects during clinical trials or after approval thereof, we may be exposed to substantial liabilities.
These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2031 under the CARES Act.
These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2031 pursuant to the CARES Act.
It is possible that the results of such trials could show that any positive previous trial results are attributable to the third-party drug and not our product candidate. Developments 56 Table of Contents related to the third-party drug may also impact our clinical trials for the combination therapy as well as our commercial prospects should we receive regulatory approval.
It is possible that the results of such trials could show that any positive previous trial results are attributable to the third-party drug and not our product candidate. Developments related to the third-party drug may also impact our clinical trials for the combination therapy as well as our commercial prospects should we receive regulatory approval.
Generally, public concern regarding the safety of biopharmaceutical products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling or require us to undertake other 50 Table of Contents activities that may entail additional costs. We have not obtained FDA approval for any product.
Generally, public concern regarding the safety of biopharmaceutical products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling or require us to undertake other activities that may entail additional costs. We have not obtained FDA approval for any product.
We will also face competition in any search for third parties to assist us with sales and marketing efforts for our product candidates. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may have difficulties generating revenue from them.
We will also face competition in any search for third parties to assist us with sales and marketing efforts for our product candidates. If we are unable to build our own distribution 54 Table of Contents and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may have difficulties generating revenue from them.
The FDA may also withdraw approval if other evidence demonstrates that our product candidate is not shown to be safe or effective under the conditions of use, we fail to conduct any required post approval trial of our product candidate with due diligence or we disseminate false or misleading promotional materials relating to our product candidate.
The FDA may also withdraw approval if other evidence demonstrates that our product candidate is not shown to be safe or effective under the conditions of use, we fail to conduct any required post approval trial 77 Table of Contents of our product candidate with due diligence or we disseminate false or misleading promotional materials relating to our product candidate.
In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed 85 Table of Contents our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
As of December 31, 2024, our executive officers, directors, holders of 5% or more of our common stock and their respective affiliates beneficially owned shares in the aggregate representing a majority of our outstanding common stock.
As of December 31, 2025, our executive officers, directors, holders of 5% or more of our common stock and their respective affiliates beneficially owned shares in the aggregate representing a majority of our outstanding common stock.
Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a 68 Table of Contents way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
If we were unsuccessful, we could lose valuable rights in intellectual property that we regard as our own. 82 Table of Contents We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
If we were unsuccessful, we could lose valuable rights in intellectual property that we regard as our own. We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
In July 2020, the Court of Justice of the European Union, or the CJEU, invalidated the EU-U.S. Privacy Shield, one of the mechanisms used to legitimize the transfer of personal data from the EEA to the United States.
In July 2020, the Court of Justice of the European Union, or the CJEU, invalidated the EU-U.S. Privacy Shield, one of the mechanisms used to legitimize the transfer of personal data from the EEA to the U.S.
While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, 60 Table of Contents resulting in partial or complete loss of patent rights in the relevant jurisdiction.
In addition, many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries also limit the enforceability of patents against government agencies or government 74 Table of Contents contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
In addition, many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Many countries also limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
Further, the FDA may determine that we must provide additional evidence and data before approving a BLA for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness for the proposed product for its intended use(s).
Further, the FDA may determine that we must provide additional evidence and data before approving a BLA for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness 70 Table of Contents for the proposed product for its intended use(s).
HHS enforcement activity can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal resources. In addition, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents.
HHS enforcement activity can result in financial liability and reputational harm, and responses 82 Table of Contents to such enforcement activity can consume significant internal resources. In addition, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents.
Furthermore, in some cases, we may not be able to obtain issued claims covering compositions of matter relating to our product candidates, and instead 78 Table of Contents may need to rely on secondary intellectual property, including patents or patent applications with claims covering formulations, methods of use and/or methods of manufacture.
Furthermore, in some cases, we may not be able to obtain issued claims covering compositions of matter relating to our product candidates, and instead may need to rely on secondary intellectual property, including patents or patent applications with claims covering formulations, methods of use and/or methods of manufacture.
We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally identifiable information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information, including comprehensive regulatory systems in the United States, EU and United Kingdom.
We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally identifiable information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information, including comprehensive regulatory systems in the U.S., EU and United Kingdom.
This may make it difficult for us to achieve our business strategy of using our product candidates in combination with existing therapies or replacing existing therapies with our product 66 Table of Contents candidates. Competition may further increase with advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
This may make it difficult for us to achieve our business strategy of using our product candidates in combination with existing therapies or replacing existing therapies with our product candidates. Competition may further increase with advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements, or for any other reasons, our studies may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidates we may develop.
If our third-party vendors do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements, or for any other reasons, our studies may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidates we may develop.
We may also seek a priority review designation for one or more of our product candidates. If the FDA determines that a product candidate is intended to treat a serious condition and, if approved, offers a significant improvement in safety or effectiveness, the FDA may designate the product candidate for priority review.
We may also seek a priority review designation for one or more of our product candidates. If the FDA determines that a product candidate is intended to treat a serious condition and, if approved, offers a significant improvement in safety or effectiveness, the FDA may 76 Table of Contents designate the product candidate for priority review.
While we have had favorable preclinical and early clinical results related to our clinical-stage product candidates, vilastobart and XTX301, we have not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in current or future clinical trials or in obtaining marketing approval thereafter.
While we have had favorable preclinical and early clinical results related to our clinical-stage product candidates, vilastobart and efarindodekin alfa, we have not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in current or future clinical trials or in obtaining marketing approval thereafter.
As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States continues to adapt to wide-ranging patent reform legislation that became effective starting in 2012.
As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the U.S. continues to adapt to wide-ranging patent reform legislation that became effective starting in 2012.
Finally, orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if 88 Table of Contents the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.
Finally, orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.
Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can 98 Table of Contents be complex and may be subject to changing interpretation. These obligations may be applicable to some or all of our business activities now or in the future.
Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation. These obligations may be applicable to some or all of our business activities now or in the future.
We also may face increased risks of a security breach or disruption due to our reliance on 104 Table of Contents internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
We also may face increased risks of a security breach or disruption due to our reliance on internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
For any of our product candidates for which we are seeking regulatory approval in the United States or the EU, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.
For any of our product candidates for which we are seeking regulatory approval in the U.S. or the EU, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this item. 132 Table of Contents
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this item. Ite m 8.
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Financial Statements and Supplementary Data The financial statements required to be filed pursuant to this Item 8 are appended to this Annual Report on Form 10-K. An index of those financial statements is found in Item 15, Exhibits and Financial Statement Schedules, of this Annual Report on Form 10-K. 112 Table of Contents It em 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. I tem 9A.
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Controls and Procedures Evaluation of Disclosure Controls and Procedures We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
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Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
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Our chief executive officer (our principal executive officer) and our chief financial and operating officer (our principal financial officer) evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025.
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Based upon such evaluation, our chief executive officer and chief financial and operating officer have concluded that, as of December 31, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.
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Management’s Annual Report on Internal Control over Financial Reporting Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal executive officer and our principal financial officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statements.
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Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures.
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Internal control over financial reporting also can be circumvented by collusion or improper management override. Also, projections of any evaluation of effectiveness of internal control over financial reporting to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.
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Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
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Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act.
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Under the supervision and with the participation of our management, including our principal executive officer and our principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting.
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Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)” published by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) to evaluate the effectiveness of our internal control over financial reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2025.
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This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm due to a transition period established by rules of the SEC for “emerging growth companies.” 113 Table of Contents Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Annual Report on Form 10-K that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Other Information Director and Officer Trading Arrangements A portion of the compensation of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) is in the form of equity awards and, from time to time, directors and officers may engage in open-market transactions with respect to the securities acquired pursuant to such equity awards or other of our securities, including to satisfy tax withholding obligations when equity awards vest or are exercised, and for diversification or other personal reasons.
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Transactions in our securities by directors and officers are required to be made in accordance with our insider trading policy , which requires that the transactions be in accordance with applicable U.S. federal securities laws that prohibit trading while in possession of material nonpublic information.
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Rule 10b5-1 under the Exchange Act provides an affirmative defense that enables directors and officers to prearrange transactions in our securities in a manner that could negate a claim of insider trading for transactions undertaken while in possession of material nonpublic information.
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None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as such terms are defined in Items 408(a) and 408(c) of Regulation S-K, respectively) during the fourth quarter of 2025. It em 9C.
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Disclosure Regarding Foreign Jurisdictions That Prevent Inspections Not applicable. 114 Table of Contents PAR T III It em 10.
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Directors, Executive Officers, and Corporate Governance Except to the extent provided below, the information required by this Item 10 will be included in our definitive proxy statement to be filed with the Securities and Exchange Commission, or the SEC, with respect to our 2026 Annual Meeting of Stockholders within 120 days of the end of the fiscal year to which this report relates, which information is incorporated herein by reference.
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We post our Code of Business Conduct and Ethics, which applies to our directors, officers, and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, in the “Corporate Governance” sub-section of the “Investor Relations” section (ir.xiliotx.com) of our corporate website https://xiliotx.com/.
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We intend to disclose on our website any amendments to, or waivers from, the Code of Business Conduct and Ethics that are required to be disclosed pursuant to the disclosure requirements of Item 5.05 of Form 8-K.
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Our website is not incorporated by reference into this Annual Report on Form 10-K and you should not consider any information contained in or accessible from our website to be a part of this Annual Report on Form 10-K. Ite m 11.
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Executive Compensation The information required by this Item 11 will be included in the section captioned “Executive Compensation” in our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates, which information is incorporated herein by reference.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this Item 12 will be included in the section captioned “Security Ownership of Certain Beneficial Owners and Management” in our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates, which information is incorporated herein by reference.
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Certain Relationships and Related Transactions, and Director Independence The information required by this Item 13 will be included in the sections captioned “Related Person Transactions,” “Policies for Related Person Transactions” and “Director Independence” in our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates, which information is incorporated herein by reference.
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Principal Accountant Fees and Services The information required by this Item 14 will be included in the section captioned “Audit Fees and Services” our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates, which information is incorporated herein by reference. 115 Table of Contents Part IV It em 15.
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Exhibits and Financial Statement Schedules (1) Financial Statements The following documents are included on pages set forth in Part II, Item 8 of this Annual Report on Form 10-K and are filed as part of this Annual Report on Form 10-K.
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Index to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm (PCAOB ID 42) F- 2 Consolidated Balance Sheets F- 3 Consolidated Statements of Operations and Comprehensive Loss F- 4 Consolidated Statements of Stockholders’ Equity F- 5 Consolidated Statements of Cash Flows F- 6 Notes to Consolidated Financial Statements F- 7 (2) Financial Statement Schedules All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
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(3) Exhibits The following is a list of exhibits filed as part of this Annual Report on Form 10-K. EXHIBIT INDEX Incorporated by Reference Exhibit Number Description of Exhibit Form File No.
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Exhibit Number Filing Date 3.1 Restated Certificate of Incorporation of the Registrant, as amended * 3.2 Second Amended and Restated Bylaws of the Registrant 8-K 001-40925 3.1 April 3, 2023 4.1 Form of March 2024 Prefunded Warrant 8-K 001-40925 4.1 March 28, 2024 4.2 Form of June 2025 Prefunded Warrant 8-K 001-40925 4.1 June 3, 2025 4.3 Form of Series A, Series B and Series C Warrant Agreement 8-K 001-40925 4.2 June 3, 2025 4.4 Description of the Registrant’s securities registered pursuant to Section 12 of the Securities and Exchange Act of 1934, as amended * 10.1 2020 Stock Incentive Plan, as amended S-1 333-259973 10.2 October 1, 2021 10.2 Form of Stock Option Agreement under 2020 Stock Incentive Plan S-1 333-259973 10.3 October 1, 2021 10.3 Form of Restricted Stock Agreement under 2020 Stock Incentive Plan S-1 333-259973 10.4 October 1, 2021 10.4 2021 Stock Incentive Plan S-1 333-259973 10.5 October 18, 2021 10.5 Form of Stock Option Agreement under the 2021 Stock Incentive Plan S-1 333-259973 10.6 October 18, 2021 10.6 Form of Non-Employee Director Stock Option Agreement under the 2021 Stock Incentive Plan S-1 333-259973 10.7 October 18, 2021 10.7 Form of Restricted Stock Unit Agreement under the 2021 Stock Incentive Plan 8-K 001-40925 10.1 January 3, 2024 10.8 2021 Employee Stock Purchase Plan S-1 333-259973 10.8 October 18, 2021 116 Table of Contents 10.9 Second Amended and Restated 2022 Inducement Stock Incentive Plan * 10.10 Form of Stock Option Agreement under the 2022 Inducement Stock Incentive Plan 10-K 001-40925 10.9 March 2, 2023 10.11 Form of Restricted Stock Unit Agreement under the 2022 Inducement Stock Incentive Plan 10-K 001-40925 10.10 March 2, 2023 10.12 2025 Stock Incentive Plan DEF 14A 001-40925 Appendix A October 20, 2025 10.13 Form of Tranche 1 Stock Option Agreement under the 2025 Stock Incentive Plan * 10.14 Form of Performance Options Stock Option Agreement under the 2025 Stock Incentive Plan * 10.15# Amended and Restated Employment Agreement, dated January 1, 2026, by and between the Registrant and René Russo * 10.16# Third Amended and Restated Employment Agreement, dated August 3, 2024, by and between the Registrant and Christopher Frankenfield 10-Q 001-40925 10.2 August 8, 2024 10.17# Employment Agreement, dated September 5, 2023, by and between the Registrant and Kevin Brennan 8-K 001-40925 10.1 September 5, 2023 10.18# Employment Agreement, dated September 5, 2023, by and between the Registrant and Katarina Luptakova, M.D. 10-K 001-40925 10.18 April 1, 2024 10.19 Form of Indemnification Agreement between the Registrant and each of its Executive Officers and Directors S-1 333-259973 10.20 October 1, 2021 10.20 Amended and Restated Non-Employee Director Compensation Policy * 10.21† Amended and Restated Exclusive License Agreement, dated as of August 16, 2016, by and between the Registrant and City of Hope S-1 333-259973 10.12 October 1, 2021 10.22† License Agreement, dated as of September 26, 2016, as amended, by and between the Registrant and WuXi Biologics (Hong Kong) Limited S-1 333-259973 10.13 October 1, 2021 10.23 Lease, dated as of August 26, 2019, by and between the Registrant and PPF OFF 828-830 Winter Street, LLC S-1 333-259973 10.14 October 1, 2021 10.24 Registration Rights Agreement, dated March 28, 2024, among the Registrant and the persons party thereto 8-K 001-40925 10.2 March 28, 2024 10.25† License Agreement, dated March 27, 2024, between Xilio Development, Inc. and Gilead Sciences, Inc. 10-Q 001-40925 10.1 May 14, 2024 10.26† Investor Rights Agreement, dated March 27, 2024, between the Registrant and Gilead Sciences, Inc. 10-Q 001-40925 10.3 May 14, 2024 10.27† Collaboration, License and Option Agreement, dated February 10, 2025, between Xilio Development, Inc. and AbbVie Group Holdings Limited 10-Q 001-40925 10.1 May 8, 2025 10.28† Investor Rights Agreement, dated February 10, 2025, between the Registrant and AbbVie Inc. 10-Q 001-40925 10.3 May 8, 2025 19 Insider Trading Policy * 21.1 Subsidiaries of the Registrant 10-K 001-40925 21.1 April 1, 2024 23.1 Consent of Ernst & Young LLP, independent registered public accounting firm * 31.1 Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * 31.2 Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * 32.1+ Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C.
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Section 1350, as * 117 Table of Contents Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 97# Executive Compensation Clawback Policy 10-K 001-40925 97 April 1, 2024 101.INS XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document * 101.SCH Inline XBRL Taxonomy Extension Calculation Linkbase Document * 101.CAL Inline XBRL Taxonomy Extension Definition Linkbase Document * 101.DEF Inline XBRL Taxonomy Extension Label Linkbase Document * 101.LAB Inline XBRL Taxonomy Extension Presentation Linkbase Document * 104 Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101) * Filed herewith. # Indicates management contract or compensatory plan or arrangement. † Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information is not material and is a type of information that the registrant treats as private or confidential. + The certifications attached as Exhibit 32.1 are being furnished solely to accompany this Annual Report on Form 10-K and will not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section.
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Such certifications will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Registrant specifically incorporates it by reference into such filing. I tem 16.
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Form 10‑K Summary None. 118 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. XILIO THERAPEUTICS, INC.
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Date: March 23, 2026 By: /s/ René Russo René Russo President and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
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Signature Title Date /s/ René Russo President, Chief Executive Officer and Director March 23, 2026 René Russo (Principal Executive Officer) /s/ Christopher Frankenfield Chief Financial Officer and Chief Operating Officer March 23, 2026 Christopher Frankenfield (Principal Financial Officer) /s/ Kevin Brennan Senior Vice President, Finance and Accounting March 23, 2026 Kevin Brennan (Principal Accounting Officer) /s/ Sara M.
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Bonstein Chair of the Board March 23, 2026 Sara M.
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Bonstein /s/ Akintunde Bello Director March 23, 2026 Akintunde Bello /s/ Aoife Brennan Director March 23, 2026 Aoife Brennan /s/ Daniel Curran Director March 23, 2026 Daniel Curran /s/ Robert Ross Director March 23, 2026 Robert Ross /s/ Christina Rossi Director March 23, 2026 Christina Rossi /s/ James Shannon Director March 23, 2026 James Shannon /s/ Yuan Xu Director March 23, 2026 Yuan Xu 119 Table of Contents Xilio Therapeutics, Inc.
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Index to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm (PCAOB ID 42 ) F- 2 Consolidated Balance Sheets F- 3 Consolidated Statements of Operations and Comprehensive Loss F- 4 Consolidated Statements of Stockholders’ Equity F- 5 Consolidated Statements of Cash Flows F- 6 Notes to Consolidated Financial Statements F- 7 F- 1 Table of Contents REPORT OF IND EPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of Xilio Therapeutics, Inc.
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Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Xilio Therapeutics, Inc.
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(the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
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In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
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Basis for Opinion These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
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We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
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We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
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The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
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Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
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Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2020.
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Boston, Massachusetts March 23, 2026 F- 2 Table of Contents XILIO THERAPEUTICS, INC.
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CONSOLI DATED BALANCE SHEETS (In thousands, except share and per share data) December 31, December 31, 2025 2024 ASSETS Current assets Cash and cash equivalents $ 137,531 $ 55,291 Collaboration and license agreement receivable 5,000 — Prepaid expenses and other current assets 2,496 4,943 Total current assets 145,027 60,234 Restricted cash 1,807 1,782 Property and equipment, net 3,892 4,472 Operating lease right-of-use asset 3,959 4,587 Total assets $ 154,685 $ 71,075 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 3,168 $ 2,574 Accrued expenses 11,739 9,981 Deferred revenue, current portion 40,023 13,518 Operating lease liability, current portion 1,343 1,188 Total current liabilities 56,273 27,261 Deferred revenue, net of current portion 20,635 19,262 Operating lease liability, net of current portion 5,611 6,954 Common stock warrant liabilities 29,560 — Liabilities to issue common stock 7,333 — Total liabilities 119,412 53,477 Commitments and contingencies (Note 8 ) Stockholders’ equity Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized, no shares issued or outstanding — — Common stock, $ 0.0001 par value; 600,000,000 shares authorized at December 31, 2025 and 200,000,000 shares authorized at December 31, 2024; 4,530,641 shares issued and outstanding at December 31, 2025; 3,268,299 shares issued and outstanding at December 31, 2024 — — Additional paid-in capital 454,062 401,351 Accumulated deficit ( 418,789 ) ( 383,753 ) Total stockholders’ equity 35,273 17,598 Total liabilities and stockholders’ equity $ 154,685 $ 71,075 The accompanying notes are an integral part of these consolidated financial statements.
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F- 3 Table of Contents XILIO THERAPEUTICS, INC.
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CONSOLIDATED STATE MENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) Year Ended December 31, 2025 2024 Revenue Collaboration and license revenue $ 43,766 $ 6,344 Total revenue 43,766 6,344 Operating expenses Research and development $ 56,039 $ 41,211 General and administrative 29,709 24,778 Restructuring — 937 Total operating expenses 85,748 66,926 Loss from operations ( 41,982 ) ( 60,582 ) Other income, net Change in fair value of common stock warrant liabilities 5,845 — Other income, net 1,101 2,341 Total other income, net 6,946 2,341 Net loss and comprehensive loss $ ( 35,036 ) $ ( 58,241 ) Net loss per share, basic and diluted $ ( 4.19 ) $ ( 15.24 ) Weighted average common shares outstanding, basic and diluted 8,359,109 3,822,244 The accompanying notes are an integral part of these consolidated financial statements.
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F- 4 Table of Contents XILIO THERAPEUTICS, INC.
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CONSOLIDAT ED STATEMENTS OF STOCKHOLDERS’ EQUITY (In thousands, except share data) Additional Total Common Stock Paid-In Accumulated Stockholders’ Shares Amount Capital Deficit Equity Balance at December 31, 2023 1,971,974 $ — $ 362,339 $ ( 325,512 ) $ 36,827 Issuance of common stock and prefunded warrants to Gilead and certain accredited investors in private placements, net of issuance costs 789,896 — 25,680 — 25,680 Issuance of common stock in connection with at-the-market offerings, net of issuance costs 500,000 — 6,825 — 6,825 Issuance of common stock under employee stock purchase plan 5,423 — 68 — 68 Vesting of restricted common stock 398 — — — — Exercise of stock options 608 — 5 — 5 Stock-based compensation expense — — 6,434 — 6,434 Net loss — — — ( 58,241 ) ( 58,241 ) Balance at December 31, 2024 3,268,299 $ — $ 401,351 $ ( 383,753 ) $ 17,598 Issuance of prefunded warrants in connection with a follow-on offering, net of issuance costs — — 10,818 — 10,818 Issuance of common stock in connection with the exercise of prefunded warrants 524,033 — 1 — 1 Issuance of common stock and prefunded warrants in connection with the exercise of Series B warrants, net of issuance costs 300,200 — 26,945 — 26,945 Conversion of Series B common stock warrant liabilities to equity — — 3,095 — 3,095 Issuance of common stock in connection with the AbbVie stock purchase agreement, net of issuance costs 310,559 — 2,810 — 2,810 Issuance of common stock in connection with at-the-market offerings, net of issuance costs 110,747 — 2,017 — 2,017 Issuance of common stock under employee stock purchase plan 7,508 — 76 — 76 Vesting of restricted common stock 7,952 — — — — Exercise of stock options 1,343 — 10 — 10 Stock-based compensation expense — — 6,939 — 6,939 Net loss — — — ( 35,036 ) ( 35,036 ) Balance at December 31, 2025 4,530,641 $ — $ 454,062 $ ( 418,789 ) $ 35,273 The accompanying notes are an integral part of these consolidated financial statements.
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F- 5 Table of Contents XILIO THERAPEUTICS, INC.
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CONSOLIDATED STATEM ENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2025 2024 Cash flows from operating activities: Net loss $ ( 35,036 ) $ ( 58,241 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,541 1,644 Stock-based compensation expense 6,939 6,434 Change in fair value of common stock warrant liabilities ( 5,845 ) — Issuance costs allocated to common stock warrant liabilities 2,284 — Loss on disposal of property and equipment — 3 Changes in operating assets and liabilities: Collaboration and license agreement receivable ( 5,000 ) — Prepaid and other assets 3,075 ( 981 ) Accounts payable 152 1,526 Accrued expenses and other liabilities ( 979 ) ( 1,543 ) Deferred revenue 27,877 32,780 Net cash used in operating activities ( 4,992 ) ( 18,378 ) Cash flows from investing activities: Purchases of property and equipment ( 518 ) ( 36 ) Net cash used in investing activities ( 518 ) ( 36 ) Cash flows from financing activities: Proceeds from issuance of prefunded warrants and common stock warrants in connection with a follow-on offering, net of issuance costs 47,033 — Proceeds from issuance of common stock, prefunded warrants and liabilities to issue common stock in connection with the exercise of Series B warrants, net of issuance costs 35,828 — Proceeds from issuance of common stock in connection with the exercise of prefunded warrants 1 — Proceeds from issuance of common stock in connection with the AbbVie stock purchase agreement, net of issuance costs 2,810 — Proceeds from issuance of common stock in connection with at-the-market offerings, net of issuance costs 2,017 6,825 Proceeds from issuance of common stock under employee stock purchase plan 76 68 Proceeds from exercise of stock options 10 5 Proceeds from issuance of common stock and prefunded warrants to Gilead and certain accredited investors in private placements, net of issuance costs — 25,680 Repayments of debt principal — ( 3,333 ) Payments of finance lease — ( 49 ) Net cash provided by financing activities 87,775 29,196 Increase in cash, cash equivalents and restricted cash 82,265 10,782 Cash, cash equivalents and restricted cash, beginning of period 57,073 46,291 Cash, cash equivalents and restricted cash, end of period $ 139,338 $ 57,073 Supplemental cash flow disclosure: Cash paid for interest $ — $ 62 Supplemental disclosure of non-cash activities: Transfer of finance lease asset to property and equipment $ — $ 85 Capital expenditures included in accounts payable or accrued expenses $ 443 $ — Issuance costs included in accounts payable or accrued expenses $ 1,550 $ — Reconciliation to amounts within the consolidated balance sheets: Cash and cash equivalents $ 137,531 $ 55,291 Restricted cash 1,807 1,782 Cash, cash equivalents and restricted cash, end of period $ 139,338 $ 57,073 The accompanying notes are an integral part of these consolidated financial statements.
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F- 6 Table of Contents XILIO THERAPEUTICS, INC. Notes to Consolidated Financial Statements (Dollars in thousands, unless otherwise stated) 1. Description of Business and Liquidity Xilio Therapeutics, Inc.
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(“Xilio” or the “Company”) is a clinical-stage biotechnology company dedicated to discovering and developing masked immuno-oncology (“I-O”) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The Company was incorporated in Delaware in June 2020, and its headquarters are located in Waltham, Massachusetts.
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Since its inception, the Company has devoted substantially all of its financial resources and efforts to research and development activities.
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As of December 31, 2025, the Company had an accumulated deficit of $ 418.8 million and has incurred significant operating losses, including net losses of $ 35.0 million and $ 58.2 million for the years ended December 31, 2025 and 2024, respectively.
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The Company expects its operating losses and negative operating cash flows to continue for the foreseeable future as it continues to advance its product candidates through clinical trials, maintains the infrastructure necessary to support these activities and continues to incur costs associated with operating as a public company.
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As of December 31, 2025, the Company had cash and cash equivalents of $ 137.5 million.
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Based on its current operating plans, the Company anticipates that its existing cash and cash equivalents as of December 31, 2025, together with the $ 37.3 million in estimated net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, received upon the closing of a follow-on offering of prefunded warrants in the first quarter of 2026, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements for at least twelve months from the date of the issuance of these consolidated financial statements.
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However, the Company has based its estimates on assumptions that may prove to be wrong.
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If actual results differ from the Company’s estimates, the Company could exhaust its available capital resources sooner than it anticipates, in which case, the Company would be required to seek additional capital sooner or curtail planned activities to reduce operating expenses, which may have an adverse impact on the Company’s ability to achieve its business objectives. 2.
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Summary of Significant Accounting Policies Basis of Presentation These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”).
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Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”). On March 13, 2026, the Company effected a reverse stock split at a ratio of 1 -for- 14 .
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The reverse stock split did not impact the number of authorized shares of common stock or preferred stock or the par value per share of the common stock or preferred stock. All share and per share amounts in these consolidated financial statements and notes thereto have been adjusted retroactively to reflect the reverse stock split for all periods presented.
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In April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107(b) of 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.
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Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
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The Company has elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company can adopt the new or revised standard at the time private companies adopt the new or revised standard and may do so until such time that the Company either (1) irrevocably elects to “opt out” of such extended transition period or (2) no longer qualifies as an emerging growth company.
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The Company may take advantage of these exemptions up until December 31, 2026, or such earlier time that it is no longer an emerging growth company. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: Xilio Development, Inc. (“Xilio Development”), a Delaware corporation, and Xilio Securities Corporation, a Massachusetts corporation.
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All intercompany accounts and transactions have been eliminated in consolidation.
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F- 7 Table of Contents Use of Estimates The preparation of financial statements in accordance with GAAP requires management to make estimates and judgments that may affect the reported amounts of assets and liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the related reporting of revenue and expenses during the reporting period.
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Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements.
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Factors that may affect estimates include expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends.
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The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates.
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Examples of estimates of accounting reflected in these consolidated financial statements include, but are not limited to, estimates related to revenue recognition, accrued expenses, the valuation of the common stock warrant liabilities, the valuation of stock-based compensation, including stock options and restricted stock units, useful life of long-lived assets and income taxes. Actual results could differ from those estimates.
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Segment Information The Company has one operating and reportable segment, the consolidated Company operations, reflecting the integrated nature of its business focused on discovering and developing masked I-O therapies. The Company’s chief operating decision maker (“CODM”) is its chief executive officer.

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