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INBX 10-K & 10-Q changes, risk factors and insider trading

Inhibrx Biosciences, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 2007919 · All filings on SEC.gov

Everything below is quoted or computed from Inhibrx Biosciences, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

25 / 13risk-factor paragraphs added / removed in latest 10-K
4new risk-factor headings
6Form 4 filings reporting open-market purchases (last 180 days)
2Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-19 (period ending 2025-12-31) with 10-K filed 2025-03-17 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

25new paragraphs
13removed paragraphs
62reworded paragraphs
39,377 → 42,436words in section

New heading “From time to time we evaluate and pursue potential alternatives for monetizing our assets, which may not result in the consummation of any transaction, or achieve the desired objectives of such a transaction. Our efforts may create a distraction for our management team and adversely affect our business operations.”

New heading “We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.”

New heading “Unfavorable global economic conditions and an uncertain geopolitical environment could have an adverse effect on our business, financial condition, results of operations and prospects”

New heading “International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.”

Removed heading “If we are required by the FDA or comparable foreign regulatory authority to obtain approval of a companion diagnostic test in connection with approval of any of our therapeutic candidates, and we do not obtain, or face delays in obtaining, FDA or foreign marketing approval of such companion diagnostic, our ability to commercialize our therapeutic candidates and generate revenue will be materially impaired.”

Removed heading “We are required to pay Former Parent for certain tax savings we may realize as a result of the Code Section 336(e) election made in connection with the Distribution.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: department of justice, fine, penalt, china
“Additionally, the U.S. Department of Justice issued a rule entitled the Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restriction on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered persons (i.e., individuals and entities who are designated as such by the U.S. …”
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Reworded topics: investigation, litigation, fine, penalt

Paragraph as it now reads, with added and removed wording marked:

We are increasingly dependent upon our technology systems to operate our business and our ability to effectively manage our business depends on the security, reliability and adequacy of our technology systems and data, which includes use of cloud technologies. A breakdown, invasion, corruption, destruction or breach of our technology systems, including the cloud technologies that we utilize, and/or unauthorized access to our data and information could subject us to liability orliability, negatively impact the operation of our business.business, result in regulatory investigations or actions, litigation, fines and penalties, reputational harm, or other adverse consequences. Our technology systems, including the cloud technologies that we utilize, continue to increase in multitude and complexity, making them potentially vulnerable to breakdown, malicious intrusion and random attack. Likewise, data privacy or security breaches by individuals authorized to access our technology systems, including the cloud technologies that we utilize, may pose a risk that sensitive data, including intellectual property, trade secrets, personal information or preclinical or clinical trial data belonging to us, our clinical trial participants, or other business partners,data, may be exposed to unauthorized persons or to the public.
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New text topics: tariff, sanction
“International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.”
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New text topics: investigation, tariff, regulation
“We operate in a global economy, which includes utilizing third-party suppliers in several countries outside the United States. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. …”
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New text topics: tariff, sanction, regulation
“The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers. …”
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New text topics: tariff, supply chain, labor
“Current or future tariffs will result in increased research and development expenses, including with respect to increased costs associated with APIs, raw materials, laboratory equipment and research materials and components. In addition, such tariffs will increase our supply chain complexity and could also potentially disrupt our existing supply chain. Unlike consumer goods, pharmaceuticals face unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. …”
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Full comparison: every changed paragraph (100)

Green = added, red = removed. Unchanged paragraphs, 3 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

•OurWe depend heavily on the success of our therapeutic candidatescandidates, which are currently in various stages of development and may fail or suffer delays (such as our partial clinical hold experienced in 2023 for ozekibart (INBRX-109)) that materially and adversely affect their commercial viability. If we are unable to advance our therapeutic candidates through clinical development, obtain marketing approval and ultimately commercialize our therapeutic candidates, or experience significant delays in doing so, our business will be materially harmed. Even if our therapeutic candidates receive regulatory approval and are commercialized, there is no assurance that our commercialization efforts will be successful.

Reworded

•If we are not able to obtain and enforce patentintellectual property protection for our technologies or therapeutic candidates, development and commercialization of our therapeutic candidates may be adversely affected.

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We have devoted substantially all of our financial resources and efforts to developing our therapeutic candidates, identifying potential therapeutic candidates and conducting preclinical studies and clinical trials. We are still in the development stage for all of our therapeutic candidates, and while we have demonstrated an ability to successfully conduct and complete certain of our clinical trials, we have yet to demonstrate an ability to conduct pivotal clinical trials, obtain marketing approval, manufacture a commercial scale product or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful product commercialization. Consequently, we have no meaningful operations upon which to evaluate our business and predictions about our future success or viability may not be as accurate as they could be if we had more experience developing therapeutic candidates. Our ability to generate revenue and achieve profitability depends in large part on our ability, alone or with license partners, to achieve milestones and to successfully complete the development of, obtain the necessary marketing approvals for, and commercialize, our therapeutic candidates. Even if we achieve development or commercial milestones, generate product royalties or generate product sales, we may never achieve or sustain profitability on a quarterly or annual basis. We do not anticipate generating revenue from sales of products for the foreseeable future. Our ability to generate future revenue from product sales depends heavily on our success in:

Added

Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our cash needs through a combination of equity and debt financings, strategic collaborations and license and development agreements. We do not have any committed external source of funds. To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.

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Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our cash needs through a combination of equity and debt financings, strategic collaborations and license and development agreements. We do not have any committed external source of funds. To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Equity and debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as redeeming our shares, making investments, incurring additional debt, making capital expenditures or declaring dividends. The incurrence of indebtedness could result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants therein, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely affect our ability to conduct our business. For example, we entered into a loan and security agreement with Oxford Finance LLC and other lenders, or collectively, Oxford, which contains certain restrictive covenants as discussed below in “Risk Factors – We have a significant amount of debt which may affect our ability to operate our business and secure additional financing in the future. If we fail to comply with the terms of our loan agreement with Oxford, our business, prospects and results of operations could be materially and adversely affected.”

Reworded

OurWe depend heavily on the success of our therapeutic candidatescandidates, which are currently in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. If we are unable to advance our therapeutic candidates through clinical development, obtain marketing approval and ultimately commercialize our therapeutic candidates, or experience significant delays in doing so, our business will be materially harmed. Even if our therapeutic candidates receive regulatory approval and are commercialized, there is no assurance that our commercialization efforts will be successful.

Added

We currently have no products on the market and our ability to achieve and sustain profitability depends on obtaining marketing approvals for and successfully commercializing our therapeutic candidates. Our two therapeutic candidates are still currently in clinical trials (ozekibart (INBRX-109) and INBRX-106). While we plan to submit a BLA to the FDA for the approval of ozekibart in patients with metastatic or unresectable chondrosarcoma early in the second quarter of 2026, there is no assurance that we will be successful in our efforts to submit a BLA on the timeline we expect or at all. Even if we are able to make such submission, the FDA may not accept our submission as complete, or may not agree that the clinical and preclinical data we have generated to date are sufficient to gain regulatory approval to commercialize ozekibart in the United States. The FDA may, despite prior advice, determine that additional trials or data are necessary in order to submit or obtain approval. Regulatory authorities may find fault with the data generated at one of our clinical sites or with the activities of our trial monitor or may disagree with our analyses of the results of our trials. Regulatory authorities may also identify deficiencies or other issues with our manufacturing or quality systems or processes. Any such findings or issues could require additional data or analyses or the need for changes to our systems or processes that could delay or prevent us from gaining approval of ozekibart.

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Clinical and preclinical development is expensive and can take many years to complete, and its outcome is inherently uncertain. We cannot guarantee that any clinical trials or preclinical studies will be conducted as planned, including whether we ourwill be able to meet expected timeframes for data readouts, or completed on schedule, if at all, and failure can occur at any time during the trial or study process. For instance, we independently decided to cease development of INBRX-105 as we determined, after evaluation of the totality of the data from the expansion cohorts, that the initial signal was not sufficiently validated to support the continuation of the program. Despite promising preclinical or clinical results, any therapeutic candidate can unexpectedly fail at any stage of clinical or preclinical development. The historical failure rate for therapeutic candidates in our industry is high, particularly in the earlier stages of development.

Reworded

Our two therapeutic candidates are still currently in clinical trials (ozekibart (INBRX-109) and INBRX-106). We have no products on the market and our ability to achieve and sustain profitability depends on obtaining marketing approvals for and successfully commercializing our therapeutic candidates. Before obtaining marketing approval for the commercial distribution of our therapeutic candidates, we must conduct extensive preclinical tests and clinical trials to demonstrate sufficient safety, purity, and potency (or efficacy) of our therapeutic candidates in patients. Before we can initiate clinical trials for any therapeutic candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about the candidate’s chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an Investigational New Drug Application, or IND, or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies for any therapeutic candidate before it allows us to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of our development programs.

Reworded

•delays or failure by our contract manufacturers or us to make any necessary changes to such manufacturing process, or failure of our contract manufacturers to produce clinical trial materials in accordance with current Good Manufacturing Practice, or cGMP,cGMPs, regulations or other applicable requirements; and

Reworded

A clinical trial may be suspended, partially suspended or terminated by us, the IRBs overseeing such trials, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold or partial clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations, administrative actions or lack of adequate funding to continue the clinical trial. Clinical holds may be placed prior to a clinical trial even beginning, in order to address potential safety and risk concerns of regulatory authorities, and partial or complete clinical holds can be imposed at any time during a trial. For example, in early 2023, the Phase 2ChonDRAgon trial of ozekibart (INBRX-109) was placed on partial clinical hold by the FDA, and the Former Parent paused patient enrollment in the trial, following the occurrence of a fatal serious adverse event (grade 5) of hepatotoxicity (or hepatic failure) triggering the predefined stopping rules built into the protocol. The FDA lifted the hold in April 2023 after the Former Parent amended the trial protocol to include additional screening criteria and to make other changes to address patients who may be at risk of significant hepatotoxicity. Furthermore, while we perform certain similar functions internally, we expect to rely on contract research organizations, or CROs, and clinical trial sites to ensure proper and timely conduct of our clinical trials and while we expect to enter into and have entered into agreements governing those CROs’ committed activities, we have limited influence over their actual performance.

Added

Even if we obtain approval of ozekibart, we may never be able to successfully commercialize the product or to meet our expectations with respect to revenues or profits. We have never marketed, sold or distributed for commercial use any pharmaceutical product. We are in the process of building the teams, infrastructure, systems, processes, policies, relationships and materials necessary for launch of ozekibart in the United States in chondrosarcoma. If we receive regulatory approval to market or sell ozekibart or any of our other therapeutic candidates, if successfully developed and approved, but are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, or if we are unable to do so on commercially reasonable terms, our business, results of operations, financial condition and prospects will be materially adversely affected. There is no guarantee that we will be successful in our launch or commercialization efforts with respect to ozekibart or with respect to any other therapeutic candidate that may be approved in the future. We may encounter issues, delays or unexpected challenges in launching or commercializing ozekibart or any of our other therapeutic candidates, if approved. For example, our results may be negatively impacted if we have not adequately sized our field teams or our physician segmentation and targeting strategy is inadequate or if we encounter deficiencies or inefficiencies in our infrastructure or processes. We may encounter unexpected limitations in the scope, breadth, availability or amount of reimbursement covering ozekibart or our other therapeutic candidates, if approved, or other limitations or issues related to the price. We may face issues related to market acceptance and use of any of our therapeutic candidates, if approved. Any of these issues could impair our ability to successfully commercialize the product or to generate substantial revenues or profits or to meet our expectations with respect to revenues or profits.

Reworded

The success of our business depends in part upon our ability to identify, develop and commercialize therapeutics and therapeutic candidates (including ozekibart (INBRX-109) and INBRX-106) based on our proprietary modular protein engineering platforms, which leverage a novel and unproven therapeutic approach. Our research methodology and novel approach to oncology and rare disease using our proprietary modular protein engineering platforms may be unsuccessful in identifying additional therapeutic candidates, and any therapeutic candidates based on our technology may be shown to have harmful side effects or may have other characteristics that may necessitate additional clinical testing that would extend development timelines and be more costly, or make the therapeutic candidates unmarketable or unlikely to receive marketing approval. If any of our therapeutic candidates prove to be ineffective, unsafe or commercially unviable, our entire pipeline could have little, if any, value, and it may prove to be difficult or impossible to finance or further continue development of our pipeline. We have observed serious adverse events in our Phase 1/2 clinical trial of INBRX-106, as well as our Phase 1 and Phase 2 clinical trials of ozekibart (INBRX-109) for chondrosarcoma, for which we have been subject to a prior partial clinical hold.

Reworded

Success in preclinical studies and early clinical trials does not ensure that later and pivotal clinical trials will generate the same results, or otherwise provide adequate data to demonstrate the safety and efficacy of a therapeutic candidate. Frequently, therapeutic candidates that have shown promising results in preclinical studies or early clinical trials have subsequently suffered significant setbacks in later or pivotal clinical trials. Our therapeutic candidates in clinical trials, including ozekibart (INBRX-109) and INBRX-106, may ultimately fail to show the desired safety and efficacy in clinical trials despite having progressed through preclinical studies and despite any initial observations of single agent activity, stable disease or partial responses. ThereWhile the registrational trial was successful for ozekibart in patients with metastatic or unresectable chondrosarcoma, there can be no assurance that anyour of ourother clinical trials will ultimately be successful or support further clinical development, including development in trials, of any of our therapeutic candidates. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies or trials, and any of these setbacks in our clinical development could have a material adverse effect on our business and operating results.

Reworded

Results of our clinical trials could reveal a high and unacceptable severity of adverse side effects and it is possible that patients enrolled in these clinical trials could respond in unexpected ways. For instance, ozekibart (INBRX-109) and INBRX-106 are therapeutic candidates targeting oncology indications that are clinically evaluated in very sick populations. Certain trial participants, including participants evaluated in our trials for ozekibart (INBRX-109),ozekibart, have in the past and others may in the future experience side effects or serious adverse events that could be related to one of our therapeutic candidates. We have observed serious treatment related serious adverse events in our Phase 1/2 clinical trial of INBRX-106 which consisted of general disorders and administration site conditions, metabolism and nutrition disorders, gastrointestinal disorders, blood and lymphatic system disorders, cardiac disorders, cytokine release syndrome, infusion-related reactions, primary adrenal insufficiency, increased blood bilirubin, myositis, toxic encephalopathy, and acute kidney injury, and in our Phase 1 and Phase 2 clinical trials of ozekibart (INBRX-109) in chondrosarcoma which consisted of abnormal laboratory findings, gastrointestinal disorders, blood and lymphatic disorders, hepatobiliary disorders, general disorders and administration site conditions, infections, metabolism and nutrition disorders, tachycardia, posterior reversible encephalopathy syndrome, muscular weakness and renal and urinary disorders.

Reworded

•the size and nature of the patient population;

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Additionally, other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which may make it more difficult for us to fully enroll any clinical trials. We also rely on, and will continue to rely on, CROs and clinical trial sites to ensure proper and timely conduct of our clinical trials and preclinical studies. Though we have entered into agreements governing their services, we will have limited influence over their actual performance. Our inability to enroll a sufficient number of patients for any of our clinical trials could result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our therapeutic candidates and in delays to commercially launching our therapeutic candidates, if approved, which would materially harm our business.

Added

From time to time we evaluate and pursue potential alternatives for monetizing our assets, which may not result in the consummation of any transaction, or achieve the desired objectives of such a transaction. Our efforts may create a distraction for our management team and adversely affect our business operations.

Added

From time to time we evaluate and pursue potential alternatives for monetizing our assets, with a focus on tax efficiency and enhancing stockholder value while minimizing dilution. Our ability to successfully execute a transaction is dependent on a variety of factors, a large number of which are out of our control, and we may not be able to implement a transaction on favorable terms, or within an advantageous timeframe, or on terms that recognize significant value for our assets. The timing and process of evaluating and pursuing such transactions is often unpredictable. For example, in 2025 we announced that we were pursuing an ozekibart transaction; however, in view of potential additional value creation in 2026, an ozekibart transaction is currently not being actively pursued, as we focus on the completion of key INBRX-106 milestones. Additionally, the negotiation and consummation of a transaction may be costly and time-consuming. A transaction may not be as efficient from a tax perspective as we desire, or enhance stockholder value, or result in any other anticipated or intended benefits. We also could incur total costs and expenses that are greater than expected, and our efforts could make it more difficult to attract and retain qualified personnel or disrupt our operations, each of which could have a material adverse effect on our business.

Added

The current market price of our common stock may reflect an assumption that a transaction involving ozekibart or our other assets will occur, and any perceived delay or failure to complete a transaction could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into potential transactions. We cannot guarantee that any transaction involving ozekibart or our other assets will be negotiated, signed or completed, be on attractive terms, enhance stockholder value or deliver any anticipated benefits.

Removed

If we are required by the FDA or comparable foreign regulatory authority to obtain approval of a companion diagnostic test in connection with approval of any of our therapeutic candidates, and we do not obtain, or face delays in obtaining, FDA or foreign marketing approval of such companion diagnostic, our ability to commercialize our therapeutic candidates and generate revenue will be materially impaired.

Removed

If the FDA believes that the safe and effective use of any of our therapeutic candidates depends on an in vitro diagnostic it may require approval or clearance of that diagnostic as a companion diagnostic at the same time that the FDA approves our therapeutic candidates, if at all. According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or indication if the companion diagnostic is not also approved or cleared for that indication. Depending on the data from our clinical trials, we may decide to collaborate with diagnostic companies during our clinical trial enrollment process to help identify patients with characteristics that we believe will be most likely to respond to our therapeutic candidates. If a companion diagnostic is not commercially available in this situation, we may be required to develop or obtain an alternative companion diagnostic, that would be subject to regulatory approval requirements. The process of obtaining or creating such diagnostics is time-consuming and costly.

Removed

Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities, and the FDA has generally required premarket approval of companion diagnostics for cancer therapies. The approval or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the use of the therapeutic product to only those patients who express the specific characteristic that the companion diagnostic was developed to detect.

Removed

If the FDA or a comparable foreign regulatory authority requires approval or clearance of a companion diagnostic for any of our therapeutic candidates, whether before, simultaneously with, or after the candidate obtains marketing approval, we and/or third-party collaborators may encounter difficulties in developing and obtaining approval or clearance for these companion diagnostics. Any delay or failure by us or third-party collaborators to develop or obtain regulatory approval or clearance of a companion diagnostic could delay or prevent approval or continued marketing of the relevant product. We or our third-party collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent us from completing our clinical trials or commercializing our therapeutic candidates, if approved, on a timely or profitable basis, if at all.

Reworded

We have provided, and will continue to provide, a number of timing estimates regarding the initiation of clinical trials and clinical development milestones, and the expected availability of data resulting from these trials for certain of our therapeutic candidates. We expect to continue to estimate the timing of these types of development milestones and our expected timing for the accomplishment of various other scientific, clinical, regulatory and other product development objectives. From time to time, we may publicly announce the expected timing of some of these eventsevents. and weWe have had in the past, and may need in the future, to adjust our previously announced timing for certain of our therapeutic candidates. The achievement of many of these milestones and events may be outside of our control. All of these timing estimations are based on a variety of assumptions we make, which may cause the actual timing of these events to differ from the timing we expect, including:

Reworded

We have existing collaborations with third parties, and may in the future enter into collaborationsadditional with third partiescollaborations, to develop or commercialize our therapeutic candidates. If these collaborations are not successful, our business could be harmed.

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We mayhave enter intoexisting collaborations with third partiesparties, and may in the future.future enter into additional collaborations, to develop or commercialize our therapeutic candidates. Any collaborations that we are party to may pose several risks, including the following:

Reworded

While we have found that our therapeutic candidates can be readily manufactured at high yields with established processes used to produce therapeutic proteins, the manufacture of biotechnology products is generally complex and requires significant expertise and capital investment. We and our contract manufacturers must comply with current Good Manufacturing Practices, or cGMP,cGMPs, and similar foreign regulations and guidelines for clinical trial product manufacture and for commercial product manufacture. Manufacturers of biotechnology products often encounter difficulties in production, particularly in scaling up, addressing product quality, product comparability, validating production processes and mitigating potential sources of contamination. These problems include difficulties with raw material procurement, production costs and yields, quality control, product quality, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if microbial, viral or other contaminations are discovered in our therapeutics or in the manufacturing facilities in which our therapeutics are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

Reworded

We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to develop and manufacture our therapeutic candidates for use in the conduct of our trials or for commercial supply, if our therapeutics are approved. Instead, we rely on, and expect to continue to rely on third-party providers to manufacture the supplies for our preclinical studies and clinical trials. We currently rely on a limited number of third-party contract manufacturers for our required raw materials, antibodies, and other biologics for our preclinical research and clinical trials, as well as for the manufacture of supplies for our therapeutic candidates. To the extent any of our manufacturing partners are unable to fulfill these obligations in a timely manner, our clinical trials may be delayed, and our business may be adversely affected. In general, reliance on third party providers may expose us to more risk than if we were to manufacture our therapeutic candidates ourselves. In addition, the facilities used by our third-party manufacturers must be approved for the manufacture of our therapeutic candidates by the FDA, or any comparable foreign regulatory authority, pursuant to inspections that will be conducted after we submit a BLA to the FDA, or submit a comparable marketing application to a foreign regulatory authority. We do not control the operational processes of the contract manufacturing organizations with whom we contract and are dependent on these third parties for the production of our therapeutic candidates in accordance with relevant regulations (such as cGMPcGMPs), which include, among other things, quality control and the maintenance of records and documentation.

Reworded

We rely, in part, on foreign CROs and CMOs, such as WuXi AppTec.CMOs. Such foreign CROs and CMOs may be subject to U.S. legislation, sanctions, trade restrictions and foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, on December 18, 2025, President Trump signed the National Defense Authorization Act for Fiscal Year 2026 into law, which includes the BIOSECURE Act. The BIOSECURE Act wasprohibits passedthe U.S. Government from procuring or obtaining biotechnology equipment or services produced or provided by thea House“biotechnology company of Representativesconcern” (“BCC”); entering into, extending, or renewing government contracts with an entity that directly or indirectly uses biotechnology equipment or services from a BCC in Septemberperformance 2024of that federal contract; and/or issuing grants or loans to purchase, obtain, or use biotechnology equipment or services produced by a BCC. The BIOSECURE Act also prohibits U.S. government loan and agrant substantiallyrecipients similarfrom billusing isfederal pendingloan or grant money to enter into contracts with entities that use equipment or services from BCCs in the Senate.performance Ifof theseany billsfederal becomeprime law,contract or similarsubcontract. lawsCompanies designated as a BCC include those that are passed,identified they would haveon the potentialU.S. toDepartment restrictof Defense’s annual List of Chinese Military Companies, also known as the 1260H List. The U.S. Government also has the ability ofto U.S.designate biopharmaceuticalentities companiesas likeBCCs usthrough a separate designation process. There is a “safe harbor” provision providing that the restrictions do not apply to purchaseequipment or services orthat productswere from,formerly but are no longer provided by a BCC, as well as a “grandfathering” provision providing that the prohibitions shall not apply for a five-year period to biotechnology equipment or otherwiseservices collaborateproduced with,or provided under a contract or agreement entered into before the applicable effective date. Given the BIOSECURE Act, we may be restricted in our ability to work with certain Chinese biotechnology companies “of concern” without losingto the abilityextent towe would contract with, or otherwise receive funding from, the U.S. government.Government. Such disruption could have adverse effects on the development of our therapeutic candidates if we are unable to find alternative suppliers.

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In addition, we have no control over the ability of third-party manufacturers and testing, packaging and labeling, and storage facilities to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or any comparable foreign regulatory authority does not approve these facilities for the manufacture our therapeutic candidates, or if such authorities withdraw any such approval in the future, we may be required to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our therapeutic candidates, if approved. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our financial position.

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If our therapeutic candidates are approved for marketing and commercialization and we are unable to developestablish effective sales, marketing and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to commercialize successfully any such therapeutic candidates.

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We are currently haveestablishing nocapabilities for sales, marketingmarketing, orand distribution capabilities.distribution. We will need to expandestablish our own internal sales, marketingmarketing, and distribution capabilities to commercialize our approved therapeutic candidates, if any, in the United States and other worldwide territories, or will need to enter into collaborations with third parties to perform these services. AnyInternal internalefforts effort would beare expensive and time-consuming, andrequiring wethe wouldcommitment need to commitof significant financial and managerial resources to developestablish an effective internal marketing and sales force with technical expertise and the related supporting distribution, administration and compliance capabilities. If we were to rely on additional third parties with these capabilities to market our future therapeutics or were to decide to co-promote products with any of our future collaborators, we would need to establish and maintain or revise existing marketing and distribution arrangements with these partners, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all. Any revenue we receive in connection with third-party license, marketing or distribution arrangements, will depend upon the efforts of these third parties, and there can be no assurance these third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance of any approved product. If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our business, financial condition, results of operations and prospects could be materially and adversely affected.

Reworded

Our therapeutic candidates are still in clinical development and our emerging pipeline is still in preclinical development; although we plan to submit a BLA to the FDA early in the second quarter of 2026 for the approval of ozekibart in patients with metastatic or unresectable chondrosarcoma, we may never have an approved product that is commercially successful. Due to the inherent risk in the development of biopharmaceutical products, it is probable that not all or none of the therapeutic candidates in our pipeline, including any that are or may be licensed to third parties, will successfully complete development and be commercialized. Furthermore, even when available on the market, our products may not achieve an adequate level of acceptance by physicians, patients and the medical community, and we may not become profitable. In addition, efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may never be successful, which would prevent us from generating significant revenue or becoming profitable. Market acceptance of any approved products by physicians, patients and healthcare payors will depend on a number of factors, many of which are beyond our control, including, but not limited to:

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•Companies developing novel therapeutics based on sdAb or alternative scaffold product candidates, including Alligator Bioscience AB, Crescendo Biologics Ltd., GlaxoSmithKline plc, Lava Therapeutics N.V., Molecular Partners AG, Precirix NV, Affibody Medical AB, Numab Therapeutics AG, GT Biopharma, Inc., and Sanofi;

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Our competitors also include other large pharmaceutical and biotechnology companies who already have marketing approval for, or may be developing therapeutic candidates withwith, mechanisms similar to or targeting the same indications as our therapeutic candidates.

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Our success largely depends on the continued service of key management, advisors and other specialized personnel, including Mark P. Lappe, our Chief Executive Officer, BrendanDavid P. Eckelman, Ph.D.,Matly, our Chief Scientific Officer,President, and Kelly D. Deck, our Chief Financial Officer, who are all employed at will and for whom we do not have “key man” insurance coverage. The loss of one or more members of our management team or other key employees or advisors could delay our research and development programs and have a material and adverse effect on our business, financial condition, results of operations and prospects. We are dependent on the continued service of our technical personnel because of the highly technical nature of our therapeutic candidates and technologies and the specialized nature of the marketing approval process. Our future success will depend in large part on our continued ability to attract and retain other highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, manufacturing, governmental regulation and commercialization. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations (many of whom have substantially greater financial resources than us), and we might not be able to attract or retain these key employees on conditions that are economically acceptable. Our inability to attract and retain these key employees could prevent us from achieving our objectives and implementing our business strategy, which could have a material adverse effect on our business and prospects.

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In January 2025, we borrowed a total of $100.0 million from Oxford under a loan and security agreement, or the 2025 Loan Agreement. In March 2026, we amended the 2025 Loan Agreement and borrowed an additional $75.0 million, for a total of $175.0 million. Our obligations under the 2025 Loan AgreementAgreement, as amended, are secured by substantially all of our assets. The 2025 Loan AgreementAgreement, as amended, requires us, and any debt arrangements or instruments we may enter into in the future may require us, to comply with various covenants that limit our ability to, among other things:

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We may incur additional indebtedness in the future. The instruments governing such indebtedness could contain provisions that are as, or more, restrictive than our existing debt instruments. Our obligations pursuant to the 2025 Loan AgreementAgreement, as amended, are secured by substantially all of our assets, including our intellectual property. If we are unable to repay, refinance or restructure our indebtedness when payment is due, the lenders could proceed against this collateral granted to them to secure such indebtedness or force us into bankruptcy or liquidation. Further, if our business is subject to liquidation, the right to repayment of Oxford and any other holders of indebtedness would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation.

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We are required to pay Former Parent for certain tax savings we may realize as a result of the Code Section 336(e) election made in connection with the Distribution.

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The Company and the Former Parent made a joint election under Section 336(e) of the Code and the applicable Treasury Regulations thereunder with respect to the Distribution, or the Section 336(e) Election. As a result of the Section 336(e) Election, for U.S. federal income tax purposes, the Company’s assets were generally deemed to have been sold in a taxable sale, which gave rise to a related step-up in the tax basis of such assets existing at the time. The Separation and Distribution Agreement requires the Company to make annual payments to the Former Parent equal to 85 percent of the Company’s actual cash tax savings, as and when realized, from such step-up in tax basis, or the Realized Tax Benefit. The calculation of Realized Tax Benefits is determined based on various assumptions set forth in the Separation and Distribution Agreement and in certain cases may exceed the actual cash tax savings the Company realizes. The payments that we may be required to make under the Separation and Distribution Agreement could be substantial.

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We anticipate that we will incur significant losses for the foreseeable future. Our ability to utilize net operating loss, or NOL, carryforwards and certain other tax attributes (if any) to offset future taxable income or tax liabilities (if any) may be limited as a result of ownership changes. Under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change” may be subject to limitations on its ability to utilize its pre-change NOLs and other tax attributes otherwise available to offset future taxable income and/or tax liability. An ownership change is generally defined as a cumulative change of 50 percentage points or more in the ownership positions of certain stockholders or groups of stockholders during a rolling three-year period. It is possible that the Company has experienced ownership changes in the past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control). Corresponding rules may apply under state tax laws. Even if there is no limitation on utilization of our NOL carryforwards as the result of an ownership change, utilization of U.S. federal NOL carryforwards is limited and may reduce taxable income in a given year by no more than 80% of the pre-NOL taxable income in such year. In addition, at the state level, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited. If we earn taxable income in a future year, such limitations on utilization of NOL carryforwards could result in increased future tax liability to us and our future cash flows could be adversely affected. Additionally, we use our best judgment in attempting to quantify and reserve for these tax obligations. However, a challenge by a taxing authority, our ability to utilize tax benefits such as carryforwards or tax credits, or a deviation from other tax-related assumptions may cause actual financial results to deviate from previous estimates.

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We may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development and regulatory affairs, as well as sales and marketing toin connection with the extentcommercialization of any of our therapeutic candidatescandidates, approachif receipt of marketing authorization.approved. To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

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CybersecuritySecurity breachesincidents or other compromises of our information technology environment could expose us to material liability, damage our reputation, compromise our confidential information or otherwise adversely affect our business.

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We maintain sensitive company data on our computer networks and third-party cloud services, including ourpersonal information, intellectual propertyproperty, and proprietary business information. We face a number of threats to our networks from unauthorized access, accidental acts or omissions that expose us to vulnerabilities, security breaches and other system disruptions. Our third-party partners, including CROs and providers of data hosting or cloud services, as well as suppliers, distributors, alliances, and other third-party service providers, face similar risks, which could affect us directly or indirectly.

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We are increasingly dependent upon our technology systems to operate our business and our ability to effectively manage our business depends on the security, reliability and adequacy of our technology systems and data, which includes use of cloud technologies. A breakdown, invasion, corruption, destruction or breach of our technology systems, including the cloud technologies that we utilize, and/or unauthorized access to our data and information could subject us to liability orliability, negatively impact the operation of our business.business, result in regulatory investigations or actions, litigation, fines and penalties, reputational harm, or other adverse consequences. Our technology systems, including the cloud technologies that we utilize, continue to increase in multitude and complexity, making them potentially vulnerable to breakdown, malicious intrusion and random attack. Likewise, data privacy or security breaches by individuals authorized to access our technology systems, including the cloud technologies that we utilize, may pose a risk that sensitive data, including intellectual property, trade secrets, personal information or preclinical or clinical trial data belonging to us, our clinical trial participants, or other business partners,data, may be exposed to unauthorized persons or to the public.

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Cyberattacks are increasing in their frequency, sophistication and intensity, and are becoming increasingly difficult to detect. They are often carried out by motivated, well-resourced, skilled and persistent actors, including nation states, organized crime groups, “hacktivistshacktivists,” andor employees or contractorsother actinginside with malicious intent.actors. Cyberattacks could include the deployment of harmful malware and key loggers, ransomware, a denial-of-service attack, a malicious website, the use of social engineering (such as phishing) and other means to affect the confidentiality, integrity and availability of our technology systems and data. Our key business partners and other third parties with whom we work face similar risks and any security breach of their systems or data could adversely affect our security posture.us. In addition, our increased use of cloud technologies could heighten these and other operational risks, and any failure by cloud technology service providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption, or loss of confidential or propriety information.

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The United States federal and all state and foreign governments have adopted or proposed requirements regarding the collection, distribution, use, security, and storage of personally identifiable information and other data relating to individuals, and federal and state consumer protection laws are being applied to enforce regulations related to the collection, use, and dissemination of data. Some of theseCertain federal, state and foreign government requirements include obligations of companies to notify individuals and others of security breaches involving certain personally identifiable information, which could result from breaches experienced by us or by our vendors, contractors, or organizations with which we have formed strategic relationships. Even though we may have contractual protections with such vendors, contractors, or other organizations, notifications and follow-up actions related to a security breach could impact our reputation, prompt regulatory scrutiny and enforcement, cause us to incur significant costs, including legal expenses, or cause us to incur remediation costs that could, under such circumstances, materially harm our business.

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Any such security breach may materially compromise information stored on our networks and may result in significant data losses or theft of our intellectual property or proprietary business information, it may also subject us to litigation, investigations, significant fines, penalties or liabilities for any noncompliance with certain privacy and security laws.laws or obligations. We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business, or reputational losses that may result from ansecurity interruptionincident of breach ofimpacting our systems.

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Our current operations are located in our facilities in La Jolla, California. Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, medical epidemics or pandemics, power shortage, telecommunication failure or other natural or man-made accidents or incidents, that results in us being unable to fully utilize our facilities, or the manufacturing facilities of our third-party contract manufacturers, may have a material and adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these facilities may result in increased costs, delays in the development of our therapeutic candidates or interruption of our business operations. Earthquakes, medical epidemics or pandemics or other natural disasters could further disrupt our operations, and have a material and adverse effect on our business, financial condition, results of operations and prospects. Certain of these natural disasters, including fires and severe weather events may be exacerbated by the effects of climate change. If a natural disaster, pandemic, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our research facilities or if similar events occurred elsewhere effecting the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which,which could have a material and adverse effect on our business. As part of our risk management policy, we maintain insurance coverage at levels that we believe are appropriate for our business. However, in the event of an accident or incident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to satisfy any damages and losses. If our facilities, or the manufacturing facilities of our third-party contract manufacturers, are unable to operate because of an accident or incident or for any other reason, even for a short period of time, any or all of our research and development programs may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects.

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The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the United States, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If we or any licensors encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished and we may face additional competition from others in those jurisdictions. Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries 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. If we or any licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position in the relevant jurisdiction may be impaired and our business and results of operations may be adversely affected.

Removed

In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position in the relevant jurisdiction may be impaired and our business and results of operations may be adversely affected.

Added

We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

Added

We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our product candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Added

Our current or future licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the U.S. government, such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

Added

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Added

Our employees can use generative artificial intelligence (“AI”) technologies in certain circumstances to perform portions of their work. There can be no assurance that employees will not inadvertently or improperly input information that is proprietary, confidential, or sensitive, including trade secrets, into AI systems in a manner that results in unauthorized disclosure or loss of confidentiality. Many generative AI tools are provided by third-party vendors, and we may have limited ability to control or verify how information submitted by employees is processed, stored, retained, or used by such providers, including whether such information may be incorporated into model training or otherwise accessed or disclosed. Any failure to adequately prevent the disclosure or misuse of our proprietary or confidential information, whether due to employee error, inadequate controls, evolving AI system functionality, or third-party practices, could result in the loss of trade secret protection and the disclosure of confidential information related to our inventions and product candidates, which could preclude us from obtaining patents covering disclosed inventions and product candidates, all of which could adversely affect our business.

Reworded

In particular, obtaining marketing approval for biological products requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the therapy candidate’s safety and efficacy, or with respect to biological products in the United States, such therapeutic candidate’s safety, purity and potency. Securing marketing approval also requires the submission of information about the product manufacturing process, and in many cases the inspection of manufacturing, processing, and packaging facilities by the regulatory authorities. Our therapeutic candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use, or there may be deficiencies in cGMPcGMPs or similar foreign requirements compliance by us or by our contract development and manufacturing organizations, or CDMOs, that could result in the candidate not being approved. Moreover, we have not obtained marketing approval for any therapeutic candidate in any jurisdiction and it is possible that none of our existing therapeutic candidates or any therapeutic candidates we may seek to develop in the future will ever obtain marketing approval.

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•the manufacturing processes orprocesses, facilities and testing sites of third-party manufacturers with which we contract for clinical and commercial supplies may fail to meet the requirements of the FDA or comparable foreign regulatory authorities; or

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ItEven though we plan to submit a BLA to the FDA for the approval of ozekibart in patients with metastatic or unresectable chondrosarcoma early in the second quarter of 2026, it may not be approved and it is possible that none of the other therapeutic candidates we may develop will obtain the marketing approvals necessary for us to sell the products either in the United States or any other country. Furthermore, approval by the FDA of a therapeutic product does not assure approval by regulatory authorities outside the United States or vice versa. Even if approval for a therapeutic product is obtained, such approval may be subject to limitations on the indicated uses or appropriate patient population that could result in a significantly reduced potential market size for the product.

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

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“While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments. Depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from the cost of work performed to date up to twelve months of future committed manufacturing costs. As of December 31, 2025, the noncancellable portion of these contracts totaled in aggregate, excluding amounts recorded in accounts payable and accrued expenses as of this date, approximately $15.9 million. …”
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“In October 2025, we announced this trial met its primary endpoint of a statistically significant and clinically meaningful median PFS for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. …”
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Net cash used in operating activities was $193.3$194.4 million during the year ended December 31, 20232024 and consisted primarily of a net lossincome of $241.4$1.7 million,billion, adjusted for non-cash itemsitems. includingNon-cash stock-basedadjustments compensationprimarily expenserelated to gains recorded upon the Merger of $24.8$2.0 million,billion. Other non-cash adjustments included accretion on our debt discount and the non-cash portion of interest expense related to our debt of $4.9$2.1 million, stock-based compensation expense, including expense related to the acceleration of options upon the Merger, of $58.5 million, depreciation and amortization of $1.2$2.3 million, and non-cash lease expense of $1.8$1.9 million. Non-cash revenue of $1.6 million earned in relation to the equity interest in Phylaxis received during the period was offset by the loss on equity method investment of $1.6 million reflecting our share of losses in Phylaxis. Changes in operating assets and liabilities also contributed to the cash used in operating activities, includingprimarily related to an increase in prepaidother expensesnon-current assets of $10.3$3.7 million, primarilymillion due to theprepayments prepaymentand foradditional clinicaldeposits drugwe substancemade manufacturing services atto our CDMOsCRO partners during the year.period. Additionally, the operating lease liability decreased by $1.9$1.4 million as a result of lease payments made throughout the year. Receivables increased by $0.5 million, primarily as a result of dividends earned and not received as of December 31, 2023. Deferred revenue decreased by $0.2 million following the recognition of $0.2 million of previously deferred revenue related to our former option agreement.period. These uses of cash were offset by an increaseincreases in accrued expenses and other current liabilities of $26.1$35.9 million andmillion, an increase in accounts payable of $2.1$17.9 million, primarilyand a decrease in prepaid expenses of $3.0 million due to the timing of clinicalpayments drug substance manufacturing services incurred atto our CDMOsCRO and clinicalCDMO activitiespartners incurredduring atthe ourperiod, CROs,each inof additionwhich toexcludes increasesthe in compensation-related accruals asliabilities related to employeeINBRX-101 bonuses.which were assumed by the Acquirer in the Merger.
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Net cash used in operating activities was $194.4$129.8 million during the year ended December 31, 20242025 and consisted primarily of a net incomeloss of $1.7$140.1 billion,million, adjusted for non-cash items.items, Non-cash adjustments primarily related to gains recorded upon the Merger of $2.0 billion. Other non-cash adjustments includedincluding accretion on our debt discount and the non-cash portion of interest expense related to our debt of $2.1$2.4 million, stock-based compensation expense, including expense related to the acceleration of options upon the Merger, of $58.5$11.1 million, depreciation and amortization of $2.3$2.5 millionmillion, and non-cash lease expense of $1.9$1.8 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, primarilyincluding relateda to an increasedecrease in other non-current assets of $3.7 million due to prepayments and additional deposits we made to our CRO partners during the period. Additionally, the operating lease liability decreasedof by $1.4$1.6 million as a result of lease payments made throughout the period. These uses of cash were offset by increases in accrued expensesperiod and other current liabilities of $35.9 million, an increasedecreases in accounts payable of $17.9$3.3 million,million and a decrease in prepaidaccrued expenses of $3.0$4.4 million due to the timing of payments to our CRO and CDMO partners during the period,period. eachThese uses of whichcash excludeswere offset in part by a decrease in prepaid expenses and other current assets of $1.4 million as a result of the liabilitiestiming relatedof payments to INBRX-101our whichCRO wereand assumedCDMO bypartners during the Acquirerperiod, as well as a decrease in theaccounts Merger.receivable and other receivables of $0.2 million.
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InOn JanuaryMay 29, 2024, Inhibrx, Inc., or the Former Parent, announced its intent, as approved by its board of directors, to effecteffected the spin-off of INBRX-101, an optimized, recombinant alpha-1 antitrypsin, or AAT, augmentation therapy in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency.deficiency, Onupon May 29, 2024,which, the Former Parent completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of our common stock of the Company,stock, or the Distribution. On May 30, 2024, the Former Parent completed a series of internal restructuring transactions, or the Separation.

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On May 30, 2024, the Former Parent completed the merger, or the Merger, of Art Acquisition Sub, Inc., a wholly-owned subsidiary of Aventis Inc., or the Acquirer, a wholly-owned subsidiary of Sanofi S.A., or Sanofi, with and into the Former Parent with the Former Parent continuing as the surviving entity. Pursuant to the Merger (i) all assets and liabilities primarily related to INBRX-101, or the 101 Business, were transferred to the Acquirer; and (ii) by way of the Separation, the Companywe acquired the assets and liabilities and corporate infrastructure associated with its ongoing programs, INBRX-106 and ozekibart (INBRX-109), and its discovery pipeline, as well as the remaining close-out obligations related to its previously terminated program, INBRX-105.

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From and after the closing, Inhibrx continues to operate as a stand-alone, publicly traded company focused on ozekibart (INBRX-109) and INBRX-106, both of which are clinical-stage programs.

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For periods prior to the spin-off, descriptions of historical business activities are presented as if the spin-off had already occurred, and the Former Parent’s activities related to such assets and liabilities had been performed by the Company.us. Refer to Note 1 to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the underlying basis used to prepare the consolidated financial statements. The operating results presented in the Company’sour historical financial statements prior to the Merger and in connection with the Separation and the Merger may not be indicative of theour results of the Company following the Merger and Separation.

Reworded

Our current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize our multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function:

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* Currently being investigated in chondrosarcoma, Ewing sarcoma, colorectal cancer, and colorectalcertain cancer.other solid tumor types.

Reworded

ozekibart (INBRX-109) ozekibart (INBRX-109) is a precisely engineered tetravalent death receptor 5, or DR5, agonist currently being evaluated in patients diagnosed with chondrosarcoma, colorectal cancer, Ewing sarcoma, and Ewing sarcoma.chondrosarcoma.

Added

In January 2025, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma, or CRC. Efficacy was assessed in 10 of the 13 patients evaluable as of the cutoff date of December 2, 2024, who received at least one dose of ozekibart, based on RECIST v1.1 criteria.

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Based on the interim data observed above, we initiated an expansion cohort enrolling 44 patients, as a fourth line of therapy for approximately 70% of patients and as a third line of therapy for approximately 30% of patients. 80% of patients had been previously treated with regimens containing irinotecan. Efficacy was assessed in 26 evaluable patients who had at least one post-baseline scan as of the cutoff date of October 15, 2025. Based on RECIST v1.1 criteria, a 23% overall response rate, or ORR, was observed and an overall disease control rate of 92% was observed.

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We plan to provide an update on the expansion cohort during the second quarter of 2026 when the PFS data is mature. If the current response and duration trends observed continue, we plan to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication.

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In November 2023, we announced interim efficacy and safety data from the cohort of the Phase 1/2 trial evaluating ozekibart in combination with Irinotecan, or IRI, and Temozolomide, or TMZ, for the treatment of advanced or metastatic, unresectable Ewing sarcoma. Overall, ozekibart in combination with IRI/TMZ was well tolerated from a safety perspective.

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Based on this preliminary data, the ongoing Phase 1/2 trial in the Ewing sarcoma cohort was expanded to enroll up to an additional 50 patients. In March 2026, we provided an update at the European Society for Medical Oncology (ESMO) Sarcoma and Rare Cancers Congress. Of the 31 patients evaluable based on a cutoff date of January 15, 2026, we observed a 64.5% ORR and a disease control rate of 87.1%. At the time of the presentation, responses were ongoing in eight patients, one of which had been on treatment and progression free for more than two years.

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We expect to complete enrollment in the Phase 1/2 trial of ozekibart in combination with IRI/TMZ for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in the second half of 2026. If the current response and duration trends observed continue, we plan to meet with the FDA in the second half of 2026 to discuss an accelerated approval pathway for this indication.

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In June 2021, based on the initial Phase 1 data results, we initiated a registration-enablingrandomized, Phaseblinded, 2placebo-controlled, registrational trial forin thepatients treatmentwith ofmetastatic, unresectable or metastatic conventional chondrosarcomachondrosarcoma, which enrolled over 200 patients in total at 68 different sites worldwide and for which the United States Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, granted orphan drug designation for the treatment of chondrosarcoma in November 2021 and August 2022, respectively. The primary endpoint for this Phase 2 trial is progression-free survival, or PFS. Data from the registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma is expected during the third quarter of 2025.

Added

In October 2025, we announced this trial met its primary endpoint of a statistically significant and clinically meaningful median PFS for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.

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Following recent regulatory interactions, we plan to submit a biologics license application early in the second quarter of 2026.

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INBRX-106 is a hexavalent OX40 agonist currently being investigated as a single agent and in combination with KEYTRUDA® (pembrolizumab), a PD-1 blocking checkpoint inhibitor, in patients with locally advanced or metastatic solid tumors. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Added

In November 2025, we completed enrollment of the Phase 1/2 trial evaluating 34 patients in checkpoint inhibitor refractory or relapsed NSCLC, in combination with KEYTRUDA®. Primary endpoints for this cohort are objective response rate, or ORR, disease control rate, or DCR, duration of response, or DOR, and safety.

Removed

In November 2023, we announced interim efficacy and safety data from the cohort of the Phase 1 trial evaluating ozekibart (INBRX-109) in combination with Irinotecan, or IRI, and Temozolomide, or TMZ, for the treatment of advanced or metastatic, unresectable Ewing sarcoma. Overall, ozekibart (INBRX-109) in combination with IRI/TMZ was well tolerated from a safety perspective. Based on this preliminary data, the ongoing Phase 1/2 trial in the Ewing sarcoma cohort was expanded. Interim data on this cohort are anticipated during the second half of 2025.

Removed

In January 2025, we announced interim efficacy and safety data from the cohort of the Phase 1 trial evaluating ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma, or CRC. Efficacy was assessed in 10 of the 13 patients evaluable as of the cutoff date of December 2, 2024, who received at least one dose of ozekibart, based on RECIST v1.1 criteria. We have expanded recruitment of this cohort by 50 patients as a result of these preliminary findings in order to validate these findings in a more uniform patient population. Data on this cohort are anticipated in the third quarter of 2025.

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INBRX-106

Removed

INBRX-106 is a precisely engineered hexavalent sdAb-based therapeutic candidate targeting OX40, designed to be an optimized agonist of this co-stimulatory receptor. It is currently being investigated as a single agent and in combination with Keytruda in patients with locally advanced or metastatic solid tumors. Parts 1 and 3, dose escalation as a single agent and in combination with Keytruda, have been completed. We observed durable responses across multiple tumor types.

Removed

In Part 4 of the Phase 1/2 trial, we continue to enroll patients with NSCLC and HNSCC, both in combination with Keytruda. Primary endpoints for these cohorts are objective response rate, or ORR, disease control rate, or DCR, duration of response, or DOR, and safety. In addition, a new cohort has been initiated in NSCLC to evaluate chemotherapy when used in conjunction with the INBRX-106 and Keytruda combination. The primary endpoint for this cohort is safety. We expect to have a more mature dataset on these cohorts during the fourth quarter of 2025 and plan to provide an update at that time.

Reworded

In June 2024, a seamless Phase 2/3 clinical trial was initiated for INBRX-106 in combination with KeytrudaKEYTRUDA® as a first-line treatment for patients with locallocally advanced recurrent or metastatic head HNSCC. This trial recruitsrecruited patients who havehad not received prior checkpoint inhibitors and whose tumors expressexpressed a PDL-1 CPScombined positive score equal to or greater than 20. WeDuring planthe tofirst enrollquarter approximatelyof 602026, we completed enrollment of 68 patients in the Phase 2 portion with a primary endpoint of ORR supported by secondary endpoints of DOR, PFS, and safety. We expectplan to announceprovide initial dataresults onfrom the Phase 2 duringtrial in the fourthsecond quarter of 2025. If positive, we anticipate this data will ungate the Phase 3 portion, where we expect approximately 350 patients will be randomized to INBRX-106 or placebo in combination with Keytruda. The co-primary endpoints for the Phase 3 portion of the study will be PFS and overall survival.2026.

Added

If positive, we anticipate this data may ungate the Phase 3 portion, where we expect approximately 350 patients will be randomized to INBRX-106 or placebo in combination with KEYTRUDA®. The co-primary endpoints for the Phase 3 portion of the study are expected to be PFS and overall survival.

Reworded

•expenses incurred in connection with commercializationpre-commercialization and business development activity; and

Reworded

During the year ended December 31, 2024, we incurred increased G&A expenses in connection towith the Merger, including stock compensation expense upon acceleration of options, and other transaction costs, including legal, advisory, and consulting services. We do not expect these expenses to recur in future years. We expect certain of our G&A expenses will continue to increase in the future to support our continued research and development activities, including costs related to pre-commercialization and business development activities. Additionally, we will continue to incur other professional service fees, including but not limited to, legal costs associated with the filing, prosecution, and maintenance of our patents for our therapeutic candidates, and other legal matters, as well as costs associated with services for compliance, accounting, legal, regulatory, tax, investor and public relations.

Removed

Loss on Equity Method Investment

Removed

Our equity interest in Phylaxis BioScience, LLC, or Phylaxis, is accounted for as an equity method investment and the Company’s proportionate share of the net income or loss of Phylaxis is included as loss in equity method investment in the consolidated statement of operations.

Reworded

License fee revenue during the year ended December 31, 2025 was $1.3 million and consisted of revenue related to Scithera License Agreement which we recognized following the completion of the transfer of all licenses, related materials, and know-how. License fee revenue during the year ended December 31, 2024 was $0.2 million and consisted of revenue related to our license agreement with Regeneron Pharmaceuticals, Inc., which we recognized following the grant of two six-month extensions of the option term during the year, each for revenue of $0.1 million. License fee revenue during the year ended December 31, 2023 was $1.8 million and consisted of $1.6 million of revenue related to our agreements with Phylaxis and $0.2 million of revenue related to a former option agreement which was completed during 2023. The revenue under our Phylaxis arrangement was earned following the transfer of a second-generation compound to Phylaxis during the year ended December 31, 2023, upon which we received an additional 5% equity interest in Phylaxis, which we recognized as revenue at its fair value of $1.6 million. See Note 6 to our consolidated financial statements included elsewhere in this Annual Report for additional information on our license and collaboration agreements.

Reworded

Research and development expense increaseddecreased by $12.1$90.7 million from $191.6 million during the year ended December 31, 2023 to $203.7 million during the year ended December 31, 2024.2024 to $113.0 million during the year ended December 31, 2025. The overall increasedecrease was primarily due to the following factors:

Added

•clinical trial expense decreased by $12.3 million primarily due to decreased expenses following the spin-off of our INBRX-101 program, which occurred during the second quarter of 2024, and the termination of our INBRX-105 program during 2024, in addition to decreases in expenses in our ozekibart (INBRX-109) registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment ahead of our data readout. These decreases in expenses were offset in part by increases in our ongoing trials for INBRX-106, in which we opened additional sites and increased enrollment during the period;

Added

•contract manufacturing expense decreased by $36.1 million compared to the prior year, primarily attributable to increased expense in the prior year associated with the purchase of raw materials for our drug substance manufacturing and process development and manufacturing activities with one of our CDMO partners for our ozekibart program, as well as decreased expenses following the spin-off of our INBRX-101 program, which occurred during the second quarter of 2024;

Removed

•contract manufacturing expense decreased by $21.6 million due to the nature of the development and manufacturing activities performed during each period at our CDMO and CRO partners supporting our clinical and preclinical therapeutic candidates, primarily due to the divestiture of INBRX-101, for which we incurred significant expenses during the year ended December 31, 2023 related to large scale drug substance manufacturing services performed by one of our CDMO partners including the utilization of raw materials;

Removed

•clinical trial expense increased by $4.7 million primarily due to the expansion of our ongoing registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma and due to the expansion of our INBRX-106 Phase 1/2 trial and initiation of the Phase 2/3 trial for HNSCC, including expenses for in-house clinical trial support, as well as costs incurred for our registration-enabling Phase 2 trial for INBRX-101 for the treatment of emphysema due to AATD, prior to our spin-off of the INBRX-101 program during the period. These expenses were offset in part by reduced clinical expenses following the termination of our INBRX-105 program;

Reworded

•personnel-related expense increaseddecreased by $25.0$37.4 million, which was primarily related to $25.9 million in stock option expense recognized during 2024 upon the acceleration of outstanding options in connection with the closingclose of the MergerMerger, in addition to a decrease in headcount during the current period;

Reworded

•facility and equipment-related expense increased by $2.3$0.5 million, which was attributable to expensesprimarily related to capitalizedour softwareoperating placedlease in service during the periodexpense; and

Reworded

•other research and development expense increaseddecreased by $1.7$5.5 million, which was primarily attributable to ana increasedecrease in clinical-relatedcertain consultingnon-recurring expensessponsored research and thepreclinical purchaseactivities, as well as a decrease in purchases of lab supplies,supplies offsetand travel expenses following the decrease in partheadcount byduring decreasesthe incurrent costs associated with preclinical studies.period.

Reworded

G&A expense increaseddecreased by $98.5$104.6 million from $29.4 million during the year ended December 31, 2023 to $127.9 million during the year ended December 31, 2024.2024 to $23.3 million during the year ended December 31, 2025. The overall increasedecrease was primarily due to the following factors:

Reworded

•one-time expenses incurred in the prior year related to the Merger of $68.1 million, consisting of legal, advisory, and consulting services performed in connection to the transaction, and SEC filing fees in connection with filings related to the transaction;

Reworded

•personnel-related expenses increaseddecreased by $19.9$23.2 million, which was primarily related to $15.2 million in stock option expense recognized during 2024 upon the acceleration of outstanding options in connection with the close of the Merger, in addition to othera bonuses paiddecrease in connectionheadcount withduring the Mergercurrent period;

Reworded

•professional feesservices-related forexpenses related to legal servicesservices, increaseddecreased by $8.2$9.6 million, which was primarily attributable to coststhe incurredconclusion in connection withof legal proceedings, which have since concluded, finding us not liable for damages,proceedings and other intellectual property matters;matters.

Removed

•pre-commercialization expenses increased by $1.7 million, primarily related to increases in consulting services and scientific publications to support our commercial operations business intelligence strategies related to ozekibart (INBRX-109) and prior to the Merger, related to INBRX-101, in addition to a focus on patient advocacy and recruitment efforts, offset in part by a decrease in market research efforts following the disposition of INBRX-101; and

Removed

•facility and equipment-related expense increased by $0.6 million, which was primarily attributable to an increase in software subscriptions and tenant improvements during the current year.

Reworded

Gain related to transaction with Acquirer. During the year ended December 31, 2024, we earned $2.0 billion of other income, consisting of gains recorded in connection with the completion of the Merger. We recorded a gain of $1.7 billion related to Merger consideration for our outstanding common stock, warrants, and stock options, in addition to $211.3 million related to the extinguishment of our loan under an amended loan agreement with Oxford, or the Amended 2020 Loan Agreement, which loan was assumed by the Acquirer. In addition to the Acquirer assuming our outstanding debt, the Acquirer assumed outstanding assets and liabilities related to INBRX-101 upon the transaction, resulting in a gain of $14.5 million. The Acquirer also reimbursed us for or paid on our behalf $68.0 million of transaction costs related to the Merger, resulting in a gain. We dodid not expect futureearn income or gains in connection with the Merger during the year ended December 31, 2025 and do not expect to in future periods.

Reworded

Interest expense. Interest expense decreasedwas by $18.3 million from $31.8$12.2 million during the year ended December 31, 20232025, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, under which we had $100.0 million in outstanding principal during the period. Interest expense was $13.5 million during the year ended December 31, 2024, all of which relatesrelated to interest incurred and the amortization of debt discounts related to the Amended 2020 Loan Agreement.Agreement, Theunder decreasewhich we had $200.0 million in interestoutstanding expenseprincipal isduring the resultperiod ofprior theto its extinguishment of the Amended 2020 Loan Agreement in connection withupon the Merger. We did not incur any interest following the close of the Merger on May 30, 2024, the date upon which the Acquirer assumed our outstanding debt.

Reworded

Interest income. During the yearyears ended December 31, 2025 and December 31, 2024, we earned $7.5 million and $10.9 millionmillion, respectively, of interest income on our sweep and money market account balances. During the year ended December 31, 2023, we earned $11.9 million of interest income, of which $7.5 million related to interest earned on our sweep and money market account balances and $4.4 million related to the accretion of discount on investments in debt securities during the period.balances.

Reworded

Income tax expense was approximately $2,000 andduring $3,000each duringof the years ended December 31, 20242025 and December 31, 2023,2024, respectively. For the years ended December 31, 20242025 and December 31, 2023,2024, we have applied a 100% valuation allowance against our federal deferred tax assets since it is more likely than not that the deferred tax assets will not be realized.

Removed

Loss on Equity Method Investment

Removed

During the year ended December 31, 2023, we received an additional 5% equity interest in Phylaxis following the achievement of a milestone under our agreements. Upon receipt of the equity interest, we established an equity method investment at its fair value of $1.6 million. The loss on equity method investment during the year ended December 31, 2023 of $1.6 million consists of our share of losses from our investment in Phylaxis, which reduced our equity investment to zero. During the year ended December 31, 2024, we did not record any gain or loss on our equity method investment.

Added

In January 2025, we entered into the 2025 Loan Agreement with Oxford, upon which we received gross proceeds of $100 million. On March 18, 2026, we entered into the First Amendment to Loan and Service Agreement with Oxford, or the March 2026 Amendment. The March 2026 Amendment provides for an additional tranche, or the Term B Loans, in an aggregate principal amount of $75.0 million, upsized from $50.0 million originally available under the 2025 Loan Agreement prior to the March 2026 Amendment, $75.0 million of which was funded on the date of the March 2026 Amendment.

Removed

In January 2025, we entered into the 2025 Loan Agreement with Oxford, upon which we received gross proceeds of $100.0 million. The 2025 Loan Agreement provides for up to an additional $50.0 million to be funded upon our request and at Oxford’s sole discretion.

Reworded

Since our inception, we have devoted substantially all of our efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of our therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing our intellectual property portfolio, and raising capital to support and expand these activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. Our net income or losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities, as well as the timing of other corporate transactions. During the year ended December 31, 2024, we had net income of $1.7 billion following the closing of the Merger, and during the year ended December 31, 2023,2025, our net loss was $241.4$140.1 million. As of December 31, 2024,2025, we had an accumulated deficit of $106.1$246.2 million and cash and cash equivalents of $152.6$124.2 million.

Reworded

The process of conducting preclinical studies and testing therapeutic candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. Though we had net income during the year ended December 31, 2024 following the Merger, we expect to continue to incur net losses for the foreseeable future until, if ever, we have an approved product and can successfully commercialize it. We expect our research and development expenses to increase as we continue our development of, and seek marketing approvals for, our therapeutic candidates (especially as we move more candidates into later stages of clinical development), and begin to commercialize any approved products, if ever. At this time, we are preparing to proceed with the commercialization of certain of our therapeutic candidates, if ever approved. As a result, we will incur significant pre-commercialization expenses in preparation for launch, the outcome of which is uncertain. Additionally, if approved, we will incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. We also expect additional general and administrative expenses as we hire additional personnel and incur increased accounting, audit, legal, regulatory and compliance, investor and public relations expense to support our continued expansion.

Reworded

Until such time we, if ever, can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including strategic licensing and collaborations, strategic transactions, or other similar arrangements and transactions, and from time to time, we engage in discussions with potential acquirers regarding the disposition of one or more of our therapeutic candidates. If the Company does raise additional capital through public or private equity or convertible debt offerings, the ownership interests of its existing stockholders will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If the Company raises capital through additional debt financings, such as our 2025 Loan Agreement with Oxford, it may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt or making certain capital expenditures. To the extent that the Company raises additional capital through strategic licensing, collaboration or other similar agreements, it may have to relinquish valuable rights to its therapeutic candidates, future revenue streams or research programs at an earlier stage of development or on less favorable terms than it would otherwise choose, or to grant licenses on terms that may not be favorable to the Company. However, there can be no assurance as to the availability or terms upon which such finances or capital might be available in the future. If we are unable to secure adequate additional funding, we will need to reevaluate our operating plan and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, or relinquish rights to our intellectual property on less favorable terms than we would otherwise choose. These actions could materially impact our business, results of operations, financial condition, and prospects.

Added

While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments. Depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from the cost of work performed to date up to twelve months of future committed manufacturing costs. As of December 31, 2025, the noncancellable portion of these contracts totaled in aggregate, excluding amounts recorded in accounts payable and accrued expenses as of this date, approximately $15.9 million. The noncancellable purchase commitments relate to future contract manufacturing of drug supply for one of our therapeutic candidates.

Reworded

Net cash used in operating activities was $194.4$129.8 million during the year ended December 31, 20242025 and consisted primarily of a net incomeloss of $1.7$140.1 billion,million, adjusted for non-cash items.items, Non-cash adjustments primarily related to gains recorded upon the Merger of $2.0 billion. Other non-cash adjustments includedincluding accretion on our debt discount and the non-cash portion of interest expense related to our debt of $2.1$2.4 million, stock-based compensation expense, including expense related to the acceleration of options upon the Merger, of $58.5$11.1 million, depreciation and amortization of $2.3$2.5 millionmillion, and non-cash lease expense of $1.9$1.8 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, primarilyincluding relateda to an increasedecrease in other non-current assets of $3.7 million due to prepayments and additional deposits we made to our CRO partners during the period. Additionally, the operating lease liability decreasedof by $1.4$1.6 million as a result of lease payments made throughout the period. These uses of cash were offset by increases in accrued expensesperiod and other current liabilities of $35.9 million, an increasedecreases in accounts payable of $17.9$3.3 million,million and a decrease in prepaidaccrued expenses of $3.0$4.4 million due to the timing of payments to our CRO and CDMO partners during the period,period. eachThese uses of whichcash excludeswere offset in part by a decrease in prepaid expenses and other current assets of $1.4 million as a result of the liabilitiestiming relatedof payments to INBRX-101our whichCRO wereand assumedCDMO bypartners during the Acquirerperiod, as well as a decrease in theaccounts Merger.receivable and other receivables of $0.2 million.

Reworded

Net cash used in operating activities was $193.3$194.4 million during the year ended December 31, 20232024 and consisted primarily of a net lossincome of $241.4$1.7 million,billion, adjusted for non-cash itemsitems. includingNon-cash stock-basedadjustments compensationprimarily expenserelated to gains recorded upon the Merger of $24.8$2.0 million,billion. Other non-cash adjustments included accretion on our debt discount and the non-cash portion of interest expense related to our debt of $4.9$2.1 million, stock-based compensation expense, including expense related to the acceleration of options upon the Merger, of $58.5 million, depreciation and amortization of $1.2$2.3 million, and non-cash lease expense of $1.8$1.9 million. Non-cash revenue of $1.6 million earned in relation to the equity interest in Phylaxis received during the period was offset by the loss on equity method investment of $1.6 million reflecting our share of losses in Phylaxis. Changes in operating assets and liabilities also contributed to the cash used in operating activities, includingprimarily related to an increase in prepaidother expensesnon-current assets of $10.3$3.7 million, primarilymillion due to theprepayments prepaymentand foradditional clinicaldeposits drugwe substancemade manufacturing services atto our CDMOsCRO partners during the year.period. Additionally, the operating lease liability decreased by $1.9$1.4 million as a result of lease payments made throughout the year. Receivables increased by $0.5 million, primarily as a result of dividends earned and not received as of December 31, 2023. Deferred revenue decreased by $0.2 million following the recognition of $0.2 million of previously deferred revenue related to our former option agreement.period. These uses of cash were offset by an increaseincreases in accrued expenses and other current liabilities of $26.1$35.9 million andmillion, an increase in accounts payable of $2.1$17.9 million, primarilyand a decrease in prepaid expenses of $3.0 million due to the timing of clinicalpayments drug substance manufacturing services incurred atto our CDMOsCRO and clinicalCDMO activitiespartners incurredduring atthe ourperiod, CROs,each inof additionwhich toexcludes increasesthe in compensation-related accruals asliabilities related to employeeINBRX-101 bonuses.which were assumed by the Acquirer in the Merger.

Reworded

Net cash used in investing activities was $2.6 million$28,000 and $4.6$2.6 million during the years ended December 31, 20242025 and December 31, 2023,2024, respectively, and was related to capital purchases of software, leasehold improvements, and laboratory and office equipment.

Removed

Net cash provided by financing activities was $71.7 million during the year ended December 31, 2024 and consisted of proceeds of $71.7 million received from the exercise of stock options.

Showing the first 60 of 61 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-13 (period ending 2026-06-30) with 10-Q filed 2026-05-14 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

27new paragraphs
0removed paragraphs
1reworded paragraphs
22 → 1,925words in section

New heading “We depend heavily on the success of our therapeutic candidates, which are currently in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. If we are unable to advance our therapeutic candidates through clinical development, obtain marketing approval and ultimately commercialize our therapeutic candidates, or experience significant delays in doing so, our business will be materially harmed. Even if our therapeutic candidates receive regulatory approval and are commercialized, there is no assurance that our commercialization efforts will be successful.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: fine, regulation
“A clinical trial may be suspended, partially suspended or terminated by us, the IRBs overseeing such trials, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold or partial clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a …”
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New text
“We depend heavily on the success of our therapeutic candidates, which are currently in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. If we are unable to advance our therapeutic candidates through clinical development, obtain marketing approval and ultimately commercialize our therapeutic candidates, or experience significant delays in doing so, our business will be materially harmed. …”
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New text topics: investigation
“Before we can initiate clinical trials for any therapeutic candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about the candidate’s chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an Investigational New Drug Application, or IND, or similar regulatory submission. …”
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New text topics: labor
“Moreover, failure can occur at any time during the clinical trial process and our future clinical trial results may not be successful. If we experience additional delays or fail to develop or terminate development of a therapeutic candidate in our pipeline, we may not have the financial resources to continue development of, or to modify existing or to enter into new license or collaboration for, a therapeutic candidate. Other issues that may again delay or potentially prevent us from completing our ongoing and planned clinical trials, include:”
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New text topics: investigation
“•IRBs suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;”
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New text
“Even if we obtain approval of ozekibart, we may never be able to successfully commercialize the product or to meet our expectations with respect to revenues or profits. We have never marketed, sold or distributed for commercial use any pharmaceutical product. We are in the process of building the teams, infrastructure, systems, processes, policies, relationships and materials necessary for launch of ozekibart in the United States in chondrosarcoma. …”
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Full comparison: every changed paragraph (28)

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Reworded

ThereExcept for the risk factor set forth below, there have been no material changes to the risk factors set forth in Part I, Item 1A of our 2025 Annual Report.Report and in Part II, Item 1A of our Quarterly Report for the three months ended March 31, 2026.

Added

We depend heavily on the success of our therapeutic candidates, which are currently in various stages of development and may fail or suffer delays that materially and adversely affect their commercial viability. If we are unable to advance our therapeutic candidates through clinical development, obtain marketing approval and ultimately commercialize our therapeutic candidates, or experience significant delays in doing so, our business will be materially harmed. Even if our therapeutic candidates receive regulatory approval and are commercialized, there is no assurance that our commercialization efforts will be successful.

Added

We currently have no products on the market and our ability to achieve and sustain profitability depends on obtaining marketing approvals for and successfully commercializing our therapeutic candidates. We have two therapeutic candidates, ozekibart (INBRX-109) and INBRX-106, currently in active clinical trials. While our BLA for ozekibart in patients with metastatic or unresectable conventional chondrosarcoma has been filed and is under review by FDA, there is no assurance that we will be successful in our efforts to gain U.S. regulatory approval on the timeline we expect or at all. The FDA may not agree that the clinical and preclinical data we have generated to date are sufficient to gain regulatory approval to commercialize ozekibart in the United States. The FDA may, despite prior advice, determine that additional trials or data are necessary in order to obtain approval. Regulatory authorities may find fault with the data generated at our clinical sites or with the activities of our trial monitor or may disagree with our analyses of the results of our trials. Regulatory authorities may also identify deficiencies or other issues with our manufacturing or quality systems or processes. Any such findings or issues could require additional data or analyses or the need for changes to our systems or processes that could delay or prevent us from gaining approval of ozekibart. For example, during FDA clinical inspections in connection with review of the BLA, Form 483 observations have been issued to us and to some ChonDRAgon clinical investigators. While corrective and preventive actions have been implemented in conjunction with those inspectional observations by us and our investigators, there can be no assurance those observations do not contribute to delay of BLA review or issuance of a complete response letter.

Added

Clinical and preclinical development is expensive and can take many years to complete, and its outcome is inherently uncertain. We cannot guarantee that any clinical trials or preclinical studies will be conducted as planned, including whether we will be able to meet expected timeframes for data readouts, or completed on schedule, if at all, and failure can occur at any time during the trial or study process. Despite promising preclinical or clinical results, any therapeutic candidate can unexpectedly fail at any stage of clinical or preclinical development. The historical failure rate for therapeutic candidates in our industry is high, particularly in the earlier stages of development. Before obtaining marketing approval for the commercial distribution of our therapeutic candidates, we must conduct extensive preclinical tests and clinical trials to demonstrate sufficient safety and efficacy of our therapeutic candidates in patients.

Added

Before we can initiate clinical trials for any therapeutic candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about the candidate’s chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an Investigational New Drug Application, or IND, or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies for any therapeutic candidate before it allows us to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of our development programs.

Added

Moreover, failure can occur at any time during the clinical trial process and our future clinical trial results may not be successful. If we experience additional delays or fail to develop or terminate development of a therapeutic candidate in our pipeline, we may not have the financial resources to continue development of, or to modify existing or to enter into new license or collaboration for, a therapeutic candidate. Other issues that may again delay or potentially prevent us from completing our ongoing and planned clinical trials, include:

Added

•inability to generate sufficient preclinical toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

Added

•obtaining allowance or approval from regulatory authorities to commence a trial or reaching a consensus with regulatory authorities on trial design;

Added

•the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;

Added

•any failure or delay in reaching an agreement with contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

Added

•delays in identifying, recruiting and training suitable clinical investigators;

Added

•obtaining approval from one or more institutional review boards, or IRBs, or ethics committees at clinical trial sites;

Added

•IRBs suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;

Added

•changes or amendments to the clinical trial protocol;

Added

•clinical sites deviating from the trial protocol or dropping out of a trial;

Added

•failure by our CROs to perform in accordance with Good Clinical Practice, or GCP, requirements or applicable regulatory rules and guidelines in other countries;

Added

•manufacturing sufficient quantities of our therapeutic candidates, or in obtaining sufficient quantities of combination therapies for use in clinical trials;

Added

•subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including subjects failing to remain in our trials;

Added

•lack of adequate funding to continue a clinical trial, or costs being greater than we anticipate;

Added

•subjects experiencing severe or serious unexpected drug-related adverse effects;

Added

•occurrence of serious adverse events in trials of the same class of agents conducted by other companies that could be considered similar to our therapeutic candidates;

Added

•selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data;

Added

•delays or failure by our contract manufacturers or us to make any necessary changes to such manufacturing process, or failure of our contract manufacturers to produce clinical trial materials in accordance with cGMPs, regulations or other applicable requirements; and

Added

•third parties being unwilling or unable to satisfy their contractual obligations to us in a timely manner.

Added

The therapeutic candidates we pursue may not demonstrate the necessary safety or efficacy requirements for marketing approval.

Added

A clinical trial may be suspended, partially suspended or terminated by us, the IRBs overseeing such trials, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold or partial clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations, administrative actions or lack of adequate funding to continue the clinical trial. Clinical holds may be placed prior to a clinical trial even beginning, in order to address potential safety and risk concerns of regulatory authorities, and partial or complete clinical holds can be imposed at any time during a trial. For example, in early 2023, the ChonDRAgon trial of ozekibart was placed on partial clinical hold by the FDA, and the Former Parent paused patient enrollment in the trial, following the occurrence of a fatal serious adverse event (grade 5) of hepatotoxicity (or hepatic failure) triggering the predefined stopping rules built into the protocol. The FDA lifted the hold in April 2023 after the Former Parent amended the trial protocol to include additional screening criteria and to make other changes to address patients who may be at risk of significant hepatotoxicity. Furthermore, while we perform certain similar functions internally, we expect to rely on contract research organizations, or CROs, and clinical trial sites to ensure proper and timely conduct of our clinical trials and while we expect to enter into and have entered into agreements governing those CROs’ committed activities, we have limited influence over their actual performance.

Added

If we experience delays in the completion of, or termination of, any clinical trial of our therapeutic candidates, the commercial prospects of our therapeutic candidates may be harmed, and our ability to generate product revenue or receive royalties from any of these therapeutic candidates may be delayed. Any delays in completing our clinical trials may increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue. If we were to cancel the development of any of our therapeutic candidates, we may still be required to pay certain non-cancellable commitments to our CROs under the terms of our various CRO contracts. Any of these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval of our therapeutic candidates.

Added

Even if we obtain approval of ozekibart, we may never be able to successfully commercialize the product or to meet our expectations with respect to revenues or profits. We have never marketed, sold or distributed for commercial use any pharmaceutical product. We are in the process of building the teams, infrastructure, systems, processes, policies, relationships and materials necessary for launch of ozekibart in the United States in chondrosarcoma. If we receive regulatory approval to market or sell ozekibart or any of our other therapeutic candidates, if successfully developed and approved, but are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, or if we are unable to do so on commercially reasonable terms, our business, results of operations, financial condition and prospects will be materially adversely affected. There is no guarantee that we will be successful in our launch or commercialization efforts with respect to ozekibart or with respect to any other therapeutic candidate that may be approved in the future. We may encounter issues, delays or unexpected challenges in launching or commercializing ozekibart or any of our other therapeutic candidates, if approved. For example, our results may be negatively impacted if we have not adequately sized our field teams or our physician segmentation and targeting strategy is inadequate or if we encounter deficiencies or inefficiencies in our infrastructure or processes. We may encounter unexpected limitations in the scope, breadth, availability or amount of reimbursement covering ozekibart or our other therapeutic candidates, if approved, or other limitations or issues related to the price. We may face issues related to market acceptance and use of any of our therapeutic candidates, if approved. Any of these issues could impair our ability to successfully commercialize the product or to generate substantial revenues or profits or to meet our expectations with respect to revenues or profits.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

29new paragraphs
3removed paragraphs
23reworded paragraphs
5,796 → 6,870words in section

New heading “Comparison of the Six Months Ended June 30, 2026 and June 30, 2025”

New heading “License Fee Revenue”

New heading “Research and Development Expense”

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“Comparison of the Six Months Ended June 30, 2026 and June 30, 2025”
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“Research and Development Expense”
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“License Fee Revenue”
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New text topics: interest rate
“Interest income. During the six months ended June 30, 2026 and June 30, 2025, we earned $2.3 million and $4.5 million, respectively, of interest income related to interest earned on our sweep and money market account balances. The decrease in interest income is due to lower average cash balances and decreased interest rates.”
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Reworded topics: interest rate

Paragraph as it now reads, with added and removed wording marked:

Interest income. During the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, we earned $1.0$1.3 million and $2.3$2.1 million, respectively, of interest income related to interest earned on our sweep and money market account balances. The decrease in interest income is due to lower average cash balances and decreased interest rates.
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Paragraph as it now reads, with added and removed wording marked:

In January 2025, we entered into the 2025 Loan Agreement with Oxford Finance LLC, or Oxford, upon which we received gross proceeds of $100.0 million.million, or the Term A Loan. On March 18, 2026, we entered into the First Amendment to Loan and Security Agreement with Oxford, or the March 2026 Amendment, or collectively with the 2025 Loan Agreement, the Amended 2025 Loan Agreement.Amendment. The March 2026 Amendment provided for an additional tranche, or the Term B Loans,Loan, in an aggregate principal amount of $75.0 million, upsized from $50.0 million originally available under the 2025 Loan Agreement. Upon closing of the March 2026 Amendment, the Term B LoansLoan werewas funded and we received gross proceeds of $75.0 million. On July 15, 2026, we entered into the Second Amendment to Loan and Security Agreement with Oxford, or the July 2026 Amendment, or collectively with the 2025 Loan Agreement and the March 2026 Amendment, the Amended 2025 Loan Agreement. The July 2026 Amendment provides for the funding of up to an additional $325.0 million in gross proceeds, $100.0 million of which we received upon execution of the amendment, or the Term C Loan, with up to an additional $225.0 million to be funded in increments of $50.0 million or more upon the Company’s request and at the Lenders’ sole discretion, or the Term D Loan.
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Full comparison: every changed paragraph (55)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Added

During the second quarter of 2026, we initiated two additional Phase 1 cohorts in CRC: (1) a second line study investigating ozekibart in combination with Folfiri and Avastin, and (2) a third/fourth line study investigating ozekibart in combination with Lonsurf and Avastin. We expect to announce interim results from these cohorts during the first quarter of 2027. We plan to meet with the FDA in the fourth quarter of 2026 to discuss our plans to initiate a first-line registrational trial in CRC, as well as the potential for an accelerated regulatory pathway for ozekibart in fourth-line CRC.

Removed

We plan to meet with the FDA in the second half of 2026 to discuss the potential for an accelerated regulatory pathway for ozekibart in fourth-line colorectal cancer and to discuss plans to initiate a first-line registrational trial in CRC.

Reworded

We expect to complete enrollment in the Phase 1/2 trial of ozekibart in combination with IRI/TMZ for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in 2027. We are evaluating the second halfsubmission of 2026.clinical Ifdata to the currentNational responseComprehensive andCancer durationNetwork® trends observed continue, we plan(NCCN®) to meetconsider withozekibart thefor FDApotential inclusion in the secondNCCN halfGuidelines® ofas 2026a totreatment discuss the potentialoption for anEwing accelerated regulatory pathway for this indication.sarcoma.

Reworded

In June 2021, we initiated a randomized, blinded, placebo-controlled, registrational trial in patients with metastatic, unresectable conventional chondrosarcoma, which enrolled over 200 patients in total at 68 different sites worldwide and for which the United States Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, granted orphan drug designation for the treatment of chondrosarcoma in November 2021 and August 2022, respectively. The primary endpoint for this trial iswas PFS.

Reworded

WeIn submittedJune a2026, the FDA accepted for filing our biologics license application to the FDA in April 2026 for the potential approval of ozekibart in conventional chondrosarcoma.

Reworded

In May 2026, we announced positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106 in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent HNSCC. The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This representsrepresented a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes. The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

Reworded

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourththird quarter of 2026. We plan to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Reworded

Based on these promising early results, we aim to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in NSCLC later this quarter.NSCLC. We believe OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. Outside of combination with checkpoint inhibitors, we plan to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

Reworded

Interest expense. Interest expense consists of interest on our Amended 2025 Loan AgreementAgreement, as amended, with Oxford Finance LLC and other lenders, or collectively, Oxford.

Reworded

Comparison of the Three Months Ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025

Added

Revenue

Added

License fee revenue during the three months ended June 30, 2025 was $1.3 million and consisted of revenue related to our License and Assignment Agreement with Scithera, Inc., or the Scithera License Agreement, which we recognized following the completion of the transfer of all licenses, related materials, and know-how. We did not recognize any revenue during the three months ended June 30, 2026.

Reworded

Research and development expenses decreasedincreased by $11.7$1.6 million from $36.9$22.3 million during the three months ended MarchJune 31,30, 2025 to $25.2$23.9 million during the three months ended MarchJune 31,30, 2026. The overall decreaseincrease was primarily due to the following factors:

Removed

•clinical trial expense decreased by $4.1 million, primarily due to decreases in expenses associated with ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment;

Reworded

•contract manufacturing expense decreasedincreased by $6.5$1.6 million, primarilymillion due to the timing and completion of certain manufacturing activities required to support our clinical trials for ozekibart (INBRX-109) and INBRX-106INBRX-106, including the initiation of certain activities associated with our filing of the BLA for potential approval of ozekibart (INBRX-109) in conventional chondrosarcoma; and

Added

•clinical trial expense increased by $1.2 million due to the progression of our clinical trials for ozekibart (INBRX-109) and INBRX-106 and the timing of the completion of enrollment in our trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma;

Reworded

•personnel-related expense decreased by $0.8$0.6 million, which was primarily related to a decrease in headcount.headcount; and

Added

•other research and development expenses decreased by $0.5 million, primarily due to a decrease in clinical consulting services.

Added

General and administrative expenses increased by $1.8 million from $6.4 million during the three months ended June 30, 2025 to $8.2 million during the three months ended June 30, 2026. The overall increase was primarily due to the following factors:

Added

•pre-commercialization expenses increased by $1.6 million, which was primarily related to the progression of our potential commercialization strategy surrounding market access and launch and the development of communication materials for ozekibart (INBRX-109) in conventional chondrosarcoma; and

Added

•personnel-related expense increased by $0.4 million, which was primarily related to an increase in stock options outstanding during the period.

Removed

G&A expenses were $5.7 million and $6.0 million during the three months ended March 31, 2026 and March 31, 2025, respectively. Expenses remained consistent in each period with a slight decrease in personnel expenses as a result of a decrease in headcount.

Reworded

Interest expense. Interest expense was $3.5$5.7 million and $2.7$3.1 million during the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, respectively, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, as amended. $100.0We incurred increased interest expense on the $175.0 million was outstanding in principal outstanding during each period through the datethree ofmonths ended June 30, 2026 following the March 2026 Amendment, upon which we received an additional $75.0 million in principal.gross proceeds, as compared to the $100.0 million in principal outstanding during the three months ended June 30, 2025.

Reworded

Interest income. During the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, we earned $1.0$1.3 million and $2.3$2.1 million, respectively, of interest income related to interest earned on our sweep and money market account balances. The decrease in interest income is due to lower average cash balances and decreased interest rates.

Added

Comparison of the Six Months Ended June 30, 2026 and June 30, 2025

Added

The following table summarizes our condensed consolidated results of operations for each of the periods indicated (in thousands, except percentages):

Added

License Fee Revenue

Added

License fee revenue during the six months ended June 30, 2025 was $1.3 million and consisted of revenue related to our License and Assignment Agreement with Scithera, Inc., or the Scithera License Agreement, which we recognized following the completion of the transfer of all licenses, related materials, and know-how. We did not recognize any revenue during the six months ended June 30, 2026.

Added

Research and Development Expense

Added

The following table sets forth the primary external and internal research and development expenses (in thousands, except percentages):

Added

Research and development expenses decreased by $10.0 million from $59.1 million during the six months ended June 30, 2025 to $49.1 million during the six months ended June 30, 2026. The overall decrease was primarily due to the following factors:

Added

•clinical trial expense decreased by $2.9 million, primarily due to a decrease in expense associated with the ozekibart (INBRX-109) trial for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment;

Added

•contract manufacturing expense decreased by $4.9 million primarily due to the timing and completion of certain manufacturing activities required to support our clinical trials for ozekibart (INBRX-109) and INBRX-106, offset in part by the initiation of certain activities associated with our filing of the BLA for potential approval of ozekibart (INBRX-109) in conventional chondrosarcoma;

Added

•personnel-related expense decreased by $1.4 million, which was primarily related to a decrease in headcount; and

Added

•other research and development expense decreased by $0.7 million, which was primarily attributable to a decrease in preclinical studies and the associated lab supplies and materials for research efforts.

Added

G&A Expense

Added

G&A expenses increased by $1.5 million from $12.5 million during the six months ended June 30, 2025 to $14.0 million during the six months ended June 30, 2026. The overall increase during the six months ended June 30, 2026, was primarily due to the following factors:

Added

•pre-commercialization expenses increased by $1.6 million, which was primarily related to the progression of our potential commercialization strategy surrounding market access and launch and the development of communication materials for ozekibart (INBRX-109) in conventional chondrosarcoma;

Added

•personnel-related expenses increased by $0.3 million, which was primarily related to an increase in stock options outstanding during the period; and

Added

•professional service fees decreased by $0.2 million, primarily due to a decrease in legal, accounting, and other consulting services.

Added

Other Expense

Added

Interest expense. Interest expense was $9.2 million and $5.8 million during the six months ended June 30, 2026 and June 30, 2025, respectively, all of which related to interest incurred and the amortization of debt discounts related to the 2025 Loan Agreement, as amended. We incurred increased interest expense on the $175.0 million in principal outstanding during the six months ended June 30, 2026 following the March 2026 Amendment, upon which we received an additional $75.0 million in gross proceeds, as compared to the $100.0 million in principal outstanding during the six months ended June 30, 2025.

Added

Interest income. During the six months ended June 30, 2026 and June 30, 2025, we earned $2.3 million and $4.5 million, respectively, of interest income related to interest earned on our sweep and money market account balances. The decrease in interest income is due to lower average cash balances and decreased interest rates.

Reworded

In January 2025, we entered into the 2025 Loan Agreement with Oxford Finance LLC, or Oxford, upon which we received gross proceeds of $100.0 million.million, or the Term A Loan. On March 18, 2026, we entered into the First Amendment to Loan and Security Agreement with Oxford, or the March 2026 Amendment, or collectively with the 2025 Loan Agreement, the Amended 2025 Loan Agreement.Amendment. The March 2026 Amendment provided for an additional tranche, or the Term B Loans,Loan, in an aggregate principal amount of $75.0 million, upsized from $50.0 million originally available under the 2025 Loan Agreement. Upon closing of the March 2026 Amendment, the Term B LoansLoan werewas funded and we received gross proceeds of $75.0 million. On July 15, 2026, we entered into the Second Amendment to Loan and Security Agreement with Oxford, or the July 2026 Amendment, or collectively with the 2025 Loan Agreement and the March 2026 Amendment, the Amended 2025 Loan Agreement. The July 2026 Amendment provides for the funding of up to an additional $325.0 million in gross proceeds, $100.0 million of which we received upon execution of the amendment, or the Term C Loan, with up to an additional $225.0 million to be funded in increments of $50.0 million or more upon the Company’s request and at the Lenders’ sole discretion, or the Term D Loan.

Reworded

Since our inception, we have devoted substantially all of our efforts to therapeutic drug discovery and development, conducting preclinical studies and clinical trials, enabling manufacturing activities in support of our therapeutic candidates, pre-commercialization activities, organizing and staffing the Company, establishing our intellectual property portfolio, and raising capital to support and expand these activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. Our net income or losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities, as well as the timing of other corporate transactions. During the threesix months ended MarchJune 31,30, 2026 our net loss was $33.4$70.1 million. As of MarchJune 31,30, 2026, we had an accumulated deficit of $279.6$316.3 million and cash and cash equivalents of $161.7$133.3 million.

Reworded

Our lease for our laboratory and office space expires in 2028, with an option to extend for an additional three years. As of MarchJune 31,30, 2026, we had future minimum rental payments under these leases of $6.6$5.9 million, of which $2.9 million and $3.7$3.0 million are current and non-current, respectively. For more information regarding these lease agreements, refer to Note 67 to the unaudited condensed consolidated financial statements.

Reworded

Under the 2025 Loan Agreement, as amended, we are required to make interest only payments through February 2028, with all principal payments and final fee payments beginning in March 2028 and continuing through the maturity date of January 2030. As of MarchJune 31,30, 2026, we have a minimum obligation of $241.7$237.9 million of long-term debt, including minimum interest and final fee payments, of which $17.0$17.7 million and $224.7$220.2 million are current and non-current, respectively. For more information regarding the Amended 2025 Loan Agreement, refer to Note 3 to the condensed consolidated financial statements.

Reworded

We enter into contracts in the normal course of business with CROs related to our ongoing preclinical studies and clinical trials and with CDMOs for clinical supplies and manufacturing scale-up activities. These contracts are generally cancellable, with notice, at our option. We have recorded accrued expenses of approximately $11.0$6.6 million in our condensed consolidated balance sheets for expenditures incurred by CROs and CDMOs as of MarchJune 31,30, 2026.

Reworded

While these contracts are generally cancellable, some may contain specific activities that involve one or more noncancellable commitments. Depending on the timing and reasoning of the exit, certain termination penalties may apply and can range from the cost of work performed to date up to twelve months of future committed manufacturing costs. As of MarchJune 31,30, 2026, the noncancellable portion of these contracts totaled in aggregate, excluding amounts recorded in accounts payable and accrued expenses as of this date, approximately $15.8$15.9 million. The noncancellable purchase commitments relate to future contract manufacturing of drug supply for one of our therapeutic candidates.

Reworded

Net cash used in operating activities was $38.0$67.9 million during the threesix months ended MarchJune 31,30, 2026 and consisted primarily of a net loss of $33.4$70.1 million, adjusted for non-cash items, including accretion on our debt discount and the non-cash portion of interest expense related to our debt of $0.7$2.0 million, stock-based compensation expense of $2.7$5.8 million, depreciation and amortization of $0.5$1.1 million and non-cash lease expense of $0.5$1.0 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, including the decrease in operating lease liability of $0.5$1.1 million as a result of lease payments made throughout the period, and an increase in prepaid expenses and other current assets of $1.1$0.7 million and a decrease in accrued expenses of $10.2$9.8 million due to the timing of payments to our CRO and CDMO partners during the period. These uses of cash were offset in part by an increase in accounts payablespayable of $2.8$3.8 million during the period.

Reworded

Net cash used in operating activities was $35.9$65.8 million during the threesix months ended MarchJune 31,30, 2025 and consisted primarily of a net loss of $43.3$72.0 million, adjusted for non-cash items, including accretion on our debt discount and the non-cash portion of interest expense related to our debt of $0.5$1.2 million, stock-based compensation expense of $2.5$5.2 million, depreciation and amortization of $0.7$1.3 million and non-cash lease expense of $0.4$0.9 million. Changes in operating assets and liabilities also contributed to the cash used in operating activities, including the decrease in operating lease liability of $0.2$0.5 million as a result of lease payments made throughout the periodperiod, an increase in accounts receivables and theother decreasereceivables of $0.6 million, and decreases in accounts payable of $0.4 million. These uses of cash were offset by a decrease in accounts receivable of $0.2 million upon the collection of balances during the period, a decrease in prepaid expenses and other current assets of $0.7$1.0 million and an increase in accrued expenses of $2.9$1.4 million due to the timing of payments to our CRO and CDMO partners during the period. These uses of cash were offset in part by a decrease in prepaid expenses and other current assets of $1.0 million.

Reworded

Net cash used in investing activities was approximately $21,000 during the threesix months ended MarchJune 31,30, 2025, and was related to capital purchases of software and laboratory equipment. We did not use any cash in investing activities during the threesix months ended MarchJune 31,30, 2026.

Reworded

Net cash provided by financing activities was $75.5$77.1 million during the threesix months ended MarchJune 31,30, 2026, which consisted primarilyof of$75.0 million in net proceeds from the March 2026 Amendment from which we received $75.0 million in gross proceeds during March 2026, and $0.5$2.1 million in proceeds from the exercise of stock options. Net cash provided by financing activities was $99.8 million during the threesix months ended MarchJune 31,30, 2025, which consisted of net proceeds from the 2025 Loan Agreement which we entered into in January 2025.

Added

In light of the market value of our common stock held by non-affiliates as of June 30, 2026, we expect that we will no longer be an emerging growth company effective on December 31, 2026.

Added

In light of our annual revenue during 2025 and the market value of the shares of our common stock held by non-affiliates as of June 30, 2026, we expect that we will no longer be a smaller reporting company beginning with our Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2027. Based on recent SEC guidance, we will, however, continue to be a non-accelerated filer through at least our fiscal year ending December 31, 2027.

INBX insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 6 Form 4 filings (3 insiders, 5 trade dates, 52,500 shares, about $5.5M) and open-market sales in 2 filings (1 insider, 5 trade dates, 2,500 shares, about $279.0K). Net open-market shares: 50,000 (purchases minus sales); net value about $5.2M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-28Lappe Mark
Director, Chief Executive Officer
Open-market purchase 1,500$98.88 $148.3K737,548 SEC
2026-09-28Lappe Mark
Director, Chief Executive Officer
Open-market purchase 3,000$101.70 $305.1K740,548 SEC
2026-09-25Lappe Mark
Director, Chief Executive Officer
Open-market purchase 3,324$98.87 $328.6K733,872 SEC
2026-09-25Lappe Mark
Director, Chief Executive Officer
Open-market purchase 2,176$99.60 $216.7K736,048 SEC
2026-09-23Kayyem Jon Faiz
Director
Open-market purchase 5,000$100.00 $500.0K434,360 SEC
2026-09-16Kayyem Jon Faiz
Director
Open-market purchase 5,000$100.00 $500.0K429,360 SEC
2026-09-15Manhard Kimberly
Director
Open-market sale 500$105.05 $52.5K7,500 SEC
2026-09-14Manhard Kimberly
Director
Open-market sale 500$110.26 $55.1K8,000 SEC
2026-09-11Manhard Kimberly
Director
Open-market sale 500$111.78 $55.9K8,500 SEC
2026-09-09Manhard Kimberly
Director
Open-market sale 500$115.80 $57.9K9,000 SEC
2026-09-08Manhard Kimberly
Director
Open-market sale 500$115.14 $57.6K9,500 SEC
2026-09-08Kayyem Jon Faiz
Director
Open-market purchase 5,000$113.52 $567.6K424,360 SEC
2026-09-08Forsyth Douglas
Director
Open-market purchase 2,500$114.65 $286.6K227,064 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 500$108.24 $54.1K719,648 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 9,681$112.28 $1.1M730,548 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 1,219$111.88 $136.4K720,867 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 5,895$99.29 $585.3K711,443 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 6,605$100.64 $664.7K718,048 SEC
2026-09-08Lappe Mark
Director, Chief Executive Officer
Open-market purchase 1,100$107.12 $117.8K719,148 SEC

Well-known investors holding INBX (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Viking Global Investors (Andreas Halvorsen) COM2026-06-301,123,929$106.5M0.3%Reduced 22%
Millennium Management (Israel Englander) COM2026-06-30147,200$13.9M0.01%Reduced 55%
Renaissance Technologies COM2026-06-3062,201$5.9M0.01%Added 24%
Point72 Asset Management (Steve Cohen) COM2026-06-3026,011$2.5M0.0%New position
Citadel Advisors (Ken Griffin) COM2026-06-3033,157$2.2M—Sold out
D. E. Shaw & Co. COM2026-06-3022,322$2.1M0.0%Reduced 71%
AQR Capital Management (Cliff Asness) COM2026-06-3011,247$1.1M0.0%Added 34%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when INBX files, watchlists and downloadable comparisons.