INKT 10-K & 10-Q changes, risk factors and insider trading
MiNK Therapeutics, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1840229 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report, including our audited financial statements and the related notes, as well as our other public filings with the SEC, before deciding to invest in our common stock. If any of the following risks are realized, our business, financial condition, results of operations and prospects, as well as the price of our common stock, could be materially and adversely affected.”
New heading “Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials and studies involving our product candidates are not necessarily predictive of our future results. Our product candidates may not show favorable results in preclinical studies or clinical trials or receive marketing approval on a timely basis, if at all.”
New heading “Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.”
New heading “Interim, “topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.”
New heading “We may develop our product in combination with other therapies, which exposes us to additional risks”
New heading “We may conduct clinical trials for our product candidates outside of the U.S. and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business”
New heading “We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve marketing approval before us or develop adoptive cell therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.”
New heading “Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for or product candidates, if any and if approved, could limit our ability to market those products and decrease our ability to generate revenue.”
New heading “If we are required by the FDA to obtain clearance or approval of a companion diagnostic in connection with approval of any of our product candidates, and we do not obtain, or face delays in obtaining, FDA clearance or approval of such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.”
New heading “Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.”
New heading “The marketing approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.”
New heading “Even if we receive marketing approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.”
New heading “Disruptions at the FDA and other government agencies caused by, funding shortages, staffing limitations, or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.”
New heading “Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.”
New heading “Our existing collaboration arrangements and any that we may enter into in the future may not be successful and we may not realize the benefits of such relationships, which could adversely affect our ability to develop and commercialize our product candidates.”
New heading “Sales of substantial amounts of our common stock in the public market, or the perception that these sales may occur, could cause the market price of our common stock to decline.”
New heading “Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.”
New heading “Scrutiny on environmental, social, and governance (“ESG”) initiatives could increase our costs, harm our reputation and adversely impact our financial results.”
Removed heading “Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.”
Removed heading “We are very early in our development efforts and only have one product candidate in early stage clinical development. It will be many years before we commercialize a product candidate, if ever.”
Removed heading “Our business is highly dependent on our iNKT cell platform, and our product candidates will require significant additional testing before we can seek regulatory approval. We may not be successful in our efforts to identify and develop additional product candidates. Additional product candidates include, but are not limited to, iNKT cell products genetically engineered to express CARs and other modifications that are designed to enhance safety and efficacy. They may also include combinations with other drug substances such as small molecules and immuno-oncology antibodies. If these efforts are unsuccessful, we may never become a commercial stage company or generate any revenues.”
Removed heading “The data produced in our clinical trials of agenT-797 is at an early stage and future data may not show responses in patients treated or support continued development. In addition, the results ultimately obtained from our preclinical studies or other clinical trials for agenT-797 or any of our other product candidates may not be predictive of future results.”
Removed heading “We may not be able to submit INDs or the foreign equivalent outside of the United States to commence additional clinical trials for cell therapies on the timeframes we expect, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.”
Removed heading “We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop adoptive cell therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.”
Removed heading “Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business.”
Removed heading “If we are unable to successfully identify patients who are likely to benefit from therapy with any product candidates we develop, or experience significant delays in doing so, we may not realize the full commercial potential of any medicines we may develop.”
Removed heading “Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any medicines that we may develop.”
Removed heading “If our ongoing clinical trials of agenT-797 or any of our future trials fail to demonstrate safety and efficacy to our satisfaction and the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates.”
Removed heading “Even if we complete the necessary trials for agenT-797 or any other product candidates we may develop, the marketing approval process is expensive, time-consuming and uncertain. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, product candidates we may develop, and our ability to generate revenue will be materially impaired.”
Removed heading “Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our product candidates could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.”
Removed heading “Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our medicines, when and if any of them are approved.”
Removed heading “We may seek fast track, breakthrough or regenerative medicine advanced therapy designation by the FDA for product candidates but may be unable to obtain such designations. Even if such a designation is granted, it may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval.”
Removed heading “We may seek priority review designation by the FDA, but we may not be able to obtain such designation and, even if obtained, priority review may not lead to a faster regulatory review or approval process and, in any event, would not assure FDA approval of any product candidates we may develop.”
Removed heading “We are a “controlled company” within the meaning of the applicable rules of Nasdaq and, as a result, qualify for exemptions from certain corporate governance requirements. If we rely on these exemptions, you will not have the same protections afforded to stockholders of companies that are subject to such requirements.”
Removed heading “A significant portion of our total outstanding shares is restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.”
Largest changes
“To the extent that any disruption or security breach were to result in a loss of, or damage to, our or our third-party vendors’, collaborators’ or other contractors’ or consultants’ data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability including litigation exposure, penalties and fines, we could become the subject of regulatory action or investigation, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed. …”see in full comparison
“While to date no cybersecurity incidents have had a material impact on our operations or financial results, we cannot guarantee that material incidents will not occur in the future. …”see in full comparison
“We can give no assurance that material weaknesses will not be identified in the future. We continue to implement measures designed to improve our internal controls over financial reporting. A material weakness in our internal control over financial reporting could result in an increased probability of fraud, litigation from our stockholders, reduction in our ability to obtain financing, and require additional expenditures to remediate. …”see in full comparison
“If we or our collaborators, manufacturers or service providers fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to enforcement actions, which could affect our ability to develop, market and sell our product candidates successfully and could harm our reputation and lead to reduced acceptance of our products, if approved. Efforts to ensure that our current and future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. …”see in full comparison
“Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.”see in full comparison
“As a public company, we are required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting for each Annual Report on Form 10-K we file with the SEC. This assessment includes disclosure of any material weaknesses identified by our management in internal control over financial reporting. …”see in full comparison
Full comparison: every changed paragraph (398)
Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report, including our audited financial statements and the related notes, as well as our other public filings with the SEC, before deciding to invest in our common stock. If any of the following risks are realized, our business, financial condition, results of operations and prospects, as well as the price of our common stock, could be materially and adversely affected.
Our business is subject to a number of risks and uncertainties. The following summarizes factors that could have a material adverse effect on the Company’s business, reputation, results of operations, financial condition and stock price. The Company may not be able to accurately predict, control or mitigate these risks. Statements in this section are based on the Company’s beliefs and opinions regarding matters that could materially adversely affect the Company in the future and are not representations as to whether such matters have or have not occurred previously. The risks and uncertainties described below are not exhaustive and should not be considered a complete statement of all potential risks or uncertainties that the Company faces or may face in the future.
Our business is subject to a number of risks and uncertainties. The following is a summary of the principal risk factors described in this section:
Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and its financial condition and results of operations.
Our business is highly dependent on the success of our lead product candidate, agenT-797, and we may fail to develop agenT-797 successfully or be unable to obtain regulatorymarketing approval for it.
Allogeneic iNKT cells represent a novel approachesapproach to immunotherapy, which may result in significant challenges to the development, regulatorymarketing approval, and commercialization of product candidates.
Our business is highly dependent on our iNKT cell platform, and our product candidates will require significant additional testing before we can seek regulatorymarketing approval.
Serious adverse events, undesirable side effects or unexpected characteristics caused by our product candidates could delay or prevent regulatorymarketing approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
We may not be able to submit INDs or the foreign equivalent to commence additional clinical trials for cell therapies on the timeframes we expect.
We face significant competition and there is a possibility that our competitors may achieve regulatorymarketing approval before us or develop adoptive cell therapies that are safer or more advanced or effective than ours.
Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or policy changes could hinder their ability to review and approve new products in a timely manner.
Agenus owns a majoritysignificant portion of our common stock and will be able to exert control over specific matters subject to stockholder approval.
Our internal computer systems, or those of our third-party vendors, collaborators or other contractors or consultants, may fail or suffer security breaches.breaches, and we and certain of our third-party providers may experience cyberattacks and other incidents.
Sales of substantial amounts of our common stock in the public market, or the perception that these sales may occur, could cause the market price of our common stock to decline.
Unfavorable global economic conditions, including tariffs and trade policy changes, could adversely affect our business, financial condition or results of operations.
We have initiated three Phase 1 clinical trials for ourOur lead product candidate, agenT-797, is in clinical development, and all of our other product candidates remain in preclinical development. We do not have any products approved for sale and have not generated any revenue from product supplies or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we obtain marketing approval for a product candidate. We expect that it will be many years, if ever, before we have a product candidate that receives such approval. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a medicineproduct or medicinescandidate with significant market potential. This will require us to be successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those medicinesproduct candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements. Even if one or more of the product candidates we may develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the United States Food and Drug Administration (“FDA”) or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations and, even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.
Our primary source of funding prior to our initial public offering was through Agenus. As of December 31, 2024,2025, our cash balance was $4.6$13.4 million. We expect that our cash as of December 31, 2024,2025, plus anticipated fundingadditional from corporate transactions,funding, will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned.
We were formed in 2017 as a subsidiary of Agenus and have operated as a majority-owned subsidiary of Agenus since that time.Agenus. Our operations to date have been limited to organizing and staffing our company, business planning, identifying potential product candidates and undertaking clinical trials and preclinical studies, and some of these activities have been performed by Agenus pursuant to services agreements between the parties. We have initiated three Phase 1 clinical trials for agenT-797 and our other programs are still in the preclinical or research stage of development, where the risk of failure is high. We have not yet demonstrated an ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials;trials, obtain marketing approvals; manufacture a commercial-scale medicine,product, or arrange for a third party to do so on our behalf; or conduct sales and marketing activities necessary for successful commercialization. It takes many years to develop a new medicineproduct from the time it is discovered to when it is available for treating patients. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer independent operating history.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
We regularly maintain cash balances at third-party financial institutions, such as Silicon Valley Bank (“SVB”), in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. In March 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. Although all depositors of SVB retained access to all of their money, including funds held in uninsured deposit accounts, if another depository institution that holds our cash or cash equivalents is subject to other adverse conditions in the financial or credit markets, it could impact access to our invested cash or cash equivalents and could adversely impact our operating liquidity and financial performance. In addition, if any parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.
Our business is highly dependent on the success of our lead product candidate, agenT-797, which is our only product candidate in clinical development. We have a limited history of conducting clinical trials and may fail to develop agenT-797 successfully or be unable to obtain regulatorymarketing approval for it.
Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our agenT-797 and our other product candidates. We cannot guarantee that agenT-797agenT-797, will bedemonstrate safethe anddegree effective,of safety, purity, potency, or efficacy required by the FDA or other regulatory authorities, or will be approved for commercialization on a timely basis or at all. Although certain of our employees and consultants have prior experience with clinical trials, regulatorymarketing approvals and current Good Manufacturing Practice (“cGMP”) manufacturing,compliance, we have not previously completed any pivotal clinical trials or submitted a Biologics License Application (“BLA”) to the FDA, or similar regulatorymarketing approval filingsapplications to comparable foreign authorities, for any product candidate, and we cannot be certain that agenT-797 or any other product candidate will be successful in clinical trials or receive regulatorymarketing approval. The FDA and other comparable global regulatory authorities can delay, limit or deny approvalsuccess of aour product candidate for many reasons. Any delay in obtaining, or inability to obtain, applicable regulatory approvalcandidates will delaydepend oron harmseveral ourfactors, abilityincluding tothe successfully commercialize agenT-797 and materially adversely affect our business, financial condition, results of operations and growth prospects.following:
successful initiation and completion of preclinical studies with favorable results, including toxicology and other studies designed to be compliant with good laboratory practice (“GLP”), requirements;
allowance to proceed with clinical trials under Investigational New Drug applications (“INDs”), by the FDA, or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates;
successful initiation, enrollment and completion of clinical studies in accordance with good clinical practice (“GCP”), requirements and other applicable rules and regulations;
the frequency and severity of adverse events observed in clinical trials;
maintaining and establishing relationships with contract research organizations (“CROs”), and clinical sites for the clinical development of our product candidates;
demonstrating the safety purity, and potency, or efficacy of our product candidates to the satisfaction of the FDA and other applicable regulatory authorities;
receipt of marketing approvals from applicable regulatory authorities, including approvals of BLAs from the FDA, and maintaining any such approvals;
making arrangements with third-party manufacturers for, or establishing, clinical or commercial manufacturing capabilities;
establishing sales, marketing and distribution capabilities and launching commercial sales of our product candidates, if and when approved, either alone or in collaboration with others;
obtaining, establishing and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates;
maintaining an acceptable safety profile of our product candidates following marketing approval, if any;
maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell our product candidates, if approved; and acceptance of our product candidates, if approved, by patients, the medical community and third-party payors.
Furthermore, because agenT-797 is our most advanced product candidate and our only product candidate in a clinical trial,development , and because our other product candidates are based on similar technology, if our clinical trials of agenT-797 encounter safety, efficacy or manufacturing problems, development delays, regulatory issues or other problems, our development plans for agenT-797 and our other product candidates in our pipeline could be significantly impaired, which could materially adversely affect our business, financial condition, results of operations and growth prospects.
The success of our business, including our ability to finance our company and generate any revenue in the future, will primarily depend on the successful development, marketing approval and commercialization of agenT-797 and our other product candidates, which may never occur. In the future, we may also become dependent on other product candidates that we may develop or acquire; however, given our stage of development, it may be several years, if at all, before we have demonstrated the safety, purity, and potency (or efficacy) of a candidate sufficient to warrant approval for commercialization. If we are unable to develop, or obtain marketing approval for, or, if approved, successfully commercialize our product candidates, we may not be able to generate sufficient revenue to continue our business.
We intend to develop our product candidates both as monotherapy and potentially as combination therapy, a common form of cancer treatment, with one or more currently approved cancer therapies. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the United States could revoke approval of the combination therapy used with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies. This could result in our own products being removed from the market or being less successful commercially.
We may also evaluate our product candidates in combination with one or more other cancer therapies that have not yet been approved for marketing by the FDA or similar regulatory authorities outside of the United States. If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval, or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with any product candidate we develop for our combination therapy, we may be unable to obtain approval of or market our product candidates.
We have concentrated our research and development efforts on utilizing allogeneic iNKT cells as ana potential immunotherapy. To date, the FDA has approved only a few adoptive cell therapies for commercialization and no allogeneic iNKT cell therapy has been approved for commercial use by any regulatory authority. The processes and requirements imposed by the FDA or other applicable regulatory authorities may cause delays and additional costs in obtaining approvals for marketing authorization for our product candidates. Because our allogeneic iNKT cell platform productsproduct candidates are novel, and adoptive cell therapies are relatively new, regulatory agencies may lack experience in evaluating product candidates like our iNKT cell product candidates, including our lead product candidate, agenT-797. This novelty may heighten regulatory scrutiny of our therapies or lengthen the regulatory review process, including the time it takes for the FDA to review our INDs if and when submitted, increase our development costs and delay or prevent commercialization of our allogeneic iNKT cell platform products.
sourcing starting material suitable for clinical and commercial manufacturing; and establishing sales and marketing capabilities to successfully launch and commercialize our product candidates if and when we obtain any required regulatorymarketing approvals, and risks associated with gaining market acceptance of a novel therapy if we receive approval, as well as developing a manufacturing process and distribution network to support the commercialization of any approved products.
Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials and studies involving our product candidates are not necessarily predictive of our future results. Our product candidates may not show favorable results in preclinical studies or clinical trials or receive marketing approval on a timely basis, if at all.
Preclinical and clinical drug development is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the preclinical study or clinical trial process. Despite promising preclinical or clinical results, any product candidate can unexpectedly fail at any stage of preclinical or clinical development. 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, and the historical failure rate for product candidates in our industry is high.
The results from preclinical studies or early clinical trials of a product candidate may not predict the results of later clinical trials of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials. In particular, while we have conducted certain clinical studies evaluating agenT-797, we do not know whether our product candidates will perform similarly in future clinical trials. It is not uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials, and many product candidates fail in clinical trials despite very promising early results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses.
For the foregoing reasons, we cannot be certain that our ongoing and planned clinical trials and preclinical studies will be successful. Any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for marketing approval of our product candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations.
Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
Before obtaining approval from the FDA or other regulatory authorities for the commercialization of any of our product candidates, we must conduct extensive clinical trials to demonstrate the safety purity, potency (or efficacy) of the product candidate in humans. Before we can initiate clinical trials for any product candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an IND or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies for any product 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 preclinical development programs. Moreover, even if we commence clinical trials, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Any such delays in the commencement or completion of our ongoing and planned clinical trials for our product candidates could significantly affect our product development timelines and product development costs and harm our financial position.
We do not know whether our planned clinical trials will begin on time or be completed on schedule, if at all. The timing for commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to:
inability to generate sufficient preclinical, toxicology, or other in vivo or in vitrodata to support the initiation or continuation of clinical trials;
obtaining allowance or approval from regulatory authorities to commence a trial or reaching a consensus with regulatory authorities on trial design;
the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;
any failure or delay in reaching an agreement with 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;
delays in identifying, recruiting and training suitable clinical investigators;
obtaining approval from one or more institutional review boards (“IRBs”), or ethics committees at clinical trial sites;
IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
We are very early in our development efforts and only have one product candidate in early stage clinical development. It will be many years before we commercialize a product candidate, if ever.
We are very early in our development efforts. Our future success depends heavily on the successful development of our product candidates. Currently, with the exception of agenT-797, which is in three Phase 1 clinical trials, all of our other product candidates are in preclinical development or in discovery. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates. Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates, which may never occur. We currently generate no revenue from sales of any product and we may never be able to develop or commercialize a marketable product.
Commercialization of our product candidates will require additional preclinical and/or clinical development; regulatory and marketing approval in multiple jurisdictions, including by the FDA and the European Medicines Agency (“EMA”); obtaining manufacturing supply, capacity and expertise; building of a commercial organization; and significant marketing efforts. The success of product candidates we may identify and develop will depend on many factors, including the following:
sufficiency of our financial and other resources to complete the necessary preclinical studies, IND-enabling studies and clinical trials;
successfulchanges enrollmentor in,amendments andto completion of,the clinical trialstrial protocol;
clinical sites deviating from the trial protocol or dropping out of a trial;
Management's Discussion & Analysis (MD&A)
New heading “You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes included elsewhere in this Form 10-K. This discussion contains forward-looking statements based upon current plans, expectations and beliefs involving risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and in other parts of this Form 10-K.”
Largest changes
“You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes included elsewhere in this Form 10-K. This discussion contains forward-looking statements based upon current plans, expectations and beliefs involving risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and in other parts of this Form 10-K.”see in full comparison
“Our pipeline is advancing next-generation allogeneic, engineered iNKT programs. Our two most advanced engineered programs are (1) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT and (2) MiNK-413, an IL-15 armored CAR-iNKT program targeting BCMA program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. …”see in full comparison
“On July 15, 2025, we entered into a Sales Agreement with B. Riley Securities, Inc., as sales agent (the “Sales Agent”) to sell shares of our common stock, from time to time through the Sales Agent, at a maximum aggregate offering price of $50.0 million. The issuances and sales under the Sales Agreement are pursuant to our registration statement on Form S-3 (File No. …”see in full comparison
“In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen ("BCMA"), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. …”see in full comparison
“In December 2023, we announced a collaboration with ImmunoScape, Inc. ("ImmunoScape") to discover and develop next-generation T-cell receptor therapies against novel targets in solid tumors. We will combine our unique, proprietary library of T cell antigens with ImmunoScape’s platform for rapid discovery of novel T cell receptors. ImmunoScape’s unique Deep Immunomics platform enables high-throughput and sensitive screening of T cells against relevant tumor targets for the rapid discovery of rare, therapeutically-relevant T-cell receptors (“TCRs”). …”see in full comparison
“In inflammatory diseases, we have completed a phase 1 study of agenT-797 in viral ARDS, leveraging the unique anti-inflammatory properties of iNKT cells. Results from our Phase 1 study were published in Nature Communications and presented at the American Thoracic Society International Conference over the past two years. We reported an encouraging survival benefit of 75%, compared to approximately 10-22% in an in-hospital control group and time-matched data from the Centers for Disease Control and Prevention. …”see in full comparison
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You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes included elsewhere in this Form 10-K. This discussion contains forward-looking statements based upon current plans, expectations and beliefs involving risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and in other parts of this Form 10-K.
MiNK Therapeutics, Inc. (“we,” “us,” “our,” or “Company” ) is focused on developing innovative treatments for cancer and immune-mediated diseases using allogeneic, ex-vivo expanded invariant natural killer T ("iNKT") cells. Amid a broader industry renaissance in innate immunity—highlighted by surging investment and clinical activity in NK, γδ T, and iNKT-based therapies—iNKT cells represent a distinct T cell (“T”) population that uniquely bridges innate and adaptive immunity. They combine durable memory responses characteristic of adaptive T cells with rapid, MHC-independent rapid cytolytic capabilities of natural killer ("NK") cells. This dual functionality enables direct tumor killing via CD1d and stress ligands, potent orchestration of the tumor microenvironment through activation of dendritic cells and NK cells, elimination of immunosuppressive myeloid populations, and restoration of exhausted T-cell function—all while naturally suppressing graft-versus-host disease ("GvHD"). This unique combination positions iNKT cells as an optimal platform for allogeneic therapy, given their natural homing capabilities, tumor clearance potential, and efficacy against infected cells.
Our approach includes advancing both native and engineered iNKT cell therapies, leveraging a pipeline composed of wholly owned or exclusively licensed assets. Additionally, we have developed a proprietary personalized neoantigen library to facilitate personalized T Cell Receptor ("TCR") development. This library enables us to identify patient-specific tumor neoantigens, which we use to create highly tailored TCR-based therapies. By harnessing these personalized neoantigen libraries, we aim to enhance precision, efficacy, and overall therapeutic outcomes for patients with various cancers and immune-mediated diseases. Our goal is to discover, develop and commercialize novel allogeneic, off-the-shelf, iNKT cell therapies to treat cancer and other immune-mediated diseases with high unmet need. We are employing iNKT cells in their native form, through our lead program agenT-797, in diseases where iNKT cells have demonstrated activity and accelerated approval pathways exist. These indications include but are not limited critical pulmonary immune failure (including severe hypoxemic respiratory failure / pneumonia), GvHD, solid tumor cancers, and other severe immune-related diseases. Our discovery efforts are focused on applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including CRs, CAR-iNKTs (such as MiNK-215 (FAP-CAR-iNKT) and MiNK-413 (BCMA-CAR-iNKT), and INKT cell engager technology.
MiNK Therapeutics, Inc. (“we,” “us,” “our,” or “Company” ) is a clinical-stage biopharmaceutical company pioneering the discovery, development and manufacturing of allogeneic, off-the-shelf invariant natural killer T (“iNKT”) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (“NK”) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (“GvHD”). Our proprietary platform is designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. As such, we believe that our approach represents a highly versatile application for therapeutic development in cancer and immune diseases. We are leveraging our platform and manufacturing capabilities to develop a wholly owned or exclusively licensed pipeline of both native and engineered iNKT cells.
Our business activities include product research and development, manufacturing, regulatory and clinical development, corporate finance, and support of our collaborations. To be successful, our product candidates require clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. We are a party to an Amended and Restated Intercompany Services Agreement (the “New Intercompany Agreement”) and an Intellectual Property Assignment and License Agreement with Agenus Inc. ("Agenus"). Under the Amended and RestatedNew Intercompany Services Agreement, Agenus provides us with certain general and administrative support, including, without limitation, financial, facilities management, human resources and information technology administrative support, and we and Agenus provide each other with certain research and development services and other support services, including legal and regulatory support. We are also entitled to use Agenus’ business offices and laboratory space and equipment in exchange for us contributing a proportionate payment for the use of such facilities and equipment, and we will be covered by certain Agenus insurance policies, subject to certain conditions, including us paying the cost of such coverage. Under the Intellectual Property Assignment and License Agreement, Agenus exclusively assigned patent rights and know-how related to our technology to us. We also have a field-limited exclusive license under certain Agenus patents and know-how; and we retain the rights to expand a proprietary pipeline of products and technologies.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. Having treated nearly 100 patients with agenT-797 across oncology and critical pulmonary immune failure, we have generated mechanistic and clinical insights that support continued development of our iNKT platform beyond into pulmonary diseases and auto-immune diseases, including in graft-versus-host disease prevention.
Under the leadership of Dr. Terese C. Hammond, our Head of Inflammatory and Pulmonary Diseases, we are advancing a differentiated franchise in critical pulmonary immune failure with agenT-797, our off-the-shelf, allogeneic iNKT cell therapy.
Building on the foundational Phase 1/2 data published in Nature Communications in February 2024 — which demonstrated >70% 30-day survival (80% in the veno-venous extracorporeal membrane oxygenation (“VV-ECMO”) subgroup) in mechanically ventilated patients with severe viral ARDS versus ~10% in contemporaneous controls — we are now advancing agenT-797 in a randomized Phase 2 adaptive, placebo-controlled trial in patients with severe pneumonia and moderate-to-severe hypoxemic acute respiratory failure ("AHRF"). Our published results highlighted rapid inflammation resolution, rescue of exhausted T cells, and reduced secondary infections, supporting the broad therapeutic potential of iNKT cells in life-threatening respiratory conditions, including interstitial lung disease ("ILD").
In cancer, our Phase 1 clinical trial enrolled 34 patients evaluating agenT-797 in refractory solid tumor cancers, as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors, pembrolizumab and nivolumab. Updated data presented at SITC 2025 demonstrated durable clinical activity, including complete remissions and long-term survivors (>2–3+ years) in heavily pretreated, checkpoint-refractory cancers such as metastatic testicular cancer, gastric cancer, thymoma, cholangiocarcinoma, renal cell carcinoma, and adenoid cystic carcinoma, with median overall survival of approximately 23 months in combination with anti-PD-1. These data showed that agenT-797, both as monotherapy and in combination with anti-PD-1 agents, produced meaningful disease control in the majority of heavily pretreated patients, including reductions in target and non-target lesions and prolonged disease stabilization. A detailed case report describing a durable confirmed partial response (42% tumor reduction with progression-free survival exceeding nine months) in a patient with chemotherapy- and PD-1-refractory gastric cancer following a single infusion of agenT-797 was published in Oncogene in January 2024 (Hadfield et al., 2024). Subsequently, a separate case report published in Oncogene in 2025 described a complete clinical, radiologic, and biochemical remission in a patient with heavily pretreated metastatic testicular (germ cell) cancer following a single infusion of agenT-797 in combination with anti-PD-1 therapy; the patient remains without evidence of disease more than two years post-treatment (Garmezy et al., 2025). AgenT-797 also exhibited long-term persistence in peripheral blood (detected up to 6 months post-infusion), independent of HLA matching and without the need for lymphodepletion.
Building on these encouraging results, a Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center was initiated (NCT06251973), with the first patient dosed in February 2024. This study is evaluating the safety and efficacy of agenT-797 in combination with Agenus' botensilimab (an Fc-enhanced anti-CTLA-4 inhibitor) and balstilimab (anti-PD-1), together with ramucirumab and paclitaxel, in patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction ("GEJ") adenocarcinoma. Early translational data from the first patients in the ongoing Phase 2 combination study were presented at the inaugural AACR Advances in Cancer Immunotherapy (AACR IO) meeting in 2025. These data demonstrated that addition of agenT-797 to botensilimab and balstilimab drove robust immune activation, including elevated interferon-gamma (IFN-γ) levels, rapid tumor infiltration, CD8+ T-cell activation, and immune reprogramming in patients with PD-1-refractory gastroesophageal cancers. Additional data are expected in early 2026.
In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen ("BCMA"), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 reported therapeutic activity in non-small cell lung cancer models, which resulted in substantial tumor elimination and improved survival compared to T cells alone. MiNK has presented data that showcased MiNK-215’s activity in preclinical colorectal cancer models. In human organoid models of CRC with liver metastases, MiNK-215 potently enhanced tumor killing by T cells and was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell infiltration. Investigational new drug application (“IND”) enabling studies for MiNK-215 are underway.
With our vertically integrated manufacturing capabilities and experienced team, we are accelerating the development of accessible, off-the-shelf iNKT-based therapies with transformative potential across oncology, critical pulmonary immune failure, and GvHD.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. iNKTs are a potent class of immune cells and serve as master regulators of immune response, possessing the killing power of NK cells and the memory of T-cells. Our proprietary manufacturing platform enables the infusion of these cells in billion-fold quantities, equipping the immune system to combat cancer and other life-threatening diseases. We have successfully established and launched in-house iNKT cell manufacturing and product release capacity, capable of supplying over 5,000 doses annually through a U.S. Food and Drug Administration (“FDA”)-cleared, scalable, fully closed, and automated process.
Our clinical development of agenT-797 is advancing in multiple therapeutic areas of significant unmet needs. These include a Phase 2 trial in 2L gastric cancer and viral acute respiratory distress syndrome (“ARDS”) in populations of patients where there are critical gaps in current treatment options.
In solid cancers, we completed a Phase 1 clinical trial of agenT-797 in solid tumor cancers, both as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors pembrolizumab and nivolumab. The trial demonstrated durable clinical benefits with a tolerable safety profile across various heavily pre-treated solid tumors, including non-small cell lung cancer (“NSCLC”), testicular cancer, and gastric cancer. Notably, the median progression-free survival exceeded six months, with approximately 30% of patients experiencing durable disease stabilization, even in cancers refractory to prior therapies such as pembrolizumab and nivolumab. Building on these results, a randomized, Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center is actively enrolling. This trial aims to evaluate the clinical safety and efficacy of the combination of agenT-797, botensilimab (a novel Fc-enhanced CTLA-4 inhibitor), balstilimab (anti-PD-1), ramucirumab, and paclitaxel in patients with previously treated, advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma. The study, which is expected to enroll approximately 38 patients with advanced, unresectable, or metastatic forms of these cancers, is a priority program for us. Encouraging activity was observed with agenT-797 in both monotherapy and combination settings, with durable responses and disease stabilization, as presented at the American Association for Cancer Research (“AACR”) and more recently at the Society for Immunotherapy of Cancer (“SITC”) conference in November 2023.
In inflammatory diseases, we have completed a phase 1 study of agenT-797 in viral ARDS, leveraging the unique anti-inflammatory properties of iNKT cells. Results from our Phase 1 study were published in Nature Communications and presented at the American Thoracic Society International Conference over the past two years. We reported an encouraging survival benefit of 75%, compared to approximately 10-22% in an in-hospital control group and time-matched data from the Centers for Disease Control and Prevention. In a cohort of 21 patients on mechanical ventilation, survival rates exceeded 70%, with an 80% survival rate among those on venovenous extracorporeal membrane oxygenation. In addition to a survival benefit, agenT-797 improved lung function and significantly reduced inflammation and secondary infections, which are major contributors to comorbidity and mortality in intensive care units. Given the lack of approved therapies for ARDS, we plan to advance agenT-797 in viral ARDS through strategic collaborations and non-dilutive external financing into a randomized Phase 2 trial.
Our pipeline is advancing next-generation allogeneic, engineered iNKT programs. Our two most advanced engineered programs are (1) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT and (2) MiNK-413, an IL-15 armored CAR-iNKT program targeting BCMA program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 has demonstrated efficacy in NSCLC and melanoma preclinical models, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor specific CD8+ T cell infiltration through tumor stroma. These data and programs were presented at AACR in 2024, International Cancer Immunotherapy Conference in 2023, SITC in 2023, and the American Society of Cell and Gene Therapy in 2023. Most recently, preclinical data from MiNK-215 in microsatellite stability colorectal cancer liver metastases were presented at AACR 2024. This presentation highlighted MiNK-215’s potent anti-tumor activity, immune activation, and tumor stroma remodeling against this difficult-to-treat solid tumor setting. Investigational new drug (“IND”) enabling activities are underway we expect to submit an IND to the FDA in 2025.
In December 2023, we announced a collaboration with ImmunoScape, Inc. ("ImmunoScape") to discover and develop next-generation T-cell receptor therapies against novel targets in solid tumors. We will combine our unique, proprietary library of T cell antigens with ImmunoScape’s platform for rapid discovery of novel T cell receptors. ImmunoScape’s unique Deep Immunomics platform enables high-throughput and sensitive screening of T cells against relevant tumor targets for the rapid discovery of rare, therapeutically-relevant T-cell receptors (“TCRs”). We have a proprietary library of phospho-peptide neoantigens derived from a wide range of solid tumors and hematologic malignancies. In this collaborative effort, ImmunoScape will leverage its capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevant TCRs targeting the library of phospho-peptide antigens. We will further characterize these tumor-specific TCRs, leveraging our proprietary capabilities to analyze and select TCR candidates for optimal tumor targeting. Any intellectual property resulting from the arrangement would be jointly owned by the parties.
R&D expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs. R&D expense decreased 59%9% to $5.8 million for the year ended December 31, 2025 from $6.3 million for the year ended December 31, 2024 from $15.5 million for the year ended December 31, 2023.2024. This decrease iswas primarily due to a $1.8 million gain recorded from the forgiveness of certain previously recorded liabilities in 2024, decreased costs associated with both the timing of our clinical trials and pre-clinical activities,activities andas well as decreased personnel costs, primarily due to decreased headcount.
G&A expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreasedincreased 42%56% to $6.7 million for the year ended December 31, 2025 from $4.3 million for the year ended December 31, 2024 from $7.4 million for the year ended December 31, 2023.2024. This decreaseincrease iswas primarily due to decreasedan personnelincrease costs,in mainlyprofessional duefees toand decreasedthe shareincremental basedshare-based compensation expense andresulting decreasedfrom headcount.the option award modification approved by shareholders in June 2025.
Other expense increased to approximately $32,400 for the year ended December 31, 2025 from income increasedof $0.3approximately million$331,000 for the year ended December 31, 2024, fromprimarily dedue minimisto expenseforeign forcurrency exchange losses partially offset by the recognition of a refundable R&D tax credit in the UK in the year ended December 31, 20232025 to income of $0.3 million for the year ended December 31, 2024, due primarilycompared to the $185,000 gain recognized on the deconsolidation of a foreign subsidiary and the recognition of a refundable R&D tax credit in the UK,UK in the year ended December 31, 2024.
Interest income decreasedincreased $291,000$7,700 for the year ended December 31, 2024,2025, from income of $463,000 for the year ended December 31, 2023 to income of $173,000 for the year ended December 31, 2024,2024 to income of $180,000 for the year ended December 31, 2025, primarily due to decreasedincreased interest earned on our money market funds andpartially offset by interest expense accrued under the Note.related party note we issued to Agenus, under the Convertible Promissory Note Purchase Agreement (the “Note”).
On July 15, 2025, we entered into a Sales Agreement with B. Riley Securities, Inc., as sales agent (the “Sales Agent”) to sell shares of our common stock, from time to time through the Sales Agent, at a maximum aggregate offering price of $50.0 million. The issuances and sales under the Sales Agreement are pursuant to our registration statement on Form S-3 (File No. 333-268143) (the “2022 Registration Statement”) filed with the Securities and Exchange Commission on November 3, 2022, the base prospectus included in the 2022 Registration Statement, dated November 8, 2022, and a prospectus supplement, dated July 15, 2025. On November 7, 2025, we filed a registration statement on Form S-3 (File No. 333-291388) (the “2025 Registration Statement”) with the Securities and Exchange Commission to replace the 2022 Registration Statement when the 2025 Registration Statement is declared effective. We sold approximately 584,000 and 193,000 shares of our common stock pursuant to the Sales Agreement during the year ended December 31, 2025 and the period of January 1, 2026 through March 27, 2026, respectively, and received aggregate net proceeds totaling $17.5 million. As of March 27, 2026, approximately $32.0 million remained available under the Sales Agreement.
We havehad a Note outstanding as of December 31, 20242025 of $5.0 million in principal plus accrued and unpaid interest of approximately $79,000.$179,000. TheIn NoteJanuary provides2026, thatin weaccordance will pay Agenus on demandwith the principal amount outstanding, together with any unpaid interest, on or after January 1, 2026. In the eventterms of a qualified financing event, as described in the Note, at Agenus’ election, we must payrepaid the principal amount outstanding and any unpaid interest, eitherNote in full or in the form of equity securities.full.
Our cash and cash equivalents balance as of December 31, 20242025 was $4.6$13.4 million. We believe that our cash and cash equivalents balance, plus anticipated funding from corporate transactions,funding, will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. Because the completion of anticipated funding is not entirely within our control, we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Annual Report on Form 10-K. The financial statements have been prepared on a basis that assumes we will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
We may take advantage of these exemptions until the last day of the fiscal year following the fifth anniversary of our initial public offering or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company earlier if we have more than $1.235 billion in annual revenue, we have more than $700.0 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1.0 billion of non-convertible debt securities over a three-year period. For so long as we remain an emerging growth company, we are permitted, and intend, to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. We may choose to take advantage of some, but not all, of the available exemptions.
What changed in the latest 10-Q
Risk Factors
Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Quarterly Report and in other documents that we file with the SEC, you should carefully consider the factors described in the section titled "Risk Factors" in our Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes to the risk factors described in Part I, Item 1A of our 2025 Form 10-K. If any of the risk factors described in the Form 10-K actually materializes, our business, financial condition and results of operations could be materially adversely affected. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC.
No wording changes found in this section.
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Management's Discussion & Analysis (MD&A)
New heading “Six Months Ended June 30, 2026 Compared to the Six Months Ended June 30, 2025”
New heading “Research and development expense”
New heading “General and administrative expense”
New heading “Interest income, net”
Removed heading “Other income (expense), net”
Largest changes
“We are collaborating with Orphan Drug Consulting (ODC) to support physician-initiated requests for agenT-797 for individually identified patients. The program expands access for patients with serious unmet medical need and provides MiNK with program revenue for product supplied. Each request is initiated by the treating physician and remains subject to case-by-case Brazilian regulatory authorization. The program is not a commercial launch or marketing authorization. ODC supports local regulatory submissions, importation, cold-chain logistics and pharmacovigilance. …”see in full comparison
“Six Months Ended June 30, 2026 Compared to the Six Months Ended June 30, 2025”see in full comparison
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Our approach includes advancing both native and engineered iNKT cell therapies, leveraging a pipeline composed of wholly owned or exclusively licensed assets. Additionally, we have developed a proprietary personalized neoantigen library to facilitate personalized T Cell Receptor ("TCR") development. This library enables us to identify patient-specific tumor neoantigens, which we use to create highly tailored TCR-based therapies. By harnessing these personalized neoantigen libraries, we aim to enhance precision, efficacy, and overall therapeutic outcomes for patients with various cancers and immune-mediated diseases. Our goal is to discover, develop and commercialize novel allogeneic, off-the-shelf, iNKT cell therapies to treat cancer and other immune-mediated diseases with high unmet need. We are employing iNKT cells in their native form, through our lead program agenT-797, in diseases where iNKT cells have demonstrated activity and accelerated approval pathways exist. These indications include but are not limited critical pulmonary immune failure (including severe hypoxemic respiratory failure / pneumonia), GvHD, solid tumor cancers, and other severe immune-related diseases. Our discovery efforts are focused on applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including CRs,TCRs, CAR-iNKTs (such as MiNK-215 (FAP-CAR-iNKT) and MiNK-413 (BCMA-CAR-iNKT), and INKT cell engager technology.
Our most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. AgenT-797agenT-797 is currently in clinical trials for solid tumors, GvHD, and critical pulmonary immune failure. Having treated nearly 100 patients with agenT-797 across oncology and critical pulmonary immune failure, we have generated mechanistic and clinical insights that support continued development of our iNKT platform beyond oncology into pulmonary diseases and auto-immuneautoimmune diseases, including in graft-versus-host disease prevention.
We are collaborating with Orphan Drug Consulting (ODC) to support physician-initiated requests for agenT-797 for individually identified patients. The program expands access for patients with serious unmet medical need and provides MiNK with program revenue for product supplied. Each request is initiated by the treating physician and remains subject to case-by-case Brazilian regulatory authorization. The program is not a commercial launch or marketing authorization. ODC supports local regulatory submissions, importation, cold-chain logistics and pharmacovigilance. The product will be supplied on a paid, per-patient basis in accordance with applicable Brazilian access regulations. The program may result in non-promotional income to MiNK while establishing the operational infrastructure needed to support responsible access to agenT-797 in additional international markets.
In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen ("BCMA"), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 reported therapeutic activity in non-small cell lung cancer models, which resulted in substantial tumor elimination and improved survival compared to T cells alone. MiNK has presented data that showcased MiNK-215’s activity in preclinical colorectal cancer models. In human organoid models of colorectal cancer (CRC) with liver metastases, MiNK-215 potently enhanced tumor killing by T cells and was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell infiltration. Investigational new drug application (“IND”) enabling studies for MiNK-215 are underway.
Three Months Ended MarchJune 31,30, 2026 Compared to the Three Months Ended MarchJune 31,30, 2025
Research and development (“R&D”) expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs. R&D expense decreasedincreased 5%3% to $1.2$1.9 million for the three months ended MarchJune 31,30, 2026 from $1.3$1.8 million for the three months ended MarchJune 31,30, 2025. ThisThe decreaseincreased expense was primarily due to decreasedincreased costs associated with both the timing of our clinical trials and pre-clinical activities as well as decreasedincreased personnel costs, primarilypartially dueoffset by the credits applied in Q2 2026 related to decreasedpreviously headcount.billed clinical activities.
General and administrative (“G&A”) expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense increaseddecreased 32%28% to $1.7 million for the three months ended March 31, 2026 from $1.3 million for the three months ended MarchJune 31,30, 2026 from $1.8 million for the three months ended June 30, 2025. ThisThe increasedecreased expense was primarily due to ana increasedecrease in share-based compensation expense, professional fees and other G&A costs.
Other income (expense), net
Other incomeincome, net increased to approximately $58,600$16,000 for the three months ended MarchJune 31,30, 2026 from $80,000$186,000 of other expense for the three months ended MarchJune 31,30, 2025, primarily due to foreign currency exchange losses in the three months ended MarchJune 31,30, 2025, compared to foreign currency exchange gains in the three months ended MarchJune 31,30, 2026.
Interest incomeincome, net increased $67,300$72,500 for the three months ended MarchJune 31,30, 2026, from income of $14,000less than $1,000 for the three months ended MarchJune 31,30, 2025 to income of $81,000$73,000 for the three months ended MarchJune 31,30, 2026, primarily due to increased interest earned on our money market funds and the repayment of our related party note (the “Note”) in January 2026.
Six Months Ended June 30, 2026 Compared to the Six Months Ended June 30, 2025
Research and development expense
Research and development (“R&D”) expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of expert consultants, and administrative costs. There was no change in R&D expense for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.
General and administrative expense
General and administrative (“G&A”) expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreased 4% to $3.0 million for the six months ended June 30, 2026 from $3.1 million for the six months ended June 30, 2025. The decreased expense was primarily due to a decrease in share-based compensation expense, professional fees and other G&A costs.
Other income, net increased to approximately $74,000 for the six months ended June 30, 2026 from $265,000 of other expense for the six months ended June 30, 2025, primarily due to foreign currency exchange losses in the three months ended June 30, 2025, compared to foreign currency exchange gains in the three months ended June 30, 2026.
Interest income, net
Interest income, net increased $139,900 for the six months ended June 30, 2026, from income of $14,000 for the six months ended June 30, 2025 to income of $154,000 for the six months ended June 30, 2026, primarily due to increased interest earned on our money market funds and the repayment of our related party note (the “Note”) in January 2026.
We have incurred annual operating losses since inception in 2017, and we had an accumulated deficit of $159.4$162.5 million as of MarchJune 31,30, 2026. We expect to incur losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products.
On July 15, 2025, we entered into a Sales Agreement with B. Riley Securities, Inc., as sales agent (the “Sales Agent”) to sell shares of our common stock, from time to time through the Sales Agent, at a maximum aggregate offering price of $50.0 million. The issuances and sales under the Sales Agreement are pursuant to our registration statement on Form S-3 (File No. 333-268143) (the “2022 Registration Statement”) filed with the Securities and Exchange Commission on November 3, 2022, the base prospectus included in the 2022 Registration Statement, dated November 8, 2022, and a prospectus supplement, dated July 15, 2025. On November 7, 2025, we filed a registration statement on Form S-3 (File No. 333-291388) (the “2025 Registration Statement”) with the Securities and Exchange Commission to replace the 2022 Registration Statement. We sold approximately 193,000 and 13,100313,478 shares of our common stock pursuant to the Sales Agreement during the threesix months ended MarchJune 31,30, 2026 and the period of April 1, 2026 through May 13, 2026, respectively, and received aggregate net proceeds totaling $3.2$4.4 million. As of MayJune 13,30, 2026, approximately $31.8$30.6 million remained available under the Sales Agreement.
Our cash and cash equivalents balance as of MarchJune 31,30, 2026 was $9.5$8.8 million. Subsequent to the quarter end, we received $150,000 from the sales of common stock in at the market offerings. We believe that our cash and cash equivalents balance, plus anticipated funding, will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. Because the completion of anticipated funding is not entirely within our control, we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes we will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Management continually monitors the Company's liquidity position and adjusts spending as needed in order to preserve liquidity. To support our liquidity requirements we will require additional funding. Potential sources of additional funding include: (1) seeking strategic partnerships and collaborations, as well as out-licensing opportunities, for our portfolio programs and product candidates, (2) exploring avenues for securing non-dilutive financing, such as grants, collaborations, and providing fee-based services to strengthen our balance sheet, and (3) potential of equity or debt financing options.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 and 2025 was $1.7$3.8 million and $1.3$2.9 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, and our ability to enter into collaborations.
More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 as updated by Part II-Item 1A “Risk Factors” elsewhere in this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.statements other than as required by law.
INKT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 1 filing (1 insider, 1 trade date, 1,500 shares, about $19.1K). Net open-market shares: -1,500 (purchases minus sales); net value about -$19.1K.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 date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-01 | Wiinberg Ulf |
Grant/award | 1,279 | $10.95 | $14.0K |
| 2026-09-01 | Holcomb John Bradley |
Grant/award | 1,233 | $10.95 | $13.5K |
| 2026-09-01 | Behner Peter |
Grant/award | 1,485 | $10.95 | $16.3K |
| 2026-09-01 | Ryan Barbara |
Grant/award | 1,622 | $10.95 | $17.8K |
| 2026-09-01 | Corvese Brian |
Grant/award | 1,633 | $10.95 | $17.9K |
| 2026-06-04 | Ryan Barbara |
Open-market sale | 1,000 | $12.80 | $12.8K |
| 2026-06-04 | Ryan Barbara |
Open-market sale | 500 | $12.68 | $6.3K |
| 2026-06-01 | Holcomb John Bradley |
Grant/award | 1,091 | $12.38 | $13.5K |
| 2026-06-01 | Ryan Barbara |
Grant/award | 1,434 | $12.38 | $17.8K |
| 2026-06-01 | Corvese Brian |
Grant/award | 1,444 | $12.38 | $17.9K |
| 2026-06-01 | Behner Peter |
Grant/award | 1,313 | $12.38 | $16.3K |
| 2026-06-01 | Wiinberg Ulf |
Grant/award | 1,131 | $12.38 | $14.0K |
| 2026-03-02 | Holcomb John Bradley |
Grant/award | 1,239 | $10.90 | $13.5K |
| 2026-03-02 | Ryan Barbara |
Grant/award | 1,629 | $10.90 | $17.8K |
| 2026-03-02 | Corvese Brian |
Grant/award | 1,640 | $10.90 | $17.9K |
| 2026-03-02 | Behner Peter |
Grant/award | 1,491 | $10.90 | $16.3K |
| 2026-03-02 | Wiinberg Ulf |
Grant/award | 1,285 | $10.90 | $14.0K |
Well-known investors holding INKT (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 15,440 | $180.5K | 0.0% | New position |