{"url_path":"/sec/inkt/10-q/2026/item-2","section_key":"item-2","section_title":"Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations.","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-15","source_url":"https://www.sec.gov/Archives/edgar/data/1840229/0001193125-26-226804-index.html","accession_number":"0001193125-26-226804","cik":"0001840229","ticker":"INKT","issuer_name":"MiNK Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1840229/0001193125-26-226804-index.html","primary_entity_key":"0001840229","primary_entity_name":"MiNK Therapeutics, Inc."},"word_count":3677,"has_tables":true,"body_markdown":"Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.\n\nYou should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2025, included in our Form 10-K (the “Annual Report”) filed with the SEC on March 31, 2026. 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 in the section titled “Risk Factors” in our Annual Report as may be updated from time to time in our other filings with the SEC.\n\nOverview\n\nMiNK 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.\n\nOur 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.\n\nOur 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 New Intercompany 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.\n\nOur most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. AgenT-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 into pulmonary diseases and auto-immune diseases, including in graft-versus-host disease prevention.\n\nUnder 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.\n\n13\n\n \n\nBuilding 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\"). The study, which initiated in Lviv, Ukraine, in partnership with First Lviv Territorial Medical Union and UNBROKEN Ukraine, is designed to evaluate clinically meaningful ICU endpoints including survival, ventilator-free days, and secondary infections, with U.S. sites enrolling in parallel and preliminary data expected in the second half of 2026. 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\"). Data presented at ASGCT 2026 in May 2026 further demonstrated that agenT-797 produces context-dependent immune reprogramming—driving anti-inflammatory benefit in ARDS from the same manufacturing donor batch, without genetic engineering—supporting its broad therapeutic potential in life-threatening respiratory conditions, including interstitial lung disease (“ILD”) and idiopathic pulmonary fibrosis (“IPF”).\n\nIn 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.\n\nBuilding on these encouraging results, a Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center was initiated (NCT06251973), 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. Updated clinical and translational data from the ongoing study were presented at the AACR Annual Meeting in April 2026 in San Diego, California. In heavily pretreated, checkpoint-refractory gastroesophageal adenocarcinoma patients, induction treatment with agenT-797 in combination with botensilimab and balstilimab prior to chemotherapy was associated with encouraging progression-free and overall survival outcomes, including emergence of a long-term survival tail in a population with historically poor expected outcomes. Translational analyses demonstrated coordinated immune activation, including elevated interferon-gamma (IFN-γ), enhanced CD8+ T-cell activation, tumor immune infiltration, and evidence of immune reprogramming in PD-1-refractory gastroesophageal cancers.\n\nIn GvHD, MiNK and the University of Wisconsin–Madison have announced an investigator-sponsored Phase 1 clinical trial evaluating agenT-797 for the prevention of GvHD in patients undergoing allogeneic hematopoietic stem cell transplantation for high-risk leukemias and other blood cancers. The program is supported by non-dilutive funding, including an NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID) for preclinical development and the Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison to directly fund enrollment, immune monitoring, and operations, with first patient dosing expected in mid-2026.\n\nIn 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\n\n14\n\n \n\nkilling 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.\n\nWith 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.\n\nHistorical Results of Operations\n\nThree Months Ended March 31, 2026 Compared to the Three Months Ended March 31, 2025\n\nResearch and development expense\n\nResearch 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 decreased 5% to $1.2 million for the three months ended March 31, 2026 from $1.3 million for the three months ended March 31, 2025. This decrease was primarily due to decreased costs associated with both the timing of our clinical trials and pre-clinical activities as well as decreased personnel costs, primarily due to decreased headcount.\n\nGeneral and administrative expense\n\nGeneral and administrative (“G&A”) expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense increased 32% to $1.7 million for the three months ended March 31, 2026 from $1.3 million for the three months ended March 31, 2025. This increase was primarily due to an increase in share-based compensation expense, professional fees and other G&A costs.\n\nOther income (expense), net\n\nOther income increased to approximately $58,600 for the three months ended March 31, 2026 from $80,000 of other expense for the three months ended March 31, 2025, primarily due to foreign currency exchange losses in the three months ended March 31, 2025, compared to foreign currency exchange gains in the three months ended March 31, 2026.\n\nInterest income, net\n\nInterest income increased $67,300 for the three months ended March 31, 2026, from income of $14,000 for the three months ended March 31, 2025 to income of $81,000 for the three months ended March 31, 2026, primarily due to increased interest earned on our money market funds and the repayment of our related party note (the “Note”) in January 2026.\n\nResearch and Development Programs\n\nR&D program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions.\n\n \n\n \n\n \n\nFor the Three Months Ended\nMarch 31,\n\n \n\n \n\nFor the years ended December 31,\n\n \n\n \n\n \n\n2026\n\n \n\n \n\n2025\n\n \n\n \n\n2024\n\n \n\nPayroll and personnel costs\n\n \n\n$\n\n692,250\n\n \n\n \n\n$\n\n3,389,016\n\n \n\n \n\n$\n\n4,634,647\n\n \n\nProfessional fees\n\n \n\n \n\n247,155\n\n \n\n \n\n \n\n53,416\n\n \n\n \n\n \n\n1,353,448\n\n \n\nForgiveness of liability\n\n \n\n \n\n—\n\n \n\n \n\n \n\n—\n\n \n\n \n\n \n\n(1,788,204\n\n)\n\nAllocated services\n\n \n\n \n\n113,933\n\n \n\n \n\n \n\n560,486\n\n \n\n \n\n \n\n517,861\n\n \n\nMaterials and other\n\n \n\n \n\n150,752\n\n \n\n \n\n \n\n1,754,569\n\n \n\n \n\n \n\n1,618,323\n\n \n\nTotal\n\n \n\n$\n\n1,204,090\n\n \n\n \n\n$\n\n5,757,487\n\n \n\n \n\n$\n\n6,336,075\n\n \n\nOur product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new products is lengthy, expensive and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research\n\n15\n\n \n\nand development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.\n\nLiquidity and Capital Resources\n\nWe have incurred annual operating losses since inception in 2017, and we had an accumulated deficit of $159.4 million as of March 31, 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.\n\nOn 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 13,100 shares of our common stock pursuant to the Sales Agreement during the three months ended March 31, 2026 and the period of April 1, 2026 through May 13, 2026, respectively, and received aggregate net proceeds totaling $3.2 million. As of May 13, 2026, approximately $31.8 million remained available under the Sales Agreement.\n\nWe had a Note outstanding as of December 31, 2025 of $5.0 million in principal plus accrued and unpaid interest of approximately $179,000. In January 2026, in accordance with the terms of the Note, we repaid the Note in full.\n\nOur cash and cash equivalents balance as of March 31, 2026 was $9.5 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.\n\nManagement 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.\n\nNet cash used in operating activities for the three months ended March 31, 2026 and 2025 was $1.7 million and $1.3 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.\n\nForward-Looking Statements\n\nThis Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” and “future,” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, and other important factors, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to develop, including our ability to develop and obtain licensure of agenT-797, MiNK-215, and MiNK-413, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, our cash runway and anticipated sources of funds, our ability to operate as a going concern, as well as our plans, objectives, expectations, and intentions.\n\n16\n\n \n\nMore 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.\n\nJOBS Act\n\nWe qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.\n\nWe may take advantage of these exemptions until the last day of the fiscal year following the fifth anniversary (December 31, 2026) 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 (i) we have more than $1.235 billion in annual revenue, (ii) we are deemed to be a large accelerated filer, which among other things would require us to have more than $700.0 million in market value of our stock held by non-affiliates as of the last business day of our prior second fiscal quarter, or (iii) 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.\n\nIn addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.\n\n17"}