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

Our subsidiaries MiNK Therapeutics may be unsuccessful at advancing its cell therapy business, andsubsidiary, SaponiQx, Inc. may be unsuccessful in advancing its vaccine adjuvant business. Our subsidiary,equity Atlantinvestee, Clinical,MiNK Therapeutics may be unsuccessful inat maintaining and growingadvancing its clinicalcell researchtherapy organization ("CRO") businesses.business.

Investment in I-O product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. Our net losses for the years ended December 31, 2025, 2024, and 2023, and 2022, were $232.3$3.1 million, $257.4$232.3 million and $230.7$257.4 million, respectively. We expect to incur significant losses for the foreseeable future as we continue our research and development efforts, seek regulatory approvals, and begincontinue toward commercial readiness efforts for our product candidates. We anticipate that our expenses will increase substantially if, and as, we:

further develop our antibody programs and platforms, MiNK's cell therapy programs,platforms and our saponin-based vaccine adjuvants (through SaponiQx);

expand in-house clinical and commercial manufacturing capabilitiesexpertise;

establish aand maintain commercial manufacturing sourcesources and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval;

As of December 31, 2024,2025, we had $40.4$3.0 million of cash and cash equivalents. Based on our current plans and projections, we believe that our cash resources as of December 31, 2024,2025, plus funding received in the first quarter of 2026 and anticipated funding will be sufficient to satisfy our critical liquidity requirements throughinto the second quarter of 2025.2027. However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital in order to complete clinical development of our current programs. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

We have no products approved for commercial sale and have not generated any revenue from commercial product sales. Our ability to generate product revenue or profits will depend on the successful development, regulatory approval and eventual commercialization of our product candidates, which may never occur. We may never be able to develop or commercialize a marketable product.

Global credit and financial markets have experienced extreme volatility and disruptions in the past several years, including increased inflation, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability, and the volatility of such market and economic conditions have increased as a result of the conflicts in the Middle East and the Russian invasion of Ukraine, and may increase as a result of other geopolitical actions, including newlynew imposedor ongoing tariffs and other actions that directly or indirectly impact the global economy. The scope, duration and long-term impact of conflicts in the Middle East and the Russian invasion are unknown at this time, so there can be no assurance how significant any deterioration in credit and financial markets and confidence in economic conditions will be and how long it may continue. Our general business strategy may be adversely affected by any such economic downturn, volatile geopolitical and business environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, or do not improve, it may make any necessary debt or equity financing more difficult, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans for some or all of our pipeline candidates. In addition, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive these difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget.

We believe we have sufficient capital to fund our critical expenses throughinto the second quarter of 2025.2027. Going forward, if we are unable to obtain sufficient funding to support our operations or pay our obligations, we could be forced to delay, reduce or eliminate all of our research and development programs, product portfolio expansion or commercialization efforts, our financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. In the future, reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, if at all.

Our obligations to the holders of our promissory notes and certain finance leases could materially and adversely affect our liquidity and operations.

In February 2015, we issued subordinated promissory notes in the aggregate principal amount of $14.0 million, of which $10.5 million remainsremained outstanding (the “2015 Subordinated Notes”). as of December 31, 2025. In January 2026, we repaid approximately $5.4 million of the 2015 Subordinated Notes. The 2015 Subordinated Notes have been amended to extend the maturity date to JulyJune 2026 and increase the interest rate to 9%. The 2015 Subordinated Notes include default provisions that allow for the acceleration of the principal payment of the 2015 Subordinated Notes in the event we become involved in certain bankruptcy proceedings, become insolvent, fail to make a payment of principal or (after a grace period) interest on the 2015 Subordinated Notes, default on other indebtedness with an aggregate principal balance of $13.0 million or more if such default has the effect of accelerating the maturity of such indebtedness, or become subject to a legal judgment or similar order for the payment of money in an amount greater than $13.0 million if such amount will not be covered by third-party insurance. If we default on the 2015 Subordinated Notes and the repayment of such indebtedness is accelerated, our liquidity could be materially and adversely affected.

In 2024, we entered into a promissory note for a loan in the aggregate principal amount of $22.0 million, which loan was modified in 2025 to increase the principal balance to $24.75 million (as modified, the “Loan”). The Loan has a two-year term and iswas principally secured by our manufacturing facility in Berkeley, CA (the “Berkeley Facility”) and parcels of land located in Vacaville, CA (the “Vacaville Land”) and bears interest at an annual rate of 12% through November 30, 2025 and 13% from December 1, 2025 through November 30, 2026. Interest under the Note is payable monthly, one half in cash and one half of the Company’s common stock. Additionally, $1.8 million of the Loan funds were held back to serve as an interest payment reserve for the Loan. The Loan was further modified in January 2026 whereby the lender agreed to release the Berkeley Facility as collateral for the Loan in exchange for the Company’s payoff of a senior lien on the Vacaville Land, thereby giving the lender a first priority lien on the Vacaville Land as the primary security for the Loan. The Note contains customary representations, warranties and covenants, including customary events of default, including failure to repay the Loan when due. Any event of default, if not cured or waived in a timely manner, could result in the acceleration of the Loan.

If we do not have sufficient cash on hand to service or repay our obligations, or to maintain our required minimum cash balance,obligations we may be required to raise additional capital which entails the risks described herein.

we may experience delays in reaching, or fail to reach, agreement on acceptable terms with trial sites and CROs,Clinical Research Organizations ("CRO"), the terms of which can be subject to extensive negotiation and may vary significantly;

we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe ,safe, pure and potent and has a favorable risk-benefit profile for its proposed indication;

If we choose to pursue accelerated approval, there can be no assurance that the FDA will agree that our proposed primary endpoint is an appropriate surrogate endpoint. Similarly, there can be no assurance that after subsequent FDA feedback that we will continue to pursue accelerated approval, even if we initially decide to do so. For example, although we planned to seek accelerated approval for BOT/BAL based on our Phase 2 results in adult patients with r/r MSS CRC with NLM, FDA advised against the submission based on the observed magnitude of effect, remaining questions about contributions of the components of the combination product, and their view that objective response rates may not translate to survival benefit, and they recommended the inclusion of a BOT monotherapy arm in the planned Phase 3 study. If we submit an application for accelerated approval,approval (as we currently intend to do in 2026 in the United States along with application for a conditional approval in the European Union for BOT plus BAL in refractory microsatellite-stable metastatic colorectal cancer without active liver metastases), there can be no assurance that any such application will be accepted or that approval will be granted on a timely basis, or at all. The FDA also could require us to conduct further studies or trials prior to considering our application or granting approval of any type. We might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays, or approval might not be granted because our submission is deemed incomplete by the FDA. Even if we receive accelerated approval from the FDA for one or more of our product candidates, there is no guarantee that we will be able to successfully complete one or more confirmatory trials needed to obtain full approval. We also will be subject to rigorous post-approval requirements, including submission to the FDA of all promotional materials prior to their dissemination. The FDA could withdraw accelerated approval for multiple reasons, including our failure to conduct any required post-approval study with due diligence, or the inability of such study to confirm the predicted clinical benefit. A failure to obtain accelerated approval or any other form of expedited review or approval for a product candidate could result in a longer time period prior to commercializing such product candidate, increase the cost of development of such product candidate, and harm our competitive position in the marketplace.

The legislation and regulations that govern marketing approvals, pricing and reimbursement for new drug products vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or drug licensing approval is granted and, in some countries, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product candidate in a particular country, but then be subject to price regulations that delay our commercial launch of the product candidate, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product candidate in that country. In the United States, there is increasingcontinued scrutiny from the Congress and regulatory authorities of the pricing of pharmaceutical products. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.

Our product candidates are uniquely manufactured. If we or any of our third-party manufacturers encounter difficulties in manufacturing our product candidates, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

The manufacturing process used to date to produce certain of our product candidates is complex and novel and has not yet been validated for commercial production. As a result of these complexities, the cost to manufacture certain of our product candidates ishas been, and may continue to be, potentially higher than traditional antibodies and the manufacturing process is less reliable and is more difficult to reproduce. Furthermore, ourthe current manufacturing process for certain of our product candidates has not been scaled up to commercial production. The actual cost to manufacture and process certain of our product candidates could be greater than we expect and could materially and adversely affect the commercial viability of such product candidates.

Our manufacturing process may be susceptible to logistical issues associated with the CMO relationship, the collection of materials sourced from various suppliers as well as shipment of the final product to clinical centers, manufacturing issues associated with interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, inconsistency in production batches, and variability in product characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields, lot failures, product defects, product recalls, product liability claims and other supply disruptions. If microbial, viral, or other contaminations are discovered in our product candidates or in ourthe manufacturing facilities in which our product candidates are made, production at such manufacturing facilities may be interrupted for an extended period of time to investigate and remedy the contamination. Further, as we transition from late-stage clinical trials toward approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

AlthoughIn January 2026 we continuedivested toour optimizeassets that comprised our in-house planned manufacturing division, and as a result we will for the foreseeable future or longer rely on outsourced manufacturing for all of our manufacturing processneeds. This divestiture included the sale of our owned facility in Berkeley, California as well as our leasehold interest in our facility in Emeryville, California. In connection with the divestiture, we entered into a contract manufacturing agreement with Zydus for certain of our antibodymanufacturing productneeds. candidates,We doingwill soneed isto abe difficultmonitoring our manufacturing needs on an ongoing basis and uncertainbe task, and there are risks associated with scalingprepared to theestablish levelrelationships requiredas for commercialization, including, among others, cost overruns, potential problemsneeded with process scale-up, process reproducibility, stability issues, lot consistency, and timely availability of reagents and/or raw materials. We ultimately may not be successful in transferring our in-house clinical scale production system to any commercial scale manufacturing facilities that we establish ourselves or establish at a contract manufacturing organization (“CMO”). IfThe weprocess areof unableestablishing an outsourced manufacturing relationship with a contracted CMO will require us to adequately, validateamong orother scale-up the manufacturing process for our product candidates with our contracted CMO, we will need to transfer to another manufacturer andthings, complete the manufacturing validation process, which can be lengthy. If we are able to adequately validatelengthy, and scale-up the manufacturing process for our product candidates with a contract manufacturer, we will still need to negotiate with such contractcontracted manufacturerCMO an agreement for clinical and commercial supply and it is not certain we will be able to come to agreement on terms acceptable to us for all product candidates. As a result, we may ultimately be unable to reducenegotiate the cost of goods for our product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized.

Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects. Our future success depends on our ability to manufacturehave our products manufactured on a timely basis with acceptable manufacturing costs, while at the same time maintaining good quality control and complying with applicable regulatory requirements, and an inability to do so could have a material adverse effect on our business, financial condition, and results of operations. In addition, we could incur higher manufacturing costs if manufacturing processes or standards change, and we could need to replace, modify, design, or build and install unanticipated equipment, all of which would require additional capital expenditures.change. Specifically, because our product candidates may have a higher cost of goods than conventional therapies, the risk that coverage and reimbursement rates may be inadequate for us to achieve profitability may be greater.

We are dependent on suppliers for some of our components and materials used to manufacture our product candidates.

We currently depend on suppliers for some of the components necessary for our product candidates. We cannot be sure that these suppliers will remain in business, that they will be able to meet our supply needs, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose. There are, in general, relatively few alternative sources of supply for these components. These suppliers may be unable or unwilling to meet our future demands for our clinical trials or commercial sale. Establishing additional or replacement suppliers for these components could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements. Any disruption in supply from a supplier or manufacturing location could lead to supply delays or interruptions which would damage our business, financial condition, results of operations and prospects. If we are able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay and additional costs. While we seek to maintain adequate inventory of the materials used to manufacture our products, any interruption or delay in the supply of materials, or our inability to obtain materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders. In addition, as part of the FDA’s approval of our product candidates, we will also require FDA approval of the individual components of our process, which include the manufacturing processes and facilities of our suppliers. Our reliance on these suppliers subjects us to a number of risks that could harm our business, and financial condition, including, among other things: interruption of product candidate or commercial supply resulting from modifications to or discontinuation of a supplier’s operations; delays in product shipments resulting from uncorrected defects, reliability issues, or a supplier’s variation in a component; a lack of long-term supply arrangements for key components with our suppliers; inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms; difficulty and cost associated with locating and qualifying alternative suppliers for our components and precursor cells in a timely manner; production delays related to the evaluation and testing of products from alternative suppliers, and corresponding regulatory qualifications; delay in delivery due to our suppliers prioritizing other customer orders over ours; and fluctuation in delivery by our suppliers due to changes in demand from us or their other customers. If any of these risks materialize, our manufacturing costs could significantly increase and our ability to meet clinical and commercial demand for our products could be impacted.

We rely on third parties for the manufacture of clinical supplies of certain of our product candidates and expect to rely on third parties for commercial supplies of any approved product candidates untilfor ourthe newforeseeable commercial manufacturing facility is fully commissioned and qualified.future. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We expect to rely on third-party manufacturers for the manufacture of commercial supplies of our drug candidates untilfor ourthe ownforeseeable commercial manufacturing facility is fully commissioned and qualified.future. At present, we do not have long-term supply agreements with all of the vendors needed to produce our product candidates for commercial sale and we may be unable to establish such agreements with third-party manufacturers or do so on acceptable terms.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States. Facilities used by our third-party manufacturers must be inspected by the FDA before potential approval of the drug candidate. Similar regulations apply to manufacturers of our drug candidates for use or sale in foreign countries. Until our own commercial manufacturing facility is completed and validated, weWe will not control the manufacturing process and will be for the foreseeable future completely dependent on our third-party manufacturers for compliance with the applicable regulatory requirements for the commercial manufacture of our drug candidates. If our manufacturers cannot successfully manufacture material that conforms to the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, they will not be able to secure the applicable approval for their manufacturing facilities. If these facilities are not approved for commercial manufacture, we may need to find alternative manufacturing facilities, which could result in delays in obtaining approval for the applicable drug candidate as alternative qualified manufacturing facilities may not be available on a timely basis or at all. In addition, our manufacturers are subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. Failure by any of our manufacturers to comply with applicable cGMPs or other regulatory requirements could result in sanctions being imposed on us or the contract manufacturer, including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply and criminal prosecutions, any of which could significantly and adversely affect supplies of our drug candidates and have a material adverse impact on our business, financial condition and results of operations as well as cause reputational damage. Any drugs that we may develop may compete with other drug candidates and drugs for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Our current and future dependence upon others for the commercial manufacture of our drug candidates or drugs until our own facility is completed and qualified may adversely affect our future profit margins and our ability to commercialize any drugs that receive marketing approval on a timely and competitive basis.

We are dependent upon our collaboration with Bettathird parties to further develop and commercialize certain antibody programs. If we or Bettaany Pharmaceuticalscollaboration party fail to perform as expected, the potential for us to generate future revenues under such collaboration could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected.

In June 2020,2025, we entered into a license and collaboration agreement with BettaZydus PharmaceuticalsLifeSciences Ltd. related to collaborate on the development and commercialization of balstilimab and zalifrelimabbotensilimab in greaterIndia China.and Sri Lanka. This license agreement closed in January 2026. Pursuant to the license and collaboration agreement, BettaZydus Pharmaceuticals received an exclusive license to develop, manufacture and commercialize zalifrelimab and balstilimab in all fields (other than intravesical delivery) in greater China. Under the agreement, Betta PharmaceuticalsLifeSciences is responsible for all of the development, regulatory approval, manufacturing and commercialization costs in greaterIndia China.and Sri Lanka. As part of the collaboration, BettaZydus Pharma made an upfront cash payment of $15.0 million andLifeSciences agreed to make uppay to $100.0the millionCompany ina aggregateroyalty milestoneequal paymentsto plusfive tieredpercent royalties(5%) onof net sales of zalifrelimab and balstilimab. Royalties range from mid-single digitrelated to low-twentiesthe percent,licenses product, subject to certain reductions under certain circumstances. Accordingly, the timely and successful completion by BettaZydus PharmaceuticalsLifeSciences of development, regulatory approval, manufacturing and commercialization activities will significantly affect the timing and amount of any milestones or royalties we may receive from BettaZydus Pharmaceuticals.LifeSciences. BettaZydus Pharmaceuticals’LifeSciences’ activities will be influenced by, among other things, the efforts and allocation of resources by BettaZydus Pharmaceuticals,LifeSciences, which we cannot control. Zydus LifeSciences was also granted a right of first negotiation for the territory of China.

In addition, our collaboration with BettaZydus PharmaceuticalsLifeSciences may be unsuccessful due to other factors, including, without limitation, that BettaZydus PharmaceuticalsLifeSciences:

has control over the development, regulatory approval, manufacturing and commercialization of balstilimab and zalifrelimabbotensilimab in greaterIndia Chinaand Sri Lanka;

may change the focus of its business efforts or prioritize other programs more highly and, accordingly, reduce the efforts and resources allocated to balstilimab and zalifrelimabbotensilimab; and may choose not to develop and commercialize balstilimab and zalifrelimabbotensilimab in all markets within greaterIndia Chinaand orSri for one or more indications,Lanka, if at all.

Additionally, the US-ChinaUS-India relationship hasis deterioratedsometimes instrained, recent years and, further deteriorationwhich may impact the ability of Agenus and BettaZydus PharmaceuticalsLifeSciences to successfully collaborate.

Failure to enter into and/or maintain additional significant licensing, distribution and/or collaboration agreements in a timely manner and on favorable terms to us may hinder or cause us to cease our efforts to develop and commercialize our product candidates, increase our development timelines, and/or increase our need to rely on partnering or financing mechanisms, such as sales of debt or equity securities, to fund our operations and continue our current and anticipated programs. Even if we enter into and maintain such agreements, they may not prove successful, and/or we may not receive significant payments from agreements.

Among other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to increase in time. We engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities. The Russian invasion of Ukraine has resulted in new and expanded U.S. and EU sanctions against Russia which have impacted the conduct of business with Russian entities, has and may continue to impact existing sales of services within Russia by our wholly-owned, independently-operated subsidiary, Atlant Clinical, a CRO based in Moscow, Russia, which we acquired in 2020.entities.

We currently have research and developmentclinical operations in the United Kingdom (“UK”) and clinical operations in eastern Europe,, and we expect to pursue pathways to develop and commercialize our product candidates in both U.S. and ex-U.S. jurisdictions. Various risks associated with foreign operations may impact our success. Possible risks of foreign operations include fluctuations in the value of foreign and domestic currencies, requirements to comply with various jurisdictional requirements such as data privacy regulations, disruptions in the import, export, and transportation of patient tumors and our products or product candidates, the product and service needs of foreign customers, difficulties in building and managing foreign relationships, the performance of our licensees or collaborators, geopolitical instability, unexpected regulatory, economic, or political changes in foreign and domestic markets, including without limitation any resulting from the UK’s withdrawal from the EU or our current political regime, and limitations on the flexibility of our operations and costs imposed by local labor laws.

As a result of the UK exiting the EU, commonly known as Brexit, since January 1, 2021, any transfers of personal data to the UK are subject to the requirements of Chapter V of the GDPR and of the Law Enforcement Directive and absent an adequacy finding under GDPR, transfers of personal data from the EU to the UK, including to our facility in Cambridge, UK, would be illegal without adequate safeguards provided for under EC-approved mechanisms, such as current standard contractual clauses or, if approved in the future, an EU-UK privacy shield similar to the current framework in place between the EU and the United States. The extensive authority of UK intelligence and law enforcement agencies, including to conduct surveillance on personal data flows, could reduce the likelihood that the EC would give the UK an adequacy finding and reduce the likelihood that the EC would approve an EU-UK privacy shield. Accordingly, we may be exposed to legal risk for any of our EU-UK personal data transfers, including those that involve sensitive data such as patient and genetic data. Given the uncertainties surrounding the UK’s departure from the EU, it is difficult to precisely identify or quantify the risks described above.

Antibody candidate programs, including our lead assets, botensilimab ("BOT") (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1181) and balstilimab ("BAL") (a programmed death receptor-1 (PD-1) blocking antibody).

We regularly evaluate development, commercialization, and partnering strategies for each product candidate based on various factors, including pre-clinical and clinical trial results, competitive positioning, funding requirements, and available resources. Our lead program, BOT is progressing through multiple clinical programs as a monotherapy and in combination with BAL. In April 2023, BOT in combination with BAL received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with non-microsatellite instability-high (“MSI-H”) and/or deficient mismatch repair (“dMMR”) metastatic colorectal cancer without active liver involvement. This designation specifically targets patients who are heavily pretreated and have shown resistance or intolerance to standard chemotherapies, including fluoropyrimidine, oxaliplatin, and irinotecan, as well as those who have received a VEGF inhibitor, an EGFR inhibitor, and/or a BRAF inhibitor, if indicated. Based on the BOT/BAL clinical data generated to date, we have developed designs for registration-enabling trials in MSSMicrosatellite CRCStable colorectal cancer across neoadjuvant, first-line, and late-line mCRC.metastatic Thesecolorectal cancer. We, together with the Canadian Cancer Trials Group (“CCTG”), are conducting BATTMAN/CO.33, a global Phase 3 trial(s) will launch upon completion of strategicbotensilimab transactions.plus Thebalstilimab optionsversus beingbest consideredsupportive arecare partnerships,in licensing,refractory orMSS/mismatch jointrepair ventures.proficient ("pMMR") colorectal cancer, with sites activated and prepared to enroll patients.

Pursuant to our collaboration agreement with Incyte, we had exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, as well as an additional undisclosed target. Under the terms of our agreement, Incyte was responsible for all future development expenses, and we were eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales. Incyte has terminated the OX40 program, effective October 2023, and both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us. In July 2024, Incyte announced that it would discontinue further development of the LAG-3 program and TIM-3 program and in February 2025, Incyte notified us of their intent to terminate the entire Collaboration Agreement, effective February 2026. Upon terminationtermination, the rights to the remaining programs will revertreverted back to us.

Pursuant to our collaboration and license agreement with Merck, we exclusively licensed MK-4830 to Merck,Merck a monospecific antibody targeting ILT4 (MK-4830), which Merck advanced in a Phase 2 clinical trial. Merck is responsible for all future development expenses, and we are eligible to receive up to an additional $85.0 million in potential milestone payments, as well as royalties on future sales. In 2024,2024 Merck notified us that the further clinical development of MK-4830 will be limited to a neoadjuvant ovarian study of MK-4830 in combination with pembrolizumab and chemotherapy with or without bevacizumab that is ongoing.

In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery. We received an upfront payment of $10.0 millionmillion. andIn areNovember eligible2025 toUrogen receivenotified upus tothey $200.0were millionterminating the license agreement in milestoneaccordance payments,with asthe wellterms asof royaltiesthe on future sales.agreement.

In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”). Under the terms of the Betta License Agreement, we received $15.0 million upfrontupfront. andIn are2025, eligiblewe tonotified receiveBetta upof tothe $100.0termination millionof inthe milestoneBetta paymentsLicense plus royalties on any future sales in Greater China.Agreement.

In May 2024, we, and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the “Ligand Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”) for the sale to Ligand of (i) 31.875% of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with BMS, UroGen, Gilead, Merck and Incyte, (the “Covered License Agreements”) (ii) 18.75% of the royalties we receive under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”). The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events. After taking into account our obligations under the Ligand Purchase Agreement, XOMA Royalty Purchase Agreement and the recent status of our collaboration agreements, we remain eligible to receive up to approximately $136.3 million and $49.4 million in potential development, regulatory, and commercial milestones from UroGen and Merck, respectively.Merck.

ResearchPre-commercial and developmentproduct revenue

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant to HCR. As described in Note 1718 to our Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK decreasedincreased $13.6$7.6 million, to approximately $108.6 million for the year ended December 31, 2025, from $101.0 million for the year ended December 31, 2024, from $114.6 million for the year ended December 31, 2023, due to decreasedincreased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant.

R&D expense include the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, clinical manufacturing costs, contract research organization costs, costs of consultants, and related administrative costs. R&D expense decreased 34%49% to $79.3 million for the year ended December 31, 2025 from $155.5 million for the year ended December 31, 2024 from $234.6 million for the year ended December 31, 2023.2024. Decreased R&D expenses in the year ended December 31, 20242025 primarily relate to a $52.7$51.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $11.4$14.3 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $2.0 million decrease in other research and development expenses, and a $18.1$7.9 million decrease in expenses attributable to the activities of our subsidiaries.subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK. These decreases were partially offset by a $3.2$0.2 million increase in otherprofessional research and development expenses.fees.

General and administrative (“G&A”) expense consists primarily of personnel costs, facility expenses, and professional fees. G&A expense decreased 9%24% to $54.4 million for the year ended December 31, 2025 from $71.9 million for the year ended December 31, 2024 from $78.7 million for the year ended December 31, 2023.2024. Decreased G&A expenses in the year ended December 31, 20242025 primarily relate to a $4.6$9.1 million decrease in personnel related expenses, mainly due to decreased share based compensation expense and a decrease in headcount, a $0.3$3.4 million decrease inother professionalgeneral feesand administrative expenses and a $3.3$5.1 million decrease in expenses attributable to the activities of our subsidiaries.subsidiaries, Thesewhich decreasesdecrease wereis partially offsetattributable byto athe $1.3deconsolidation millionof increase in other general and administrative expenses.MiNK.

Non-operating income (expense)

Non-operating incomeexpense increased $5.8$8.1 million for the year ended December 31, 2024,2025, from income of $37,000 for the year ended December 31, 2023, to income of $5.8 million for the year ended December 31, 2024, to expense of $2.2 million for the year ended December 31, 2025, primarily due to the $3.5 million loss on the deconsolidation of a certain foreign subsidiary, partially offset by the recognition of R&D tax credits in the UK in 2025, compared to the recognition of a $5.3 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK, compared to de minimis activityUK in 2023.2024.

Interest expense, net increaseddecreased to $55.3 million for the year ended December 31, 2025 from $117.6 million for the year ended December 31, 2024 from $97.9 million for the year ended December 31, 2023,2024, mainly due to increaseddecreased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCRHCR, andprimarily attributable to decreased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant, partially offset by an increase of the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

We currently have multiple antibody programs in pre-clinical or clinical development, which include our next generation anti-CTLA-4 antibody, botensilimab, an IgG1 anti-CTLA-4 antagonist, our anti-PD-1, balstilimab, and anti-CTLA-4, zalifrelimab, programs (both partnered with Betta in Greater China),programs, our anti-CD137, AGEN2373, an anti-TIGIT bispecific antibody, AGEN1777, an ILT2 monospecific antibody, AGEN1571, an anti-LAG3, INCAGN2385, and anti-TIM3, INCAGN2390. For additional information regarding our antibody discovery platforms and immunotherapy programs, please read Part I-Item 1. “Business” of this Annual Report on Form 10-K.

OurWe majorityhave owneda subsidiary,significant equity investment in MiNK. MiNK, is a focused on developing allogeneic iNKT cell therapies to treat cancer and other immune-mediated diseases. iNKTs have a dual-mechanism of action with an internal targeting and homing device that modulates both arms of immunity, innate and adaptive. iNKTs combine the killing features of natural killer cells with the durable memory response of T cells. iNKT cells have been demonstrated to be highly effective in treating solid tumor cancers in their native form and MiNK has demonstrated that these cells can be further engineered or edited for super-targeting. For additional information regarding iNKT cell therapies, please read Part I-Item 1. “Business” of this Annual Report on Form 10-K.

As of December 31, 2024,2025, we had debt outstanding of $35.2$45.5 million in principal, $2.5$8.4 million of which was paid and $7.0 million of which was forgiven in Februaryconnection 2025,with $10.5close of the Zydus transactions in January 2026, $5.1 million is due JulyJune 2026, and $22.0$24.75 million is due November 2026.

Currently we are in discussions with entities including operating companies and financial entities to provide the funding necessary to support our operations through our planned registration and launch strategy for botensilimab/balstilimab. However, becauseBecause the completion and timing of cashpotential fundingfinancing and strategic transactions isare not entirely within our control, and in accordance with accounting standards, substantial doubt continues to existexists about our ability to continue as a going concern for aat period ofleast one year after the date of filing of this Annual Report on Form 10-K. The consolidated financial statements have been prepared onassuming a basis that assumes Agenuswe 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 continues to diligently address the Company’s liquidity needs and has continuedalso toimplemented adjustcost spendingmanagement in ordermeasures to preserve liquidity. We expect our sources of funding to include additional out-licensing agreements, asset sales, project financing, and/or sales of equity securities.

We are party to multiple royalty financing transactions. We have recorded the proceeds from these transactions as a liability on our consolidated balance sheets that will be amortized using the interest method over the estimated life of the associated agreement. As a result, we impute interest on the transactions and record non-cash interest expense at the estimated interest rate. Our estimate of the interest rate under each agreement is based on the amount of royalty payments to be received by the purchaser over the life of the arrangement. We periodically assess the expected royalty payments using multiple sources, including historical results, forecasts from market data sources and internally developed forecasts. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we will prospectively adjust the amortization of the liability. There are a number of factors that could materially affect the amount and timing of royalty payments, all of which are not fully within our control. Such factors include, but are not limited to, failures or delays in clinical development, failure to receive marketing approval from governmental health authorities or delay in that approval, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates, and other events or circumstances that could result in reduced royalty payments made to the purchasers, all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the associated agreement. Conversely, if sales of the underlying products are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by us would be greater over the life of the associated agreement.

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. 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.

Agenus is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious disease.disease Our primary business is immuno-oncology ("I-O"), where we are advancing antibody-based programs to activate innate and adaptive immunity, overcome tumor immune evasion and expand the population of patients who may benefit from immunotherapy. Our lead clinical program is botensilimabBOT, ("BOT"a ormultifunctional, "AGEN1181"),Fc-enhanced anti-CTLA-4 antibody, alone and in combination with balstilimabBAL, ("BAL").a Wefully alsohuman maintainmonoclonal selectIgG4 clinical-stageanti-PD-1 immuno-oncologyantibody. assetsBOT is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses, with the goal of extending immunotherapy benefit to “cold” tumors that maygenerally berespond usedpoorly asto standalonestandard agentsof care and to conventional PD-1 and CTLA-4 therapies. BAL is designed to block PD-1 from interacting with PD-L1 and PD-L2. BOT/BAL is investigational and has not been approved by the U.S. Food and Drug Administration (the “FDA”) or asauthorized complementsfor tocommercial BOT plus BAL ("BOT/BAL"). Agenus also maintains an equity investmentsale in MiNK Therapeutics, Inc. ("MiNK"), with an approximate fair value of $22.9 million as of March 31, 2026, and a majority ownership of a vaccine adjuvant business through our subsidiary SaponiQx, Inc. ("SaponiQx"). Our common stock is listed on The Nasdaq Capital Market under the symbolEuropean "AGEN."Union or any other jurisdiction.

Previously reported data include the following. In our randomized Phase 2 trial reported at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2025, the BOT 75 mg plus BAL regimen achieved a 19% objective response rate and a 55% disease control rate in heavily pretreated patients with refractory MSS metastatic colorectal cancer without active liver metastases, with no objective responses observed in the control arm. In long-term follow-up data from the Phase 1b study (n=123) presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress in July 2025, BOT plus BAL showed approximately 42% two-year overall survival and median overall survival of approximately 21 months in this population. Pan-tumor data from more than 400 heavily pretreated patients in the Phase 1b C-800-01 study, presented at the European Society for Medical Oncology Congress in October 2025, showed approximately 39% two-year overall survival and median overall survival of 17.2 months across multiple tumor types. Sarcoma data published in the Journal of Clinical Oncology in January 2025 (n=52) showed a 19.2% overall response rate, with 27.8% in angiosarcoma. Ovarian cancer data published in the Journal for ImmunoTherapy of Cancer in December 2025 showed a 23% overall response rate and 14.8 months median overall survival in heavily pretreated patients.

Our strategy is to focus capital on execution of programs that we believe have the clearest path to meaningful clinical and commercial value, led by BOT/BAL in colorectal and colon cancer and selected other tumor types. We maintain manufacturing flexibility through strategic collaborations, with an emphasis on our Zydus collaboration. Our internal discovery and translational platforms support target identification, antibody generation, biomarker analysis and candidate selection, and have supported development of agents directed to CTLA-4, PD-1, CD137, CD73/TGF-beta, ILT2, LAG-3, TIM-3 and TIGIT, all of which remain proprietary assets of Agenus.

Three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025

We recognized pre-commercial product revenue of approximately $4.6$6.4 million during the three months ended MarchJune 31,30, 2026, representing sales of BOT+/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted.

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $5.6$3.3 million, to approximately $29.1$28.1 million for the three months ended MarchJune 31,30, 2026, from $23.6$24.8 million for the three months ended MarchJune 31,30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 45% to $11.8$14.8 million for the three months ended MarchJune 31,30, 2026 from $21.5$26.7 million for the three months ended MarchJune 31,30, 2025. DecreasedThe decreased expenses in the three months ended MarchJune 31,30, 2026 primarily relate to a 1.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $3.3$4.5 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $2.4$3.1 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $1.9$4.3 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 56%45% to $6.9$8.5 million for the three months ended MarchJune 31,30, 2026 from $15.7$15.5 million for the three months ended MarchJune 31,30, 2025. DecreasedThe decreased expenses in the three months ended MarchJune 31,30, 2026 primarily relate to a $3.2$1.1 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026 andpartially aoffset decreaseby an increase in share-based compensation expense, a $1.9$1.4 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $1.7$1.9 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $2.0$2.8 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $1.4$2.5 million for the three months ended MarchJune 31,30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.

The $40.4 million gain recognized at the closing of the Zydus transactions in January 2026 represents the total gain recognized from the Zydus Asset Purchase Agreement and Securities Purchase Agreement. This gain is not expected to recur. Refer to Note R to our Condensed Consolidated Financial Statements for additional detail.

Interest expense, net increased to approximately $14.7$29.9 million for the threesix months ended MarchJune 31,30, 2026 from $12.8$26.1 million for the threesix months ended MarchJune 31,30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

For the threesix months ended MarchJune 31,30, 2026, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of MarchJune 31,30, 2026. We expect to incur significant 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. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through MarchJune 31,30, 2026, we have raised aggregate net proceeds of approximately $2.06$2.08 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.

As of March 31, 2026, weWe had cash and cash equivalents of $35.0$18.7 million,million as of June 30, 2026, compared with $3.0 million as of December 31, 2025. The March 31, 2026 cashThat balance excludes the $7.5$7.6 million held in escrow under the Zydus agreements, whichincluding is$0.1 releasable to the Company in accordance with the predefined provisionsmillion of thoseaccrued agreements,interest, and does not reflectexcludes outstanding receivables under our early access programs for botensilimab/balstilimab — including France’s Autorisation d’Accès Compassionnel (“AAC”) framework and paid named patient programs in other jurisdictions where permitted —programs, which we expect to collect during the secondthird quarter of 2026. SubsequentAs toof quarterJune end,30, 2026, we receivedhad andebt additionaloutstanding $11.7of $30.4 million in net proceeds from salesprincipal, of commonwhich stock$24.75 undermillion ouris at-the-marketdue equityNovember offering2026 program.and $5.1 million is due January 2027. See Note G.