What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-11 compared with 2025-11-10 · 115 added, 139 removed, 53 unchanged (83% of the section changed)

12 unchanged sentences

Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.

Agenus, MiNK, Prophage, Retrocyte Display and STIMULON are trademarks of Agenus Inc.

Agenus, Prophage, Retrocyte Display and STIMULON are trademarks of Agenus Inc.

and its subsidiaries.

We are a clinical-stage biotechnology company specializing in discovering and developing therapies to activate the body's immune system against cancer and infections.

Our pipeline includes immune-modulatory antibodies, vaccine adjuvants (via SaponiQx, Inc.

("SaponiQx")), and adoptive cell therapies (via our investment in MiNK Therapeutics, Inc.

Our primary focus is immuno-oncology (“I-O”), and our diverse pipeline is supported by our in-house capabilities, including current good manufacturing practice (“cGMP”) manufacturing and a clinical operations platform.

To succeed in I-O, innovation and speed are paramount.

We are a vertically integrated biotechnology company equipped with a suite of technology platforms to advance from novel target identification through manufacturing for clinical trials of antibodies and cell therapies.

By understanding each patient's cancer, we aim to substantially expand the population benefiting from current I-O therapies.

In addition to a diverse pipeline, we have assembled fully integrated end-to-end capabilities including novel target discovery, antibody generation, cell line development and cGMP manufacturing.

Leveraging our science and capabilities, we have established strategic partnerships to advance innovation.

We believe the next generation of cancer treatment will build on clinically validated antibodies targeting cytotoxic T-lymphocyte antigen 4 (“CTLA-4”) and a programmed death receptor-1 (“PD-1”) combined with novel immunomodulatory agents designed to address underlying tumor escape mechanisms.

Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

• Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.

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

• Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).

• A pipeline of novel allogeneic invariant natural killer T cell (“iNKT”) therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.

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.

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 Microsatellite Stable colorectal cancer across neoadjuvant, first-line, and late-line metastatic colorectal cancer.

These trial(s) will launch upon completion of strategic transactions.

The options being considered are partnerships, licensing, or joint ventures.

We have entered into collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd.

(“Betta”), UroGen Pharma Ltd.

(“UroGen”), Gilead Sciences, Inc.

(“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharp & Dohme (“Merck”).

These collaborations, along with our internal programs, have resulted in over a dozen antibody pre-clinical or clinical development programs.

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 termination, the rights to the remaining programs will revert back to us.

Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to 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 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 September 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”).

Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party.

In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”).

Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, and the exclusive option to license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody.

Gilead elected to return AGEN1423 to us in November 2020 and terminated the license agreement.

We ceased development of AGEN1223 in the third quarter of 2021, and the option and license agreement for AGEN1223 was formally terminated in October 2021.

In August 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

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 million.

In November 2025 Urogen notified us they were terminating the license agreement in accordance with the terms of the 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 upfront and are eligible to receive up to $100.0 million in milestone payments plus royalties on any future sales in Greater China.

In May 2021, we entered into a License, Development, and Commercialization Agreement with BMS for our pre-clinical anti-TIGIT bispecific antibody program, AGEN1777.

BMS received an exclusive worldwide license to develop, manufacture, and commercialize AGEN1777 and its derivatives.

We received a non-refundable upfront cash payment of $200.0 million.

In October 2021, we achieved a $20.0 million milestone upon the dosing of the first patient in the AGEN1777 Phase 1 clinical trial and in

December 2023, we announced that the first patient was dosed in an AGEN1777 Phase 2 clinical trial, triggering the achievement of a $25.0 million milestone.

We received this milestone in January 2024.

On July 30, 2024, we received notice from BMS that it was voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.

Upon termination, BMS returned AGEN1777 to us.

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 current status of our collaboration agreements, we remain eligible to receive up to approximately $49.4 million in potential development, regulatory, and commercial milestones from Merck.

In September 2021, we launched SaponiQx to lead innovation in novel adjuvant discovery and vaccine design, focusing on our saponin-based adjuvants.

We are particularly dedicated to the development of the next-generation cultured plant cell QS-21.

To support this initiative, we partnered with Ginkgo Bioworks, Inc.

to develop SaponiQx’s saponin products from sustainably sourced raw materials.

Our goal is to meet the demands of the vaccine industry, especially for pandemic vaccines.

Our bark extract QS-21 adjuvant is partnered with GSK and plays a vital role in multiple GSK vaccine programs.

These programs are at various stages, including GSK’s approved shingles and RSV vaccines, SHINGRIX and AREXVY, which received FDA approval in the United States in October 2017 and May 2023, respectively.

In January 2018, we entered into a Royalty Purchase Agreement with Healthcare Royalty Partners III, L.P.

and certain of its affiliates (together, “HCR”), pursuant to which HCR purchased 100% of our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant.

We do not incur clinical development costs for products partnered with GSK.

We were also entitled to receive up to $40.35 million in milestone payments from HCR based on sales of GSK’s vaccines as follows:

(i) $15.1 million upon reaching $2.0 billion last-twelve-months net sales any time prior to 2024 (the “First HCR Milestone”) and (ii) $25.25 million upon reaching $2.75 billion last-twelve-months net sales any time prior to 2026 (the “Second HCR Milestone”).

We received the First HCR Milestone after GSK’s net sales of Shingrix for the twelve months ended December 31, 2019 exceeded $2.0 billion.

The Second HCR Milestone was received in 2022 after GSK’s net sales of Shingrix for the twelve months ended June 30, 2022 exceeded $2.75 billion.

In October 2021, we completed the initial public offering (“IPO”) of MiNK, which trades on the Nasdaq Capital Market under the ticker symbol “INKT.” MiNK is a clinical stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (“iNKT”) cell therapies to treat cancer and other life-threatening immune diseases.

Our business activities include product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations.

Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace.

Part of our strategy is to develop and commercialize some of our product candidates through arrangements with academic and corporate collaborators and licensees.

Our common stock is currently listed on The Nasdaq Capital Market under the symbol “AGEN.”

Agenus is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious 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 botensilimab ("BOT" or "AGEN1181"), alone and in combination with balstilimab ("BAL").

We also maintain select clinical-stage immuno-oncology assets that may be used as standalone agents or as complements to BOT plus BAL ("BOT/BAL").

Agenus also maintains an equity investment 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 symbol "AGEN."

The first quarter of 2026 and the period shortly thereafter included several developments that materially advanced our strategic priorities:

continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partner;

the commencement of patient enrollment in the global Phase 3 BATTMAN trial;

the closing of the strategic collaboration with Zydus Lifesciences Ltd.

and the triggering of the first $20.0 million contingent payment under that collaboration;

the conclusion of the U.S.

Securities and Exchange Commission's investigation as to the Company;

and the dismissal of the related putative securities class action by the U.S.

District Court for the District of Massachusetts.

In France, BOT/BAL is available under the national Autorisation d'Accès Compassionnel ("AAC") framework for eligible patients in MSS metastatic colorectal cancer without active liver metastases (added September 2025), platinum-resistant or platinum-refractory ovarian cancer (added January 2026), and certain advanced soft-tissue sarcomas (added January 2026).

Treatment under the AAC framework is reimbursed through the French national health system.

Outside France, BOT/BAL may be available in select countries through paid named-patient programs initiated by treating physicians and governed by local regulations and national reimbursement or coverage frameworks.

In April 2026, we named BAP Pharma as our global distribution partner to support BOT/BAL access programs end-to-end, including request coordination, regulatory navigation, distribution logistics and payment processing.

These programs do not constitute marketing approval, may be modified or discontinued by applicable authorities, and do not assure future regulatory approvals.

In April 2026, the global Phase 3 BATTMAN (CCTG CO.33) trial commenced patient enrollment.

Conducted together with the Canadian Cancer Trials Group ("CCTG") and participating cooperative groups, BATTMAN is evaluating BOT plus BAL versus best supportive care in approximately 830 patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer across more than

100 sites in Canada, France, Australia and New Zealand, and is intended to support potential regulatory filings in the United States and the European Union.

In January 2026, we closed the strategic collaboration with Zydus Lifesciences Ltd.

("Zydus"), under which we received $91.0 million in cash consideration at closing, comprising $75.0 million for the transfer of our Emeryville and Berkeley biologics manufacturing facilities and a $16.0 million equity investment in Agenus common stock.

The collaboration also includes an exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories, and provides for up to $50.0 million in additional contingent payments tied to BOT and BAL production orders.

In March 2026, the first $20.0 million contingent payment was triggered based on contracted work orders for BOT/BAL chemistry, manufacturing and controls (CMC) and production activities.

The Zydus collaboration secures dedicated, long-term U.S.

biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply.

Based on existing data, we intend during 2026 to seek Accelerated Approval in the United States and Conditional Approval in the European Union for BOT plus BAL in refractory microsatellite-stable metastatic colorectal cancer without active liver metastases.

On May 4, 2026, the U.S.

Securities and Exchange Commission informed the Company that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action against the Company.

On March 24, 2026, the U.S.

District Court for the District of Massachusetts granted the Company's motion to dismiss the related putative securities class action in its entirety.

The lead plaintiff has filed a Notice of Appeal.

See Note S to our Condensed Consolidated Financial Statements and Part II, Item 1 (Legal Proceedings) for additional information.

Botensilimab is a multifunctional anti-CTLA-4 antibody designed to activate both innate and adaptive anti-tumor immune responses, with mechanisms intended to extend immunotherapy benefit to "cold" tumors that generally respond poorly to standard of care and to conventional PD-1/CTLA-4 therapies.

Botensilimab is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses.

Balstilimab is a fully human monoclonal IgG4 anti-PD-1 antibody designed to block PD-1 from interacting with PD-L1 and PD-L2.

BOT, alone and in combination with BAL, has been evaluated in approximately 1,300 patients across more than 60 centers worldwide and across nine tumor types, including colorectal cancer, sarcoma, non-small cell lung cancer, hepatocellular cancer, pancreatic cancer, melanoma, ovarian cancer and triple-negative breast cancer.

BOT plus BAL is investigational and has not been approved by the U.S.

Food and Drug Administration (the "FDA") or the European Medicines Agency for commercial sale.

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 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.

Historical Results of Operations

Three months ended September 30, 2025 compared to the three months ended September 30, 2024

Non-cash royalty revenue related to the sale of future royalties

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 $4.5 million, to approximately $29.1 million for the three months ended September 30, 2025, from $24.7 million for the three months ended September 30, 2024, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense

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 43% to $23.6 million for the three months ended September 30, 2025 from $41.1 million for the three months ended September 30, 2024.

Decreased expenses in the three months ended September 30, 2025 primarily relate to a $11.1 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 $3.4 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $0.5 million decrease in other research and development expenses, and a $2.4 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

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees.

General and administrative expenses decreased 37% to $10.9 million for the three months ended September 30, 2025 from $17.3 million for the three months ended September 30, 2024.

Decreased expenses in the three months ended September 30, 2025 primarily relate to a $2.5 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $0.5 million decrease in professional fees, a $1.0 million decrease other general and administrative expenses and a $2.5 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Non-operating income (expense)

Non-operating expense increased to approximately $19.3 million for the three months ended September 30, 2025 from income of $19,000 for the three months ended September 30, 2024, primarily due to the $20.3 million MiNK investment fair value adjustment, partially offset by the recognition of R&D tax credits in the UK in the three months ended September 30, 2025, compared to de minimis activity in the three months ended September 30, 2024.

Interest expense, net

Interest expense, net decreased to approximately $13.2 million for the three months ended September 30, 2025 from $35.7 million for the three months ended September 30, 2024, mainly due to decreased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to decreased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant, partially offset by an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Nine months ended September 30, 2025 compared to the nine months ended September 30, 2024

Three months ended March 31, 2026 compared to the three months ended March 31, 2025

Pre-commercial product revenue

We recognized pre-commercial product revenue of approximately $4.6 million during the three months ended March 31, 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.

Non-cash royalty revenue related to the sale of future royalties

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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 $2.5 million, to approximately $77.5 million for the nine months ended September 30, 2025, from $75.0 million for the nine months ended September 30, 2024, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Non-cash royalty revenue related to our agreement with GSK increased $5.6 million, to approximately $29.1 million for the three months ended March 31, 2026, from $23.6 million for the three months ended March 31, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense

Research and development expense decreased 41% to $71.8 million for the nine months ended September 30, 2025 from $121.8 million for the nine months ended September 30, 2024.

Decreased expenses in the nine months ended September 30, 2025 primarily relate to a $34.0 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 $9.5 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $0.8 million decrease in other research and development expenses, and a $5.7 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Research and development expense decreased 45% to $11.8 million for the three months ended March 31, 2026 from $21.5 million for the three months ended March 31, 2025.

Decreased expenses in the three months ended March 31, 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 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 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 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

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees.

General and administrative expenses decreased 17% to $42.1 million for the nine months ended September 30, 2025 from $50.9 million for the nine months ended September 30, 2024.

Decreased expenses in the nine months ended September 30, 2025 primarily relate to a $5.7 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $1.3 million decrease in other general and administrative expenses, and a $2.4 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is

partially attributable to the deconsolidation of MiNK.

These decreases were partially offset by a $0.6 million increase in professional fees.

Non-operating income (expense)

Non-operating expense increased to approximately $19.6 million for the nine months ended September 30, 2025 from income of $6.1 million for the nine months ended September 30, 2024, primarily due to the $20.3 million MiNK investment fair value adjustment, partially offset by the recognition of R&D tax credits in the UK in the nine months ended September 30, 2025, compared to the recognition of a $5.5 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the nine months ended September 30, 2024.

General and administrative expenses decreased 56% to $6.9 million for the three months ended March 31, 2026 from $15.7 million for the three months ended March 31, 2025.

Decreased expenses in the three months ended March 31, 2026 primarily relate to a $3.2 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 and a decrease in share-based compensation expense, a $1.9 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $1.7 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 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

MiNK Therapeutics, Inc.

equity method investment fair value adjustment

The MiNK Therapeutics, Inc.

equity method investment fair value adjustment of $1.4 million for the three months ended March 31, 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.

Gain on Zydus asset sale

The $40.4 million gain recognized at the closing of the Zydus transactions represents the total gain recognized from the Zydus Asset Purchase Agreement and Securities Purchase Agreement.

Refer to Note R to our Condensed Consolidated Financial Statements for additional detail.

Interest expense, net

Interest expense, net decreased to approximately $39.3 million for the nine months ended September 30, 2025 from $96.9 million for the nine months ended September 30, 2024, mainly due to decreased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to decreased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant, partially offset by an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Interest expense, net increased to approximately $14.7 million for the three months ended March 31, 2026 from $12.8 million for the three months ended March 31, 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.

Research and Development Programs

For the nine months ended September 30, 2025, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).

Nine Months Ended September 30,

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

Three Months Ended March 31,

Year Ended December 31,

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Liquidity and Capital Resources

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.2 billion as of September 30, 2025.

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of March 31, 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 September 30, 2025, we have raised aggregate net proceeds of approximately $2.04 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.

From our inception through March 31, 2026, we have raised aggregate net proceeds of approximately $2.06 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.

We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units.

The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 20.6 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market

Issuance Sales Agreement (the “Sales Agreement”) with B.

Riley Securities, Inc.

as our sales agent.

We sold approximately 7.6 million and 1.1 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2025 and the period of October 1, 2025 through November 7, 2025, respectively, and received aggregate net proceeds totaling $32.0 million.

As of November 7, 2025, approximately 9.4 million shares remained available for sale under the Sales Agreement.

Our cash and cash equivalents at September 30, 2025 were $3.5 million.

Subsequent to quarter end, we entered into a $10.0 million Promissory Note Agreement with Zydus Pharmaceuticals (USA) Inc.

and received $4.5 million from sales of our common stock in at the market offerings.

In addition, we anticipate receiving $91.0 million from our agreements with Zydus Lifesciences Ltd and its affiliates, during the first quarter of 2026.

As of September 30, 2025, we had debt outstanding of $35.6 million in principal, $10.5 million is due June 2026, and $24.75 million is due November 2026.

Based on our current plans and projections, we believe that our cash resources of $3.5 million at September 30, 2025, along with the post-quarter cash infusions noted above, anticipated revenues under our reimbursed compassionate access in France, and projected additional cash inflows from funding we expect to receive in 2026, will be sufficient to satisfy our critical liquidity requirements through 2026.

To support operations on an ongoing basis we require additional funding.

Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales, and proceeds from debt and equity issuances.

We transact at-the-market sales from time to time in order to manage our cash balances.

We execute at-the-market offerings based on market conditions and our stock price.

We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.

Currently we are in discussions with entities including operating companies and financial entities to provide the additional funding to support our operations through our planned registration and launch strategy for botensilimab/balstilimab.

However, because the completion of cash funding transactions is not entirely within our control, and in accordance with accounting standards, substantial doubt continues to exist 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 Agenus 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 continued to adjust spending in order 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 sold approximately 284,000 and 2.8 million 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 7, 2026, respectively, and received aggregate net proceeds totaling $12.7 million.

As of May 7, 2026, approximately 5.3 million shares remained available for sale under the Sales Agreement.

Our cash and cash equivalents at March 31, 2026 were $35.0 million.

As of March 31, 2026, we had debt outstanding of $30.5 million in principal, $5.1 million is due June 2026, and $24.75 million is due November 2026.

During the first quarter of 2026, we materially strengthened our liquidity position.

MiNK Therapeutics repaid a $5.2 million related-party note receivable, and we closed agreements with Zydus Lifesciences Ltd ("Zydus") and its affiliates, under which we received $91.0 million of consideration, subject to certain adjustments.

These adjustments include reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses, and $7.5 million placed into a twelve-month escrow, which is to be released in accordance with the predefined parameters set forth in the Zydus agreements.

See Note R for further discussion of the proceeds received in connection with the Zydus closing.

As of March 31, 2026, we had cash and cash equivalents of $35.0 million, compared with $3.0 million as of December 31, 2025.

The March 31, 2026 cash balance excludes the $7.5 million held in escrow under the Zydus agreements, which is releasable to the Company in accordance with the predefined provisions of those agreements, and does not reflect 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 — which we expect to collect during the second quarter of 2026.

Subsequent to quarter end, we received an additional $11.7 million in net proceeds from sales of common stock under our at-the-market equity offering program.

Also during the first quarter, we made cash payments of approximately $18.0 million to contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs).

CDMO payments principally funded the release of commercial-grade botensilimab supply and progressed manufacturing readiness for balstilimab.

CRO payments principally supported the generation and delivery of clinical data sets required for our planned accelerated approval submission in the United States and conditional marketing authorization application in the European Union.

These payments substantially settled liabilities accrued in prior periods and are reflected in the period-over-period decrease in accounts payable rather than in operating expenses for the three months ended March 31, 2026.

The output of these activities — clinical and pre-commercial supply of botensilimab and progressing supply of balstilimab, together with the regulatory data packages supporting planned U.S.

submissions — represents productive assets supporting future revenue generation across multiple periods.

Cash deployments of this nature are distinct from our recurring operating expense base.

We expect continued payments of this type during the second quarter as supply build and data-package completion advance, with the magnitude of those payments determined by the timing of CDMO and CRO milestone deliverables.

We have incurred significant losses since our inception in 1994.

As of March 31, 2026, we had an accumulated deficit of $2.1 billion.

Based on our current operating plan and projections, including scheduled debt payments in the look-forward period (the majority of which is secured by certain real estate properties), and assuming completion of additional capital transactions currently under discussion, we believe our existing cash resources, together with anticipated revenues from our early access programs, will be sufficient to support our critical liquidity requirements into 2027.

Advancing our planned registration and commercialization strategy for botensilimab/balstilimab and funding the Company through achievement of profitability will require additional capital.

We have historically financed our operations through corporate partnerships, advance royalty transactions, and debt and equity financings.

We are actively pursuing additional financing and strategic alternatives, including corporate transactions, out-licensing arrangements, asset sales, project financing, additional debt or equity financings, and other strategic transactions, and we are in active discussions with potential strategic and financial partners regarding several of these alternatives.

Because the timing and completion of these transactions are not entirely within our control, in accordance with applicable accounting standards, substantial doubt exists about our ability to continue as a going concern for at least one year after the filing date of this Quarterly Report on Form 10-Q.

The consolidated financial statements have been prepared assuming we will continue as a going concern and contemplate the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

We have also implemented cost management measures to preserve liquidity.

Our operating expenses for the quarter ended March 31, 2026, include cash and non-cash expenses.

Non-cash expenses for the period include share-based compensation expense, depreciation and amortization expense and certain other non-cash items.

Operating expenses in the first quarter also included expenses associated with our manufacturing facilities in the period before the facilities were sold to Zydus and costs incurred for services provided by Zydus that will be settled through the first contingent payment under the Zydus Purchase Agreement.

During the first quarter of 2026 we made cash payments totaling approximately $51.8 million, this included significant payments to settle liabilities accrued in prior periods and are not reflected in operating expenses for the three months ended March 31, 2026.

These payments consisted of $18.0 million to contract development and manufacturing organizations (CDMOs) for the release of commercial-grade botensilimab supply, to contract research organizations (CROs) and clinical support organizations for clinical data sets supporting our planned accelerated approval submission in the United States and our conditional marketing authorization application in the European Union, $22.0 million in other non-recurring payments, including payments to settle finance lease and debt obligations in connection with the closing of the Zydus transactions and payments related to our manufacturing operations sold to Zydus in January 2026.

The remaining $11.8 million in payments related to our other recurring operating activities.

We have also entered into payment plans with a portion of our existing vendors, allowing us to repay the associated accounts payable balances over a defined period.

Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs.

Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials.

Since inception, we have entered into various agreements with contract manufacturers,

institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials.

Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $690.2 million over the term of the related activities.

Through September 30, 2025, we have expensed $624.3 million as research and development expenses and $571.2 million has been paid under these agreements.

Through March 31, 2026, we have expensed $629.9 million as research and development expenses and $586.1 million has been paid under these agreements.

The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider.

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As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.

Net cash used in operating activities for the nine months ended September 30, 2025 and 2024 was $60.6 million and $129.7 million, respectively.

Net cash used in operating activities for the three months ended March 31, 2026 and 2025 was $36.0 million and $25.6 million, respectively.

Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis