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Item 2. Management’s Discussion and Analysis

2025-05-12 compared with 2024-11-12 · 74 added, 101 removed, 106 unchanged (62% of the section changed)

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These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.

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, 2023 and in Part II-Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the period ended June 30, 2024.

We encourage you to read those descriptions carefully.

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

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

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

and its subsidiaries.

We are a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents.

Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc.

(“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc.

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, adoptive cell therapies (via MiNK Therapeutics, Inc.

("MiNK")), and vaccine adjuvants (via SaponiQx, Inc.

("SaponiQx")).

We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.

In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing.

We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards.

Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.

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 CTLA-4 and 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 (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1181) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody).

• 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).

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

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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, botensilimab (AGEN1181), is progressing through multiple clinical programs designed to support accelerated development as a monotherapy and in combination with balstilimab.

In April 2023, botensilimab in combination with balstilimab received Fast Track designation from the U.S.

Food and Drug Administration ("FDA") for the treatment of patients with not-microsatellite instability-high ("MSI-H")/deficient mismatch repair ("dMMR") metastatic colorectal cancer with no active liver involvement.

Patients targeted with this designation are heavily pretreated with standard of care chemotherapy, anti-VEGF and anti-EGFR if RAS wild type.

We completed enrollment of patients with refractory MSS mCRC non-active liver metastases ("NLM") in a Phase 1 trial (n~150) and randomized Phase 2 trial (n~230) in October 2023.

We are likely not to pursue accelerated approval pathways and intend to initiate a Phase 3 study with plans to ensure continued funding via partnering activities.

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 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.

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(“UroGen”), Gilead Sciences, Inc.

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

(“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 have exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, which Incyte is currently advancing in various clinical trials, as well as an additional undisclosed target that Incyte is advancing in preclinical studies.

Under the terms of our agreement, Incyte is responsible for all future development expenses, and we are eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales.

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.

On July 30, 2024, Incyte announced that it would discontinue further development of the LAG-3 and TIM-3 monoclonal antibodies.

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.

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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 were formally terminated in October 2021.

On August 5, 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

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.

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We received this milestone in January 2024.

On July 30, 2024, we received notice from BMS that it is returning AGEN1777 back to us and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.

On July 30, 2024, we received notice from BMS 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;

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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, $49.4 million and $183.1 million in potential development, regulatory, and commercial milestones from UroGen, Merck and Incyte, respectively.

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.

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

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

and its affiliates (“HCR”).

HCR purchased our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant.

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.

Under the agreement with HCR, we were entitled to receive milestone payments based on GSK’s vaccine sales.

These milestones include $15.1 million upon GSK reaching $2.0 billion in last-twelve-months net sales prior to 2024 (the “First HCR Milestone”) and $25.25 million upon GSK reaching $2.75 billion in last-twelve-months net sales 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, and we received the Second HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended June 30, 2022, exceeded $2.75 billion.

Our business activities include product research and 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 by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.

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.

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.

MiNK’s most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy.

MiNK is currently expanding its clinical programs, with a notable externally funded Phase 2 trial in second-line gastric cancer actively enrolling at Memorial Sloan Kettering Cancer Center.

MiNK is currently expanding its clinical programs, with an externally funded Phase 2 trial in second-line gastric cancer actively enrolling at Memorial Sloan Kettering Cancer Center.

Additionally, MiNK is evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome (“ARDS”) in planning for a randomized Phase 2 study through a predominantly externally financed program.

Recently, MiNK secured a $5.8 million private placement financing at a 25% premium, led by GKCC, LLC.

This funding will propel the clinical development of MiNK-215, its leading allogeneic CAR-iNKT cell therapy targeting fibroblast activation protein (“FAP”) in solid tumors, which is scheduled to enter clinical trials in early 2025.

In May 2024, MiNK secured a $5.8 million private placement financing at a 25% premium, led by GKCC, LLC.

This funding will be used for the clinical development of MiNK-215, its leading allogeneic CAR-iNKT cell therapy targeting fibroblast activation protein (“FAP”) in solid tumors, which is scheduled to enter clinical trials in early 2025.

In addition to its lead clinical program, MiNK has announced a collaboration with ImmunoScape, Inc.

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This partnership leverages MiNK’s proprietary library of T-cell antigens and ImmunoScape’s platform for rapid discovery of novel T-cell receptors.

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.”

Historical Results of Operations

Three months ended September 30, 2024 compared to the three months ended September 30, 2023

Research and development revenue

We did not recognize any research and development revenue in the three months ended September 30, 2024, but recognized research and development revenue of approximately $3.4 million during the three months ended September 30, 2023.

Research and development revenues in the third quarter of 2023 primarily consisted of $2.9 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.

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 F 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 $4.3 million, to approximately $24.7 million for the three months ended September 30, 2024, from $20.4 million for the three months ended September 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.

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 20% to $41.1 million for the three months ended September 30, 2024 from $51.4 million for the three months ended September 30, 2023.

Decreased expenses in the three months ended September 30, 2024 primarily relate to a $4.2 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 $2.9 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $4.1 million decrease in expenses attributable to the activities of our subsidiaries.

These decreases were partially offset by a $0.8 million increase in other research and development expenses.

General and administrative expense

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

General and administrative expenses decreased 9% to $17.3 million for the three months ended September 30, 2024 from $18.9 million for the three months ended September 30, 2023.

Decreased expenses in the three months ended September 30, 2024 primarily relate to a $1.0 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $0.7 million decrease in professional fees and a $0.5 million decrease in expenses attributable to the activities of our subsidiaries.

These decreases were partially offset by a $0.7 million increase in other general and administrative expenses.

Interest expense, net

Interest expense, net increased to approximately $35.7 million for the three months ended September 30, 2024 from $18.6 million for the three months ended September 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Nine months ended September 30, 2024 compared to the nine months ended September 30, 2023

Research and development revenue

We recognized research and development revenue of approximately $0.3 million and $8.5 million during the nine months ended September 30, 2024 and 2023, respectively.

Research and development revenues in the first nine months of 2023 primarily consisted of $7.2 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.

Three months ended March 31, 2025 compared to the three months ended March 31, 2024

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 $13.5 million, to approximately $75.0 million for the nine months ended September 30, 2024, from $61.5 million for the nine months ended September 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.

Non-cash royalty revenue related to our agreement with GSK decreased $4.2 million, to approximately $23.6 million for the three months ended March 31, 2025, from $27.8 million for the three months ended March 31, 2024, due to decreased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense

Research and development expense decreased 27% to $121.8 million for the nine months ended September 30, 2024 from $167.8 million for the nine months ended September 30, 2023.

Decreased expenses in the nine months ended September 30, 2024 primarily relate to a $25.9 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 $8.9 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $14.7 million decrease in expenses attributable to the activities of our subsidiaries.

Research and development expense decreased 51% to $21.5 million for the three months ended March 31, 2025 from $43.9 million for the three months ended March 31, 2024.

Decreased expenses in the three months ended March 31, 2025 primarily relate to a $16.3 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, mainly due to a decrease in headcount, and a $3.3 million decrease in expenses attributable to the activities of our subsidiaries.

These decreases were partially offset by a $0.4 million increase in other research and development expenses.

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

General and administrative expenses decreased 11% to $50.9 million for the nine months ended September 30, 2024 from $57.6 million for the nine months ended September 30, 2023.

Decreased expenses in the nine months ended September 30, 2024 primarily relate to a $3.2 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $1.5 million decrease in professional fees and a $2.9 million decrease in expenses attributable to the activities of our subsidiaries.

These decreases were partially offset by a $1.0 million increase in other general and administrative expenses.

Non-operating income (expense)

Non-operating income increased $5.8 million for the nine months ended September 30, 2024, from income of $0.2 million for the nine months ended September 30, 2023 to income of $6.1 million for the nine months ended September 30, 2024, primarily due 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 in the nine months ended September 30, 2024, compared to de minimis activity in the nine months ended September 30, 2023.

General and administrative expenses decreased 7% to $15.7 million for the three months ended March 31, 2025 from $16.9 million for the three months ended March 31, 2024.

Decreased expenses in the three months ended March 31, 2025 primarily relate to a $1.5 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $0.1 million decrease in other general and administrative expenses and a $0.4 million decrease in expenses attributable to the activities of our subsidiaries.

These decreases were partially offset by a $0.8 million increase in professional fees.

Interest expense, net

Interest expense, net increased to approximately $96.9 million for the nine months ended September 30, 2024 from $53.7 million for the nine months ended September 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Interest expense, net decreased to approximately $12.8 million for the three months ended March 31, 2025 from $29.5 million for the three months ended March 31, 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 the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Research and Development Programs

For the nine months ended September 30, 2024, 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, 2025, 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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The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain.

Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.

Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing

such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.

Liquidity and Capital Resources

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of September 30, 2024.

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.2 billion as of March 31, 2025.

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, 2024, we have raised aggregate net proceeds of approximately $2.0 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, 2025, we have raised aggregate net proceeds of approximately $2.01 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.

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as our sales agent.

We sold approximately 1.9 million and 1.8 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2024 and the period of October 1, 2024 through November 8, 2024, respectively, and received aggregate net proceeds totaling $33.0 million.

As of November 8, 2024, approximately 18.1 million shares remained available for sale under the Sales Agreement.

We have funded our operations largely from cash received from partners, royalty financing transactions and equity offerings.

We sold approximately 2.8 million and 0.6 million shares of our common stock pursuant to the Sales Agreement during the three months ended March 31, 2025 and the period of April 1, 2025 through May 6, 2025, respectively, and received aggregate net proceeds totaling $7.7 million.

As of May 6, 2025, approximately 14.7 million shares remained available for sale under the Sales Agreement.

Our cash and cash equivalents at March 31, 2025 were $18.5 million, a decrease of $21.9 million from December 31, 2024.

Cash and cash equivalents of our subsidiary, MiNK, at December 31, 2024, were $4.6 million.

MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.

As of March 31, 2025, we had debt outstanding of $36.0 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 our cash resources of $18.5 million as of March 31, 2025, along with funding we expect to receive in 2025, will be sufficient to satisfy our critical liquidity requirements through the second quarter of 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.

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

As of September 30, 2024, we had debt outstanding of $13.0 million in principal due February 2025.

Our cash and cash equivalents at September 30, 2024 were $44.8 million, a decrease of $31.3 million from December 31, 2023.

Cash and cash equivalents of our subsidiary, MiNK, at June 30, 2024, were $9.3 million.

MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.

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

Based on our current plans and projections, we believe that our cash resources of $44.8 million as of September 30, 2024, will be sufficient to satisfy our critical liquidity requirements through the end of the year and into 2025.

To support operations further, meet our subordinated notes obligation, and to execute on our business plans, we require additional funding.

Currently we are in discussions with several entities including biotechnology and pharmaceutical partners, as well as dedicated healthcare funds to provide the funding necessary to support our operations through our planned biologics license application, or marketing authorization, submission for botensilimab/balstilimab.

However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q.

Currently we are in discussions with entities including operating companies and financial entities to provide the additional funding necessary 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 address the Company’s liquidity needs and has continued to adjust spending in order to preserve liquidity.

In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%.

Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash.

We continuously evaluate the likelihood of success of our programs.

As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis.

We expect our sources of funding to include payments from current collaborations which include out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties;

additional third-party agreements;

further royalty monetization;

project financing, and/or sales of equity securities.

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.

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

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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 $660.7 million over the term of the related activities.

Through September 30, 2024, we have expensed $598.1 million as research and development expenses and $562.4 million has been

paid under these agreements.

Through March 31, 2025, we have expensed $618.7 million as research and development expenses and $572.0 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.

2 unchanged sentences

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, 2024 and 2023 was $129.7 million and $183.8 million, respectively.

Net cash used in operating activities for the three months ended March 31, 2025 and 2024 was $25.6 million and $38.2 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.

See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K, Part II and Item 1A "Risk Factors" of our Q2 2024 Form 10-Q.

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