What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-10 compared with 2025-08-11 · 41 added, 48 removed, 151 unchanged (37% of the section changed)

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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")).

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.

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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 and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.

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”).

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We received this milestone in January 2024.

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

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.

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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 current 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.

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.

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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 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 addressing an urgent unmet need in patients with pulmonary dysfunction.

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

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

(“ImmunoScape”) to discover and develop next-generation T-cell receptor therapies targeting novel solid tumor antigens.

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.

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Historical Results of Operations

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

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 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 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 $2.2 million, to approximately $24.8 million for the three months ended June 30, 2025, from $22.6 million for the three months ended June 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 $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 27% to $26.7 million for the three months ended June 30, 2025 from $36.8 million for the three months ended June 30, 2024.

Decreased expenses in the three months ended June 30, 2025 primarily relate to a $6.6 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 $2.7 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.8 million decrease in other research and development expenses.

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 8% to $15.5 million for the three months ended June 30, 2025 from $16.8 million for the three months ended June 30, 2024.

Decreased expenses in the three months ended June 30, 2025 primarily relate to a $1.8 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.2 million decrease in other general and administrative expenses.

These decreases were partially offset by a $0.3 million increase in expenses attributable to the activities of our subsidiaries and a $0.3 million increase in 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 $12,000 for the three months ended June 30, 2025 from income of $7.1 million for the three months ended June 30, 2024, primarily due to de minimis activity in the three months ended June 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 three months ended June 30, 2024.

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 $13.3 million for the three months ended June 30, 2025 from $31.7 million for the three months ended June 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.

Six months ended June 30, 2025 compared to the six months ended June 30, 2024

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

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 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 decreased $2.0 million, to approximately $48.4 million for the six months ended June 30, 2025, from $50.3 million for the six months ended June 30, 2024, due to decreased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

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.

Research and development expense

Research and development expense decreased 40% to $48.2 million for the six months ended June 30, 2025 from $80.7 million for the six months ended June 30, 2024.

Decreased expenses in the six months ended June 30, 2025 primarily relate to a $22.9 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 $6.0 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $3.3 million decrease in expenses attributable to the activities of our subsidiaries and a $0.4 million decrease in other research and development expenses.

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.

General and administrative expense

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

administrative expenses decreased 7% to $31.2 million for the six months ended June 30, 2025 from $33.7 million for the six months ended June 30, 2024.

Decreased expenses in the six months ended June 30, 2025 primarily relate to a $3.3 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.3 million decrease in other general and administrative expenses.

These decreases were partially offset by a $1.1 million increase in professional fees and a $0.1 million increase in expenses attributable to the activities of our subsidiaries.

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 $0.3 million for the six months ended June 30, 2025 from income of $6.0 million for the six months ended June 30, 2024, primarily due to de minimis activity in the six months ended June 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 six months ended June 30, 2024.

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.

Interest expense, net

Interest expense, net decreased to approximately $26.1 million for the six months ended June 30, 2025 from $61.2 million for the six months ended June 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 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.

Research and Development Programs

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

Six Months Ended June 30,

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,

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 June 30, 2025.

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.2 billion as of September 30, 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 June 30, 2025, we have raised aggregate net proceeds of approximately $2.03 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 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.

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 5.9 million and 0.8 million shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2025 and the period of July 1, 2025 through August 7, 2025, respectively, and received aggregate net proceeds totaling $23.8 million.

As of August 7, 2025, approximately 11.4 million shares remained available for sale under the Sales Agreement.

Our cash and cash equivalents at June 30, 2025 were $9.5 million, a decrease of $30.9 million from December 31, 2024.

Subsequent to quarter end we received $5.2 million from sales of our common stock in at the market offerings, and we anticipate receiving $75.0 million upfront plus a $16.0 million equity investment from the closing of our agreements with Zydus Lifesciences Ltd and its affiliates, during the third quarter.

Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2025, were $3.2 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 June 30, 2025, we had debt outstanding of $35.8 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 $9.5 million as of June 30, 2025, along with the post-quarter cash infusions noted above and additional cash inflows from funding we expect to receive in 2025, will be sufficient to satisfy our critical liquidity requirements through 2026.

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.

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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.

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.

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.

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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 June 30, 2025, we have expensed $623.3 million as research and development expenses and $571.1 million has been paid under these agreements.

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.

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 six months ended June 30, 2025 and 2024 was $45.8 million and $76.4 million, respectively.

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.

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