What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-11 compared with 2025-05-12 · 53 added, 34 removed, 146 unchanged (37% of the section changed)

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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.

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 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).

• 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”).

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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.

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.

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.

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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.

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.

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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 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 $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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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.

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.

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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Historical Results of Operations

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

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

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.

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 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.

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.

General and administrative expense

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

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.

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.

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.

Interest expense, net

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.

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

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 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.

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.

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.

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.

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.

Research and Development Programs

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,

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,

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 $2.2 billion as of March 31, 2025.

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

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.

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.

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

Riley Securities, Inc.

as our sales agent.

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.

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 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.

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.

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

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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 March 31, 2025, we have expensed $618.7 million as research and development expenses and $572.0 million has been paid under these agreements.

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.

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 three months ended March 31, 2025 and 2024 was $25.6 million and $38.2 million, respectively.

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.

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