AGENUS INC

Previous wording

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 BOT, a multifunctional, Fc-enhanced anti-CTLA-4 antibody, alone and in combination with BAL, a fully human monoclonal IgG4 anti-PD-1 antibody. BOT is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses, with the goal of extending immunotherapy benefit to “cold” tumors that generally respond poorly to standard of care and to conventional PD-1 and CTLA-4 therapies. BAL is designed to block PD-1 from interacting with PD-L1 and PD-L2. BOT/BAL is investigational and has not been approved by the U.S. Food and Drug Administration (the “FDA”) or authorized for commercial sale in the European Union or any other jurisdiction.

Current wording

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"), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, alone and in combination with balstilimab ("BAL"), a fully human monoclonal IgG4 anti-PD-1 antibody. BOT is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses, with the goal of extending immunotherapy benefit to “cold” tumors that generally respond poorly to standard of care and to conventional PD-1 and CTLA-4 therapies. BAL is designed to block PD-1 from interacting with PD-L1 and PD-L2. BOT/BAL is investigational and has not been approved by the U.S. Food and Drug Administration (the “FDA”) or authorized for commercial sale in the European Union or any other jurisdiction.

Previous wording

We also maintain select clinical-stage immuno-oncology assets that may be used as standalone agents or as complements to BOT/BAL. Agenus also maintains an equity investment in MiNK Therapeutics, Inc. ("MiNK"), with an approximate fair value of $25.5 million as of June 30, 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."

Current wording

We also maintain select clinical-stage immuno-oncology assets that may be used as standalone agents or as complements to BOT/BAL. Agenus also maintains an equity investment in MiNK Therapeutics, Inc. ("MiNK"), with an approximate fair value of $27.3 million as of September 30, 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."

Previous wording

The six months ended June 30, 2026 and the period shortly thereafter included several developments that materially advanced our strategic priorities: the closing of the strategic collaboration with Zydus Lifesciences Ltd. and the Company meeting the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026; the conclusion of the SEC’s investigation as to the Company; the dismissal of the related putative securities class action; continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partner; the announcement of ROBBIN, our planned registrational Phase 3 trial of neoadjuvant BOT/BAL in high-risk Stage II and Stage III MSS colon cancer, together with the discontinuation of our financial support for the CCTG-sponsored BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer and the closing of a private placement providing approximately $85.0 million in upfront gross proceeds, before the deduction of placement expenses, and up to an additional $255.0 million upon the full exercise of the accompanying purchase warrants.

Current wording

The nine months ended September 30, 2026 included several developments that materially advanced our strategic priorities: the closing of the strategic collaboration with Zydus Lifesciences Ltd. and the Company meeting the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026; the conclusion of the SEC’s investigation as to the Company; the dismissal of the related putative securities class action; continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partner; the announcement of ROBBIN, our planned registrational Phase 3 trial of neoadjuvant BOT/BAL in high-risk Stage II and Stage III MSS colon cancer, together with the discontinuation of our financial support for the CCTG-sponsored BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer and the closing of a private placement providing approximately $85.0 million in upfront gross proceeds, before the deduction of placement expenses, and up to an additional $255.0 million upon the full exercise of the accompanying purchase warrants.

Previous wording

Strategic Prioritization of Neoadjuvant BOT/BAL in MSS Colon Cancer

Current wording

Strategic Prioritization of Neoadjuvant BOT/BAL in Colon Cancer

Previous wording

ROBBIN is a planned global randomized Phase 3 trial evaluating neoadjuvant BOT/BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (“EFS”) as its primary endpoint. Following interactions with the FDA, key elements of the proposed ROBBIN Phase 3 trial design, including patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan, have been informed by FDA feedback.

Current wording

ROBBIN is a planned global randomized Phase 3 trial evaluating neoadjuvant BOT/BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial is expected to enroll approximately 850 patients, randomized 1:1, with event free survival (“EFS”) as its primary endpoint. Following interactions with the FDA, key elements of the proposed ROBBIN Phase 3 trial design, including patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan, have been informed by FDA feedback.

Previous wording

The clinical rationale for ROBBIN is derived from NEST and UNICORN, two independent investigator-sponsored Phase 2 studies evaluating neoadjuvant BOT/BAL in MSS colorectal cancer. Across those studies, BOT/BAL produced pathologic response in approximately 60% to 70% of patients, major pathologic response in approximately 35% to 40% of patients, and pathologic complete response in approximately 30% of patients. Deep pathologic responses in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer. With median follow-up of approximately 9 to 18 months, all treated patients remained disease free, and circulating tumor DNA clearance was observed during treatment. NEST and UNICORN were small studies. Neither included a comparison arm, and neither was designed to determine whether BOT/BAL reduces the risk of recurrence. ROBBIN is intended to address that question. Further details from both studies are anticipated to be published in the second half of 2026.

Current wording

The clinical rationale for ROBBIN is derived from NEST and UNICORN, two independent investigator-sponsored Phase 2 studies evaluating neoadjuvant BOT/BAL in MSS colorectal cancer. Across those studies, BOT/BAL produced pathologic response in approximately 60% to 70% of patients, major pathologic response in approximately 35% to 40% of patients, and pathologic complete response in approximately 30% of patients. Deep pathologic responses in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer. At median follow-up of approximately 23.5 months for NEST 1, 32.2 months for NEST 2 and 19.2 months for UNICORN MSS cohort, all treated patients remained disease free, and circulating tumor DNA clearance was observed during treatment. NEST and UNICORN were small studies. Neither included a comparison arm, and neither was designed to determine whether BOT/BAL reduces the risk of recurrence. The Phase 3 ROBBIN study is designed to evaluate whether neoadjuvant BOT/BAL improves event free survival compared with standard of care alone. Results from NEST and UNICORN were published in Clinical Cancer Research and Nature Medicine, respectively.

Previous wording

In connection with this prioritization, Agenus discontinued financial support for the BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer, after which CCTG formally terminated the study. See Note U.

Current wording

In connection with this prioritization, Agenus discontinued financial support for the BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer, after which CCTG formally terminated the study.

Previous wording

Previously reported data include the following. In our randomized Phase 2 trial reported at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2025, the BOT 75 mg plus BAL regimen achieved a 19% objective response rate and a 55% disease control rate in heavily pretreated patients with refractory MSS metastatic colorectal cancer without active liver metastases, with no objective responses observed in the control arm. Pan-tumor data from more than 400 heavily pretreated patients in the Phase 1b C-800-01 study, presented 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.

Current wording

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. Pan-tumor data from more than 400 heavily pretreated patients in the Phase 1b C-800-01 study, presented in October 2025, showed approximately 39% two-year overall survival and median overall survival of 17.2 months across multiple tumor types.

Previous wording

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.

Current wording

BOT, in combination with BAL, has been evaluated in approximately 1,500 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.

Previous wording

In January 2026, we closed the strategic collaboration with Zydus Lifesciences Ltd. ("Zydus"), under which we sold our Emeryville and Berkeley biologics manufacturing facilities and received $91.0 million in cash consideration at closing, comprising $75.0 million for the 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 restricted to services provided to us by Zydus. In March 2026, the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026, were met based on contracted work orders for BOT/BAL chemistry, manufacturing and controls 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. See Note R to our Condensed Consolidated Financial Statements for additional information.

Current wording

In January 2026, we closed the strategic collaboration with Zydus Lifesciences Ltd. ("Zydus"), under which we sold our Emeryville and Berkeley biologics manufacturing facilities and received $91.0 million in cash consideration at closing, subject to certain adjustments, comprising $75.0 million for the 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 restricted to services provided to us by Zydus. In March 2026, the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026, were met based on contracted work orders for BOT/BAL chemistry, manufacturing and controls 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. See Note R to our Condensed Consolidated Financial Statements for additional information.

Previous wording

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 appealed to the U.S. Court of Appeals for the First Circuit, and briefing in the appeal commenced in June 2026. See Note S to our Condensed Consolidated Financial Statements and Part II, Item 1 (Legal Proceedings) for additional information.

Current wording

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 appealed to the U.S. Court of Appeals for the First Circuit, and briefing in the appeal commenced in June 2026 and concluded in September 2026. See Note S to our Condensed Consolidated Financial Statements and Part II, Item 1 (Legal Proceedings) for additional information.

Previous wording

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

Current wording

We recognized pre-commercial product revenue of approximately $6.1 million during the three months ended September 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted.

Previous wording

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 $3.3 million, to approximately $28.1 million for the three months ended June 30, 2026, from $24.8 million for the three months ended June 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Current wording

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 decreased $3.7 million, to approximately $25.4 million for the three months ended September 30, 2026, from $29.1 million for the three months ended September 30, 2025, due to decreased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Previous wording

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 45% to $14.8 million for the three months ended June 30, 2026 from $26.7 million for the three months ended June 30, 2025. The decreased expenses in the three months ended June 30, 2026 primarily relate to a $4.5 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $3.1 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $4.3 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Current wording

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 $11.6 million for the three months ended September 30, 2026 from $23.6 million for the three months ended September 30, 2025. The decreased expenses in the three months ended September 30, 2026 primarily relate to a $4.7 million decrease in professional service fees, mainly due to a decrease in external legal expenses, a $3.6 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 $3.3 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 $0.2 million decrease in expenses attributable to the activities of our subsidiaries.

Previous wording

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

Current wording

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 22% to $8.4 million for the three months ended September 30, 2026 from $10.9 million for the three months ended September 30, 2025. The decreased expenses in the three months ended September 30, 2026 primarily relate to a $0.7 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 partially offset by an increase in share-based compensation expense, a $1.9 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026,partially offset by a $0.2 million increase in professional fees, mainly due to an increase in external legal expenses.

Previous wording

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

Current wording

The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $1.9 million for the three months ended September 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.

Previous wording

Interest expense, net increased to approximately $15.2 million for the three months ended June 30, 2026 from $13.3 million for the three months ended June 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Current wording

Interest expense, net increased to approximately $14.5 million for the three months ended September 30, 2026 from $13.2 million for the three months ended September 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Previous wording

Six months ended June 30, 2026 compared to the six months ended June 30, 2025

Current wording

Nine months ended September 30, 2026 compared to the nine months ended September 30, 2025

Previous wording

We recognized pre-commercial product revenue of approximately $11.0 million during the six months ended June 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted.

Current wording

We recognized pre-commercial product revenue of approximately $17.0 million during the nine months ended September 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s AAC framework and NPPs, where permitted.

Previous wording

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 $8.9 million, to approximately $57.3 million for the six months ended June 30, 2026, from $48.4 million for the six months ended June 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Current wording

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $5.2 million, to approximately $82.7 million for the nine months ended September 30, 2026, from $77.5 million for the nine months ended September 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Previous wording

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 45% to $26.6 million for the six months ended June 30, 2026 from $48.2 million for the six months ended June 30, 2025. The decreased expenses in the six months ended June 30, 2026 primarily relate to a 1.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs and clinical trials, a $7.9 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 $5.6 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 $6.3 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Current wording

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 47% to $38.2 million for the nine months ended September 30, 2026 from $71.8 million for the nine months ended September 30, 2025. The decreased expenses in the nine months ended September 30, 2026 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 and clinical trials, a $11.5 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $8.9 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 $6.6 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Previous wording

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 51% to $15.3 million for the six months ended June 30, 2026 from $31.2million for the six months ended June 30, 2025. The decreased expenses in the six months ended June 30, 2026 primarily relate to a $4.3 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 and a decrease in share-based compensation expense, a $3.4 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $3.5 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 $4.9 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Current wording

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 44% to $23.8 million for the nine months ended September 30, 2026 from $42.1 million for the nine months ended September 30, 2025. The decreased expenses in the nine months ended September 30, 2026 primarily relate to a $5.0 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 $3.1 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $5.4 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 $4.8 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.

Previous wording

The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $1.2 million for the six months ended June 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.

Current wording

The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $3.0 million for the nine months ended September 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.

Previous wording

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

Current wording

Interest expense, net increased to approximately $44.4 million for the nine months ended September 30, 2026 from $39.3 million for the nine months ended September 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Previous wording

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

Current wording

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

Previous wording

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of June 30, 2026. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through June 30, 2026, we have raised aggregate net proceeds of approximately $2.08 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.

Current wording

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of September 30, 2026. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through September 30, 2026, we have raised aggregate net proceeds of approximately $2.2 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.

Previous wording

We had cash and cash equivalents of $18.7 million as of June 30, 2026, compared with $3.0 million as of December 31, 2025. That balance excludes the $7.6 million held in escrow under the Zydus agreements, including $0.1 million of accrued interest, and excludes outstanding receivables under our early access programs, which we expect to collect during the third quarter of 2026. As of June 30, 2026, we had debt outstanding of $30.4 million in principal, of which $24.75 million is due November 2026 and $5.1 million is due January 2027. See Note G.

Current wording

We had cash and cash equivalents of $66.9 million as of September 30, 2026, compared with $3.0 million as of December 31, 2025. That balance excludes the $7.6 million held in escrow under the Zydus agreements, including $0.1 million of accrued interest, and does not include outstanding receivables under our early access programs, of which we have received $5.9 million during the third quarter of 2026 and we expect to receive the remaining balance, net of accrued rebates, of $11.8 million in future periods. As of September 30, 2026, we had debt outstanding of $30.2 million in principal, of which $24.8 million is due November 2029 and $5.1 million is due January 2027. See Note G.

Previous wording

During the six months ended June 30, 2026, MiNK repaid a $5.2 million related-party note receivable, and we closed agreements with Zydus under which we received $91.0 million of consideration, subject to adjustments for reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses, and $7.5 million placed into a twelve-month escrow. See Note R.

Current wording

During the nine months ended September 30, 2026, MiNK repaid a $5.2 million related-party note receivable, and we closed agreements with Zydus under which we received $91.0 million of consideration, subject to adjustments for reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses, and $7.5 million placed into a twelve-month escrow. See Note R.

Previous wording

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 3.9 million shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2026 and received aggregate net proceeds totaling $15.1 million.

Current wording

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 3.9 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2026 and received aggregate net proceeds totaling $15.1 million.

Previous wording

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), we believe our existing cash and cash equivalents, together with the net proceeds from the Private Placement, are expected to fund operations and capital expenditure requirements into the third quarter of 2027, assuming no exercise of the Series A or Series B Warrants. That plan reflects anticipated revenues from our early access programs and scheduled debt payments in the look-forward period. If all such warrants are exercised for cash, the Company expects these resources to fund operations through year-end 2031. Advancing our planned registration and commercialization strategy for BOT/BAL, and funding the Company through achievement of profitability, will require additional capital.

Current wording

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), we believe our existing cash and cash equivalents, which include the net proceeds from the Private Placement, are expected to fund operations and capital expenditure requirements through the third quarter of 2027, assuming no exercise of the Series A or Series B Warrants. These projections reflect anticipated revenues from our early access programs and scheduled debt payments in the look-forward period. If all such warrants are exercised for cash, the Company expects these resources to fund operations through year-end 2031. Advancing our planned registration and commercialization strategy for BOT/BAL, and funding the Company through achievement of profitability, will require additional capital.

Previous wording

Our operating expenses for the six months ended June 30, 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.

Current wording

Our operating expenses for the nine months ended September 30, 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 nine months ended September 30, 2026 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.

Previous wording

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. 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 $690.7 million over the term of the related activities. Through June 30, 2026, we have expensed $630.5 million as research and development expenses and $593.4 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. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs, including ROBBIN.

Current wording

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. 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 $690.7 million over the term of the related activities. Through September 30, 2026, we have expensed $635.8 million as research and development expenses and $609.7 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. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs, including ROBBIN.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $67.2 million and $45.8 million, respectively. Net cash used in operating activities increased principally because of working-capital changes, including a $24.0 million reduction in accounts payable and a $12.9 million increase in accounts receivable, including receivables associated with our early access programs. These outflows more than offset the benefit of the reduced operating-expense base during the period.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 and 2025 was $87.2 million and $60.6 million, respectively. Net cash used in operating activities increased principally because of working-capital changes, including a $36.3 million reduction in accounts payable and a $15.2 million increase in accounts receivable, including receivables associated with our early access programs. These outflows more than offset the benefit of the reduced operating-expense base during the period.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2026 was $69.2 million, driven principally by $63.9 million of net proceeds from the Zydus asset sale and $5.0 million from the repayment of the MiNK related party note.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2026 was $49.3 million, driven principally by $63.9 million of net proceeds from the Zydus asset sale and $5.0 million from the repayment of the MiNK related party note, partially offset by $20.0 million in purchases of short-term investments.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $13.7 million, consisting principally of $15.1 million of net proceeds from at-the-market sales of common stock and $6.4 million of net proceeds from the sale of common stock under the Zynext SPA, partially offset by $8.4 million of debt repayment.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $101.3 million, consisting principally of $84.8 million of net proceeds from the Private Placement, $15.1 million of net proceeds from at-the-market sales of common stock, $6.4 million of net proceeds from the sale of common stock under the Zynext SPA, and $3.4 million of proceeds from employee stock purchases and option exercises, partially offset by $8.4 million of debt repayment.