Agenus Inc 8-K, filed Nov 5, 2026
Agenus Inc (AGEN)
About this 8-K
Agenus Inc filed this 8-K on November 5, 2026.
Agenus Inc. reported third-quarter revenue of $31.5 million and operating income of $11.4 million. Armenia granted the first worldwide marketing authorizations for Botvymo® and Evamplix®, while ROBBIN is targeted to enroll its first patient in Q1 2027. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 5, 2026, Agenus Inc. announced its financial results for the quarter ended September 30, 2026. In connection with the announcement, the Company issued a press release, which is being furnished as Exhibit 99.1 to this current report on Form 8-K.
The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit
The following exhibit is furnished herewith:
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: |
November 5, 2026 |
By: |
/s/ Garo H. Armen |
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Garo H. Armen, Chairman and CEO |
FOR IMMEDIATE RELEASE
Agenus Reports Third Quarter 2026 Results, Highlighted by First Marketing Authorizations for BOT+BAL and Global Investigator Support for Phase 3 ROBBIN Study
LEXINGTON, Mass. – November 5, 2026 – Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the third quarter ended September 30, 2026, and highlighted progress preparing its global randomized Phase 3 ROBBIN trial of botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, before surgery in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer.
The clinical foundation for ROBBIN has strengthened through two independent, peer-reviewed Phase 2 studies of short-course BOT+BAL before surgery. NEST, published in Clinical Cancer Research in August, and the multicenter UNICORN study, published in Nature Medicine on November 2, 2026, each reported pathologic complete responses in approximately 30% of patients with MSS colon cancer treated with neoadjuvant BOT+BAL. Neither study reported colon cancer recurrences in the BOT+BAL cohorts at the respective data cutoffs, with median follow-up of 32.2 and 23.5 months across NEST-1 and NEST-2 and 19.2 months in the UNICORN MSS cohort. The depth of response and encouraging follow-up strengthen our confidence in advancing BOT+BAL in the curative-intent setting, where ROBBIN will test whether treatment before surgery can prevent recurrence and increase the potential for cure.
Long-term outcomes in advanced, metastatic cancer add another dimension to the BOT+BAL evidence. In the Phase 1b C-800-01 program that enrolled more than 400 patients with advanced, metastatic solid tumors, extended follow-up of 123 heavily pretreated patients with MSS metastatic colorectal cancer without active liver metastases demonstrated 33% three-year overall survival, presented at ESMO GI 2026 in July and subsequently published in Clinical Cancer Research. The heavily pretreated recurrent ovarian cancer cohort, in which patients had received a median of four prior therapies and nearly three-quarters had platinum-resistant or refractory disease, demonstrated 48% estimated overall survival at three years, unchanged from the two-year estimate, as presented at International Gynecologic Cancer Society (IGCS) 2026 Meeting. The durability observed in refractory disease strengthens the rationale for investigating
BOT+BAL before surgery, when the primary tumor and tumor-draining lymph nodes remain intact and may provide an opportunity to generate a broader immune response.
“We have moved beyond planning ROBBIN to mobilizing investigators and activating sites around the world in preparation for patient enrollment,” said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “The strong investigator engagement in Madrid and São Paulo, together with the peer-reviewed NEST and UNICORN publications, strengthens our confidence in the potential of BOT+BAL to change outcomes for patients with MSS colon cancer. We have a clear registrational path and financing aligned with key development milestones anticipated in 2027. Our priority is to bring BOT+BAL earlier in the treatment of cancer, before surgery and other systemic therapies, with the goal of preventing recurrence and increasing the potential for cure.”
Armen continued, “At the same time, patients with advanced cancer need better options today. We continue to see growing international demand for BOT+BAL through France’s AAC program and physician-initiated named-patient programs. Armenia’s decision to grant the first marketing authorizations for BOT and BAL anywhere in the world marks an important step in bringing treatment options to patients with advanced disease who need it today.”
Third Quarter and Recent Business Highlights
Global investigator support advances ROBBIN Phase 3 readiness
Investigator and site meetings in Madrid alongside ESMO and in São Paulo brought together teams preparing to enroll ROBBIN across North America, Europe, South America and Asia. Site qualification and startup activities are advancing toward first patient dosing anticipated in the first quarter of 2027. ROBBIN, the global, randomized registrational Phase 3 trial is designed with feedback from the FDA to enroll approximately 850 patients and will evaluate event-free survival as its primary endpoint, with an interim pathologic response assessment of the first 100 patients enrolled anticipated in Q4 of 2027.
MSS disease accounts for approximately 85% of early-stage colorectal cancers.¹,² Despite important immunotherapy advances in mismatch repair-deficient disease (dMMR), patients with MSS colon cancer continue to rely principally on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved for this population in more than two decades. ROBBIN addresses an estimated 38,000 newly diagnosed U.S. patients each year, representing an estimated annual U.S. total addressable market exceeding $7 billion.
Independent Neoadjuvant Evidence Strengthens the Curative-Intent Rationale
Two independent, peer-reviewed Phase 2 studies strengthen the rationale for short-course BOT+BAL before surgery in MSS colon cancer. NEST, published in Clinical Cancer Research, reported a 32% pathologic complete response rate in MSS tumors, with no observed colorectal cancer recurrences at median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. UNICORN, published in Nature Medicine, reported a 29% pathologic complete response rate and 36% major pathologic response rate in its MSS BOT+BAL cohort, with no observed recurrences at 19.2 months of median follow-up. Although BOT alone produced some tumor regression in MSS disease, the deeper major and complete pathologic responses occurred with the BOT+BAL combination. Together with NEST’s longer follow-up, the multicenter UNICORN findings provide independent clinical and biological evidence strengthening the
curative-intent rationale for ROBBIN. Importantly, neoadjuvant BOT+BAL did not delay planned surgery in NEST, and 98% of patients in UNICORN underwent surgery on schedule, with no new safety concerns identified.
Additional neoadjuvant evidence from the investigator-initiated NEOASIS study in the mismatch repair-deficient (dMMR) colon cancer cohort was presented at ESMO 2026. Following six weeks of BOT+BAL, 72% of 18 patients achieved a pathologic complete response and 83% achieved a major pathologic response. Although dMMR is a distinct molecular population from the MSS patients targeted by ROBBIN, the results add to the clinical experience with short-course treatment before surgery.
Financing aligned with development milestones
The oversubscribed July private placement provided approximately $85 million in upfront gross proceeds, with milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised. Based on the current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory activities and operations through the third quarter of 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.
Armenia grants first worldwide marketing authorizations for BOT+BAL
Shortly after quarter-end, Armenia’s Ministry of Health granted marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab), each for use in combination with the other in adult patients with microsatellite stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The authorizations followed a rigorous review of the registration dossier and were supported by clinical evidence from the fully enrolled Phase 1b C-800-01 MSS metastatic colorectal cancer cohort and the randomized Phase 2 C-800-25 study, both reported in peer-reviewed publications. The milestone establishes an approved treatment pathway for eligible patients with advanced disease and provides a foundation for Agenus to pursue potential additional marketing authorizations in other Eurasian Economic Union member countries.
Growing international interest in authorized patient-access programs
Physician and patient interest in BOT+BAL continues to grow across authorized access pathways. In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Physician-initiated paid named-patient programs provide additional access across select countries in Europe and South and Central America, where permitted by local regulations. Patients from outside these countries, including the United States, have also traveled to markets where authorized access is available to receive treatment.
Pre-commercial BOT+BAL product revenue from these programs was $6.0 million in the third quarter of 2026, compared with $6.4 million in the second quarter, and $17.0 million for the first nine months of 2026. These are non-promotional access programs, and recognized revenue can vary with country-specific pricing, reimbursement, taxation, distribution arrangements and timing; it does not necessarily move in proportion to physician inquiries or patient treatment activity.
Third Quarter 2026 Financial Results
Revenue. Total revenue for the third quarter of 2026 was $31.5 million, compared with $30.2 million for the third quarter of 2025, and included $6.0 million of pre-commercial BOT+BAL product revenue, compared with $6.4 million in the second quarter of 2026, and $25.5 million of non-cash royalty revenue, compared with $28.1 million in the second quarter. Total revenue for the first nine months of 2026 was $99.7 million, compared with $80.0 million for the same period in 2025, and included $17.0 million of product revenue and $82.7 million of non-cash royalty revenue. Non-cash royalty revenue relates to royalty interests Agenus previously monetized and does not generate cash for the company.
Operating income and net income. Operating income was $11.4 million for the third quarter, the third consecutive quarter of positive operating income, compared with an operating loss of $4.6 million in the third quarter of 2025. Net income was $2.8 million for the quarter and $41.4 million for the first nine months of 2026.
Cash and financing. Cash, cash equivalents and short-term investments were $86.9 million at September 30, 2026, compared with $18.7 million at June 30, 2026. The oversubscribed private placement completed in July provided approximately $85 million in upfront gross proceeds and includes milestone-aligned warrants that provide up to approximately $255 million in additional gross proceeds if fully exercised. Based on the current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory activities and operations through the third quarter of 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.
Financial Summary
($ in millions)
Metric |
Q1 2026 |
Q2 2026 |
Q3 2026 |
YTD Q3 2026 |
Q3 2025 |
YTD Q3 2025 |
Pre-commercial product revenue |
$4.6 |
$6.4 |
$6.0 |
$17.0 |
— |
— |
Non-cash royalty revenue |
29.1 |
28.1 |
25.5 |
82.7 |
29.1 |
77.5 |
Service and other revenue |
— |
— |
— |
— |
1.1 |
2.5 |
Total revenue |
$33.7 |
$34.5 |
$31.5 |
$99.7 |
$30.2 |
$80.0 |
Operating income (loss) |
$15.1 |
$11.3 |
$11.4 |
$37.8 |
$(4.6) |
$(34.6) |
Net income (loss) |
$39.2 |
$(0.6) |
$2.8 |
$41.4 |
$63.9 |
$7.5 |
Cash, cash equivalents and short-term investments |
$35.0 |
$18.7 |
$86.9 |
$86.9 |
$3.5 |
$3.5 |
Upcoming Milestones
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. BOT augments immune responses across a wide range of tumor types by priming and activating T cells, reducing intratumoral regulatory T cells, activating myeloid cells and inducing durable memory responses.
BOT+ balstilimab (BAL) has been studied in over 1,500 patients across more than nine tumor types, spanning late-line refractory disease and early-stage neoadjuvant settings. The combination is being developed to expand immunotherapy benefit to more patients, including those with microsatellite stable (MSS) disease and tumors considered immunologically “cold” or resistant to existing immunotherapies. Agenus’ Phase 3 ROBBIN study is designed to evaluate BOT+BAL given before surgery in earlier-stage colon cancer. For more information about botensilimab trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
Botvymo and Evamplix Armenia Approval and Indication
Botvymo® (botensilimab) and Evamplix® (balstilimab) are separately authorized in Armenia, each for use in combination with the other, for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies. The Armenian marketing authorizations are conditional and valid for one year, with renewal based on annual clinical updates provided to the regulator. Their use in other indications and in other countries remains investigational.
Agenus’ Commitment to Patient Access
Agenus is committed to expanding patient access to BOT+BAL through regulatory approvals, clinical trials and authorized early-access pathways. Following the first marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab) in Armenia for eligible adults with previously treated microsatellite-stable (MSS) metastatic colorectal cancer without active liver metastases, BOT+BAL remains investigational outside Armenia and is not approved by the U.S. Food and Drug Administration (FDA).
In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to BOT+BAL for eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. In a growing number of other countries, BOT+BAL is available through physician-initiated named-patient programs under local regulations. BAP Pharma serves as Agenus’ global partner for the French AAC pathway and named-patient access programs.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus’ botensilimab and balstilimab programs, access programs, clinical development plans and ROBBIN milestones, expected regulatory timelines and filings, the conditional Armenian marketing authorizations and their renewal, liquidity, anticipated cash runway, the Company’s need for additional capital, the exercise of the Series A and Series B warrants, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “potential,” and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Agenus’ most recent Annual Report on Form 10-K for 2025 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
References
1. Buchler T. Front Oncol. 2022;12:888181. 2. Guven DC, et al. Oncologist. 2024;29(5):e580–e600.
Source: Agenus Inc.
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