Agenus

What Agenus does

Agenus Inc. (NASDAQ: AGEN) is a clinical-stage immuno-oncology company founded in 1994 by Garo H. Armen and headquartered in Lexington, Massachusetts, with approximately 510 employees across US R&D, antibody discovery in Cambridge UK, Northern California manufacturing, and European clinical operations. The company's lead asset is a fixed-dose combination of botensilimab (BOT), a proprietary Fc-enhanced anti-CTLA-4 antibody designed to lower the immune-activation threshold needed for anti-tumor activity, and balstilimab (BAL), an anti-PD-1 antibody. The BOT+BAL combination is being developed to convert immunologically "cold" solid tumors — including MSS metastatic colorectal cancer, ovarian, sarcoma, melanoma, hepatocellular carcinoma, and gastroesophageal cancer — into immune-active tumors, with approximately 1,200 patients treated across Phase 1 and Phase 2 trials generating response rates and survival data in indications with limited prior therapeutic options. The most advanced program is the global Phase 3 BATTMAN trial of BOT+BAL in refractory MSS metastatic colorectal cancer.

Agenus monetizes its investigational therapy through a combination of pre-approval revenue mechanisms rather than traditional commercial sales. France's nationally reimbursed Autorisation d'Accès Compassionnel (AAC) covers BOT+BAL in MSS mCRC, ovarian cancer, and soft-tissue sarcomas; global Named Patient Programs serve other ex-US markets; and a $141 million strategic collaboration with Zydus Lifesciences (announced January 2026) provides $75M upfront cash, a $16M equity investment, up to $50M in volume-based milestones, and 5% royalties on India/Sri Lanka net sales in exchange for transferring Emeryville and Berkeley manufacturing facilities to Zydus. Distribution relies on medical affairs-led engagement with global KOLs, investigator-initiated trials at leading academic centers, and a cooperative-group-led Phase 3 BATTMAN trial across 100+ sites in Canada, France, Australia, and New Zealand. The company is also building an AI-enabled patient stratification capability through a partnership with Noetik, applying the OCTO virtual cell foundation model and a TARIO-2 image biomarker to predict BOT+BAL response (64% response rate in AI-identified subgroup vs 9% in remaining cohort in MSS mCRC).

As of March 2026, Agenus reported a market capitalization of approximately $130 million, FY2025 early-access revenue of $4.2 million, and Q1 2026 net income of $39.2 million driven primarily by the one-time Zydus upfront payment of $91M plus $29.1M of non-cash royalty revenue. Key regulatory milestones include FDA Fast Track designation for BOT+BAL in MSS colorectal cancer and the expanded French AAC across three solid-tumor settings. Investor-relevant catalysts center on the Phase 3 BATTMAN readout, validation and potential companion-diagnostic positioning of the Noetik AI biomarkers, scaling of pre-approval access revenue, and further strategic capital or partnership transactions similar to the Zydus deal.

Name

Agenus

Legal name

Agenus Inc.

Website

https://agenusbio.com

Company type

Public

Founded year

1994

Operating status

Operating

Headcount range

101–250 employees

Short description

Agenus is a clinical-stage immuno-oncology company developing the BOT+BAL antibody combination (Fc-enhanced anti-CTLA-4 plus anti-PD-1) to treat immunologically cold solid tumors, currently monetizing through France's AAC compassionate access program, global Named Patient Programs, and strategic collaboration revenue ahead of Phase 3 readout in MSS metastatic colorectal cancer.

Ownership category

akta.pro rank

Product category

Cancer Immunotherapy

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG)

akta.pro secondary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

Keywords

• Immuno-oncology therapies
• Checkpoint inhibitor antibodies
• Cancer immunotherapy development
• Clinical-stage biopharmaceutical
• Antibody drug pipeline

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Early Access Programs: Revenue from early access programs including France's AAC and Named Patient Programs providing BOT+BAL to patients before regulatory approval. Recognized $4.2 million in initial revenue from early access programs in 2025.
2. Zydus Strategic Collaboration: $141 million strategic collaboration with Zydus Lifesciences including $75M upfront cash, $16M equity investment, up to $50M in milestone payments, plus 5% royalties on net sales in India and Sri Lanka. Zydus acquired manufacturing facilities in Emeryville and Berkeley, California.
3. Manufacturing Capacity Rights: Agenus retains committed U.S. manufacturing capacity for Phase 3 BOT+BAL combination therapy while Zydus operates facilities under Zylidac Bio LLC subsidiary for CDMO services globally.
4. Non-cash Royalty Revenue: $29.1 million in non-cash royalty revenue reported in Q1 2026, plus $91 million upfront payment from Zydus collaboration.

Pricing tiers

Go-to-market motion4 records

Distribution channels3 records

Marketing channels6 records

Core offering

Agenus is a clinical-stage immuno-oncology biopharmaceutical company developing antibody-based cancer immunotherapies. Its lead program is the BOT+BAL combination of botensilimab (an Fc-enhanced anti-CTLA-4 antibody) and balstilimab (an anti-PD-1 antibody) for treating immunologically cold and treatment-resistant solid tumors. The company also develops complementary modalities including iNKT cell therapy (AgenT-797) and AI-enabled biomarker platforms to support patient selection and combination strategies.

Product overview

Agenus is a clinical-stage immuno-oncology company developing a portfolio of immunotherapies centered on its lead BOT+BAL combination (botensilimab plus balstilimab). Botensilimab is a next-generation Fc-enhanced anti-CTLA-4 antibody that activates cancer-fighting T cells, while balstilimab is a next-generation anti-PD-1 inhibitor that sustains T cell engagement. Together, BOT+BAL is designed to convert immunologically 'cold' tumors into immuno-active tumors. The company also develops AgenT-797, an allogeneic iNKT cell therapy, in collaboration with MiNK Therapeutics. The pipeline targets multiple solid tumor indications including metastatic colorectal cancer (MSS), ovarian cancer, sarcoma, melanoma, hepatocellular carcinoma, and gastroesophageal cancer.

Differentiator

Problem solved

Functional benefit

Products and services

• Botensilimab (BOT) Fc-enhanced anti-CTLA-4 monoclonal antibody designed to broaden and deepen immune responses against solid tumors, including those resistant to conventional checkpoint blockade. Used in oncology clinical settings and made available to eligible patients through early access programs.
• Balstilimab (BAL) Anti-PD-1 monoclonal antibody intended for combination immunotherapy regimens. Used by oncologists treating advanced solid tumors, often paired with botensilimab as part of the BOT+BAL combination regimen.
• BOT+BAL Combination Therapy Next-generation combination immunotherapy pairing Fc-enhanced anti-CTLA-4 (botensilimab) with anti-PD-1 (balstilimab) to treat immunologically cold and treatment-resistant solid tumors. Targeted at oncology centers, treating oncologists, and eligible patients in geographies where early access or named-patient programs exist.
• AgenT-797 Allogeneic invariant natural killer T (iNKT) cell therapy candidate designed to provide off-the-shelf cellular immunotherapy for oncology indications, including combination strategies with checkpoint antibodies. Aimed at oncologists and investigational cancer centers.

Quantifiable outcome

• 17% objective response rate and 26% clinical benefit rate in 341 evaluable patients with treatment-refractory MSS mCRC; median OS of 17.2 months and 38% 24-month OS
• +5 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature5 records

Partnerships

Eleven partnerships are on record, tiered secondary, core and minor.

• MiNK TherapeuticssecondaryStrategic or Co-development Partner · 3 April 2026Collaboration combining Agenus's BOT+BAL with MiNK's agenT-797 allogeneic iNKT cell therapy for PD-1 refractory gastroesophageal cancer. Phase 2 trial at Memorial Sloan Kettering Cancer Center showed 77% disease control rate with induction therapy approach. MiNK is engaged in discussions with multiple parties regarding potential combination trials and strategic minority investments.
• Zydus LifesciencescoreStrategic or Co-development Partner · 15 January 2026$141 million strategic collaboration including $75M upfront cash, $16M equity investment, and up to $50M in milestone payments. Zydus acquired Agenus biologics manufacturing facilities in Emeryville and Berkeley, California (operating under Zylidac Bio LLC subsidiary) and obtained exclusive rights to develop and commercialize BOT+BAL in India and Sri Lanka. Agenus retains committed U.S. manufacturing capacity for Phase 3 development and is eligible for 5% royalties on net sales in those territories.
• NoetikcoreTechnology or Integration · 17 June 2025Collaboration to develop AI-enabled predictive biomarkers for BOT/BAL using Noetik's OCTO virtual cell foundation model with 1.5 billion parameters trained on multimodal spatial data from nearly 200 million tumor and immune cells. Partnership aims to identify which patients are most likely to respond to BOT/BAL treatment and improve clinical trial outcomes. Agenus has exclusive rights to apply resulting biomarker insights in drug development and commercialization.
• GSKminorChannel Partner/ Reseller/ DistributorHistorical partnership for development and commercialization of certain immunotherapy candidates (logo shown on website partnerships page).
• IncyteminorChannel Partner/ Reseller/ DistributorHistorical partnership for development and commercialization of certain immunotherapy candidates (logo shown on website partnerships page).
• UroGen PharmaminorChannel Partner/ Reseller/ DistributorHistorical partnership; UroGen returned anti-CTLA-4 drug zalifrelimab to Agenus after phase 1 data did not meet benchmarks. Licensing agreement terminated affecting potential milestone payments.
• Canadian Cancer Trials Group (CCTG)coreStrategic or Co-development PartnerCooperative group leading the global Phase 3 BATTMAN registrational trial for BOT+BAL in refractory MSS metastatic colorectal cancer, partnering with academic networks including GI Cancer Trials and France's PRODIGE consortium.
• GI Cancer TrialssecondaryStrategic or Co-development PartnerAcademic network partner collaborating on Phase 3 BATTMAN registrational trial for BOT+BAL in colorectal cancer.
• PRODIGE Consortium (France)secondaryStrategic or Co-development PartnerFrench academic consortium collaborating on Phase 3 BATTMAN registrational trial for BOT+BAL in colorectal cancer.
• Various Academic Medical CenterscoreStrategic or Co-development PartnerInvestigator-initiated trials conducted at leading academic cancer centers including Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, and others for BOT+BAL across multiple tumor types.
• OncoDailyminorGTM or Marketing PartnerOncoDiscovery Award program supporting early-career medical oncologists with week-long fellowships at Agenus headquarters in Boston focused on drug discovery and early drug development, including mentorship and networking.

Scale indicators13 records

Recent moves8 records

Expansion highlights7 records

Broad incumbents

• Merck & Co. Merck's Keytruda (pembrolizumab) is the dominant anti-PD-1 across most solid tumors and sets the standard against which any BOT+BAL indication expansion must compete. Merck also has internal next-generation IO programs that could preempt Agenus's positioning.
• Roche: Roche/Genentech markets Tecentriq (atezolizumab, anti-PD-L1) and is developing next-generation IO combinations including tiragolumab, directly competing for the same combination-immunotherapy slots BOT+BAL targets across colorectal, lung, and GI tumors.
• Pfizer: Pfizer co-promotes Bavencio (avelumab, anti-PD-L1) and has multiple internal IO programs through its Seagen acquisition; the broad oncology pipeline overlaps with Agenus's solid tumor ambitions in colorectal, ovarian, and sarcoma.

Emerging players

• Compugen: Compugen develops PVRIG/ TIGIT-pathway immuno-oncology antibodies with AstraZeneca partnership, focusing on combinations in solid tumors including colorectal cancer - directly competitive with BOT+BAL's combination strategy.
• CytomX Therapeutics: CytomX's Probody therapeutic platform enables masked antibodies activated in the tumor microenvironment, including anti-PD-1 and anti-CTLA-4 Probody candidates - a parallel next-generation approach to BOT's Fc-enhanced CTLA-4 mechanism.
• BioNTech: BioNTech has built a diversified IO pipeline including mRNA cancer vaccines, bispecific antibodies, and checkpoint combinations - overlapping with Agenus's combination immunotherapy approach in colorectal cancer and other solid tumors.
• Arcus Biosciences: Arcus Biosciences is a clinical-stage IO company developing combinations including domvanalimab (anti-TIGIT) and quemliclustat, partnered with Gilead; competes with Agenus for combination-IO slots in MSS colorectal and other cold tumors.

Direct peers

• AstraZeneca: AstraZeneca's IMJUDO (tremelimumab, anti-CTLA-4) + IMFINZI (durvalumab, anti-PD-1) combination directly mirrors the BOT+BAL dual-checkpoint strategy, including in HCC - a lead indication for both companies. Agenus CCO Robin Taylor previously led AstraZeneca's IO franchise.
• Regeneron: Regeneron markets Libtayo (cemiplimab, anti-PD-1) and is developing next-gen IO combos including fianlimab (anti-LAG-3) + Libtayo in melanoma and other tumors - directly comparable to BOT+BAL's PD-1 + second-checkpoint strategy.
• Bristol-Myers Squibb: Bristol-Myers Squibb markets the Yervoy (ipilimumab, anti-CTLA-4) + Opdivo (nivolumab, anti-PD-1) combination - the original and most direct clinical competitor to Agenus's BOT+BAL combination across the same tumor types including MSS colorectal cancer.

Market position

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

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Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors10 records

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M&A3 records

Investments

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Frequently asked questions about Agenus