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Agenus

Logo: Agenus, Public domain, via Wikimedia Commons5

Biotechnology company

Agenus Inc. is a Lexington, Massachusetts-based biotechnology company focused on immunotherapy including immuno-oncology, a field that uses the immune system to control or cure cancer. The company is developing checkpoint modulators (CPMs), patient-specific anti-cancer vaccines, and adjuvants designed for use with various vaccines. CPM development is a particularly fast-moving field, since early products have produced unprecedented clinical benefits for patients.3 It was founded by Garo H. Armen.1 Its chief executive is Garo H. Armen.1 Wikipedia text CC BY-SA 4.0

Price unavailable

Last updated Oct 21, 2026.

Overview

1994Founded1

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  • TickerAGEN on Nasdaq1
  • Industrybiotechnology1
  • HeadquartersLexington1
  • Websitewww.agenusbio.com
  • Incorporated inDE6
  • Business address3 Forbes Road, Lexington, Ma 024216
  • Filer categoryAccelerated filer, Smaller reporting company6
  • Legal formCorporation4
  • LEI529900NDQQGU5H4UJK814
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressc/o The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, 19801 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 31249294

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Agenus Inc. is a Lexington, Massachusetts-based biotechnology company focused on immunotherapy including immuno-oncology, a field that uses the immune system to control or cure cancer. The company is developing checkpoint modulators (CPMs), patient-specific anti-cancer vaccines, and adjuvants designed for use with various vaccines. CPM development is a particularly fast-moving field, since early products have produced unprecedented clinical benefits for patients.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-17.7%Operating margin8
-2.7%Net margin8
10.4%Revenue growth, 20258
-$77.2MFree cash flow8

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Non Cash Revenue Related To Sale Of Future Royalties brought in 49% of the revenue Agenus broke down this way in fiscal 2025.

  1. Non Cash Revenue Related To Sale Of Future Royalties$108.6M849%up 8% from 2024
  2. Non Cash Royalty Revenue$108.6M849%up 8% from 2024
  3. Pre Commercial Product Revenue$4.2M82%
  4. Revenue$1.0M80%down 48% from 2024
  5. Clinical Product Revenue$334.0K80%down 31% from 2024
  6. Research And Development Revenue$334.0K80%down 31% from 2024
Products and services by year
Products and services202320242025
Non Cash Revenue Related To Sale Of Future Royalties$114.6M$101.0M$108.6M
Non Cash Royalty Revenue$114.6M$101.0M$108.6M
Pre Commercial Product Revenue$0$0$4.2M
Revenue$3.0M$2.0M$1.0M
Clinical Product Revenue$116.0K$482.0K$334.0K
Research And Development Revenue$38.8M$482.0K$334.0K

Regions

United States brought in 99% of the revenue Agenus broke down this way in fiscal 2025.

  1. United States$113.2M899%up 12% from 2024
  2. Outside the United States$1.0M81%down 48% from 2024
Regions by year
Regions202320242025
United States$153.3M$101.5M$113.2M
Outside the United States$3.0M$2.0M$1.0M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$1.0M
  • Research and development69¢$79.3M
  • Other costs30¢$33.8M

Out of $114.2M in revenue.8 The company lost money this year.

Financial statements

Revenue91011128$114.2M in 2025−24% since 2019
0$100.0M$200.0M$300.0M2019: $150.0M$150.0M20192020: $88.2M$88.2M2020−41%2021: $295.7M$295.7M2021+235%2022: $98.0M$98.0M2022−67%2023: $156.3M$156.3M2023+59%2024: $103.5M$103.5M2024−34%2025: $114.2M$114.2M2025+10%
Operating income91011128-$20.2M in 2025−71% since 2019
-$200.0M-$100.0M0$100.0M2019: -$70.1M-$70.1M20192020: -$117.2M-$117.2M2020+67%2021: $25.7M$25.7M20212022: -$179.4M-$179.4M20222023: -$159.5M-$159.5M2023−11%2024: -$120.5M-$120.5M2024−24%2025: -$20.2M-$20.2M2025−83%
Net income911128-$3.1M in 2025−97% since 2019
-$300.0M-$200.0M-$100.0M02019: -$111.6M-$111.6M20192020: -$182.9M-$182.9M2020+64%2021: -$28.7M-$28.7M2021−84%2022: -$230.7M-$230.7M2022+703%2023: -$257.4M-$257.4M2023+12%2024: -$232.3M-$232.3M2024−10%2025: -$3.1M-$3.1M2025−99%

Every line of the income statement as filed: the last 3 fiscal years, latest first.8

Period ending2025-12-312024-12-312023-12-31
Total revenues$114.2M$103.5M$156.3M
Cost of revenue-$1.0M-$486.0K-$3.1M
Research and development-$79.3M-$155.5M-$234.6M
General and administrative-$54.4M-$71.9M-$78.7M
Fair value adjustments$387.0K$4.0M$556.0K
Operating loss-$20.2M-$120.5M-$159.5M
Non-operating income (expense)-$2.2M$5.8M$37.0K
MiNK Therapeutics, Inc. equity method investment fair value adjustment-$26.3M$0$0
Gain from deconsolidation of MiNK Therapeutics, Inc.$100.9M$0$0
Interest expense, net-$55.3M-$117.6M-$97.9M
Net loss-$3.1M-$232.3M-$257.4M
Dividends on Series A-1 convertible preferred stock-$216.0K-$215.0K-$213.0K
Less: net loss attributable to non-controlling interest-$3.2M-$5.1M-$11.7M
Net loss attributable to Agenus Inc. common stockholders-$101.0K-$227.4M-$246.0M
Basic net loss attributable to Agenus Inc. common stockholders$0.00-$10.59-$13.75
Diluted net loss attributable to Agenus Inc. common stockholders$0.00-$10.59-$13.75
Basic29.7M shares21.5M shares17.9M shares
Diluted29.7M shares21.5M shares17.9M shares
Foreign currency translation gain (loss)$959.0K-$443.0K-$1.9M
Other comprehensive income (loss)$959.0K-$443.0K-$1.9M
Comprehensive income (loss)$858.0K-$227.9M-$247.8M

Compare Agenus with another company

Corporate structure

Agenus sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Agenus

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What Agenus reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$62.9M8 Dec 31, 2025$192.6M8 Dec 31, 2024−67.3%
Accumulated depreciation$47.5M8 Dec 31, 2025$72.6M8 Dec 31, 2024−34.6%
Property and equipment, net$15.5M8 Dec 31, 2025$120.1M8 Dec 31, 2024−87.1%
Finance-lease assets$202.0K8 Dec 31, 2025$31.7M8 Dec 31, 2024−99.4%
Operating-lease assets (leased space)$7.7M8 Dec 31, 2025$27.3M8 Dec 31, 2024−71.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$3.0M8 Dec 31, 2025$40.4M8 Dec 31, 2024−92.6%
Stakes in other companies (equity method)$24.3M8 Dec 31, 2025$08 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$24.1M8 Dec 31, 2025$24.1M8 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$3.0M8 Dec 31, 2025$3.4M8 Dec 31, 2024−10.0%
Accumulated amortization$17.3M8 Dec 31, 2025$17.0M8 Dec 31, 2024+2.0%

Properties, in its own words

We lease our main research and development, manufacturing and corporate offices in Lexington, Massachusetts occupying approximately 82,000 square feet. This lease agreement terminates in August 2033.

We believe substantially all of our property and equipment is in good condition and that we have sufficient capacity to meet our current operational needs. We do not anticipate experiencing significant difficulty in retaining occupancy of any of our research and development, manufacturing or office facilities and will do so through lease renewals prior to expiration or through replacing them with equivalent facilities.

Item 2 of the 10-K filed Mar 16, 2026.16

The story

Founded by Garo H. Armen in 1994.1

Agenus (formerly Antigenics Inc.) was founded in 1994 by Garo H. Armen and Pramod K. Srivastava. The company has pioneered immunotherapies, including heat shock protein-based cancer vaccines, a program that has developed into its Prophage Series of personalized anti-cancer vaccines. Antigenics became a public company in February 2000 on the NASDAQ exchange with the ticker symbol AGEN. In 2000 Agenus acquired Aquila Biopharmaceuticals and a year later it acquired Aronex Pharmaceuticals. In February 2014 the company acquired a European firm, 4-Antibody, along with their portfolio of checkpoint modulators (CPMs) and a platform (Retrocyte Display® technology) to rapidly and efficiently discover new antibodies.

In October 2013, Agenus CEO Garo Armen issued a press release revealing that after an 18-month follow up on the RTS,S Malaria vaccine using QS21-Stimulon®, it was working well enough to support a regulatory filing in 2014. This was the first proof of the efficacy of Agenus's patented "QS-21 Stimulon" adjuvant

In April 2014, Agenus signed a deal with Merck potentially worth $100 million. Under the terms of that deal, Agenus is using its proprietary Retrocyte Display technology to discover antibodies against a pair of undisclosed checkpoint targets for the treatment of cancer. Agenus has advanced two of its own CPM candidates into early drug development and the company is planning to advance several more antibodies in clinical trials.

Today, Agenus is focused on developing a range of immuno-oncology products, including the Prophage vaccines, multiple checkpoint modulators (also known as checkpoint inhibitors or checkpoint antibodies) and its QS21-Stimulon adjuvant. The company's personalized, heat shock protein-based vaccines are in Phase 2 studies. The QS-21 Stimulon adjuvant platform is partnered with GlaxoSmithKline and Janssen. Several of those collaborations involve Phase 3 trials. Altogether, the company and its partners are sponsoring approximately 20 clinical trials of Agenus products.

In August 2023, Agenus announced a strategic restructuring to prioritize its botensilimab and balstilimab (BOT/BAL) clinical programs. The plan included a 25% reduction in its workforce (approximately 85 positions) and the temporary suspension of most preclinical and clinical programs not related to the BOT/BAL combination. The company stated the reorganization was intended to reduce annual operating expenses by approximately $40 million.

In 2025, Agenus sold their CDMO business to Zydus Lifesciences including their two biologics manufacturing sites in Emeryville and Berkeley. In addition, they would partner with Zydus to commercialize their molecules in India.

From Wikipedia’s article on Agenus, shared under CC BY-SA 4.0.7

Leadership

Who has led Agenus, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Garo H. Armen2006–now

Chair

  1. Garo H. Armen2006–2023
  2. Jennifer Buell2024

President

  1. Jennifer Buell2020–2021

Chief financial officer

  1. Peter Thornton2006
  2. Shalini Sharp2006–2012
  3. Charles Evan Ballantyne2015–2016

Chief operating officer

  1. Jennifer Buell2018–2021
1995200020052010201520202025
Board members and other officers (39)

Products and brands

Checkpoint modulators (CPMs) interfere with cancers’ ability to “hijack” natural immune defense systems. To protect the body against disease, but without attacking healthy cells, the immune system uses multiple “checkpoint” systems. Some checkpoints stimulate immune responses while others inhibit them. Cancer cells can evolve means to evade checkpoints, and CPMs can reverse that effect, helping the immune system better fight the cancer.

Agenus has programs targeting the checkpoint modulators GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company is expanding that portfolio by using a proprietary process to generate fully human therapeutic antibody drug candidates. The platform is a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells.

The Prophage series of patient-specific cancer vaccine candidates can also enhance the immune system's response to tumors. Because each cancer is unique, the vaccine is derived from the patient's own tumor sample. To process these samples, Agenus has established a multi-product "good manufacturing practices" facility, which has already helped process over 1,000 tumor samples from across the globe.

The company's QS-21 Stimulon® adjuvant platform strengthens and broadens immune responses to antigens on cancers or foreign invaders’ surfaces. Agenus has multiple partnerships around this product to study its effects with vaccines for diseases including Alzheimer's, melanoma, and malaria. In October 2013, GlaxoSmithKline and Agenus announced positive data from an 18-month follow-up of GSK's RTS,S malaria vaccine with QS21-Stimulon. GSK stated that the treatment was working well enough to support a regulatory filing. RTS,S is the most advanced vaccine for malaria in development.

Read the full text

Agenus is the sole US-manufacturer of a patented and FDA-approved triterpene glycoside extract known as (QS-21, Matrix M), which is a key component in the manufacturing of the Oxford–AstraZeneca COVID-19 as well as the Novavax COVID-19 vaccines. Supplies are tightly controlled, and the US has invoked the US Defence Production Act to preserve vaccine raw materials for its own companies.

From Wikipedia’s article on Agenus, shared under CC BY-SA 4.0.7

Former names

  • ANTIGENICS INC /DE/Nov 30, 1999 to Jan 5, 20116

Timeline

  1. Aug 18, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares63
  2. Aug 13, 20268-K Executive or director change64
  3. Aug 11, 20268-K Executive or director change65
  4. Aug 6, 20268-K Results of operations66
  5. Jul 13, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure67
  6. Jul 6, 20268-K Entered a material agreement68
  7. Jun 23, 20268-K Shareholder vote69
  8. May 15, 20268-K Executive or director change70
  9. May 11, 20268-K Results of operations71
  10. Mar 26, 20268-K Other events72
  11. Mar 16, 20268-K Results of operations73
  12. Jan 16, 20268-K Completed an acquisition or sale; Unregistered sale of shares; Regulation FD disclosure74
  13. Feb 23, 2006New chief executive Garo H. Armen becomes CEO1
  14. Feb 4, 2000Went public Listed on NASDAQ1
  15. 1994Founded Founded1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $1.94 a share, on Nov 10, 2025.75

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results66
  2. May 11, 2026Reported quarterly or annual results71
  3. Mar 16, 2026Reported quarterly or annual results73
  4. Nov 10, 2025Reported quarterly or annual results76
  5. Aug 11, 2025Reported quarterly or annual results77
  6. May 12, 2025Reported quarterly or annual results78
  7. Mar 11, 2025Reported quarterly or annual results79
  8. Nov 12, 2024Reported quarterly or annual results80

Drug trials and FDA: coming up

  1. Dec 2026Phase 1/2 trial readout expected Phase 1/2 trial of CR6086 and AGEN2034 in Refractory Metastatic Colorectal Cancer, run by Rottapharm Biotech: primary completion expected Dec 2026 (ClinicalTrials.gov NCT05205330).81
  2. Sep 2027Phase 2 trial readout expected Phase 2 trial of Botensilimab, Balstilimab and others in Metastatic Colorectal Cancer: primary completion expected Sep 2027 (ClinicalTrials.gov NCT05608044).82
  3. Oct 2027Phase 1/2 trial readout expected Phase 1/2 trial of Evofosfamide, Zalifrelimab and others in Metastatic Prostate Cancer, run by ImmunoGenesis: primary completion expected Oct 2027 (ClinicalTrials.gov NCT06782555).83

Drug trials and FDA: recently

  1. Jan 5, 2026Phase 2 trial completed Phase 2 trial of Botensilimab, Gemcitabine and others in Metastatic Pancreatic Ductal Adenocarcinoma: primary completion Jan 5, 2026, no results posted yet (ClinicalTrials.gov NCT05630183).84
  2. Jul 15, 2022Phase 1/2 trial completed Phase 1/2 trial of Zalifrelimab and Balstilimab in Cervical Cancer: primary completion Jul 15, 2022, results posted Aug 11, 2026 (ClinicalTrials.gov NCT03495882).85

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

367 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 209 insider forms, 33 large holders, 44 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Sep 16, 20264 EDGAR
  4. Sep 15, 20263 EDGAR
  5. Sep 11, 2026S-3 EDGAR
  6. Sep 2, 2026S-8 EDGAR
  7. Aug 18, 20268-K EDGAR
  8. Aug 17, 2026424B3 EDGAR
  9. Aug 14, 2026EFFECT EDGAR
  10. Aug 13, 20268-K EDGAR
  11. Aug 12, 20264 EDGAR
  12. Aug 11, 20268-K EDGAR
  13. Aug 11, 20264 EDGAR
  14. Aug 11, 20264 EDGAR
  15. Aug 7, 202610-Q EDGAR
  16. Aug 7, 2026S-8 EDGAR
  17. Aug 7, 2026S-3 EDGAR
  18. Aug 7, 20264 EDGAR
  19. Aug 7, 20264 EDGAR
  20. Aug 7, 20264 EDGAR

The 367 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

3 open-market trades by officers, directors and large owners since October 2021: 2 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 15, 2024ARMEN GARO HSee RemarksBuy500,000$0.65$325.0KForm 4
Nov 15, 2023WIINBERG ULFDirectorBuy25,000$0.76$19.0KForm 4
Jan 6, 2022O'Day Steven JChief Medical OfficerSale38,679$3.06$118.4KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Stakes it holds

Agenus has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Christine M. Klaskin$298.2K$6100
2025Garo H. ArmenPh.D.$715.3K$6100
2025Steven J. O’DayM.D.$594.9K$6100
2024Chief Executive Officer$715.3K$6100
2024Chief Medical Officer$594.9K$6100
2024Vice PresidentFinance$298.2K$6100

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.2,564,884$7.8M0.0%+2,019,222
Vanguard Capital Management LLC1,676,096$5.1M0.0%+235,864
Vanguard Portfolio Management LLC1,427,587$4.4M0.0%+232,478
Siren, L.L.C.1,064,250$3.3M0.1%No change
Geode Capital Management, LLC1,035,040$3.2M0.0%+686,645
Mackenzie Financial Corp714,175$2.2M0.0%New
Goldman Sachs Group Inc448,383$1.4M0.0%+416,929
Marshall Wace, Llp439,621$1.3M0.0%−248,582
Raymond James Financial Inc430,078$1.3M0.0%+190,524
Globeflex Capital L P418,581$1.3M0.2%New
State Street Corp412,383$1.3M0.0%+256,200
Man Group plc340,425$1.0M0.0%+61,445
Northern Trust Corp314,052$961.0K0.0%+224,332
Connor, Clark & Lunn Investment Management Ltd.310,035$948.7K0.0%+111,533
Vanguard Fiduciary Trust Co271,614$831.1K0.0%+71,116
Morgan Stanley262,068$801.9K0.0%−33,753
Renaissance Technologies LLC228,346$698.7K0.0%−57,300
Panagora Asset Management Inc179,589$549.5K0.0%+16,441
Susquehanna Portfolio Strategies, LLC158,737$485.7K0.0%New
Jump Financial, LLC103,981$318.2K0.0%−53,219
Bank of New York Mellon Corp101,773$311.4K0.0%New
Charles Schwab Investment Management Inc99,392$304.1K0.0%+84,392
Two Sigma Investments, LP98,685$302.0K0.0%−72,237
Strs Ohio76,900$235.3K0.0%New
Canada Pension Plan Investment Board67,100$205.3K0.0%+15,300

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Agenus is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAGENUS INC2
  • CIK0001098972
  • Employer ID (EIN)06-156241716
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address3 Forbes Road, Lexington, MA 024212
  • Phone781-674-44102
  • Shares outstanding45,020,407 as of Aug 4, 202614
  • Public float$135.4M as of Jun 30, 202516
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; it also attests to the company’s internal control over financial reporting16
  • On EDGAR sinceNov 30, 19992
  • Filings2,377 in all: 4 (1,058), 8-K (394), 424B3 (221), 10-Q (80), SC 13G/A (80), 3 (40), CT ORDER (38), SC 13G (38)2
    All 52 form types

    4/A (36), CORRESP (36), EFFECT (35), UPLOAD (34), S-3 (33), DEF 14A (29), S-8 (29), S-3/A (26), 10-K (25), 424B5 (21), POS AM (17), PRE 14A (13), D (11), DEFA14A (7), SC 13D (7), S-1/A (6), 425 (5), 8-K/A (5), ARS (5), S-3ASR (5), 10-Q/A (4), S-1 (4), SCHEDULE 13G/A (4), 10-K/A (3), 5 (3), SCHEDULE 13G (3), DEFR14A (2), NT 10-Q (2), S-4 (2), SC 13D/A (2), 10-K405 (1), 144 (1), 424B1 (1), 424B4 (1), 8-A12G (1), NT 10-K (1), POSASR (1), RW (1), S-1MEF (1), S-8 POS (1), SC TO-C (1), SC TO-I (1), SC TO-I/A (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 18, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $.01 Par ValueAGENNasdaq

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Agenus names in Item 1A of its 10-K filed Mar 16, 2026: 69 risks under these headings, as written.16

  • Risks Related to our Financial Position and Need for Additional Capital
  • Risks Related to the Development of Our Product Candidates
  • Risks Related to the Commercialization of Our Product Candidates
  • Risks Related to Manufacturing and Supply
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Government Regulation
  • Risks Related to Our Intellectual Property
  • Risks Related to Business Operations, Employee Matters and Managing Growth
  • Risks Related to Our Common Stock
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.
  • We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we will not be able to complete the development and commercialization of our product candidates.
The other 67 risks
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • The nature and length of our operating history may make it difficult to evaluate our technology and product development capabilities and predict our future performance.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements, and it is possible that such report on our financial statements may include such an explanation again in the future.
  • Our obligations to the holders of our promissory notes could materially and adversely affect our liquidity and operations.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
  • Our business is highly dependent on the success of our clinical stage programs, including botensilimab and related combination therapy programs, which still require significant additional clinical development.
  • Clinical drug development involves a risky, lengthy and expensive process, with an uncertain outcome. We may encounter substantial delays in completing our clinical trials which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of FDA and other foreign regulatory authorities.
  • The successful development of immune modulating antibodies, including botensilimab, alone and in combination with other therapeutic candidates, is highly uncertain.
  • Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Preclinical development is uncertain. Some of our antibody programs are in early stage development that may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, and which would have an adverse effect on our business.
  • Our clinical trials or those of our current and future collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
  • We intend to develop our existing antibody candidates, and may develop future product candidates, alone and in combination with one or more additional cancer therapies. The uncertainty resulting from the use of our product candidates in combination with other cancer therapies may make it difficult to accurately predict side effects in future clinical trials.
  • Positive results from preclinical and preliminary findings from the earlier clinical studies of our product candidates are not necessarily predictive of the results of later preclinical studies and any future clinical trials of our product candidates. If we cannot replicate the positive results from our earlier studies of our product candidates in our later studies and future clinical trials, we may be unable to successfully develop, obtain regulatory for and commercialize our product candidates.
  • If we encounter difficulties enrolling patients in our clinical trials or if our clinical trial sites encounter staffing shortages that impact their operations, our clinical development activities could be delayed or otherwise adversely affected.
  • The number of product candidates that we are attempting to simultaneously advance creates a significant strain on our resources and may prevent us from successfully advancing any product candidates. If, due to our limited resources and access to capital, we prioritize development of certain product candidates, such decisions may prove to be wrong and may adversely affect our business.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • We may seek accelerated approval for some of our product candidates but may not be able to obtain it as the sufficiency of our clinical trial results for accelerated approval are subject to the FDA’s discretion.
  • The FDA or comparable foreign regulatory authorities could require the clearance or approval of a companion diagnostic device as a condition of approval of our product candidates, which may require substantial financial resources and could delay regulatory approval.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Our product candidates may cause unacceptable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Our competitors may have superior products, manufacturing capability, selling and marketing expertise and/or financial and other resources.
  • Even if our product candidates receive marketing approval, we, or others, may subsequently discover that such product is less effective than previously believed or causes undesirable side effects that were not previously identified and our ability to market such product will be compromised.
  • Even if our product candidates receive marketing approval, such products may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Even if we are able to commercialize any product candidates, such products may not receive coverage or may become subject to unfavorable pricing regulations, inadequate coverage and reimbursement by third party payors, or healthcare reform initiatives that otherwise adversely affect demand for and access to such products,, all of which would harm our business.
  • The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small, and our estimates of the prevalence of our target patient populations may be inaccurate.
  • Prior to a product approval, we would need to build marketing, sales and commercial compliance functions, and as a company, we have no experience in marketing, selling and distributing products or adhering to commercial compliance standards and regulations. If we are unable to establish such capabilities or enter into agreements with third parties to perform such functions, we may not be able to generate product revenue.
  • Our product candidates are uniquely manufactured. If any of our third-party manufacturers encounter difficulties in manufacturing our product candidates, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • We are dependent on suppliers for our components and materials used to manufacture our product candidates.
  • We rely on third parties for the manufacture of clinical supplies of our product candidates and expect to rely on third parties for commercial supplies of any approved product candidates for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We are dependent upon our collaboration with third parties to further develop and commercialize certain antibody programs. If we or any collaboration party fail to perform as expected, the potential for us to generate future revenues under such collaboration could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected.
  • In May 2025 we terminated a license and collaboration agreement with Betta Pharmaceuticals covering the license of balstilimab and zalifrelimab in the territory of greater China, which could result in a dispute or litigation.
  • We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.
  • Risks Related to Government Regulations
  • The regulatory approval process for our product candidates in the United States, European Union and other jurisdictions is currently uncertain and will be lengthy, time-consuming and inherently unpredictable and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.
  • The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization of our product candidates, which may be difficult to predict.
  • Breakthrough Therapy Designation or Fast Track Designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in the United States.
  • We may seek priority review designation for one or more of our other product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • We may not be able to obtain or maintain orphan drug designations from the FDA for our current and future product candidates, as applicable.
  • If approved, our product candidates that are regulated as biological products, or biologics, may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Our business operations and current and future arrangements with third parties such as investigators, healthcare professionals and other healthcare providers, third-party payors, patients, patient organizations and purchasers of our products, may expose us to investigations, litigation, criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Even if we receive regulatory approval of any product candidates or therapies, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, limit how we market and manufacture our products, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
  • European Union drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states.
  • European data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.
  • Laws and regulations governing any international operations may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.
  • Our use of new and evolving technologies, such as artificial intelligence, or AI, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions (including sanctions against Russia following their invasion of Ukraine), and other trade laws and regulations. We can face serious consequences for violations.
  • Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • If we do not comply with environmental laws and regulations, we may incur significant costs and potential disruption to our business.
  • If we or our employees, independent contractors, consultants, commercial partners and vendors fail to comply with laws or regulations, it could adversely impact our reputation, business and stock price.
  • Risks associated with doing business internationally could negatively affect our business.
  • The exit of the UK from the European Union may materially affect the regulatory regime that governs our handling of EU personal data and expose us to legal and business risks under European data privacy and protection law.
  • Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.
  • If we are unable to obtain and enforce patent protection for our product candidates and related technology, our business could be materially harmed.
  • If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
  • If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our product candidates.
  • We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • If we do not obtain patent term extension and/or data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.

Legal proceedings

In September 2024, a putative securities class action lawsuit captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, was filed in the U.S. District Court for the District of Massachusetts (the “Court”) against the Company and certain of its executives and directors. The Court appointed a lead plaintiff pursuant to the Private Securities Litigation Reform Act, and the lead plaintiff filed an amended complaint on February 7, 2025. The amended complaint alleges that Agenus, three of its current officers, and one member of its advisory board violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. The lead plaintiff seeks to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023, and July 17, 2024, and seeks damages and interest, and an award of costs, including attorneys’ fees. On April 8, 2025, the Company moved to dismiss the securities class action. On June 6, 2025 plaintiff filed an opposition to the motion to dismiss, and on July 7, 2025, the Company filed its reply brief. Oral argument on the motion to dismiss was held on March 3, 2026. As of the date of this filing, the Company’s motion to dismiss is pending before the court. We have not recorded any accrual for a contingent liability associated with these legal proceedings.

The opening of Item 3, Legal Proceedings.16

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