Agenus : Corporate Overview

Published: 2026-04-15 12:30:17 ET AGEN

Published on 04/15/2026 at 12:30 pm EDT

Agenus Corporate Overview | April 2026

Botensilimab + Balstilimab ("BOT+BAL") is a Differentiated ICI Combo with Multiple Value Drivers Across Development, Registration, and Expansion Opportunities

Late-Line BLA

Submission Planned

Accelerated approval potential based on

Phase 1b & Phase 2 late-line MSS mCRC NLM dataset

Phase 3 Underway

Registrational, randomized controlled trial

(RCT; "BATTMAN") with Overall Survival endpoint enrolling at ~100 sites across Canada, France, Australia & New Zealand

Expansion in Early

Disease Settings

Strong rationale for Phase 3 Neoadjuvant

Colon Study based on significant pathologic responses and no relapsesa in two Phase 2 investigator-sponsored trials (NEST and UNICORN)

2 ICI, immune checkpoint inhibitor; MSS mCRC NLM, microsatellite-stable metastatic colorectal cancer and no active liver metastases.

aMedian follow-up 6-18 months.

Rising CRC Burden

Colorectal cancer (CRC) is now the

leading cause of cancer-related death among Americans under 501

~150k new cases annually in US2

~2M new cases annually worldwide3

16% 5-year survival rate for mCRC4

Most CRC lacks effective

immunotherapy options

Microsatellite stable (MSS) accounts for 85-95% of CRC cases5,6

No major immune checkpoint inhibitor (ICI) advances in MSS CRC in

>20 years6

MSS CRC remains unaddressed by first-generation ICI6

Colorectal Cancer (CRC) Faces Two Urgent Challenges: Rising Burden of Disease and Limited Innovation - Especially in Microsatellite Stable (MSS) Disease

1. Siegel RL, et al. JAMA. 2026;335(7):632-634. 2. Siegel RL, et al. CA Cancer J Clin. 2025;75(1):10-45. 3. Bray F, et al. CA Cancer J Clin. 2024;74(3):229-263. 4. National Cancer Institute. SEER Cancer Stat Facts: Colorectal Cancer. Bethesda, MD: National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/colorect.html. 5. Buchler T. Front Oncol. 2022;12:888181. 6. Guven DC, et al. Oncologist. 2024;29(5):e580-e600.

Immunotherapy: A Proven Path to Long-Term Survival with Curative Potential

Long-term survival "tails" have been observed with dual checkpoint blockade

Theoretical example

Immunotherapy Approach

Long-term survival "tails" have been

observed with dual checkpoint blockade

% Survival

Immunotherapy can enable durable, treatment-free survival by activating the immune system to continuously kill cancer cells1-2

New immunotherapies are needed to "raise the survival tail" & enable long-term survival for more patients

Time

4 1. Larkin J, et al. N Engl J Med. 2019;381(16):1535-1546. 2. Wolchok JD, et al. N Engl J Med. 2025;392(1):11-22. 3. Haslam A, Olivier T, Prasad V. Int J Cancer. 2025;156(12):2352-2359.

Corporate Overview | April 2026

Botensilimab (BOT): A Differentiated Anti-CTLA-4 Designed to Overcome Resistance and Activate Anti-Cancer Immunity1-5

Botensilimab

APCs

X Complement

Factors

T Cell

Treg NK Cell

Fc-Enhanced

BOT ± BAL* is active in cold & treatment-refractory tumors

*Balstilimab (BAL): Agenus' PD-1 inhibitor with properties comparable to approved PD-1 inhibitors

Activates APCs/Myeloid Cells

Enhances T cell Priming, Activation & Memory

Reduces Intratumoral Regulatory T cells

Avoids Difficult-To-Treat Immune-Related AEs

5 1. Bullock AJ, et al. Nat Med. 2024;30(9):2558-2567. 2. Waight JD, et al. Cancer Cell. 2018;33(6):1033-1047.e5. 3. Chand D, et al. Cancer Discov. 2024;14(12):2407-2429. 4. O'Malley DM, et al. Gynecol Oncol.

2021;163(2):274-280. 5. O'Malley DM, et al. J Clin Oncol. 2022;40(7):762-771.

BOT+BAL Is Uniquely Effective in Driving Durable Anti-Cancer Immunity and Converting Tumors from "Cold" (Immune Evading) to "Hot" (Immune Activated)

"Cold" Tumors1

Hidden from the immune system

Poor/no response to approved immunotherapy

"HOT" Tumors2

Detectable by the immune system

Sensitive to immunotherapy

BOT+BAL TURNS COLD TUMORS INTO HOT TUMORS2-3

BOT "lights up" the tumor, while BAL drives sustained anti-cancer killing response

Immunosuppressive cells

Tumor-killing immune cells

Dying tumor cell

Treg

Myeloid cell

CD8 T cell

NK cell

6 1. Khosravi GR, et al. Cancer Commun (Lond). 2024;44(5):521-553. 2. Chand D, et al. Cancer Discov. 2024;14(12):2407-2429. 3. Waight JD, et al. Cancer Cell. 2018;33(6):1033-1047.e5.

BOT + BAL

Potential of Immunotherapy Approach with BOT+BAL

Examples of 100% tumor regression

After 1 dose of BOT + 2 doses of BAL with no concurrent nor prior therapy; from ongoing neoadjuvant Phase 2 trials (NEST and NEOASIS)

MSS Colorectal Cancer5

Chemotherapy-free option

Manageable safety profile

Organ-sparing potential

Considers quality of life (especially important in early-onset cancer)

7 weeks

Merkel Cell Carcinoma6

6 weeks

Corporate Overview | April 2026

Single-patient images; images shared with patient consent.

NON-CONFIDENTIAL

1. Gordon MS, et al. Oral Presentation at ESMO Annual Meeting. Berlin, Germany. 2025. 1517MO. 2. Schlechter BM, et al. Poster presented at the ESMO GI Congress. Barcelona, Spain. 2025. Poster 8P. 3. Hissong E, et al. Poster presented at the ASCO GI Congress. Chicago, IL, USA. 2025. Abstract 207. 4. Ghelardi F, et al. Poster presented at the ASCO GI Congress. Chicago, IL, USA. 2025. Poster F20. 5. Kasi P, et al. Oral presentation at the ESMO GI Congress. Munich, Germany. 2024. Presentation 743. 6. Chalabi M, et al. Oral presentation at AACR. Chicago, IL, USA. 2025. Abstract CT130.

BOT+BAL Represents a Large and Growing Market Opportunity, with ~$10B+ in Peak Annual Global Revenue Potential in MSS CRC

$>25B

$2-3B

$8-10B

Annual patients

~10,000 US | 35,000 Global

Annual patients

~35,000 US | 200,000 Global

Data in 9+ tumor types including NSCLC, HCC, ovarian, sarcoma, breast, and melanoma

Durable Survival with BOT+BAL Beyond Historical Expectations in MSS mCRC, where ≥2 yr Survival is Rare

BOT+BAL R/R MSS mCRC1

100

Overall Survival Probability (%)

BOT + BAL

Median OS: 20.9 months 2-Year Survival Rate: 42%

Benchmarks

3L+ Standard of Carea

Median OS: 10-14 months Long-term survival uncommon

Best Supportive Care (BSC)b

Median OS: 3.5-5 months

Censored

R/R MSS mCRC NLM (N=123)

0 3 6 9 12 15

18 21 24 27 30 33 36 39 42

45 48 51 54

No. at risk

123 119 105 89 78 63

Time Since Start of Therapy (Months)

47 37 26 22 14 7 5 2 1

1 1 1 0

9 aRegorafenib, trifluridine/tipiracil ± bevacizumab, or fruquintinib in patients without active liver metastases.2-4 bNo systemic anticancer therapy; the control arm in ongoing BATTMAN Phase 3 RCT. Reference values from the CO.26 trial5-6

1. Schlechter BM, et al. Poster presented at the ESMO Gastrointestinal Cancers Congress 2025. Barcelona, Spain. 2025. Poster #8P. 2. Cohen R, et al. Eur J Cancer. 2024;207:114160. 3. Tabernero J, et al. Poster presented at the ASCO

Annual Meeting. Chicago, IL, USA. 2024. Abstract #3584. 4. Garcia-Carbonero R, et al. Poster presented at the ASCO Annual Meeting. Chicago, IL, USA. 2024. Poster 520P. 5. Chen EX, et al. JAMA Oncol. 2020;6(6):831-838. 6. Chen EX, et al.

Selected BATTMAN (Ph3) Dose

Safety event, n (%)

1 mg/kg (n=228)

2 mg/

kg (n=183)

Overall (N=411)

Any grade TRAE

Grade 1-2 TRAEs

Grade ≥3 TRAEs

85%

57%

28%

86%

48%

38%

85%

53%

32%

Grade 1 or 2

Grade ≥3

Grade 1 or 2

Grade ≥3

Grade 1 or 2

Grade ≥3

Any treatment-related imAEa,b

24%

18%

27%

25%

22%

Most common (≥3%) treatment-related imAEsa

Diarrhea/colitisc

17%

10%

21%

19%

14%

Thyroidd

Hepatitise

Skinf

Pneumonitisg

Safety signals consistent across trials

The most common imAEs were GI-related, which were reversible

There was a low incidence of visceral toxicities outside the GI tract

No treatment-related deaths were observed (grade 5)

Data cutoff: 13-MAR-2025. Safety analysis set (N=411; participants who received ≥1 dose of study drug).

aimAEs were medically adjudicated. bGrade 4 imAEs (n=1 each) of colitis (2 mg/kg group), autonomic neuropathy (1 mg/kg group), diabetic ketoacidosis (2 mg/kg group), and thrombocytopenia (1 mg/kg group) were reported; no other grade ≥4 imAEs occurred. cGrouped term that included preferred term events of autoimmune colitis, colitis, diarrhea, duodenitis, enteritis, enterocolitis, and immune-mediated enterocolitis. dGrouped term that included preferred term events of blood thyroid stimulating hormone increased, hyperthyroidism, hypothyroidism, immune-mediated hypothyroidism, immune-mediated thyroiditis, and thyroiditis. eGrouped term that included preferred term events of AST increased, ALT increased, autoimmune hepatitis, blood alkaline phosphatase increased, and immune-mediated hepatitis. fGrouped term that included preferred term events of immune-mediated dermatitis, lichen sclerosus, linear IgA disease, rash, rash erythematous, and

rash maculo-papular that were treated systemically. gGrouped term that included preferred term events of immune-mediated lung disease, and pneumonitis.

BATTMAN: Phase 3 RCT Designed to Confirm Survival Benefit in R/R MSS mCRC; FDA Aligned to Support Registration (NCT07152821)

Patients with pMMR (MSS)

Advanced CRC (N=834)

BOT + BAL

BOT: 75 mg IV Q6W x 4 doses BAL: 450 mg IV Q3W

Primary Endpoint:

Overall Survival

Select Secondary Endpoints:

Randomize

•

1:1

•

Refractory to available

agents

Unresectable

~100 sites across Canada, France,

Australia and New Zealand

Best Supportive Care (BSC)

No systemic anticancer treatment; care focuses on symptom management and quality of life.

Progression-Free Survival

Overall Response Rate

Clinical Benefit Rate

Quality of Life

Safety and Toxicity

Strong Clinical Activity Observed Previously with BOT+BAL Compares Favorably to BSC Benchmarks, Supporting High Probability of Success for Phase 3 BATTMAN Trial

R/R MSS Metastatic CRC

BATTMAN Primary Endpoint: Overall Survival (N=834)

Population

BOT+BAL Phase 1b Data

Best Supportive Care (BSC)

Benchmark Data

(CO.26 Study)

3L+ without active liver mets (NLM)

20.9 months

Median OS (n=123)1

~5 months Median OSa

3L+ with active liver mets (LM)

7.5 months

Median OS (n=25)2

~3.6 months Median OSa

aBest supportive care arm in CO.26 trial conducted by CCTG; Chen EX, et al. JAMA Netw Open. 2023;6(12):e2346094.

12 1. Schlechter BM, et al. Poster presented at the ESMO GI Congress. Barcelona, Spain. 2025. Poster #8P. 2. Bullock et al. Nat Med. 2024;30(9):2558-2567.

Expanding From Late-Line R/R MSS mCRC into the Earlier Disease Neoadjuvant Setting with Curative Intent with BOT+BAL

NEST Study

(Cornell Univ.)1

UNICORN Study

(11 Centers, Italy)2

BOT+BAL

~4 weeks to surgery

BOT+BAL

~8 weeks to surgery

BOT + BAL

5 weeks to surgery

BOT

5 weeks to surgery

% Tumor Regression

-25% -25%

-50%

Pathologic

(≥50%)

-50%

-75%

-100%

Major

Pathologic (≥90%)

Complete Pathologic (100%)

-75%

-100%

No recurrences to date with any patients treated with BOT+BAL (median follow-up 6-18 months)

13 1. Hissong E, et al. Poster presented at the 2025 ASCO GI Congress. Chicago, IL, USA. Abstract #207. 2. Ghelardi F, et al. Poster presented at the 2025 ASCO GI Congress. Chicago, IL, USA. Poster #F20.

Consistently Favorable Safety Profile with BOT+BAL in Neoadjuvant CRC and No Impact on Surgical Feasibility

NEST1

UNICORN2

NEST-1 (n=10)

NEST-2 (n=14)

Total population (n=56)

Any Grade ≥3 2 (20%) 1 (7%)

Grade ≥3 imAEs 2 (4%)

No delays in surgery due to imAEs 1 surgery delay <4 weeks

Among 70 Patients:

Low rate of grade ≥3 imAEs No unresolved imAEs

One delay of less than 4 weeks due to treatment-related hyperthyroidism

14 1. Hissong E, et al. Poster presented at the ASCO Gastrointestinal Cancers Congress. Chicago, IL, USA. 2025. Abstract #207.

2. Ghelardi F, et al. Poster presented at the ASCO Gastrointestinal Cancers Congress 2025. Chicago, IL, USA. 2025. Poster #F20.

Strong BOT+BAL Neoadjuvant Activity Supports Rationale for Expansion into Phase 3 Trial

Rational for Phase 3 RCT Neoadjuvant Trial in Stage III, Resectable, Locally Advanced MSS CRC

Primary Endpoint: Event-Free Survival

Population

Prior BOT+BAL Phase 2 Data1-2

Historical Benchmark Data

Neoadjuvant (Stage III) MSS colon cancer

0% recurrence at 6-18-month follow-up

(n=38)

28%-35% recurrence

at 3 yearsa

36%-41% major pathological response rate

8% major pathological response rate equivalentb

aAdjuvant FOLFOX in MOSAIC trial; André T, et al. N Engl J Med. 2004;350(23):2343-2351.

bNeoadjuvant FOLFOX in the FOxTROT trial (based on complete plus marked regression rates); Morton D, et al. J Clin Oncol. 2023;41(8):1541-1552.

BOT+BAL Clinical Activity Observed Across Multiple Metastatic Solid Tumor Types

>9 tumor types

with activity

2-year OS of 39-43%

across cohorts1,2

Consistent efficacy

across overall R/R and late-line MSS mCRC cohorts2

Clinical Outcome

Pan Tumor Population (Efficacy Evaluable)1

n=339

Previously Reported MSS mCRC NLM

R/R Patients2 n=123

Late-Line R/R Patients2

n=37b

24-month OS

(95% CI)

39%

(33-45)

42%

(32-52)

43%

(25-59)

Median OS

(95% CI)

17.2 months

(14.8-20.9)

20.9 months

(16.2-26.6)

16.2 months

(9.7-NR)

Confirmed ORR

n (95% CI)

17%

58 (13-22)

20%

24 (13-28)

19%

7 (8-35)

DCRa

n (95% CI)

66%

222 (60-71)

69%

85 (60-77)

70%

26 (53-84)

16 aDCR defined as complete response, partial response, or stable disease for ≥6 weeks. bPreviously received at least one regimen of regorafenib, trifluridine/tipiracil ± bevacizumab, or fruquintinib.

Gordon MS, et al. Oral Presentation at ESMO Annual Meeting. Berlin, Germany. 2025. #1517MO. Data cutoff: 13-MAR-2025.

CSocrhploercahtteeOr BveMrv,ieewt a|l.APporisl t2e0r2p6resented at the ESMO Gastrointestinal Cancers Congress. Barcelona, Spain. 2025. Poster #8P. Data cutoff: 13-Mar-2025.

Zydus Partnership Strengthens Balance Sheet, Reduces Burn, and Supports Manufacturing Readiness

Sharper financial profile

Transaction-related benefits and operating discipline reduced annualized operating burn to approximately $50M

Program Expansion

AAC Expanded to 3 Tumor

Types, NPP to New Markets

The French regulatory authority approved BOT+BAL for paid reimbursement in MSS CRC, sarcomas, and ovarian cancer in January 2026

High Interest

Documented HCP and Patient

Interest

France AAC and self-pay markets indicate that patients and physicians will seek BOT+BAL where access is available

Regulatory context

Unmet Need Remains Evident

Paid pre-approval use does not substitute for

clinical evidence, but it underscores urgency of access and real-world interest in treatment

Large Safety Database

>1,200 patients treated with BOT+BAL combo

Consistent safety across trials

Efficacy Benefit

Consistent long-term efficacy in R/R MSS mCRC NLM setting

N=245 patients across Ph1+Ph2

21.2 mo mOS (vs. SOC mOS of 10-14 mo)

42% 2-yr survival rate

19% ORR (vs. SOC reported ORR of 3-8%)

Regulatory Context

Rapidly evolving FDA; focus on patient access

Urgency is building: FDA leadership is calling for innovation, as CRC has become the leading cause of cancer deaths in Americans under 50 yrs of age

Rationale supporting a BLA submission through accelerated approval pathway

Ongoing Phase 3 BATTMAN trial will be meaningfully enrolled by time of potential PDUFA date

Mature data demonstrating long-term survival that is unprecedented relative to existing therapies

Clear and growing patient unmet need validated by Paid Compassionate Access programs

Changes at FDA focused on innovative therapies

Clinical

Momentum

Phase 3 BATTMAN trial is underway with

first patient in, activated sites, and ongoing screening

Neoadjuvant data in MSS CRC and other solid tumors continuing to mature favorably

Existing sponsored data and ongoing ISTs supporting expansion across metastatic and neoadjuvant settings

Market Interest &

Commercial Readiness

Early HCP and patient interest

demonstrated through French AAC and NPP programs

Near-term realized income through paid access pathways

Zydus partnership strengthens balance sheet and secures manufacturing and submission support

Long-Term Value

& Durability

Expansion opportunities across multiple

tumor types in metastatic and neoadjuvant settings, including MSS CRC, ovarian, sarcoma, breast, HCC, and NSCLC

Patent life for BOT and BAL through 2036-2038, with extensions to 2040-2042

Disclaimer

Agenus Inc. published this content on April 15, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 15, 2026 at 16:29 UTC.