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Corporate Presentation November 15, 2017

Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Page 1: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Corporate Presentation November 15, 2017

Page 2: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

This presentation contains forward-looking statements. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and made available on our website at www.agenusbio.com. When evaluating Agenus’ business and prospects, careful consideration should be given to these risks and uncertainties. These statements speak only as of the date of this presentation, and Agenus undertakes no obligation to update or revise these statements. This presentation and the information contained herein do not constitute an offer or solicitation of an offer for sale of any securities.

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Forward-Looking Statements

Page 3: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Agenus: driving success in I-O

Record of speed and efficiency in advancing I-O portfolio to clinic

Optimal pipeline of leads for effective combinations

Enabling partnerships for validated & novel agents and cGMP product for clinical/pivotal trials*

Fully integrated capabilities from discovery to GMP manufacturing

Separate cell therapy business advancing; designed to unlock shareholder value

Highly experienced team

*AGEN1884 (CTLA-4) and AGEN2034 (PD-1)

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Page 4: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Agenus I-O 1.0 Pioneer Cancer Vaccines QS-21 Stimulon® Adjuvant

1994 – 2007

Page 5: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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2008 – 2013

Agenus I-O 2.0 Cancer Experience & Endurance

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2014 – 2017

Agenus I-O 3.0 Growth with a Complete Arsenal Neoantigen Vaccines, Checkpoint Antibodies Cell Therapy, QS-21 Stimulon® Adjuvant

Page 7: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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FUTURE

Agenus I-O 4.0 Combination and Speed Speed of discovery and development Optimizing the activity of leads

Page 8: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

We successfully integrated strategic building blocks

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Capabilities

Key Acquisitions

•  Aquila (2000) adjuvants

•  4-AB (2014) checkpoints

•  PhosImmune (2015) novel neoantigens

•  XOMA (2015) antibody manufacturing

Platforms/Products

•  5 platforms

•  GMP manufacturing

•  5 clinical candidates*

Partnerships

•  GlaxoSmithKline

•  Incyte

•  Amgen

*Includes 2 programs partnered with INCY

•  Merck

•  UCB

Page 9: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Close on near-term revenue opportunities

Licensing & Partnerships

Innovation drives business sustainability

Prioritize for partnering & investment

Operational excellence

Funding our business

Monetization and BD activities

Path to Commercial*

AGEN1884 + Keytruda: 1L NSCLC PD-L1+++ AGEN2034 + AGEN1884: 1L NSCLC PD-L1+++, 2L Cervical AGEN2034 Monotherapy: CSCC, 2L Cervical

Fastest path to

commercialization to

Fuel innovation

Our plan: Integrating combinations, speed & partnerships

*Potential path to BLA

Page 10: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

5 INDs^ filed in 2016 - 2017

4 Therapeutic modalities

6 Technology platforms

5 Ongoing/planned trials^

5 Partnerships

Since entering the I-O space, we have made substantial progress

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I-O Capabilities & Portfolio

Speed & Efficiency

Validated targets CTLA-4 and PD-1

Effective Combinations for Patients

CPMs, Vaccines, Cell Therapy*, Adjuvants

Mammalian, Yeast, Phage, Bispecific, PTTs, TCR* Manufacturing Commercial yields (>4g/L)

Pipeline >12 pipeline products

CPM + Vaccine CTLA-4 + AutoSynVax

CPM + CPM Novel CPM + CTLA-4 + PD-1

*Program expected to advance through a separate subsidiary, AgenTus Therapeutics ^Includes 2 programs partnered with INCY

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1

2

3

4

5

6

7

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Roche AZ Pfizer Incyte Merck BMS Agenus Novartis

Our speed to clinic places us solidly among the leaders in I-O

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Number of I-O programs with US Phase I trials initiated since 2H2015

2 programs partnered

with Agenus

5 programs into clinic

in 2 years*

*Includes 2 programs partnered with INCY

Page 12: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Broad I-O portfolio ranges from early- to late-stage programs

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AGEN1884 and AGEN2034 are being evaluated in 2L cervical cancer, advanced cutaneous squamous cell carcinoma, and non-small cell lung carcinoma AGEN1884 and AGEN2034 are partnered with Recepta for certain South American rights * Phase 2 recruiting in Australia

Product Disease/Target Partner Preclinical Ph1 Ph2 Ph3 Filed Approved Checkpoint Antibodies AGEN1884 CTLA-4 (antagonist)* next-gen CTLA-4 CTLA-4 (antagonist) AGEN2034 PD-1 (antagonist)

CD-137 (agonist) TIGIT (antagonist) Bispecific (regulatory T cell depletion) Bispecific (TME conditioning) Undisclosed

INCAGN1876 GITR (agonist) INCAGN1949 OX40 (agonist)

TIM-3 (antagonist) LAG-3 (antagonist) Undisclosed

Vaccines ProphageTM Glioblastoma (newly diagnosed) AutoSynVaxTM Cancers PhosphoSynVaxTM Cancers Adjuvant QS-21 Stimulon® Shingles

Malaria

Agenus fully-owned programs Partnered programs

Page 13: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Developing effective combinations

Jennifer S. Buell, PhD Chief Communications and External Affairs Officer

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Page 14: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Multi-platform I-O portfolio well positioned for effective combinations

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Checkpoints Antibodies Shape Immune response

Personalized Cancer

Vaccines Educate

Immune system

Adoptive Cell Therapy* Augment

Immune system

>12 programs • 3 mAb display platforms •

Bi-specific discovery • Cell line development •

GMP mAb manufacturing •

• 3 platforms including PTT antigens

• Adjuvants, QS-21 Stimulon®

• GMP vaccine manufacturing

• Unique targets and product format strategy

• Leverages other platforms- discovery to manufacturing

*Program expected to advance through a separate subsidiary, AgenTus Therapeutics

Page 15: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Agenus development plan for sustained revenue generation

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PD-1/CTLA-4

PD-1+ CTLA-4

(+novel CPMs)

Neo-antigen vaccines (+CPMs)

Adoptive cell therapy (CPM/vaccine combo)

Checkpoint Monotherapy

Checkpoint Combinations

Neoantigen Vaccines + Checkpoints

Cell Therapy* (+ Checkpoints)

Pat

ient

Pen

etra

tion

with

Effe

ctiv

e Tr

eatm

ents

Develop, register, launch validated CTLA-4 & PD-1 in 2020

Expand market with novel target combos (Neo-antigen vaccine, TIGIT, CD137)

Expand strategic partnerships (GSK, Merck, Incyte, UCB, etc.)

ü ü ü

*Program expected to advance through a separate subsidiary, AgenTus Therapeutics

Page 16: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

2017

Q1 Q2 Q3 Q4 Q1

AGEN2034 2L Cervical cancer*

AGEN1884/AGEN2034 Pivotal trial launch**

AGEN1884 Ph 1

2018

Q2 Q3

2019

Q4 Q1 Q2 Q3

2020

Q4 Q1 Q2 Q3 Q4

*Potentially in combination with AGEN1884; **Projections ^Designed as potential pivotal trials 1=AGEN1884; 2=AGEN2034;

US filing ** US approval **

Q4

Q4 Q1 Q2 Q3 Q1

MFG ready to supply pivotal programs 1

•  Develop, register, launch validated CTLA-4 & PD-1 •  Selected indications de-risk path to BLA •  Trials designed as pivotal for BLA filing as soon as 2H2019 •  Global site participation AGEN2034 P1

AGEN1884 + Keytruda in 1L NSCLC

Path to BLA: AGEN2034 (anti-PD-1) & AGEN1884 (anti-CTLA-4)

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AGEN2034 Cutaneous squam cell*

Trials designed as registrational trials to support BLA filing as soon as 2H2019^

Ph1 accrual

Pivotal design

2

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1

2

3

4

2017 2018 2019 2020 2021 2022

We expect to submit our first BLA by 2H2019, followed by other product opportunities

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Number of Programs

PD-1

ASV

TIGIT

CD137

Multi-specific 2

Next-Gen CTLA-4

LEAD CPMs

CTLA-4/PD-1

Multi-specific 1

Novel mAb

Cell Therapy*

ASV

BLA IND

Potential novel

Potential novel

*Program expected to advance through a separate subsidiary, AgenTus Therapeutics

Page 18: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

2016 / 2017 2017 2018

Accomplishments •  Five programs to clinic ‒  CTLA-4 (AGEN1884)* ‒  GITR (INCAGN1876)** ‒  OX40 (INCAGN1949)** ‒  PD-1 (AGEN2034)* ‒  Neoantigen vaccine (AutoSynVax™) in

clinic

•  US FDA and Health Canada approval of GSK SHINGRIX containing Agenus QS-21 Stimulon® adjuvant

•  CDC ACIP recommended Shingrix as preferred vaccine for prevention of shingles

Deliverables •  Clinical results ‒  Optimal monotherapy dose for AGEN2034* ‒  Target dose to initiate combinations

AGEN2034* + AGEN1884*

•  Clinical trials ‒  Initiate CTLA-4 + PD-1combination trials

•  Clinical responses ‒  CTLA-4 & PD-1 preliminary clinical data ‒  ASV safety and proof-of-mechanism

•  GMP MFG readiness to supply clinical CTLA-4 and PD-1

Clinical Activity & Readouts •  Complete enrollment and

top-line data for pivotal cohorts+ cohort: ‒  Pharmacodynamic data ‒  Response rate ‒  Duration of response ‒  Safety and tolerability

•  GMP MFG readiness to supply CTLA-4 and PD-1 pivotal trials (1H2018)

Our recent accomplishments and near-term milestones

* Partnered with Recepta for certain South American rights; ** Partnered with INCY; + planned data from 2LCC and/or CSCC 18

Page 19: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Expanding benefit through first-in-class/best-in-class products

Page 20: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

*Clinically validated in viral dx setting and oncology compassionate use setting

AutoSynVax™ clinically validated* neoantigen vaccine platform

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•  Potential best-in-class vaccine blueprint with QS-21 Stimulon® adjuvant for efficacy and manufacturing

•  Clinically validated in viral setting*

•  Long-term memory response (preclinical)

•  MHC class I and II presentation

•  Optimized delivery and peptide sparing

•  End-to-end logistics: 20 years operational & FDA audited

AutoSynVaxTM Clinical Status

•  Phase 1 ongoing •  Safety and immunological readout expected 2017

Media (Negative Control)

Viral Peptides (Positive Control)

Neoantigen Peptide Pool

AutoSynVax™ promotes de novo immune recognition in clinic*

Post-Dose 3 Post-Dose 5

0 0 0

965 1035 1059

0 0 1

1096 1149 1161

278 307 318 31 44 45

Uduman et al. 2017 AACR

Page 21: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Mechanism #1 Blockade of CD80 & CD86 binding to CTLA-4

Anti-CTLA-4 antibodies – advancing innovation

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Mechanism #2 Depletion of intratumoral Tregs via co-engagement of FcγRs

Mechanism #3 (Distinct)

Smyth M. et al., ICB 2014 Bulliard Y. et al., ICB 2014 Bulliard Y. et al., JEM 2013 Simpson et al., JEM 2013 Shelby et al., Can. Immunol. Res. 2013

Ligand blocking assay

Isotype Anti-CTLA-4 CD80

Isotype Anti-CTLA-4 CD86

CTLA-4 is a validated and foundational target with demonstrated clinical relevance

Agenus’ lead anti-CTLA-4 IgG1 is advancing in the clinic with combination trials planned in 4Q2017

Agenus is also advancing a novel IgG1 antibody that exhibits a distinct mechanism for CTLA-4 antagonism

Page 22: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

TIGIT modulates the innate and adaptive arms of the immune system to impair productive anti-tumor immunity

Antibody blockade of TIGIT combines effectively with other immune modulators (co-inhibitory and co-stimulatory antibodies) to promote tumor rejection in preclinical mouse tumor models. Example: PD-1/PDL-1 pathway

TIGIT: Potent novel negative regulator of immune synapse

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Prevention of CD226 co-stimulation

1

2

3

4

1

2

3

4 Induce immunosuppressive DCs (↑IL-10)

TIGIT-induced suppression of T and NK cells

Enhance Treg suppressive activity

Manieri et al., 2016

Page 23: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Building value for our partners

Page 24: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Our strategy builds value for Agenus, our partners, and patients

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Next generation Products

Efficacious Foundational CPMs Differentiated

x = Next

Generation

Bi-specifics TIGIT

CD137 vaccines

CTLA-4 PD-1

Validated

checkpoint targets

Expanded efficacy and market leadership

Page 25: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Agenus is partnered with industry leaders

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•  1 undisclosed target •  Lead selection complete; antibody advancing, milestone recently announced •  Up to an additional $99 million in milestones

•  Preclinical: LAG-3, TIM-3, 1 undisclosed ‒  Royalty rates are generally 6-12%

•  Clinical: GITR, OX40 ‒  Royalty rate 15%

•  Up to $510 million in milestones across all programs

•  QS-21 Stimulon® adjuvant for Shingrix •  Approved in US and Canada; Filed in EU, Japan, AUS •  CDC's Advisory Committee on Immunization Practices recommended

Shingrix as preferred vaccine for prevention of shingles •  Royalties partly monetized

Page 26: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Cell Therapy Business Entity

Page 27: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Bruno Lucidi – CEO AgenTus Therapeutics

•  30 years of industry experience •  Vice President and Head of Pediatric Vaccines at GSK Biologicals

(developed $3bn global business) •  Worldwide Vice-President Virology & Oncology at Johnson &

Johnson •  Leadership at Bristol-Myers Squibb responsible for EU strategy and

launch of Videx® (didanosine), Zerit® (stavudine), Paraplatin® (carboplatin) and Taxol® (paclitaxel).

•  Founding CEO of Idenix and the Chairman of Pharmasset where he laid the foundation for multi-billion dollar companies (acquired by MRK and GILD for $4bn and $11bn, respectively)

Page 28: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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Allogeneic Format

Allogeneic approach; “Off-the-shelf” Scalable, shorter diagnosis to treatment interval

T-Rx Mammalian Display - Direct selection for function Targets optimal balance between activity and specificity

Novel Targets

Proprietary target discovery and validation platforms Proprietary Phosphopeptide Tumor Targets

Precision Receptors

Differentiated cancer cell therapy

Page 29: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

Agenus: driving success in I-O

Record of speed and efficiency in advancing I-O portfolio to clinic

Optimal pipeline of leads for effective combinations

Enabling partnerships for validated & novel agents and cGMP product for clinical/pivotal trials*

Fully integrated capabilities from discovery to GMP manufacturing

Separate cell therapy business advancing; designed to unlock shareholder value

Highly experienced team

*AGEN1884 (CTLA-4) and AGEN2034 (PD-1)

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Page 30: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are

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