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June 1, 2015

Jeffries Healthcare Conference

ImmusanT, Inc • One Kendall Square, Suite B2004 • Cambridge, MA 02139Confidential & Proprietary – Not For Distribution

1. 2June 1, 2015 Confidential & Proprietary – Not For Distribution

Executive Summary

• Celiac disease represents an untapped growing market with high

unmet need:

• 2.2 million cases in the U.S. with a diagnosis rate of 18% (~400,000

diagnosed patients)

• A definitive diagnosis today requires an invasive biopsy of the small

bowel

• Currently, the only intervention available is a gluten-free diet (GFD),

which has numerous shortfalls

• ImmusanT is developing a novel immunotherapy, Nexvax2, for the

treatment of celiac disease:

• Only drug in development with potential disease-modifying activity

• Targets 80-90% of celiac disease population

• Established proof of principal / unprecedented results in two Phase

1b trials

• In parallel, developing companion diagnostic/monitoring toolkit to

manage disease

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Executive Summary

• Potential market worth U.S. $8 billion by 2019

• Proprietary discovery platform for epitope-specific immunotherapy

has potential applications for next-generation celiac disease

therapies

• Also addresses other autoimmune diseases, such as T1D

• Robust patent estate

• Experienced leadership team

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Celiac Disease Background

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Celiac Disease: An Auto-Immune-Like Disease

Chronic, systemic, immune-mediated disease triggered by dietary gluten in genetically susceptible people

Primary target: proximal small intestine (inflammation)

• Morbidities include: nutrient deficiencies, altered bowel habit, weight loss

Common systemic features include:

• Anemia

• Fatigue, depression, feeling of social isolation

• Delayed development/shortness

• Fractures, osteoporosis

• Lymphoma and certain GI cancers (tied to persistent inflammation of small intestine)

• Problems during pregnancy/birth

• Dental enamel defects

• Dermatitis herpetiformis

~30% of adults with celiac disease have autoimmune diabetes and/or thyroid disease

• Shared genetics with or without an effect of celiac disease

Source: NICE clinical guideline 86. Celiac disease. Recognition and assessment of celiac

disease; London: National Institute for Health and Clinical Excellence, 2009.

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Normal Small Bowel Celiac Disease

Ingestion of gluten

leads to

inflammation in the

small bowel

Strict adherence to a

gluten-free

diet leads to a healing

of the small bowel

Celiac DiseaseIntroduction and Removal of Gluten Results in Reversible Changes to the Small Intestine

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Therapeutic Unmet Need

Treatment• A strict gluten-free diet is the only available intervention

• Often adopted before definitive diagnosis

• Compliance is challenging and often inadequate• GFD carries a burden similar to dialysis

• It rarely leads to intestinal recovery

• “Gluten-free” foods are not entirely gluten-free

They may still contain up to 20 parts per million of gluten

Acute food poisoning symptoms after gluten exposure is not uncommon

1/100th of a slice of bread can be toxic for celiac patients

“Fear of food” remains

There is no pharmaceutical available treat the disease

• No regulatory pathway established

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Issues with Celiac Disease Diagnosis

• Despite prevalence, only ~18% diagnosis rate in the U.S.

• Definitive diagnostic (endoscopic biopsy) is invasive, flawed and

uncomfortable for patients

• 10% of the US population avoids dietary gluten without adequate

medical workup to exclude celiac disease

• There is a significant need for a non-invasive, highly sensitive

and specific diagnostic

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Pharmacogenetics

Celiac Disease

Patients

1.6% HLA-DQ2.5+

91%

Target Population of Nexvax2:

HLA-DQ2.5+ celiac disease patients (91%

have the HLA-DQ2.5+ gene)

Of the general population, 1.6%

have celiac disease and 24%

have the HLA-DQ2.5+ gene

European Genetics Cluster on Celiac Disease (n=1,007)

DQ2.579%

DQ2.5 &DQ89%

DQ2.2 Only6%

DQ8 Only6%

Other0%

HLA-DQ8+

9%

Karell K, et al. Human Immunology 64, 469–477 (2003).

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Source: 1 .Rubio-Tapia A. et al., Am J Gastroenterol. 2012;107(10):1538-44. 2 Fasano A., et al. Arch Intern Med.

2003;163(3):286-92. 3 Riddle MS. Et al. Am J Gastroenterol. 2012;107(8):1248-55. 4 Mustalahti K et al.Ann Med.

2010;42(8):587-95.

U.S. Europe

Prevalence0.7%1,2

2.2m cases 2015

1.0-1.5%4

5.1-7.7m cases (EMEA countries)

Diagnosis Rate

18% diagnosis rate in 20101

0.4m diagnosed patients in 2010

0.75m @17% p.a. growth3 in 2014

20% diagnosis rate 20124

1.1-1.7m diagnosed patients 20144

Available

Intervention

A gluten-free diet is the only available intervention,

with an 85% adoption rate among patients

Market Size Multi-billion

Potential Upside: Recent studies show that the Middle East and regions in Northern India and Bangladesh have

comparable prevalence of the HLA-DQ2.5 gene as seen in the U.S. and Europe

Market Opportunity: Significant Unmet Need

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Nexvax2: Review of Scientific Basis

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Peptides

absorbed &

deamidated

CD4 T-cell

Dendritic

cell

HLA-

DQ2.5/8

Gluten proteins enter

body from consuming

wheat, barley and/or rye

1

“Toxic”

fragments

survive

digestion in

the gut

2

tTG

deamidation

3

Disease

Tissue damage

Blistering skin rash

Auto-antibodies

Gliadin antibodies

Immune Tolerance

Pathogenesis of Celiac Disease

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Therapy using peptides to

target gluten-specific T-cells

Patients receive intradermalinjections of Nexvax2

Damaged intestine when gluten is eaten before Nexvax2

Healthy intestine when gluten is eaten after Nexvax2T cells secrete chemicals to destroy gluten

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Nexvax2: Target Product Profile

Disease-modifying T-cell epitope derived peptide immunotherapy

indicated for prevention of relapse when consuming an unrestricted

diet in HLA -DQ2.5+ patients with celiac disease

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Intradermal injection of disease-

modifying T-cell epitope derived

peptides for the prevention of relapse

when consuming an unrestricted diet

in HLA -DQ2.5+ celiac patients

Measure the activity of T-cells causing

celiac disease by a simple whole blood

ELISA (6 days after antigen exposure)

IFN-ɣ

Therapy Companion Diagnostic

Provocative serum blood test

(4-6 hours after antigen exposure)

Measure cytokines triggered by

peptides in Nexvax2

Standalone

Nexvax2: Product Summary

A “Model” for a New Class of Highly Specific Tolerogenic Immunotherapies

Cytokine(s)

Cytokine

Standalone

Measure the activity of T-cells causing

celiac disease in plasma

(4 hours after antigen exposure)

Ex-Vivo peptide stimulated whole

blood ELISA

Measure cytokines triggered by

expanded pool of peptides

Identify CD patients on or off GFD

Companion

Cytokine(s)

Identify patients suitable for

therapy

Identify patients responding to

therapy

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Key Achievements to Date

• Three studies completed

• Total of 116 patients dosed to date

• 1001 first man trial – 34 patients; completed 2010

• 1002 AUS/NZ trial – 39 patients; completed 2014

• 1003 U.S./AUS/NZ trial – 43 patients; completed 2015

• Received approved CTA for UK / MHRA

• Unprecedented results (manuscript in preparation)

• Nexvax2® provides the first in vivo proof-of-principle that CD4+ T cells implicated in a

human autoimmune disease are selectively activated and then rendered unresponsive by

repeated systemic administration of immunodominant major histocompatibility (MHC)

class II-restricted epitopes

• Activation of cognate CD4+ T cells and downstream stimulation of the immune system

occurs as early as two hours after systemic administration of peptide

• Biomarker discovery toolbox developed

• Distinct cytokine/chemokine signature within 2-6 hours of dosing

• Indicative of CD4 T cell activation

• Patent Portfolio Expansion

• FTO searches performed

• Numerous new filings

1. 17June 1, 2015 Confidential & Proprietary – Not For Distribution

Clinical Development

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1002 – 5 sites in AUS/NZ

Safety/tolerability/dosing/efficacy signals

1003 – 7 sites in U.S. and 4 in AUS/NZ

Safety/tolerability; Lower doses than

1002

201520142013

Exploratory – T1D/CD

Exploration of platform potential

Nexvax2 Clinical Development Overview

2012Prior

1001 – First-In-

Man

Safety/tolerability

Next Generation Nexvax2

Expand patient population to HLA-DQ8

Nexvax2 Type 1 Diabetes Next Generation Nexvax2

2 Phase IIa trial

2016 2018-20202017

Phase II/III trial

Registration trials

Diagnostic

Development:

Companion &

Standalone

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Clinical Development Summary

• 116 patients dosed to date

• 1001 first in man trial – completed 2010

• 1002 AUS/NZ trial – completed 2014

• 1003 US/AUS/NZ trial – completed 2015

• Received approved CTA for UK / MHRA

• Biomarker discovery toolbox developed

• Dose Titration Study – initiated (FPI, June, 2015)

• Australia and New Zealand

• 2004 – Proof of Concept Study – targeted start Q4, 2015

• US, UK, Finland, Ireland, Norway, Australia, New Zealand

1. 20June 1, 2015 Confidential & Proprietary – Not For Distribution

Company

ProductDisease Modifying? MOA

Current

PhaseDescription / Update

Immusant

Nexvax2Yes

Peptide-based

immune tolerance Phase 2Immune therapy that seeks to promote the body’s tolerance to

gluten by using a series of peptides to treat people with the most

common genetic form of celiac disease, HLA-DQ2.5

Alba

Larazotide acetateNo Tight junction regulator Phase 2b

Has initiated planning for Phase 3 clinical trials for the definitive assessment of the

oral peptide's efficacy and safety

Alvine

ALV003No

Gluten-specific protease

inhibitor Phase 2bALV003 is an orally administered mixture of two gluten-specific proteases shown in

vitro to degrade gluten to be administered as an adjunct to an attempted gluten-free

diet

Celimmune No Anti-IL15

Phase 1Licensed from Amgen; Targeting refractory disease.

Note: ChemoCentryx product Triaficet-EN was discontinued for celiac disease after Phase 2 trials in 2008

Source: Company websites and press releases; Life Science Analytics report

Nexvax2 is the only disease-modifying treatment for celiac disease in

clinical development today that would enable patients to return to a

normal diet, good health and improved quality of life

Competitive LandscapeCeliac Disease – Clinical Stage Candidates

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Competitive LandscapeCeliac Disease – Preclinical Candidates

Company

ProductCurrent Phase MOA Description / Update

Actogenix

ActoBioticsPreclinical Immunogenic antigens

Has demonstrated in a celiac disease animal model that ActoBiotics delivering immunogenic

antigens of gluten results in an antigen-specific induction of immune tolerance. ImmusanT is

following Actogenix due to potential patent infringement

Artielle Immunotherapeutics PreclinicalRecombinant T-cell

receptor ligands

Preparing to test their recombinant T-cell receptor ligands (RTLs) in human cells and an animal

model. ImmusanT is following Artielle due to potential patent infringement

Avaxia Biologics

AVX-176Preclinical Gluten antibodies

In December 2011, received first patent for AVX-176, an orally administered antibody designed

to bind to gluten

BioLineRx

BL-7010Preclinical Gliadin sequestering

High molecular weight polymer with high affinity for gliadins, the immunogenic peptides that

cause celiac disease. BL-1010 would be an addition to a gluten-free diet

Dr. Falk Pharma

Zed-101Preclinical Transglutaminase inhibitor

Zedira licensed Zed-101 to Dr. Falk Pharma in November 2011. Zed-101 is a transglutaminase

inhibitor

Cour Discovery TIMP / GliadinDelivery - highly specific immune targeting capability being applied to immune (antigen)

tolerization in CD

Numerate Discovery Transglutaminase inhibitorTransglutaminase 2 inhibitors for the treatment of celiac sprue in collaboration with Stanford

University

Provid Pharmaceuticals DiscoveryInhibits gluten peptide

binding to DQ2 and DQ8

Ongoing projects directed toward inhibitors of DQ2 and DQ8, associated with celiac disease

and Type 1 diabetes

Sitari Discovery TG2 Inhibitor R&D support to screen compounds that could be used to target TG2 (GSK/Avalon)

1. 22June 1, 2015 Confidential & Proprietary – Not For Distribution

Proprietary discovery platform for targeted (epitope-specific) immunotherapy

Developing a therapeutic, companion diagnostic and monitoring toolkit for celiac disease

Phase 1b AUS/NZ clinical trial (1002) complete

Phase 1b US/AUS/NZ clinical trial (1003) complete

Unprecedented results

Applicability as a platform to address other autoimmune diseases

Exploratory studies ongoing in Type 1 diabetes and celiac disease

Celiac disease is an ideal disease model for tolerizing peptide immunotherapy

Pharmacogenetics: HLA-associated disease (HLA-DQ2.5)

Defined antigens

Companion functional T-cell diagnostic – defines responders

Access to organ via endoscopy and a reversible disease (small intestine heals)

Celiac disease represents an untapped growing market with high unmet need

Potential market worth U.S. $8 billion by 2019

2.2 million cases in the U.S. with a diagnosis rate of 18% (~400,000 diagnosed patients)

A definitive diagnosis today requires an invasive biopsy of the small bowel

Currently, the only intervention available is a gluten-free diet, which has numerous shortfalls

Experienced leadership team

Robust, blocking and expanding intellectual property estate

Multiple new patents filed

FTO completed

Corporate Highlights

23ImmusanT, Inc • One Kendall Square, Suite B2004 • Cambridge, MA 02139Confidential & Proprietary – Not For Distribution