Redefining Allergy Immunotherapy

Company and Technology Overview

June 2015

• New York City

Location

• February 2012

Founded

• Erick Berglund, PhD - CEO

• William Reisacher, MD - Chief Medical Advisor

• Michael Nelson, JD - CFO

Founders

• To expand the use of immunotherapy among allergy sufferers by offering products that are easy to administer, more effective, and safer

Mission

Allovate, LLC

2

Allerdent Product Platform

3

A novel immunotherapy for allergies…

…that works when you brush

your teeth.

4

• http://www.aafa.org/

• AAAAI

Allergies strike

1 out of 5 Americans

Allergy dwarfs other indications

5

Allergies:

A Significant Global Health Burden

Demographics of Allergy

Population Allergy Prevalence People with allergy

USA 319M 20-25% (3) 60-70M

EU 743M 22% (4) 160M

Japan 127M 30-39% (1) 38-50M

(Japanese cedar)

China 1.4B 18% (2) 240M

RoW 4.6B 22% (5) >1B

(1) Okamoto Y, et al. Allergol Int. 2009;58:155-162.

(2) World Allergy Organization.

(3) Settipane RA. Allergy Asthma Proc. 2001;22:185-189

(4) Bauchau V, Durham SR. Eur Respir J. 2004;24:758-764.

How Do We Meet Needs of a Large Market

6

Allergy Medications

• Temporary symptom relief

Immunotherapy

• Disease Modifying

Importance of Allergy Immunotherapy

7

Symptom reduction / Improve QoL

Medication reduction

Potential for long-term benefit after

stopping treatment

Preventing new allergic sensitizations

Decrease risk of developing asthma

Burton, M.J. Otolaryngol Head Neck Surg 2007; 136:511-514

Novembre, E. et al. J Allergy Clin Immunol 2004; 114:851-857 2004

DNA

based

allergy

vaccine

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The Evolution of Allergy Immunotherapy

1900 1980 1990 2000 2010 2020

SCITLiquid

SLIT

Tablet

SLIT

Short

Course

SCIT

Transdermal

Patch

Increasing patient friendliness

Adherence

Uptake

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Daily immunotherapy

administration

A New Approach to Immunotherapy:

Allergen extract delivery via toothpaste vehicle

Regular dosing delivered seamlessly via ritual of

regular dental care

Intended for prescription use

Allam JP, et al. Distribution of Langerhans cells and mast cells within the human oral mucosa: new application sites of allergens in sublingual immunotherapy? Allergy. 2008; 63(6):720-727.

Allerdent tissue contact

SLIT

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Key Allerdent Advantages

Efficiency

• Immunotherapy integrated into a daily, habitual activity

• Increased adherence Increased efficacy Optimized outcomes

Adherence

Allerdent Development Benchmarks

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Functional Allerdent Formulations Developed

• Toothpaste homogeneously combines with allergens

• Texture and usability consistent with consumer expectations for toothpaste

• No abnormal taste or aftertaste

Stability Verified

• Biological integrity of allergens verified to 12 months

• Stability of fluoride verified

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Anti-Der f 1 MAb Detection In Allerdent Treatment Set: Der f 1, Fel d 1, Phl p 5, and Alt a 1

CONFIDENTIAL

AD-16 = Allerdent w/ fluoride

Property of Allovate

Dust mite extract

Human Feasibility of

Oral Mucosal Immunotherapy (OMIT)

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Case Report: Three allergic rhinitis patients

treated with OMIT for 4 months

Decreased symptoms

Decreased medication use

Decreased SPT reactivity

2015 - Patients continue OMIT

Reisacher, W, et al. Oral Mucosal Immunotherapy Using a Toothpaste Delivery System for the

Treatment of Allergic Rhinitis. Int. J. of Pharm. Compounding. 2014; 18(4):287-290.

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OMIT Clinical Investigation

Location Weill-Cornell Medical College

Size 24 adult AR patients

Duration 12 months (Last patient out June 22, 2015)

Design • Open label

• 12 OMIT vs. 12 SLIT

• Real-World allergen treatment according to SPT

Endpoints • QOL scores (from RQLQ)

• Total combined score: Symptom and medication scores

• Adherence

• Specific IgG4

• Total and sIgE

• IL-5, IL-10, IL-13, gamma-INF

• AEs

Data

Presentation*

• American Academy of Otolaryngic Allergy (AAOA), Annual

Scientific Meeting, Sept 25-27, 2015, Dallas TX

Clinical Proof-of-Concept of

Oral Mucosal Immunotherapy (OMIT)

* Pending acceptance of submitted speaker abstract

Three Allerdent Product Profiles

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Allerdent

Manufactures with

Fixed Allergen(s)*

Medical Device for

Compounding

Personalized

Immunotherapy

Maintenance of Food

Allergen Tolerance

Following

Immunotherapy

*Natural-sourced or

recombinant

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Allovate Summary

• Allerdent is the initial product platform of Allovate

• Allerdent allows seamless integration of IT into a patient’s

daily routine

• Allerdent platform enables multiple products: Easily adaptable

to regional regulatory requirements, patient preferences, and

clinical practice patterns

• Clinical validation data will be available in 2015

Allovate Team

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Erick Berglund, PhD, CEO

• 12 years experience in biotech sector

• IP management

• Business development / due diligence

• Strategic marketing

Michael Nelson, JD, CFO

• 14 years experience in healthcare

• Healthcare banking – buy and sell side

• General corporate counsel experience

• Previous bioventure CFO role

William Reisacher, MD, Chief Medical

Advisor

• 12 years clinical and research experience as

ENT-Allergist (Weill-Cornell Medical

College)

• Director of Allergy at Cornell’s

Department of Otolaryngology

• Board Member of the American Academy

of Otolaryngic Allergy (AAOA)

Kate Rochlin, PhD, Scientific Consultant

• 10 years experience in biochemistry and cell

biology research

• Ph.D. Biochemistry & Cellular Biology - Weill

Cornell

• CSO of Immunovent

Roger Stier, PhD, Formulation Consultant

• 40 years experience R&D and formulation of

consumer products at GSK, Novelle,

Firmanich

• Inventor of patents related to Aquafresh

toothpaste formulations

Anthony Robinson, MS, CRNP, MBA,

Clinical Advisor:

• Entrepreneur with extensive operational

experience

• Clinical Program Director at Covance, Shire

Thank You!

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Adherence to IT is Suboptimal

• Kiel MA, et al. Real-life compliance and persistence among users of subcutaneous and sublingual allergen immunotherapy. J Allergy Clin Immunol. 2013 Aug;132(2):353-60.• Senna G, et al. How adherent to sublingual immunotherapy prescriptions are patients? The manufacturers' viewpoint. J Allergy Clin Immunol. 2010 Sep;126(3):668-9.

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2013 NetherlandsSCIT vs SLIT Patient Records

SCIT77% SCIT dropout before 3 yrs

1.7 yr median

SLIT93% SLIT dropout before 3 yrs

0.6 yrs median use of SLIT

2010 ItalyReview of SLIT Rx Records

“…alarming rate of SLIT discontinuation.”

~50% discontinued at 1 year

80-90% discontinued at 3 years

Summary of Projected Allerdent Advantages

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Allergy

MedsShots Drops Tablet Allerdent

Long-term efficacy ─ ++ ++ ++ ++

Adherence n.a. +/─ ─ ─ ++

Convenience + ─ + + ++

Discomfort +/─ ─ + + ++

Safety (for home use) + ─ ++ ++ ++

Self-administration ++ ─ ++ ++ ++

Multiple allergen IT n.a. ++ ++ ─ ++

Unconscious addition

to patient’s routine─ ─ ─ ─ ++

Promote dental health ─ ─ ─ ─ ++

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Antigen-Specific Immunotherapy (SIT)

Oral Mucosal Immunotherapy (OMIT)

Sublingual Immunotherapy

(SLIT, AIT)

Other sites in the OC?

Cutaneous delivery techniques

SQ injections (SCIT)

Transdermal patches