Allergy immunotherapy as simple ASIT can be… Investor ......This presentation is not a prospectus...

Allergy immunotherapy as simple ASIT can be…

Investor Presentation

1

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This presentation has been prepared by the management of ASIT biotech SA (the Company). It does not constitute or form part of, and should not be construed as, anoffer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company nor should it or any part of it form the basis of, or berelied on in connection with, any contract to purchase or subscribe for any securities of the Company, nor shall it or any part of it form the basis of or be relied on inconnection with any contract or commitment whatsoever.

This presentation is not a prospectus and recipients should not purchase, subscribe for or otherwise acquire any securities of the Company except on the basis ofinformation in the prospectus. Copies of the prospectus will, following approval by the FSMA and passporting into France, be available at the Company’s registeredoffice and can also be obtained from KBC Team at +32 (0)16 432 915 and at the head office of Société Générale in Belgium at 11 rue des Colonies, 1000 Brussels.Subject to selling and transfer restrictions, the Prospectus is available to prospective investors on the following websites: www.kbc.be, www.cbc.be,www.kbcsecurities.be, www.bolero.be, www.fsma.be and www.amf-org.fr.

The information included in this presentation has been provided to you solely for your information and background and is subject to updating, completion, revisionand amendment and such information may change materially. No person is under any obligation to update or keep current the information contained in thispresentation and any opinions expressed in relation thereto are subject to change without notice. No representation or warranty, express or implied, is made as tothe fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for anyloss howsoever arising, directly or indirectly, from this presentation or its contents.

This presentation includes forward-looking statements that reflect the Company's intentions, beliefs or current expectations concerning, among other things, theCompany’s results, condition, performance, prospects, growth, strategies and the industry in which the Company operates. These forward-looking statements aresubject to risks, uncertainties and assumptions and other factors that could cause the Company's actual results, condition, performance, prospects, growth oropportunities, as well as those of the markets it serves or intends to serve, to differ materially from those expressed in, or suggested by, these forward-lookingstatements. The Company cautions you that forward-looking statements are not guarantees of future performance and that its actual results and condition and thedevelopment of the industry in which the Company operates may differ materially from those made in or suggested by the forward-looking statements contained inthis presentation. In addition, even if the Company's results, condition, and growth and the development of the industry in which the Company operates areconsistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments infuture periods. The Company and each of its directors, officers and employees expressly disclaim any obligation or undertaking to review, update or release anyupdate of or revisions to any forward-looking statements in this presentation or any change in the Company's expectations or any change in events, conditions orcircumstances on which these forward-looking statements are based, except as required by applicable law or regulation.

In this presentation, references are made to the Company’s product candidates, for which marketing authorisation has not yet been obtained. These productcandidates are designated throughout this presentation by their internal project names at the Company. The names used are not meant to refer to these products (ifand when they will be approved), as it is yet uncertain if and under what names these product candidates would be marketed in the future. Nothing in thispresentation should be construed as endorsing or advertising such product candidates.

Disclaimer

2

Thierry Legon, Co-Founder & CEO

Co-Founder of the company

10 years in charge of the intellectual property and technology transfer at the Free University of Brussels (ULB)

8 years at Euroscreen as a member of the board

Engineer in Agronomy, MBA

François Meurgey, Chief marketing officer and Board Member

25 years in biopharma Sales & Marketing

Expert consultant on product launch and reimbursement of pharmaceutical products in Europe and US

Director of Global Marketing for Prozac (Eli Lilly)

Former SVP Global Marketing (UCB): managed late lifecycle of Zyrtec, launched Xyzal and in-licensed ragweedimmunotherapy vaccine from Dynavax

MS, MBA

Today’s speakers

Everard van der Straten, Board Member and CFO

25 years of experience in finance and industry

Representing long-term Belgian private shareholders

Master at Solvay Business School

3

A Global Issue according to the World Allergy Organization1…

Approximately 30 to 40% of the world’s population suffers from allergic diseases

Approximately 400 million people affected annually by allergic rhinitis, a risk factor for asthma

Approximately 300 million individuals worldwide have asthma (likely to increase to 400 million by the year 2025)2

Approximately 200 to 250 million people annually affected by food allergies

…with high unmetmedical need

A major public health problem:

High drug-related costs > $10 billion for allergic rhinitis symptomatic drugs only3

Impaired quality of life

High indirect costs due to high number of missed work and school days

Fatal allergic reactions

Allergy …

1) World Allergy Organization, World Allergy Week 16 – 22 April 2012

2) World Health Organization, see World Allergy Organization World Allergy Week 16 – 22 April 2012

3) Visiongain - Allergic rhinitis drugs market forecast 2015-2025

4

• > 95% symptomatic drugs requiring daily intake

• Immunotherapy

theoretically the best available treatment

targeting the cause of allergic diseases

providing a sustained effect

underused: €0.9 billion1

long and cumbersome treatments

Current allergy drugs

1) Allergy & Asthma Foundation of America 2005 Survey

2) Source: Stallergenes Doc. Ref 2014

LOW ACCEPTANCE

LOW COMPLIANCE

LOW REAL-LIFE EFFECTIVENESS

>25% PATIENTS LOOKING FOR NEW DRUGS2

5

The ASIT biotech value proposition

TO COMMERCIALIZE WORLDWIDE SHORT-COURSE

IMMUNOTHERAPY TREATMENTS IMPROVING

Innovative active ingredients to result in:

→ Rapid onset of action

→ Year-long protection

→ Good safety profile

ACCEPTANCE

1

COMPLIANCE

2REAL-LIFE

EFFECTIVENESS

3

6

ASIT biotech at a glance

Spin-off of the Free University of Brussels (ULB)

€35 million raised since inception

19 employees including 10 MDs or PhDs

Unique technology platform to develop new active ingredients

– 1st product candidate gp-ASIT+™ for grass pollen rhinitis in late stage of development

Proof of concept achieved through statistically significant phase IIa & IIb clinical studies

Phase III trial ongoing: recruitment completed

– 2nd product candidate hdm-ASIT+™ for house dust mite rhinitis

First phase of regulatory required preclinical development completed

Entering Phase I/II in 2016

Significant potential upside if demonstrated impact on asthma

– First evidence of applicability on other respiratory (ragweed) and food allergens (egg white & peanut)

Large market potential

1Breakthrough

technology

2Short time to

market

3

Large market potential

1

8

High allergy prevalence leading to substantial disease burden

ALLERGIC RHINITIS

125m patients (Europe1 + US)²

ALLERGIC ASTHMA

55m patients (Europe1 + US)3

FOOD ALLERGY

26m to 60m patients (Europe1 + US)4

1) 4 major countries (DE, ES, FR, IT)

2) Company estimates based on Bauchau & Durham 2004, Nathan 2008

3) Company estimates

High direct medical and indirect societal costs

ALLERGIC RHINITIS (US, 2005)

$20.9bn5

ASTHMA (US, 2010)

$56 bn5

4) Company estimates based on WAO White Book on Allergy 2013 update

5) WAO White book on Allergy 2011, Member Societies Survey Report pp.234-236

9

Current allergy treatments do not satisfy the patient needs

1) Visiongain allergic rhinitis drugs market forecast 2015-2025

2) Stallergènes Document de référence 2014

Status Limitations

> $10 billion1

CAGR ≤ 0%1

Numerous generics

€0.9 billion2

CAGR > 10%

Market size

Real need for short-course immunotherapy with improved compliance and real life effectiveness

Symptomatic drugs

1st line treatment for respiratory diseases

Registered: anti-histamines, leukotriene receptor antagonists, nasal or inhaled steroids, or combined therapy

Not curative

Multiple side effects e.g. drowsiness, sedation

Low compliance

Immunotherapy treatments

The only treatment

– targeting the cause of allergy

– resetting the immune system

– providing sustained effect

Currently prescribed to moderate to severe allergic patients

Mainly named patient products (NPP)

Cumbersome treatment regimen

– Low patient acceptance: <50%

– Low patient compliance: > 70% drop out before the end of the treatment (3 to 5 years)

– Limited real-life effectiveness

Difficult to apply even for food allergyAllergen avoidance

First solution for all allergies

Sole solution for food allergy

10

Year 1 Year 2 Year 3

Only 50% of patients accept current immunotherapy treatments1

Only 30% of patients comply to the full treatment schedule1

ADMINISTRATION ROUTES

SCIT

Subcutaneous immunotherapy

SLIT

Sublingual immunotherapy

Daily administration

180 to 365 days/year

SCIT 40-60 doctor visits

Low acceptance and compliance regardless the administration route

1) ALK-Abellò IR presentation 6 December 2014

11

Allergy immunotherapy market: a major opportunity

1) NPP: Named Patient Products

Market in transition from NPP1

towards registered products with full documentation on the drug’s quality, efficacy and safety

RegulatoryEnvironment

High unmet need

Mainly short course SCIT treatment

Preferably without an adjuvant

New Players

SCIT: the dominant route of administration in the major markets: better treatment control, allergists’ preference and better perceived efficacy

SLIT: no improvement of patient real-life effectiveness, acceptance and compliance

Current allergyimmunotherapy products

Breakthrough technology

2

13

ASIT+™ allergens: optimal size to reset the immune system

ASIT+TM a unique know-how to treat allergies more quickly and more efficiently

WHOLE ALLERGEN

Complete information to reset the immune system

Significant risk of allergic reaction Possibly dangerous Lack of real-life effectiveness due

to low patient compliance

OPTIMALLY-SIZED ALLERGEN

Preserved information to reset the immune system

Low risk of allergic reaction Short course regimenHigher expected real-life effectiveness

due to improved patient compliance

SYNTHETIC PEPTIDES

Reduced risk of allergic reaction Information necessary to reset the

immune system still unclear Possible lack of effectiveness due

to possible lack of information

CURRENT IMMUNOTHERAPIESSYNTHETIC

IMMUNOTHERAPIES

14

Allergic reaction

ASIT+TM allergen fragments induce less mast cell degranulationthan current whole allergens

ASIT+™ fragments: how it works?

Reduced allergic reaction

Inactivated mast cells loaded with allergen-specific IgE

Unactivated mast cells loaded

with allergen-specific IgE

Release of pro-inflammatory mediators due

to bridging of IgE by the allergens

Exposure to allergens

ASIT+TM are significantly less

capable to bridge specific IgE

ASIT+TM fragments



Release of pro-inflammatory mediators due to bridging of IgE by the allergens








ASIT+TM fragments











ASIT+TM fragments










ASIT+TM fragments



ASIT+TM are significantly less capable to bridge specific IgE

Inactivated mast cells loaded with allergen-specific IgE








ASIT+TM fragments










ASIT+TM fragments



ASIT+TM fragments

15

Year 1 Year 2 Year 3

ASIT+TM improves acceptance and compliance for a better real-life effectiveness

SCITSubcutaneous

immunotherapy

SLIT

Sublingual immunotherapy

Daily administration

180 to 365 days/year

SCIT 40-60 doctor visits

Short course treatment improves patient acceptance and compliance

1) ALK-Abellò IR presentation 6 December 2014

4 doctor visits 3 weeks prior each

pollen season gp-ASIT+TM

Existing products

16

Diversified drug candidates portfolio

Pre-clinical Phase I Phase II Phase III

Two key indications already covered in respiratory allergiesHigh development potential in other allergies

gp-ASIT+™ Grass pollen-induced allergic rhinitis

Phase IIb completed with statistically significant positive results

Phase III trial launched in 6 European countries: recruitment completed

hdm-ASIT+™

House dust mite-induced rhinitis

First phase of regulatory required pre-clinical phase completed

Documentation for Phase I/II clinical trial filed in Germany

Other ASIT+™ products

A third ASIT+TM product candidate for ragweed-induced rhinitis

Potential ASIT+TM products for food allergies

At the discovery stage

17

gp-ASIT+™: lead product candidate for grass pollen rhinitis

18

gp-ASIT+™ currently in Phase III

Note: CPT = conjunctival provocation test (see slide 29)

2010

Double-blind Dose escalation Single center in Belgium

Safety and clinical tolerability

Immunogenicity

• Positive impact on the immune system• Reduced the reactivity to a provocation test

2012

Open-label Dose escalation Single center in Germany


ImmunogenicityClinical efficacy assessed by CPT

Phase IIa

(65 patients)

Double-blind Placebo- controlled 56 centers in Europe

Regulatory approval obtained

Start in 2016

Clinical tolerability

Clinical safety Clinical efficacy 2017

Phase III

(549 patients randomized)

Phase I

(27 patients)

2014

Double-blind Dose ranging Multi-center in Germany


ImmunogenicityClinical efficacy assessed by CPT

Dose-finding assessed by CPT

Phase IIb(198 patients)

19

Score 3100 U / mL

1,000 U / mL

No response

Score 2

Score 1

Score 0

10,000 U / mL

No response

No response

Response

(redness, swelling and tearing…)

Response


Response


Used as primary efficacy outcome for Phase IIa and Phase IIb and as secondary efficacy outcome for phase III

Test performed before, during and after the treatment

3 different allergen concentrations used: 100, 1,000 and 10,000 U/mL

Measurement on a 4-point scale

CPT – Conjunctival Provocation Test

20

gp-ASIT+TM decreases the mean CPT score by 77% after a 3 week treatment

Phase IIa demonstrates high clinical effect

1,92

0,44 0,320,0

0,5

1,0

1,5

2,0

2,5

Baseline 3-week treatment 5-week treatment

CP

T Sc

ore

- 83%- 77%

p < 0.001

p < 0.001

21

Phase IIb confirms clinical effect in 3 weeks

CPT score reduction and 3 week treatment schedule confirmed in Phase IIb

0,0

0,5

1,0

1,5

2,0

2,5

Placebo 2-week treatment 3-week treatment 4-week treatment

CP

T Sc

ore

CPT score at the end of the study

- 38%

p < 0.01

P = 0,015

- 36%

22

0,0

1,0

2,0

3,0

4,0

5,0

Placebo 2-week treatment 3-week treatment 4-week treatment

Titr

e d

e l'a

xe

At Baseline After treatment

gp-ASIT+™ activates immune system regulatory mechanisms

Clinical effect supported by immunological parameters

p < 0.01

p < 0.001

p < 0.001

23

hdm-ASIT+™: product candidate for house dust mite allergy

24

Confirmation of immunogenicity in animal models

Specific-IgG production (p< 0.001 at day 28 compared to placebo, n=20)

Specific-spleen cell proliferation (p< 0.01 at 90 µg/ml compared to placebo, n=7)

hdm-ASIT+TM ready to enter in clinical development

Production of natural allergen-specific IgG Spleen cell proliferation concentration

0,0

2,0

4,0

6,0

8,0

10,0

12,0

14,0

1 3 10 30 90

Stim

ula

tio

n In

de

x

HDM-ASIT + TM concentration (µg/ml)

0,0

2 000,0

4 000,0

6 000,0

8 000,0

10 000,0

12 000,0

14 000,0

16 000,0

0 14 28 42

HD

M a

llerg

en

-sp

eci

fic

IgG

(A

.U.)

Days

Placebo Hdm-ASIT+TM

25

ASIT+™, a breakthrough allergy immunotherapy treatment…

Novel active ingredient extracted from natural sources of allergens

No need for adjuvant thanks to optimal size selection

Short-course SCIT treatment: 4 doctor visits over 3 weeks

Rapid onset of action, both on symptomatic and immunological parameters

Safety in line with existing products

Statistically significant positive impact on immunological parameters and challenge test

Lead product in Phase III: potential to be first registered SCIT across EU and in the US

26

…with benefits for all stakeholders

Fast onset of action

Improved real-life effectiveness

Significant savings in terms of time and money

Better quality of life

Patients

Interest for innovative technology

Use of a registered product with full dossier

Improved acceptance and compliance resulting in better real-life effectiveness

Fewer visits per patients but larger number of successfully-treated patients

Allergists

Better real-life effectiveness

Reduced direct and indirect costs

Documented safety and efficacy

Healthcare systems

Short time to market strategy

3

28

Exclusive focus on allergist target group

Set-up of a Marketing/Medical Affairs organisation and sales force, subject to the clinical results for the phase III clinical trial with gp-ASIT+™ and additional funding

Easy expansion into food allergy market by targeting paediatricians

Prepare the commercial platform

2

Seek registration for grass pollen (gp-ASIT+™)

Start clinical development for house dust mite (hdm-ASIT+™)

First evidence of applicability of the ASIT+™ platform to ragweed and food allergens

Leverage the ASIT+™ technology platform

1

Product development and marketing strategy

29

549 randomized2:1 (active: placebo)

Safety and clinical tolerability Clinical efficacy

Double-blind Placebo controlled 56 centers in Europe

Trial # patients Primary objective Design

Demonstration of the clinical efficacy of gp-ASIT+TM during the grass pollen seasonbased on reduction of the combined symptom-medication score

Seek registration in Germany in case of robust Phase III clinical results

Conduct a Phase III study in North America, allowing registration in the US and other EU countries

gp-ASIT+™ ongoing development

Strategic target

Phase III

1

30

Between 20 and 40

Assessment of the maximum tolerated dose Safety and clinical tolerability Immunogenicity Impact on reactivity to a challenge test

2016

Trial # patients Aim Completed

hdm-ASIT+™ - early stage clinical development

Phase I/II

1

Start clinical development in 2016 with a Phase I/II clinical study

Proceed as soon as possible to a dose-ranging Phase IIb study

Strategic target

31

Results

Results

Preclinical

Results

Expected clinical development timeline

gp-ASIT+™

2016 2017 2018 2019

H1 H2 H1 H2 H1 H2 H1 H2

Results

Phase I/II Phase IIb dose ranging

Phase III Short-term

efficacy in adults

Registration

hdm-ASIT+™

Other ASIT+™

productsFurther (pre-)clinical development e.g. ragweed, peanut, egg white, cow milk

Phase III Short-term

efficacy in adults

1

Phase IIb if necessary

Registration

Pre-IND meeting with FDA

32

Allergic rhinitis: a large addressable market

1) Based on 25% of patients looking for a new treatment - Marple BF Otolaryngol Head Neck Surg. 2007 Jun;136(6 Suppl):S107-24; Didier A et al Rev. Fr Allergol. 1999 ; 39 : 171-1852) Based on the prevalence of the sensitization by allergen - EU: Bauchau & Durham 2004; US: Nathan 1997 & 2008.

2

Estimated market potential for ASIT biotech: 12.5 million treatments

In million

Grass pollen House Dust Mite

France, Italy, Spain

1,3

2,2

1,0

8,6

Potential number of treatments

Poorly controlled adults

Adults with allergic rhinitis

3,6

6,4

2,9

25,4




2,0

3,3

1,7

13,1




1

1

1

2

2

2

33

A competitive pricing strategy

Note: * Pollinex Quattro ex-factory price is €600.

Sources: AVOS interviews; ZenRx; Pharmacoeconomic assessment of specific immunotherapy versus current symptomatic treatment for allergic rhinitis and asthma in France; German List Prices based on Arzneimittelverordnungsreport 2011 and in line with 2010 update of HTA assessment for AIT in allergic rhinitis; Centers for Medicare and Medicaid Physician Fee Schedules; Spain & Italy- AVOS Cat Tanderproject 2013; http://www.petrone.it/index.php/en/company-activities, accessed May 2015 for Italian and Spanish Oral treatments.

Country SCIT NPP SLIT tablets

Germany €520 - €600* €750 - €1,500

USA €650 €2,000 - €2,300

Spain €450 €850 - €1,300

France €400 €400 - €650

Italy €450 €800 - €1,500

Yearly ex-factory price

2

http://www.petrone.it/index.php/en/company-activities

34

Market access strategy

1) NDC-National Coverage Determination

CPT-Current Procedural Terminology

HCPCS-Health Care Common Procedure Coding System

ObjectiveGain rapid adoption by

allergists in commercial and Medicaid segments

Competitive pricing vs. existing SLIT tablets

Superior clinical profile

Strong cost-effectiveness argument

Inclusion in Medical Benefit at competitive price

Quick granting of procedure and billing codes

Complementarity with current SCIT business model

Superior clinical profile

ObjectiveGain rapidly at least

parity reimbursement with current SCIT

Europe USA

2

35

* Medical Science Liaisons** 500 “pure“ allergists plus 1,500 physicians with double specialty (pulmonologist, ENT, etc.)

5,500 allergists100 reps/MSLs*

2,000 allergists**10 reps

1,000 allergists15 reps


15,000 Practicing clinicians

500 Regional KOLs

120 National KOLs

2Marketing strategy: focus on specialists

25 Int'l KOLs


Step 1After positive 1st Phase III results

Step 2After positive 2nd Phase III results

Step 3After EU approval

36

H2 2015 H1 2016 H2 2016

Approval of Phase III trial for gp-ASIT+™ in participating countries

Patient recruitment completed for pivotal European Phase III trial

2017

Clinical results of Phase III trial

Start of Phase III clinical study in the US

End of the first phase of regulatory required pre-clinical study on hdm-ASIT+™

Regulatory approval for Phase I/II clinical study

Recruitment of first patients for Phase I/II clinical study

Full readout on Phase I/II clinical study

First pre-clinical results with 3rd product candidate

Start of Phase IIb clinical study

Start of Phase I clinical study for 3rd product candidate

Anticipated upcoming newsflowgp

-ASI

T+™

hd

m-A

SIT+

™o

ther

-ASI

T+™

Regulatory filing for Phase I/II clinical study

Pre-IND FDA meeting

Today

Filing for a registration in Germany

37

Sole safe and efficacious SCIT treatment in grass pollen rhinitis in 3 weeks without any adjuvant

3

Potential for first registered SCIT product across EU and in the US

5

Demonstrated clinical proof-of-concept and expected short time to market in grass pollen rhinitis

4

Proprietary patents on ASIT+™ platform

6

Allergy: a global opportunity with significant unmet medical need

1

Further upsides: - other EU and emerging markets- allergic asthma- food allergies

7ASIT+™ innovative technology platform applicable to other

allergens

2

ASIT biotech key investment highlights

38

Key transaction parameters

Issuer ASIT biotech SA

Listing Regulated market of Euronext Brussels and Paris under the symbol “ASIT”

Offering structure

• An initial public offering to retail investors (minimum 10% of offering) and institutional investors in Belgium andFrance

• Private placement to institutional investors in Europe and Switzerland in reliance with Reg S

Offering size

Total IPO size from €24.5m to €39.3m, structured in the following way:

• A base offering of up 3,500,000 new shares, ie € 24.5m to €29.8m

• 15% increase option

• 15% over-allotment option

• Minimum size of €22m

Standstill and Lock-up

Use of proceeds

• approx. 60% for gp-ASIT+TM (grass pollen induced allergic rhinitis)• approx. 25% to support the last preclinical development for hdm-ASIT+TM(house dust mite induced allergic rhinitis)

including the completion of a Phase I/II and Phase IIb clinical study;• approx. 8% for general corporate purposes,• remainder to accelerate discovery of new ASIT+™ platform based product candidates and pre-clinical development

thereof.

Price range €7.00 – €8.50 per share

Market cap post IPO €94m to €123m post-IPO market cap depending on the pricing and exercize of extension/ over-allotment options

Pre-commitments Certain existing shareholders have committed to subscribe for an aggregate amount of 8.26m

SyndicateJoint Global Coordinators/Joint Bookrunners: KBC Securities and Société Générale CIB

Placement agent: Gilbert Dupont

• Statutory lockup of 12m for all pre-IPO shares

• Standstill 12m

39

Key transaction dates

Date Event

28 April – 09 May 2016 Offering period (subject to early closing)

10 May 2016 Pricing and allocation

10 May 2016 Publication of the Offer Price and results of the Offering

11 May 2016 Expected listing date and start of (conditional) trading

12 May 2016 Expected closing date (payment, settlement and delivery of the shares)

Appendices

41

Thierry Legon, Co-Founder & CEO

Founded the company in 1997 8 years at Euroscreen as a member of the board 10 years in charge of the intellectual property and technology transfer at the Free University of Brussels Co-inventor of the major ASIT biotech patents Ir. Agronomy, MBA

Everard van der Straten, Board Member and CFO

25 years financial and industrial experience Representing long-term Belgian private shareholders

Sabine Pirotton, in charge of Clinical development

At ASIT biotech since 2005 Joined ASIT biotech after 20 years as senior scientist at the Free University of Brussels and the University of Namur Co-inventor of the major ASIT biotech patents. In charge of the design, submission and management of the clinical trials. PhD in Biochemistry

Gaël Placier, in charge of Product development

At ASIT biotech since 2005 20 years of experience as researcher including a senior scientist position in Industrielle Genetik Institute of Stuttgart in Germany Co-inventor of the major ASIT biotech patents PhD in Biochemistry

Executive team: demonstrated experience in the biotech industry

ASIT biotech team

François Meurgey, Chief Marketing Officer and Board Member

25+ years in biopharma Sales & Marketing Expert consultant on product launch and reimbursement of pharmaceutical products in Europe and US Director of Global Marketing for Prozac (Eli Lilly) Former SVP Global Marketing (UCB): managed late lifecycle of Zyrtec, launched Xyzal and in-licensed ragweed immunotherapy vaccine from Dynavax MS, MBA

42

Meusinvest SA (represented by Marc Foidart)

Bruservices SA (represented by Henri De Meyer)

Thierry Legon

2%Rodolphe de Spoelberch

12%

SRIW Techno4%

MEUSINVEST5%

SFPI13%

START-IT2%

BRUSTART4%

SRIB4%

Private investors

49%

Directors and management

5%

ASIT biotech governance

Board of Directors Shareholding structure pre IPO (Dec. 2015)

Béatrice De Vos, Chairwoman of the Board

25 years in clinical research and medical affairs departments of major international pharmaceutical companies. Former VP Global Medical Affairs at GSK Biologicals and Sanofi Pasteur

Thierry Legon, CEO

Everard van der Straten, Director and CFO

Gerd Zettlmeissl, Independent Director

Working in the biopharma & vaccine industry since 1985 : e.g. former CEOof the Austrian-based biotech Valneva SE (formerly Intercell AG), chairmanof the Board of GlycoVaxyn 2013-2015, member of the Board of Aeras

Jean Duchateau, Director & Co-founder

Allergist. One of the inventor of the 1st patents on tolerance induction toallergy and graft rejection, new LED tests, owned by ASIT biotech

François Meurgey, Director

Yves Désiront, Independent Director

43

FY 2015 financial summary

Thousands of € 31 Dec 2015 31 Dec 2014 31 Dec 2013

Income Statement

Revenues 4 5 7

Gross profit 1 5 10

Research and development expenses (6,691) (3,541) (1,670)

Other operating expenses (950) (782) (638)

Operating Profit / (Loss) (7,640) (4,318) (2,298)

Profit / (Loss) before taxes (7,715) (4,429) (2,319)

Net Profit / (Loss) for the period (7,715) (4,429) (2,319)

Balance sheet

Non-current assets 506 215 42

Current assets 4,968 8,565 1,327

Total equity (858) 7,432 42

Financial Debt 4,232 - 885

Other loans Current liabilities 2,100 1,349 443

TOTAL Equity and Liabilities 5,474 8,780 1,369

44

201420101997 2006 2007 2009 2011 2012 2015 H12013

Start of Phase III for gp-ASIT+™ in EU

End of first phase of regulatory-required preclinical study for hdm-ASIT+™

Foundation of the company as a spin-off of the UniversitéLibre de Bruxelles

Creation of the ASIT+TM platform

and filing of patents

Phase IIa for gp-ASIT+™

Phase IIb for gp-ASIT+™

2015 H2

CO

RP

OR

ATE

EV

ENTS

& C

LIN

ICA

L D

EVEL

OP

MEN

TFU

ND

ING Issuance of €4m convertible

bond + €8m equity commitment€11.6m capital

increase€4.2m raised

€5.2m capital increase

€10.3m raised

Phase I/II for gp-ASIT+™

ASIT biotech history

45

Abnormal immune response to foreign substances called allergens

Plant pollens

House dust mites

Animal dander

Certain food

What is allergy?

House Dust Mites PeanutsPollen

46

What are the symptoms?

Mild to moderate – coughing, sneezing, itchy eyes, runny nose and scratchy throat

Severe – rashes, low blood pressure, breathing troubles, asthma attacks and, even, death

Rhinitis OedemaAsthma

47

B cell activation

Allergen-specific IgE production

Specific IgE bind to mast cells

Subsequent allergen exposure result in: mast cell degranulation histamine release allergic symptoms

1

2

3

5

4

Overreaction of the immune system to harmless foreign

substances resulting in local and systemic

inflammatory symptoms

Mechanism of allergic reaction

48

Current allergy immunotherapy mechanism of action

Source: Immunotherapy – 2012 Future Medicine Ltd. - http://www.medscape.com/

Aiming to induce immunological tolerance symptoms reduction

Consisting in the administration of progressively higher doses of allergen (dose escalation) monthly injections of maintenance dose

IgE decrease

IgG and IgG4 induction ofwith blocking activity

lymphocyte response reduction

Reduction of the local andsystemic inflammation

Allergen injections

IgG and IgG4

IgE

Lymphocyte responses

6 months 2 years

Allergen Injections

Time

Symptoms

Title

49

ALK-Abello Alutard® 8 36

Allergopharma Allergovit® 7 30

HAL Allergy Purethal® 6 8

Stallergènes Alustal® 13 36

Stallergènes Phostal® 13 36

ALK-Abello Alutard® 8 36

HAL AllergyPurethal®

Mites8 36

HAL AllergyDepot-HAL®

Mites8 60

Stallergènes Phostal® 13 60

Stallergènes Alustal® 13 60

LETILaboratorios

Depigoidl® 4 24

ASIT biotechgp-ASIT+TM Phase III 3 0

BiomayBM32® Phase IIb 8 0

CircassiaGrass-Spire® Phase II 16 0

AllergyTherapeutics

PollinexQuatro®

Phase III 3 0

ALK-AbelloAvanz® Phase III 4 60

On-going development

Current existing treatments

Company Name

Treatment courseUse of

adjuvant?Esc. (weeks)

Maintenance.(months)

Company Name


adjuvant?Esc. (weeks)Maintenance.

(months)

On-going development

Current existing treatments

Company

NamePhase



(months)

Company

NamePhase



(months)

ASIT biotechhdm-ASIT+TM Phase I/II 3 0

CircassiaHDM-Spire® Phase IIb 12 0

Grass pollen House dust mite

Existing treatments

50

Primary objective

Demonstration of the clinical efficacy of gp-ASIT+TM during the grass pollen season following the administration: reduction of the combined symptom medication scores taking into account the symptoms of rhinoconjunctivitis and the use of anti-symptomatic medication during the grass pollen season.

Secondary objectives

Assessment of the individual symptom and medication scores

Assessment of the changes in allergic reactivity to Conjunctival Provocation Test (CPT)

Assessment of the Quality-of-Life of patients and health economic aspects

Assessment of the safety and clinical tolerability of gp-ASIT+TM treatment.

Exploratory objective (in a subset of patients)

Assessment of the impact of gp-ASIT+TM treatment on the immunological status of the patients

gp-ASIT+™ Phase III objectives

51

ASIT biotech Specialist Distributor Site of care

AIT considered a Medical Benefit product (not PharmaceuticalBenefit)

Unlikely that any discount/rebates will apply

Specialty distributor mark-ups are 8-10%

Distributors typically make a 2% marking but in the case of AIT this falls under the remit of a specialist distributor

Allergist clinic administers shot and bills insurance for medical procedure (including drug)

6% mark-up on ASP (average sales price)

Marketed as “buy & bill” drugs

Most health insurance coverages include a $1,000 to $2,000 per year deductible

Co-pay of 20% once the deductible limit has been met

Patient co-pay

US Financial/Reimbursement Pathway

52

IP rights covering the ASIT+TM Technology Platform

BTT04

ALLERGEN PURIFICATION

The patent family is directed to a special way

of purifying and denaturing extracts of natural

allergens and a special way of hydrolysing

allergens.

Pending patent application in Europe, China,

USA, Japan, India, and Brazil

Divisional application pending in Japan.

June 28, 2027

(expected)

BTT07

PRODUCTION OF

HYDROLYSED ALLERGENS

(PEANUT)

The patent family covers an improved

method for the production of hydrolysed

allergens, especially applicable to peanut

allergens

Pending patent application in Europe, USA,

Japan, China, Brazil, India, Canada and Australia

June 15, 2032

(expected)

Date post:	16-Oct-2020
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Allergy immunotherapy as simple ASIT can be… Investor ......This presentation is not a prospectus...

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