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INNOVATION IN ALLERGY IMMUNOTHERAPY INVESTORS PRESENTATION APRIL 2019

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Page 1: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

INNOVATION IN ALLERGYIMMUNOTHERAPY

INVESTORS PRESENTATION

APRIL 2019

Page 2: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Disclaimer

This presentation (“Presentation”) has been prepared by ASIT biotech (“ASIT”) to provide an overview of the Company, it does not constitute a prospectus, an audit or due diligence review and should not be construed as such. While the information contained in this Presentation is believed to be accurate, no representation or warranty, express or implied, is made as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this Presentation of its contents.

The Presentation includes forward looking statements and includes assumptions about future developments, operations and results. Although such statements are believed to be reasonable, there can be no assurances that such assumptions and views of the future are accurate, or that estimates and projections will be realized. Forward looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. No representation, warranties or other assurances will be made by ASIT concerning the anticipated performance of the company.

This document and its contents may not be viewed by persons within the United States (within the meaning of Regulation S under the Securities Act) other than (i) by QIBs (qualified Institutional Buyers) or (ii) in “offshore transactions” within the meaning of Regulation S. This document and any materials distributed in connection with this document are not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe any such restrictions. This document does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of ASIT nor should it or any part of it from the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company, nor shall it or any part of it from the basis of or be relied on in connection with any contract or commitment whatsoever.

2

Page 3: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech team3

Louis Champion, Chairman of the Board

• MD, graduated from Lyon (France) medical school, and MBA from INSEAD

• COO of Stallergènes from 2000 to 2011, where he built up the commercial operations, the R&D organization and the project management group

• He is Board member of several companies in private primary care, biotechnology and medical device sectors.

Michel Baijot, Director & Chief Executive Officer

• Bioengineer, PhD

• Over 25 years of experience in building biologicals businesses with significant contribution in strategy, licensing, M&A and technology transfer

• Previously Executive Director Europe at Serum Institute of India, Head of Cipla Global Vaccine, Chief Business Officer at Janssen/Crucell, Vice President Worldwide Strategic Alliances and Business Development at GlaxoSmithKline Biologicals and Vice President Business Development at Innogenetics.

Yves Désiront, Chief Financial Officer ad interim

• Master degree as Ingénieur Commercial in Business Administration and Technology Interface from I.C.H.E.C. Brussels

• Managing Partner of 3T Finance, a private equity fund based in Brussels

• Previously Group CFO under a consulting contract with BGP Investment, a Luxembourg real estate group, and Group CFO of Orco Property Group, listed in Paris and Prague.

Page 4: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech: a listed advanced-clinical stage immunotherapy company4

A BIOPHARMACEUTICAL COMPANY

OWNING A TECHNOLOGICAL PLATFORM

DEVELOPING PRODUCTS BASED ON A

UNIQUE MIXTURE OF NATURAL

ALLERGEN PEPTIDES TARGETING

RESPIRATORY AND FOOD ALLERGIES

A ROBUST SCIENTIFIC TRACK RECORD IN DEVELOPING INNOVATIVE ALLERGY

IMMUNOTHERAPY TREATMENTS:

gp-ASIT+™: LEAD CANDIDATE IN GRASS POLLEN ALLERGY WITH FIRST

PHASE III (554 PATIENTS) AND A CONFIRMATORY ONE WITH PRIMARY END

POINTS EXPECTED IN DECEMBER 2019

pnt-ASIT+™ & hdm-ASIT+™: CANDIDATES IN RESPECTIVELY PEANUT-

AND HOUSE-DUST MITES ALLERGIES, DEDICATED TO PARTNERING UPON

COMPLETION OF PRECLINICAL PACKAGES EXPECTED MID-2019

Invested more than €80 million since inception

€23.4m IPO (2016) on Euronext Brussels & Paris

€15.4m private placement (2018)

€12m equity line (2018, convertible bonds to be called until January 2020)

Cash position (31.12.18): €8.5 million, reinforced by a €8 million convertible bonds still to be called as of that

date (€5.9 million as of end of March 2019) and €4.2 million warrants at an exercise price of €3.83 per share

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

Page 5: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

5The allergy immunotherapy (AIT) market:<15% of the allergy drug market because of inefficient therapies

Sources: 1 World Allergy Organization, White Book on Allergy, Update 2013 2 Visiongain, Global Allergic Rhinitis Drugs Market 2018-2028, August 20183 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025

23

1

Page 6: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Competitive landscape in AIT market6

Use of adjuvant

Rapidity

of treatment

With adjuvant

Adjuvant free

Short-term Long-term

Page 7: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Long and cumbersome AIT treatments result in low acceptance and poor compliance7

* Source: Kiel MA et al. J Allergy Clin Immunol 2013; 132: 353-60

** (23% compliance for SCIT and 7% for SLIT after Y3)*acceptance rate (50%)

Page 8: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

8

ASIT’s short course immunotherapy is much more efficient than current AIT

Only 4 visits for gp-ASIT+™ treatment are expected to provide protection for the entire pollen season

and protection mechanisms are already in place 1 week after the last visit

Page 9: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech developed a versatile platform for allergy immunotherapy9

ASIT BIOTECH TREATMENTS CONSIST OF A UNIQUE MIXTURE

OF HIGHLY PURIFIED PEPTIDES FROM DIFFERENT SELECTED SIZES,

PRODUCED FROM NATURAL SOURCES OF ALLERGENS, FREE OF

ADJUVANT, FOR ALLERGY IMMUNOTHERAPY

THE ASIT+™ PLATFORM OFFERS:

A validated production process

at commercial scale

Validated QC procedures

A scalable solution that is

applicable to various allergens

(e.g., House Dust Mites, Peanuts)

Already available Ex-vivo

screening, immunogenicity and

therapeutic models

HIGH GRADE

PURIFICATION

OF ALL ALLERGENS

FROM NATURAL

EXTRACTS

STANDARD

ENZYMATIC

HYDROLYSIS

SELECTION OF

ALLERGEN

FRAGMENTS

BASED ON SIZE

DISTRIBUTION*

HIGHLY

PURIFIED

ALLERGEN

FRAGMENTS

WITH OPTIMAL

SIZE

DISTRIBUTION

* 1-10 kDa

Page 10: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech‘s strategy: focus on the ongoing confirmatory Phase III study with gp-ASIT+™ and partnerships for the platform & other drug candidates

10

gp-ASIT+™

ASIT+™ platform

Business Development

• Focus of financial capacity & human resources on the finalization of the second

phase III study, conceived according to an improved protocol, with primary end points

delivered by end of the year 2019

• Option upon financing: initiate a follow-up study for 2020 with the same patients

developing long term data’s with a 2nd season treatment

• Finalize toxicity and ex-vivo studies on hdm-ASIT+™ (house dust mite) and pnt-

ASIT+™ (peanut) by mid-2019

• Demonstrate efficacy of the platform in selecting product candidates

• Establish partnership for the IND and clinical phases in the US

• Establish partnerships for the clinical phases of hdm-ASIT+™ and pnt-ASIT+™

• Establish partnerships for the selection of new product candidates

Page 11: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT Biotech pipeline & expected milestones11

2019 2020

gp-ASIT+™ confirmatory phase III

H1 H2 H1

Candidate Selection

FDA MeetingResults

Filing (GER)

H2

The time to market for the gp-ASIT+™ is expected to be 12 to 18 months after the initiation of

the discussions with the German regulator end of the second quarter in 2020.

Grass pollen

gp-ASIT+™

Peanut

pnt-ASIT+™

House dust mite

hdm-ASIT+™

Other allergens + Partner

Egg white / cow’s milk

pnt-ASIT+™

(phase I)

Results*

hdm-ASIT+™

(phase I )

Results*

PA

RT

NE

RS

HI

P

Follow up

Page 12: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

gp-ASIT+™ demonstrated safety and efficacy in a first Phase III study 12

PL: Placebo; LPP: Lolium Perenne Peptides (gp-ASIT+™)

* CSMS : Combined Symptom-Medication Score

** CPT: conjunctival provocation test (score from 1 to 4; most severe patients = CPT 3 & 4)

# ASIT received positive scientific advice from the German regulator, the Paul-Ehrlich Institute, and is now ongoing a redesigned confirmatory Phase III study (all patients randomized)

0

0,5

1

1,5

All patients Most severe**

CS

MS

Placebo

gp-ASIT+

CSMS OVER

ENTIRE

POLLEN

SEASON

P=0.03 P=0.05

0

0,5

1

1,5

2

All patients Most severe**

CS

MS

Placebo

gp-ASIT+

CSMS:

PEAK

POLLEN

PERIOD

P=0.04 P=0.05

17.9% 24.4%

15.5% 19.8%

In a Phase III study

• gp-ASIT+™ resulted in a statistically significant improvement

in CSMS* during the peak pollen period and the entire pollen

season in the whole Phase III patient population

• The predefined absolute average 20% difference in CSMS*

between placebo and the treatment group was nearly achieved

over the peak season despite a poor results in Germany, which

was heavily weighted in the study#

• In a patient subgroup with the highest CPT** reactivity at

baseline (more than ½ of patients), CSMS* improvement was

even higher

Secondary endpoint

• Reactivity to the conjunctival provocation test (CPT) decreased

significantly in 60.0% of patients treated with gp-ASIT+™

compared with 35.6% in the placebo group

CLINICAL DATA FROM PHASE II AND PHASE III HAS BEEN PUBLISHED BY WORLD-CLASS SCIENTIFIC PARTNERS IN HIGHLY RANKED JOURNALS

Page 13: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Reliable immunological data correlates with strong efficacy data*13

* Blood samples from a representative sub-group of Phase III patients in Belgium (n=32) were compared from V8 (after the grass pollen season) vs. V6 (after treatment before the pollen season)

** CSMS : Combined Symptom-Medication Score

The production of sIgE due to exposure

to natural allergens during the pollen

season was blunted in a sub-group of

Belgian patients* receiving gp-ASIT+™

compared to those receiving placebo

0

10

20

30

40

gp-ASIT+ Placebo

sIg

E(k

UA/L

) sp

ecif

ic

to g

rass

po

llen

P<.001

IgE PRODUCTION

DURING THE POLLEN SEASON

BELGIUM *

Data from 32 patients in Belgium

showed a 35% reduction in CSMS**

during the peak pollen period and

>50% reduction for the entire

pollen season (both highly

significant)

Page 14: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Ongoing gp-ASIT+™ phase III study: next milestones14

2019

Q1 Q2 Q3

LPLV

Q4

A reduced level of exposure to execution risks over time

Ris

ksc

ale

Achieved with

strict criteriaPatients’ recruitment

>85% achieved Patients’ treatment

Pollen season 70 sites selected

Compliant reporting Data collection on E-diaries

Results

December

2019LP Treated

Page 15: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Key success factors of the ongoing confirmatory gp-ASIT+™ phase III study15

• Strong efficacy for most severe patients

• sIgE (pro-allergic antibodies) are blunted and production of sIgG4 (blocking antibodies that prevent sIgE

antibodies from binding allergens) is boosted

• Identification of the biological process with the Imperial College of London allowing an ex-vivo study on the

selected product candidates

1

Learning’s

from the

1st phase III

• Early start of recruitment with 30 to 35 patients per site over 70 sites with an online follow-up of the recruitment

for each site. Enrollment target of a total of 624 patients reached

• Recruit only moderate to severe patients with moderate to severe RC during the 2017-2018 seasons based on

ARIA criteria AND significant sIgE level AND SPT wheal diameter

• High pollen count and high-quality data recording history has been used to select the clinical centres

2

Patients’

recruitment

• The study is subcontracted to one single Top Ten CRO experienced in allergy studies, ICON plc.

• Paper diaries are replaced by smart phone electronic diaries (including an alert system)

• Pollen count monitoring is centralized by the European Aeroallergen Network from the University of Vienna

3

Data

collection

Randomization successfully completed with the anticipated number of patients

Page 16: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

gp-ASIT+™ will take over significant market share of an existing AIT market 16

• Long and cumbersome existing AIT treatments result in low acceptance and poor compliance

• ASIT offers a pre-season treatment consisting of 4 visits with two injections per visit

An opportunity in allergy immunotherapy (AIT) to migrate from old,

inefficient therapies to a new generation of preventive treatment

1

Short

treatment

• Only 1/3 of the 100 Million patients estimated to suffer from Allergic Rhinitis (AR) are offered AIT, out of which

50% accept the treatment with a low level of compliance :

Less than 10% of eligible patients complete the existing treatments

2

Underserved

market

• Pricing will potentially range from €500 (all Europe except Germany), to €750 (Germany) and $1,200 (USA) based

on the cost of existing treatments. The pricing should be correlated with the efficacy demonstrated. No Generics.

Pricing policy could be supported by long-term results from a follow up study in 2020

3

Potential

pricing

A clear market access strategy to commercialize gp-ASIT+™ directly or with a strategic partner

Page 17: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

A clear partnering strategy for gp-ASIT+™, preclinical candidates & new products17

hdm-ASIT+™

Ready for Phase I (mid-2019)

New products

Develop/pay on demand

(e.g. Japanese Cedar,

Birch)

gp-ASIT+™

The proof of concept

pnt-ASIT+™

Ready for Phase I

(mid-2019)

ASIT+™ Patform

• Purified peptides from natural

allergens

• Immunological signature similar to

that of the gp-ASIT+™

• Direct / partner in the EU

• Develop for US with a partner

• Co-development and commercialization with a partner in

major developed (USA & Europe) and emerging markets

(China)

• Filing of a request for Phase I/II as soon as the Company

identifies a partner

• Launch partnerships

in birch allergy or

allergy to Japanese

cedar for example

Page 18: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

Strategic achievements since the beginning of 201918

AchievementsObjectives

Reinforced cash positionSetting up of a €9-12m convertible

bond issueFinancing

Optimization of the development of new

product candidates

First interest for pnt and hdm as well

as for Japanese cedarPartnering

Optimization of the management structureDedicated team to gp-ASIT+™

Structured BD strategy & teamManagement

SAB organized by ASIT recommended to

develop long term data and pediatric

investigation plan

Improving market position of gp-

ASIT+™ with long term dataKOL support

gp-ASIT+™ study Phase III well on trackRandomization of all patients

completedClinical development

Full control of the manufacturingOngoing internalization for

commercial capacityManufacturing

Page 19: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech held SAB with highly recognized experts in allergy immunotherapy 19

Pr. KLIMEK

Pr. MOSGES

Pr. PANZNER

Pr. PFAAR

Pr. PRIEELS

Pr. SHAMJI Pr. CALDERON

Pr. DEMOLY

Pr. BACHERT

Follow up season

Confirm LT effects to prescribers and regulators

Optimal Target Product Profile (TPP)

Confirm the interest of targeting the most severe

patient population

Pediatric Investigational Plan (PIP)

Clarifying the optimal approach to address the

challenges of pediatric development

SAB Agenda

Page 20: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

ASIT biotech: innovation in allergy immunotherapy20

A unique investment opportunity at the edge of the confirmatory phase III results

in grass pollen rhinitis

Potentially the first registered

SCIT short-course treatment

across EU and in the US

3Further upsides: - partnerships in house-dust

mite & peanut allergies- new products from the

ASIT+™ platform

5

ASIT+™ innovative

technology platform

applicable to other allergens

4

Seasoned management team

with solid know-how in the

field of allergy

6

Allergy: a global issue with

significant unmet medical

need

1

An expected short time to

market in grass pollen rhinitis

2

Page 21: INNOVATION IN ALLERGY IMMUNOTHERAPY...3 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025 2 3 1 Competitive landscape in AIT market 6 Use of adjuvant Rapidity of treatment

www.asitbiotech.com

Registered address

Avenue Ariane 5

1200 Brussels, Belgium

Operations

Rue des Chasseurs Ardennais 7,

4031 Liège, Belgium

Contact: [email protected]