Allergy immunotherapy as simple ASIT can be…
Investor Presentation
1
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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
Unactivated mast cells loaded
with allergen-specific IgE
Release of pro-inflammatory mediators due to bridging of IgE by the allergens
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
Unactivated mast cells loaded
with allergen-specific IgE
Exposure to allergens
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
Unactivated 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
Unactivated mast cells loaded
with allergen-specific IgE
ASIT+TM are significantly less capable to bridge specific IgE
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
Unactivated 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
Unactivated mast cells loaded
with allergen-specific IgE
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
Safety and clinical tolerability
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
Safety and clinical tolerability
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
(redness, swelling and tearing…)
Response
(redness, swelling and tearing…)
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
Potential number of treatments
Poorly controlled adults
Adults with allergic rhinitis
2,0
3,3
1,7
13,1
Potential number of treatments
Poorly controlled adults
Adults with allergic rhinitis
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
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
1,500 allergists20 reps
15,000 Practicing clinicians
500 Regional KOLs
120 National KOLs
2Marketing strategy: focus on specialists
25 Int'l KOLs
5,000 allergists50 reps
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
Treatment courseUse of
adjuvant?Esc. (weeks)Maintenance.
(months)
On-going development
Current existing treatments
Company
NamePhase
Treatment courseUse of
adjuvant?Esc. (weeks)Maintenance.
(months)
Company
NamePhase
Treatment courseUse of
adjuvant?Esc. (weeks)Maintenance.
(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)