Investor presentation November 2017 - ASIT biotech
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Investor presentation November 2017
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➢ ASIT biotech pitch
We aim to restore ➢ Market opportunity in allergy
quality of life of
➢ ASIT+™ Technology
millions of allergic
people! ➢ ASIT+™ Clinical Development
➢ Investment opportunity
ASIT biotech pitch
Thierry Legon, Everard van der Straten,
Co-Founder & CEO CFO- Master’s degree, Solvay
Engineer in Agronomy, MBA Business School
Clinical stage biopharmaceutical company focused
on the development and future commercialization of a range
of breakthrough drug products for the most allergic patients
looking for new treatments.
About ASIT biotech • ASIT biotech has dual market listing in Brussels (Belgium) and Paris (France) since May 2016. • Raised €59.1 million since inception and €23.4 million by IPO. • Secured €7.2 million non-dilutive financing granted by the Walloon Region. • Partnership with internationally renowned institutions.
• Our primary focus is to deliver on unmet medical need of > 20 millions allergic patients
looking for new treatments.
• We have built-up a unique technology platform, ASIT+TM, generating novel active ingredients
for the treatment of the most prevalent allergies i.e. pollen & mite rhinitis and food allergies
• These novel active ingredients allow for short-course allergy immunotherapy treatments
(AIT)
• Proof Of Concept (PoC) supported by positive clinical Phase III results in grass pollen rhinitis
Market opportunity in allergy
Allergy – a mistaken of the immune system
PATHOGENS &
IMMUNE SYSTEM FOREIGN SUBSTANCES
HEALTHY IMMUNE RESPONSE
‒ protection against pathogens
(bacteria, virus, moulds,
parasites) and foreign substances
‒ induction of specific antibodies
‒ specific antibodies mark foreign
substances for destruction
ANTIBODIES ANTIBODIES & FOREIGN
SUBSTANCE COMPLEXESAllergy – a mistaken of the immune system
ALLERGENS
IMMUNE SYSTEM ALLERGIC IMMUNE RESPONSE TO SOME
(food, pollen, dust, venom)
FOREIGN SUBSTANCES
- different class of specific antibodies
referred as specific IgE
- IgE naturally binding to sentry cell surface
(mast cell and basophil)
- each times foreign substances bind to
specific IgE loaded on sentry cell surface
quick histamine release
+ allergic symptoms
Histamine Allergic
Release Symptoms
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLSAllergy leads to symptoms
impairing quality of life
Reduced work
productivity
Eye symptoms
Asthma
Nasal Angiodema
symptoms
Sleep deprivation
Reduced
school performance
Anaphylactic reactionAllergic Rhinitis:
up to 400 million people worldwide
Pollen Dust
Animals Mold
Bauchau V & Durham SR Eur Respir J 2004; 24: 758-764
Katelaris, C.H. et al., 2012. Clinical and experimental allergy 42(2), pp.186–207
C.F., M. & Tong Janice S.C. Lin, 2015. European Academy of Allergy and Clinical Immunology, pp. 62–63.Food allergy:
more than 200 millions people worldwide
• 15 million of American, 17 million of Europeans
suffer from food allergy1
• Increasing prevalence in both developed and
developing countries2
• Peanut, cow’s milk and egg white concern
>74% children3
• Total annual food allergy management cost
estimate/child in the US: $ 4,1844
1. Commins et al. 2016 and World Allergy Organization
2. Prescott et al. 2013
3. Scott et al. 2011
4. Gupta et al 2013Current drugs block the symptoms with no
impact on the root cause of the disease
IMMUNE SYSTEM ALLERGENS Allergic rhinitis & asthma
• $20 billion/year
• daily intake required during allergen
exposure (seasonal/perennial)
Nonspecific
immunosuppressors • no long-term effect
Intranasal steroids
Inhaled steriods
• limited effectiveness due to low
Leukotriene modifiers compliance
• >90% of the market
Food allergy
• no drugs available
• excepted epinephrine injection
IgE-specific
blockers (mAb) Antihistamines
Omalizumab Zyrtec, Xyzal, Allegra, Claritin
(Novartis/Genentech)
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLSAllergy immunotherapy (AIT) is the only treatment
targeting the root cause of the disease
IMMUNE SYSTEM ALLERGENS
Injection of high dose of allergens
regulatory cells
down regulation
• allergic immune system
(Th2 cells)
• IgE synthesis
• histamine release
REGULATORY synthesis of IgG4 & IgA
CELLS
Blocking BEST AVAILABLE TREATMENT
ANTIBODIES
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLSAIT market
< 10% of the allergy drug market
Country Sales % Market Share
€700 millions
Germany - €275 millions (39%) ALK - Abelló (33%)
Europe 78%
France - €215 millions (31%) Stallergènes (31%)
Italy / Spain = 50 millions each Allergy Therapeutics (7%) WHY SUCH A LOW
ALK - Abelló
MARKET SHARE?
USA € 90 millions 10% Hollister - Stier
Stallergènes / Greer
Japan € 5 millions
ROW €105 millions 12%
ALK - Abelló (33%)
TOTAL € 900 millions 100%
Stallergènes (28%)
Sources: Global Data “Allergic Rhinitis Immunotherapy Market 2018” (Sep-2014)
ALK-Abelló, Stallergènes and Allergy Therapeutics annual reportsCurrent allergy immunotherapy
is long and cumbersome
Year 1 Year 2 Year 3
COMPLIANCE
SCIT
Subcutaneous
SCIT 40-60
immunotherapy
Doctor visits < 25%
Daily
SLIT administration
Sublingual 180 to 360
immunotherapy days/year < 12.5%
Only ¼ patient looking for a new treatment start
immunotherapy in EuropeASIT™ technology
Active ingredients make the difference
IMMUNE SYSTEM CURRENT ALLERGENS
Current allergens activate
allergic reaction before
allergy regulation
REGULATORY
CELLS
Blocking
ANTIBODIES
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLSActive ingredients make the difference
IMMUNE SYSTEM ASIT+TM ALLERGENS
ASIT+TM induces directly
and immediately the
adequate allergy
regulation
REGULATORY
CELLS
Blocking
ANTIBODIES
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLSA straight mechanism of action
shorten the treatment
4 doctor visits in 3 weeks before each pollen season
Year 1 Year 2 Year 3
ASIT Biotech’s
proposal
ASIT biotech makes the best available allergy treatment
really attractiveASIT+™ Clinical Development
ASIT biotech pipeline: achieved milestones
Pre-clinical Phase I Phase II Phase III
Q1 2017 - Positive phase III
Grass pollen
gp-ASIT+™
Q2 2017 - Positive Phase I/II
House dust mite
hdm-ASIT+™
Launch of preclinical development program
Food
Peanut - Egg white - Cow’s milk
food-ASIT+™gp-ASIT+™
first Phase III clinical study (BTT009): positive results
TRIAL # PATIENTS PRIMARY OBJECTIVE DESIGN
‒ 2:1 (active : placebo) ‒ Clinical efficacy during pollen ‒ Double-blind
‒ 93% retention rate: 512 season based on reduction in ‒ Placebo controlled
Phase III
patients attended the the combined symptom- ‒ 67 centers in Europe
last visit medication score (CSMS)
Feedback of the PEI
• symptom and drug intake reduction statistically significant -15.5% during the peak and -17.9% over the pollen season (p more allergic patient -> improved homogeneity of the population
• higher number of clinical center -> limited number of patient/clinical center -> improved coherence of the results
• use of e-DIARY -> improved reliability of the raw data -> improved quality of the study
• one CRO supervised by M-E Pinelli M.D. responsible for the development of Zyrtec & Xyzal (UCB)hdm-ASIT+™
first in man clinical study: safety of ASIT+TM confirmed
TRIAL # PATIENTS AIM COMPLETED
‒ Assessment of the maximum tolerated ‒ Q2 2017
‒ 36 patients randomized
Phase I/IIa dose
‒ Safety and clinical tolerability
‒ Immunogenicity
‒ Impact on reactivity to a challenge test
• 27 patients treated with hdm-ASIT+™ - 9 placebo.
• safety and tolerability of hdm-ASIT+™ confirmed
• slight positive immunological and clinical impact in a limited number of treated patients
• no complementary effect after 8 months of natural allergen challenge
• 3 new product prototypes in testing by Prof. M. Shamji at ICL to select the best active ingredient before Phase II clinical
studyfood-ASIT+™
product prototypes screening on-going
PRE-CLINICAL DEVELOPMENT AIM COMPLETED
Product ‒ Selection of product candidate
prototype ex peanut, cow’s milk & egg white ‒ Q2 2018
vivo
screening
‒ ex vivo safety and tolerability
‒ ex vivo immunogenicity
• non-dilutive funding from the Walloon Region to co-finance 55% 1
• collaboration with Prof. M. Shamji (ICL), and Dr. S. Till (King’s)
• first-in-man Phase I/II trial in peanut allergy expected to be conducted from H1 2018 to end-2019
1 a recoverable cash advance granted in January 2017ASIT biotech pipeline: next milestones
Pre-clinical Phase I Phase II Phase III
gp-ASIT+™ FDA feedback - Q4 2017
Grass pollen Second Phase III Q4 2018 - Q4 2019
Selection of a new ASIT+TM active ingredient - Q1 2018
hdm-ASIT+™ Second Phase I/II clinical trial with improved prototype – Q1 2019
House dust mite
food-ASIT+™
Food Selection of ASIT+TM active ingredient for each allergen - Q2 2018
Peanut - Egg white - Cow’s milk First Phase I/II clinical trial in food - H2 2018Investment opportunity
Addressing the unmet Patients’ need!
Patient Healthcare systems Allergists
4 doctor visits Documented safety and efficacy New therapeutic option
Time & Money saving Improved acceptance More patient accepting AIT
Reduction of symptoms and Improved compliance Patients more compliant
rescue medication in the real life Improved real-life efficacy Fast onset of action
Improved quality of life Reduced direct & indirect costs Better patient follow-up
Higher patient satisfactionInvestment opportunity
Focus on moderate to severe allergic patients (respiratory & food)
Focus on improving allergy immunotherapy, the best available allergy treatment
A dedicated team supported by internationally renowned experts and institutions
A unique technology platform, ASIT+TM
• novel active ingredients
• improved safety/efficacy ratio
• applicable to pollens, mites and food (peanut, milk and egg white)
Short course treatment thanks to novel active ingredients
• improving patients acceptance and compliance
• proof of concept supported by positive Phase 3 results in grass pollen rhinitis
• straight and optimal down-regulation of the allergic reactions1
Further developments
• preparation of a second Phase 3 in grass pollen rhinitis on-going
• Selection of new product prototypes for house dust mite and food allergy
1. Shamji et al, EAACI, 2017 Oral presentationBoard of Directors
Gerd Zettlmeissl, Thierry Legon, Everard van der Straten, François Meurgey, Jean Duchateau,
Chairman of the Board CEO Director and CFO Director Director & Co-founder
Working in the biopharma & vaccine Allergist. One of the inventor of
industry since 1985 : e.g. former CEO of the 1st patents on tolerance
the Austrian-based biotech Valneva SE induction to allergy and graft
(formerly Intercell AG), chairman of the rejection, new LED tests, owned
Board of GlycoVaxyn 2013-2015, by ASIT biotech
member of the Board of Aeras
RE Finance Consulting SA, Bruservices SA (represented by Meusinvest SA (represented
Independent Director Henri De Meyer) by Marc Foidart)
(represented by Yves Désiront)Shareholder structure post-IPO
S.R.I.W.
6%
S.R.I.B.
7%
S.F.P.I.
11%
Float
Mr de Spoelberch 54%
9%
MEUSINVEST
3%
Management
4%
EPIMEDE
6%ASIT biotech on the stock market Market data Change in stock price since the IPO • Market: Euronext Brussels and Paris • IPO price: €7.00 (11/05/2016) • Current price: €4.049 (16/11/2017) • Highest: €8.399 • Lowest: €3.150 • Number of shares (fully diluted) : 13,056,600 • Average volume: 10,760 shares / day (since IPO) Stock market codes • Name: ASIT • Ticker: ASIT • ISIN code: BE0974289218
Contacts
ASIT Biotech NewCap
Thierry Legon – CEO Investor Relations & Strategic Communications
Tel.: +32 2 264 03 90 Pierre Laurent / Dusan Oresansky
investors@asitbiotech.com Tel.: +33 1 44 71 94 92
www.asitbiotech.com asitbiotech@newcap.eu
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