Investor presentation November 2017 · • symptom and drug intake reduction statistically...
Transcript of Investor presentation November 2017 · • symptom and drug intake reduction statistically...
Investor presentation November 2017
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➢ ASIT biotech pitch
➢ Market opportunity in allergy
➢ ASIT+™ Technology
➢ ASIT+™ Clinical Development
➢ Investment opportunity
We aim to restore quality of life of
millions of allergicpeople!
ASIT biotech pitch
Thierry Legon,
Co-Founder & CEOEngineer in Agronomy, MBA
Everard van der Straten,
CFO- Master’s degree, Solvay Business School
Clinical stage biopharmaceutical company focusedon the development and future commercialization of a rangeof 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 ingredientsfor 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
HEALTHY IMMUNE RESPONSE‒ protection against pathogens
(bacteria, virus, moulds, parasites) and foreign substances
‒ induction of specific antibodies‒ specific antibodies mark foreign
substances for destruction
IMMUNE SYSTEMPATHOGENS &
FOREIGN SUBSTANCES
ANTIBODIES ANTIBODIES & FOREIGNSUBSTANCE COMPLEXES
Allergy – a mistaken of the immune system
ALLERGIC IMMUNE RESPONSE TO SOME FOREIGN SUBSTANCES
- different class of specific antibodiesreferred 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
IgE ANTIBODIES
HistamineRelease
IMMUNE SYSTEMALLERGENS
(food, pollen, dust, venom)
IgE - ALLERGEN COMPLEXES ON MAST CELLS
AllergicSymptoms
+
Allergy leads to symptomsimpairing quality of life
Reduced work productivity
Eye symptoms
Nasalsymptoms
Sleep deprivation
Reducedschool performance
Anaphylactic reaction
AngiodemaAsthma
Allergic Rhinitis:up to 400 million people worldwide
Bauchau V & Durham SR Eur Respir J 2004; 24: 758-764 Katelaris, C.H. et al., 2012. Clinical and experimental allergy 42(2), pp.186–207C.F., M. & Tong Janice S.C. Lin, 2015. European Academy of Allergy and Clinical Immunology, pp. 62–63.
Pollen
Animals Mold
Dust
Food allergy:more than 200 millions people worldwide
• 15 million of American, 17 million of Europeanssuffer 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 costestimate/child in the US: $ 4,1844
1. Commins et al. 2016 and World Allergy Organization2. Prescott et al. 20133. Scott et al. 20114. Gupta et al 2013
IgE ANTIBODIES
IMMUNE SYSTEM ALLERGENS
Current drugs block the symptoms with no impact on the root cause of the disease
Allergic rhinitis & asthma
• $20 billion/year• daily intake required during allergen
exposure (seasonal/perennial)• no long-term effect• limited effectiveness due to low
compliance
• >90% of the market
Food allergy
• no drugs available• excepted epinephrine injection
NonspecificimmunosuppressorsIntranasal steroids
Inhaled steriodsLeukotriene modifiers
IgE-specificblockers (mAb)
Omalizumab(Novartis/Genentech)
AntihistaminesZyrtec, Xyzal, Allegra, Claritin
IgE - ALLERGEN COMPLEXES ON MAST CELLS
IMMUNE SYSTEM
IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS
REGULATORYCELLS
Allergy immunotherapy (AIT) is the only treatmenttargeting the root cause of the disease
Injection of high dose of allergens
regulatory cells
down regulation• allergic immune system
(Th2 cells)• IgE synthesis• histamine release
synthesis of IgG4 & IgA
BEST AVAILABLE TREATMENTBlockingANTIBODIES
ALLERGENS
AIT market< 10% of the allergy drug market
WHY SUCH A LOW MARKET SHARE?
Sources: Global Data “Allergic Rhinitis Immunotherapy Market 2018” (Sep-2014)ALK-Abelló, Stallergènes and Allergy Therapeutics annual reports
Country Sales % Market Share
Europe
€700 millions
78%Germany - €275 millions (39%) ALK - Abelló (33%)France - €215 millions (31%) Stallergènes (31%)
Italy / Spain = 50 millions each Allergy Therapeutics (7%)
USA € 90 millions 10%
ALK - Abelló
Hollister - Stier
Stallergènes / Greer
Japan € 5 millions
ROW €105 millions 12%
TOTAL € 900 millions 100%ALK - Abelló (33%)Stallergènes (28%)
Current allergy immunotherapyis long and cumbersome
Year 1 Year 2 Year 3
SCIT 40-60Doctor visits
Daily administration
180 to 360 days/year
COMPLIANCE
< 25%
< 12.5%
Only ¼ patient looking for a new treatment start immunotherapy in Europe
SCITSubcutaneous
immunotherapy
SLITSublingual
immunotherapy
ASIT™ technology
Active ingredients make the difference
IgE ANTIBODIES
IMMUNE SYSTEM
IgE - ALLERGEN COMPLEXES ON MAST CELLS
CURRENT ALLERGENS
REGULATORYCELLS
BlockingANTIBODIES
Current allergens activateallergic reaction beforeallergy regulation
Active ingredients make the difference
IgE - ALLERGEN COMPLEXES ON MAST CELLSIgE ANTIBODIES
IMMUNE SYSTEM ASIT+TM ALLERGENS
REGULATORYCELLS
BlockingANTIBODIES
ASIT+TM induces directlyand immediately the adequate allergyregulation
A straight mechanism of actionshorten the treatment
ASIT Biotech’sproposal
4 doctor visits in 3 weeks before each pollen season
Year 1 Year 2 Year 3
ASIT biotech makes the best available allergy treatmentreally attractive
ASIT+™ Clinical Development
ASIT biotech pipeline: achieved milestones
Pre-clinical Phase I Phase II Phase III
Grass pollen
Q1 2017 - Positive phase III
gp-ASIT+™
hdm-ASIT+™
Q2 2017 - Positive Phase I/II
House dust mite
Launch of preclinical development program
food-ASIT+™
FoodPeanut - Egg white - Cow’s milk
gp-ASIT+™first Phase III clinical study (BTT009): positive results
Feedback of the PEI
• symptom and drug intake reduction statistically significant -15.5% during the peak and -17.9% over the pollen season (p<0.05).
• all the results pointed to symptom improvement
• robust immunological results supporting the clinical efficacy data
• Phase III results missed the predefined 20% reduction of symptoms and drug intake
• PEI considers BTT009 study as supportive and ask for a second Phase III clinical study
• intended improvement to the next Phase III • more selective inclusion criteria -> 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)
‒ 2:1 (active : placebo)‒ 93% retention rate: 512
patients attended the last visit
‒ Clinical efficacy during pollen season based on reduction in the combined symptom-medication score (CSMS)
‒ Double-blind‒ Placebo controlled‒ 67 centers in Europe
TRIAL # PATIENTS PRIMARY OBJECTIVE DESIGN
Phase III
hdm-ASIT+™ first in man clinical study: safety of ASIT+TM confirmed
• 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 clinicalstudy
‒ 36 patients randomized‒ Assessment of the maximum tolerated
dose ‒ Safety and clinical tolerability‒ Immunogenicity ‒ Impact on reactivity to a challenge test
‒ Q2 2017
TRIAL # PATIENTS AIM COMPLETED
Phase I/IIa
‒ Selection of product candidatepeanut, cow’s milk & egg white
‒ ex vivo safety and tolerability‒ ex vivo immunogenicity
‒ Q2 2018
PRE-CLINICAL DEVELOPMENT AIM COMPLETED
Product prototype ex
vivo screening
food-ASIT+™product prototypes screening on-going
• 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 2017
ASIT biotech pipeline: next milestones
Pre-clinical Phase I Phase II Phase III
Grass pollen
gp-ASIT+™ FDA feedback - Q4 2017Second Phase III Q4 2018 - Q4 2019
hdm-ASIT+™House dust mite
Selection of a new ASIT+TM active ingredient - Q1 2018Second Phase I/II clinical trial with improved prototype – Q1 2019
FoodPeanut - Egg white - Cow’s milk
food-ASIT+™Selection of ASIT+TM active ingredient for each allergen - Q2 2018
First Phase I/II clinical trial in food - H2 2018
Investment opportunity
Addressing the unmet Patients’ need!
Patient4 doctor visits
Time & Money saving
Reduction of symptoms and rescue medication in the real life
Improved quality of life
Healthcare systemsDocumented safety and efficacy
Improved acceptance
Improved compliance
Improved real-life efficacy
Reduced direct & indirect costs
AllergistsNew therapeutic option
More patient accepting AIT
Patients more compliant
Fast onset of action
Better patient follow-up
Higher patient satisfaction
Investment 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 presentation
Board of Directors
Gerd Zettlmeissl,Chairman of the Board
Working in the biopharma & vaccine industry since 1985 : e.g. former CEO of the Austrian-based biotech Valneva SE (formerly Intercell AG), chairman of the
Board of GlycoVaxyn 2013-2015, member of the Board of Aeras
Thierry Legon,CEO
Everard van der Straten, Director and CFO
François Meurgey,Director
Jean Duchateau,Director & Co-founder
Allergist. One of the inventor of the 1st patents on toleranceinduction to allergy and graft
rejection, new LED tests, ownedby ASIT biotech
RE Finance Consulting SA, Independent Director
(represented by Yves Désiront)
Bruservices SA (represented by Henri De Meyer)
Meusinvest SA (representedby Marc Foidart)
Shareholder structure post-IPO
Float54%
EPIMEDE6%
Management4%
MEUSINVEST3%
Mr de Spoelberch9%
S.F.P.I.11%
S.R.I.B.7%
S.R.I.W. 6%
ASIT biotech on the stock market
Market data• 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 (sinceIPO)
Stock market codes • Name: ASIT
• Ticker: ASIT
• ISIN code: BE0974289218
Change in stock price since the IPO
Contacts
ASIT Biotech
Thierry Legon – CEOTel.: +32 2 264 03 90
NewCap
Investor Relations & Strategic CommunicationsPierre Laurent / Dusan Oresansky
Tel.: +33 1 44 71 94 [email protected]
www.newcap.eu